Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of fixed doses of bms 820836 in the treatment of patients with treatment resistant major depression

Conditions: Depression

Summary: the purpose of the study is to evaluate the efficacy of study drug (bms-820836) as compared with continued duloxetine/escitalopram in the treatment of patients with treatment resistant depression (trd).


Eligibility criteria:
inclusion criteria: * men and women of age 18-65 years (argentina minimum age will be 24 years of age) * patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use. * patients with a diagnosis of major depressive disorder, currently experiencing a major depressive episode, as defined by diagnostic and statistical manual of mental disorders- fourth edition (text revision)\[dsm iv tr\] criteria. the current depressive episode must be \> 8 weeks in duration and \< 3 years duration. * in the current major depressive disorder (mdd) episode, patients should report a history of inadequate response to 1-3 adequate trials of antidepressant treatment. * patients must have a 17-item hamilton depression rating scale (ham-d17) total score ≥ 18 at screening and baseline. exclusion criteria: * patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode. * patients who have failed duloxetine and escitalopram at an adequate dose and for an adequate duration in their current episode.
neonatal estimation of brain damage risk and identification of neuroprotectants

Conditions: Brain Damage, Chronic

Summary: neobrain brings together small and medium sized enterprises (smes), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. the focus of neobrain is to identify strategies prevention of brain damage mainly observed in preterm newborns. (copy from www.neobrain.eu)


Eligibility criteria:
inclusion criteria: * gestational age \< 28 weeks
trial to increase fep attendance

Conditions: First-Episode Psychosis

Summary: individuals with first-episode psychosis (fep) are at high-risk for several poor functional and clinical outcomes, including suicide. coordinated specialty care (csc) is a multidisciplinary, team-based intervention known to improve such outcomes, including suicide risk. however, 30-50% of patients disengage from csc, thereby limiting its impact. this pilot study will develop and test feasibility of a behavioral change program that uses moderate financial incentives to encourage treatment engagement in 2 csc programs. a single-arm of 80 patient-participants at these two clinics will be recruited to assess feasibility and acceptability from patient perspectives. additionally,15 clinicians at these two clinics will be recruited to assess feasibility and acceptability from clinician perspectives, and 50 clinicians from peer clinics not involved in the intervention will be recruited to assess scalability of the intervention. the trial will feature an three-month period for recruitment and baseline data collection and will subsequently feature three intervention periods (3 months each) where modifications to the interventions will be tested (each informed by the feasibility and acceptability findings of the prior period) with the aim of sequentially improving it.


Eligibility criteria:
inclusion criteria: 1. for all participants, age ≥ 18 years old. 2. for intervention trial and patient feasibility and acceptability measurement: patients with first-episode psychosis, enrolled in coordinated specialty care at the psychosis education, assessment, care and empowerment (peace) clinic and psychosis evaluation and recovery center (perc). 3. for clinician feasibility and acceptability measurement at intervention sites: clinicians working at peace and perc where the intervention will be piloted. 4. for clinician implementation facilitator and barrier assessment at other connection lhs sites to assess for scalability: clinicians in connection lhs who work at sites other than peace and perc.participants must sign the informed consent form exclusion criteria: 1. for intervention trial and patient feasibility and acceptability measurement: expectation of leaving coordinated specialty care programing within 6 months (which will exclude all of the pi's patient panel) and/or intellectual disability of sufficient degree that the patient's primary psychiatrist expects to compromise capacity to consent to this research and/or psychosis secondary to another medical condition (which may not share the same motivational features that are otherwise understood about the primary psychiatric conditions with psychosis). 2. for clinician feasibility and acceptability measurement at intervention sites: study investigators who work at these clinics will be excluded from participation in the feasibility and acceptability study component given their role in the trial planning and execution. 3. for clinician implementation facilitator and barrier assessment at other connection lhs sites to assess for scalability: none.
the impact of nbp on the collateral circulation in ica/m1 occlusion

Conditions: Cerebrovascular Occlusion; Collateral Blood Circulation; Anterior Cerebral Circulation Infarction

Summary: stroke is the first leading cause of death in china, and is responsible for almost 22.4% of deaths. in approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of blood flow to part of the brain from an acute arterial occlusion. survival of penumbral tissue distal to an arterial occlusion depends on collateral circulation via the circle of willis and leptomeningeal anastomises. collateral flow is dynamic and failure is associated with infarct growth. the presence of adequate collaterals has been shown to be associated with age, history of statin use, and non-hypertension. dl-3-n-butylphthalide (nbp), isolated from the seeds of celery, and found to exert protective effects against ischemic brain and increase leptomeningeal blood flow. this study investigate whether nbp injection prescribed during acute stroke will have a significant effect to improve collateral circulation in patients of anterior circulation occlusion.


Eligibility criteria:
inclusion criteria: 1. men or women ≥ 18 years old; 2. acute occlusion of m1 or intracranial internal carotid artery within 72 hours; 3. for patients who receive recombinant tissue-type plasminogenactivator therapy, the arterial occlusive lesion scale of 24-72 hours post-thrombolysis imaging should be 0 or 1; 4. ischemic stroke with national institutes of health stroke scale ≥ 4; 5. baseline mrs before this stroke onset less than 2; 6. able and willing to comply with study requirements; 7. signed informed consent by patients self or legally authorized representatives. exclusion criteria: 1. cerebral hemorrhage; 2. posterior circulation infarction; 3. severe tendency of hemorrhage, such as thrombocytopenia, leukemia, allergic purpura; 4. currently using urinary kallidinogenase or alprostadil; 5. be allergic to nbp or celery; 6. impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl); 7. patients with evidence of severe congestive heart failure or history of end-stage cardiovascular disease (e.g. congestive heart failure new york heart association class iii or iv); 8. metastatic neoplasm or multiple organ failure; 9. pregnancy or breastfeeding; 10. history of mental instability or dementia.
density lowering effect of "ofs add on to tmx"(delfino trial)

Conditions: Breast Cancer Invasive

Summary: delfino tial is designed to investigate the role of "ofs add on to tmx ", based on mmg density as a surrogate marker in premenopausal women * premise - mmg density as a surrogate marker of hormone therapy * assumption - "add on ofs to tmx" would have further decrease of density * 3-arm(observation arm + randomised 2-arm), phase iii, rct with 1:1 allocation

enroll : sep03,2018\~(planned n= 224) 1. inclusion criteria * premenopausal * er+ * planned tamoxifen(tmx) * no planned ovary function suppression(ofs) * regardless of chemotx * mammography(mmg) density check via volpara\*(=baseline mmg density, bamd) (\*volpara= software to check mmg density) 2. check mmg density via volpara after 1yr tmx (at1yrmd) check menopausal status after 1yr tmx(menstruation episode or fsh \<30) 3. mmg density reduction(mdr =bamd-atmd ) at 1yr 4. mdr ≥5% -\> keep go on tmx mdr \ 1:1 randomization -\> keep go on tmx vs ofs add on to tmx 5. analysis : 5yr mdr (1'endpoint), 5yr dfs(2'endpoint), 5yr os 6. calculation of patients' number in previous study(\ ) mdr (mammography density reduction) was found in about 50% of all patients who received endocrine therapy. expected * mdr in "tmx only" cohort -\> 6 ± 7% * mdr in "ofs add on to tmx" -\> 10 ± 7% * after 1yr, significance level 5%, average mdr 4% difference, 80% power, 10% dropout rate =\> 1:1 randomization number = 112(56:56) total number = 224

Eligibility criteria:
inclusion criteria: * premenopausal women, er+ breast cancer, stage i\~iii, underwent standard treatment including surgery, planned tmx * available mmg density check via volpara exclusion criteria: * bilateral breast cancer * prior endocrine therapy * postmenopausal status * unavailable mmg density check via volpara before and after tmx

Keywords: premenopausal women, mmg density, ovary function suppression
evaluating immune function tests in people with hiv

Conditions: HIV Infections

Summary: some people's immune systems are able to control hiv infection without anti-hiv drugs. other people with hiv must take drugs to prevent the virus from destroying their immune systems. there are many different laboratory tests that measure immune function in people with hiv. this study will compare some of these tests to see if they consistently measure differences between people who control the hiv without anti-hiv drugs and those who must take drugs.

the efficiency of the immune response to hiv antigens is the critical feature that allows some individuals with chronic hiv infection to maintain low level viremia (less than 3000 copies/ml). the fundamental measurement of this response is the steady state level of viremia in the absence of antiretroviral drugs. however, using this clinical endpoint in vaccine and drug trials is time-consuming. several laboratory assays of hiv t cell function have been developed to measure the key characteristics of an efficient immune response. this study will evaluate these assays in two distinct patient populations. two patient cohorts will be followed in this study. cohort a will enroll patients who are stable on highly active antiretroviral therapy (haart). these patients will have been on the same haart regimen for at least 9 months prior to study entry. cohort b will enroll patients with chronic hiv infection and efficient immune control. these patients will have not been on any antiretroviral drugs for at least 6 months and will have viral loads less than 3,000 copies/ml. participants in both cohorts will have blood drawn at study entry and weeks 12 and 24. blood samples will be used for cd4/cd8 cell count, plasma hiv-1 rna, and immunologic assays.

Eligibility criteria:
inclusion criteria for cohorts a and b: * hiv-1 infection * cd4 cell count \> 300 cells/mm3 within 60 days prior to study entry * negative pregnancy test within 14 days of starting study * agree to use acceptable methods of contraception while in study inclusion criteria for cohort a (stable haart) only: * stable haart regimen, defined as the suppression of viral load to undetectable levels, for at least 9 months prior to study entry * viral load \< 75 copies/ml on at least three occasions within 9 months prior to study entry, with at least one of these values obtained between 6 and 9 months prior to study entry * no single viral load \>= 75 copies/ml within 9 months prior to study entry inclusion criteria for cohort b (efficient immune control) only: * not taking any antiretroviral drugs for at least 6 months prior to study entry * meets study definition of efficient immune control (generally hiv-1 viral load \< 3,000 copies/ml, with some exceptions) exclusion criteria: * pregnancy or breast-feeding * active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements * history of an aids-defining opportunistic infection

Keywords: treatment experienced antiretroviral therapy, highly active hiv antigens cohort studies immunity, cellular t-lymphocytes
contrast-enhanced spectral mammography (cesm)

Conditions: Breast Cancer

Summary: the study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (cem) , considering as reference the classification obtained with vacuum assisted breast biopsy (vabb).

breast cancer is the most diagnosed cancer in women and is one of the leading causes of morbidity and death from malignancy. improvement in survival and quality of life of patients with breast malignancies depends on the ability of imaging to diagnose the neoplasm in its early stages. the main focus of imaging applied to the study of the breast is to obtain a good balance between the number of false positives and false negatives in the prediction of malignancy: good diagnostic performance should be achieved in identifying even small and insidious neoplasms without requiring excessive examinations for benign findings. the main diagnostic method of screening for breast malignancy still remains mammography also considering its quick execution and low cost: however as is well known the diagnostic performance of mammography is highly impaired, in patients with dense breasts. the reduced sensitivity of mammography in women with dense breasts can result in a significant underdiagnosis rate, failing to prevent death due to breast cancer in a non-negligible number of women. the sensitivity of mammography is reported in the literature as between 62-68% in dense breasts: such performance is far too low to ensure adequate support in the management of breast malignancy; supplemental screening should be recommended in women with dense breasts. for this purpose, a diagnostic technique called contrast-enhanced mammography (cem) has been developed in recent years: cem is based on the use of an iodinated contrast medium to assess the vascularity of any breast lesions and its first use was approved in 2011 by the food and drug administration (fda). the diagnostic performance of cem in detecting and predicting the malignancy of breast lesions has been evaluated in many studies that have shown very promising result: cem seems to provide excellent performance, particularly where conventional diagnostic methods seem to be struggling: the low sensitivity of mammography in dense breasts; the high operator dependence of breast ultrasound; the high cost, the high number of false positives and the time required to perform magnetic resonance imaging (mri). the purpose of this studt is to assess the diagnostic performance of recombined cem image, in predicting malignancy of breast lesions in a population mainly represented by patients with dense breasts.

Eligibility criteria:
inclusion criteria: * patients with breast lesions, who underwent bilateral cem * histological assessment exclusion criteria: * the subject is known to have risks of adverse effects with iodine contrast agents * the subject has breasts too large to be adequately positioned on full field digital mammography (ffdm) digital receptor without anatomical cut off during an ffdm examination

Keywords: mammography enhancement contrast enhanced mammography
a study of volociximab in metastatic melanoma

Conditions: Stage IV Melanoma

Summary: this is a phase 2, multicenter, research study determining the effects of an investigational drug called volociximab in metastatic melanoma. the purpose of the study is to compare the clinical benefit and safety of volociximab. pharmacokinetics and mechanism of action will also be evaluated.


Eligibility criteria:
inclusion criteria 1. must give written informed consent and any authorizations required by local law (e.g., protected health information \[phi\]). 2. aged \>=18 years old at the time of informed consent. 3. stage iii and stage iv unresectable melanoma with documented progression during or following the most recent prior melanoma therapy. 4. must have failed at least 1 prior therapy for metastatic disease. 5. must have at least 2 cutaneous, subcutaneous, or nodal metastases that are safely accessible for pre treatment and post treatment biopsies. 6. must agree to pre-treatment and post-treatment biopsies of tumor lesions (subjects in stage 1 only). 7. must have at least 1 measurable target lesion for ct/mri assessment, according to recist criteria. 8. ecog performance status \<=1. 9. acceptable laboratory results 10. life expectancy \>=12 weeks. 11. male subjects and female subjects of child bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after last infusion of study treatment. exclusion criteria 1. subjects with any other active malignancy in addition to metastatic melanoma. 2. cns metastases, unless stable for at least 2 months following definitive local therapy (surgery, stereotactic radiation). subjects may not require treatment with steroids or anticonvulsants. 3. history of any other significant medical condition, including cardiovascular, pulmonary, neurologic, or autoimmune disease; active infections (e.g., bacterial or fungal); or a psychiatric condition within 6 months of day 1 4. history of hepatitis b or c. 5. known history of hiv infection or aids. 6. history of thromboembolic or cerebrovascular events, such as stroke, transient ischemic attack, deep vein thrombosis, or bleeding disorders within 12 months prior to day 1. 7. prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy for melanoma within 4 weeks prior to day 1. 8. previous exposure to volociximab. 9. aspirin, high dose warfarin, or heparin use. (note: aspirin \<=81 mg/day, low-dose warfarin 1 mg/day or low-dose heparin for iv catheter patency is allowed.) 10. major surgery within 4 weeks prior to day 1. 11. requirement for immunosuppression, and/or systemic steroid therapy. 12. investigational therapies within 4 weeks prior to day 1 or 4 half lives of the prior investigational drug (whichever is longer). 13. known hypersensitivity to murine or chimeric antibodies. 14. any condition that, in the opinion of the investigator, makes the subject unsuitable for study participation. 15. female subjects who are pregnant or currently breastfeeding.

Keywords: melanoma antibody angiogenesis volociximab
unblinded data collection study of concussion using brainpulse

Conditions: Concussion, Intermediate

Summary: this is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years old) in collegiate sports. the cohorts are defined in accordance to the athlete's exposure of injury. all subjects will complete a minimum of one recording based on their assigned cohort. concussed athletes will complete an additional 3 weeks of follow-up recordings post injury. the symptomatic evaluation, physical examination, neurological baseline testing, and brainpulse recordings will be entered in a database to determine clinical outcome and assess device utilization.

cohort i is defined as all enrolled athletes at the university of wyoming and is divided into two sub-cohorts: cohort ia include all athletes participating in division 1 athletics; cohort ib are athletes subscribed to the head health network. cohort ii is defined as all injured athletes participating in the teams and includes two sub-cohorts: cohort iia is defined as non- concussed injured athletes; cohort iib concussed athletes per reference standard.

Eligibility criteria:
inclusion criteria: 1. male or female young athletes between ages 18-28 yrs 2. enrolled at the university of wyoming and currently participating in division 1 athletics 3. completed the following baseline testing: sway balance, king-devick, c3-logix 4. willing and able to participate in all study evaluations and allow access to medical testing and records 5. signed informed consent, or have a legally authorized representative willing to provide informed consent on behalf of the subject if the subject is a minor exclusion criteria: 1. prior concussion diagnosed by a physician in the last 2 weeks assessed via interview with athlete (not including a recent concussion within the last 3 days) 2. any serious medical, social or psychological condition that in the opinion of the investigator would impair ability to provide informed consent or otherwise disqualify a patient from participation
the efficacy and safety of abt-493/abt-530 in adults with chronic hepatitis c virus genotype 4, 5, or 6 infection (endurance-4)

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (svr12) after 12 weeks of treatment with abt-493/abt-530 and to evaluate the safety of the regimen in participants with chronic hepatitis c virus (hcv) genotype (gt) 4, 5, or 6 infection.


Eligibility criteria:
inclusion criteria: 1. screening laboratory result indicating hepatitis c virus (hcv) genotype (gt) 4, 5, or 6 infection. 2. chronic hcv infection. 3. hcv treatment-naïve or treatment experienced (interferon \[ifn\] or pegylated interferon \[pegifn\] with or without ribavirin \[rbv\]; sofosbuvir \[sof\] plus rbv with or without pegifn). 4. non-cirrhotic participants. exclusion criteria: 1. history of severe, life-threatening or other significant sensitivity to any excipient of the study drugs. 2. female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. 3. recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 4. positive test result at screening for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab). 5. co-infection with more than one hcv genotype.

Keywords: hepatitis c genotype 4 hepatitis c chronic hepatitis c hepatitis c genotype 6 hepatitis c genotype 5