Kornimate/medical-research-clean huggingface dataset:
a study of ly3337641 in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the main purpose of this study is to evaluate the safety and effectiveness of ly3337641 in adults with rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * female subjects of childbearing potential test negative for pregnancy at screening and agree not to breastfeed * female subjects: agree to use a reliable method of birth control from the start of screening until 28 days after the last dose of study drug or be of nonchildbearing potential * male subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or have undergone vasectomy * have a diagnosis of ra based on the 2010 american college of rheumatology (acr)/european league against rheumatism criteria * have at least 1 of the following: * rheumatoid factor or anti-citrullinated peptide antibodies (acpa) at screening or * radiographs documenting bony erosions * have active ra, defined as: * part a: ≥3 swollen joints (based on 66-joint counts) * part b: * ≥6 swollen joints (based on 66-joint counts) * ≥6 tender joints (based on 68-joint counts) * hscrp levels greater than the upper limit of normal (uln) or positive for acpa * part b only: have had inadequate response, loss of response, or intolerance to at least 1 synthetic or biologic disease-modifying antirheumatic drug (dmard) exclusion criteria: * have received any of the following: * part b only: any prior treatment with a product directly targeting bruton's tyrosine kinase (btk) (marketed or investigational) * belimumab, natalizumab, or vedolizumab within 6 months prior to baseline * b-cell-depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-cluster of differentiation 3 (cd3) antibody) within 12 months prior to screening for part a or at any time prior to screening for part b * have known hypogammaglobulinemia * have hepatitis c virus, hepatitis b virus or human immunodeficiency virus * have active tuberculosis (tb) * are at high risk of infection or have recent evidence of clinically significant infection * have had lymphoma, leukemia, or any malignancy within the previous 5 years except for treated basal cell or squamous epithelial carcinomas of the skin * have received a live (attenuated) vaccine within 28 days prior to baseline or plan to receive one during the study
sex-related differences in the response to the muscle relaxant drug mivacurium

Conditions: Muscle Relaxation; Sex

Summary: muscle relaxants are drugs providing muscle relaxation during surgical treatment. previous studies have shown that males and females respond differently to this kind of drug. our hypothesis is that males are more sensitive to the effect of mivacurium (a muscle relaxant) than females, meaning that males need a lower blood concentration of the drug than females in order to obtain a given effect.

muscle relaxants are a type of drug used to provide muscle relaxation during induction of anesthesia and surgical treatment. residual drug effect postoperatively (i.e. residual muscle relaxation) occurs frequently and studies have shown that this may be harmful in certain groups of patients. of special concern is residual effect on upper airway and breathing muscles. a previous study has shown that males and females respond differently to the effect of this kind of drug. it appears that some muscle groups which are important for airway protection and breathing are more sensitive to the effect of muscle relaxants in males than females. males may therefore be more susceptible to postoperative lung complications than females. in this study we try to determine what causes the observed sex-related difference in response to the muscle relaxant mivacurium. we have previously shown that this sex-related difference cannot be explained by different pharmacokinetics (what the body does to the drug) in males and females. our hypothesis is that a pharmacodynamic (what the drug does to the body) difference between sexes exists, i.e. that a lower blood concentration of mivacurium is needed in males than females in order to obtain a predefined degree of muscle relaxation in certain muscle groups.

Eligibility criteria:
inclusion criteria: healthy individuals with no current medication - exclusion criteria: previous complications during anesthesia, pregnancy, allergy to muscle relaxants, smoking, gastrointestinal reflux. -

Keywords: nondepolarizing neuromuscular blocking drug mivacurium sensitivity sex
a study of veliparib in combination with carboplatin and paclitaxel in japanese subjects with solid tumors

Conditions: Solid Tumors

Summary: this is a phase 1 open-label study and consists of 3 treatment groups (dose levels) . treatment cycles are 3 weeks in duration. the primary objective of this study is to determine the recommended phase two dose (rptd) of veliparib (abt-888) when administered in combination with carboplatin and paclitaxel in japanese subjects with solid tumors. secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in the subjects.


Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed malignant solid tumor. * patients who are amenable to standard combination chemotherapy of carboplatin and paclitaxel. * patients should have received less than or equal to 1 prior chemotherapy regimens for advanced stage disease. * eastern cooperative oncology group (ecog) performance status less than or equal to 2. * patients must have normal organ and marrow function exclusion criteria: * patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or the adverse events due to agents administered more than 3 weeks earlier have not recovered to less than grade 2. * known history of allergic reactions to carboplatin or cremophor-paclitaxel. * patients who have previously received a poly(adp-ribose) polymerase (parp) inhibitor. * uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection requiring treatment, symptomatic congestive heart failure, angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * history of seizure disorder. * hepatitis b surface antigen (hbsag) positive, hepatitis c virus (hcv) antibody positive or human immunodeficiency virus (hiv)-positive patients.
phase 2a open label safety study of fovista® (anti-pdgf bb) regimen administered in combination with anti-vegf therapy to study sub-retinal fibrosis in neovascular amd

Conditions: Age-related Macular Degeneration

Summary: the objective is to evaluate the safety of intravitreal fovista® (anti-pdgf bb) administered in combination with anti-vegf therapy.

the objective is to evaluate the safety of intravitreal fovista® (anti-pdgf bb) administered in combination with anti-vegf therapy in either a "simultaneous" regimen (fovista® administered with anti-vegf same day) or "pre-treatment" regimen (monotherapy fovista® day 0 followed by fovista® administered in combination with anti-vegf day 2).

Eligibility criteria:
inclusion criteria: * subjects of either gender aged ≥ 50 years * all fluorescein angiographic subtypes with presence of active choroidal neovascularization exclusion criteria: * any intraocular surgery or thermal laser within three (3) months of trial entry. any prior thermal laser in the macular region, regardless of indication * subjects with subfoveal scar or subfoveal atrophy * any ocular or periocular infection in the past twelve (12) weeks * history of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant

Keywords: wet amd choroidal neovascularization fovista® e10030 avastin® eylea®
effects of core stabilization and strengthening exercise on quality of life in clinical lumbar instability

Conditions: Chronic Low Back Pain

Summary: this study will compare the effects of 2 exercise programs including core stabilization exercise and general trunk strengthening exercise programs on trunk muscle activity, physical dysfunction, quality of life and lumbar motion in low back pain patient with clinical lumbar instability.

clinical lumbar instability is the one of causes of chronic low back pain, that affects to pain intensity and quality of life. for clinical studies using core stabilization exercise (cse) as treatment have revealed conflicting findings on pain, functional disability and muscle responses in chronic low back pain. the cse promotes local muscle system that to provide lumbar stability. however, the stability of spine related to global muscle system, that using in this study.

Eligibility criteria:
inclusion criteria: * chronic low back pain due to clinical lumbar instability exclusion criteria: * specific low back pain * cuada equine syndrome * neurological deficit
application of in vivo splitting technique in adult liver transplantation

Conditions: Liver Transplantation

Summary: the feasibility of split liver transplantation (slt) remains controversial. this study aimed to evaluate the outcomes of slt in adult recipients and to identify specific areas of improvements. a retrospective analysis was conducted on adults who underwent full size slt between january 2021 and december 2023. the short-term outcomes of these patients who underwent slt were compared with those of patients who underwent whole liver transplantation (wlt) during the same period.


Eligibility criteria:
inclusion criteria: * for the donor graft: 1. age of 18-60 years; 2. bmi of 19-28 kg/m2; 3. hemodynamic stability or use of a single vasoactive drug with a small dosage (norepinephrine ≤ 0.1 μg/kg/min or dopamine ≤ 5 μg/kg/min); 4. liver steatosis ≤ 10%; 5. liver functional indicators (alt, ast, total bilirubin quantification) ≤ 3 times the normal value; 6. blood sodium ≤ 160 mmol/l; for the slt recipients 1. patients who had registered in the china organ transplant response systems. 2. initial liver transplantation. 3. graft-to-recipient weight ratio (grwr) ≥ 1%. exclusion criteria: * for the donor graft 1. uncontrollable infection 2. significant vascular and biliary variation. for the recipients 1. severe portal hypertension. 2. significant vascular variation.

Keywords: split liver transplantation whole liver transplantation short-term outcomes surgical complications morbidity and mortality
evaluation of xiaflex: trial of effectivenss in dupuytren's

Conditions: Dupuytren's Disease

Summary: this is a prospective, multi-centre, pragmatic randomized controlled trial to compare both the clinical effectiveness and cost-effectiveness of collagenase injections (ci) versus limited palmar fasciectomy (lpf) to determine if collagenase is a superior treatment in terms of improved quality of life and reducing recurrence of the disease without serious complications. since collagenase injections are costly it is also important to know if this novel intervention is cost-effective from the patient, ministry of health and societal perspectives.

limited palmar fasciectomy (lpf) and collagenase injection (ci) are the most common procedures to manage symptoms of dupuytren's disease. this randomized controlled trial (rct) aimed to directly compare patient outcomes 12 months following ci and lpf. twenty-two patients with dupuytren's disease were randomized to either lpf or ci. the primary outcome was health state measured by the michigan hand questionnaire. secondary outcomes were health status (the health utility index-3), function (the unité rhumatologique des affections de la main and the southampton dupuytren's scoring scheme), and range of motion (rom) of treated digits. measurements were collected at baseline and 1-, 3-, 6-, and 12-months post-procedure.

Eligibility criteria:
inclusion criteria: 1. canadian citizen 2. 18 years of age or older 3. dupuytren's contracture of the metacarpophalangeal (mcp) joint or of the proximal interphalangeal (pip) joint with a fixed flexion contracture of 20º or greater in at least 1 finger (not the thumb) 4. demonstrated inability to simultaneously place the affected finger and palm flat on a table 5. able to understand and communicate in english exclusion criteria: 1. previous treatment of the primary joint within 90 days of study inclusion 2. patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel release, stenosing tenosynovitis release) 3. persistent extension deficit from a previous surgery of the same digit 4. any chronic muscular or neuromuscular disorder affecting wrist or hand 5. patient generally unfit for surgery 6. patient with specific treatment preference 7. bleeding disorder or recent stroke 8. allergy to collagenase 9. collagenase treatment or treatment with any investigational drug within 30 days of study inclusion 10. use of a tetracycline derivative within 14 days of first dose of study drug (because tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs \[i.e., matrix metalloproteinases\]) 11. pregnant or breast feeding patients 12. patients who do not have insurance coverage for collagenase injections 13. patients who are unable to provide informed consent or are unable to complete quality of life questionnaires due to mental capacity or neuro-psychological problems.
predicitve use of spot urine protein/creatinine ratios in preeclampsia

Conditions: Preeclampsia

Summary: the investigators intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-hour urine protein collection. furthermore, the investigators plan to investigate whether analysis of proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-hour collection period is predictive of the 24-hour sample. lastly, the investigators plan to determine whether a combination of the random test with a shorter collection interval is comparable to the 24-hour collection.

preeclampsia affects approximately 5-8% of pregnancies in the united states with approximately 10% occurring before 34 weeks gestation. the diagnosis of preeclampsia is determined by the presence of hypertension with proteinuria after 20 weeks gestation. the gold standard for measuring proteinuria is a 24-h urine collection for total protein. in the non-pregnant patient, a random urinary protein-to-creatinine ratio has been shown to be a reliable indicator of significant proteinuria. the reliability of this test remains unclear in the pregnant population. because there are relatively few studies in the pregnant population and many of these studies were poorly designed, limited by sample size, or confounded by other variables, further research in this area is still necessary. the purpose of this study is to determine if there are alternative diagnostic tools for the quantification of total protein excretion in 24-hours to aid in the diagnosis of preeclampsia that can be performed more quickly and efficiently than the gold standard 24-hour urine collection. we intend to perform a large prospective study looking at the predictability of the random urine protein-to-creatinine ratio compared to the gold standard 24-h urine protein collection. furthermore, we plan to investigate whether analysis of proteinuria at shorter time intervals (4 and 8 hours) within the overall 24-h collection period is predictive of the 24-h sample. lastly, we plan to determine whether a combination of the random test with a shorter collection interval is comparable to the 24-h collection. the goal would be to make the diagnosis of preeclampsia in a more timely fashion to aid in the prevention of maternal and neonatal morbidity and mortality including eclampsia, hellp syndrome, acute renal failure, pulmonary edema, dic, iugr, iufd, intracranial bleeding and stroke, additionally, an earlier diagnosis could also impact patient care by reducing hospital stay, nursing demands, and eliminating the need for cumbersome and likely inaccurate patient 24-h home collections.

Eligibility criteria:
inclusion criteria: * pregnant women over the age of 18 between 24-42 weeks who are being evaluated for preeclampsia with a 24 hour urine protein exclusion criteria: * patients with pre-existing proteinuria (\>300mg) * renal disease * evidence of a current or recent (within two weeks of admission) urinary tract infection

Keywords: preeclampsia proteinuria
cognitive processing therapy vs. sertraline for the treatment of ptsd & sud in egyptian patients

Conditions: Psychologic Manipulation

Summary: the present research was aimed at comparing the effects of cognitive processing therapy (cpt) with the effects of sertraline in treating patients who have dual diagnosis ptsd \& sud. the present study examines the extent to which cpt is effective in treating ptsd symptoms for patients with ptsd and sud.

patients with co-occurrence ptsd \& sud disorders were grouped into 3 groups: first: cognitive processing therapy (cpt) in which participants completed 12 sessions of cpt. second: were treated by sertraline. third: a placebo control group.

Eligibility criteria:
inclusion criteria: * patients diagnosed with sud exclusion criteria: * patients diagnosed with other psychotic disorders

Keywords: ptsd cpt sud
multi-centre study to evaluate acaf versus laminoplasty in treating cervical ossification of the posterior longitudinal ligament

Conditions: Ossification of Posterior Longitudinal Ligament; Cervical Spondylosis With Myelopathy

Summary: the purpose of this study is to compare the efficacy, safety and imaging outcomes between anterior controllable antedisplacement and fusion (acaf) and laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament.

this is a national, multicenter, prospective, randomized controlled trial to compare the safety and efficacy of acaf and posterior laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament. in this study, 164 adult patients aged 18-70 with severe copll were randomly assigned to the experimental group (using acaf) and the control group (using lamp) according to the ratio of 1:1. the patients were followed up for 2 years.

Eligibility criteria:
inclusion criteria: 1. the patient's age is 18-70 years old, regardless of gender; 2. the patient was diagnosed as severe ossification of the posterior longitudinal ligament (x-ray or ct showed ossification of the posterior longitudinal ligament); the imaging findings showed occupied ratio ≥ 60% or involved three or more segments; 3. symptoms of spinal cord and nerve root compression, or accompanied by spinal cord compression symptoms such as dysfunction of urination and defecation, conservative treatment was ineffective or aggravated gradually; 4. the participant (or his legal guardian) can sign the informed consent. exclusion criteria: 1. congenital malformations (including but not limited to occipitocervical malformations, congenital cervical fusion, cervical related neurovascular malformations), ossification of cervical ligamentum flavum, cervical trauma, cervical cancer, cervical tuberculosis and other inflammatory diseases; 2. patients with other spinal diseases such as thoracolumbar vertebrae that affect clinical symptoms; patients with motor neuron diseases such as amyotrophic lateral sclerosis and other nervous system diseases; 3. the symptoms were aggravated due to recent trauma; 4. patients who participated in other clinical trials in recent 3 months; 5. the participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent; 6. those who are in poor health and can not tolerate surgery; the patients were not suitable for surgical treatment after preoperative examination.

Keywords: opll cervical spondylotic myelopathy acaf laminoplasty multicenter study
eucaloric ketogenic diet in covid-19 cytokine storm syndrome

Conditions: Covid19; Ketogenic Dieting

Summary: covid 19 pandemia is causing millions of deaths worldwide. to date, the evidence gathered suggests that the subgroup of patients who present the most serious clinical feature of covid-19 could have a "cytokine storm syndrome" better defined as secondary hemophagocytic lymphohistiocytosis (shlh), characterized by acute respiratory distress (ards) and septic shock, followed by multi-organ failure due to an excess of cytokines induced by the inflammatory response to the virus. the reduction of phagocytic hyperactivation represents a possible treatment for hlh. lowering the availability of glucose, the only substrate of aerobic glycolysis and of the warburg effect in activated macrophages, through the use of ketogenic diets could be a promising solution. actually diet is not recognized as impacting on the evolution of covid-19, however, scientific literature data show that a low carbohydrate and high lipid diet (ketogenic diet) can inhibit inflammation and lead to a clinical improvement of respiratory function. the hypothesis of this study is that the administration of a ketogenic diet could improve mortality, lower the access to icu and the need of niv. the plan is to enroll 50 patients with covid 19 infection and administer a 1:4 ketogenic formula during hospitalization in order to verify these outcomes.


Eligibility criteria:
inclusion criteria: * documented clinical diagnosis of covid-19 supported by clinical features and by the positivity to at least one pharyngeal swab * age ≥18 years * informed written consent exclusion criteria: * type i diabetes * type ii diabetes in therapy with insulin, sulphonylureas, repaglinide, glp-1 analogues, sglt2 inhibitors * recent acute cardiovascular event (within a month) * food allergies to diet components * any metabolic disorder capable of influencing gluconeogenesis * clinical history of severe hypertriglyceridemia with or without pancreatitis * pregnancy and/or breastfeeding
no antibiotics for elective cesarean with low risk of infection

Conditions: Antibiotics , Elective Cesarean, China

Summary: the purpose of this study is to discuss whether the parturients who underwent elective cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and economic benefits involved.


Eligibility criteria:
inclusion criteria: * elective cesarean * with normal temperature; * no signs of infection; * normal degree of cleanliness in vaginal; .normal amniotic fluid. exclusion criteria: * failure of vaginal delivery and emergency cesarean; * premature rupture of membranes; * antibiotics having been applied to 3 days before cesarean; * having inflammation before cesarean: such as vaginitis, pelvic inflammatory disease, chorioamnionitis; * having infections in respiratory or urinary system before cesarean; * placenta previa or placental abruption; * with medical and surgical complications; * bmi ≥ 30kg/m2; * total blood loss more than 1000ml within 2 hours after cesarean

Keywords: antibiotics, cesarean