Kornimate/medical-research-clean huggingface dataset:
extended treatment in metastatic breast cancer with eribulin

Conditions: Breast Cancer

Summary: decision-making for treatment of metastatic breast cancer after the second line of chemotherapy was limited by the lack of established predictive factors of benefit for further chemotherapy regimens. eribulin has emerged as the only single agent demonstrating an overall survival improvement in the third-line setting or beyond. the purpose of this study was to define the clinical profile of metastatic breast cancer participants achieving long-term benefit from chemotherapy with eribulin in the third-line setting or beyond.

this was a multicenter, retrospective, observational, case study analysis to assess long-term eribulin treatment in metastatic breast cancer. the study was conducted in 26 spanish hospitals participating in a national pre-market access program to eribulin between 2011 and 2014. an exploratory comparison with a group of short-term responders included in a similar observational study was performed.

Eligibility criteria:
inclusion criteria: * participants with advanced or metastatic breast cancer on eribulin for at least 7 months exclusion criteria: * lack of accessible clinical records

Keywords: advanced or metastatic breast cancer eribulin
early prophylactic donor lymphocyte infusion after allo-hsct for patients with aml

Conditions: Acute Myeloid Leukemia

Summary: allogeneic hematopoietic stem cell transplantation (allo-hsct) is a curative option for patients with acute myeloid leukemia (aml). however, transplantation related toxicity and mortality as well as the existence of hla identical sibling donor represent major limitations. over the 20 past years, the development of reduced intensity conditioning (ric) regimen and the use of alternative donors allowed extending the possibility of allo-hsct for aml, with decreased toxicity and mortality. this invited to propose this strategy to more advanced patients, making that aml recurrence has become one of the main issues after allo-hsct. thus, to develop prophylactic and preemptive strategies to minimize disease recurrence after allo-hsct is now the main challenge in the field. among cellular and/or pharmacological treatments after allo-hsct, donor lymphocyte infusion (dli) is probably one of the most commonly used treatments after allo-hsct. indeed, dli were reported as a potential efficient immunotherapy more than 20 years ago for the treatment of patients with leukemia relapsing after allo-hsct. however, most of experiences were reported in the setting of relapse after allo-hsct and no prospective evaluation of prophylactic dli is available so far. thus no strong recommendation for the use of dli after allo-hsct can be made. our study proposal would like to assess the question of prophylactic dli efficacy, as a proof of concept of early immune intervention after allo-hsct. the investigators, therefore, designed a prospective multicenter randomized trial evaluating the impact of early dli on outcome after allo-hsct for aml.


Eligibility criteria:
inclusion criteria: * aml in hematological complete remission at the time of inclusion * patient age from 18 to 70. * able to comply with the protocol. * written informed consent. * allogeneic stem cell transplantation from any donor except cord blood. * unmanipulated bone marrow or peripheral blood stem cells as graft source are allowed * ongoing gvhd prophylaxis using cyclosporin a at the time of inclusion. exclusion criteria: * presence or history of grade 2 to 4 acute gvhd. * no hematological cr of aml at the time of inclusion. cr patients positive with molecular or phenotypic minimal residual disease (mrd) can be included. * pregnancy/breast feeding. * patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up. * concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure...). * primary or secondary graft failure. * previous solid organ allogeneic transplantation.

Keywords: allogeneic hematopoietic stem cell transplantation donor lymphocyte infusion
improving prevention systems to reduce disparities for high priority populations

Conditions: HIV Infections

Summary: this project collaborates with the new york city department of health and mental hygiene (nyc dohmh) to develop and test a field-based comprehensive sexual health intervention for hiv-exposed contacts notified by its partner services (i.e., hiv contact tracing) program. the goal of the study is to develop and test the impact of this new intervention on improving rates of hiv testing, linkage to hiv prevention/care, and prep uptake among highest risk contacts recently exposed to hiv. we will conduct a 6-month pilot project, followed by a cross-sectional stepped wedge cluster randomized trial in which 12 clusters of nyc neighborhoods are exposed to the intervention sequentially, with three clusters moving from control to intervention every 6 months (n = 1150). primary outcomes are hiv testing, timely prep/arv uptake, and linkage to prep/hiv care. secondary outcomes are std testing and receipt of std treatment (if indicated).


Eligibility criteria:
inclusion criteria: * contacts referred to the partner services program during the study time period exclusion criteria: * none
joint pain and medication adherence in postmenopausal women receiving aromatase inhibitors

Conditions: Arthralgia; Breast Cancer

Summary: rationale: gathering information over time about joint pain and stiffness from postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors plan treatment and help patients live more comfortably. purpose: this observational epidemiologic cohort is designed to study arthralgia, patient-reported outcomes, and medication adherence in postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors.

objectives: primary * estimate the incidence, time to onset, prevalence, and clinical and demographic predictors of arthralgia in post-menopausal women with early-stage breast cancer receiving aromatase inhibitors (ai). * chart the trajectory of arthralgia symptom severity over the course of ai treatment in these patients. secondary * measure the impact of arthralgia on sleep quality, depression, and physical function in these patients. * develop a roster of current physician-advised or prescribed treatments, including self-management techniques being used for ai-induced arthralgia, for intervention development. outline: patients complete questionnaires about joint pain and stiffness, sleep, depression, physical function, medications and treatment, exercise and social support, demographics, comorbidities, body mass index (bmi), and performance status at baseline and then periodically for approximately 1 year after beginning aromatase inhibitor (ai) therapy. patient medical records are reviewed for comorbidities, bmi, use of prior hormone replacement therapy, vitamin d levels and deficiency, performance status, histological stage, prior treatment, and medications at baseline and then periodically for approximately 1 year after beginning ai therapy.

Eligibility criteria:
disease characteristics: * planning to begin aromatase inhibitor (ai) therapy or taken fewer than 10 doses of adjuvant ai therapy * hormone-receptor status not specified patient characteristics: * postmenopausal * ecog performance status 0-1 * able to understand and respond to questions in english * no condition that would impair the ability to provide informed consent * no other non-breast cancer condition prior concurrent therapy: * see disease characteristics * no more than 9 prior doses of ai

Keywords: arthralgia stage i breast cancer stage ii breast cancer stage iiia breast cancer
the impact of oral glutathione on oxidative damage and glycated hemoglobin (hba1c) levels in type 2 diabetes patients

Conditions: Type 2 Diabetes

Summary: this trial aims to assess the effectiveness of l-glutathione, supplemented with bioavailability boosters (tannin, low molecular weight chitosan, and polyethylene glycol), on improving antioxidant levels and glycemic control in patients with type 2 diabetes (t2d). the study is designed as a randomized, double-blind, placebo-controlled trial intending to enroll 240 t2d patients. the primary objective is to measure changes from baseline to 180 days in several key biomarkers, including endogenous reduced glutathione (gsh), oxidized glutathione (gssg), 8-hydroxydeoxyguanosine (8-ohdg), and glycated hemoglobin (hba1c), along with other metabolic parameters. hypothesis: the anticipated outcome is a significant increase in gsh levels and a decrease in markers of oxidative damage among participants receiving l-glutathione compared to those in the placebo group, potentially indicating improved antioxidant defenses and some effects on glycemic regulation in t2d patients. this trial aims to fill gaps in current research regarding the role of l-glutathione supplementation in managing oxidative stress and metabolic control in diabetes.


Eligibility criteria:
inclusion criteria: * subjects with diabetes mellitus type 2 with confirmed levels of glycated hemoglobin (hba1c) ≥ 6.5% exclusion criteria: * pregnancy and breastfeeding * heavy smoking: individuals consuming more than 20 cigarettes per day; * excessive alcohol consumption: participants who consume alcohol in excess of established limits, defined as more than 14 standart doses for men and 7 for woman; * active clinical infections * recent cardiovascular events: individuals who suffered from cardiovascular event in the last 6 months; * subjects receiving antioxidant drugs or dietary supplements;

Keywords: oxidative stress glutathione antioxidants preventive supplementation
transcranial direct current stimulation (tdcs) for auditory hallucinations in early onset schizophrenia (eos)

Conditions: Schizophrenia

Summary: youths diagnosed with early onset schizophrenia will demonstrate amelioration of auditory hallucinations after one week of twice daily treatment with transcranial direct current stimulation (tdcs).

background: early onset schizophrenia (eos) involves positives symptoms such as psychotic behaviors, as well as negative symptoms such as disruptions to normal emotions and behaviors. antipsychotics are the primary method of treatment in pediatric populations, but can produce unpleasant or dangerous side effects. medication response is highly variable. recent evidence demonstrates transcranial direct current stimulation (tdcs) relieving auditory hallucinations (ah) associated with schizophrenia in adults, and to a lesser degree negative and cognitive symptomology. such studies provide important scientific and technical knowledge that may be applied to pediatric populations. hypothesis: 1. primary: youths with eos will demonstrate amelioration of ah after administration of tdcs. 2. tdcs will be well-tolerated in pediatric populations with minimal adverse side effects.

Eligibility criteria:
inclusion criteria: * structured clinical interview for diagnostic and statistical manual (dsm) disorders (scid) primary diagnosis of dsm-iv (diagnostic and statistical manual of mental disorders-version iv) schizophrenia or schizoaffective disorder * ages 8 to 25 years-old * persistent auditory hallucinations * full scale intelligent quotient (iq) greater than 60. * stable antipsychotic medication for \> 4 weeks * if female and not infertile patient must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment or an interuterine device (iud). * legal guardian has provided written informed consent and the subject has provided written informed assent when able. expectation that a majority of subjects will be able to assent but the potential for the younger children and/or those that are of borderline intellectual functioning will not be able to assent. exclusion criteria: * history of alcohol, substance dependence or abuse in the past 90 days * open skin wounds that would preclude use of tdcs electrodes * if female, pregnancy or breast feeding, as determined during eligibility pre-screen call * subjects exhibiting significant ongoing severe disruptive, aggressive, self-injurious, or sexually inappropriate behavior will not be eligible for enrollment. * presence of any medical condition that would make treatment with tdcs less safe. this includes any implanted metal device or any cardiac pacemaker. subjects with a history of a seizure disorder are permitted if the subject has been seizure free for 6 months and is currently treated with an anticonvulsant that has been stable for 4 weeks. * presence of any other condition that would make the participants unable to comply with the requirements of the study for any reason. this may include an appreciable hearing or visual impairment.

Keywords: tdcs
safety study of nifurtimox for relapsed or refractory neuroblastoma

Conditions: Neuroblastoma

Summary: there is currently no curative treatment for children with relapsed/refractory neuroblastoma, and for these children the 5 year survival rate is \<10%. as such, new therapeutic approaches are needed to treat these children. this phase 1 clinical trial is specifically designed to test the safety and toxicity of nifurtimox when given in combination with cyclophosphamide and topotecan for the treatment of relapsed and/or refractory neuroblastoma . prior to study opening, 3 pediatric patients with neuroblastoma have received nifurtimox in combination with this chemotherapy regimen, and all have had significant measurable responses without undue toxicity. these case reports, as well as our in vitro and in vivo investigations into the biologic effect of nifurtimox on neuroblastoma cells has prompted the development of this phase i study. this phase i study will involve a dose escalation trial of daily oral nifurtimox alone for one 21 day cycle of therapy, followed by continuation of nifurtimox with the addition of standard doses of cyclophosphamide (5 days) and topotecan (5 days) for 3 additional 21 day cycles. our primary aim is to evaluate the safety of nifurtimox alone and in combination with these chemotherapy agents in multiply relapsed/refractory patients. our secondary aim will be to evaluate the pharmacokinetics of nifurtimox as well as treatment response.


Eligibility criteria:
inclusion criteria: 1. age: 0-21 years at the time of study entry. 2. diagnosis: histologic verification of neuroblastoma at original diagnosis or relapse. 3. disease status: refractory or first or multiple relapsed neuroblastoma with measurable disease by radiographic scan (ct or mri and mibg), abnormal urinary catecholamine levels, or positive bone marrow biopsy/aspirate. mibg not required if subject's neuroblastoma is previously determined to not uptake mibg isotope (not mibg avid). 4. current disease state must be one for which there is currently no known curative therapy. 5. a negative urine pregnancy test is required for female participants of child bearing potential (\>13 years of age). 6. patients must have adequate liver function as defined by ast or alt \<10x normal and a bilirubin \<1.5mg/dl 7. informed consent: all patients and/or legal guardians must sign informed written consent. assent, when appropriate, will be obtained according to institutional guidelines exclusion criteria: 1. life expectancy \<3 months 2. investigational drugs: patients who are currently receiving another investigational drug. 3. anti-cancer agents: patients who are currently receiving other anticancer agents. 4. infection: patients who have an uncontrolled infection. 5. patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. 6. patients may not receive bisphosphonates (i.e. zometa) within 7 days of start of therapy.

Keywords: treatment refractory or relapsed
trial studying chemotherapy in nigerian women with triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: the primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. this will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in nigerian women with triple negative breast cancer (tnbc). all enrollment to this trial will occur at sites in nigeria. university of chicago is serving as coordinating center and will be involved in data analysis.


Eligibility criteria:
inclusion criteria: 1. women ages of 18 to 70 years old 2. women who are able and willing to read understand and sign an informed consent document 3. biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm) 4. patients with histologically confirmed carcinoma of the female breast with triple-negative status by immunohistochemistry (ihc). patients who are low estrogen reception (er) expression (\< 20%), progesterone receptor (pr) negative and human epidermal growth factor 2 (her2) negative are eligible. 5. clinical stages iia -iiic (ajcc 2009) 6. chemotherapy-naïve patients (for this cancer) 7. performance status: eastern cooperative oncology group (ecog) performance status 0-1 8. non-pregnant and not nursing. * granulocyte greater than or equal to 1,500/microliter * platelet count greater than or equal to 100,000/microliter * absolute neutrophil count (anc) greater than or equal to l500/microliter * hemoglobin greater than or equal to 10g/deciliter * bilirubin less than or equal 1.5 x upper limit of normal * aspartate aminotransferase (alt or sgot) and alanine transaminase (ast or sgpt) less than 2.5 x upper limit of normal 7. creatinine within institutional normal limits or glomerular filtration rate greater than or equal to 30 ml/min/1.73 m2 by chronic kidney disease epidemiology collaboration (ckd epi) equation 10. baseline left ventricular ejection fraction of greater than or equal to 55% exclusion criteria: 1. pregnant or lactating women. 2. patients with distant metastasis (brain and/or visceral metastasis) 3. serious, uncontrolled, concurrent infection(s). 4. treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (ccis) 5. participation in any investigational drug study within 4 weeks preceding the start of study treatment 6. other serious uncontrolled medical conditions that the treating investigator feels might compromise study participation including but not limited to chronic or active infection, hiv-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.
effect of vitamin d supplementation on endothelial function in obese adolescents

Conditions: Obesity; Endothelial Dysfunction; Vitamin D Deficiency

Summary: vitamin d deficiency has been linked to endothelial dysfunction in adults. obese adolescents have a high prevalence of vitamin d deficiency as well as evidence of endothelial dysfunction. our hypothesis is that supplementation of vitamin d deficient adolescents with vitamin d would lead to improvement in endothelial dysfunction.

subjects had a brief screening visit with one of the study team members. past medical history, current medications and a brief dietary history was taken. the dietary history was taken to assess calcium intake in a day and was obtained via the validated short calcium questionnaire. blood pressure, heart rate as well as height,weight, waist and hip circumference measurement was obtained by study staff. in addition, a brief physical examination to determine tanner stage was also completed. this involved examination of both breasts and genitalia for adolescent female and only genitalia in males. a physical activity questionnaire (ipaq) was also administered by the study staff at this visit. a blood draw of 5 ml to measure plasma 25(oh) d, calcium, phosphorus was obtained as part of the screening visit. for girls who had started menstruating, a urine pregnancy test was also obtained. after the screening visit eligible subjects had baseline biochemical tests and an endothelial function assessment. study participants received a pill container with six total pills of vitamin cholecalciferol (d3) (1 pill = 50,000 iu), with directions to take two pills once a month (100,000 iu) at the same time for a period of 3 months. compliance was assessed at the 3 month visit by counting the number of pills remaining in the container. at 1 month, the subjects had tests for serum calcium and 25 hydroxy vitamin d levels. a urine test for random calcium to creatinine ratio was also obtained. at 2 months, the serum calcium, 25 hydroxy vitamin d levels, and calcium to creatinine ratio tests were repeated. at the end of 3 months, biochemical tests and an endothelial function assessment were repeated. medical history, questionnaires, and the physical exam were also repeated.

Eligibility criteria:
inclusion criteria: 1. age 12-18 years 2. bmi \>95% for age and gender 3. 25 (oh) d levels less than 30 ng/ml exclusion criteria: 1. 25 (oh) d levels \>30 ng/ml 2. serum calcium \>10.4 mg/dl 3. serum phosphorus \> 4.7 mg/dl 4. pregnancy or nursing 5. current cancer 6. patients on vitamin d3 supplementation exceeding 400 iu/day 7. hypertension defined as blood pressure over the 95th percentile for age, gender and height 8. dietary calcium intake exceeding 1500 mg/day 9. hepatic or renal disorders 10. type 1 or type 2 diabetes mellitus 11. subjects receiving insulin, metformin, or oral hypoglycemic medications 12. subjects with malabsorption disorders (celiac disease, cystic fibrosis, inflammatory bowel disease)

Keywords: obesity endothelial dysfunction vitamin d deficiency