Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, pharmacokinetics, and pharmacodynamics of jnj-56022473 in subjects with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: the purpose of this study is to assess the safety and tolerability of jnj-56022473 following multiple subcutaneous (sc) study agent administrations in subjects with systemic lupus erythematosus (sle) and to determine whether premedication with corticosteroids is required to improve the tolerability of sc jnj-56022473.


Eligibility criteria:
inclusion criteria: * subject must have a body weight in the range of 40 to 100 kilogram (kg), inclusive, and have a body mass index (bmi) of 18 to 32 kilogram per meter square (kg/m\^2), inclusive, at screening * subjects eligible for enrollment in this study must qualify as follows: a) must meet systemic lupus international collaborating clinics (slicc) criteria for diagnosis of lupus and b) must have at least one non-serologic clinical activity defined by the systemic lupus erythematosus disease activity index 2000 (sledai-2k) within 3 months prior to first study agent administration * have a positive gene signature score during screening, prior to first administration of study agent * subjects using allowed pre-existing lupus treatments, if stable for at least 6 weeks prior to the first dose of study medication: 1. oral corticosteroids equivalent to an average dose up to or equal to (\<=) 10 milligram (mg) of prednisone/day 2. use of antimalarials (such as chloroquine or hydroxychloroguine) for at least 8 weeks 3. maximum of 1 non-corticosteroid immunosuppressive drug exclusion criteria: * subject with history or suspected occurrence of drug-induced systemic lupus erythematosus (sle) * subject has unstable lupus nephritis and/ or has active central nervous system (cns) lupus or history of severe cns lupus, including but not limited to seizures, psychosis, transverse myelitis, cns vasculitis and optic neuritis * major surgery prior to, and, if planned, during and shortly after the study is not eligible * subject has or has had an acute illness, including a common cold, within 2 weeks prior to the study agent administration or has had a major illness or hospitalization within 4 months prior to the screening visit * any other inflammatory diseases that might confound the evaluations of efficacy are excluded
a study comparing the pharmacokinetic, pharmacodynamic and safety of chf 1535 (fixed combination of beclomethasone + formoterol) administered via the next dpi, versus the free combination of licenced beclomethasone dpi and formoterol dpi in asthmatic adolescent and adult patients.

Conditions: Asthma

Summary: the purpose of this study is to demonstrate that the chf 1535 (fixed combination of beclometasone dipropionate (bdp) 100 µg / formoterol fumarate (ff) 6 µg) delivered via the next dry powder inhaler (dpi) does not show a greater exposure to bdp, beclometasone-17-monopropionate(b17mp, active metabolite of bdp) and ff in comparison to a free combination of bdp dpi plus ff dpi licensed products after a morning dose administration of bdp and ff (total dose of bdp 400 µg / ff 24 µg) in adolescent and adult asthmatic patients.


Eligibility criteria:
main inclusion criteria: 1. male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old) 2. written informed consent; 3. diagnosis of asthma as defined in the gina guidelines; 4. patients with stable asthma, according to the investigator's opinion; 5. asthmatic patients already treated with ics or using short-acting inhaled β2-agonists as reliever to control asthma symptoms; 6. patients with a forced expiratory volume in one second (fev1) \> 70% of predicted values; 7. patients with a peak inspiratory flow (pif) \> 40 l/min 8. reversibility test; 9. non- or ex-smokers; 10. a cooperative attitude and ability to be trained about the proper use of dpi and compliant to study procedures; main exclusion criteria: 1. pregnant or lactating female; 2. having received an investigational drug within 2 months before the screening visit 3. diagnosis of copd as defined by the current gold guidelines; 4. significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality; 5. known hypersensitivity to the active treatments; 6. history of drug addiction or excessive use of alcohol; 7. treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening; 8. hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit; 9. inability to perform the required breathing technique and blood sampling; 10. lower respiratory tract infection within 1 month prior to the screening visit; 11. blood donation (450 ml or more) or significant blood loss in the 12 weeks before the screening visit.

Keywords: asthma pk adolescents adults
screening of coexistence between sickle cell anaemia and g6pd deficiency

Conditions: Sickle Cell Disease and G6PD Deficiency

Summary: g6pd deficiency may have a subtle effect on the severity of hemolysis and also worsen the degree of anaemia in scd when the two disorders coexist. therefore, selective decision should be taken in patients in whom the two conditions coexist in the choice of drug and in the treatment of infections.the prevalence of the g-6-pd deficiency is high in scd patients, but does not differ from that observed among non-scd subjects .however, the g-6-pd deficiency appears to worsen the clinical features of scd, there were more hospitalizations, major vaso-occlusive crises among g-6-pd deficient sickle cell patients.

sickle cell disease (scd) is not frequent in egypt except in the oases where the carrier rate varies from 9 to 22%. it is a hereditary blood disorder characterized by the production of abnormal hemoglobin molecules that cause red blood cells to take on a crescent or sickle shape. this haemoglobin called haemoglobin s, which causes red blood cells to become stiff and sticky, leading to various health complications as recurrent pain, fatigue, anaemia, and increased infection susceptibility.prevalence of g6pd deficiency is 4.3% with a male:female ratio of 3.2:1. enzyme activity was significantly higher in males than females. it is located on x chromosome which leads to a lower level of reduced glutathione, an antioxidant, in red blood cells (rbcs). most of the time, those who are affected have no symptoms. however, they should avoid specific triggers that may promote oxidative stress such as fava beans, that may fragilize rbcs and cause hemolysis. g6pd deficiency may have a subtle effect on the severity of hemolysis and also worsen the degree of anaemia in scd when the two disorders coexist. therefore, selective decision should be taken in patients in whom the two conditions coexist in the choice of drug and in the treatment of infections. the prevalence of the g-6-pd deficiency is high in scd patients, but does not differ from that observed among non-scd subjects .however, the g-6-pd deficiency appears to worsen the clinical features of scd, there were more hospitalizations, major vaso-occlusive crises among g-6-pd deficient sickle cell patients.

Eligibility criteria:
inclusion criteria: - all new born with good general health exclusion criteria: * 1-new born with high reticulocytic count 2-new born with bad general health
quadruple versus sequential therapy for helicobacter pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: helicobacter pylori (hp), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. up to 20% of patients infected with h. pylori may develop peptic ulcers. however, failure rate is rising due to multiple resistant h. pylori infection. the eradication rate of first line clarithromycin based therapy has fallen to below 80%. both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. the aim of this clinical trial is to compare the efficacy and tolerability of h. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.

helicobacter pylori (hp), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. up to 20% of patients infected with hp may develop peptic ulcers. however, failure rate is rising due to multiple resistant hp infection. the eradication rate of first line clarithromycin based therapy has fell to below 80% and increasing number of patients also failed the second line quadruple therapy. the aim of this clinical trial is to compare the efficacy and tolerability of h. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment. methods: eligible h. pylori positive patients were randomized to receive either quad (esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline 500mg four times daily and metronidazole 400mg four times daily) for 10 days or seq (esomeprazole 20mg twice daily for 10 days, amoxicillin 1g twice daily for first 5 days, clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent 5 days). all patients returned 8 weeks after completing the treatment for a urea breath test (ubt) to confirm eradication. patients who failed their respective therapy were crossover to receive the alternative regimen.

Eligibility criteria:
inclusion criteria: * patients with age 18 or above, diagnosed to have gastric hp infection exclusion criteria: * patients with age less than 18, with past allergy to the study medications, concurrent critical illnesses, a history of previous upper gastrointestinal surgery, intake of nonsteroidal anti-inflammatory drugs, antibiotics, probiotics, bismuth preparation, proton pump inhibitors, anticoagulants or steroids in the previous one month, pregnant or breast-feeding women, drug abusers or alcoholic, history of previous h. pylori treatment

Keywords: sequential quadruple first line helicobacter pylori infection
the liberatory maneuver for the treatment of benign paroxysmal positional vertigo (bppv)

Conditions: Vertigo; Vestibular Disease

Summary: this study is being done because the investigators would like to know how effective the liberatory maneuver is in treating benign paroxysmal positional vertigo (bppv).

bppv is a problem with the inner ear that causes brief periods of vertigo triggered by changes in the position of the head such as rolling, looking up, or bending down. bppv is presently thought to be caused by small pieces of debris or crystals becoming displaced within the inner ear. it can be treated by moving the patient through a series of positions called a maneuver. there are 2 different maneuvers currently used to treat bppv by the clinician called the liberatory maneuver and the canalith repositioning procedure. we would like to determine how effective the liberatory maneuver is in the treatment of bppv compared to a placebo maneuver.

Eligibility criteria:
inclusion criteria: * bppv involving the posterior canal on only one side exclusion criteria: * no other canals involved (anterior canal or lateral canal), no central nervous system disorder, and no other medical condition that would not enable the individual to have the maneuver done.

Keywords: benign paroxysmal positional vertigo bppv pc bppn vertigo
resin infiltration to arrest early tooth decay

Conditions: Dental Caries

Summary: the purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.

a 3-year prospective, randomized control clinical trial (rct) is designed incorporating a split mouth intra-oral design. young volunteers (18-24 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to standard-of-care preventative measures. lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.

Eligibility criteria:
inclusion criteria: * dmft ≥ 3 (dmft = index of decayed-missing-filled permanent teeth) * having at least two early caries lesions in approximal posterior tooth surfaces * lesions visible on radiograph exclusion criteria: * current participation in another clinical study * medically compromised subjects * hyposalivation * pregnancy * allergic to methylmethacrylates * allergic to latex * symptomatic teeth

Keywords: dental caries proximal surfaces posterior teeth carious lesions tooth diseases preventive therapy
cost effective treatment for dually diagnosed homeless

Conditions: Cocaine Dependence; Mental Disorder; Homelessness; Unemployment

Summary: this randomized controlled trial examined whether an abbreviated treatment using abstinence contingency management for housing and work/training (cm, n=103) with cocaine dependent, non-psychotic, dually diagnosed homeless persons, would show non-inferior outcomes compared to the full treatment (cm+, n=103). it was hypothesized that cm+ would show superior abstinence and retention outcomes, but that cm, with components derived from previously effective behavioral day treatment, would obtain non-inferior outcomes, defined as 75% or more of those observed for the full treatment (cm+) during active treatment months 1-6. the cm+ included all cm components but added behavioral day treatment that included voucher reinforcement of $7.50-15.00, for objective weekly therapeutic goal attainment in five domains of functioning: drug dependence, homelessness, unemployment, non-drug related recreational activities, and behavioral, health, or mental health problems. abstinence was assessed by observed urine specimen collection and weekly testing weeks 1-52, and randomly, bi-monthly for months 13-18. abstinence, homelessness, employment and other outcomes were also assessed at baseline, 2, 6, 12, and 18 months.


Eligibility criteria:
inclusion criteria: mckinney act criteria for homelessness; dsm iv diagnosis for cocaine dependence; self-reported use within the last 2 weeks; psychological distress indicated by score of 70 on 1 or more brief symptom inventory scales; willingness to participate; no plans to move from birmingham area for 18 months; - exclusion criteria: cognitive impariment precluding informed consent; requiring immediate inpatient medical treatment

Keywords: cocaine dependence mental disorder dual diagnoses homelessness
use of the leva® pelvic health system for fecal incontinence

Conditions: Fecal Incontinence

Summary: the goal of this clinical trial is to learn about how the duration of use of the leva pelvic health system® affects treatment of fecal incontinence in women. the main question it aims to answer is to test whether use of the the leva pelvic health system® for 8 weeks is as good as using it for 16 weeks. participants will complete surveys, and use the leva device.

this study will assess whether 8 weeks of use of the leva pelvic health system (leva) is non-inferior to 16 weeks of use for the treatment of chronic fecal incontinence (symptoms \>/= 3 months) in adults with a vagina. participants will be instructed to complete pelvic floor muscle training using the leva for 8 or 16 weeks. the hypothesis is that 8 weeks of use of leva is non-inferior to 16 weeks of use, assessed by a validated fi symptom severity survey. surveys will be completed at 0 weeks, 16 weeks, and 24 weeks. long-term surveys will be completed at 1 year and 2 years from enrollment.

Eligibility criteria:
inclusion criteria: * adult, age ≥ 18years, assigned female at birth * fecal incontinence, defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment * able to stand to perform daily training for at least 3 minutes * able to speak and read english due to leva smartphone application availability in only english at this time * have an email address, owns a smartphone, and can download an app exclusion criteria: * inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum) * current diagnosis of colorectal or anal malignancy * diagnosis of uncontrolled inflammatory bowel disease * current rectovaginal fistula or cloacal defect * rectal prolapse (mucosal or full thickness) * inability to utilize smart phone technology ("app" use) * chronic stool types 6 or 7 * fecal impaction by exam * stage 4 pelvic organ prolapse * concurrent supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback * presence of sacral neuromodulator * pelvic floor surgery (including anal sphincteroplasty) within the past 3 months * currently pregnant

Keywords: anal incontinence accidental bowel leakage pelvic health system
health disparities on the labor floor

Conditions: Pain; Pregnancy Related

Summary: the agency for healthcare research and quality (ahrq) defines a disparity as a difference or a gap that exist between two groups, which is both statistically significant, larger than 10%, and indicates poor quality for the minority (non-referent) group. despite advances in public health initiatives and medicine, disparities in healthcare are persistent. for example, in the united states, maternal mortality ratio has doubled since 1987 to 2009 where african american women were 4 times as likely to die from childbirth. although there was no observed racial disparity in maternal deaths at university of alabama birmingham, there is anecdotal experience that may suggest health disparities do exist on the labor floor when examining neuraxial utilization and effectiveness. this retrospective study will seek to examine the successful extension of labor analgesia for cesarean section as it relates to insurance status.


Eligibility criteria:
inclusion criteria: * pregnancy * age \>/= age 18 years exclusion criteria: * women less than age 18 will be excluded.
influence of iodinated contrast volume injected during coronarography on contrast nephropathy.

Conditions: Nephropathy

Summary: coronary heart disease remains one of the main causes of death in the world. one of the treatments for coronary heart disease is percutaneous coronary intervention (pci). this requires the arterial administration of iodinated contrast medium (icp) to visualize the state of the coronary arteries and possibly apply the treatment. for the vast majority of the population, exposure to icp is perfectly well tolerated. nevertheless, some complications can occur including a nephropathy induced by the injection of a contrast product (nic). nic is the third cause of an acquired acute renal failure within the hospital.it significantly increases morbidity and mortality and prolongs the hospital stay. of all the procedures requiring icp administration, pci is associated with the highest rate of nic.this evidence is explained by the fact that patients benefiting from such exploration have a higher risk profile in terms of cardiovascular comorbidities and associated pathologies.age, preexisting alteration of renal function, diabetes mellitus, polypharmacy, congestive heart failure, type and volume of iodinated contrast medium are the main risk factors for developing nic. nowadays, the use of pci in the assessment of coronary heart disease in patients with these risk factors is becoming more frequent. this is linked to the aging of the population and the increasing incidence of cardiovascular diseases. icp-induced nephrotoxicity results from two main phenomena: the renal medullary hypoxia caused by the vasoconstriction of peritubular capillaries and a direct cytotoxicity towards tubular epithelial cells.these intra-renal mechanisms lead to an acute renal function impairment.nic is defined as an increase of serum creatinemia ≥ 0.5 mg / dl (or a 25% increase) from the baseline in the 48-72h following pc injection with no other obvious etiology. it reaches its peak between the 3rd and 5th day with a resolution in 10 to 21 days. the prevention of nic based primarily on the identification of patients at risk and the use of pharmacological means (as hydration protocol). in contrast, there is little data on the relationship between nic and the pci volume used. to the investigator's knowledge, the threshold of toxic volume is not well defined. taking into account these elements, the investigators propose to study the relation between the volume of iodinated contrast product injected during an icp and the occurrence of a nic according to the criteria mentioned above.


Eligibility criteria:
inclusion criteria: * all adult patients who have undergone percutaneous coronary intervention with contrast medium xenetic (lobitridol ®) in the chu brugmann hospital coronary angiography unit since 2013 * access to extensive demographic, clinical and biological data exclusion criteria: none
anti-ox40 antibody (medi6469) in patients with metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: this study will test the ability of an immune modulator, anti-ox40 (medi6469) to alter the immune cell environment within colorectal cancer metastases. the drug will be administered to patients before surgical treatment.

there will be three distinct cohorts of patients which will vary the timing of the medi6469 dose, starting three weeks before surgery and decreasing the interval before surgery by one week with each cohort, as long as no dose-limiting toxicity attributable to the anti-ox40 are observed. immunohistochemistry will be used to measure the immune cells within primary and metastatic tumors when resected tissue is available, and surgically ablated tumors, giving each specimen an "immune score". the primary endpoint of the study will be the difference in immune scores of patients treated with anti-ox40 compared to historical controls (immune scores of untreated patients). secondary endpoints will include both clinical (survival) and immunological data (specific measurements of immune cell populations based on flow cytometry and immunohistochemistry).

Eligibility criteria:
inclusion criteria: * patients who will undergo staged liver resections are included in this study. in these cases, preoperative medi6469 will be given prior to the initial procedure. * patients with small \ 2 cm away from central bile ducts will be considered for either radiofrequency ablation or resection, the choice of which will be determined at the time of surgery. * eastern cooperative oncology group (ecog) performance status 0 or 1 * laboratory values during preoperative assessment within the protocol specified range * ability to give informed consent and comply with the protocol. patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy. * no active gastrointestinal bleeding. * no clinical or laboratory coagulopathy * anticipated lifespan greater than 12 weeks exclusion criteria: * metastatic disease outside of the liver that is not considered surgically resectable or curable. * active infection. * active autoimmune disease including patients with inflammatory bowel disease as determined by an autoimmune questionnaire. * previous treatment with mouse monoclonal antibodies. * need for chronic maintenance oral steroids. * any medical or psychiatric condition that in the opinion of the pi would preclude compliance with study procedures. * enrollment in a clinical trial in which a different investigational agent is administered within 4 weeks prior to the first dose of medi6469.

Keywords: metastatic colorectal cancer liver lesion anti-ox40 antibody medi6469 immunotherapy