Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety and efficacy of lenacapavir (gs-6207) in combination with an optimized background regimen (obr) in heavily treatment experienced participants living with hiv-1 infection with multidrug resistance

Conditions: HIV-1-infection

Summary: the primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly gs-6207) administered as an add-on to a failing regimen (functional monotherapy) in people with human immunodeficiency virus (hiv) (pwh) with multi-drug resistance (mdr).


Eligibility criteria:
key inclusion criteria: * adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in north america and dominican republic) * currently receiving a stable failing arv regimen for \> 8 weeks * have hiv-1 rna ≥ 400 copies/ml at screening * have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of arv) * have no more than 2 fully active arv remaining from the 4 main classes that can be effectively combined to form a viable regimen * able and willing to receive an obr together with lenacapavir * no hepatitis c virus (hcv) ongoing infection note: other protocol defined inclusion/exclusion criteria may apply.
to assess compliance with a once-daily regimen of lamivudine, efavirenz and didanosine

Conditions: AIDS

Summary: to assess compliance of once daily dosing to assess their benefits in terms of potency and safety as well as their impact on adherence and quality of life.


Eligibility criteria:
inclusion criteria: * 18 or older, required lab results, currently taking no more than two of the proposed once daily arm medications with medications administered twice daily and women of child bearing potential. exclusion criteria: * virological failure, serious medical condition, known toxicities to any of the once daily arm medications, lab abnormalities, women who are pregnant/breastfeeding
spine quantitative computed tomography (qct) for the assessment of osteoporosis on children

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to compare healthy children to children who have systemic lupus erythematosus (sle). sle is a childhood disease that has high risk for low bone mass and vertebral compression fractures.

the purpose of this research study is to measure bone mass in children with sle using different measurement techniques. children with chronic illnesses are at risk of bone fragility. this is important because bone fragility can result in childhood fractures especially children with sle. therefore better diagnosis technique can lead to better management of bone health.

Eligibility criteria:
inclusion criteria: * for sle subjects: subjects age 5-21 drawn from rheumatology clinic at children's hospital of philadelphia diagnosed with sle for at least 1 month. also subjects with no known vertebral compression fracture of l2. * for control subjects: subjects age 5-21. controls will be a 50% male/female. exclusion criteria: * for sle subjects: subjects with sle will be excluded if they have conditions or drug exposure unrelated to sle and known to impact growth or bone health. * for control subjects: chronic disease or syndrome known to affect growth or bone health, prematurity (\<37 weeks gestation), or use of any medication known to affect growth.

Keywords: systemic lupus erythematosus sle lupus children with sle
study to assess vb-201 in patients with psoriasis

Conditions: Active Plaque Psoriasis

Summary: the purpose of this study is to examine the efficacy, safety and tolerability of vb-201 as compared with placebo on measures of disease activity in patients with psoriasis.


Eligibility criteria:
inclusion criteria: * male or female patients, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months * non-anorexic subjects with a bmi ≥20 * psoriasis area and severity index (pasi) score of ≥12 * plaque psoriasis covering ≥10% of body surface area (bsa) * psoriasis severity at least moderate, scoring at least 3 on the 0 to 5 point physician global assessment (pga) scale exclusion criteria: * the subject presents with the predominant type of psoriasis as guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis * the subject has not undergone wash-out periods of sufficient duration for the following treatments at baseline: topical psoriasis treatments; systemic, oral or injected, psoriasis treatments; phototherapy * the subject anticipates getting enough ultra-violet light during the study to cause psoriasis to improve * the subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation * history of cancer, the exception is skin cancer * has a clinically significant systemic infection within 30 days of day 0, or a history or presence of recurrent or chronic infection * evidence of tuberculosis as indicated by a positive tuberculin skin test or a quantiferon test in subjects known to have a + ppd and a negative chest x-ray at screening * history of clinically significant hypoglycemia * subjects with currently active peptic ulcer / gastroesophageal reflux disease

Keywords: psoriasis
the efficacy of omega-3 in treatment of atrophic/erosive lichen planus

Conditions: Oral Lichen Planus

Summary: this study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of olp (presence of painful and atrophic-erosive oral lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines). 2. age between 30-60 years 3. ability to complete the present clinical trial. exclusion criteria: 1. pregnant or breast feeding women (pregnancy test for women of child bearing age). 2. lichenoid reactions caused by certain drugs or dental amalgam. 3. therapy for oral lichen planus (olp) in the 6 months prior to the study. 4. patient doesn't have hepatitis c \[after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2 5. presence of candidiasis before treatment. 6. patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dl before initiating steroid therapy were excluded. 7. hypertensive patients 8. contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations).

Keywords: oral lichen planus corticosteroid omega -3
investigating the effects of cardiac rehabilitation exercise modalities on physical and mental health outcomes

Conditions: Coronary Artery Disease (CAD)

Summary: coronary revascularization improves survival for patients with coronary artery disease. however,many patients are left with poor physical and mental health. traditional cardiac rehabilitation involves moderate intensity continuous exercise (mice). alternatives to traditional cardiac rehabilitation programming may however provide superior understudied benefits to patients with poor physical and mental health. nordic walking (nw) and high-intensity interval training (hiit) are two examples of alternative programs for cardiac rehabilitation, which may provide superior physical and mental health benefits when compared to traditional mice. the main purpose of this project is, therefore, to determine the short and long term physical and mental health benefits of alternative cardiac rehabilitation modalities, including nw and hiit on exercise capacity, quality of life and depression after a 12-week program.


Eligibility criteria:
inclusion criteria: * patient with cad who recently underwent pci (within 2-10 weeks) pci or coronary artery bypass grafting (within the last 18 weeks); * patient is referred to university of ottawa heart institute cardiac rehabilitation program; * patient is able to walk independently * patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks; * at least 40 years of age; * patient is willing and able to provide informed consent exclusion criteria: * currently participating in routine exercise training (\>2x/week) and/or using nordic walking poles; * active infection or inflammatory condition; * over 75 years of age; * persistent or permanent atrial fibrillation; * pregnant, lactating or planning to become pregnant during the trial period; * unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; * unable to read and understand english or french; * unwilling or unable to return for follow-up visit at weeks 12 and 26;

Keywords: coronary artery disease percutaneous coronary intervention (pci)
sevuparin/df02 as an adjunctive therapy in subjects affected with uncomplicated falciparum malaria

Conditions: Malaria, Falciparum

Summary: the purpose of this study is to determine the tolerability and pharmacokinetics of sevuparin/df02 when administered as an i.v. infusion in combination with malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. the study will also assess the potential of sevupatin/df02 to reduce infected erythrocyte sequestration and rosette formation. the study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with sevuparin/df02 and malanil® versus malanil® alone (part 2).


Eligibility criteria:
inclusion criteria: * presence of acute uncomplicated p. falciparum malaria, confirmed by positive blood smear with asexual forms of a single species (p. falciparum) * counts of asexual forms of p. falciparum: 10 000- 100 000/ul with or without gametocytaemia * presence of fever defined as \> 38°c tympanic temperature or a history of fever within the last 24 hours exclusion criteria: * mixed infection with other plasmodium species * any criteria of severe or complicated malaria as defined by the who, 2010 * use of high doses aspirin (more than 100 mg/day) or dual anti-platelet therapy or use of heparin,low molecular weight heparin (lmwh) or warfarin * presence of significant anemia as defined by hb \<8 g/dl or hct \< 25% * a platelet count \< 50,000/μl * presence of febrile conditions caused by diseases other than malaria

Keywords: uncomplicated falciparum malaria plasmodium falciparum antimalarial treatment sevuparin/df02 adjuvant therapy malanil peripheral blood parasitemia rosette formation maximum tolerated dose
prevalence of frailty and associated factors in coronary artery bypass patients

Conditions: Frailty

Summary: this study aimed to determine the prevalence of and factors affecting frailty in patients with coronary artery bypass graft. the main question it aims to answer are: what are the prevalence of and factors affecting frailty in patients with coronary artery bypass graft type of study: descriptive cross-sectional study participant population: coronary artery bypass grafting patients


Eligibility criteria:
inclusion criteria: * 18 years and older * planned cabg surgery * volunteer to participate in the study exclusion criteria: * limb amputations * stroke-related sequela * hearing problems * clinically unstable
the effects of dezocine pretreatment on dexamethasone induced perineal irritation

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the efficacy of dezocine pretreatment on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. the major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. some patients undergo spontaneous remission, while others develop into severe pain or pruritus. dezocine, a new synthetic opiate agonist-antagonist, has been used for the treatment of pain and pruritus, but its role in relieving dexamethasone induced perineal irritation has not been studied yet. the aim of this study was to investigate the efficacy of dezocine pretreatment on dexamethasone induced perineal irritation.

Eligibility criteria:
inclusion criteria: * aged 18-65 years * asa physical status i-ii * bmi 18-24.5 kg/m2 exclusion criteria: * on regular use of analgesic * contraindication or allergy to steroid or dezocine * drug or alcohol abuse * diagnosed with paresthesia or mental diseases * communication disorders * pregnancy or nursing

Keywords: dezocine dexamethasone 21-phosphate pain pruritus
influence of the use of hearing protection in the salivary cortisol level and in the sleep of premature infants

Conditions: Premature Newborn

Summary: the aim of this study was to investigate the influence of the use of headphones in salivary cortisol levels in newborns (nb) during periods of nap aimed at noise reduction, brightness and handling nb, measure the concentrations of salivary cortisol before (baseline) and after the use of hearing protection (response) in the neonatal intensive care unit (nicu). a nicu nap periods and compare the influence of the use and non-use of hearing protection in salivary cortisol levels and sleep patterns of infants during nap periods of the nicu.

the aim of this study was to investigate the influence of the use of headphones in salivary cortisol levels in newborns (nb) during periods of nap aimed at noise reduction, brightness and handling nb, measure the concentrations of salivary cortisol before (baseline) and after the use of hearing protection (response) in the nicu nap periods and compare the influence of the use and non-use of hearing protection in salivary cortisol levels and sleep patterns of infants during nap periods of the nicu. being the chance prosposta the use of headphones during periods of environmental control has an influence on the level of salivary cortisol and sleep in preterm infants. this is a randomized clinical trial, controlled, crossover, in which clinical intervention is introduced by the researcher that controls and varies, featuring experimental research. in this study the intervention being tested is the use of hearing protection in infants. the ear is employed in certain periods of the day. these periods established by the neonatal intensive care unit (icu), are intended to promote environmental noise control and manipulation of the nb. levels of cortisol present in the saliva of the newborn will be analyzed, allowing to measure the biologically active free cortisol in the body.

Eligibility criteria:
inclusion criteria: * premature newborn male or female; * inside the incubator; * clinically stable; * no change in evoked otoacoustic emissions; * current weight between 1200 to 2000g. exclusion criteria: * in phototherapy; * in invasive mechanical ventilation and noninvasive; * with any type of congenital malformation; * periventricular hemorrhage with grade ii, iii and iv; * in using any medication depressant, analgesic or corticosteroid in last 24 hours; * premature newborn whose mother has a history of illicit drug use during pregnancy.

Keywords: premature newborn cortisol stress
leukotriene d4 bronchial provocation test (ltd4-bpt) as an indicator for the use of leukotriene receptor antagonist (ltra)

Conditions: Bronchial Asthma

Summary: background: therapeutic outcomes of leukotriene receptor antagonist (ltra) vary in asthmatics，and there's not an ideal and simple way for prediction at present. objective：to investigate whether leukotriene d4 bronchial provocation test (ltd4-bpt) could be an indicator of actual therapeutic outcome of ltra. methods：a single centre, open-labeled trial was performed in 32 asthmatics with positive ltd4-bpt result for a month. all subjects were categorized according to airway responsiveness to leukotriene d4（pd20fev1-ltd4）. subjects received montelukast therapy (10mg, once per night), and reassessment was performed (3\~5) days after withholding ltra. the primary end-point was the difference in monthly pefr. secondary endpoints included the difference in feno, pd20fev1-ltd4, pd20fev1-mch, pre-test fev1, act score, aqlq symptom score, week 4 pefmax and pefmin as compared with week 1, gradual decrease in the use of salbutamol and the days without using salbutamol.

our primary goal was to determine whether ltd4-bpt could be a clear indicator for assessing efficacy of ltra. logistic regression model was adopted for statistical analysis. in this model, pre-treatment pd20fev1-ltd4 represented anticipated efficacy. the median of pd20fev1-ltd4 was used for classification of asthmatics, with a lower figure representing a better anticipated outcome. various variables, including the difference in pre- and post- treatment feno, pefmax, pefmin, pefr, pd20fev1 and asthma scores, were introduced in the model representing the actual efficacy of ltra. we aimed to test whether there would be certain parameters that assist prediction of anticipated outcome.

Eligibility criteria:
inclusion criteria: * subjects aged between 18 and 65，without acute upper respiratory tract infection for the past 2 weeks * had a normal chest radiographic result * had a baseline spirometry with the forced expiratory volume in one second (fev1) of not less than 60% predicted * had withheld leukotriene receptor antagonists (ltra) for over 5 days * oral glucocorticosteroid or anti-histamine for 3 days * oral xanthenes or long-acting bronchodilators for 2 days * inhaled corticosteroid or long-acting bronchodilator for a day as well as short-acting bronchodilator for 4 hours prior to the measurement exclusion criteria: * subjects had a fall of no less than 15% in fev1 after repetitive forced respiration or a fall of no less than 20% in fev1 after the inhalation of ethanol diluent control * had a past confirmed history of respiratory disease other than bronchial asthma (copd, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.） * had a poor cooperation to the test or limited understandings, were immunocompromised, or had participated other clinical trials for the past 3 months.

Keywords: leukotriene leukotriene receptor antagonist bronchial provocation test therapeutic outcome
dexmedetomidine pharmacokinetics in the obese

Conditions: Obesity

Summary: the aim of this study is to characterize, using two different modeling approaches, one based on purely statistic concept and one using a more mechanistic analysis, the influence of body weight and composition on the pharmacokinetic of dexmedetomidine.

twenty obese patients and 20 non-obese patients scheduled for elective laparoscopic surgery will give dexmedetomidine 0.5 μg.kg-1 over 10 minutes and then randomized to either dexmedetomidine 0.25 mcg.kg-1.h-1 or dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). blood samples will be taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion. population pharmacokinetic modeling will be performed using nonlinear mixed-effects model.

Eligibility criteria:
inclusion criteria: * american society anesthesiologist classification i-iii patients * between 18 and 60 years of age * scheduled for elective laparoscopic surgery * obese patients with a bmi \>35 kg m-2 (20 patients) * non-obese patients (bmi 18.5-25 kg m-2)(20 patients) exclusion criteria: * known allergy to study drugs * uncontrolled hypertension * heart block greater than first degree * those who had taken any drug acting in the central nervous system 24 h before surgery

Keywords: anaesthetics iv dexmedetomidine pharmacokinetic
inflammatory cytokines in symptom production in multiple myeloma

Conditions: Multiple Myeloma

Summary: the goal of this research study is to learn about the pain and/or other symptoms that patients may experience either while you are being monitored by your doctor before a decision is made to start you on treatment for your mm, or during and after treatment for mm, and how these symptoms may affect therapy. a second goal is to learn how differences in genes may affect the symptom burden from cancer and cancer therapy.

if you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled clinic visit. these questionnaires will measure pain and other symptoms, such as your mood and quality of life. you will also be asked to give a tissue sample by inserting a swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about a minute at most. completing the 5 questionnaires and the swab sample collection takes about 30 minutes in total. this is an investigational study. up to 500 patients will take part in the cross-sectional phase of this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. must speak and understand english; 2. must be diagnosed with mm and meet one of the following criteria: 1) have been treated for mm with steroids only, or have received no more than two cycles of induction chemotherapy for mm and are going to be treated with bortezomib or thalidomide for induction therapy; 2) have received induction therapy and have been approved (or are being approved) medically and financially to receive autologous hematopoietic stem cell transplantation (auto-hsct); 3) cross sectional study patients will be either with a current diagnosis of asymptomatic mm not receiving treatment; or at least 12 months from the mm diagnosis, had received induction therapy, with or without received autologous hematopoietic stem cell transplantation (auto-hsct) and follow-up treatments. this cohort for a cross sectional survey may include the cases been enrolled, either completed or dropped from the same study. it may also include patients who did not participate on the first phase of the protocol (longitudinal cohort). 3. patients \>= 18 years old. exclusion criteria: 1. patients who do not understand the intent of the study, so cannot or will not give informed consent 2. patients who are unable to use the interactive voice response (ivr) system due to physical limitations (e.g., hearing impairment). 3. induction therapy patients with a neuropathy score of 3 or greater on the nci's common terminology criteria (ctc version 3.0) either at the beginning of induction chemotherapy or after 1-2 cycles of chemotherapy as a result of previous treatment or from some other comorbid cause. this exclusion criteria does apply to the auto-hsct patients.

Keywords: multiple myeloma phone call treatment naive inflammatory cytokines questionnaire survey interactive voice response symptom production pain ivr mm
safety and efficacy of next generation ophthalmic irrigating solution compared to bss plus

Conditions: Cataract

Summary: the purpose of this study is to determine the safety and efficacy of next generation ophthalmic irrigating solution (ngois) compared to bss plus for use during cataract extraction and intra-ocular lens (iol) implantation.


Eligibility criteria:
inclusion criteria: * patients any race or sex 18 or older and undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens. * other protocol-defined inclusion criteria may apply. exclusion criteria: * under 18 * other protocol-defined exclusion criteria may apply.