Kornimate/medical-research-clean huggingface dataset:
effect of local cold applıcatıon on paın and vıtal sıgns durıng port catheter needle insertıon

Conditions: Catheter Placement and Perceived Pain; Vital Sign Monitoring; Pain

Summary: in this study, the effect of cold application on the pain experienced during port catheter needle insertion and the change in the patient's vital signs will be evaluated. it is thought that with this application, patients will experience less pain during port catheter needle insertion. the change in the patient's vital signs and pain status will also be evaluated. the research will be conducted in the outpatient chemotherapy department of a hospital.

the effects of lidocaine cream, cryotherapy (cold application to the skin), cutaneous stimulation therapy (pressure and massage) methods , virtual reality application and aromatherapy applied via inhalation on reducing pain were investigated in order to reduce the pain during port catheter needle insertion. in this study, the effect of cold application on the pain experienced during port catheter needle insertion and the change in the patient's vital signs will be evaluated. it is thought that with this application, patients will experience less pain during port catheter needle insertion. the change in the patient's vital signs according to the pain status will also be evaluated. the research will be conducted in the outpatient chemotherapy department of necmettin erbakan university faculty of medicine hospital. the universe of the research will consist of all patients with port catheters in the outpatient chemotherapy department of necmettin erbakan university faculty of medicine hospital. the sample of the research will consist of patients who meet the inclusion criteria and agree to participate in the research.

Eligibility criteria:
inclusion criteria: patients between the ages of 18-65, who are pain-free, receiving treatment in an outpatient chemotherapy unit, who have a port catheter, who have a huber port needle of l (large) 20 mm-20 gauge, and who can read and write in turkish. exclusion criteria: patients taking "oxaliplatin" patients aged 65 and over patients who have started using a port catheter but whose stitches have not yet healed patients who have not passed 30 days since the port catheter was inserted patients with any redness, swelling or tenderness in the port catheter area
the effect of treatment on circulating tumor cells in bladder cancer patients with muscle-invasive or advanced disease

Conditions: Bladder Cancer

Summary: the investigators hypothesize that circulating tumor cells (ctc) will be observed in patients with muscle-invasive or metastatic bladder cancer and that ctc will become undetectable, at least transiently, in a fraction of patients after treatment. to investigate this hypothesis, investigators will assess the levels of ctcs both before and after treatment. the feasibility and potential value of fluorescent in situ hybridization (fish) in the ctcs will be assessed.

the measurement of circulating tumor cells is pursued in several cancers including breast and prostate cancer. the number of cells measured in these cancers has been shown to be prognostic. there is little information on the presence or importance of circulating tumor cells in bladder cancer. this trial is designed to determine if patients with advanced bladder cancer have circulating tumor cells and if these circulating cells are affected by treatment of the cancer.

Eligibility criteria:
inclusion criteria: * pathological diagnosis of transitional cell carcinoma of the urothelium of at least t2-4, nx, mx stage. mixed histologies will be allowed (e.g. squamous differentiation) as long as a transitional cell component is present. * clinical plans for surgery (with or without chemotherapy), radiation therapy, or chemotherapy. * participants must not have any condition which in the investigator's opinion may compromise the feasibility of completing the study. * subject must be 18 years of age or older * subject must be willing to have up to 4 peripheral blood samples obtained over a 6 month period of study. * prior therapies for bladder cancer will be allowed if patient currently has muscle-invasive or metastatic bladder cancer despite the previous treatments. * predicted life expectancy of \> 12 weeks. exclusion criteria: * subjects who are unwilling or unable to comply with the study guidelines as determined by the principal investigator.

Keywords: bladder cancer
biomarker panel in ovarian torsion

Conditions: Ovary Torsion; Adnexal Torsion

Summary: the overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion.

the overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion. the specifc aims of the current study are: 1. screen for changes in blood protein biomarkers concentrations specifc for patients with ovarian torsion. the biomarkers are: d-dimer (21.7-5,280 ng/ml), fabp4/a-fabp (0.637-155 ng/ml), gm-csf (0.012-2.98 ng/ml), icam-1/cd54 (6.9-1674 ng/ml), ifn-γ (0.058-14.2 ng/ml), il-1α (0.005-1.27 ng/ml), il-6 (0.005-1.2 ng/ml), il-10 (0.005-1.2 ng/ml), il-17/il-17a (0.012-3.1 ng/ml), park7/dj-1 (0.26- 63.1 ng/ml), tnf-α (0.01-2.4 ng/ml), tslp (0.003-0.7 ng/ml), vcam-1/cd106 (7.8-1891 ng/ml) and vegf (0.008-2.4 ng/ml). 2. compare the amount of oxidative stress defense proteins sod1, catalase, and thioredoxin amount in the peritoneal fluid wash between patients with or without confirmed ovarian torsion. to our knowledge, this is the first study that specifically evaluates the expression of oxidation stress defense proteins in ovarian torsion. the results will enable us to decide whether to include oxidation stress biomarkers within the panel. 3. study population methodology and techniques a prospective, 12-24 months study. 20 patients with confirmed ovarian torsion will be enrolled. the patients will complete a questionnaire prior to and following the procedure 3.5ml blood samples will be obtained immediately before laparoscopy, postoperative day, and four weeks after laparoscopy during the follow-up. the peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure. 20 patients suspected of ovarian torsion with no ovarian torsion, as confirmed by laparoscopy, will be enrolled. the patients will complete a questionnaire prior to and following the procedure 5ml blood samples will be obtained immediately before laparoscopy and four weeks after laparoscopy during the follow-up. the peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure. 20 healthy controls will be enrolled and provide a 5ml blood sample.

Eligibility criteria:
inclusion criteria: * female patients between 12 and 50 years who were admitted to the gynecological emergency room at assuta medical center with signs and symptoms suggestive of ovarian torsion * patients that will undergo laparoscopy for the diagnosis of ovarian torsion * able to provide informed consent for themselves or have a legal guardian that can provide informed consent (in cases of patients under 18 years old) exclusion criteria: \* patients that are unable to provide informed consent
maintenance study including re-induction therapy for patients who did not show a clinical effect in study c87037 (nct00291668)

Conditions: Crohn's Disease

Summary: this 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at weeks 16, 20, 24, 28 and 32) in subjects with active crohn's disease who had no clinical response at week 6 to induction therapy in the 6-week double-blind main study, c87037 (nct00291668), but subsequently showed clinical response at week 14 to repeated induction therapy (dosed at weeks 8, 10 and 12) in this extension study.

this study is an open-label extension study which follows on from the 6-week double-blind main study c87037 (nct00291668). all 'week' numbers quoted are relative to the start of the double-blind main study. the first visit in this extension study is at week 8, and the final efficacy assessment in this extension study, 26 weeks later, is at week 34.

Eligibility criteria:
inclusion criteria: * subjects who gave written informed consent and who did not show clinical efficacy at week 6 of the double-blind main study (nct00291668) \[reduction in crohn's disease activity index (cdai) score of ≥100 points from week 0, or remission (cdai ≤150)\] exclusion criteria: * subjects who experienced aggravation of crohn's disease during the double-blind main study (nct00291668) and required treatment change

Keywords: crohn's disease cdp870 certolizumab pegol czp
evaluation of innovative tools in development of antibiotics

Conditions: Pneumonia

Summary: the investigators will determine the difference of pharmacokinetics of ciprofloxacin and imipenem between healthy volunteers and intensive care patients suffering from pneumonia in plasma and at the target site - lung - using bronchoalveolar lavage. as additional aspect the feasibility of combining microdosing of c14 ciprofloxacin with microdialysis, saliva sampling and bronchoalveolar lavage is studied by comparing pharmacokinetics of microdose and macrodose.


Eligibility criteria:
inclusion criteria: * healthy male subjects aged 18 to 55 years * good state of health (mentally and physically) * body mass index within a range of 18 to 28kg/m2 inclusive. * non-smoker * a signed and dated written informed consent form. * the subject is able to understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions. * negative serology (human immunodeficiency virus, hepatitis b-ag and c-ab) at screening. * vital signs should be within the following ranges: * oral or tympanic temperature between 35 and 37.5°c. * systolic blood pressure, 90-140 mmhg. * diastolic blood pressure, 50-90 mmhg. * pulse rate, 50-90 bpm. exclusion criteria: * any acute or chronic illness or clinically relevant (investigator's judgement) abnormality identified on the screening medical assessment, laboratory tests or ecg, unless in the opinion of the investigator it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject. * all subjects with known seizure disorder, with the exception of a febrile seizure in childhood * use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to the first dose of study medication. * any intake of grapefruit juice within 1 week prior to the first dose. * allergies (except for mild forms of hay fever), a history of hypersensitivity reactions including psychological or neurological symptoms or signs, or anaphylactic shock following administration of any medicine. * allergy to or any contraindication against the active or inactive ingredients in the study medication (ciprofloxacin, imipenem, cilastatin, propofol, midazolam, remifentanil, xylocain, and sevoflurane) and radioactive labelling with 14c. * smoker * alcohol or drug abuse * participation in a trial with any drug within 30 days or five half-lives (whichever is longer) before the start of the study. * donation of blood within a period of 4 weeks prior to dosing. * creatinine clearance ≤70ml/min/1.73m3 * any other reason that the investigator considers to make the subject unsuitable to participate.
a comparison of silicone hydrogel contact lenses: air optix® colors versus air optix® aqua

Conditions: Myopia

Summary: the purpose of this study was to compare the overall fit of air optix® colors to air optix® aqua contact lenses.

eligible participants were randomized at visit 1 (screening) to receive 1 of the 2 investigational products (1:1 assignment). between visit 1 and visit 2, participants wore their habitual air optix® aqua lenses. investigational products were dispensed at visit 2 (baseline), after which participants were asked to return for 2 additional visits: visit 3 (day 14) and visit 4 (day 28).

Eligibility criteria:
inclusion criteria: * visual acuity of at least 20/30 (snellen) in each eye at distance with contact lenses and best corrected visual acuity ≥ 20/25 in each eye. * manifest cylinder less than or equal to 0.75 diopter (d) (within the previous year) in each eye. * successful wear of air optix® aqua soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. * willing to sign an informed consent form. if under legal age of consent, legally authorized representative must also sign an informed consent form. * other protocol-specified inclusion criteria may apply. exclusion criteria: * any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study. * wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis). * monovision, monocular (only one eye with functional vision), or fit with only one lens. * history of intolerance or hypersensitivity to any component of the test articles. * use of any over-the-counter (otc) or prescribed topical ocular medications within previous 7 days (excluding rewetting drops). * moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications, and any corneal infiltrates. * current or history of ocular infection, severe inflammation, or disease within previous 6 months. * any systemic disease that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions. * ocular or intra-ocular surgery within the previous 12 months (excluding placement of punctal plugs). * use of medications contributing to dry eye or ocular irritation unless on a stable dosing regimen for a minimum of 30 days prior to study entry and able to remain on stable regimen throughout the study. * participation in any investigational clinical study within previous 30 days. * other protocol-specified exclusion criteria may apply.

Keywords: contact lenses color contact lenses myopia
study of blood samples from patients with osteosarcoma

Conditions: Localized Osteosarcoma; Metastatic Osteosarcoma; Recurrent Osteosarcoma

Summary: this research trial studies blood samples from patients with osteosarcoma. studying the genes found in samples of blood from patients with osteosarcoma may help doctors identify biomarkers related to the disease.

primary objective: i. conduct a large-scale candidate gene association study in osteosarcoma (os) using cases from the national children's oncology group (cog) os biology study (p9851 and successor study aost06b1). secondary objectives: i. conduct a genome-wide association study (gwas) of os. ii. fine-map genomic regions associated with os to identify putative functional loci. iii. conduct whole-exome sequencing of germline os deoxyribonucleic acid (dna) samples. iv. investigate the functional implications of promising genetic variants associated with os. outline: blood samples undergo polymorphism analysis of common single-nucleotide polymorphisms and haplotypes to examine genetic variation, gene-gene interactions, and the population structure.

Eligibility criteria:
inclusion criteria: * blood samples collected from clinical trials cog-p9851 and cog-aost06b1
a study to evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects with cf, homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: to evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 through 11 years with cystic fibrosis (cf), homozygous for the f508del cf transmembrane conductance regulator (cftr) mutation


Eligibility criteria:
inclusion criteria: * subjects who weigh ≥15 kg without shoes a the screening visit * subjects with confirmed diagnosis of cf at the screening visit. * subjects who are homozygous for the f508del cftr mutation * subjects with ppfev1 of ≥70 percentage points adjusted for age, sex, and height * subjects with a screening lci2.5 result greater than or equal to 7.5 exclusion criteria: * history of any comorbidity reviewed at the screening visit that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. * any clinically significant laboratory abnormalities at the screening visit that would interfere with the study assessments or pose an undue risk for the subject * clinically significant abnormalities in hemoglobin, liver function, or renal function at the screening visit. * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before day 1 * history of solid organ or hematological transplantation at the screening visit
effectiveness of bioactive resin varnish and fluoride containing xylitol varnish in management of teeth hypersensitivity

Conditions: Tooth Hypersensitivity

Summary: will the use of bio-smart light cured protective shield with bioactive s-prg filler or the use of sodium fluoride with xylitol-coated calcium and phosphate (cxp™) varnish be able to reduce the teeth hypersensitivity similar to sodium fluoride varnish?

the null hypothesis tested in this study, that there is no difference in clinical effectiveness between bio-smart shield with bioactive s-prg filler and fluoride varnish containing xylitol-coated calcium and phosphate (cxp™) compared to sodium fluoride varnish in management of hypersensitivity in adult patients after 3 minutes, 2, 4 and 8 weeks. p (population): patient with teeth hypersensitivity. intervention-1: bio-smart light cured protective shield with bioactive s-prg (surface pre-reacted glass ionomer) filler technology (prg barrier coat) by (by shofu inc., japan). intervention-2: 5% sodium fluoride with xylitol-coated calcium and phosphate (cxp™) varnish (embrace™ varnish) by (pulpdent corporation) c (comparator): 5% sodium fluoride varnish (duraphat®) by (colgate palmolive company, new york, ny) o (outcome): * primary outcome: pain due to hypersensitivity * secondary outcome: dentinal tubules occlusion

Eligibility criteria:
inclusion criteria: * patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentin) * teeth scoring pain (vas score: greater than or equal to 5) during application of stimulus (air blast, thermal and tactile sensitivity test). * patients with good oral hygiene. * co-operative patients who show interest to participate in the study accept the 2-months follow-up period. exclusion criteria: * patients participating in another dental study that may alter the results of this study. * a medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders). * any chronic medical condition that requires the regular use of anti-inflammatory pain medications. * patients used or applied a desensitizing varnish within the last four weeks. * patients with dental problems; chipped teeth, defective restorations, fractured un-displaced cuspids or deep dental caries. * patients with orthodontic appliances, or bridge work that might interfere with evaluation * lack of patient's approval and compliance. * patients who are allergic to any ingredients will be used in the study.

Keywords: hypersensitivity sodium fluoride xylitol coated calcium and phosphate biosmart light cured protective shield
anterior segment imaging with ultrahigh-resolution oct in patients with glaucoma and pex - a pilot study

Conditions: Glaucoma

Summary: the aim of the present study is to develop a measurement protocol for optimal imaging of the anterior segment of the eye, including anterior chamber angle, schlemm's canal, filtering bleb and pseudoexfoliation deposits on the lens based on measurements in patients with glaucoma and pex. in glaucoma the structures of the anterior chamber are important for classification, therapy, progression and prognosis and imaging of the angle between the iris and the cornea is the key for open angle and closed angle glaucoma differential diagnosis. for this purpose, a customized ultrahigh resolution spectral domain oct will be used to validate whether the protocol can also be more widely applied in these patients. based on the obtained measurement protocol, further studies investigating anatomy and pathophysiology of the anterior segment of the eye as well as surgical outcome in patients with glaucoma and pex can be planned. the aim of the study is to develop a measurement protocol for oct imaging and characterization of the anterior chamber in glaucoma patients.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years for patients with primary open angle glaucoma: * diagnosed primary open angle glaucoma * visual field defects and optic nerve head appearance characteristic for glaucoma * open anterior chamber angle as evidenced by gonioscopy * no previous glaucoma surgery * no previous cataract surgery for patients with primary angle closure: * angle closure predisposition as evidenced from goniosocopy * no previous glaucoma surgery for patients with neovascular glaucoma: - neovascularization in the anterior chamber angle for patients with pseudoexfolation deposits on the lens: * pex glaucoma as evidenced from slit lamp examination * visual field defects and optic nerve head appearance characteristic for glaucoma * open anterior chamber angle as evidenced by gonioscopy * no previous glaucoma or cataract surgery for glaucoma patients with filtering bleb after trabeculectomy: * patients with history of trabeculectomy secondary to open angle glaucoma in the previous three months * no cataract surgery for healthy volunteers: * no evidence of ocular disease * no degenerative changes in the retina in funduscopy after mydriasis * ametropia less than 3 dpt. exclusion criteria: * presence of any abnormalities preventing reliable measurements as judged by the investigator * pregnancy, planned pregnancy or lactating * ocular inflammation and ocular disease interfering with the study aims as judged by the investigator

Keywords: schlemm's canal lumen area pex