Kornimate/medical-research-clean huggingface dataset:
continued efficacy and safety of zoledronic acid (q 4 wks vs. q 12 wks) in the 2nd year of treatment in patients with bone metastases from breast cancer

Conditions: Breast Cancer

Summary: clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. this study is prospective, double-blind, stratified, multi-center, and two-arm.


Eligibility criteria:
inclusion criteria: female patients ≥ 18 years of age. confirmed breast cancer with bone metastasis. pretreated with zometa®, or aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses; exclusion criteria: abnormal kidney function determined by serum creatinine levels. current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw. recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants). diagnosis of metabolic bone disease other than osteoporosis (e.g., paget's disease of bone). known hypersensitivity to zometa. treatment with other investigational drugs within 30 days prior to randomization. other protocol-defined exclusion criteria may have applied.

Keywords: breast cancer zoledronic acid bone metastases
the effect of caffeine reduction on snoring and quality of life

Conditions: Snoring

Summary: snoring is a problem for many people, often disturbing energy level, quality of sleep, and the relationship with a bed partner. two observational studies that have indicated a relationship between the consumption of caffeine and snoring. the objective of this study will be to observe the degree of snoring and quality of sleep when caffeine intake is reduced over a period of four weeks. this will be a prospective, before-and-after study of a behavioral intervention. this study will engage thirty adults who report snoring, drink two cups of coffee or more per day (or an equivalent amount of caffeine), and have a consistent bed partner who can report on snoring severity. both subject and partner will be asked to fill out a diary each day. the subjects will record the type of caffeine consumed, time at which each beverage was ingested, the total minutes of physical exercise, any caffeine withdrawal symptoms, quality of sleep, and energy in the morning. the partner (reporter) will rate his or her own sleep quality and energy in the morning, as well as the snoring level of the subject. beginning the second week of the study, the subject will reduce caffeine intake to half the baseline consumption, and on the third week, will eliminate caffeine altogether. at the end of each week, the participants will be asked to mail their diaries in to the researchers and start a new series of entries. the study team will also call each week to answer any questions or concerns of the subject and reporter, and encourage continued reporting. when six weeks have elapsed following the completion of the last diary, the investigators will make a final call to the participants to record their current level of snoring, quality of sleep, and daily energy level.


Eligibility criteria:
inclusion criteria: * age at least 18 years * consume 16 ounces of coffee or 25 ounces of caffeinated soda or tea * consistent bed partner willing to serve as reporter * reported as a loud snorer (6 or more on 10 point scale) most days of an average week exclusion criteria: * pregnant * diagnosed by doctor with sleep apnea, facial or airways defect * any facial or airways surgery that has changed snoring pattern. * upper airways infection that requires antibiotics, cough suppressants, etc. in the last month * use any continuous positive airway pressure (cpap) device or dental appliance * bed partner hearing impairment or defects.

Keywords: caffeine snoring sleep
biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is studying biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia.

objectives: * to perform high-resolution, genome-wide profiling of dna copy number alterations and loss-of-heterozygosity in samples from adult patients with acute lymphoblastic leukemia (all) obtained at diagnosis. * to perform candidate gene resequencing of diagnostic all samples. * to examine correlation of genetic alterations with outcome. * to examine the correlation between microarray multi-gene and multi-exon expression signatures with specific alterations and outcome. * to understand genetic events that contribute to the formation, development, and relapse of adult all by integrating the copy number and sequence alterations with the multi-gene signatures, and by comparing these data with data already generated in pediatric all. outline: diagnostic, complete remission, and germ-line specimens are analyzed for dna profiling and gene resequencing by the affymetrix snp6.0 microarray platform, pcr, and fluorescence in situ hybridization (fish). frequency of genetic alterations are performed by the agilent 2100 bioanalyzer. results are then compared with the data already generated from pediatric patients.

Eligibility criteria:
inclusion: • diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (all) treated on protocols calgb 9511, calgb-19802, calgb-10001, calgb-10102, and calgb-10403 and who have been registered on the companion study calgb-9665 (the calgb leukemia tissue bank)

Keywords: adult acute lymphoblastic leukemia
evaluation of the effectiveness of bone-anchored hearing aids (baha)

Conditions: Conductive Hearing Loss; Mixed Hearing Loss; Unilateral Deafness

Summary: a bone-anchored hearing aid (baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant. the sound processor delivers bone conducted stimuli to the cochlea, bypassing the outer and middle ear. some patients who are unable to wear or do not benefit from a conventional air-conduction hearing aid, are candidate for a baha. typically, these patients suffer from a conductive or a mixed hearing loss. recently however, baha's are also being recommended in patients with unilateral deafness. sound coming from the deaf side is captured and transmitted through bone conduction to the normal inner ear. the overall benefit of a baha is more difficult to assess in those patients. therefore, the goal of the current study is to examine the benefit of a baha in patients with different audiological profiles (unilateral or bilateral conductive or mixed hearing loss, and unilateral deafness). special attention will be given to predictive determinants of the benefit with a baha, and to the improvement of pre-operative criteria and counseling of patients.


Eligibility criteria:
inclusion criteria: * patients (males and females) already implanted with a bone-anchored hearing aid (baha) are included in the study. * only patients above 18 years will be included.

Keywords: conductive hearing loss mixed hearing loss unilateral deafness implanted with baha conductive or mixed hearing loss implanted with a baha or unilateral deafness implanted with a baha
feasibility of hiv prevention cohort studies among men who have sex with men in sub-saharan africa

Conditions: HIV

Summary: this study aims to determine the feasibility of recruiting and retaining men who have sex with men (msm) in a multi-country prospective cohort study in preparation for human immunodeficiency virus (hiv) prevention studies in sub-saharan africa (ssa).

hptn 075 is an observational cohort study. participants will be accrued over six months at four sites in ssa using convenience sampling strategies, with no replacement for participants lost to follow-up. each participant will be followed for 12 months, during which five study visits involving structured hiv behavioral assessments, medical examinations, and collection of biological samples will be conducted (including enrollment and quarterly follow-up visits). participants who do not complete 12 months of follow-up will be contacted to explore reasons for no longer participating.

Eligibility criteria:
inclusion criteria: * biologically male at birth, according to self-report; * 18-44 years old (inclusive); * willing and able to provide informed consent; * willing to undergo hiv testing throughout the study and to receive those test results; * reporting at least one act of anal intercourse in the previous 3 months (12 weeks) with a person reported by the participant to be biologically male; * able to provide complete locator identification for themselves and at least two other personal contacts; * willing to participate in all scheduled study assessments, including specimen collection, laboratory assessments, and sample storage; * committing to not participate in any hiv intervention or vaccine study while participating in hptn 075; * planning to remain in the study area for at least one year; * for hiv-uninfected men: all hiv test results at the screening visit must be non-reactive/negative; * for hiv-infected men (up to 20 per site): all hiv test results at the screening visit must be reactive/positive. men who are already on prep will not be excluded. additionally, self- or other-identified transgender women and male sex workers will not be excluded. there will, however, be no specific effort to recruit these groups. exclusion criteria: * unwilling to adhere to study procedures; * past or current participation in a biomedical and/or behavioral hiv/sti intervention or cohort study, including hiv vaccine studies; however, participation in local/area prep demonstration projects does not preclude participation in hptn 075; * hiv-infected men who report that they are already on art or in hiv care; * any other reason or condition that in the opinion of the investigator of record (ior) would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. * men who have discordant hiv test results at screening (i.e., at least one reactive or positive result and at least one non-reactive or negative result). these men will receive hiv counseling and will be referred for further diagnostic tests and care.
hippocampal memory circuits in delusions

Conditions: Psychosis

Summary: this study will investigate dentate gyrus (dg) and hippocampal ca3 sub field function, using the pattern separation paradigm, as reflected by the difference in brain activation in response to same-as-previously- seen (old) vs. similar-to-previously-seen (sim) objects in first episode psychosis (fep) subjects before and after anti psychotic treatment and in matched healthy controls (hc). the current study uses three novel high-resolution task-based and post-encoding resting fmri measures to probe hippocampal circuitry in delusions. it will also study ca1 function, using a sequential associative mismatch paradigm, as reflected by activation of ca1 in response to mismatching information compared to memory of that stimulus in fep subjects before and after antipsychotic treatment and in matched hc. finally, this study will evaluate plasticity of hippocampal intrinsic functional connectivity (ifc) in response to memory consolidation, using an encoding-plasticity paradigm, in fep subjects before and after anti psychotic treatment and in matched hc. for each of the three imaging projects, a total of 50 fep subjects and 50 matched healthy controls (hc) will be studied; hence, 300 subjects will be studied over 5 years. within each paradigm, medication-naive fep subjects will be studied at baseline and 8 weeks after starting anti psychotic medication. hc participants will be studied at baseline and 8 weeks later but will not receive any treatment.


Eligibility criteria:
inclusion criteria: * males and females 16 to 35 years of age, inclusive, at the time of informed consent * right-handed * must have experienced a first episode of non-affective psychosis over the past five years * must exhibit a persistence of delusions for at least 4 days per week for at least 4 weeks in the absence of psychotomimetic substance use or other potential organic etiologies, including epilepsy or significant head trauma. * must score at least a 2 (mild to moderate) on the "amount of preoccupation with delusions" and "conviction" items on the psychotic symptom rating scale (psyrats). exclusion criteria: * diagnosis of major mood disorder or other axis i disorder other than schizophrenia, schizoaffective disorder or schizophreniform disorder. * significant medical or neurological illness by history or physical exam including seizure disorder, history of loss of consciousness related to head trauma or developmental disorder including mental retardation. * metal implants, pacemaker, or other metal in the body or medicinal patch. * history of claustrophobia. * currently taking any anti psychotic medication (within 4 weeks).
neoadjuvant nivolumab+ipilimumab followed by adjuvant nivolumab or neoadjuvant nivolumab+ipilimumab followed by adjuvant observation compared with adjuvant nivolumab in treatment-naive high-risk melanoma participants

Conditions: Melanoma

Summary: the purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pcr) and near pcr rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. neoadjuvant immunotherapy aims to enhance the systemic t-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pcr and near pcr rates that may translate to prolonged clinical benefit.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * males and females, ≥ 12 years of age \[except: where local regulations and/or institutional policies do not allow for participants \< 18 years of age (adolescent population) to participate. for those sites, the eligible participant population is 18 years of age or local age of majority, inclusive\] * diagnosed with cytologically or histologically confirmed stage iiib, iiic, or iiid cutaneous melanoma as per american joint committee on cancer (ajcc) staging system, with ≥ 1 clinically detectable lymph node metastases (n1b, n2b, n3b), which are measurable according to response evaluation criteria in solid tumors version 1.1 (recist 1.1) * adult participants and adolescents 16 to 18 years old must have an eastern cooperative oncology group (ecog) scale performance status of 0 or 1. adolescents \< 16 years old must have lanksky play-performance status scale performance of ≥ 60 * must be treatment-naïve (ie, no prior systemic anticancer therapy as adjuvant therapy for melanoma or unresectable/metastatic melanoma) * women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial exclusion criteria: * women who are breastfeeding * patients with serious or uncontrolled medical disorders * prior treatment with an anti-programmed cell death protein 1 (pd-1), anti-programmed death-ligand 1 (pd-l1), anti-programmed death-ligand 2 (pd-l2), or anti cytotoxic t-lymphocyte antigen 4 (ctla-4) antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways other protocol-defined inclusion/exclusion criteria apply
efficacy and safety of radiofrequency renal denervation in drug resistant hypertension

Conditions: Hypertension

Summary: single-center, single group study of the efficacy and safety of transcatheter renal denervation for treatment of patients with essential hypertension uncontrolled despite combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic. bilateral transcatheter renal denervation will be performed on the top of existed pharmacotherapy. change in blood pressure (bp), left ventricle (lv) mass, carotid artery thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of follow-up.


Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 80 years at time of randomization * informed consent * treatment with full doses of 3 or more anti-hypertensive medications of different classes, of which one is a diuretic. * office systolic bp (sbp) ≥ 160 mmhg or diastolic bp (dbp) ≥ 100 mmhg exclusion criteria: * an estimated glomerular filtration rate (egfr) of \< 30 ml/min/1.73 m2 * ambulatory blood pressure monitoring (abpm) 24 hour average sbp \< 135 mmhg or dbp \< 85 mmhg * symptomatic(secondary) hypertension * severe renal artery stenosis or renal arteries abnormalities * individual is pregnant, nursing or planning to be pregnant * severe hepatic dysfunction * any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)

Keywords: hypertension radiofrequency catheter ablation renal artery sympathetic nerve block
an acellular epithelial skin substitute in deep partial-thickness burns

Conditions: Wound Healing; Scar Formation

Summary: the purpose of the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (stsgs) in deep partial-thickness burns. the objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for another additional option of wound coverage in deep partial-thickness burns. the investigators hypothesized that the acellular epithelial skin substitute is at least not inferior to autologous skin grafts.


Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * verified deep partial-thickness burns * early tangential excision of burn wound (3-5 days after trauma) exclusion criteria: * pregnancy * absi-score \>13 * active tumor or immune-mediated disease * patient refusal

Keywords: skin substitutes split-thickness skin graft burn wound scar formation skin quality
prospective randomized study of accelerated radiation therapy (prart)

Conditions: Breast Cancer

Summary: patients with stage 0 ductal carcinoma in situ (tis (dcis), stage t1-t2, lymph node negative(n0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (arm 1, standard) versus 10 fractions (arm 2, experimental).


Eligibility criteria:
inclusion criteria: * women status post segmental mastectomy * if unilateral, pt1-2 breast cancer excised with negative margins * if bilateral, pt1-2 breast cancer excised with negative margins and/or ptis excised with negative margins. * clinically n0 or pn0 or sentinel node negative * ductal carcinoma in situ dcis with negative margins (no dcis on inked margins). exclusion criteria: * previous radiation therapy to the ipsilateral breast. * 90 days from last surgery, unless s/p adjuvant chemotherapy * 60 days from last chemotherapy * male breast cancer
efficacy and safety of jtt-705 300, 600 and 900mg in comparison with placebo in patients with type ii hyperlipidaemia

Conditions: Type II Hyperlipidaemia

Summary: to demonstrate the effect of jtt-705 doses from 300 mg to 900 mg on the elevation of hdl-c and on the inhibition of cetp activity versus placebo, in patients presenting with mild dyslipidaemia. these objectives will be tested after 4 weeks of treatment.


Eligibility criteria:
inclusion criteria: * patients with of type ii hyperlipidaemia * patients having lipid values as indicated below: * hdl-c \< 1.6 mmol/l * tg \< 4.5 mmol/l * male and females between 18 and 65 years old (if female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception) exclusion criteria: * body mass index (bmi) \> 35 kg/m² * pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception * concomitant use of medications identified in the protocol

Keywords: cetp inhibitor hdl-c ldl-c apolipoprotein
effects of arzoxifene on bone fractures and incidence of breast cancer

Conditions: Osteoporosis, Postmenopausal

Summary: the purpose of this trial is to study: * effects of arzoxifene on bone fractures and bone mass. * effects of arzoxifene on getting breast cancer. * effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke. * effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health. * effects of arzoxifene on the uterus. * the safety of arzoxifene and any side effects.


Eligibility criteria:
inclusion criteria: * 60-85 years of age * female * at least two years since last menstrual cycle exclusion criteria: * abnormal or unexplained vaginal bleeding. * bone disorders, other than osteoporosis or low bone mass * history of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer). * history of cerebral vascular accidents or venous thromboembolic events * medications outlined
comparison of apixaban versus enoxaparin

Conditions: Bladder Cancer

Summary: the goal of this randomized trial is to compare bladder cancer patient experiences taking prophylactic anticoagulation at home after surgery to remove their bladder. the main questions it aims to answer are: * are patients equally adherent to apixaban as they are enoxaparin? why or why not? * do patients prefer apixaban or enoxaparin? * what is the typical patient cost to take apixaban vs enoxaparin after surgery? participants will be randomized to receive a prescription for either enoxaparin or apixaban which they will then fill themselves and self-administer at home until post-operative day 30. they will receive phone calls from study coordinators at days 30 and 90 to complete questionaries over the phone to assess trial outcomes.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. able to communicate in english over the phone 4. male or female, age \>18 years 5. diagnosed with biopsy-proven, urothelial cell carcinoma (any t stage, n0-1, m0) with plan for radical cystectomy with urinary diversion and concurrent pelvic lymph node dissection as treatment exclusion criteria: 1. preoperative use of a therapeutic dose of anticoagulant (this notably does not exclude patients taking antiplatelet agents) 2. failure to undergo radical cystectomy with concurrent urinary diversion and pelvic lymph node dissection 3. failure to be discharged by post-operative day 14 4. failure to receive a script for enoxaparin or apixaban. 5. any medical condition which precludes treatment with either enoxaparin or apixaban (including dialysis, hemophilia or any other bleeding diathesis)