Kornimate/medical-research-clean huggingface dataset:
study of the safety, tolerability, and pharmacokinetics of once weekly zicronapine in patients with schizophrenia

Conditions: Schizophrenia

Summary: the main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.

the study includes 2 treatment periods. the open-label run-in period will begin at patient enrolment and continue for 3 weeks, during which all patients will receive once daily treatment with zicronapine. the double-blind period will begin at patient randomization and continue for 5 weeks, during which the patients will be assigned to one group receiving once daily treatment with zicronapine and 3 groups receiving once weekly treatment with zicronapine.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia according to the diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) * a score of \<=4 (moderately ill) on clinical global impression - severity of illness (cgi-s) scale * a total score \>=60 on positive and negative syndrome scale (panss) * a score of \<=4 (moderate) on panss items: p7 (hostility) and g8 (uncooperativeness) exclusion criteria: * acute exacerbation requiring hospitalization within the last 3 months or requiring change of antipsychotic medication within the last 4 weeks * diagnosis or history of substance dependence or substance abuse according to dsm-iv-tr within the last 3 months * significant risk of harming himself/herself or others * positive serology for hepatitis a, b, c, or hiv * present condition that might compromise liver function * medical or neurological disorder or treatment that could interfere with study treatment or compliance * previous exposure to zicronapine other inclusion and exclusion criteria may apply.

Keywords: schizophrenia antipsychotic zicronapine lu 31-310
caregiver protocol for remotely improving, monitoring, and extending quality of life

Conditions: Stress; Quality of Life; Sleep Disturbance

Summary: the purpose of this study is to test an intervention to improve health promoting behaviors in family caregivers of patients receiving cancer therapy


Eligibility criteria:
inclusion criteria: * eligible family caregivers will be: * an unpaid family member or friend who provides assistance and support with healthcare of a non-institutionalized patient receiving some form of treatment for stage iii or iv colorectal cancer at moffitt cancer center * age 18+ years * english or spanish speaking * able to complete questionnaires and engage in short discussions with coaches * able to identify a primary care medical provider * willing/able to use a mobile device provided by the study team or their own their device. exclusion criteria: * participants who do not meet the study inclusion criteria

Keywords: family caregiver well-being
a study of avelumab in combination with axitinib in advanced hcc (vegf liver 100)

Conditions: Carcinoma, Hepatocellular

Summary: to evaluate the safety, efficacy and pk of avelumab in combination with axitinib as first line treatment in patients with advanced hcc


Eligibility criteria:
inclusion criteria: * diagnosis of locally advanced or metastatic hcc, obtained by histology/cytology (on a prior tumor biopsy) or by imaging with serum α-fetoprotein (afp) ≥400 ng/ml. * all patients must provide at least 1 archival tumor specimen. if archival tumor specimen is no longer available, de novo tumor biopsy will be required during screening. * hcc not amenable to local therapy. * measurable disease according to recist v. 1.1. * child pugh class a disease. * bclc stage b or c disease. * no evidence of uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. * ecog performance status 0 or 1. * adequate bone marrow function, renal and liver functions * left ventricular ejection fraction (lvef) ≥ lower limit of normal (lln) as assessed by multigated acquisition (muga) scan or echocardiogram (echo). exclusion criteria: * prior systemic treatment for advanced hcc, including prior treatment with approved or investigational drugs. * any prior locoregional therapy within 4 weeks and radiotherapy or surgical procedure within 2 weeks (4 weeks for major surgery) of enrollment. * patients with known symptomatic brain metastases requiring steroids. * presence of hepatic encephalopathy (ie, child pugh score of 2 or 3) and/or clinically relevant ascites (ie, child pugh score of 3). * presence of main portal vein invasion by hcc. * any of the following within the 12 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, lvef less than lln, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack. * active infection requiring systemic therapy except for hepatitis c virus (hcv) and hepatitis b virus (hbv).

Keywords: cancer hepatocellular carcinoma liver disease avelumab axitinib
effects of akpharma's calcium glycerophosphate nasal spray wash

Conditions: Allergic Rhinitis

Summary: over 20 million americans have allergic nasal symptoms including stuffiness, sneezing and a "runny" nose. akpharma's calcium glycerophosphate used as a nasal spray wash is believed to improve these symptoms without side effects common to over the counter and prescription medication. it is hypothesized that calcium glycerophosphate will have a perceived improvement in breathing comfort.

subjects will be screened for inclusion and exclusion criteria and consented if they fit the same criteria. they will be instructed on keeping a nasal diary of symptoms "runny, itchy, congestion, sneezing, voice changes and throat clearing". they will have blood drawn for allergy testing. after a 1 week run-in, subjects will return their diary. if they still qualify based on the diary they will have baseline labs drawn and baseline breathing test (spirometry) performed. they will also have a nasal wash and specimen collection performed. they will be instructed on use of the nasal wash. there will be three more weekly visits before study conclusion which will include diary submission, spirometry and nasal wash and specimen collection. on the final visit blood will again be collected as well.

Eligibility criteria:
inclusion criteria: * male or female 18-80 years of age * twelve months or more of allergic rhinitis symptoms * allergic antibodies to perennial aeroallergens to be confirmed by blood draw exclusion criteria: * intranasal or systemic glucocorticosteroids within one month of study entry * intranasal cromolyn for 2 weeks prior to study * intranasal or systemic antihistamine for 3 days prior to the study * loratadine for ten days prior to study * history of rhinitis medicamentosa * planned travel outside the study area that will inhibit study follow-up visits _persons with asthma with more than 2 episodes per week or month of nighttime awakenings * persons with known sensitivity to calcium or phosphorus supplements * persons taking antihistamine treatment intermittently. (chronic steady use throughout study is acceptable) * immunomodulatory or cytotoxic drugs * clinically significant uncontrolled disease that in the opinion of the investigator would put the subject at risk or may confound the study interpretation * persons with hypercalcemia * persons whose nasal obstruction(s) would be significant to obstruct air flow * persons who are employees of investigator or akpharma or whose spouse, parent, child or sibling is employee of investigator * pregnant persons or persons planning to conceive/inseminate partner during study or for one month after

Keywords: rhinitis stuffy nose congestion sneezing
a study of ro5045337 in patients with solid tumors

Conditions: Neoplasms

Summary: this open-label, randomized, cross-over study will evaluate the effect of food on the pharmacokinetics of single oral doses of ro5045337 in patients with solid tumors. the anticipated time on study treatment is 3 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * histologically confirmed solid tumor * life expectancy of \>/=12 weeks * ecog performance status of 0 or 1 * adequate bone marrow, renal and hepatic function exclusion criteria: * patients receiving any other investigational agent or therapy administered with the intention to treat their malignancy within 28 days prior to study start * patients with pre-existing gastro-intestinal disorder * patients with uncontrolled intercurrent illness
global hemostatic methods in hemophilia and von willebrand's disease

Conditions: Hemophilia A; Hemophilia B; Von Willebrand's Disease

Summary: patients with hemophilia who have the same level of deficient factor(s) may express different severity of clinical presentation and bleeding tendency. therefore a test which could determine overall hemostasis rather than simple concentration of a single deficient factor may correlate better with clinical phenotype in these patients. the investigators will therefore study the usefulness of global hemostatic methods (endogenous thrombin potential (etp), overall hemostatic potential (ohp), fibrin clot structure) and microparticles in the prediction of severity of bleeding and estimation of response to the treatment in patients with hemophilia. since hemophilia patients on prophylactic treatment virtually do not bleed, additional patients who are treated on demand only will be included enabling to study possible modulatory effects of different hemostatic factors (particularly prothrombotic and thrombin activatable fibrinolysis inhibitor (tafi)) on clinical presentation. the investigators will correlate both those factors and clinical severity with global hemostatic methods. the investigators expect to prove that individual tailoring of the treatment, which may enable lowering the prophylactic dose of factor concentrate without increasing the risk of bleeding, is justified in some hemophilia patients. this approach would reduce the amount of necessary factor concentrate in certain patients and decrease the cost (which represents extensive burden for health care systems) of treatment without potential risk for the patients.


Eligibility criteria:
inclusion criteria: * patients with bleeding disorders exclusion criteria: * none

Keywords: hemophilia a hemophilia b von willebrand's disease endogen thrombin potential overall hemostatic potential microparticles fibrin clot
clinical study on prostate thermal vapor ablation guided by mri/trus fusion imaging

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: objective of the clinical trial the objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under mri/turs guidance. the primary questions it aims to address are: can precise prostate thermal vapor ablation under mri/turs guidance effectively treat benign prostatic hyperplasia (bph) and alleviate lower urinary tract symptoms (luts)? what safety issues may arise in participants after undergoing prostate thermal vapor ablation? study procedures participants preoperative evaluation: participants will undergo comprehensive preoperative assessments, including clinical examinations and laboratory tests. procedure: participants will receive precise prostate thermal vapor ablation under mri/turs guidance. postoperative follow-up: regular follow-up to reassess prostate volume. periodic completion of the international prostate symptom score (ipss) questionnaire. regular measurement of maximum urinary flow rate (qmax) and post-void residual urine volume (pvr). research team the research team will conduct precise prostate thermal vapor ablation under mri/turs guidance for the participants and manage their follow-up assessments.


Eligibility criteria:
inclusion criteria: * age 45-85 years; * international prostate symptom score (ipss) ≥ 8, indicating moderate to severe lower urinary tract symptoms (luts) that significantly impact quality of life; * poor response to pharmacological treatment or refusal of pharmacological treatment; * prostate volume 30-80 ml; * maximum urinary flow rate (qmax) \< 15 ml/s; * post-void residual urine volume (pvr) \< 300 ml; * willingness to provide informed consent and participate in postoperative follow-up. exclusion criteria: * prostate volume \ 80 ml; * severe urinary tract infection; * preoperative definitive diagnosis of prostate cancer; * known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-bph causes of urinary obstruction; * patients with prostatitis; * history of invasive prostate interventions, such as radiofrequency ablation, laser therapy, or microwave treatment; * patients with severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, hepatic or renal dysfunction, or systemic bleeding disorders, as assessed by the investigator to be unsuitable for surgery.

Keywords: benign prostatic hyperplasia rezum mri-trus
evaluating the safety of shortened infusion times for different oncological immunotherapie

Conditions: Oncology; Infusion Reaction

Summary: this study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile. infusion times will be gradually shortened if tolerability allowes.

after two cycles with normal infusion times, infusion time will be shortened to 15 mintues en 10 minutes subsequently if no infusion reaction occurs. patient satisfaction will be evaluated.

Eligibility criteria:
inclusion criteria: * starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab. * 18 years and older. * no known history of increased susceptibility to immunological reactions. * subject is able and willing to sign the informed consent form prior to screening evaluations. exclusion criteria: * other research medication within 4 weeks of the start of the study. * inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions * dosage deviates from standard protocol * patients whom receive drugs through a central venous catheter (and for example porth-a-cath).
safety and efficacy of the coronavirus disease 2019 vaccine in hemodialysis patients

Conditions: Coronavirus Disease 2019 Vaccines; Renal Dialysis

Summary: it is unknown whether coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy. objectives: to evaluate the safety and efficacy of coronavirus disease 2019 vaccines in hemodialysis patients.

given the vulnerability of people with chronic kidney disease to coronavirus 2019 , leading nephrology societies such as the national kidney federation and the american kidney foundation have issued statements calling for prioritization of these patients for vaccination. it is unknown whether coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy. objectives: 1. estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a coronavirus disease 2019 vaccine 2. determine the levels of immunoglobulin g antibodies in patients who received a coronavirus disease 2019vaccine between the time before the first dose, at 21 days, at 40 days and at 120 days after immunization. methods design: multicenter, observational and analytical study of a prospective cohort of hemodialysis patients 18 years and older who received immunization with a coronavirus disease 2019 vaccine in the autonomous city of buenos aires in a vaccination plan. analysis the proportion of patients with adverse events presumably attributable to vaccination and immunization will be estimated with its 95% confidence interval. the immunoglobulin g titer for coronavirus type 2 causing severe acute respiratory syndrome will be compared using generalized estimating equations models.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age on hemodialysis in an immunization plan with a coronavirus disease 2019 vaccine. exclusion criteria: * contraindication to receive the vaccine.

Keywords: seroepidemiologic studies renal dialysis coronavirus disease 2019 vaccines
a study of lintuzumab (sgn-33) in combination with low dose cytarabine in patients 60+ years with aml

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with aml.


Eligibility criteria:
inclusion criteria: * untreated aml that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder. * after being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for aml. * at least 20% blasts in blood or marrow. * must have a minimum of 50% leukemic blasts that express cd33. * ecog performance status score of 0 to 2. * wbc less than 30,000/µl exclusion criteria: * no known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia. * no other active systemic malignancies treated with chemotherapy within the last 12 months. * must not have received previous chemotherapy (except hydroxyurea) for aml. * must not have significantly abnormal kidney or liver disease. * must not have known human immunodeficiency virus (hiv).

Keywords: lintuzumab antigens, cd33 antibodies, monoclonal leukemia, myeloid, acute hematologic diseases leukemia
a pilot study of sorafenib examining biomarkers in refractory or relapsed t-cell lymphoma patients

Conditions: T Cell Lymphoma

Summary: this study will be a pilot study of sorafenib 400mg po twice daily in refractory t-cell lymphomas including peripheral t-cell lymphoma (ptcl), angioimmunoblastic lymphadenopathy (aild), cutaneous t cell lymphoma (ctcl), anaplastic large cell lymphoma (alcl) and other transformed t-cell lymphomas with the primary objective of studying the biological effects of the multikinase inhibitor, sorafenib.

primary objectives: • to study the biological effects of sorafenib 400mg bid on the mitogen-activated protein kinase (mapk) pathway, specifically the inhibition of extracellular signal-regulated kinases (erk) phosphorylation, and to correlate with clinical activity in patients with t-cell lymphoma. secondary objectives: * to observe the clinical activity of sorafenib 400mg bid by determining response rate, and progression free survival in patients with t-cell lymphoma. duration of response and duration of stable disease will also be measured. * to determine the tolerability of sorafenib in patients with t-cell lymphoma. exploratory objectives: * to observe the effects of sorafenib on t-cell subsets (cd4/cd8 ratio, and tregs), and the effects of sorafenib on the monocytoid population. * to observe the effects of sorafenib on the serum cytokine profile. * to observe the effects of sorafenib on the t-cell receptor pathway, i.e. lck, zap-70, and syk. * to observe changes in lymph node or skin morphology including tumor cell infiltrate, vasculature, and the tumor microenvironment in patients treated with sorafenib by performing serial biopsies of lymph nodes or skin.

Eligibility criteria:
inclusion criteria: * histologically confirmed t-cell lymphoma including ptcl, aitl, ctcl, alcl (alk+, and alk-), and other transformed t-cell lymphomas * age \> 18 years old * measureable disease, as defined by the cheson criteria * ecog performance status of 0 or 1 * life expectancy \> 12 weeks * adequate bone marrow, liver and renal function * patients with hemoglobin \< 8.5g/dl, or anc 500-1000/mm3, or platelets 50,000-75,000/mm3 (grade 3), whose cytopenias are due to bone marrow involvement by t-cell lymphoma will also be eligible exclusion criteria: * prior treatment with sorafenib, or other agents with similar activity, i.e. bevacizumab, imatinib, sunitinib. * prior treatment with allogeneic stem cell transplant * cardiac disease: congestive heart failure \> class ii nyha.

Keywords: relapsed or refractory t cell lymphoma
personal protective equipment for the prevention of sars-cov-2 during neonatal resuscitation

Conditions: Neonates Needing Resuscitation at Birth

Summary: there has been an increasing number of sars-cov-2 infections in pregnant women and neonates. interventions including open airway suctioning, positive pressure ventilation, non-invasive respiratory support, tracheal intubation, and endotracheal drug administration are aerosol-generating medical procedures and may create a risk to the unprotected healthcare providers. the impact of using personal protective equipment during neonatal resuscitation maneuvers is unknown. the objective of this study will be to compare the beginning of ppv and the duration of intubation between performing resuscitation with ppe for the prevention of sars-cov-2 infection and resuscitation without ppe for the prevention of sars-cov-2 infection.


Eligibility criteria:
inclusion criteria: * level iii neonatal intensive care unit consultants, pediatric residents, and nurses. participants will be divided into teams including a consultant and a nurse or a resident and a nurse during the simulation. exclusion criteria: * there are no exclusion criteria for this study.
precision immunology to determine the immune response in patients with covid-19

Conditions: SARS-CoV 2; COVID

Summary: to better understand the immune response to sars-cov-2 infection, we devised a precision immunology approach to systematically study the immune function of different patient cohorts


Eligibility criteria:
inclusion criteria: * sars-cov2 positive pcr exclusion criteria: * pregnancy
chronic pelvic pain in females and males

Conditions: Pelvic Pain Syndrome; Sacroiliac Disorder; Piriformis Syndrome; Sacrococcygeal Disorder; Inguinal Hernia

Summary: pelvic pain is under-reported in healthy adults. many patients with pelvic pain under-estimate the problem. chronic pelvic pain can be managed properly, if diagnosed promptly. this is a quantitative analysis of prospective clinical data. it evaluates the management of pelvic pain in a cohort population, and analyzes the treatment outcome.

pelvic pain is common, but under-reported in healthy adults. pelvic pain is reported more commonly in women than in men. many patients with pelvic pain under-estimate the severity of the problem. chronic pelvic pain can be managed successfully, if diagnosed properly. many combinations of multimodal analgesia and rehabilitation therapy may be safe and effective for pelvic pain. this study is a quantitative analysis of prospective clinical data. it is an evaluation of the prevalence and management of pelvic pain in a cohort population of chronic pain patients. this is an analysis of multimodal analgesia types, rehabilitation therapy types, treatment outcome, and complications.

Eligibility criteria:
inclusion criteria: * patients with chronic pelvic pain * patients with sacroiliac pain * patients with inguinal pain * patients with coccygeal pain * patients with piriformis pain exclusion criteria: * patients with spinal pain * patients who had spine surgery

Keywords: pelvic pain