Kornimate/medical-research-clean huggingface dataset:
tmc114-c214: trial of tmc114 administered with low dose ritonavir (rtv) in hiv-1 infected treatment experienced patients

Conditions: HIV Infection

Summary: study tmc114-c214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of tmc114 boosted with low dose ritonavir (rtv) versus kaletra (lpv)/rtv in lopinavir-naïve treatment-experienced hiv-1 infected patients.

study tmc114-c214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability of tmc114 boosted with low dose ritonavir (rtv) versus kaletra (lpv)/rtv in treatment-experienced hiv-1 infected patients. this research study will look at the safety of tmc114 and effectiveness in reducing the amount of hiv(viral load) in the blood. people included in this study will have received either non-nucleoside reverse transcriptase inhibitors (nnrtis) or protease inhibitors (pis) or both. the duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period. tmc114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of ritonavir. kaletra (lpv/rtv) is either a tablet or capsule taken twice a day. the oral capsule contains 133.3 mg lpv, 33.3 mg rtv and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir. dosing for all medication will occur for 96 weeks and you will be randomly assigned to either tmc114 or kaletra.

Eligibility criteria:
inclusion criteria: * patient has documented hiv-1 infection * treatment with an antiretroviral regimen (containing at least 2 nrtis in combination with at least 1 nnrti and/or 1 pi) for at least 12 weeks * plasma hiv-1 rna \>1000 copies/ml * general medical condition does not interfere with the assessments and the completion of the trial exclusion criteria: * patients for whom an investigational antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval) * tenofovir, emtricitabine, atazanavir, fosamprenavir * previous or current use of lopinavir, enfuvirtide (t-20), tipranavir and tmc114 * life expectancy of less than 6 months * pregnant or breast-feeding * females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period * patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels * participation in other investigational trials without prior approval of the sponsor

Keywords: human immunodeficiency virus treatment experienced tmc114-c214
parents workgroup about emotion regulation

Conditions: Autism Spectrum Disorders

Summary: the purpose of this study is examine emotional regulation and reflective functioning in parents of children with autism spectrum disorders (asd) before and after an educational training (four sessions of group workshops). our experimental aims are the following: 1) examine parental emotion regulation and reflective functioning in daily life, 2) examine child emotion regulation in their daily life 3)learn about the training efficacy for asd parents. this research study will help to formulate innovative treatment methods to reinforce positive emotion regulation and reflective functioning in both asd children and their parents.

the parents will answer questionnaires and parent development interview (pdi) and the five minute free speech sample (fmss) as well as a number of other questionnaires. parents will be randomized between intervention group and control group. first session * introduction * setting expectations and goals * general explanation of emotions and their development. * how to recognize emotions? why is it important to recognize them? * minding parents and child emotions. second session * emotion regulation (general explanation). * strategic for emotion regulation (adults) * strategic for emotion regulation (children) * parental emotion regulation and the influence on the child emotion regulation * difficulties in er among children with asd third session * three steps method: feel, think-rethink, regulate. * theory, explanation and implementation. * discussion: role play of challenging highly affective parent-child interaction fourth session: * three steps method: feel, think-rethink, regulate. * theory, explanation and implementation. * discussion: role play of challenging highly affective parent-child interaction the parents will do another pdi and will fill up the questionnaires

Eligibility criteria:
inclusion criteria: * parents of children with autism ages 3-18 exclusion criteria: * if they cant understand english they can not be part of the study.
clinical trial to evaluate the efficacy and safety of 'ursa soft cap. (udca-003)' in fatigue patients with liver dysfunction

Conditions: Fatigue

Summary: a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'ursa soft cap. (udca-003)' in fatigue patients with liver dysfunction


Eligibility criteria:
inclusion criteria: * cis greater than or equal to 76, hads less than or equal to 10 * alt greater than upper limit of normal or fatty liver on us exclusion criteria: * subjects who have diseases that can cause fatigue * subjects who are taking medication that can cause fatigue
incidence and risk of influenza in myasthenic patients

Conditions: Myasthenic Crisis; Upper Respiratory Infection

Summary: upper respiratory infection , including influenza, may exacerbate the symptoms of myasthenia gravis (mg), which is an autoimmune disease that causes muscle weakness and, in some cases, can precipitate a myasthenic crisis in the present study, we investigated the incidence and risk factors of influenza infection on in myasthenia gravis patients.

this is a descriptive study. the data will be analyzed retrospectively . inclusion of 416 cases of influenza in myasthenic patients treated in the intensive care unit of garches hospital between january 1, 2009 and december 31, 2017. patients who meet the inclusion and non inclusion criteria and do not object to participate in the study will be collected in a database for analysis.

Eligibility criteria:
inclusion criteria: * men or women over the age of 18. * myasthenic patients hospitalized in intensive care. * patients with confirmed influenza infection exclusion criteria: * age \<18 years, * other neuromuscular diseases, * patient opposing the use of his data

Keywords: influenza a virus myasthenia gravis neurocritical care clinical neuromuscular disease
reno diet heart study

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to study weight maintenance behaviors, weight trends, and behavioral differences between healthy, normal weight and mildly obese adults.

background: the treatment of obesity has met with limited success and clinically significant weight losses have been difficult to achieve and maintain. screening to determine which patient will benefit most from treatment, emphasis on maintenance of weight loss and understanding individual weight trends and goals, all have demonstrated significant impact on long-term treatment outcome. stunkard established a new classification of obesity according to severity and predicted outcome to treatment, distinguishing mild and moderate overweight from severe forms of obesity. those who were classified as mildly obese were those who were most likely to be successful in traditional forms of treatment. a comprehensive study of this mildly obese population and normal weight maintenance behaviors provided important information on which to build future treatment interventions and/or effective strategies. this would be of particular importance in the prevention of obesity and progressive escalation of the obese state. design narrative: subjects were studied retrospectively by history and prospectively in their natural setting for five years. a 2 x 2 x 5 multifactorial design was used where sex (males versus females) and weight (obese versus normal) were crossed with five different age groups according to decades (20-29, 30-39, 40-49, 50-59 and 60 or more years) respectively. a total of 50 (25 normal and 25 obese) were recruited for each age/sex group. dependent variables included: weight, weight trends, fluctuation, body composition; diet; activity or exercise; weight maintenance behaviors and adaptive responses; general well-being, emotional states, psychopathology; routine blood and urinalyses; cardiovascular disease risk profile including lipids, blood pressure, sodium, potassium, calcium and phosphorus levels, diet, smoking, alcohol and caffeine use, onset of menopause and changes in medical status or medication use. comprehensive assessment was done yearly. the study was renewed in 1992 to extend follow-up and evaluation of the reno diet heart study and to complete and extend testing of the primary hypotheses. the three major hypotheses tested included: 1) weight fluctuations affected cardiovascular disease (cvd) risk factors over and above weight change alone; 2) weight changes, fluctuations and patterns interacted with nutritional, behavioral, psychological and medical factors, but these factors also affected cvd risk independent of weight; and 3) retrospective, self-reported weights, fluctuations and patterns were predictive of prospective weights and weight fluctuations. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
the effect of colchicine on the pharmacokinetic profile of lc350189 in healthy aldults.

Conditions: Gout; Hyperuricemia

Summary: this is a phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pk, pd, safety, and tolerability of lc350189 and colchicine when administered alone and in combination in healthy subjects.


Eligibility criteria:
inclusion criteria: * the subject is male or female 18 to 50 years of age, inclusive. * the subject has a body mass index 18 to 32 kg/m2, inclusive, at screening. * the subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram (ecg) results, and physical examination findings at screening. * the subject agrees to comply with all protocol requirements. * the subject is able to provide written informed consent. exclusion criteria: * the subject has a medical history with any issues affecting absorption or metabolism, as judged by the investigator. * the subject has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening. * the subject has used any prescription (excluding hormonal birth control and hormone replacement therapy) or over the counter medications (except paracetamol \[up to 2 g per day\]), including herbal or nutritional supplements, within 14 days before the first dose of study drug or throughout the study. * the subject has consumed grapefruit or grapefruit juice, seville orange or seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or throughout the study. * the subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug. * the subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake \>21 units per week for male subjects and \>14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint \[200 ml\] of beer, 1 small glass \[100 ml\] of wine, or 1 measure \[25 ml\] of spirits). * the subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug. * the subject is a female who is pregnant, planning to become pregnant within the next 6 months, or currently breastfeeding. * in the opinion of the investigator, the subject is not suitable for entry into the study.
feasibility of a smartphone application for asthma self-management

Conditions: Asthma Chronic

Summary: the primary goal of this project is to determine the feasibility, acceptability, and adherence of a smartphone application for improving asthma self-management in a pilot randomized controlled trial (rct). the app is specifically designed to appeal to adolescents. adolescents with persistent asthma will be randomized to receive: 1) standard-of-care or 2) the self-management app in addition to standard-of-care. feasibility will be assessed by the ability to recruit and retain subjects, technical barriers to implementation, and the appropriateness of the intervention among adolescents and providers. the acceptability of the intervention will be determined by appraising perceived usefulness, entertainment, and ease of use of the app. adherence to usage of the app over a 6-month period will be assessed by examining the frequency of app usage and the features that were used, and the extent of data regarding self-management that was entered. a secondary objective is to obtain preliminary estimates of effectiveness of the app on clinical outcomes (act score, spirometry, chsa-c, exacerbations, and medication adherence) relative to standard-of-care. it is hypothesized that the app will result in a high level of adherence and will be a feasible and acceptable intervention to improve self-management among adolescents with persistent asthma.


Eligibility criteria:
inclusion criteria: * at least 12 and less than 18 years at enrollment * established mild, moderate, or severe persistent asthma with a diagnosis verified by clinic physicians * speak english * not planning on moving out of the tampa bay area during the trial period * must have a suitable iphone or android device available to use with the app exclusion criteria: * having mental or other development disorder that may make self-management of a chronic condition difficult * having other chronic lung disease or one or more of the following disorders including cystic fibrosis, neuromuscular disease, immunodeficiency or autoimmune disorders, blindness or severe vision impairment that may interfere with the ability to use the mobile app * having participated in the app development phase of the funded project
robotic versus conventional training on hemiplegic gait.

Conditions: Stroke

Summary: the incidence of stroke in the industrial world is still high. most of the patients are suffering from paresis of the affected side, speech and cognition problems. modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. in the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. but so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.


Eligibility criteria:
inclusion criteria: * subacute first-time stroke patients(hemorrhage and ischemic) * age 18-80 years. * impaired functional ambulation category at initial score 0-2 * cardiovascular stable * given signed inform consent exclusion criteria: * unstable general medical condition * severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree * any functional impairment prior to stroke * can not adequately cooperate in training * severe communication problems * severe cognitive - perceptual deficits

Keywords: stroke rehabilitation gait training robot-assisted therapy
a double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity of oral ab1010 in adults patients with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: a double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity of oral ab1010 in adults patients with moderate to severe chronic plaque psoriasis

to evaluate the activity of oral ab1010, administered at two dose levels during 12 weeks to patients with moderate to severe chronic plaque psoriasis, assessed on : i)body surface area (bsa), psoriasis area and severity index (pasi), overall lesion severity (ols), physician's global assessment (pga) and patient's global psoriasis assessment (pgpa) ii)clinical and biological safety parameters iii) pharmacokinetic profile of ab1010

Eligibility criteria:
inclusion criteria: * male or female outpatients aged 18 to 75 years with chronic plaque psoriasis * plaque psoriasis covering ≥ 10% bsa * disease duration ≥ 6 months * pasi ≥ 12.0 at screening exclusion criteria: * guttate, erythrodermic or pustular psoriasis as sole or predominant form of the disease * clinically significant psoriasis flare during screening or at time of enrollment * systemic therapy for psoriasis or systemic immunosuppressive therapy for other indications within 28 days prior to enrollment * topical treatment for psoriasis within 14 days prior to enrollment * use of cyp3a4 moderate and strong inhibitors within 4 weeks prior to randomization * active current bacterial, viral (including hepatitis b and c, hiv, ebv, cmv, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection

Keywords: severe psoriasis kinase inhibitor masitinib
pda treatment with ibuprofen and changes in tissue oxygenation.

Conditions: Patent Ductus Arteriosus After Premature Birth

Summary: babies who are born very prematurely are often born with murmurs in the heart. in preterm babies, one of the most common causes of murmur is the presence of a pda. this is the persistence of a connection that normally exists in the baby before it is born, connecting between the major blood vessels that leave the heart. in term babies, this channel closes shortly after birth when normal adult circulation is achieved. however, in preterm babies, the pda can remain open, which can lead to multiple problems in the baby. our current standard of treatment in the neonatal intensive care unit (nicu) is to perform cardiac ultrasound (echocardiogram) in all babies less than 29 weeks gestation to diagnose the presence of hspda. we also use an echocardiogram to follow the pda until complete closure. if present, the standard treatment in the nicu is to give medication, usually ibuprofen, a non-steroidal anti-inflammatory drugs (nsaid), to close the pda. near-infrared spectroscopy (nirs) is a new type of device to detect oxygenated blood supply to the brain, kidney, and abdominal regions. this device is used to assess the effects of ibuprofen on oxygen supply to these three regions.


Eligibility criteria:
inclusion criteria: * preterm infants less than (\< )29 weeks gestation at birth * echocardiographic evidence of hspda (as outlined in the nicu pda treatment guidelines) at 7-21 days of life requiring pharmacologic treatment as determined by the managing physician. exclusion criteria: * not able to consent for any reason * preterm infants with congenital heart disease except for pda, pfo (patent foramen ovale), small and restrictive asd (atrial septal defect), or small vsd (ventricular septal defect). * preterm infants with lethal genetic malformations. * preterm infants with congenital abdominal wall defects (omphalocele, gastroschisis). * preterm infants with congenital or acquired brain anomaly. * infants who receive ibuprofen for pda treatment during the first week of life will be excluded. we will recruit infants between day 7 and 21 only because high-dose ibuprofen is not indicated during the first week of life * preterm infants with contraindications to ibuprofen therapy, including severe intraventricular hemorrhage (ivh), low platelet count \ 160 mmol/l or necrotizing enterocolitis (nec) \> stage 2 (using modified bell's criteria). * preterm infants with spontaneous intestinal perforation (sip). * acute kidney injury (defined as an increase in serum creatinine of 50% or more from the previous lowest value or a urinary output of less than 1 ml/kg per hr.).

Keywords: ibuprofen
effects of hysteroscopy and transvaginal surgery on reproductive prognosis in patients with post cesarean scar defect

Conditions: Post Cesarean Scar Defect; Hysteroscopy

Summary: the study is to compare hysteroscopic repair and transvaginal intervention for correcting uterine defect in patients with post cesarean scar defect (pcsd) and the reproductive prognosis.

post cesarean scar defect (pcsd), refers the lower uterine segment form a reservoir-like pouch during healing process after transverse lower uterine segment cesarean section connected with uterine cavity. the pouch has a valve-like effect, obstructing blood drainage and accumulating blood in depression. these causes may lead to a variety of gynecological disturbances, secondary dysmenorrheal and infertility. some patients can occur some serious obstetric complications, such as cesarean scar pregnancy and even the rupture of uterus during a subsequent pregnancy. at present, the causes and mechanisms of pcsd are not clear, diagnosis and treatment are not uniform. surgical methods include abdominal surgery, laparoscopic surgery, transvaginal surgery, hysteroscopic surgery, hysteroscopic with laparoscopic surgery and so on. hysteroscopic and transvaginal surgery to treating pcsd both are minimally invasive and feasible surgical approach. however, hysteroscopic surgery and transvaginal surgery have not been compared for correcting the uterine defect in patients with pcsd before.

Eligibility criteria:
inclusion criteria: * patients had a history of transverse lower uterine segment cesarean section; * patients had a previous regular menstruation, while after caesarean section, they occurred prolonged postmentrual bleeding (10-20days) * medication failed(contraceptive pills). * sex hormone test is normal; * tvu or hysteroscopy showed a triangular or u-shaped anechoic liquid dark area and on the anterior lower uterine segment in relation to cesarean section scar during menstruation of 7-12 days or hysteroscopic examination showed uterine anterior wall defect like dome changes at isthmus below internal orifice of cervix. exclusion criteria: * irregular menstrual cycle before cesarean section * previous placement of an intrauterine contraceptive device * presence of other organic uterine pathology responsible for abnormal uterine bleeding, such as endometrial hyperplasia, polyps or submucosal myomas, cervical cancer, endometrial cancer, etc * existence of endocrine diseases, such as dysfunction of pituitary, ovarian, adrenal gland, and thyroid; * coagulation dysfunction.

Keywords: post cesarean scar defect hysteroscopy transvaginal intervention endometrial receptive