Kornimate/medical-research-clean huggingface dataset:
study of combination treatment with imo-2125 and ribavirin in naïve hepatitis c-infected, genotype 1 patients

Conditions: Hepatitis C, Treatment Naïve, Genotype 1 Patients

Summary: phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of imo-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (rbv). each cohort of 15 patients will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo and rbv arm (3 patients).

this is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of imo-2125 in combination with standard ribavirin or placebo plus ribavirin. each cohort will be randomized 4:1 to receive the investigational treatment arm or placebo and ribavirin. three varying dose levels of imo-2125 will be included. in both arms, ribavirin will be dosed based on patient weight. approximately 50 patients will be enrolled in france and russia. patients will provide informed consent prior to any screening procedures being performed. screening will occur within 21 days prior to randomization. enrolled patients who qualify and proceed successfully through the screening period will be randomized to receive 4 weeks of either the investigational treatment arm (imo-2125 and ribavirin) or placebo and ribavirin, with a 4 week follow-up period. patients who are randomized to the investigational treatment arm will receive one of 3 dose levels of imo 2125 sc once weekly; each patient will receive the same dose throughout the 4 weeks of treatment. in addition to imo-2125 treatment they will also receive daily ribavirin, which will be given based on the patients weight and will be taken twice daily for a total of 4 weeks.

Eligibility criteria:
inclusion criteria: * documented genotype 1 * hcv-positive with documented detectable plasma viral concentration \> 10,000 iu/ml exclusion criteria: * positive test for hiv or hbsag * inadequate bone marrow, liver, and renal function * treatment with any ifn-based or other experimental or antiviral therapies - prior or current * other significant medical disease * concurrent or planned treatment during the study
network analysis of urinary molecular signature complements clinical data to predict postoperative acute kidney injury

Conditions: Acute Kidney Injury

Summary: the risk for postoperative acute kidney injury (paki), as for any other postoperative complications (pc), comes from a number of interactions between a patient's health before surgery, strength to tolerate surgery and influences on the operating room environment. at this time doctors do not have good tools to predict which patients may be at risk of having this complication. the purpose of this research study is to develop a urine test that can be used to predict the risk for having problems with kidney function after major surgery.

during hospitalization, a urine sample will be collected and additional tests will be added to the daily standard of care blood samples before, during and three times following an elective surgical procedure. study participants will complete telephone interviews at 6 and 12 months after discharge from the hospital with a study team member. the telephone interview will consist of a short questionnaire asking about state of health and a health survey. at the same times of the phone interviews, the study team will mail a urine dipstick that is used to detect any amount of protein in the urine. study participants will be asked to urinate on dipstick and send it back to the study team in provided shipping material. healthy controls will be enrolled to establish baseline values for kidney health based upon a single urine collection and a brief health questionnaire.

Eligibility criteria:
inclusion criteria for surgical group: * patients undergoing major in-hospital surgery * planned hospital stay of at least 24 hours * able to enroll prior to undergoing surgery exclusion criteria for surgical group: * patients not recruited 4 hours prior to undergoing surgery inclusion criteria for healthy volunteers: \> 18 years old that elect to serve as a control group exclusion criteria for healthy volunteers: renal replacement therapy aki/ckd nephrectomy organ transplant any of the following within the last 12 months: * stroke/transient ischemic attack * heart attack * major thoracic, abdominal, or vascular surgery * radiation therapy * chemo therapy * immunosuppressive therapy iv contrast within the past 72 hours

Keywords: postoperative acute kidney injury paki stress injury on the kidney chronic kidney disease ckd
a study of palbociclib (pd-0332991) + letrozole vs. placebo+ letrozole for 1st line treatment of asian postmenopausal women with er+/her2- advanced breast cancer [paloma-4]

Conditions: Breast Neoplasms

Summary: the study is designed to compare the clinical benefit following treatment with letrozole in combination with palbociclib versus letrozole in combination with placebo in asian postmenopausal women with er(+)/her2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.


Eligibility criteria:
inclusion criteria: * adult asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy * confirmed diagnosis of er positive breast cancer * no prior systemic anti-cancer therapy for advanced er+ disease * postmenopausal women * measurable disease as per response evaluation criterion in solid tumors \[recist\] or bone-only disease * eastern cooperative oncology group \[ecog\] 0-1 * adequate organ and marrow function * patient must agree to provide tumor tissue exclusion criteria: * confirmed diagnosis of her2 positive disease * patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term * known uncontrolled or symptomatic cns metastases * prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment * prior treatment with any cdk 4/6 inhibitor

Keywords: breast cancer postmenopausal women estrogen-receptor positive her2 negative locoregionally recurrent metastatic
efficacy and safety of regan tangjiang for treating the common cold with wind-heat syndrome

Conditions: Cold

Summary: efficacy and safety of regan tangjiang for treating the common cold with wind-heat syndrome: a multicenter, randomized, double-blind, parallel-group, placebo and active-controlled phase 2b study


Eligibility criteria:
inclusion criteria: * diagnosis of common cold according to western medicine，with symptoms onset and fever less than 24 hours prior to randomization； * after the onset of the disease, with the following symptoms: sore throat and axillary temperature between 38.5 and 38.9°c inclusive. * diagnosis of wind-heat syndrome according to tcm； * aged between 18 to 65 years； * willingness to participate and to sign the informed consent form. exclusion criteria: * participants with pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute and chronic sinusitis, pulmonary tuberculosis and other diseases; * white blood cell count \>11.0×109/l, or neutrophil percentage\>75%; * participants with liver function 1.5 times higher than the normal upper limit or serum creatinine higher than the normal upper limit; * participants with severe primary diseases of cardiovascular, brain, lung, liver, kidney and hematopoietic system , such as viral hepatitis, hemophilia, diabetes, psychosis and so on; * participants who had used other drugs to treat common cold after the onset of the disease, including antivirals, antibiotics and traditional chinese medicine. * women who are pregnant or breast-feeding; * allergic condition (refer to history of allergy to two or more drugs or food) or allergy to the drug composition(s); * participation in another clinical study of an investigational drug within 3 months * participants who are not suitable for the trial decided by the researchers for any reason, such as pregnancy, frequently changes in work or living environments.
headache analysis and intervention

Conditions: Headache

Summary: diagnosing and treating posture-related headache (prh), such as tension-type and cervicogenic headache, is seriously hampered because of common features and complex interaction of the neurological and musculoskeletal system. current therapies are therefore not as effective and the population of patients with prh keeps on increasing. the diagnostic as well as the therapeutic process need more structure in order to select the most effective treatment; thereby contributing to preventive measures. this goal can be achieved through fundamental research with a clinically oriented background. our study starts from a clinical problem, with a growing incidence, and is therefore highly relevant. because sitting-posture seems to play an important role in prh, the first step in the diagnostic process is to analyse postural differences between a prh- and a control-group. in addition, the role of the dura mater in the headache-process will be examined. patients with prh will be classified in homogeneous groups based on these results. in a second phase individual-specific treatment programs will be composed. the general treatment-approach of postural abnormalities in the past failed because of the heterogeneous patient-populations. sub-classifying musculoskeletal problems has been proven to be successful in the past (o'sullivan \& dankaerts, non-specific low back pain). our study is divided in 2 phases: * phase 1: profile analysis (no intervention, experimental headache-group vs. asymptomatic controls) * phase 2: interventional phase (clustered headache-groups, based on the results of phase 1


Eligibility criteria:
inclusion criteria headache-group: 1. males and females between 20 and 50 years 2. confirmed medical diagnosis of tension-type headache, cervicogenic headache or a mixture 3. headache can be provoked by awkward cervical and/or head postures exclusion criteria headache-group: 1. pregnancy 2. history of pericranial surgery 3. serious pathology (neurological/cardiovascular/endocrine/musculoskeletal) 4. red flags 5. physical or manual therapy treatment for headache \< 4 weeks prior the study 6. excessive (\> 10 days/month for \> 3 months) use of: ergotamine, nsaid's, opioids, triptans, acetylsalicylic acid and simple analgesics 7. psychiatric comorbidity 8. visual or temporo-mandibular dysfunction inclusion criteria control-group: 1. males and females between 20 and 50 years 2. asymptomatic, no headache-history exclusion criteria control-group: 1. pregnancy 2. history of pericranial surgery 3. excessive (\> 10 days/month for \> 3 months) use of: ergotamine, nsaid's, opioids, triptans, acetylsalicylic acid and simple analgesics 4. visual or temporo-mandibular dysfunction

Keywords: posture, sit
effects of active video games in physically inactive children

Conditions: Self-Perception; Body Weight

Summary: inactivity was reported to be high in children and considered to be the fourth common cause of death in all ages. the reason for children is usually the increasing indoor use of sedentary screen time. active video games (avg) have recently been introduced for decreasing the sedentary time for children and directing them to physical activity (pa) at home.the aim of this study is to show the quantitative effect of games on physical fitness parameters like weight, body mass index (bmi) and fat ratio (fr). the study also aims at the factors for motivation or continuance of the games as self-perception and enjoyment levels together with qualitative effects of games on satisfaction and attitude changes in inactive children.

research related a causal association between inactivity, low esteem, and excess weight for children. for this reason, academic performance decreases and obesity associated diseases such as hypertension, diabetes, coronary heart diseases, depression, and cancer might ensue. children usually do not prefer to perform outdoor pa due to several causes including low sense of self perception. so far studies have shown an almost equivalent energy spent through avgs to the physical activity of moderate intensity. games have been previously demonstrated to prevent excess weight. there were no studies of avg in children with varying weights, inactivity and technology preoccupation. similarly, no qualitative research of avg in children exploring enjoyment levels and attitude changes were encountered. thus, the investigators aim to find the quantitative effect of avg on physical fitness parameters like weight, bmi and fr. other aims are studying factors for motivation or continuance of the games as well as the feelings and perspectives of the participant children's parents for the games.

Eligibility criteria:
inclusion criteria: 1. being 8-13 years old 2. being preoccupied with technology 3. being physically inactive exclusion criteria: 1. having circulatory, respiratory and musculoskeletal disease 2. having neuropsychiatric diseases 3. history of syncope or seizures 4. history of exercise induced anaphylaxis 5. morbid obesity 6. short stature

Keywords: inactive children active video games physical fitness self-perception enjoyment obesity
acrysof® restor® aspheric +3.0 d add power intraocular lens (iol)

Conditions: Cataract

Summary: randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing acrysof® restor® aspheric +3.0 d add power iol model sn6ad1 implanted in both eyes to acrysof® restor® aspheric +4.0 d add power iol model sn6ad3 implanted in both eyes.


Eligibility criteria:
inclusion: * adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts * calculated lens power is within the available range * willing and able to complete all required postoperative visits * planned cataract removal by phacoemulsification and/or liquifacture * potential postoperative visual acuity of 0.2 logmar or better in study eyes * preoperative astigmatism of 1.0 diopter (d) or less, measured by keratometry in study eyes * clear intraocular media other than cataract in study eyes * able to comprehend and sign a statement of informed consent * preoperative best corrected distance visual acuity (bcdva) worse than 0.2 logmar, or if bcdva is equal to or better than 0.2 logmar, bcdva with a brightness acuity tester (bat) on "medium" setting must be worse than 0.2 logmar exclusion: * significant irregular corneal aberration as demonstrated by corneal topography * subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logmar * subjects who may reasonably be expected to require laser treatments at any time * previous corneal refractive surgery * amblyopia * clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy) * diabetic retinopathy * extremely shallow anterior chamber, not due to swollen cataract * microphthalmos * previous retinal detachment * previous corneal transplant * recurrent severe anterior or posterior segment inflammation of unknown etiology * rubella or traumatic cataract * iris neovascularization * glaucoma (uncontrolled or controlled with medication) * aniridia * optic nerve atrophy * pregnancy * current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1a adrenoceptor (e.g.flomax® (tamsulosin hcl), hytrin®, or cardura®) * any subject currently participating in another investigational drug or device study that may confound the results of this investigation

Keywords: cataract cataract surgery iol intraocular lens restor replacement of cataract
this study is to determine if degenerative spinal pain and disorders cause the levels of substance p to change in a patients saliva, blood and/or cerebrospinal fluid.

Conditions: Spinal Disease; Spinal Radiculopathy; Myelopathy; Neurogenic Claudication

Summary: the objective of this pilot study is to determine if degenerative spinal disorders such as acute radiculopathy, myelopathy, stenosis, or disc and facet disease cause detectable alterations in substance p levels in saliva, serum and cerebrospinal fluid. if this pilot study shows a correlation between substance p levels and pain associated with degenerative spinal disorders, then a larger study will be initiated to determine the feasibility of using substance p levels in the diagnosis and treatment of degenerative spinal disease.


Eligibility criteria:
inclusion criteria: * undergoing spinal surgery for medically refractory spinal radiculopathy, * myelopathy or neurogenic claudication based on either history, physical examination or radiologic studies demonstrating neural compression or degenerative disc disease. * undergoing surgery for medically refractory axial spinal pain. exclusion criteria: * previous spinal procedures or operations, * radicular pain, * history of fibromyalgia, * chronic pain, * rheumatoid arthritis, * autoimmune disorders, * hiv, * ptsd, * major depressive disorder, * migraine headaches or active rhinosinusitis, * nicotine intake
prenatal microarray follow-up study

Conditions: Genetic Diseases

Summary: the objectives of this multi-center collaborative study are to ascertain the frequency of specific copy number variants (cnvs) identified prenatally and to evaluate in detail through continued follow-up of the children the phenotypes associated with cnvs of known or uncertain clinical significance.

specifically the aims are as follows: 1. determine the intellectual function of the children at age 3 years 2. determine phenotypic characteristics other than intellectual function of the children at age 3 years 3. determine the frequency of specific copy number variants discovered during routine prenatal diagnostic testing 4. evaluate the educational, counseling and psychosocial implications of microarray testing as it is introduced as a standard prenatal diagnostic procedure.

Eligibility criteria:
eligibility criteria for enrollment into the 3 year follow-up cohort inclusion criteria 1. singleton or multi-fetal pregnancy with a prenatal invasive procedure resulting in a diagnosis by microarray analysis of a microdeletion/duplication less than 10 mbs, either pathogenic or of uncertain significance, which is reported to the patient. this includes: * infants diagnosed during prenatal diagnostic studies performed at the10 pre-specified prenatal diagnostic centers * infants diagnosed by analysis of microarrays performed at the collaborating laboratories * infants referred through the prenatal microarray resource center website * children who will be at least 3 years of age by january of 2018, and who had a prenatally detected cnv \<10 mbs, either pathogenic or of uncertain significance or 2. children whose mothers were enrolled in the initial study (through july 2011) and who met inclusion criteria for follow-up in that phase, referred to as the "index cohort". this includes: * cnvs of uncertain or known significance, some of which were not reported to the patient * mosaic findings by karyotype and/or microarray alone. exclusion criteria 1. patient refusal to allow infant follow-up through the age of three 2. patient not fluent in the english language 3. patient under the age of 18 4. in surrogate pregnancies, the "rearing parents" are unavailable to give consent.

Keywords: microarray prenatal copy number variant cnv microdeletion microduplication genetic
evaluation of inflammatory symptoms reduction with amoxicillin + ketoprofen in acute pharyngeal tonsillitis in pediatric patients

Conditions: Pharyngotonsillitis

Summary: the purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin.

the total duration of the study period per patient is 10 ± 1 day

Eligibility criteria:
inclusion criteria: * quick-test positive for streptococcus pyogenes; * indication for treatment with amoxicillin according to labeling and physician's clinical evaluation; * pain (for swallowing) evaluated by wong baker faces pain scale with at least grade 3; * presence of at least two of the follow symptoms: * hyperemia and edema evaluated with at least 2 out of 4 crosses * fever in the previous 48 hours * cervical adenomegaly * tonsilla with erythema or erythema and white exsudate. exclusion criteria: * history of cardiovascular, gastrointestinal, metabolic or psychiatric conditions; * history and laboratorial confirmation of hematologic, hepatic or renal disorders; * use of nonsteroidal antiinflammatory drugs (nsaid) during the last 3 weeks and gastroesophageal reflux during the last 6 months; * use of analgesic or anti inflammatory medication (except paracetamol) in the previous 12 hours; * history of allergy or hypersensitivity to amoxicillin and/ or ketoprofen. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
video versus face-to-face preoperative anaesthetic assessment

Conditions: Anesthesia; Telemedicine

Summary: randomized clinical trial rewieving difference between anaesthetic preassessment in physical consultations vs. video consultations.

preoperative anaesthetic assessment aims to reduce morbidity and mortality and are currently accepted as the gold standard of care for elective surgery. technical advances in society have led to explora-tions within the telemedicine area which continues providing safe and effective services. the video versus face-to-face preoperative anaesthetic assessment (vidface) trial aims to compare videobased preoperative anaesthetic assessment to standard face-to-face consultations with focus on patient safety and satisfaction including possible beneficial eco and economical effects compared to standard face-to-face consultations. this is a randomised, single-centre, two-arm, assessor, and data analyst blinded clinical trial. we will enrol 2260 participants undergoing elective ear-nose-throat or tooth-mouth-jaw surgery. participants will be randomised 1:1 stratified by malignant versus benign surgery to either video based preoperative anaesthetic assessment or face-to-face consultation. data will be analysed by two blinded statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind. results: the primary outcome is the incidence of six predefined serious adverse events (sae). secondary outcomes are the proportion of participant with a change in anaesthesia plan as well as delays or cancellations on the day of surgery and patient satisfaction. the vidface trial will contribute valuable knowledge on the efficacy and safety on using video consultations in the an-aesthetic preoperative assessment.

Eligibility criteria:
inclusion criteria: * ent and tmj patients * adults \> 18 years * informed consent obtained after a consideration period of minimum 24 hours exclusion criteria: * if a patient is assessed unsuitable for the video technology in example, patients with severe mental challenges (dementia, retardation, etc.), they will not be included in the trial. if excluded, the patient receives standard care, face-to-face preoperative anaesthetic assessment. * local protocol screen patients

Keywords: anaesthetic preassessment telemedicine