Kornimate/medical-research-clean huggingface dataset:
low nicotine content cigarettes in vulnerable populations: affective disorders

Conditions: Tobacco Use Disorder

Summary: while the prevalence of smoking in the united states general population has declined over the past 50 years, there has been little to no decline among people with mental health conditions. affective disorders (ads) are the most common mental health conditions in the us, and over 40% of people with ads are current smokers. a national policy of reducing the nicotine content of cigarettes has the potential to reduce tobacco use, dependence, and related adverse health outcomes. controlled trials in psychiatrically-stable smokers have shown that reducing the nicotine content in cigarettes can reduce cigarettes per day (cpd), dependence and tobacco toxicant exposure, with few adverse consequences. the goal of the proposed trial is to experimentally model whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effect of altering the nicotine in cigarettes in smokers with ads. additionally, investigators will test whether allowing participants to personalize the flavor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking. daily smokers with current ads will be recruited at brown university and the university of vermont. investigators will study two research cigarettes referred to here as research cigarette 1 (rc1) and research cigarette 2 (rc2). one of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. investigators will study two e-cigarette conditions referred to here as e-cigarette condition 1 (ec1) and e-cigarette condition 2 (ec2). both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. participants will be assigned to one of the following four study conditions: (1) rc1 only; (2) rc2 only; (3) rc2 + ec1; (4) rc2 + ec2. participants will be asked to use only their assigned study products for 16 weeks. outcome measures include total cpd, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (co), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath \[feno\]).


Eligibility criteria:
inclusion criteria * between 21 years and 70 years old * must have current diagnosis of an affective disorder. exclusion criteria * being without an affective disorder * younger than 21 years old * older than 70 years old

Keywords: biomarkers of exposure compensatory smoking nicotine dependence reduced nicotine cigarettes affective disorders tobacco withdrawal vulnerable populations e-cigarettes
the study of metabolic syndrome in hemodialysis patients

Conditions: Hemodialysis; Metabolic Syndrome X; Insulin Resistance

Summary: metabolic syndrome (ms), comprised of central obesity, glucose intolerance, hyperinsulinemia, low hdl-cholesterol (hdl-c), high triglyceride (tg) and hypertension, results in markedly increased risk for cardiovascular disease in the general population. the national cholesterol education program adult treatment panel iii (ncep atp iii) report recommended the use of five variables for the diagnosis of the ms including waist circumference (wc), serum tg concentration, serum hdl-c concentration, blood pressure and fasting glucose concentration. a waist circumference of 80 cm in women and 90 cm in men would better identify those with the ms in asian populations. however, the studies of modified asian criteria of metabolic syndrome in hemodialysis (hd) patients are scarce. we will perform prevalence investigation, cross-sectional study, and prospective investigation for metabolic syndrome in our hd patients (around 360 at present). we will enroll all the patients who receive maintenance hd more than three months in our hd center. the patients who are hospitalizing, suffered from active malignancy, active infections, recent cardiovascular events and surgery will be excluded in the beginning of study. biochemistry and anthropometric parameters including hdl-c, tg, insulin resistance index, high sensitivity c-reactive protein and wc will be collected and analyzed. we will also prospectively establish the mortality and hospitalization indices of these patients, to study the prognosis of hd patient with or without metabolic syndrome. this study will be helpful to understand whether the application of a modified criteria of metabolic syndrome in hd patients is capable to predict cardiovascular events, hospitalization and mortality rates.


Eligibility criteria:
inclusion criteria: * we will enroll all the patients who receive maintenance hd more than three months in our hd center. exclusion criteria: * the patients who are hospitalizing, suffered from active malignancy, active infections, recent cardiovascular events and surgery will be excluded in the beginning of study.
a prospective, multi-center, pivotal study to evaluate the safety and effectiveness of the novacross™ micro-catheter in facilitating crossing chronic total occlusion (cto) coronary lesions

Conditions: Chronic Total Occlusion of Coronary Artery

Summary: this study evaluates the safety and effectiveness of the a novel device called novacross to help cross chronic total occlusion (cto) lesions in coronary arteries.

the purpose of this trial is to evaluate the safety and effectiveness of the novacross™ micro-catheter when used to facilitate crossing of chronic total occlusion (cto) lesions in coronary arteries. the procedure will be conducted on consenting patients diagnosed with a cto in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.

Eligibility criteria:
inclusion criteria: * adult aged 25-80 * patient understands and has signed the study informed consent form. * patient has an angiographic documented chronic total occlusion (i.e. \>3 months occlusion duration) showing distal timi flow 0. * suitable candidate for non-emergent, coronary angioplasty * documented coronary angiography preceding the pci reveals at least one cto lesion situated in a non-infarct related coronary artery or its side branches * body mass index (bmi) \< 40 * left ventricle ejection fraction \> 25% exclusion criteria: * patient unable to give informed consent. * current participation in another study with any investigational drug or device. * patient is known or suspected not to tolerate the contrast agent. * aorta-ostial cto location (ostial bifurcation origins may be considered), svg cto, in-stent cto. * intolerance to aspirin and/or inability to tolerate a second antiplatelet agent (clopidogrel and prasugrel and ticagrelor). * appearance of a fresh thrombus or intraluminal filling defects. * recent major cerebrovascular event (history of stroke or tia within 1 month) * cardiac intervention within 4 weeks of the procedure * renal insufficiency (serum creatinine of \> 2.3mg/dl or 203μmol/l) * active gastrointestinal bleeding * active infection or fever that may be due to infection * life expectancy \< 2 years due to other illnesses * significant anemia (hemoglobin \< 8.0 mg / dl) * severe uncontrolled systemic hypertension (\> 240 mmhg within 1 month of procedure) * severe electrolyte imbalance * congestive heart failure \[new york heart association (nyha) class iii\\iv\] csa class iv. * unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (ptca) or coronary artery bypass graft (cabg) * recent myocardial infarction (mi) (within the past two weeks) * uncontrolled diabetes \>2 serum glucose concentrations of \>350 mg/dl within 7 days. * unwillingness or inability to comply with any protocol requirements * pregnant or nursing * extensive prior dissection from a coronary guidewire use * drug abuse or alcoholism. * patients under custodial care. * bleeding diathesis or coagulation disorder; * kawasaki's disease or other vasculitis
study to evaluate the cardiac safety of tas-102 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors (Excluding Breast Cancer)

Summary: the purpose of this study is to evaluate the cardiac safety of tas-102 in patients with advanced solid tumors.

this is a phase 1, nonrandomized study to evaluate the cardiac safety of tas-102 in patients with advanced solid tumors. the study is conducted in 2 phases: the cardiac safety evaluation phase to investigate cardiac repolarization and the cardiac safety profile (cycle 1) and the extension phase to assess the safety profile and antitumor activity (subsequent cycles).

Eligibility criteria:
inclusion criteria: 1. has provided written informed consent 2. has advanced solid tumors (excluding breast cancer) for which no standard therapy exists 3. has received no more than 5 prior cancer therapies 4. ecog performance status of 0 or 1 5. is able to take medications orally 6. corrected qt interval using bazett's correction is no more than 450 msec on resting ecg 7. has adequate organ function (bone marrow, kidney and liver) 8. women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. males must agree to adequate birth control. exclusion criteria: 1. has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration 2. certain serious illnesses or medical condition(s) 3. has a family history of unexplained sudden death or long qt syndrome 4. has had a documented cardiovascular complication following a fluoropyrimidine-derived treatment 5. is a patient for whom it is not technically possible to obtain quality ecg tracings 6. is receiving a concomitant drug that is known to affect qt interval or to be arrhythmogenic 7. has unresolved toxicity of greater than or equal to ctcae grade 2 attributed to any prior therapies 8. known sensitivity to tas-102 or its components 9. is a pregnant or lactating female 10. refuses to use an adequate means of contraception (including male patients)

Keywords: advanced solid tumors (excluding breast cancer) for which no standard therapy exists
combined cytidine and creatine-containing drug in the treatment of the bipolar depression

Conditions: Depression, Bipolar

Summary: this research is aimed to investigate the efficacy and safety of the creatine and cytidine augmentation in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.


Eligibility criteria:
inclusion criteria: * aged 19-65 years * bipolar disorder i or ii (dsm-iv-tr) with current depressive episode * informed consent exclusion criteria: * use of medication for bipolar depression or other psychotropic drugs * current axis i mental disorders other than bipolar depression based on structured clinical interview * current borderline or antisocial personality disorder based on structured clinical interview * major medical or neurological illnesses (epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc) * hypersensitivity to divalproate or valpromide * diagnosis of porphyria * current or past liver diseases * severe dysfunction in liver or pancreas * use of mefloquine * alcohol or substance abuse/dependence * intelligence quotient of 80 or below * contraindications to magnetic resonance imaging * pregnancy or breastfeeding * allergy or intolerance to the study drugs

Keywords: bipolar depression cytidine creatine magnetic resonance spectroscopy
contrast enhanced spectral mammography with digital breast tomosynthesis for patients with newly diagnosed breast cancer

Conditions: Breast Carcinoma

Summary: this pilot clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. digital breast tomosynthesis uses multiple x-ray pictures to produce a 3-dimensional rendering of the entire breast. contrast enhanced spectral mammography with digital breast tomosynthesis may highlight areas of concern within the breast in more detail than a standard mammogram and improve the accuracy of tumor size.

primary objectives: i. to compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional \[d\], magnetic resonance imaging \[mri\], contrast enhanced spectral mammography \[cesm\], 3d) to gold standard index lesion size from surgical pathology (the largest diameter). ii. to document the additional ipsilateral and contralateral breast cancer lesions detected by the mri, cesm, and 3d readings listed above. outline: patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. as part of the research study, patients receive contrast agent intravenously (iv) and then undergo a cesm with digital breast tomosynthesis (dbt) over 30 minutes. patients also receive a contrast agent, gadolinium, iv and undergo bilateral breast contrast enhanced (ce)-mri over 10 minutes. after completion of study, patients are followed up within 24-96 hours.

Eligibility criteria:
inclusion criteria: * newly diagnosed breast cancer patients exclusion criteria: * women with history of surgical, medical, or radiation therapy for breast cancer * women with renal failure or insufficiency * women with iodine contrast allergy * women with gadolinium contrast allergy * women who are pregnant, possibly pregnant, or lactating * women undergoing neoadjuvant chemotherapy
phase 1 safety testing of sar405838

Conditions: Neoplasm Malignant

Summary: primary objectives: * to determine safety and the maximum tolerated dose (mtd) of sar405838 through the characterization of dose-limiting toxicities (dlts). * to assess biological activities in patients with dedifferentiated liposarcoma during mtd cohort expansion. secondary objectives: * pharmacokinetic (pk) profile of sar405838. * biomarkers in association with sar405838. * anti-tumor activity in response to sar405838. * food effect on sar405838 pk. * compliance with sar405838 treatment. * cytochrome p450 3a4/5 (cyp3a4/5) activity.

total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. patients with lymphomas may be enrolled. * for dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status; for mtd cohort expansion, only dedifferentiated liposarcoma will be included. * presence of locally advanced or metastatic disease with at least one measurable lesion. exclusion criteria: * age \<18 years. * eastern cooperative oncology group (ecog) performance status of \>1. * life expectancy \<12 weeks. * unstable brain or leptomeningeal disease based on history and physical examination. * inadequate organ functions, positive pregnancy test. * pregnancy or breast-feeding. * any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin c or nitrosoureas) or 5 half-lives of the drug prior to study treatment, whichever is shorter, prior to study treatment. * unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods. * recent (3 months) history of acute pancreatitis. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study evaluating the safety and efficacy of hormone replacement therapy with st-1891 compared to levothyroxine in patients with primary hypothyroidism

Conditions: Hypothyroidism

Summary: st-1891-201 is a multicenter, randomized, double-blind, partial crossover, phase 2 study evaluating the safety and efficacy of hormone replacement therapy with st-1891 compared to levothyroxine in patients with primary hypothyroidism.


Eligibility criteria:
inclusion criteria: * diagnosed with primary hypothyroidism * on continuous thyroid replacement therapy with levothyroxine for at least 12 months immediately prior to screening * on a stable daily dose of levothyroxine for the 3 months prior to screening * willing to give written informed consent for the study exclusion criteria: * any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of st-1891 or levothyroxine * female patients who are pregnant or are breastfeeding starting 30 days prior to screening * anticipated initiation or change in concomitant medications * concomitant use of prohibited medications * currently participating in another clinical study or have received active treatment with an investigational drug within 30 days or 5 half-lives of the investigational drug of screening, whichever is longer
patient preferences with pharmaceutical care: in-person versus digital health

Conditions: Patient Preference

Summary: digital pharmaceutical care, also known as e-pharmaceutical care or telepharmacy, refers to using digital technologies to provide remote pharmaceutical care services. it involves the application of digital tools and platforms to deliver medication-related services, patient counseling, medication management, and other pharmaceutical care activities. it allows patients to access pharmaceutical services conveniently from their homes or any location with an internet connection. this is particularly beneficial for individuals with limited mobility, those living in rural or underserved areas, or patients with difficulty visiting a physical pharmacy. however, it is essential to note that while digital pharmaceutical care provides many benefits, it may only suit some patients or situations. some individuals may still prefer face-to-face interactions or may require hands-on assistance, especially for complex medication management. healthcare providers should assess the appropriateness of digital solutions on a case-by-case basis and ensure patient privacy and data security when implementing digital pharmaceutical care services.


Eligibility criteria:
inclusion criteria: * patients who took at least one medication in the past month * patient visiting two community pharmacies exclusion criteria: * those refusing to participate * those with severe hearing or mental problems

Keywords: pharmaceutical care preference digital care
sar3419 in acute lymphoblastic leukemia

Conditions: Acute Lymphocytic Leukaemia

Summary: primary objective: participants achieving an objective response rate secondary objectives: * response duration * progression free survival * minimal residual disease * safety * pharmacokinetics

the duration of the study for an individual patient will include: * the screening period = up to 4 weeks prior to the first administration of sar3419. * the treatment period: * induction period = 4 to 8 weeks * maintenance = up to a total maintenance treatment of 6 months * a safety follow-up period of 42 days after the last dose. * any patient who discontinues the study treatment without disease progression will be followed every 2 months until disease progression, initiation of a new anti-cancer therapy, death or end-of-study date, whatever comes first.

Eligibility criteria:
inclusion criteria: * previously treated acute lymphoblastic leukemia of b cell origin (including burkitt's lymphoma) in relapse or primary refractory. patients in first relapse will be eligible regardless of the first remission duration. * no more than 3 prior salvage therapies. * philadelphia positive patients failing treatment with imatinib mesylate are accepted. * cd19 positive patients. exclusion criteria: none the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
the feasibility of frame running as an exercise option for people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: there is ample evidence that regular exercise can reduce ms specific symptoms and improve health and wellbeing in people with ms. however, for people with ms to engage in exercise activities long term, it is important that they are offered a range of exercise opportunities that are safe, feasible and potentially effective to reduce ms symptom. this will allow people to select an activity they enjoy, is adapted to their needs and thus are more sustainable long-term. frame running (fr) provides an opportunity for people with walking and balance problems to walk or run safely without the risk of falling. the frame consists of three wheels and has a saddle and handlebars like a trike without pedals. the proposed mixed methods study aims to examine the feasibility and acceptability of fr as a sustainable aerobic exercise option for people with ms and the feasibility of conducting a future definite trial into the impact of fr on functional mobility, fatigue, cardiorespiratory function and psychosocial outcomes. people who experience problems with their walking and/or balance will be eligible to take part in this study which consists of a 12 weekly group fr training sessions led by a qualified coach. fr training attendance, recruitment, retention, outcome measure completion and adverse events will be recorded and the participant views on the feasibility, acceptability and impact of fr will be explored through the use of focus groups. physical function, physical activity and psychosocial outcomes will be assessed at baseline, 6 and 12 weeks.


Eligibility criteria:
inclusion criteria: * people with a definite diagnosis of ms according to the revised macdonald criteria, aged 18 and over, experiencing walking or balance difficulties but able to transfer independently will be eligible to take part in this study. this equates to people with an edss of 3.5 to 7. in order to be eligible for taking part in the frame running sessions, people should also be able comprehend and follow instructions relating to participation training as well as have sufficient understanding of the english language to complete the consent forms and questionnaires exclusion criteria: * those with contraindications to exercise, those unable to safely propel the frame for any distance on their own using the try-out sessions and those with more than 10 hours of fr experience will be excluded from participation in this study. other exclusion criteria are lower limb surgery less than 3 months prior to the start of the study, having started disease modifying and/or spasticity treatment less than 3 months prior to the start of the study and severe visual impairment affecting the ability to safely take part in frame running training sessions.