Kornimate/medical-research-clean huggingface dataset:
comparing the efficacy of reverse hybrid therapy and bismuth quadruple therapy

Conditions: Helicobacter Pylori Infection

Summary: reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

a 14-day hybrid therapy invented by our study group appears very promising in h. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. however, whether reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Eligibility criteria:
inclusion criteria: * consecutive h pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis exclusion criteria: * previous h pylori-eradication therapy * ingestion of antibiotics or bismuth within the prior 4 weeks * patients with allergic history to the medications used * patients with previous gastric surgery * the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) * pregnant women

Keywords: helicobacter pylori eradication rate
aware - chronic urticaria

Conditions: Chronic Urticaria

Summary: non interventional study collecting patient reported outcomes. the study aims to assess the disease burden of chronic urticaria patients and to record the therapies used in daily clinical practice in the uk and the impact they have on the quality of life and work productivity of individual patients.


Eligibility criteria:
inclusion criteria: subjects must be 18 years old subject must be willing and able to provide written informed consent for collection and analysis of routine data and pros subject must have medically confirmed diagnosis of chronic urticaria present for more than 2 months. subject must be refactory to at least one h1 antihistamine exclusion criteria: subjects who in the estimation of the treating physician are unlikely to be available for the full duration of the follow-up period of 24 months. subjects taking must not take part in any other concurrent urticarial study. -
tranexamic acid in on-pump cabg with premature clopidogrel cessation

Conditions: Coronary Artery Disease; Coronary Artery Bypass Graft

Summary: the use of platelet aggregation inhibitors, including aspirin and clopidogrel, has become a standard management strategy for patients with acute coronary syndrome. on this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition. tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has been suspended in 2007.the release of plasmin during cpb activates fibrinolysis and may contribute to platelet dysfunction. pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after cpb and decrease postoperative bleeding. tranexamic acid prevents plasmin formation and inhibits fibrinolysis. many studies and meta-analyses have shown a reduction in postoperative bleeding and transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery. unfortunately the preoperative antiplatelet therapy was either neglected or obscure. few studies specify the time between the last clopidogrel ingestion and surgery.several studies were keen on the blood loss and allogeneic transfusion in patients who received their last clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. concerning the secession of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population. the purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion less than 7 days prior to surgery. the working hypothesis is that tranexamic acid would reduce bleeding and transfusion requirements in this specific population of patients.


Eligibility criteria:
inclusion criteria: * men and women aged 18-85 years undergoing primary and isolated on-pump cabg * last ingestion of clopidogrel and aspirin within 7 days preoperatively exclusion criteria: * previous cardiac surgery * hematocrit \<33% * platelet count \<100,000/ml * allergy to tranexamic acid * recruited in other studies

Keywords: coronary artery disease coronary artery bypass graft platelet aggregation inhibitors tranexamic acid
pharmacokinetic study to compare itepekimab exposure when administered with an autoinjector versus prefilled syringe

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this phase 1, single-center study will be conducted in an open-label, randomized, parallel design. healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (sc) administered by either a prefilled syringe (pfs) or an autoinjector (ai). itepekimab will be administered by a trained healthcare professional (hcp). female and male participants will have a body weight between 50.0 and 100.0 kg and body mass index (bmi) \>18.5 and ≤30 kg/m2. participants who satisfy the inclusion criteria will be randomized to one of the 2 study intervention groups: * itepekimab administered via ai (test) * itepekimab administered via pfs (reference) the randomization will be stratified by weight category (\<70 kg, ≥70 to \<80 kg and ≥80 kg) and injection site (abdomen, thigh, and arm). study duration for each participant is up to approximately 162 days, including: * screening period: up to 21 days * institutionalization: 2 days including 1 treatment day (day 1) * follow-up period: 140 days (±5 days) * end of study (eos): day 141 (± 5 days)


Eligibility criteria:
inclusion criteria: • having given written informed consent prior to undertaking any study-related procedure. exclusion criteria: participants are excluded from the study if any of the following criteria apply: • any participant who, in the judgment of the investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
bausch & lomb ophthalmic viscosurgical device (ovd) dispersive (dvisc40)

Conditions: Cataract

Summary: a study to document the safety and effectiveness of a new ovd when compared to a control ovd

this is a multicenter, controlled, randomized, monocular trial evaluating the safety and effectiveness of the bausch \& lomb dvisc40 dispersive ovd compared to the alcon viscoat® dispersive ovd when used in cataract surgery. subjects will be randomized to one of the two treatment groups in a 1:1 ratio (dvisc40:viscoat®).

Eligibility criteria:
inclusion criteria: * the subject must be at least 45 years old and have a clinically documented diagnosis of age-related non-complicated cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and iol implantation. 2. the subject must have the capability to provide written informed consent on the institutional review board (irb)/ethics committee (ec) approved informed consent form (icf) and provide authorization as appropriate for local privacy regulations. 3. the subject must be willing and able to return for all scheduled follow-up examinations through 90 days following surgery. study #877 protocol dvisc40 28jul2017 v1.0 confidential page 16 of 53 4. the subject must have clear intraocular media other than the cataract in the operative eye. exclusion criteria: * 1. the subject has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation. 2. the subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye. 3. the subject has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye. 4. the subject has any condition which prevents reliable specular microscopy in the operative eye.
a pilot study of perioperative nivolumab and paricalcitol to target the microenvironment in resectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin d) and nivolumab on pancreatic tumors in patients who are treated with gemcitabine and abraxane. the study will also look at the safety of including paricalcitol and nivolumab as part of the gemcitabine and abraxane chemotherapeutic regimen.


Eligibility criteria:
inclusion criteria: * previously untreated, apparently resectable adenocarcinoma of the pancreas at registration. * age greater than or equal to 18 years * ecog performance status of 0-2. * standard laboratory criteria for hematologic, biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the subject on the trial. a. note: subjects must have: creatinine \ 1.5x109/l, total bilirubin \ 100,000/mm3 * ability to provide written informed consent exclusion criteria: * subjects with hypercalcemia (blood levels greater than 11.5 mg/dl). in subjects creatinine clearance \<60ml/min, blood calcium levels must be 9.5 mg/dl or lower. * subjects who are currently pregnant, planning to become pregnant, or breast-feeding 1. females participants of child-bearing potential are required to use an effective contraception method (see appendix a) or abstain from intercourse during treatment and for at least 5 months following the last dose 2. males participants with partners of child-bearing potential are required to use an effective contraception method (see appendix a) or abstain from intercourse during treatment and for at least 5 months following the last dose 3. subjects who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation 4. subjects with contraindications to immune checkpoint therapy, as follows: 1. interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity 2. prior organ allograft or allogeneic bone marrow transplantation 3. pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication 4. active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator 5. condition requiring systemic treatment with either corticosteroids * systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted. steroids as anti-emetics for chemotherapy are strongly discouraged (see section 5.1.3) * intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted
aflibercept for retinopathy of prematurity - intravitreal injection versus laser therapy

Conditions: Retinopathy of Prematurity (ROP)

Summary: the purpose of this study is to demonstrate how well aflibercept works in babies with rop, comparing it with laser therapy. the study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.


Eligibility criteria:
inclusion criteria: * gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g * subjects with treatment-naïve rop classified according to the international classification for rop in at least one eye as: * zone i stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or * zone ii stage 2 plus or 3 plus, or * aggressive posterior retinopathy of prematurity (ap-rop) * weight at baseline (day of treatment) ≥ 800 g * signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * known or suspected chromosomal abnormality, genetic disorder or syndrome * previous exposure to any ivt or systemic anti-vascular endothelial growth factor (vegf) agent, including maternal exposure during pregnancy and/or during breastfeeding * clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure) * pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a nicu specialist and a study ophthalmologist * presence of active ocular infection within 5 days of the first treatment * advanced stages of rop with partial or complete retinal detachment (rop stages 4 and 5) * rop involving only zone iii * ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint * postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of prednisone ≥ 1 mg/kg/day for \> 2 weeks within 14 days of the first study intervention * previous surgical or nonsurgical treatment for rop (ivt anti-vegf injection, ablative laser therapy, cryotherapy, and vitrectomy) * participation of the subject or the mother in other clinical trials requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening, or within 30 days or 5 half-lives of administration of the previous study drug, whichever is longer
efficacy of li-swt on persistent storage symptoms after transurethral surgery for bpo

Conditions: Overactive Bladder; Urinary Incontinence, Urge; Urgency-frequency Syndrome; Post Prostatectomy

Summary: comparing the outcome of low-intensity shock wave therapy (li-swt) versus solifenacin on persistent storage symptoms after transurethral surgery for benign prostatic obstruction (bpo)

benign prostatic hyperplasia (bph) is a common cause of lower urinary tract symptoms (luts) in aging men including both voiding and storage symptoms. after prostatectomy, 20-30% of the patients still have persistent storage symptoms. the pathophysiology of persistent storage symptoms after surgical relief of benign prostatic obstruction (bpo) remains unclear. it may be due to bladder changes produced by long standing bladder outlet obstruction (boo) including bladder ischemia and denervation or it may be related to other factors rather than preoperative boo such as aging, chronic inflammation or a subtle neurological disorder. after exclusion of urinary tract infection (uti) and boo, antimuscarinics are the commonly used medications for post-prostatectomy persistent storage symptoms. however, these medications are associated with side effects which may interfere with the patient compliance. low-intensity shock wave therapy (li-swt) is a non invasive procedure that has a beneficial effect in promoting revascularization and enhancing tissue regeneration. it has been applied to the penis for erectile dysfunction and to the perineum for chronic pelvic pain syndrome (cpps) with encouraging results. in a rat model, it has been reported that defocused li-swt leads to improvement of bladder innervation and vascularization. based on the previously mentioned studies, the investigators hypothesized that li-swt can offer benefit in improvement of persistent storage symptoms after surgical relief of bpo. in the present study, the investigators will evaluate the effect of li-swt on persistent storage symptoms after transurethral surgery for bpo compared to antimuscarinics in a randomized controlled trial (rct).

Eligibility criteria:
inclusion criteria: * patients have to fulfill all the following criteria to be included in the study: 1. ability to give informed consent and reply to questionnaires. 2. average urgency episodes per 24 hrs ≥ 1 and average daytime frequency ≥ 8 during the baseline 3-day voiding diary. 3. relief of boo as proved by non-invasive uroflowmetry, pressure flow study (pfs) or urethrocystoscopy. exclusion criteria: * patients who have any of the following will be excluded from the study: 1. untreated uti. 2. boo such as bladder neck contracture (bnc), residual obstructing adenoma or urethral stricture. 3. neurogenic lower urinary tract dysfunction (lutd). 4. uncontrolled diabetes mellitus. 5. depression or any psychogenic disorders. 6. prior radiation therapy to the pelvic area. 7. history of prostate cancer, bladder tumor or intravesical bacillus calmette guerin (bcg) therapy. 8. poor coagulopathy. 9. severe cardiovascular disease.

Keywords: low-intensity shock wave therapy persistent storage symptoms benign prostatic obstruction
study of tgf-β receptor inhibitor galunisertib (ly2157299) and enzalutamide in metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the primary objective of this study is to compare the progression free survival (pfs) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with ly2157299 (arm 1) versus enzalutamide alone (arm 2).


Eligibility criteria:
inclusion criteria: * have metastatic castration-resistant prostate cancer * must have had prior abiraterone treatment * life expectancy of greater than 3 months * eastern cooperative oncology group (ecog) performance status 0 or 2 * age ≥18 years * have measurable disease * patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator). * ability to take oral medication * patients must have adequate organ and marrow function defined by study-specified laboratory tests * must use acceptable form of birth control while on study * ability to understand and willingness to sign a written informed consent document exclusion criteria: * known history or evidence of brain metastases * prior chemotherapy for metastatic disease in castration-resistant prostate cancer * had surgery within 4 weeks prior to the first dose of study drug * had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug * had second-line hormonal therapy within 2 weeks prior to the first dose of study drug * systemic steroids within 1 weeks prior to the first dose of study drug * had prior enzalutamide, arn-509, or galeterone therapy * have moderate or severe cardiovascular disease * have a history of a seizure * have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements * have a history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and crohn's disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (sle) autoimmune vasculitis (e.g., wegener's granulomatosis), central nervous system (cns) or motor neuropathy considered to be of autoimmune origin (e.g., guillian-barre syndrome, myasthenia gravis, multiple sclerosis) * have known history of infection with hiv, hepatitis b, or hepatitis c

Keywords: metastatic castration-resistant prostate cancer enzalutamide ly2157299 tgf-β receptor inhibitor
in vivo evaluation of the nipro elisio™ dialyzer

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to compare the efficacy and biocompatibility of the nipro elisio 210h dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.

hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. however, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. this is the case of elisio™-h dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.

Eligibility criteria:
inclusion criteria: * ckd dialysis patients on treatment with three times a week hd for more than three months * with a stable anticoagulation scheme * with haemoglobin level \>10.5 g/dl * with vascular access allowing a stable blood flow of 300 ml/min during treatment exclusion criteria: * patient already enrolled in another study * pregnancy * symptoms or signs of acute/chronic inflammatory or infectious diseases

Keywords: ckd dialysis hemodialysis hemodiafiltration elisio dialyzer efficacy biocompatibility
post market clinical follow-up study protocol for profemur® z revision femoral stems

Conditions: Joint Disease

Summary: single center, prospective follow-up of previously implanted subjects

post market clinical follow-up study protocol for profemur® z revision femoral stems

Eligibility criteria:
inclusion criteria: 1. has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone). 2. subject is implanted with the profemur® z revision femoral stem at the time of their revision tha. 3. subject is willing and able to complete required study visits or assessments. 4. plans to be available through the 10 year postoperative follow-up visit. previously implanted bilateral subjects can have both thas enrolled in the study provided: 1. the profemur z revision femoral stem was implanted in both, 2. all other aspects of the inclusion/exclusion criteria are satisfied, 3. enrollment does not exceed the subject count specified in the clinical trial agreement, and 4. the subject agrees to a second informed consent document specific to the second tha. prospective enrollment of a previously unimplanted hip is not permitted in this study. exclusion criteria: 1. subjects currently enrolled in another clinical study which could affect the endpoints of this protocol. 2. subject has a profemur neck varus/valgus cocr 8 degree, part number phac 1254 implanted in the enrolled tha. 3. has or had an overt infection at the time of implantation. 4. has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation. 5. has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation. 6. has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable. 7. subjects unwilling to sign the informed consent document. 8. subjects with substance abuse issues. 9. subjects with an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study. 10. subjects who are incarcerated or have pending incarceration.