Kornimate/medical-research-clean huggingface dataset:
clinical trial assessing once daily raltegravir administration (800 mg qd) in hiv-1-infected patients receiving unboosted atazanavir (400 mg qd)- based antiretroviral therapy

Conditions: HIV Infections

Summary: the co-administration of raltegravir with medicinal products that are knouwn to be potent ugt1a1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. so once daily raltegravir (800 mg qd), instead of twice a day (400 mg bid), could be an appropriate therapeutic option in hiv-infected patients also receiving atazanavir-containing antiretroviral regimens. in this study, pharmacokinetic data supporting this hypothesis are recovered.

treatment adherence is crucial for the effectiveness of antiretroviral therapy, and, in an attempt to promote treatment adherence by the patients, once daily (qd) regimens are preferred rather than twice daily (bid) regimens. the dose of 400 mg bid of raltegravir has been recently licensed for the treatment of human immunodeficiency virus (hiv-1) infection in treatment-experienced adult patients. raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase (ugt1a1)-mediated glucuronidation pathway. thus, co-administration of raltegravir with medicinal products that are known to be potent ugt1a1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. based on these data, it could be hypothesized that once daily raltegravir (800 mg qd) could be an appropriate therapeutic option in hiv-infected patients also receiving atazanavir-containing antiretroviral regimens. however, pharmacokinetic data supporting this hypothesis are lacking.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 65 years old with documented hiv-1 infection. 2. patients on antiretroviral regimen that includes atazanavir 400mg qd for at least 4 weeks. 3. complete virological suppression (\<50 copies/ml) for at least 12 months. 4. voluntary written informed consent. 5. ability of compliance with visit schedule. exclusion criteria: 1. aids defining condition within 4 weeks prior to the initiation of the study. 2. concomitant treatment with ritonavir as well as with inducers (nnrti, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit. 3. concomitant therapy with tenofovir. 4. history or suspected poor adherence to haart. 5. history of drug allergy to raltegravir

Keywords: atazanavir raltegravir once-daily pharmacokinetics hiv
hmg or recombinant fsh on ohss prevention in pcos patients undergoing ivf

Conditions: Polycystic Ovary Syndrome

Summary: there have been some controversies regarding the use of preparations with lh activity in patients with polycystic ovary syndrome (pcos) who have high endogenous lh activity. in this research we aimed to compare urinary menotrophin versus recombinant fsh (rfsh) with respect to the prevention of ohss

polycystic ovary syndrome was diagnosed according to the rotterdam criteria. patients older than 38 years or with serum fsh level ≥12miu/ml and a history of ovarian surgery were excluded from the study. all of our patients were given combined oral contraceptive (yasmin) prior to ovulation induction cycles. leuprolide acetate (lucrin daily; abbott, istanbul) therapy was started in mid-luteal phase to induce pituitary down regulation, and was initiated at a dose of 1.0 mg sc daily until pituitary down-regulation was established. the leuprolide acetate dose was then reduced to 0.5 mg daily until the day of human chorionic gonadotropin (hcg) administration. after gnrh analogue suppression was achieved, the patients were randomized using block randomization (block of two) to stimulation with hmg (menogon; ferring pharmaceuticals. istanbul) or rfsh (gonal-f; serono istanbul). starting dose was 150iu for the first 3 days of stimulation, after which daily dosing was determined individually. serial estrodiol (e2) levels and two-dimensional follicle measurements by transvaginal ultrasonography (logic 200 pro, general electric, korea) were performed until at least two dominant follicles reached dimensions of 18 mm or greater in diameter. human chorionic gonadotropin (pregnyl, organon, 10,000 iu- im) was then administered, followed by transvaginal oocyte retrieval 36 hours later. the criteria of coasting in our institute were serum e2 \>3600 pg/ml and multiple intermediate follicle. during coasting period, gonadotropin was withheld, but leuprolide acetate was continued at 0.5mg/d. icsi was performed for all the patients. fertilization was assessed at 20h (±1h), and embryo quality was assessed at 28, 44, and 68h (±1h) after oocyte retrieval. a top- quality embryo was defined as four to five cells on day 2, seven or more cells on day 3, and no multinucleation. vaginal progesterone gel 90 mg/day 8% (crinone;serono) for luteal support was given from the oocyte retrieval until the clinical pregnancy (9-10 weeks of gestation) or negative serum βhcg test (13-15 days after embryo transfer).

Eligibility criteria:
inclusion criteria: * women with pcos exclusion criteria: * patients older than 38 years or with serum fsh level ≥12miu/ml and a history of ovarian surgery were excluded from the study

Keywords: ivf icsi ohss pcos recfsh hmg
efficacy and safety of tildrakizumab 100 milligrams (mg) in participants with moderate-severe chronic plaque psoriasis and its impact on their quality of life (tribute)

Conditions: Plaque Psoriasis

Summary: the main aim of the study is to evaluate the efficacy, safety and impact on the health-related quality of life (hrqol) in participants with moderate-to-severe chronic plaque psoriasis who are treated with tildrakizumab 100 milligrams (mg).


Eligibility criteria:
inclusion criteria: * provide signed written and dated informed consent given before any study related activity is performed * participants with a diagnosis of moderate to severe plaque psoriasis * participants eligible for systemic biologic treatment as assessed by the investigator or having had a primary/secondary failure to treatment with one or more anti-tumor necrosis factor (tnf) biologic agents for psoriasis exclusion criteria: * unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study * participants meeting any of the exclusion criteria specified in the summary of product characteristics (smpc) of ilumetri® * women currently pregnant, or intend to become pregnant or breastfeeding. unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary) * other forms of psoriasis than chronic plaque-type * current severe and/or uncontrolled psoriatic arthritis (psa), or participants with psa that is currently receiving systemic treatment * drug-induced psoriasis at the screening visit * concurrent malignancy, current relevant autoimmune diseases other than psoriasis * participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the screening visit * active infection disease or history of recurrent infection * active or latent tuberculosis (tb) at screening visit * positive test for human immunodeficiency virus or any other immunosuppressive disease * participants with exposure to psoriasis systemic investigational drugs in the previous year * live vaccination within 4 weeks prior to the baseline visit * participants who intend to use any concomitant medication with immunomodulating or systemic corticosteroids

Keywords: tildrakizumab moderate-to-severe chronic plaque psoriasis quality of life (qol)
human anaplasmosis in eastern france

Conditions: Anaplasmosis; Tick-borne Disease; Ehrlichia

Summary: anaplasmosis is a tick-borne transmitted infection. its clinical expression include fever, cytopenia and hepatitis.this infection was initially described in united states. in europe, its epidemiology is not well known. some isolated cases have been diagnosed in several country, were the tick ixodes ricinus is known to transmitted another infection :the lyme borreliosis.the purpose of our study is to look systematically for anaplasmosis, in patient living in eastern france, and presenting with compatible clinical symptoms using a new diagnosis tool : pcr in blood samples. so we will have new data about epidemiology in our country and the clinical symptoms that are associated with anaplasmosis.


Eligibility criteria:
inclusion criteria: * patient with at least one of following symptoms : fever or muscular pain or articular pain or respiratory signs or neurological signs or meningitis or erythema occurring during the three weeks after a tick bite- * or * patient with fever with at least one of following criteria : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities. * or * patient with tick-borne encephalitis, or primary stage lyme borreliosis exclusion criteria: * children less that 10 years * pregnancy * patients with an other diagnosis that can explain clinical symptoms or biological abnormalities * antibiotherapy with cyclins during the days before inclusion
atrial fibrillation detection using garmin wearable technology

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the feasibility of detecting atrial fibrillation (af) in patients with af using a wearable wrist device/smart watch.

even though af is common and associated with increased risk of stroke, quite often it goes undetected until late in the course of the condition. if af can be detected with simpler tools like a smart watch, it would enable providers to identify patients with af much earlier in the course of the condition (even before being seen by a physician) and hopefully be able to prevent stroke. this study is being done to identify a technology that can likely identify af using a smart watch.

Eligibility criteria:
inclusion criteria: * all patients with af scheduled to undergo electrical cardioversion at the university of kansas health system exclusion criteria: * patients with no detectable ppg * hemodynamically unstable patients * patients who cannot give informed consent * patients with tattoos on the wrists

Keywords: smart watch garmin wearable cardioversion
safety, tolerability and efficacy of mbs2320 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. mbs2320, the drug being tested in this trial, represents a new approach to treating ra, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage.the aim of this project is to test the safety, tolerability and efficacy of mbs2320 in patients with ra in combination with an existing treatment, methotrexate.

rheumatoid arthritis is a chronic autoimmune disease characterised by synovial inflammation and cartilage and bone degradation, leading to joint destruction and progressive disability. the aim of the study is to evaluate the safety and tolerability of mbs2320 in patients with ra following chronic administration. in addition, the study aims to evaluate the effects of mbs2320 on measures of disease activity.

Eligibility criteria:
inclusion criteria: * male or female patients of childbearing or non-childbearing potential with with active ra, receiving stable once-weekly methotrexate * between 18 and 75 years of age, inclusive. exclusion criteria: * patients who are currently pregnant or breastfeeding. * patients who are being treated with biological or non-biological disease-modifying anti-rheumatic drug therapy. * patients with a history of any other inflammatory or arthritic disease in addition to ra that may interfere with the study.
safety and risk assessment of obese parturient underwent cesarean section(cs) delivery under different anesthesia ways

Conditions: Cesarean Section

Summary: 900 parturient who underwent cs under general anesthesia(ga) , intraspinal anesthesia included epidural anesthesia(ea) and combined spinal-epidural anesthesia(csea), which were divided into 3 groups: morbid obesity group (n=300) with body mass index (bmi) \>40 kg/m2 , severe obesity group (n=300) with 30 kg/m2≤bmi ≤40 kg/m2 and non-obesity group(n=300) with bmi\ 40 kg/m2, 30 kg/m2≤bmi ≤40 kg/m2 and bmi\<30 kg/m2.900 patients completed the protocol and related data were analysed.

900 parturient who underwent cs under general anesthesia(ga) , intraspinal anesthesia included epidural anesthesia(ea) and combined spinal-epidural anesthesia(csea), which were divided into 3 groups

Eligibility criteria:
inclusion criteria: * patients with asa physical status gradeιι～ιιι. exclusion criteria: * scoliosis, congenital heart disease, lung, liver, kidney diseases or increased intracranial pressure (icp)

Keywords: obesity anesthesia complications body mass index (bmi)
abilify as an adjunctive treatment for refractory depression

Conditions: Depressive Disorder, Major

Summary: this is a study of the effectiveness of adding abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (ssri) antidepressant treatment for depressed outpatients who are not responding fully to ssri treatment alone. it is hypothesized that patients' functioning will improve after 12 weeks of treatment with aripiprazole and ssri medication.

this is a pilot study of the effectiveness of adding abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (ssri) antidepressant treatment for depressed outpatients who are not responding fully to ssri treatment alone. fifteen subjects will be given aripiprazole in a flexible dosing schedule and followed for 12 weeks, while continuing their ongoing ssri medication. assessments of depressive symptoms, overall functioning, social functioning, and side effects will be completed. it is hypothesized that patients' functioning will improve after 12 weeks of treatment with aripiprazole and ssri medication.

Eligibility criteria:
inclusion criteria: * male and female outpatients between the ages of 18 and 70. * patients with a principal diagnostic and statistical manual fourth edition (dsm-iv) diagnosis of major depressive disorder, unipolar, nonpsychotic type * patients with a total of 14 or higher on the 17-item hamilton depression scale at baseline * patients who have had treatment with an ssri at an adequate dose (see table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in table 2) * patients who agree to use acceptable method of birth control throughout the study exclusion criteria: * patients with any of the following dsm-iv diagnoses: delirium, dementia, amnestic, or other cognitive disorders. bipolar disorder or cyclothymia, schizophrenia, delusional (paranoid) disorders and psychotic disorders not elsewhere classified, severe borderline personality disorder, anorexia nervosa, or bulimia. * patients who, within the past 6 months, met dsm-iv criteria for abuse of or dependence on any drug, including alcohol. * patients who are pregnant or nursing women. * patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the hamilton depression rating scale item #3 as rated by the treating clinician at week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening * patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure\>150/90), cardiovascular disease, diabetes, hiv (by report of patient). * patients with a history of seizures.

Keywords: major depression depression unipolar depression treatment resistant depression adjunctive treatment
responsiveness and mid of 4 metre gait speed in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this study measures the 4 metre gait speed (4mgs) test in patients with idiopathic pulmonary fibrosis (ipf). the investigators are interested to see whether usual walking speed in ipf patients changes following pulmonary rehabilitation and if it changes, what is the smallest change that is meaningful to patients.

this observational study is investigating a simple test of usual walking speed, measured using the 4 metre gait speed (4mgs) test in patients with a lung disease called idiopathic pulmonary fibrosis (ipf). drug development for this disease is slow in part because there is a lack of reliable measurements that can assess effectiveness of treatment. slow walking speed has been shown to relate to poor outcomes in older adults and people with another lung disease called chronic obstructive pulmonary disease (copd). the investigators are interested to see whether usual walking speed in ipf patients changes following a treatment called pulmonary rehabilitation (an exercise and education programme for patients with lung disease) and if it changes, what is the smallest change that is meaningful to patients (the minimum important difference - mid). the investigators are also investigating whether the change in walking speed can predict survival, number of hospital admissions and lung disease progression. this will help inform us of the potential use of 4mgs as an outcome measure. to do this, participants who consent to taking part in the study will be timed walking at their usual walking speed over a distance of 4 metres (13.12 feet) before and after a course of pulmonary rehabilitation and follow-up 1 year after completing pulmonary rehabilitation.

Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic pulmonary fibrosis according to nice guidelines referred for pulmonary rehabilitation * provided informed consent exclusion criteria: * significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation) * any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease) * any condition that precludes providing informed consent e.g. cognitive impairment or poor english

Keywords: gait speed pulmonary rehabilitation
parent mentor asthma study

Conditions: Asthma

Summary: asthma disproportionately affects minorities, but few studies have evaluated interventions to improve asthma outcomes in minority children.the purpose of the study is to determine whether parent mentors (pms) are more effective than traditional asthma care in reducing minority children's asthma morbidity, costs, and use of services, while increasing families' quality of life and parental self-efficacy.


Eligibility criteria:
inclusion criteria: * the child was 2-18 years old * african-american or latino race/ethnicity for the child (by parental identification) * primary residence in a milwaukee zip code * ed or inpatient ward admission with a primary diagnosis of asthma. exclusion criteria: * significant co-morbidity, including other pulmonary conditions, cardiac pathology, renal abnormalities, diabetes mellitus, epilepsy, and other co-morbidities that might lead to ed visits or hospitalizations, and current enrollment in a case management, intervention, or outreach program for childhood asthma management.

Keywords: using parent mentors to improve asthma care for urban minority children
a study of an investigational v212/heat-treated varicella-zoster virus (vzv) vaccine in immunocompromised adults (v212-002)

Conditions: Herpes Zoster; Herpes Zoster-related Complications

Summary: this study will evaluate the safety and immunogenicity of a heat-treated vzv vaccine in autologous or allogeneic hematopoietic cell transplant (hct) recipients, human immunodeficiency virus (hiv)-infected participants with a baseline cluster of differentiation 4 (cd4) cell count ≤200 cells/mm\^3, participants with solid tumor malignancy (stm; breast, colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with hematologic malignancy (hm; leukemia or leukemia-like disease, lymphoma or lymphoma-like disease, or multiple myeloma). the primary hypothesis is that the heat-treated vzv vaccine will elicit significant vzv-specific immune responses measured by either glycoprotein-based enzyme-linked immunosorbent assay (gpelisa) or vzv gamma interferon enzyme-linked immunospot (ifn-elispot) at 28 days post dose vaccination 4 in, hiv-infected participants, participants with stm, and participants with hm. the primary immunogenicity objective and endpoints were considered by the protocol as exploratory for the autologous and allogeneic hct groups.


Eligibility criteria:
inclusion criteria: * men and women \> or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment * hiv-infected participants with a baseline cd4 cell count \< or = to 200 cells/mm\^3 * participants with hematologic malignancies; or participants who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies exclusion criteria: * history of allergy to any vaccine component * prior history of hz * prior history of receipt of any varicella or zoster vaccine

Keywords: prevention of herpes zoster and hz-related complications