Kornimate/medical-research-clean huggingface dataset:
pivotal study of iodine i 131 tositumomab for chemotherapy-refractory low-grade or transformed low-grade b-cell non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: the results from phase 1/2 (rit-i-000) and phase 2 (rit-ii-001) studies of tositumomab and iodine i 131 tositumomab (tst/i-131 tst) demonstrated that tst/ i-131 tst produced a high response rate in patients with chemotherapy-relapsed/refractory, low-grade or transformed low-grade non-hodgkin's lymphoma (nhl). on the basis of these results this study was designed to compare the efficacy of tst/ i-131 tst to the last qualifying chemotherapy regimen in patients with chemotherapy-refractory, low-grade or transformed low-grade nhl.


Eligibility criteria:
inclusion criteria: * male and female subjects ≥18 years of age with histologically confirmed at initial diagnosis, previously treated (at least 2 prior chemotherapy regimens), low-grade nhl or low-grade lymphoma that had transformed to intermediate- or high-grade histology. exclusion criteria: * subjects with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. bilateral posterior iliac crest core biopsies are required if the percentage of intratrebecular space involved exceeds 10% in a unilateral biopsy. the mean of bilateral biopsies must be no more than 25%. * cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity. * prior stem cell transplant. * active obstructive hydronephrosis. * evidence of active infection requiring intravenous (iv) antibiotics at the time of study entry. * new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation. * prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years. * known hiv infection. * known brain or leptomeningeal metastases. * subjects who are pregnant or nursing. * previous allergic reactions to iodine. this does not include reactions to intravenous iodine-containing contrast materials. * prior exposure to monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes, including engineered chimeric and humanized antibodies. * prior radioimmunotherapy. * progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with \>3500 cgy. * current use of either approved or non-approved (through another protocol) anti-cancer drugs or biologics * de novo intermediate- or high-grade lymphoma.

Keywords: non-hodgkin's lymphoma radioimmunotherapy nhl bexxar lymphoma tositumomab
a study to evaluate the safety of mrna-0184 in participants with heart failure

Conditions: Chronic Heart Failure

Summary: the primary objective of this study is to evaluate the safety and tolerability of single and multiple doses at escalating dose levels of mrna-0184.

the study includes a sad stage and mad stage; the stages of sad and mad may overlap. the sad stage will begin first, and data from this stage will inform decisions about dose levels in subsequent sad cohorts and in the mad stage.

Eligibility criteria:
key inclusion criteria: * documented diagnosis of heart failure (hf) based on medical records. * left ventricular ejection fraction (lvef) ≥ 35% and \< 50% at screening, or documented within the 3 months before screening, measured by transthoracic echocardiogram (tte) or cardiac magnetic resonance imaging (mri). * new york heart association (nyha) hf class i or ii. * on a stable regimen of cardiovascular medication(s) for a duration of at least 4 weeks before screening. key exclusion criteria: * hospitalized for cardiovascular causes within 3 months before screening. * decompensated hf, acute myocarditis, hypertrophic and/or restrictive/constrictive cardiomyopathy, or moderate or severe valvular heart disease (as classified by echocardiography) at screening or within the 3 months before screening. moderate tricuspid regurgitation is not exclusionary. congenital heart disease as the primary etiology for heart failure will be excluded. * symptoms of angina pectoris at screening. * severe obstructive or restrictive pulmonary pathology, including chronic obstructive pulmonary disease gold stage iii or iv, current use of oxygen therapy, or group 1, 3, 4, or 5 pulmonary hypertension. group 2 pulmonary hypertension is not exclusionary. * history of sustained ventricular tachycardia or atrial fibrillation/atrial flutter with a ventricular response ≥ 110 beats per minute (bpm) at the time of screening. * history of hypersensitivity to any components of the investigational product (ip). * participant has received or is expected to receive a covid-19 vaccination within 7 days of the planned date of ip administration. * for sad cohort participants to be rolled over into the mad stage, have experienced a dose-limiting toxicity (dlt) in a sad cohort. * participation in another clinical study of another ip within 30 days before screening or within 5 terminal elimination half-lives of the ip, whichever is longer. * any other clinically significant medical condition that, in the investigator's opinion, could interfere with the interpretation of study results or limit the participant's participation in the study, including poorly controlled diabetes mellitus.

Keywords: single ascending dose multiple ascending dose mrna-0184 heart failure
long term interferon for patients who did not clear hepatitis c virus with standard treatment

Conditions: Chronic Hepatitis c; Cirrhosis, Liver; Fibrosis, Liver; Hepatic Cirrhosis

Summary: the halt-c trial is a national institute of diabetes and digestive and kidney diseases sponsored, randomized clinical trial of long-term use of peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. all patients who enter the trial will be treated for 6 months with peginterferon alfa-2a and ribavirin. patients who respond to this 6 month treatment will continue to be treated for an additional 6 months. patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with peginterferon alfa-2a or to discontinue treatment for 3.5 years. patients in both arms of this study will be followed closely with quarterly study visits. the combination of peginterferon plus ribavirin has recently been approved by the fda for treatment of chronic hepatitis c. patients who remain hcv-rna positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the halt-c trial. the halt-c study is designed to determine if continuing interferon long-term over several years will suppress hepatitis c virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.


Eligibility criteria:
inclusion criteria: * age at entry at least 18 years. * positive for hepatitis c. * previous treatment with any interferon or interferon and ribavirin for at least 3 months. * documented non-response to treatment with interferon. * a liver biopsy demonstrating significant liver scarring. exclusion criteria: * no other liver disease. * no unstable major medical diseases or conditions. * no major complications of cirrhosis. * no recent abuse of alcohol or illicit drugs.

Keywords: liver disease hepatitis c virus antiviral agent cirrhosis
periodontal infection and endothelial dysfunction

Conditions: Periodontitis

Summary: the purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease

periodontitis is one of the most prevalent chronic diseases and a frequent cause of tooth loss. accumulation of subgingival dental biofilm in susceptible individuals is associated with an inflammatory host response characterized by the production of matrix metalloproteinases, reduction in collagen synthesis, increase in cytokine gene expression, and apoptosis of gingival fibroblasts. finally, inflammation leads to destruction of periodontal ligament, alveolar bone resorption, and chronic periodontitis. periodontitis is associated with increased serum levels of inflammatory cytokines and acute phase reactants. multiple case-control and cohort studies have suggested that periodontitis is an independent risk factor for cardiovascular events, diabetic end-organ damage, pregnancy complications and respiratory diseases. recent interventional studies have found that periodontal therapy could increase endothelium-dependent brachial artery flow-mediated dilation. the purpose of this controlled clinical trial is to determine the effect of periodontal therapy on endothelial function in subjects with moderate to severe chronic periodontitis. furthermore, the relationship between putative periodontal pathogens and endothelial function will be also evaluated.

Eligibility criteria:
inclusion criteria: * subjects must be 25 years of age or older * three or more periodontal pockets with a probing depth (pd) \> 5mm * have at least 20 natural teeth * provide informed consent and willingness to cooperate with the study protocol exclusion criteria: * history of antibiotic use in the previous three months * pregnant or lactating females * treatment with antihypertensive, antilipemic, antiarrhythmic, and other cardiovascular drugs * systemic diseases such as diabetes, hiv/aids, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases * previous history of cardiovascular disease: acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular block, peripheral vascular disease, cerebrovascular accident * patients who received periodontal treatment within the last 3 months * patients who require antibiotic prophylaxis before examination or treatment * patients with mental retardation and dementia

Keywords: periodontitis oral health cardiovascular disease
effect of perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant

Conditions: Chronic Liver Disease

Summary: liver transplantation has been a lifesaving treatment for individuals with end stage liver disease and acute liver failure. however, initial poor function of a liver allograft after liver transplantation, termed early graft dysfunction (egd), has been associated with increased allograft loss or mortality after transplantation. egd in ldlt is multifactorial. factors affecting egd are grwr, ischemia reperfusion injury, recipient metabolic demand, graft quality, graft inflow and outflow. studies shows that the incidence of egd is 15-38%. it is associated with increased allograft loss \& mortality. rifaximin is an antibiotic that reduces egd by 50% as shown by 2 studies but this study was done in ddlt setting and rifaximin was given in the pretransplant group. in this investigators will study the effect of perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.

methodology: * study population: all patients undergoing adult living donor liver transplant recipients * study design: open label randomized control study * study period: after ethical board clearance, all ldlt recipients satisfying inclusion criteria till june 2025 * sample size: n=100 * intervention: preoperative rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op pod 1 to 7 * monitoring and assessment: not valid * adverse effects: no adverse effect is expected to occur out of study protocols. except vomiting, headache, dizziness, nausea * stopping rule not valid (b) expected outcome of the project: perioperative oral rifaximin decreases early allograft dysfunction in recipients of adult living donor liver transplant. (c) ethical issues in the study and plans to address these issues: none expected

Eligibility criteria:
inclusion criteria: * all recipients (adults) undergoing living donor liver transplant in ilbs. exclusion criteria: * negative consent * hypersensitivity to rifaximin * patients undergoing retransplant * alf, aclf * pediatrics patients * patients on rifaximin
health-e you efficacy trial for male adolescents

Conditions: Sexually Transmitted Diseases; Sexual Health; Reproductive Health

Summary: this study will involve evaluating health-e you/salud ìtu™, a web-based, pre-visit mobile app designed to support adolescent male youth and his clinicians in discussing sexual and reproductive health (srh) topics and care. it will test its efficacy among male patients in clinical settings using a stepped wedge cluster randomized controlled trial design.

health-e you is a pre-visit, web-based mobile app designed to support an adolescent male youth and his clinician in discussing srh topics and care. it is shared with an adolescent patient prior to a clinic visit, and contains initial questions that subsequently provide the patient with individually-tailored health information. in addition, the app provides relevant information to the clinician on patients' srh to optimize the time together as part of the visit. in total, the app takes approximately 10-15 minutes to complete. the purpose of this study is to evaluate the efficacy of the health-e you app among male youth ages 12-21 using a cluster-randomized stepped-wedge design. a participant will be considered to have completed the study if the participant has completed the baseline assessment, worked through the app, an immediate follow-up assessment, and a 2-month post-visit follow-up assessment. the end of the study is defined as completion of the 2-month follow-up assessment. hypotheses include compared to usual care, app users will have greater improvements in male method use behaviors (i.e., condom use) as well as knowledge about pregnancy and sexually transmitted infection (st)i prevention methods, male method use self-efficacy, beliefs about male/female methods, improved knowledge about srh care, self-efficacy talking with a clinician about srh, beliefs about srh promotion, and srh care receipt.

Eligibility criteria:
inclusion criteria: * assigned male sex at birth * age 12 to 21 years old * english and/or spanish as preferred language to read, listen, and converse * self-reported engagement in vaginal and/or anal sex in the past 12 months * access to phone or internet for follow-up study activities exclusion criteria: * aged 11 or younger or older than 21 * primary language other than english or spanish * not able to provide informed consent * unable to communicate due to cognitive, mental, language, or other difficulties * not sexually active, engaged in oral sex only, or more than 12 months have passed since last vaginal and/or anal sex. * previous participation in a health-e you study activity or the app

Keywords: male adolescent condom use mhealth
is dexmedetomidine associated with a lower incidence of postoperative delirium when compared to propofol or midazolam in cardiac surgery patients

Conditions: Delirium

Summary: the purpose of this chart review study is to determine whether the use of dexmedetomidine, a selective α2-adrenergic receptor agonist with sedative, analgesic, and antinociceptive properties, would be associated with a lower incidence of delirium when compared to propofol and midazolam. we hypothesize that sedation with dexmedetomidine following cardiac surgery with cpb will be associated with a lower incidence of postoperative delirium.

delirium is the most common psychiatric syndrome found in the general hospital setting. between 32 - 80% of cardiac surgery patients may experience post-operative delirium. because failure to recognize delirium leads to increased morbidity and mortality and prolonged hospital stays, there are compelling clinical and financial reasons to improve the identification and treatment of delirium. dexmedetomidine, a selective alpha2-adrenergic receptor agonist, may be an alternative to current postoperative sedation when it comes to lowering the incidence of delirium. comparisons: the use of postoperative (at sternal closure) dexmedetomidine will be compared to current standards of care propofol and midazolam for postoperative sedation.

Eligibility criteria:
inclusion criteria: 1. diagnosis of a coronary artery disease, cardiac valve disease, or vascular problems requiring elective surgical intervention 2. age older than 18 years of age, less than 90 years of age 3. fluency in english, and willingness to participate in the study 4. no history of recent (\< 3 months) of alcohol or drug abuse 5. no pre-operative evidence of heart block 6. no history of dementia, schizophrenia, or post-traumatic stress disorder exclusion criteria: 1. a preexisting diagnoses of dementia, schizophrenia, active or recent alcohol or drug abuse/dependence; post-traumatic stress disorder; acute intoxication (i.e., positive urine drug and/or alcohol test at the time of initial evaluation or upon hospitalization for surgery) 2. age younger than 18, or older than 89 years of age 3. inability to understand enough english to complete required diagnostic testing 4. unwillingness to participate in the study 5. inability of subject or surrogate to consent. 6. pregnancy

Keywords: cardiac surgery valvular surgery delirium postoperative delirium cognitive dysfunction altered mental status
metatastic renal carcinoma lines

Conditions: Renal Cell Carcinoma

Summary: the hypothesis of this study are as follows: * prognostic evaluation of patients based on an integrative model provides better assessment of overall survival, and thus improves setting of care goals. * in a routine care population, antitumour drugs may have a significant impact on overall survival through their targeted antitumor effect, but also through their toxicity profile and their impact on comorbidities. * the optimization of patient support (supportive care, drug tolerance monitoring) can have an impact on the prognosis.


Eligibility criteria:
inclusion criteria: 1. patients with locally advanced or metastatic renal cell carcinoma 2. whose first-line treatment included at least one anti-angiogenic agent (tyrosine kinase inhibitor or monoclonal antibodies) and / or an mtor inhibitor; 3. whatever was the overall ecog-ps score (eastern cooperative oncology group performance status) at treatment initiation time 4. with first-line treatment carried out between 2007 and june 2016. exclusion criteria: 1. patient previously treated with only one cytokine (interferon α2a, high-dose interleukin-2) 2. refusal of processing of personal data
home-based exercise for management of hiv-associated cardiovascular disease risk

Conditions: Cardiovascular Diseases; Hyperlipidemia; Obesity

Summary: because of advances in drug treatment, people living with hiv/aids (plwha) are living longer, but are also at greater risk for cardiovascular disease (cvd) and diabetes. exercise and increased physical activity can reduce the risk factors for these diseases in plwha, but no studies have tested an at-home exercise program that would benefit low income people and others who do not have access to exercise facilities. this study will test the feasibility of an at-home exercise program for plwha and prepare for a full-scale intervention study, which may lead to a reduction in cvd risk among plwha.


Eligibility criteria:
inclusion criteria: * age 18 years and older * medical diagnosis of hiv-1 positive serostatus * sedentary lifestyle: not actively exercising ≥ 3 d•wk-1 for 20 min per session * 18.5 kg/m2 \< bmi \< 40.0 kg/m2 * stable, dhhs-approved art regimen for previous 3 months, with hiv viral load below 75 copies/ml * capable of performing the required exercise regimen * have daily access to a telephone for approximately 10 months * capacity and willingness to provide informed consent and accept randomized group assignment exclusion criteria: * individuals who have a clinical history strongly suggestive of type 1 diabetes. * history of serious arrythmias, cardiomyopathy, congestive heart failure, stroke or transient ischemic cerebral attacks, peripheral vascular disease with intermittent claudication, myocardial infarction, or cabg. * malignancies in the past 5 years, except therapeutically controlled skin cancer. * plans to be away \> 4 weeks in the next 9 months * score of 5 or greater on the dast or mast (signifying excessive use of drugs or alcohol). * weight loss in excess of 10% body weight in previous 12 weeks. * chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions. * inflammatory-related conditions such as collagen disorders. * any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise.

Keywords: hiv physical activity cardiovascular disease risk
a study of tl-925 as a treatment for dry eye disease

Conditions: Dry Eye Disease

Summary: in this prospective, phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (ded) will be randomly assigned (1:1) to receive either tl-925 or placebo as topical ophthalmic eye drops administered bilaterally bid. the study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.


Eligibility criteria:
inclusion criteria: * individuals aged 18 years or older * a diagnosis of dry eye disease for at least 6 months * an unanesthetized schirmer's test score (sts) of ≤ 10mm and ≥ 1mm in the study eye * a tear film break-up time (tfbut) of ≤ 5 seconds in the study eye * a corneal fluorescein staining score of ≥ 2 in at least one region of the cornea * a sum corneal fluorescein staining score of ≥ 4 in the study eye * a total lissamine green conjunctival score of ≥ 2 in the study eye * female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study. exclusion criteria: * any clinically significant slit lamp finding * any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation * any keratorefractive surgery within the last 12 months * any intraocular or extraocular surgery within 3 months

Keywords: tl-925 phase ii