Kornimate/medical-research-clean huggingface dataset:
ags-1c4d4 in patients with advanced hormone refractory prostate cancer

Conditions: Prostate Cancer

Summary: the present study will investigate the safety, tolerability and spectrum of side effects of ags-1c4d4. as such, this study will characterize the dose limiting toxicities (dlt) and potentially the maximum tolerated dose (mtd) of ags-1c4d4 in patients with advanced hrpc.

cohorts of 1-6 patients will be administered ags-1c404 in sequentially rising dose levels. dose escalation will continue until the mtd of ags-1c4d4 is established or the maximum planned dose is reached.

Eligibility criteria:
inclusion criteria: * patient has hormone-refractory metastatic prostate cancer exclusion criteria: * patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects * patient is currently participating or has participated in an investigational study within the past 30 days * patient has illness or circumstance that could limit compliance with the study requirements * patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year * patient has hepatitis b or c

Keywords: hrpc advanced hormone refractory prostate cancer
assessment of maximal oxygen uptake in cardiac rehabilitation

Conditions: Oxygen Consumption

Summary: to advance the methodology for evaluating persons with heart disease and their maximal oxygen uptake, the primary aim of this study is to investigate the occurrence of a plateau in oxygen uptake. this plateau will be examined for the purpose of assessing vo2 max in persons enrolled in exercise-based cardiac rehabilitation. furthermore, this study aims to investigate the age-related respiratory exchange ratio, and rating of perceived exertion, and describe their association with the presence of a plateau. heart disease and characteristics for all participants are obtained. participants underwent a maximal exercise test on an ergometer cycle with direct measurement of oxygen uptake to assess oxygen plateau attainment. this included measurement of the maximal oxygen uptake, respiratory exchange ratio, heart rate and the ratio of perceived exertion (borg6-20).

oxygen uptake is measured breath-by-breath by a cardiopulmonary exercise test (cpet), and oxygen and carbon dioxide sensors were calibrated before each test along with the flow sensor, there was calibrated with a 3-litre syringe. to examine the primary aim, the incidence of a plateau in oxygen uptake was examined by comparing the moving average of the last 15 consecutive breaths with the penultimate 15 breaths and cut-offs at \<50 ml and \<100 ml of oxygen. secondary criteria; respiratory exchange ratio (rer max), rating of perceived exertion (borg rpe max) and heart rate (hr max) are examined to determine if the participant performs the exercise test with a maximal effort to exertion. the respiratory exchange ratio (vco2/vo2) using age-depending rer cut-offs; 1.10 for ages 40-59 years, 1.06 for ages 60-69 years and +70 years to determine if a maximal effort is provided. there are no recommendations for rer cut-off when participants are aged above 69 years. therefore, they must reach the rer cut-off 1.06 to be evaluated as maximal effort. the rating of perceived exertion using the borg rpe 6-20 scale evaluation \> 17 is considered maximal effort. the test was supervised by experienced physiotherapists, an in-house nurse supported if necessary, and a physician was available upon request. participants and physiotherapists were blinded for vo2 max results from cpet. cpet gas exchange system was operated by an experienced researcher. maximal heart rate is rated as a maximal effort by cut-offs calculated as 208 - (0.7 x age in years) according to age group. using respectively, \> 92% and \> 89% of the calculated hr max for the age group 40-59 years and the age groups 60-69 years and +70 years to consider maximal effort.

Eligibility criteria:
inclusion criteria: * participants with heart disease referred to exercise-based cardiac rehabilitation in primary healthcare settings were included exclusion criteria: * heart-related symptoms according to clinical guidelines that prevent participants from performing a maximal exercise test.

Keywords: physical fitness heart disease oxygen consumption
safety study of oa-235i in subjects with nonalcoholic steatohepatitis

Conditions: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver

Summary: this study is a phase 1, first-in-human single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oa-235i in subjects with nonalcoholic steatohepatitis.

the purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single ascending dose (sad) in participants with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (nafld)/nonalcoholic steatohepatitis (nash) without advanced hepatic fibrosis. this dose-escalating strategy will test the safety of oa-235i when given as a single subcutaneous dosage using up to five successive cohorts. each cohort will have three non-randomized participants receiving the active medication. one (1) planned multiple dose (md) expansion dose cohort with 8 nafld/nash subjects will be enrolled for a 7-day dosing regimen at a dose level to be determined from the sad portion of the study.

Eligibility criteria:
main inclusion criteria: 1. male and female subjects between the ages of 18 and 70 years, inclusive, at screening. 2. body mass index (bmi) of ≥25 and \<40 kg/m2 with a total body weight 50-150 kg (inclusive) at screening and day 1 pre-dose. 3. suspected or confirmed diagnosis of noncirrhotic nafld/nash without advanced hepatic fibrosis by one of the following: 1. histologically with liver biopsy within 2 years prior to screening (documentation with pathology report); or 2. radiologically with ≥5% steatosis measured by magnetic resonance imaging-derived proton density fat fraction (mri-pdff), or controlled attenuation parameter (cap) \>288 db/m via fibroscan assessment, or presence of hepatic steatosis on abdominal ultrasound within 1 year prior to screening; or 3. clinically with a diagnosis of metabolic syndrome (mets) reflecting the presence of at least 3 of 5 factors/criteria (ie, abdominal obesity, elevated triglycerides, reduced hdl-c, elevated blood pressure, and/or elevated fasting glucose \[ifg or type 2 diabetes mellitus\]) as defined by the national cholesterol education program's adult treatment panel iii (ncep atp iii) \[grundy 2005\]; and fatty liver on imaging within 1 year prior to screening. key exclusion criteria: 1. history or presence of cirrhosis as assessed by investigator following review of diagnostic measures (clinical, imaging, histopathology, or laboratory). 2. clinical evidence of hepatic decompensation (laboratory or clinical abnormalities- ascites, variceal bleeding, etc.). 3. history or presence of other concomitant liver disease (eg, hepatitis b \& c, alcoholic liver disease, autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin (a1at) deficiency, bile duct obstruction, liver primary or metastatic cancer, drug-induced liver disease.
insulin and standard management in hypertriglyceridemic acute pancreatitis

Conditions: Hypertriglyceridemia; Acute Pancreatitis

Summary: to compare the efficacy of infusion containing insulin and infusion without insulin on reduction of triglycerides in acute hypertriglyceridemic pancreatitis


Eligibility criteria:
inclusion criteria: * acute pancreatitis * triglycerides \> 15 mmol/l exclusion criteria: * diabetes on peroral therapy or insulin * blood glucose \> 11 mmol/l * pregnancy
project impact: chw intervention

Conditions: Hypertension

Summary: the proposed study "project impact: chw intervention" is part of a larger study examining the efficacy, adoption, and impact of integrated ehr-based decision-support and physician feedback interventions with community health worker (chw)-led self-management and coaching support for south asian patients with uncontrolled hypertension. this is a randomized control intervention utilizing community health worker (chw)-led self-management and coaching support for south asian patients with uncontrolled hypertension at pcp clinics in new york city.

the goal of this study is that: 1. ehr-based decision support and performance feedback interventions will be more effective in improving hypertension control for south asian patients than standard care; 2. a combined ehr-chw intervention will be more effective in improving hypertension control for south asian patients compared to standard care and the ehr-based intervention investigators hope to implement and assess the efficacy of chw-led coaching through promotion of team-based care and use of culturally tailored education to improve hypertension control and mitigate risk factors related to cvd among south asian patients with uncontrolled hypertension. study findings can provide translatable and scalable models for other limited english proficient communities.

Eligibility criteria:
inclusion criteria: chw intervention * diagnosis of hypertension or at least two systolic blood pressure measurements of 140 mm hg or greater, or at least two diastolic bp 90 mm hg or greater in the past 12 months. focus group * any clinical patients meeting the inclusion criteria for the chw intervention who participated in the chw intervention pilot round. exclusion criteria: * pregnant patients are excluded. * no children or vulnerable subjects will be enrolled in this study.
alvocidib in patients with previously treated chronic lymphocytic leukemia or prolymphocytic leukemia arising from chronic lymphocytic leukemia (cll)

Conditions: Leukemia, Lymphocytic, Chronic

Summary: multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients. primary objective is to determine overall response rate. the secondary objectives are: * to assess overall safety, * to assess duration of response, progression free survival, and overall survival. clinical benefit and pharmacokinetics parameters are also evaluated.

treatment until disease progression or no evidence of treatment response; occurrence of unacceptable toxicity, intercurrent medical problem, or adverse event (ae); or a maximum of 6 cycles. follow-up of 6 months after the last treatment with alvocidib. the maximum duration of the study participation for patient will be about 15 months.

Eligibility criteria:
inclusion criteria: * patient must have documentation of histologically confirmed and measurable chronic lymphocytic leukemia (cll) or prolymphocytic leukemia (pll) arising from cll; * patient must have symptomatic and progressive disease; * patient must have received prior alkylating agent(s) and be fludarabine refractory; * patient must have the adequate organ functions; * patient's eastern cooperative oncology group performance (ecog) status must be 0-2; exclusion criteria: * patient with de novo pll; * patient with secondary malignancy that will limit survival ≤5 years; * patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months; * patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry; * patient with known history of glucose-6-phosphate dehydrogenase deficiency; * patient with autoimmune hemolytic anemia; * patient with known central nervous system involvement; * patient with active, uncontrolled serious bacterial, viral or fungal infections the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: cll pll flavopiridol
demeclocycline fluorescence for intraoperative delineation brain tumors

Conditions: Brain Tumor

Summary: this research study is studying a drug called demeclocycline that may help brain surgeons see tumors with a microscope during surgery.

this research study is a feasibility study, which is the first time investigators are examining this study intervention.the fda (the u.s. food and drug administration) has not approved demeclocycline for your specific disease but it has been approved for other uses. in this research study, the investigators would like to determine the lowest dose of demeclocycline that will allow surgeons to detect tumor cells during surgery. these cells will be marked through a process called fluorescence, which will cause tumor cells to glow brightly on an image in comparison to its surroundings.

Eligibility criteria:
inclusion criteria: * participants must present with a gadolinium-enhancing brain lesion (or lesions) that are thought by the neuroradiologist and the neurosurgeon to be consistent with high-grade glioma. these may be newly diagnosed lesions or recurrent tumors. * the patient must not be pregnant or nursing. tetracycline (demeclocycline, doxycycline, minocycline, tetracycline, and tigecycline) are classified as fda pregnancy category d. maternal ingestion of tetracyclines during pregnancy may cause tooth discoloration, enamel defects, and other congenital anomalies. tetracyclines are excreted in human breast milk; however, the extent of absorption of tetracyclines by the breastfed infant is not known. * participants must have normal organ and marrow function as defined below: * leukocytes ≥ 3,000/mcl * absolute neutrophil count ≥ 1,500/mcl * platelets ≥ 100,000/mcl * total bilirubin within normal institutional limits * ast(sgot)/alt(sgpt) ≤ 4 × institutional upper limit of normal * creatinine \< 2mg/dl * ability to understand and the willingness to sign a written informed consent document. * participants must be undergoing a surgical procedure with the intention of removing more tissue than what would be taken for a biopsy. exclusion criteria: * history of allergic reactions attributed to compounds of similar chemical or biologic composition to demeclocycline. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant and/or nursing women are excluded from this study because demeclocycline is a known teratogenic agent, pregnancy category d. it is known to be excreted in breast milk. * patients taking etinoid medications by mouth (such as acitretin, isotretinoin), strontium ranelate may not take demeclocycline because of toxic interactions * patients taking any tetracycline class of drug (i.e. minocycline, etc).

Keywords: brain tumor surgery
a training set for the hrd model in eoc

Conditions: Epithelial Ovarian Cancer; BRCA Mutation; Loss of Heterozygosity; Prognosis; Platinum Resistance; Homologous Recombination Deficiency

Summary: a homologous recombination deficiency (hrd) scoring model based on loss of heterozygosity (loh) is little explored in epithelial ovarian cancer (eoc) patients. this study would recruit 200 chinese eoc patients with known brca1/2 mutation status and resistance to platinum-based chemotherapy. a loh-hrd model is to be constructed based on the genetic testing in these patients. the mutated genes, hrd score model and their relationship with the prognosis, would provide a full description of for the chinese eoc patients, and a potential explanation of platinum-resistance in such population.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * pathological confirmation of epithelial ovarian cancer * with available tumor tissues * given consents to participate the study exclusion criteria: • not meeting all of the inclusion criteria
observational registry of acthar gel for participants with multiple sclerosis relapse

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: acthar gel was first approved by the food and drug administration in 1952. it has been used to treat many different illnesses, including multiple sclerosis. this study will observe how treatment with acthar affected the daily lives of patients who suffer with relapsing/remitting ms. it will collect information on symptoms, recovery, treatment patterns and safety outcomes.

acthar gel (repository corticotropin injection) contains a non-bovine analogue of adrenocorticotropic hormone (acth) for intramuscular or subcutaneous use. it was initially approved by the fda in 1952 and is used for multiple indications. this registry will evaluate the use of acthar gel for the treatment of ms exacerbations in the united states.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age. 2. patient has a clinically definite relapsing form of multiple sclerosis according to mcdonald criteria (2010 revision). 3. patient with an acute ms exacerbation as determined by their treating clinician. 4. patient planning to initiate acthar gel for the treatment of an acute ms exacerbation. 5. patient capable of providing informed consent. exclusion criteria: 1. patients with a diagnosis of progressive ms. 2. patients that require concomitant corticosteroid therapy. 3. patients receiving experimental drug therapy. 4. patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years. 5. patient has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the enrollment visit, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix. 6. patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin. 7. if female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.

Keywords: multiple sclerosis relapsing-remitting acthar corticotropin ms
efficacy of low dose hcg on oocyte maturity in poor responder women undergoing intracytoplasmic sperm injection

Conditions: Infertility

Summary: this study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hcg on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (icsi) treatment.

in this study all eligible patients were randomly allocated into three study groups by a permuted block randomization method: group a (control group) received only recombinant fsh, group b received rfsh supplemented by 100iu hcg in the late follicular phase. group c received rfsh supplemented by 200iu hcg in the late follicular phase. all of the patients underwent a standard long protocol and received gnrh-a (suprefact), 0.5cc subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was started 14 days thereafter. patients were categorized according to the following stimulation protocols: group a (control group): which 300 iu r-fsh was administered for the first 5 days of the stimulation cycle. then the first ultrasound scan was performed to monitor response. at this stage the dose of rfsh adjusted according to the ovarian response and continued until the day of ovulatory hcg administration. group b: rfsh supplemented with daily administration of 100 iu hcg in the late follicular phase based on the follicle size (14mm). group c: rfsh supplemented with daily administration of 200 iu hcg in the late follicular phase based on the follicle size (14mm). to assess the pregnancy outcomes, serum hcg was measured 2 weeks after embryo transfer. clinical pregnancy was defined by the observation of sac with fetal heart rate on ultrasonography 4 weeks after embryo transfer.

Eligibility criteria:
inclusion criteria: 1. poor ovarian response to ovulation induction according to the eshre definition\[20\] and presence of at least 2 of the criteria needed to define poor responders including advanced maternal age, history of low ovarian response in previous ivf/icsi treatments and abnormal ovarian reserve test(antral follicle number \< 5) 2. indication for icsi treatment, second or third cycle 3. age 37 to 43 years 4. body mass index (bmi) ≤ 30 kg/m2 5. the presence of two functional ovaries and no previous ovarian surgery 6. the presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation 7. basal (day 2 or 3) serum fsh levels ≤13 iu/l 8. normal semen analysis 9. no history or signs of endometriosis 10. no untreated endocrinologic disease

Keywords: icsi ovarian stimulation hcg low dose oocyte maturity poor respond
stereotactic radiosurgery with nivolumab and valproate in patients with recurrent glioblastoma

Conditions: Glioblastoma

Summary: the purpose of this study is to evaluate the safety and feasibility of the immunotherapeutic agent nivolumab given in combination with gamma knife therapy and valproate in patients with recurrent glioblastoma, a common and lethal type of brain cancer.

immune checkpoint inhibitors have the potential to treat a wide range of diverse cancers. of particular interest to researchers is the pd-1 receptor-ligand interaction, a major pathway that many cancers hijack in order to suppress immune control. anti-pd-1 antibodies such as nivolumab show a strong potential to treat many types of cancers including glioblastoma, the most common and most lethal brain cancer. this study will examine a means of further focusing immune response on glioblastoma by combining stereotactic "gamma knife" radiosurgery with nivolumab. the rationale behind this intervention is that the radiation therapy will enhance immune response rate by providing additional tumor antigens from dying cells. additionally, a study from investigators at johns hopkins indicates that histone deacetylase (hdac) inhibitors may boost the anti-cancer efficacy of pd-1 antibodies like nivolumab. valproate, a class i hdac inhibitor, will be used concurrently with nivolumab with the goal of enhancing the effects of both the nivolumab and the radiotherapy.

Eligibility criteria:
inclusion criteria: * confirmed malignant, recurrent glioblastoma or gliosarcoma * subject must have adequate organ function * subject must still be able to care for most of his or her personal needs exclusion criteria: * subject is pregnant * subject has extracranial metastatic or leptomeningeal disease * subject has an additional malignancy that is progressing or requires active treatment, exceptions being basal cell and squamous cell carcinomas of the skin, indolent prostate cancer, chronic lymphocytic leukemia, or in situ cervical cancer * subject has received chemotherapy, biological therapy, or had surgery 4 weeks prior to beginning the study * subject has had radiation therapy within 10 weeks prior to entering beginning the study * subject has had prior therapy with bevacizumab * subject has had previous treatment with carmustine wafer except when administered as first-line treatment no less than six months prior to beginning the study * subject requires escalating supraphysiologic doses of corticosteroids greater than 2 mg of dexamethasone or an equivalent * active autoimmune disease requiring systemic treatment within the past 3 months or any syndrome that requires immunosuppressive agents * interstitial lung disease or active, non-infectious pneumonitis * evidence of greater than grade 1 cns hemorrhage or greater than grade 3 venous thromboembolism * history of uncontrolled cardiac disease * subject unable or unwilling to have a head contrast enhanced mri

Keywords: brain cancer immunotherapy nivolumab radiosurgery gamma knife