Kornimate/medical-research-clean huggingface dataset:
assessing bay86-9766 plus sorafenib for the treatment of liver cancer.

Conditions: Carcinoma, Hepatocellular

Summary: this study investigates the safety and efficacy of the combination therapy with bay86-9766 and sorafenib in patients with liver cancer. safety will be determined by laboratory and other evaluations. efficacy of the combination bay86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.


Eligibility criteria:
inclusion criteria: * male or female age \>/= 18 years of age * life expectancy \>/= 12 weeks * histologically or cytologically confirmed diagnosis of hcc, unresectable advanced or metastatic * liver function status of child-pugh class a. child-pugh status based on clinical findings and laboratory results during the screening period * eastern cooperative oncology group performance status (ecog ps) of 0 or 1 * patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by ct or mri according to recist 1.1 * adequate bone marrow, liver and renal function exclusion criteria: * previous or concurrent cancer other than hcc, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors. * history of cardiac disease: congestive heart failure (chf), unstable angina, arrhythmias, uncontrolled hypertension * clinically significant gi bleeding (ctcae grade 3 or higher) within 30 days * renal failure requiring hemo- or peritoneal dialysis * known human immunodeficiency virus (hiv) infection * known history or symptomatic metastatic brain or meningeal tumors * history of organ allograft. * history of interstitial lung disease (ild). * excluded previous therapies and medications: * prior use of systemic anti-cancer treatment for hcc including cytotoxic chemotherapy, targeted agents, or any experimental therapy * radiotherapy within 4 weeks prior to start of study treatment * any other investigational agents within 4 weeks from the first dose of study treatment * major surgery within 4 weeks of start of study * concomitant use of strong inhibitors and strong inducers of cyp3a4

Keywords: hepatocellular carcinoma (hcc) mek inhibitor sorafenib disease control rate (dcr) safety
compassion s3 - evaluation of the sapien 3 transcatheter heart valve in patients with pulmonary valve dysfunction

Conditions: Complex Congenital Heart Defect; Dysfunctional RVOT Conduit; Pulmonary Valve Insufficiency; Pulmonary Valve Degeneration

Summary: this study will demonstrate the safety and effectiveness of the edwards lifesciences sapien 3/sapien 3 ultra resilia transcatheter heart valve (thv) systems in subjects with a dysfunctional right ventricular outflow tract (rvot) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.


Eligibility criteria:
inclusion criteria: 1. weight ≥ 20 kg (44 lbs.) 2. dysfunctional rvot conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the instructions for use 3. subject presents with at least moderate pr and/or mean rvot gradient ≥ 35 mmhg. 4. the subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. exclusion criteria: 1. active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics) 2. history of or active endocarditis (active treatment with antibiotics) within the past 180 days 3. leukopenia, anemia, thrombocytopenia or any known blood clotting disorder 4. inappropriate anatomy for femoral introduction and delivery of the study valve 5. need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty 6. angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (tpvi) 7. interventional/surgical procedures within 30 days prior to the tpvi procedure. 8. any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the tpvi procedure. 9. history of or current intravenous drug use 10. major or progressive non-cardiac disease resulting in a life expectancy of less than one year 11. known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications 12. known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated 13. participating in another investigational drug or device study that has not reached its primary endpoint. 14. female who is lactating or pregnant

Keywords: tetralogy of fallot aortic valve defect/disease resulting in ross procedure pulmonary atresia pulmonary stenosis truncus arteriosus transposition of the great arteries transcatheter pulmonary valve implantation transcatheter pulmonary valve replacement tpv tpvr tpvi
imatinib in kit-negative systemic mastocytosis

Conditions: Systemic Mastocytosis

Summary: the aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of imatinib mesylate therapy in patients with systemic mastocytosis lacking kit mutations.

in vitro studies have proven that imatinib inhibits wild type kit (wtkit) and suppresses proliferation of the hmc-1v560g cell line, while it is ineffective on inhibiting the growth of hmc-1v560g, d816v cells. apart from wtkit, kit molecules carrying mutations in the extracellular, transmembrane and juxtamembrane domains, such as v560g, f522c and k509i, remain sensitive to imatinib. in contrast, several experiments have provided compelling evidence regarding the resistance against the growth-inhibitory effects of imatinib on cells carrying the d816v kit mutation. as a consequence, sensitive and specific methods should be used in order to avoid "false" kit mutation-negative cases and, for that purpose, mainly in cases with low bone marrow mast cell numbers, mutational studies should be performed using highly purified bone marrow mast cells by means of facs sorting systems better than whole bone marrow, unsorted mononuclear cell fraction or mononuclear cell fraction pre-enriched using magnetic beads conjugated with anti-cd25 monoclonal antibody. in the present study mutational studies were performed in all cases in purified bone marrow mast cells (purity \> 97%) using a facsaria system (becton-dickinson biosciences) as previously described. patients without b or c findings according to the world health organization, and without features of biological progression of the disease receive oral imatinib mesylate 300 mg daily for up to 12 months or until clinical progression/unacceptable toxicity. patients with b or c findings or biological progression initially receive oral imatinib mesylate 300 mg daily for two weeks; then, dose is increased up to 400 mg/day except in patients who develop hematological or any other dose-limiting toxicity. biological progression is defined as the presence of at least one of the following features: i) increased serum tryptase levels \> 200 ng/ml, ii) diffuse bone sclerosis, iii) patchy sclerosis with osteolysis and increased risk of bone fracture or significant bone pain, and, iv) organomegalies or lymph node enlargement due to mastocytosis.

Eligibility criteria:
inclusion criteria: * age older than 18 years. * diagnosis of systemic mastocytosis in the absence of c-kit mutation. * ecog ≤ 3. * signed informed consent. exclusion criteria: * previous therapy with a tyrosin kinase inhibitor. * positive antibodies against hiv or active viral hepatitis. * impaired liver function (total bilirubin ≥ 2.0 mg/dl, ast or alt \> 3 x upper limit of normal). * impaired renal function (≥ 2.0 mg/dl). * grade iii-iv cytopenias not related to mastocytosis. * severe cardiopathy (grade iii/iv of nyha, or left ventricular ejection fraction \< 50%). * pregnancy or breastfeeding. * female patients who do not use contraceptive methods.

Keywords: mast cell mastocytosis mast cell disease
adjuvant chemotherapy compared with observation in treating patients with resected early stage ovarian epithelial cancer

Conditions: Ovarian Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more cancer cells. purpose: randomized phase iii trial to compare the effectiveness of adjuvant therapy using platinum-based chemotherapy drugs with no adjuvant therapy in treating patients with early stage invasive ovarian epithelial cancer.

objectives: i. determine whether adjuvant chemotherapy with a platinum-containing regimen (e.g., carboplatin or cap: cyclophosphamide/doxorubicin/cisplatin) prolongs survival in patients with early stage ovarian cancer compared to those receiving no adjuvant treatment. outline: randomized study. patients are randomized to arm i or ii; treatment should begin within 6 weeks of surgery. regimens listed in arm i are recommended, but other platinum-containing regimens are allowed provided the doses at a minimum meet those listed below. arm i: single-agent chemotherapy or 3-drug combination chemotherapy. carboplatin, cbdca, nsc-241240; or cap: cyclophosphamide, ctx, nsc-26271; doxorubicin, dox, nsc-123127; cisplatin, cddp, nsc-119875. arm ii: observation. no adjuvant therapy. projected accrual: a maximum of 2,000 patients will be randomized.

Eligibility criteria:
disease characteristics: histologically confirmed invasive ovarian cancer of epithelial origin all tumor resected prior to randomization uncertain whether immediate chemotherapy is required patient characteristics: age: any age performance status: sufficient to receive chemotherapy hematopoietic: not specified hepatic: not specified renal: not specified other: no prior malignancy except nonmelanomatous skin cancer no clear contraindication to chemotherapy prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy surgery: minimum recommended surgical procedures (when possible): thorough surgical staging total hysterectomy/bilateral salpingo-oophorectomy omentectomy, as follows: total supracolonic omentectomy if omentum involved removal of distal 2 cm or infracolonic omentectomy in the absence of macroscopic disease

Keywords: stage i ovarian epithelial cancer stage ii ovarian epithelial cancer
establishing technique for pecs2 catheter insertion

Conditions: Breastcancer; Phyllodes Breast Tumor

Summary: the investigators are trying to establish an easy technique for insertion of a catheter for continuous infusion while performing pectoral type 2 (serratus) block, as a post operative pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence

as the space between the pectoralis minor and the serratus anterior is a fashial plane with a connective tissue occupying. we are trying to demonstrate a simple technique for inserting a catheter within that fashial plane and making sure of the catheter position, to ensure post operative analgesia for cases performing simple mastectomy. now the pectoralis type 2 block (pecs type 2) is an established technique as regional block technique for chest wall procedures. we are trying to maximizing the benefit of the block with a catheter insertion to use it for continuous infusion of bupivacaine for controlling post operative pain in cases performing simple mastectomy procedure

Eligibility criteria:
inclusion criteria: * female patient scheduled for simple mastectomy * accepted performing the block exclusion criteria: * patients on anticogulants * chest wall infection * patient refusal

Keywords: pecs block breast surgery ultrasound guidence
influence of immersion in water during labor on the request of epidural anesthesia by pregnant women

Conditions: Delivery; Labor Pain

Summary: women are showing a growing interest in less medicalized childbirth. according to the french 2021 perinatal survey, 52.2% of women want to limit medical procedures and 38.2% of women want childbirth without epidural anesthesia. between 77 and 82% of deliveries nevertheless lead to an epidural anesthesia. the painful feeling seems to be the main motivation for using this mode of anesthesia.

in the scientific literature, few data from clinical studies focus on the effects of immersion in water during childbirth. the analgesic effects of immersion in water to lessen the painful experience are yet to be proven. the opening of a physiological delivery room with a bathtub at the saint-etienne university hospital since october 2020 provides data that has not been exploited yet and could make possible to answer the question of the analgesic effects of immersion in water during labour. the difficulties of analysis and the subjectivity of the painful feeling led us to consider the request of epidural anesthesia as the main analysis criterion.

Eligibility criteria:
inclusion criteria: * all women who used the physiological delivery room of the saint-etienne university hospital between october 2020 and december 2022. exclusion criteria: * absence of physiological desire for childbirth. * medical indication for epidural anesthesia.

Keywords: water immersion waterbirth childbirth labor pain epidural anesthesia physiological delivery pregnant women general medicine
cosopt (timolol/dorzolamide combination) normal tension glaucoma study (mk0507a-161)(completed)

Conditions: Glaucoma

Summary: a study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (cosopt) on decrease in intraocular pressure (iop) at 2 hours after the study drug administration


Eligibility criteria:
inclusion criteria: * patients who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma * patients with primary open-angle glaucoma based on gonioscopy * patients with normal tension glaucoma diagnosed based on accompanying optic disc cupping and reappearance of visual field defect corresponding to retinal nerve fiber layer defect. * subjects with \< 22 mm hg of diurnal iop measured using goldmann applanation tonometer (every two hours between 9 a.m. and 5 p.m.) exclusion criteria: * patients with another type of glaucoma but primary open-angle glaucoma * patients treated with other glaucoma medications within 6 weeks prior to study participation * patients with a history of chronic ocular inflammation or recurrent ocular inflammation * patients using contact lenses * patients who are allergic to timolol or dorzolamide * patients with a history of any of the following cosopt (timolol/dorzolamide combination) contraindications: * reactive airway diseases * sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock * severe renal impairment * patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study * patients with a history of a corneal disease * patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study * pregnant women
safety and efficacy study of ulocuplumab and nivolumab in subjects with solid tumors

Conditions: Solid Tumor

Summary: the purpose of this study is to determine whether the combination of ulocuplumab and nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.

* intervention model: single group for stage 1 dlt, then parallel * data monitoring committee: no (stage 1) yes (stage 2 randomized ph2)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * sclc or pac that is advanced or has spread to other parts of the body * treated with at least one other chemotherapy that did not work or where cancer relapsed * minimal limitations on activities of daily living as measured by eastern cooperative oncology group (ecog) score of 0-1 exclusion criteria: * patients with cancer that spread to the brain * active, known or suspected autoimmune disease * prior treatment with any drug that targets t cell co-stimulation pathways (such as checkpoint inhibitors)
safety and tolerability study of ro7171009 in participants with geographic atrophy (ga) secondary to age-related macular degeneration (amd)

Conditions: Geographic Atrophy

Summary: this phase 1, open-label, multicenter study will investigate the safety and tolerability of ro7171009 following single and multiple intravitreal (itv) administrations in patients with ga secondary to amd. the study consists of two stages: single dose-escalation (sad) and multiple-dose (md) stages.


Eligibility criteria:
inclusion criteria: * participants aged greater than or equal to (\>/=) 50 years * well demarcated area(s) of ga secondary to amd with no evidence of prior or active choroidal neovascularization (cnv) in study eye exclusion criteria: ocular exclusion criteria, study eye: * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd * previous laser photocoagulation for cnv, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy * prior treatment with visudyne®, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy ocular exclusion criteria (both eyes): * ga in either eye due to causes other than amd * evidence of prior or active cnv * previous participation in interventional clinical trials for ga or dry amd, except for vitamins and minerals, irrespective of the route of administration (i.e., ocular or systemic) within the last 6 months
evaluation of the dexcom g6 continuous glucose monitoring system with a non-interferent sensor

Conditions: Diabetes Mellitus

Summary: the objective of the study is to demonstrate effectiveness of the g6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.

the interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the g6 cgm system after administration of acetaminophen. bias will be evaluated by comparing cgm values to a laboratory referenceusing venous sample measurements.

Eligibility criteria:
inclusion criteria: * ages 18 or older * diagnosis of diabetes exclusion criteria: * pregnancy * known gastroparesis * abnormal liver function
study of egg-derived influenza vaccine and cell culture-derived influenza vaccine in healthy children and adolescents

Conditions: Influenza, Human

Summary: this study is a multi-center, randomized, double-blind phase iii clinical trial. the aim of the study is to describe the immunogenicity and safety of the trivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

subjects are randomly assigned in a 4:1 ratio to nbp607-qiv versus agrippal s1. to assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(hi) assay from sera obtained at pre-vaccination and 28 days post-vaccination. to assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. the serious adverse events are collected during 6 months post-vaccination.

Eligibility criteria:
inclusion criteria: * healthy children and adolescents aged 6 months to 18 years. * those who was born after normal pregnancy period(37 weeks) for aged 6 months to 2 years. * those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements. exclusion criteria: * subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products. * subjects with immune deficiency disorder. * history of guillain-barre syndrome. * thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day or with any acute respiratory infection. * subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening. * subjects who had received blood products or immunoglobulin within 3 months before screening. * subjects who had received influenza vaccination within 6 months prior to the screening. * subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after study vaccination. * subjects who had participated in other clinical trial within 4 weeks prior to study vaccination. * subjects who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination. * subjects with clinically significant chronic disease or malignant cancer. * pregnant women, breast-feeding women. * any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
evaluation of biomimetic mineralization plus soft laser irradiation in dentin hypersensitivity management

Conditions: Dentin Hypersensitivity

Summary: randomized clinical trial to investigate the efficacy of diode laser , biomimetic mineralization desensitizing agents curodont d'senz (cs) gel both in combination and alone, and the efficacy of bifluoride 10 (5 % sodium fluoride) varnish alone in cervical dentin hypersensitivity patients. also, to assess the duration of sensitivity relief immediately after 15 minutes of application, after 2 weeks, after 1 month and 3 months , the null hypothesis that there will be no difference between the treatment groups in different times.

current research focuses on increasing the mineral density of the dentin surface making it possible to improve its resistance to wear by both acid erosion and abrasion and plugging and sealing open tubules with a calcium and phosphate containing dentin-like substance, which would block diffusion through the tubules into the dentin sub-surface, thereby increasing acid resistance. self-assembling peptide matrix (p11-4) supplied commercially as curodont d'senz (cs) gel (credentis ag, windisch, switzerland) is based on the nanofiber technology that enhances biomimetic repair and the remineralization of dental tissues. self-assembling peptide matrix hydrogel revealed more reduction of the opened dentinal tubules in comparison to other selected desensitizing toothpaste.lasers have been recently been introduced as another possibility for in-office treatment of dh and may open up new horizons in the treatment of dentin hypersensitivity. of interest is the fact that the laser irradiation can augment the effect of the desensitizer for a longer duration than when they are used alone. they hypothesized that laser favor the durability of the desensitizer for extended time. some studies recommend desensitizing agent to remain above tooth surface for one minute before laser irradiation.

Eligibility criteria:
inclusion criteria: * age from 18-60 years old. * non-smokers. * disease-free patients. * good oral hygiene. * having at least one teeth suffering from cervical dentin hypersensitivity with vas pain score ≥5 * recording pain to thermal, mechanical or tactile stimuli. * acceptance to participate in the study exclusion criteria: * smoking and bad oral hygiene. * presence of carious lesions, restorations or fracture in the test area. * presence of painful pathology restored less than three months in the test area. * using any desen¬sitizing agents. * undergo any peri¬odontal surgery in the last 6 months. * drug abusers. * administration of potent analgesics or anti-inflammatory drugs.

Keywords: curodont de senz laser fluoride varnish