Kornimate/medical-research-clean huggingface dataset:
a phase 3, randomized, double-blinded, placebo-controlled study of arq 197 plus erlotinib versus placebo plus erlotinib

Conditions: Non-small-cell Lung Cancer

Summary: the primary objective of this study is to determine if the combination regimen of arq 197 with erlotinib will improve overall survival (os) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous nsclc with wild-type egfr who have received 1 or 2 prior systemic anti-cancer therapies in the intent-to-treat (itt) population.


Eligibility criteria:
inclusion criteria 1. male or female at least 20 years of age with life expectancy ≥ 3 months 2. histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage iiib/iv) non-squamous nsclc with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 l858r mutation)) egfr gene status confirmed by a highly sensitive pcr assay 3. evaluable disease according to recist, version 1.1 4. received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-based therapy 5. ecog performance status of 0 or 1 6. demonstrate adequate bone marrow, liver, and renal functions, defined as: • alt and ast ≤ 2.5 × upper limit of normal (uln), total bilirubin ≤ 1.5 × uln, anc ≥1.5 × 10\^9/l, platelet count ≥100 × 10\^9/l, hemoglobin ≥9.0 g/dl, and serum creatinine ≤1.5 mg/dl. 7. voluntary written informed consent form before performance of any study-specific procedures or tests exclusion criteria 1. prior therapy with an egfr inhibitor and/or tivantinib 2. any systemic anti-tumor treatment for nsclc or investigational agents within 4 weeks prior to randomization 3. palliative radiotherapy within 2 weeks, or radiotherapy for curative intent of target lesions within 8 weeks for chest and within 4 weeks for other areas prior to randomization 4. major surgical procedure within 4 weeks prior to randomization 5. history of cardiac disease 6. known symptomatic brain metastases 7. need to breastfeed a child during or within 12 weeks of completing the study 8. significant gastrointestinal disorder that could interfere with absorption of tivantinib and/or erlotinib 9. history of malignancy other than nsclc 10. known infection with hiv, active hbv or hcv 11. clinically significant interstitial lung diseases detected by ct scan or prior history of such diseases 12. psychiatric disease that could affect the informed consent process 13. subjects who wish to have a child and who would not agree to use one or more contraceptive measures that are highly effective 14. positive serum or urine pregnancy test in female subjects of childbearing potential 15. any other significant co-morbid condition that, in opinion of the investigator/sub-investigator, would impair study participation or cooperation
labor scale versus who partograph for management of labor (scalp)

Conditions: Dystocia

Summary: the current study aims at evaluating the impact of the implementation of the labor scale, in comparison to the standard who partograph, in the management of primiparous women, including cd rate, maternal and neonatal outcomes of labor.

since the procedure was first introduced to clinical practice, cesarean delivery (cd) has significantly contributed to peripartum maternal and fetal safety when appropriately indicated. nevertheless, cd rate has significantly increased over the last two decades without parallel improvement in maternal or neonatal outcomes. globally, one out of three pregnancies would be delivered by cd, resulting in growing surgical, obstetric and financial burden. over years, long-term sequelae of current cd rate have become evident such as increased incidence of placenta accreta spectrum and exponential rise in cd trend, since 90% of women who had cd are susceptible to cd in future pregnancies. these concerns have triggered a global act to control cd rates within the margins of safe obstetric practice. the most common indication of cd is labor dystocia. however, the definition of labor dystocia is inconsistent, and standardization of diagnosis has been heavily investigated. the who partograph was established at the end of the last century to serve as a tool to recognize labor dystocia and has been universally accepted to verify cd decision however, a cochrane review by lavender et al. revealed that role of who partograph, in improving clinical outcomes, is lacking. in addition, there is no evidence that any published modification of the current partograph is superior to another. the "labor scale," a novel alternative to the classic partograph, was first introduced to literature in 2014. the tool was designed based on evidence-based guidelines and integrates both diagnosis and interventions to manage labor dystocia. initial data showed that labor scale contributed to decreased incidence of cd and oxytocin administration. however, further studies are required to verify these results.

Eligibility criteria:
inclusion criteria pregnant women aged 18 to 45 years old with the following criteria: nulliparous, had been pregnant for 37 to 41 weeks with a singleton viable fetus, and vertex presented, and with estimated fetal weights between 2,500 and 4,500 g. exclusion criteria women with following criteria will be excluded: significant maternal medical or surgical comorbidity, previous uterine scar

Keywords: labor scale partograph spontaneous labor primigravida
the pharmacokinetics of ketorolac tromethamine administered intranasally (in) for postoperative pain in children aged 12 through 17 years

Conditions: Postoperative Pain

Summary: this was an open-label pk study in pediatric subjects who had undergone general surgery. each subject's study participation consisted of a screening visit, a single-dose treatment with intranasal ketorolac (in) tromethamine, and a follow-up visit. following surgery, subjects received in ketorolac 15 mg (weight \ or = 50 kg) when pain relief was indicated. for pain not relieved by the study drug, the subjects had access to an opioid analgesic administered by patient-controlled analgesia (pca). blood samples for pharmacokinetic analysis were obtained at specified time points following the dose of ketorolac.


Eligibility criteria:
inclusion criteria: * children aged 12 through 17 years * body weight \> or = 30 kg and \< or = 100 kg * female subjects of childbearing potential must have a negative serum or urine pregnancy test result prior to entry into the study * a legal representative able to provide written informed consent * willing and able to comply with all testing and requirements defined in the protocol * willing and able to complete the posttreatment visit exclusion criteria: * allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (edta) * allergic reaction to aspirin or other nsaids * had an upper respiratory tract infection or other respiratory tract condition (eg, active allergic rhinitis) that could interfere with the absorption of the nasal spray or with the assessment of aes * use of any in product within 24 hours prior to study entry * clinically significant abnormality on screening laboratory tests * history of cocaine use resulting in nasal mucosal damage * history of peptic ulcer disease or gastrointestinal bleeding * had advanced renal impairment or a risk for renal failure due to volume depletion * a history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation * participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study * allergy or significant reaction to opioids * was pregnant or breastfeeding * previously participated in this study * the surgical procedure involved head, neck, oral, or nasal surgery
fosrenol post-marketing surveillance in japan

Conditions: Hyperphosphatemia; Kidney Disease

Summary: this study is a regulatory post-marketing surveillance in japan and it is a local prospective and observational study of patients who have received fosrenol. the objective of this research is to collect information on the safety of fosrenol after its launching, which means collecting information on adverse events, especially adverse events in the digestive system including constipation and serious adverse events, and adverse drug reactions when the drug is administered to the below-mentioned target patients for six months. the secondary objective is to collect information on the safety of the drug when administered for more than six months, which means collecting information on the safety of the drug when administered for up to 12 months to the target patients who have already been treated with the drug for six months. and also if at the time of 12 months after administration of lanthanum carbonate the dialysis is not conducted, extending its' administration will be continued until conduction of dialysis, or until sept. 30, 2015. the efficacy of fosrenol is evaluated by observing the serum p(phosphorus) level and serum pth (parathyroid hormone) level change.


Eligibility criteria:
inclusion criteria: * patients whom investigators have decided to treat with lanthanum carbonate for the first time at the respective medical institutions. those medical institutions have to understand the objective of this investigation and conclude a written contract with bayer yakuhin. * the decision to treat patients with lanthanum carbonate will be made independently by the investigator prior to study inclusion. * patients treated with lanthanum carbonate in the indication "hyperphosphatemia" with chronic kidney disease not on dialysis". exclusion criteria: * patients who are contraindicated based on the product label. * patients who have been already treated with fosrenol

Keywords: fosrenol hyperphosphatemia chronic kidney disease not on dialysis
peng block or suprascapular nerve block for postoperative analgesia in shoulder artroscopy ?

Conditions: Orthopedic Disorder; Shoulder Pain; Surgery; Analgesia

Summary: arthroscopic shoulder surgery, which has been frequently applied in recent years, provides long-term positive clinical results and increases the quality of life after surgery, while it can cause severe pain in the early postoperative period. postoperative pain management is very important in shoulder arthroplasty. adequate pain control; mental state, nutrition, cost of care, rehabilitation, and patient satisfaction, are of great importance for the patients' recovery and contribute to a successful surgical outcome. in this study, the investigators aimed to compare the effects of suprascapular nerve block and shoulder pericapsular nerve block, which will be performed preoperatively with ultrasound, on the level of postoperative pain in patients who will undergo shoulder arthroscopy surgery under general anesthesia.

as a result of the power analysis the investigators conducted for this study, the minimum sample size was calculated as 32 people for each group, 64 people in total, at the 90% confidence interval. 64 patients who meet the inclusion criteria will be included in our study. the participants will be randomized and divided into 2 groups. accordingly, the peng block will be applied to 32 patients, and the suprascapular block will be applied to 32 patients.

Eligibility criteria:
inclusion criteria: * patients who will have shoulder arthroscopy surgery under general anesthesia * ages of 18-75 * asa i-iii exclusion criteria: * patients with deformity and pathology in the shoulder region * patients with known local anesthetic allergy * patients with bmi\>35 * patients with alcohol and substance addiction * patients with opioid addiction * patients who cannot perceive and evaluate pain, such as psychiatric illness, mental retardation

Keywords: peng block suprascapular nerve block postoperative analgesia
study to evaluate the effect of xmab®5871 on disease activity in patients with igg4-related disease (rd)

Conditions: IgG4-RD

Summary: the purpose of this phase 2 study is to investigate the effect of xmab5871 on igg4-related disease (rd) activity


Eligibility criteria:
inclusion criteria: * active igg4-rd * compatible pattern of organ involvement consistent with igg4-rd that cannot be attributed to other causes * histopathologically-proven diagnosis of igg4-rd * peripheral blood plasmablast count \>900 cells/ml and/or elevated igg4-rd levels during screening * able and willing to complete the entire study according to the study schedule * able and willing to provide written informed consent exclusion criteria: * history or evidence of a clinically unstable/uncontrolled disorder, condition or disease other than igg4-rd that, in the opinion of the investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion * malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin, or prostate cancer with no recurrence ≥3 years following prostatectomy) * presence of recurrent or chronic infections, defined as ≥3 infections requiring antimicrobials over the past 6 months prior to screening * active infection requiring hospitalization or treatment with parenteral antimicrobials within the 60 days prior to randomization or oral antimicrobials within the 21 days prior to enrollment * patient is taking \>40 mg of prednisone qd * prior use of rituximab (or other b cell depleting agents) within 6 months of enrollment. prior use of any b cell depleting agent greater than 6 months from enrollment is allowed if the cd19+ b cell count is within the normal reference range during screening * use of any investigational agent within 5 half-lives of the agent (or 6 months if the half-life is unknown) prior to enrollment * immunosuppressive agent use within the three months prior to enrollment * has received live vaccines within 2 months of enrollment * patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to end-of-study visit * unable or unwilling to partake in the follow-up assessments or required protocol procedures
reappraisal of atrial fibrillation: race-v - work package 5

Conditions: Atrial Fibrillation

Summary: in the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of atrial fibrillation (af). also the contribution of the individual genetic background will be investigated. furthermore, the investigators aim to identify clinical parameters and biomarkers informing on the main mechanisms of af progression in atrial tissue. for this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.

an estimated 380 patients will be included four patient categories will be included enabling to study patients with different stages of af progression; 1. patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group), 2. patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring, 3. patients with self-terminating atrial fibrillation at inclusion, and 4. patients with non-self-terminating atrial fibrillation at inclusion. at baseline in-depth phenotyping and genotyping will be performed. continuous rhythm monitoring will also be performed in all patients. the combination of extensive phenotyping, genotyping and atrial fibrillation burden follow-up offers the unique opportunity to study the atrial tissue alterations and atrial gene expression changes in different stages of atrial fibrillation progression and to correlate these data to the phenotype of the patients.

Eligibility criteria:
inclusion criteria: * age \> 18 years; * undergoing first elective open chest cardiac surgery or surgical ablation for atrial fibrillation; * able and willing to sign informed consent for the registry; * able and willing to undergo implantation of implantable loop recorder (unless the patients has a pacemaker or implantable cardioverter-defibrillator (icd) with atrial leads) exclusion criteria: * • deemed unsuitable or not willing to undergo implantation of implantable loop recorder or attend follow-up visits. * pregnancy. * life expectancy of less than 2.5 years. * history of prior cardiac surgery or ablation for atrial fibrillation.
efficiency of e-learning and role-playing for the training of nursing home caregivers in the support of agitation in neurodegenerative diseases

Conditions: Neuro-Degenerative Disease

Summary: this study will investigate the effects of "i-learn cognition and behaviour" training in the care in agitation in patients with neurodegenerative diseases. this training for caregivers, aims to reduce agitation and psycho-behavioral disorders of patients living in nursing home. in addition, amount of psychotropic drugs prescribed, as well as the number of hospitalizations during the study will be assessed.


Eligibility criteria:
inclusion criteria: * diagnosis of major neurocognitive disorder according to dsm 5 * with agitation and npi agitation item score of 4 or more (frequency x severity) * information and verification of the non-opposition of the patient and his guardian / curator if he is under legal protection. exclusion criteria: * patient under court protection * inability to understand the french language * patient whose state of health is not stabilised at the time of inclusion and/or in palliative care

Keywords: agitation dependent elderly people psycho-behavioral disorders nursing home
comparative study of amniotic membrane injectable in the treatment of recalcitrant plantar fasciitis

Conditions: Plantar Fasciitis

Summary: the purpose of this study is to determine whether the amniofix injectable human amniotic membrane is effective in the treatment of recalcitrant plantar fasciitis.


Eligibility criteria:
inclusion criteria: 1. at least 18 years old. 2. both male and female patients will be selected. 3. plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities 1. rice 2. corticosteroid injection 3. stretching exercises 4. nsaids 5. orthotics 4. females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). 5. patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen. 6. patient has read and signed the irb/iec approved informed consent form before screening procedures are undertaken. exclusion criteria: 1. prior surgery at the site 2. site that exhibits clinical signs and symptoms of infection 3. history of chronic plantar fasciitis of more than twelve months 4. evidence of significant neurological disease of the feet 5. non ambulatory patients 6. the presence of comorbidities that can be confused with or can exacerbate the condition including: * calcaneal stress fracture * nerve entrapment syndrome (baxter nerve syndrome or tarsal tunnel) * plantar fascial rupture * systemic disorders associated with enthesiopathy such as gout, reiters syndrome, rheumatoid arthritis, etc. * achilles tendonitis * fat pad atrophy * fibromyalgia 7. patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. 8. patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening. 9. history of radiation at the site. 10. known history of having acquired immunodeficiency syndrome (aids) or hiv. 11. study foot has been previously treated with tissue engineered materials such as prp within the last 30 days. 12. patients who are unable to understand the aims and objectives of the trial. 13. presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment. 14. pregnant or breast feeding. no pregnancy within the past 6 months. 15. allergy to gentamycin streptomycin
clinical evaluation of rtx locator attachments for implant-supported mandibular complete overdenture

Conditions: Vertical Alveolar Bone Loss

Summary: this study was conducted to clinically and radiographically evaluate locator rtx attachments for two implant-supported mandibular overdenture using two loading protocols

thirty edentulous patients received two implants in the interformaninal region in the canine area . according to the loading protocol used for attaching mandibular overdenture, patients were randomly assigned into two equal groups. group i (control): patients who would be delivered mandibular implant overdenture retained by two rtx locator attachments using conventional loading protocol. group ii (study): patients who would be delivered mandibular overdenture retained by two rtx locator attachments using early loading protocol. peri-implant tissue health \[plaque (pl) and (gi) gingival scores, pocket depth (pd), and crestal bone loss (cbl)\] were evaluated immediately after denture insertion (t0), 6 (t6), and 12 (t12) months after insertion.

Eligibility criteria:
inclusion criteria: * adequate bone quantity \[class iii -v according to cawood and howell in the interforaminal area of the mandible to receive 2 implants (4×13 mm) * adequate restorative space \[12-15 mm from the mucosa of the mandibular ridge to the occlusal plane, class i according to ahuja and cagna for rtx supported implant overdenture. exclusion criteria: * systemic diseases that contraindicate implant placement * bone metabolic diseases as diabetes mellitus * irradiation of the head and neck region * chemotherapy within the past 3 years * smoking habits.