Kornimate/medical-research-clean huggingface dataset:
cefixime clinical trial

Conditions: Syphilis; Human Immunodeficiency Virus

Summary: this study aims to evaluate the efficacy of cefixime compared to benzathine penicillin g in the treatment of syphilis.

this will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin g (2.4 million units, intramuscularly) in patients with and without hiv infection. in total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the u.s. and peru. participants will participate in follow-ups to monitor clinical outcomes and serological response (rpr titer) every 3 months for 9 months. study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with hiv infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.

Eligibility criteria:
inclusion criteria: * diagnosed cases of primary, secondary, or early latent syphilis with rpr titer ≥1:8 within 3 weeks prior to enrollment * 18 years of age or older * able to provide informed consent * individuals with hiv infection must be on treatment for hiv infection and virologically suppressed (viral load \<200 copies/ml) or have a cd4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment exclusion criteria: * pregnancy or a positive pregnancy test on the day of enrollment * patients showing signs and symptoms of neurosyphilis * serofast rpr titer, defined as persistently positive rpr titer without more than 4-fold (2-titer level) change for 12 months or greater * recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin) * individuals with hiv infection who report hiv treatment interruption for more than 4 weeks since their most recent viral load or cd4 test * self-reported allergy to cephalosporins or penicillin * unwilling or unable to attend follow-up visits

Keywords: cefixime treponema pallidum penicillin early syphilis
trial of pxd101 (belinostat) in combination with idarubicin to treat aml not suitable for standard intensive therapy

Conditions: Acute Myeloid Leukemia

Summary: an open-label, non-randomized, multi-centre, phase i/ii trial to assess the efficacy and safety of 2 schedules of pxd101 in combination with idarubicin in patients with aml not suitable for standard intensive therapy.

this trial is an open-label, multi-centre, dose-escalation phase i/ii study to evaluate safety, explore efficacy, pharmacodynamics, and pharmacokinetics of the combination of pxd101 with idarubicin administered in two different schedules in patients with aml. the pxd101 plus idarubicin treatment will be repeated at suitable intervals (target is every 3 weeks for schedule a and every 2 weeks for schedule b) depending upon toxicities or disease progression. safety and efficacy assessments will be performed at every cycle. schedule a uses pxd101 by 30 min infusion daily for 5 days every 3 weeks with escalating doses of idarubicin. schedule b uses escalating doses of continuous infusion (48h) of pxd101 alone or in combination with idarubicin. in both regimens the trial may be expanded at the maximum tolerated dose (mtd).

Eligibility criteria:
inclusion criteria: (abbreviated) 1. signed consent 2. aml patients: 1. above 60 years in first relapse or refractory. 2. 18-60 years 2nd relapse or refractory to at least two intensive chemotherapy regimens. 3. above 60 years with high risk features (cytogenetics, secondary or treatment related aml) d) above 60 years with myelodysplastic syndrome with \>10% blasts in bone marrow (who raeb-2 (refractory anemia with excess blasts-2)). for patients below 60 years potential curative treatments should have been exhausted. 3. performance status (ecog) ≤ 2 4. age ≥ 18 years 5. acceptable liver, renal and bone marrow function as defined 6. serum potassium within normal range. 7. acceptable coagulation status as defined 8. precautions for female patients with reproductive potential as defined exclusion criteria: 1. treatment with investigational agents within the last 4 weeks 2. prior treatment with hdac (histone deacetylases) inhibitors including valproic acid 3. prior anti-leukemic therapy (except hydroxyurea) within the last 3 weeks of trial dosing 4. co-existing active infection (including hiv) or any co-existing medical condition likely to interfere with trial procedures, including significant cardiovascular disease 5. altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures. 6. concurrent second malignancy. 7. history of hypersensitivity to idarubicin 8. cumulative idarubicin dose exceeding 100 mg/m², or a (with respect cardiotoxicity) corresponding dose of other anthracyclines 9. lvef (left ventricular ejection fraction) below normal range (\< 45% ) 10. known central nervous system (cns) leukemia

Keywords: acute myeloid leukemia pxd101 belinostat idarubicin
leveraging mobile health technology to optimize early stimulant medication treatment: a feasibility pilot

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the goal of this study is to develop and test a mobile web application to optimize early stimulant medication treatment for children receiving care for attention/deficit hyperactivity disorder (adhd) in a publicly-funded mental health clinic.

in other words, the study will find out whether it is feasible and acceptable for parents to receive reminders for clinic visits and adhd medication and enter daily ratings of their child's adhd symptoms and medication side effects into a smart phone. it will also examine whether it is feasible and acceptable for doctors to use this information summarized on a tablet (ipad) screen during a medication follow-up visit. if the parent consents, the study will also examine whether it is feasible and acceptable for the child's teacher to enter their ratings of adhd symptoms twice a week using a link on their email. this information will also be included in the doctor's ipad screen. if this technology is found to be promising, then a larger study will be done to examine if medication treatment is safer, more consistent, and more effective using this technology compared to usual care. this is important because the technology may remove the burden on parents and teachers to report adhd symptoms and medication side effects using paper forms, and for doctors to record this information in the medical record. in total, there will be 12 parent/ child dyads, 6 clinicians and up to 12 teachers enrolled. each parent/child dyad will be videotaped for up to 3 visits with the clinician (n=36 videotaped sessions). the study time period is from the first visit that adhd medication is prescribed to the time of the third follow-up medication visit. we anticipate that the follow-up visits will be every 1-2 weeks during this early phase of stimulant medication treatment. thus, the study time period for each parent/child dyad will be between 4-8 weeks. we anticipate that data collection will occur between august 19, 2013 and june 31, 2014.

Eligibility criteria:
inclusion criteria: * parent's and child's primary language is english or spanish * child is between 5-11 years * child received a clinical diagnosis of adhd * child is receiving stimulant medication for the first time * child does not take any other medication on a regular basis (like every day) exclusion criteria: * any chronic medical condition that requires on-going medication management * prescription of combined psychotropic medication * moderate-severe developmental delays, mental retardation or autism

Keywords: adhd
genetic determinants and clinical consequences of early-onset severe obesity

Conditions: Childhood Obesity

Summary: the aim of the present study is to identify new obesity-related genetic defects and determine their association with clinical manifestations in families with childhood-onset severe obesity. the investigators hypothesize that by exploring children with severe early-onset obesity they can find new obesity-related genetic defects and by exploring obesity-associated clinical manifestations the investigators can elucidate the outcomes of severe childhood obesity.

obesity is a complex disorder with many contributing genetic and environmental factors. the genetic causes and mechanisms for severe childhood obesity are still incompletely understood. it is acknowledged that obesity in some individuals could be a consequence of rare genetic variants with strong effect - these rare variants might be population specific. the aims of this study are to determine * inheritance patterns of early-onset obesity * new obesity-related genetic variants and disease-causing gene mutations * the association between obesity-related genetic defects and clinical manifestations * the association between obesity-related genetic defects and psychiatric symptoms in patients with early-onset obesity and their first-degree relatives significant advancements in genetic methodology provide new tools to explore genetic defects underlying obesity. family-based approach provides several advantages compared to cohort studies to investigate genetic determinants of complex diseases.the unique genetic composition of the finnish population enables identification of novel genetic entities. discovery of genetic defects associated with severe childhood-onset obesity will increase the investigators understanding of the pathogenesis of obesity and allows early detection, by genetic testing, of those at increased risk and optimal targeting of preventive measures.

Eligibility criteria:
inclusion criteria: * children and adolescents age 10-18 years * height-adjusted weight \>60 % before the age of 7 years. * finnish descent exclusion criteria: * patients with a known endocrine or genetic disorder underlying obesity (e.g. prader-willi syndrome, hypercortisolism, hypothyroidism)
food concentrates supplementation to alleviate asthma in children

Conditions: Asthma

Summary: the purpose of this study is to determine whether food concentrates supplementation (vegetable plus fruit, fish, probiotics) are effective to alleviate drug used, asthma symptoms and lung function in children due to asthma.

the prevalence of asthma is increasing in taiwan and worldwide. this could be related to dietary factors and their interactions with genes and the environment. ample evidence from cross-sectional and case-control observational studies suggested that consumption level of fruits, vegetables, and potentially vitamins a, c, e from foods have negative association with asthma risk, and positive association with lung function. however, single nutrient supplementation neither improved asthma symptoms and lung function, nor reduced inflammatory mediators. some studies had shown probiotics could regulate human immunity. a number of trials have suggested that fish oil supplement improves lung function and reduces inflammatory mediator. the potential interactions among multiple components in foods have been neglected in the past. recently, observational studies on dietary pattern analyses or intervention trials modifying the overall dietary composition have caught tremendous scientific attentions. therefore, the investigators will design an intervention trial with food-based principle to investigate the the joint effect of several beneficial dietary components on asthma symptoms. for practicality and efficiency, vegetable plus fruit concentrates, fish oil, and probiotic concentrate are considered as supplements to asthmatic children. the investigators hope that the study can provided a direction for dietary modification in asthma children.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma exclusion criteria: * subjects received immunotherapy over the past 6 months * long-term used oral corticosteroids * have other diseases such as heart disease, kidney disease, liver abnormalities * have been supplement fish oil, probiotics, and high levels of vitamin supplements in the past three months * vegetarian * subjects have hemorrhagic disease

Keywords: asthma
hormonal and metabolic consequences of sleep disorders in young obese patients

Conditions: Obesity; Sleep Disorders

Summary: there is a well-documented relationship between short sleep duration and high body mass index (bmi). the mechanism linking short sleep duration and weight gain is unknown. current studies in healthy young volunteers have shown that experimental sleep restriction is associated with dysregulation of the neuroendocrine control of appetite and with alterations in glucose metabolism. the goal of our study is to determine the metabolic and hormonal modifications induced by chronic sleep curtailment in obese adolescents and young adults and to observe if short sleep is a negative prognostic factor in their weight evolution.

the main purpose of the study is investigate whether the concentrations of 2 hormones that regulate appetite (leptin, ghrelin), cytokines (tnf-a, il-6) and crp are modified in obese adolescents and young adults who had sleep disorders in comparison to obese adolescents and young adults who sleep longer.

Eligibility criteria:
inclusion criteria: * 13-25 years old * bmi \> 30 kg/m2 (if adolescents aged under 18 years: bmi equivalent to a bmi for age and sex to a bmi of 30, according to the cole et al. obesity criteria). exclusion criteria: * infection * liver disease * chronic inflammatory disease * endocrine disease * use of drugs that alter the sensitivity of insulin
functional outcomes from diets in multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Summary: the purpose of this study is to test the effects of two dietary interventions, glycemic load and calorie restriction, on physical function, cognition, pain, fatigue, mood, and anxiety in adults with multiple sclerosis (ms). the investigators will also explore the how the diet interventions impact inflammation, immunity, and metabolic biomarkers.

100 participants will be randomized 1:1 to follow either a low glycemic load (gl) or standard gl diet for 32 weeks. for the first 16 weeks, all participants will eat enough calories to maintain their baseline weight. during the second 16 weeks, all participants will reduce calorie intake by 500kcal/day, with a goal of losing 5-10% of initial body weight. participants will complete data collection at baseline (prior to randomization), at 17 weeks (after the weight stable phase) and again after completing the calorie restriction phase. all participants will receive meal plans and groceries for the duration of the trial.

Eligibility criteria:
inclusion criteria: * diagnosed with rrms or spms * bmi 25-50 kg/m2 (overweight/obese) * edss ≤6.5 (able to walk 100m with or without assistance) * if on disease-modifying treatment (dmt), stable for 6 months * if not on dmt, no dmt in previous 6 months * no expected change to dmt in next 34 weeks * responsible for food preparation or have input into food preparation exclusion criteria: * ms relapse in previous 30 days * unable to walk 25 feet with or without assistive device * pregnant or breastfeeding * current use of insulin or sulfonylurea agents * score indicating low cognitive functioning on the telephone interview for cognitive status (tics-m) assessment * actively engaged in a weight loss program or unwilling to follow assigned dietary pattern * unable to receive, store, or prepare food according to diet plan * medical contraindication to either treatment or control diet (including severe allergies that cannot be accommodated within either group)
a study of brentuximab vedotin in adults with cd30-positive lymphoma

Conditions: Lymphoma

Summary: participants with cd30-positive lympoma will be treated with brentuximab vedotin according to their clinic's standard practice. the main aim of this study is to collect information on any side effects from treatment with brentuximab vedotin. other aims are to collect information on how brentuximab vedotin is used to treat these participants and the outcomes of these participants.

this is an observational, non-interventional, prospective study in participants with cd30-positive lymphoma who are receiving or will receive the standard treatment of brentuximab vedotin. this study will assess the safety profile and effectiveness of brentuximab vedotin in the real-world clinical practice. the study will enroll approximately 1000 participants. the data will be collected and recorded in the medical record for the purpose of medical care and also recorded in electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: • all participants with cd30-positive lymphoma this multi-center trial will be conducted in china. all participants will be followed up for 24 months unless withdrawal of informed consent, lost or death, whichever comes first. the overall duration of the study will be approximately 4 years.

Eligibility criteria:
inclusion criteria: 1. undergoing treatment with brentuximab vedotin (of less than 3 months from initial treatment with brentuximab vedotin) or to be received with brentuximab vedotin. 2. cd30-positive lymphoma by inv (any cd30 expression) exclusion criteria: 1. who currently participates in or with plan to participate in any interventional clinical trial.

Keywords: drug therapy
phase 2 chronic low back pain study

Conditions: Chronic Low Back Pain

Summary: the primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

this phase 2, multicenter, double-blind (db), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (clbp). participants met pre-defined criteria at the conclusion of the open-label (ol) titration period to proceed to randomization into the double-blind (db) maintenance period of the study. study drug was given for a total of approximately 5 weeks, which included 2 weeks in ol, 2 weeks in db, and a 3-day taper. during the ol period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. during the db period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily.

Eligibility criteria:
inclusion criteria: adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration exclusion criteria: subjects with a history of surgical or invasive intervention
randomized study of sunitinib plus folfox versus bevacizumab plus folfox in metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: this study will compare the safety and efficacy of sunitinib in combination with folfox versus bevacizumab in combination with folfox for the treatment of patients with metastatic colorectal cancer who have not been treated before.

the study was terminated on april 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in april 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in pfs. the decision to terminate the trial was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the colon or rectum with locally advanced or metastatic disease * evidence of measurable disease per response evaluation criteria in solid tumors (recist) * eastern cooperative oncology group (ecog) 0 or 1 exclusion criteria: * previous treatment with sutent, avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer * less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease * history of cardiac disease * brain mets

Keywords: metastatic colorectal cancer sunitinib (sutent) bevacizumab (avastin) randomized study
the long-term success of cardiovascular surgery in takayasu arteritis

Conditions: Arteritis, Takayasu

Summary: takayasu arteritis (ta) affects medium and large caliber arteries causing stenosis, occlusion or aneurysms. it has great predilection for the aortic arch, subclavian and extracranial arteries. the global prevalence is of 1 to 2% per million inhabitants, which varies by geographical region. the main cause of death in ta is of cardiovascular origin and includes ischemic cardiomyopathy and valvular disease. the aim of this study was to evaluate the surgical experience according to the type of surgery in subjects with ta with and without inflammatory activity. methods: this was a retrospective, descriptive, cross-sectional study run between 1977 and 2017. patients with takayasu arteritis with more than 3 classification criteria according to the american college of rheumatology (acr) were included. the surgeries were classified as: organ preservation, cardiac, bypass, exclusion and replacement. inflammatory activity was evaluated.

a review of the clinical records of patients diagnosed with ta with more than 3 criteria of the american college of rheumatology (acr) and undergoing some surgical procedure by the surgery service of the national institute of cardiology "ignacio chávez", in a period of time comprised between 1977 and 2016 was done. patients of any gender and age who had been operated on by a surgical procedure registered in their medical record were included. patients intervened in other institutions were excluded. the surgical event was classified into 6 groups: 1) organ-preservation surgery (mainly renal autograft); 2) bypass (revascularization of affected organs or segments with woven dacron graft); 3) replacement (replacement of affected aortic segment with a woven dacron graft); 4) cardiac surgery (direct procedures in heart); 5) exclusion (resection of an affected organ (nephrectomy)), and 6) other. inflammatory activity was evaluated according to the dabague-reyes criteria, in which a score greater than or equal to 5 is considered as active inflammation (9). statistical analysis: variables with a loss of the sample data greater than 20% were excluded. the categorical variables were described by percentages and prevalences and the comparison were done by chi square or fisher's exact test. a statistically significant level was considered when an error α \<0.05 was found. parametric numerical variables are described by measures of central tendency and the comparison is made by student's t test. the survival analysis was performed using kaplan-meier. ethical aspects were considered according to the helsinky declaration.

Eligibility criteria:
inclusion criteria: * patients of any gender regardless of age that has a diagnosis of ta established by a rheumatologist, * have a surgical procedure registered in your medical record exclusion criteria: * not having a digital, physical or microfilmed medical record * surgical procedures performed at another institution