Kornimate/medical-research-clean huggingface dataset:
ovitex in paraesophageal and large hiatal hernia repair

Conditions: Paraesophageal Hernia; Large Hiatal Hernia

Summary: the purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (\>5cm) or paraesophageal hernias when ovitex lpr mesh used during the repair.

this is an investigator initiated, single site, single arm study investigating the recurrence rate of hiatal hernia and safety using ovitex lpr in patients undergoing hiatal hernia repair. ovitex lpr mesh is a reinforced tissue matrix, comprised of a fine non-absorbable polymer suture interwoven through layers of absorbable biologic material in a "lockstitch" pattern.the biologic material in ovitex, derived from ovine rumen (sheep stomach), serves as the natural building block and is optimized to reduce foreign body response, enable functional tissue remodeling and promote a more natural hernia repair. the interwoven polymer fibers provide additional reinforcement, along with improved handling and load-sharing capability. the permanent polymer fiber (polypropylene) is a standard surgical suture material that is used in hiatal hernia surgery and comprises less than 5% of the final product. preop details, quality of life questionnaires and surgery details will be collected along with post op gerd (gastro esophageal reflux disease) quality of life questionnaires and barium swallow esophagrams to objectively examine recurrence of hiatal hernia at 1, 3, and 5 years post op. data will be carefully collected and reviewed for discrepancies and verified with source prior to analysis.

Eligibility criteria:
inclusion criteria: * 18-85 year old with peh and appropriate surgical indication for repair exclusion criteria: * under 22 years of age. * in need of an emergency procedure. * currently being treated with another investigational drug or device. * have had prior gastric or esophageal surgery. * have had any previous intervention for gerd. * are suspected or confirmed to have esophageal or gastric cancer. * have a body mass index (bmi) greater than 45. * cannot understand trial requirements or are unable to comply with follow-up schedule. * are pregnant, nursing, or plan to become pregnant. * have a mental health disorder that would interfere with your ability to follow study instructions. * have suspected or known allergies to ovitex * have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.

Keywords: paraesophageal hiatal hernia paraesphageal hernia hiatal hernia
effectiveness of wbv-supported core training on lumbar disc herniation

Conditions: Lumbar Disc Herniation; Low Back Pain

Summary: "this randomized controlled trial investigated the effects of conventional physiotherapy, core stabilization exercises, and wbv-supported core stabilization exercises on pain intensity, functional disability, quality of life, and sleep quality in male patients with lumbar disc herniation without neurological deficits."

"this study aimed to compare the effects of whole-body vibration (wbv)-supported core exercises, standard core exercises, and conventional physiotherapy on pain, disability, quality of life, and sleep quality among male patients aged 30-50 years with lumbar disc herniation without neurological deficits. participants were randomly allocated to one of three groups and underwent 12 sessions over 4 weeks. the outcomes assessed were pain (vas), disability (odi), quality of life (sf-36), and sleep quality (psqi)."

Eligibility criteria:
inclusion criteria: * • male gender * age between 30 and 50 years * diagnosis of lumbar disc herniation (l4-l5 or l5-s1) * no neurological deficits exclusion criteria: * • prior lumbar surgery * severe cardiopulmonary or musculoskeletal disorders * uncontrolled systemic diseases * participation in another clinical trial

Keywords: whole-body vibration core stabilization exercises low back pain sleep quality functional disability
randomized study of the effects of glucose on cognition in healthy young and elderly people and parkinson's disease patients

Conditions: Parkinson Disease

Summary: this study will determine whether glucose facilitates memory in healthy elderly people and those with parkinson's disease.

subjects fast for 8 hours before receiving a test to determine their blood glucose levels. following this test, subjects are randomized to receive either a glucose or saccharin sweetened drink. a series of memory tests and an additional 3 blood glucose level tests are administered approximately 15 minutes later. a minimum of 1 week afterward, the subjects return and receive the alternate sweetener followed by additional memory tests.

Eligibility criteria:
inclusion criteria: * three groups of subjects are eligible for this study: healthy young adults between ages 18 and 30; healthy elderly adults between ages 60 and 90; and anyone diagnosed with parkinson's disease exclusion criteria: * prior surgery to remove part of the stomach * diabetes, addison's, or cushing's diseases

Keywords: parkinson disease neurologic and psychiatric disorders rare disease
safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical effects of amg 811 in subjects with psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to assess the safety, tolerability, immunogenicity, and clinical effects of amg 811 following single subcutaneous dose administration in subjects with moderate to severe psoriasis.


Eligibility criteria:
inclusion criteria: * 18 - 55 years old inclusive at screening * active but clinically stable, plaque psoriasis * psoriasis involving ≥ 10% of the body surface area * a minimum pasi score of ≥ 10 obtained during the screening period * additional inclusion criteria apply exclusion criteria: * active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit * evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis * any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject * additional exclusion criteria apply

Keywords: amgen psoriasis safety
extension study evaluating antibody persistence and safety, tolerability and immunogenicity of booster doses of novartis rmenb±omv nz vaccine in healthy uk children who previously received one or four doses of the same vaccine

Conditions: Meningococcal Disease

Summary: the proposed study v72p6e1 is an extension study of v72p6 (nct00381615). the objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses of rmenb±omv nz administered to subjects at approximately 40 months of age. antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. these subjects will receive a two-dose catch-up regimen with rmenb+omv nz. subjects who are enrolled at 40 months of age are offered dtap/ipv and mmr vaccinations, if they have not already received these vaccines prior to enrollment.


Eligibility criteria:
inclusion criteria: * healthy 40 to 44-months-old children, who participated and completed the study v72p6 (nct00381615; follow-on subjects) * healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects) exclusion criteria: * previous ascertained or suspected disease caused by n. meningitidis * history of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component * any serious chronic or progressive disease * known or suspected impairment/alteration of the immune system * receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)

Keywords: children pre-school meningococcal disease prevention vaccination
nebivolol in patients with systolic stage 2 hypertension

Conditions: Hypertension

Summary: the primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.


Eligibility criteria:
inclusion criteria: * male of female, 18 to 64 years of age at screening * mean seated heart rate at least 60 bpm * diagnosed systolic stage 2 hypertension * unremarkable physical exam findings exclusion criteria: * high risk due to secondary hypertension or former stage 3 hypertension by jnc6 * concurrent conditions (reno, cardiovascular, obesity, thyroid, etc) * currently taking medication that cannot be stopped during the course of the study * participating other clinical trials * member of the study center personnel * documented drug abuse * contra indication to beta blocker * abnormal lab finding * poor compliance * other conditions judged by investigator that is not suitable for the study

Keywords: nebivolol bystolic tm hypertension stage 2 hypertension
study of phenotype and genotype correlations in patients with contiguous gene deletion syndromes

Conditions: Williams Syndrome; Angelman Syndrome; Prader-Willi Syndrome; Shprintzen Syndrome; Smith-Magenis Syndrome; DiGeorge Syndrome; Chromosome Abnormalities

Summary: objectives: i. investigate phenotype and genotype correlations in patients with smith-magenis syndrome (sms) associated with del(17p11.2). ii. clinically evaluate sms patients with unusual deletions or duplication of proximal 17p. iii. clinically evaluate patients with williams syndrome with molecular characterization of 7q11.23. iv. perform clinical studies of prader-willi, angelman, digeorge, and shprintzen syndrome patients with unique molecular findings in 15q11q13 or 22q11.2. v. perform genotype and phenotype correlations in prader-willi patients, particularly those with loss of expression of only some of the imprinted transcripts in 15q11-q13. vi. evaluate putative angelman syndrome patients who do not have classic large deletion, uniparental disomy, or imprinting mutations, and perform molecular studies of the angelman gene, ube3a, and identify mutations of this gene. vii. investigate phenotype and genotype correlations in patients with terminal deletions of chromosome 1p.

protocol outline: patients undergo clinical, cytogenetic, and molecular studies. these include radiographic, neurologic, developmental, and 24 hour sleep studies, ophthalmologic, otolaryngologic, speech and language, and audiologic exams, echocardiogram, and renal ultrasound. smith-magenis patients are also evaluated with the following: urine melatonin levels during day and night hours; anthropometrics; sleep and behavioral history; and renal, immunologic, and cholesterol studies. a clinical and phenotypic map is constructed. when appropriate, parental chromosome analysis is performed.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- contiguous gene deletion syndrome, e.g.: smith-magenis syndrome williams syndrome digeorge syndrome shprintzen syndrome (velo-cardio-facial syndrome) prader-willi syndrome angelman syndrome deletion of chromosome 1p patient age: any age

Keywords: angelman syndrome digeorge syndrome prader-willi syndrome shprintzen syndrome smith-magenis syndrome williams syndrome genetic diseases and dysmorphic syndromes neurologic and psychiatric disorders rare disease
the effect of gastric bypass surgery on diabetes

Conditions: Type II Diabetes

Summary: this study will investigate the effects of gastric bypass surgery on type ii diabetes. the study will recruit patients with type ii diabetes having roux-en-y gastric bypass, patients without type ii diabetes having roux-en-y gastric bypass, and control subjects (patients having gastroscopy, but no surgery). targeted enrollment is 30 patients per group. samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy. meal test with incretin measurements, and feces and blood samplings are performed before and after surgery hypotheses are: * the pathogenesis of type ii diabetes is linked to changes in the expression of intestinal endocrine cells * the changes in the incretine excretion after the gastric bypass surgery partly explain the amelioration of type ii diabetes * the oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the development of atherosclerosis * the immunologic functions of the intestine are changed by the gastric bypass surgery attenuating systemic inflammation * the gastric bypass surgery changes cholesterol and bile acid metabolism * the gastric bypass surgery changes the fecal microbiota primary end points are: * changes in the amounts of endocrine cells in ventricle, duodenum and jejunum * changes in the incretine secretion studied with liquid meal test * changes in the oxidation of lipoproteins * changes in the immunologic markers in ventricle, duodenum and jejunum * changes in the amounts of phytosterols, cholesterol metabolites and bile acids * changes in fecal microbiota


Eligibility criteria:
inclusion criteria (patients with surgery): * patients having roux-en-y gastric bypass (according to clinical guidelines) * age: 18-65 years inclusion criteria (control patients without surgery): * patients having gastroscopy (for various clinical reasons) exclusion criteria: * diabetes (applies for control patients) * bmi over 30 (applies for control patients) * insulin treatment * oral corticosteroid treatment * chronic inflammatory disease * coeliac disease * malignant disease
the safety and effectiveness of cva-flow software device for acute ischemic stroke

Conditions: Stroke; Stroke, Acute; Stroke, Ischemic; Stroke, Cardiovascular; Stroke Hemorrhagic

Summary: the purpose of this study is to demonstrate the effectiveness and safety of cva-flow, a digital health ai based telestroke system developed by cvaid ltd. company aims to assist certified medical staff to triage acute ischemic stroke patients using dedicated algorithms in order to support application for market approval for cva-flow device.


Eligibility criteria:
inclusion criteria: * suspected hyper-acute stroke patient at the ed, prior to treatment (tpa or evt) * age≥18 exclusion criteria: * intubated patients upon arrival * time from stroke symptoms onset \> 24h * patients post treatment (tpa of evt) * patient in acute psychosis state * patients who do not speak hebrew as their mother tongue
excel: exercise for cancer to enhance living well

Conditions: Cancer; Head and Neck Cancer; Colon Cancer; Breast Cancer; Prostate Cancer; Cancer Caregivers

Summary: project excel will provide community or online exercise programs to rural and remote and under-served cancer survivors, as well as encourage participants to become life-long exercisers. exercise is an evidence-based self-management strategy that benefits all cancer survivors. however, most cancer survivors who live in remote or rural places don't have adequate opportunities to be involved in exercise programs that are tailored to their needs.

as cancer survivorship numbers grow, a focus on positive health in survivorship is essential. exercise is an evidence-based effective self-management strategy that benefits all cancer survivors (cs). however, the majority of research and the limited development of evidence-based clinical or community programs in exercise and cancer has been conducted almost exclusively in urban academic and clinical settings, with very limited implementation outreach to "hard to reach" cs. in this proposed cancer exercise hybrid implementation effectiveness research, over 5 years we will use an integrated knowledge translation approach to move the current evidence-base that clearly supports the role of exercise in cancer survivorship, into sustainable and effective community-based or online settings that will optimize the delivery of exercise to rural/remote and underserved cs (rcs). implementing and evaluating the proposed exercise oncology survivorship (eos) partnership model will result in a sustainable resource to support the implementation and delivery of exercise oncology programs in rural canadian communities. investigators will work to develop lasting referral pathways between cancer care clinics and local fitness professionals. these fitness professionals will have additional cancer specific training to ensure they can effectively and safely deliver the program. eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming. if, due to covid-19 public health restrictions, community based programming cannot occur, the exercise sessions will be delivered online by fitness professionals.

Eligibility criteria:
inclusion criteria: * have a diagnosis of cancer * are over the age of 18 years * are able to participate in mild levels of activity * are about to have treatment, are currently having treatment, or have had cancer treatment within the last 5 years * can read/write in english * can access online programs, if necessary, to participate in the exercise programs. exclusion criteria: * unable to read/write in english * are unable to participate in exercise * for online programs, do not have internet or computer access

Keywords: physical activity exercise community programs online resources quality of life cancer survivor mobile health telehealth
antimicrobial pulpotomy of primary molars

Conditions: Inflammation; Necrosis

Summary: there is a lack of evidence of the long-term successful outcomes of antimicrobial endodontic treatment for primary teeth. this study intended to evaluate (by survival analysis) the effectiveness of an antimicrobial pulpotomy (chloramphenicol, tetracycline, zinc oxide/eugenol) in primary molars compared to calcium hydroxide pulpectomy, testing the hypothesis that antimicrobial pulpotomy could be an alternative pulp therapy for primary teeth with pulp inflammation or necrosis.


Eligibility criteria:
inclusion criteria: * healthy children (asa ps 1) * children presenting one or more primary molar with pulp inflammation or necrosis due to carious lesion and indicated for endodontic therapy exclusion criteria: * lost to follow-up

Keywords: pulpotomy pulpectomy primary teeth dental care for children
combination chemotherapy in treating patients with advanced 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 tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.

objectives: * determine the toxicity and tolerance of sequential therapy with prolonged * determine the response rate and time to progression in this patient * determine the relative pharmacokinetics of iv and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by iv or oral route. outline: * regimen a: patients receive cisplatin iv over 60-90 minutes on day 1 of each course. topotecan iv is administered continuously on days 1-14 of course 1. oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. treatment repeats every 28 days for 4 courses. * regimen b: after completion of regimen a, patients receive paclitaxel iv over 3 hours followed by carboplatin iv over 30 minutes on day 1. treatment repeats every 21 days for 4 courses. projected accrual: a total of 30 patients (15 per arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery * stage ic, ii, iii, or iv patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * sgot no greater than 3 times upper limit of normal * bilirubin no greater than 2.0 mg/dl * no clinically significant hepatic disorder renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance greater than 60 ml/min * no clinically significant renal disorder cardiovascular: * no clinically significant cardiovascular condition other: * normal gi function allowing reliable administration of oral medication * no active infection requiring systemic medical therapy within past week * no other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder) * no other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * no dementia or altered mental status that would preclude consent * not pregnant * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy for ovarian epithelial carcinoma endocrine therapy: * not specified radiotherapy: * no prior radiotherapy for ovarian epithelial carcinoma surgery: * see disease characteristics

Keywords: stage i ovarian epithelial cancer stage ii ovarian epithelial cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer
effect of nlr and mpv on early postoperative outcome in lower extremity arthroplasty operations

Conditions: Knee Arthropathy

Summary: in the planned study the investigators want to evaluate the relation between postoperative complications and minor/ major morbidities, mortality and mean platelet volume (mpv) and neutrophil/ lymphocyte (n/l) ratio.

* in this study the investigators aim to determine the relation between the mpv and n/l ratio and the incidence of postoperative adverse events and complications in patients undergoing knee arthroplasty. * in this study only the laboratory tests that are routinely used for the operative patients are going to be used and no extra tests will be performed. the study will begin after the postoperative blood samples are collected for routine laboratory measurements. the patients will be allocated to 4 groups according to the type of anesthesia and vas scores. preoperative and postoperative peripheral blood total whole blood mpv and n/l ratio and 1st 6th 12th ve 24th hours vas scores and complications, morbidities and mortality will be recorded. the patients will receive analgesics according to the routine practice in the ward and the doses of analgesics given will be recorded at 1st 6th 12th ve 24the hours wil be recorded. * statistical analysis: the numerical variables will be analyzed tested with kolmogorov-smirnov test for normality. for the parametric variables that are normally distributed t-test will be used for the comparison between groups. for the parametric variables that are not normally distributed mann whitney-u test will be used. all the categorical variables will be evaluated with q- square tests. a p value \< 0.05 will be determined as statistically significant.

Eligibility criteria:
inclusion criteria: * knee arthroplasty patients with general or spinal anesthesia. exclusion criteria: * patients not giving consent * reoperations * patients having inflammatory disease * infection in the knee * sepsis * bleeding disorders * hematologic diseases, * using steroids. * trauma * fracture patients, * bilateral knee prothesis * combined surgery procedures * patients needing perioperative transfusions * uncooperative patients.

Keywords: mpv nlr postoperative pain