Kornimate/medical-research-clean huggingface dataset:
obstetrical gel use to shorten labor and prevent lower genital tract trauma

Conditions: Labor Stage, Second

Summary: recent literature shows that birth injury is associated with postpartum pelvic floor dysfunction (pelvic organ prolapse and fecal and urinary incontinence). prolonged labor, namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal sphincter rupture and fecal incontinence. in addition, it is associated with increased maternal and neonatal morbidities including increased risk of lower genital tract lacerations. in an effort to shorten labor and decrease lower genital tract trauma many techniques have been investigated. the objective of our study is to investigate whether the use of obstetric gel shortens the first and second stage of labor and exerts a protective effect on the lower genital tract. neonatal and maternal morbidities will be also assessed. the study design will be a randomized controlled trial of 2 groups, where the patients presenting for vaginal delivery will be randomly assigned to either: * group 1 who will receive the standard care during labor and delivery * group 2 who will receive the standard care during labor and delivery with the vaginal application of the obstetrical gel the goal of this randomized controlled study is to compare the length of the first and 2nd stage of labor and the lower genital tract integrity in the 2 groups of patients.


Eligibility criteria:
inclusion criteria: * age between 18 and 40 years * intended vaginal delivery * singleton baby in vertex presentation * low risk pregnancy at term (37-42 weeks of gestation) * estimated birth weight between 2000 g and 4500 g (clinically or by sonography) * signed written informed consent exclusion criteria: * contraindications for vaginal delivery (placenta previa, active herpes infection, etc...) * advanced cervical dilation (≥ 5 cm) * suspected amniotic infection (fever, foul smelling discharge, fetal tachycardia, abdominal pain) * non reassuring fetal heart tracing * prolonged rupture of the membranes (24 hours) * suspected major fetal malformations * suspected cephalopelvic disproportion
cognitive evolution in tysabri treated multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: this study is designed to evaluate the effect of tysabri on cognition in multiple sclerosis (ms) patients. during a period of 24 months, the study will assess the evolution of cognitive function in tysabri treated ms patients using the symbol digit modalities test (sdmt) and the cogstate battery of tests.

tysabri reduces the relapse frequency, slows progression and preserves cognitive function as compared to placebo as per the affirm trial. the benefit on relapse rate and progression appears to be sustained in longer-term studies such as strata. in clinical practice however despite a stable condition on the expanded disability status scale (edss) patients often complain of cognitive deterioration. it has yet to be shown that tysabri will prevent cognitive deterioration after more than 2 years of treatment. the symbol digit modalities test (sdmt) is a sensitive and validated test of cognition in ms. cogstate offers a standardized battery of cognitive tests frequently used in clinical research in the fields of dementia and parkinson's disease. the cogstate battery of tests consisting of the detection test (processing speed), identification test (attention), one back test (working memory), international shopping list test (verbal learning) and the groton maze learning test (reasoning and problem solving) will further confirm and validate the results of the symbol digit modalities test(sdmt) in ms patients as well as examine other cognitive parameters. together the above tests done prospectively can assess the evolution of cognitive function in tysabri treated ms patients over the longer term.

Eligibility criteria:
inclusion criteria: * patients with multiple sclerosis who are receiving tysabri per indication and are willing and able to give an informed consent. exclusion criteria: * patients who are depressed as per the beck depression questionnaire at screening or at any time during the study. * patients with cognitive decline from causes other than ms.
long-term follow-up of gen-003-002 subjects for efficacy and immunogenicity

Conditions: Genital Herpes Simplex Type 2

Summary: this study is a follow-up study from study gen-003-002 to evaluate long-term efficacy and immunogenicity of gen-003 in subjects with genital hsv-2 infection.


Eligibility criteria:
inclusion criteria: 1. completion of study gen-003-002 2. receipt of at least 1 dose of gen-003 (any dose combination) in study gen-003-002. 3. collection of at least 45 of 56 anogenital swabs during the month 11 to 12 swab collection period in study gen-003-002. 4. willing and able to provide written informed consent. 5. willing to perform and comply with all study procedures, including attending clinic visits as scheduled. 6. for each swab collection period, willing to not use hsv-2 antiviral therapy from 14 days before the swab collection period through the end of the period. exclusion criteria: 1. any important protocol deviation in study gen-003-002. 2. use of hsv-2 antiviral therapy within 14 days before the beginning of swab collection period 1. 3. use of topical steroids or antiviral medication in the anogenital region within 14 days before the beginning of swab collection period 1. 4. use of tenofovir, lysine, or other medication or supplement known or purported to affect hsv outbreak frequency or intensity within 14 days before the beginning of swab collection period 1. 5. immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months before the visit 1, any dose of corticosteroids within 30 days before visit 1, or high-dose inhaled corticosteroids \[\>960 µg/day of beclomethasone diproprionate or equivalent\]) or other immunosuppressive agents. 6. presence or history of autoimmune disease, regardless of current treatment. 7. receipt of a vaccine containing hsv-2 antigens other than gen-003. 8. pregnant women. 9. history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the patient's ability to comply with the requirements of the study. 10. onset of an aesi since month 12 in study gen-003-002. 11. other active, uncontrolled comorbidities that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.

Keywords: hsv herpes genital herpes
ac105 in patients with acute traumatic spinal cord injury

Conditions: Acute Spinal Cord Injury

Summary: the principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of ac105 in patients with acute spinal cord injury.

to determine safety and tolerability of ac105 following a regimen of 6 intravenous doses over 30 hours in patients with acute non-penetrating traumatic spinal cord injury (sci).

Eligibility criteria:
inclusion criteria: * male or female between 18 and 65 years of age, inclusive * acute traumatic sci, at a neurological level between c4 and t11 * no evidence of penetrating or transection injury (e.g. caused by projectile or stab wound) * neurological asia impairment scale a, b or c * patient is able to provide written or verbal witnessed consent. if unable to provide either, consent may be provided by legally authorized representative (lar) * patient is able to initiate treatment within time window of injury exclusion criteria: * known allergy or hypersensitivity to polyethylene glycol * mental impairment or other conditions that would preclude a reliable asia exam or adequate consent * positive urine pregnancy test result * serum creatinine level ≥ 2 mg/dl * history or active renal failure or dialysis * mean arterial blood pressure \< 60 mmhg despite vasopressor treatment * on a current regimen of digoxin * chronic use of magnesium salts prior to the sci (within 1week of presentation) and/or the use of magnesium salts in the acute care setting prior to the administration of investigational product * any other medical condition that, in the judgment of the investigator, would preclude provision of informed consent, make participation in the study unsafe, or unreasonably complicate follow-up or the interpretation of study outcome data or may otherwise interfere with achieving the study objectives * in the judgment of the investigator, cannot adequately provide informed consent, is likely to be non-compliant, or may be unable to cooperate with study requirements

Keywords: acute traumatic sci spinal cord injury
a single center proof of concept study to assess intra and perioperative safety profile of omni surgical system

Conditions: Open Angle Glaucoma

Summary: the overall objective of this study is to determine the safety and usability of omni surgical system in performing canaloplasty and trabeculotomy. outcome measures will include 1) adverse events (intraoperative and perioperative) 2) bcva 3) secondary surgical interventions 4) mean iop and 5) mean number of hypotensive medications


Eligibility criteria:
inclusion criteria: 1. male or female subjects, 22 years or older. 2. visually significant cataract or pseudophakic with a posterior chamber intraocular lens (pciol) 3. diagnosed with open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) 4. scheduled for canaloplasty and trabeculotomy exclusion criteria: 1. any other intraocular surgery at the time of canaloplasty and trabeculotomy excepting cataract surgery for those subjects with cataract. 2. prior trabeculectomy, other bleb-forming glaucoma surgery (e.g. tube shunt), or implanted trabecular bypass stents. 3. any other ocular pathologies that may interfere with the study procedure or be exacerbated by the omni procedure.
cmr in patients with myocarditis

Conditions: Suspected Acute Myocarditis

Summary: to evaluate the additive values of t1 mapping in patients with acute myocarditis.

cardiac magnetic resonance (cmr) is an established non-invasive diagnostic tool for acute and chronic myocarditis. established cmr criteria for diagnosing myocarditis are edema on black-blood t2-weighted imaging, relative contrast enhancement seen on t1-weighted imaging for assessment of hyperemia, and late contrast-agent enhancement seen with inversion recovery late enhancement technique for visualization of myocardial fibrosis. recently, tissue characterization based on calculation of myocardial t1 relaxation time (t1 mapping) as well as t1-derived extracellular volume fraction has become available. recently, reference values for myocardial t1 relaxation times at 3t for healthy volunteers were published for cmr. however, to date no comprehensive data for multiparametric cmr in patients with suspected myocarditis at 3 tesla is available. therefore, the purpose of this prospective study was to evaluate the diagnostic value of cmr at 3t in patients with suspected acute myocarditis using a multiparametric cmr approach including t1 mapping as novel tool for tissue characterization. cmr will be performed within 7 days after hospital admission for "suspected acute myocarditis".

Eligibility criteria:
inclusion criteria: * patients with suspected acute myocarditis and otherwise unremarkable cardiac history exclusion criteria: * exclusion of cad in invasive coronary angiography * pregnancy * contraindications for mr imaging
to perform a post-market study of the performance of the idylla thyroidprint assay using clinical samples in predicting the nature of indeterminate thyroid nodules (itns) across multiple centers.

Conditions: Thyroid Cancer

Summary: to perform a post-market study of the performance of the idylla™ thyroidprint® assay using clinical samples in predicting the nature of indeterminate thyroid nodules (itns) across multiple centers.

this is a multicenter, non-interventional (observational), prospective, post-market study, matching the idylla™ thyroidprint® ruo assay result to the gold standard of surgical pathology. the study population is defined as cases where the thyroid nodule has been reported as indeterminate. primary endpoints are the calculation of the sensitivity, specificity, and the negative and positive predictive values of the idylla™ thyroidprint® ruo assay for indeterminate thyroid nodules. secondary endpoint: to assess the failure rate of idylla™ thyroidprint® ruo assay, including errors and invalids; describe the nature of false negative and false positive cases.

Eligibility criteria:
inclusion criteria: * thyroid nodule ≥1.0 cm * with indeterminate cytology * surgery due to be performed exclusion criteria: * specimens which fail to meet the inclusion criteria. * fna fixed in formalin or transferred in alcohol-based collection buffers which is not according to the protocol instructions. * rna extracts. * patients with ultrasound evidence of malignant cervical adenopathy
sofosbuvir and daclatasvir in treating hepatitis c, a study on 1000 patients

Conditions: Hepatitis C

Summary: the fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis c in iran. in this study the efficacy of this combination is evaluated in 1000 patient with hepatitis c.

all cases of hepatitis c whether cirrhotic, post organ transplant, co-infected with hiv or hepatitis b, active drug abuse, on immune suppression and from all genotypes will be included. patients will be treated by a single daily dose of a fixed-dose combination pill of 400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. if a patient is cirrhotic, defined by liver stiffness \> 12 kilopascal, either weight based ribavirin will be added or the treatment duration will be prolonged to 24 weeks.

Eligibility criteria:
inclusion criteria: * positive qualitative hepatitis c virus rna test on two occasions at least 6 months apart exclusion criteria: * heart rate \< 50/min, * taking amiodarone

Keywords: hepatitis c sofosbuvir daclatasvir
healthy hearts in the heartland

Conditions: Cardiovascular Diseases

Summary: this study evaluates the ability of small primary care practices to 1) implement point-of-care and population management quality improvement strategies to improve cardiovascular quality of care (e.g., clinical decision support, patient education and counseling, or referral to smoking quit lines), and 2) implement the pophealth performance measurement software to evaluate performance on the abcs (aspirin when appropriate, blood pressure control, cholesterol management, and when applicable, smoking cessation) and allow regional benchmarking. this minimal risk study is a practice-randomized trial to determine a) whether point of care strategies improve abcs performance measures compared to baseline, and b) whether adding locally tailored population management strategies to poc strategies improves performance on the abcs measures more than poc strategies alone.

the investigators specific aims are to: 1. evaluate the ability of small practices in the investigators region to 1) implement point-of-care (poc) and population management (pm) quality improvement strategies to improve the abcs, and 2) implement the pophealth quality measurement software to evaluate performance on the abcs and allow regional benchmarking. 2. conduct a practice-randomized trial to determine a) whether poc strategies improve abcs performance measures (i.e. aspirin prescribing, blood pressure control, cholesterol management, and smoking cessation counseling) compared to baseline, and b) whether adding locally-tailored pm strategies to poc strategies improves performance on the abcs measures more than poc strategies alone. 3. deploy an open source quality measurement platform (pophealth) to establish a regional qi benchmark based on participating practice abcs measures and enable longitudinal tracking of electronic clinical quality measures (ecqms) across the investigators region. the investigators will perform a mixed-methods evaluation to examine changes in practices' perceived capacity for quality improvement and whether access to comparative quality data within a region improves the capacity of practices to sustain their quality improvement program around the abcs and provides a long-term framework for practices to implement new qi activities.

Eligibility criteria:
inclusion criteria: * providers practicing in wisconsin, illinois, and indiana. * practice is adult primary care-focused; \[further defined: health care organization dedicated to the provision of primary care, and a significant proportion of their patients are adults. includes, but not limited to, family medicine, general internal medicine, general practice, geriatricians, nurse practitioners and physician assistants.\] * practice has 20 or fewer primary care providers; \[community health centers with 20 or fewer lead clinicians may be included; multi-specialty practices that provide primary care and have ≤ 20 lead clinicians may be included.\] * providers must provide informed consent. exclusion criteria: * non-english speaking providers

Keywords: preventive measures quality improvement
evaluation of ocular comfort with ista tears vs systane

Conditions: Dry Eye Disease

Summary: to assess the comfort preference of ista tears vs systane in patients with dry eye disease (ded)


Eligibility criteria:
inclusion criteria: * osdi \>12 exclusion criteria: * presence of any active ocular disease other than dry eye
antimicrobial resistance in acute cholangitis

Conditions: Cholangitis Acute; Biliary Tract Diseases; Jaundice; Malignant; Jaundice, Obstructive; Choledocholithiasis

Summary: this study prospectively explores antimicrobial resistance in patients with acute cholangitis undergoing ercp procedures. by analyzing patient profiles, microbial cultures, and treatment outcomes, the current study seeks to identify specific patterns of resistance, assess the effectiveness of current antimicrobial therapies, and explore potential strategies to optimize treatment regimens.

given the extensive utilization of antibiotics and the worldwide rise of multidrug-resistant organisms, there are ongoing initiatives to ascertain microbiological traits and discern patterns of drug resistance associated with intra-abdominal infections. microbial cultures from bile and blood samples will be established and characterized using appropriate methodologies. for patients with moderate and severe acute cholangitis (ac), blood cultures will be initiated upon admission, adhering to the tokyo guidelines for ac 2018 recommendations. bile specimens will be obtained after cannulation through the sphincterotome before the therapeutic intervention. initially, a minimum of 5 ml of the procured bile will be discarded, followed by the collection of an additional 5 ml in a sterile vessel containing a medium conducive to both anaerobic and aerobic bacterial cultures. the samples will undergo a minimum incubation period of seven days at 37 °c until microbial proliferation becomes evident. antibiotic susceptibility assessments, specifically minimum inhibitory concentration (mic), will be performed and interpreted according to established guidelines.the analysis of samples will occur within the laboratory of each respective center, with antibiograms conducted in accordance with established protocols.

Eligibility criteria:
inclusion criteria: * patients with acute cholangitis * ability to provide an informed consent * age over 18 years * any gender exclusion criteria: * age under 18 * pregnancy * post-ercp perforation * the patient's decision to abstain from study enrollment * patients unable to express informed consent * patients from whom a bile sample could not be collected.

Keywords: acute cholangitis antibiotics multidrug resistance (mdr)
evaluation of intestinal parasites in patients with intestinal cancer in sohag, egypt.

Conditions: Intestinal Parasites in Patients With Intestinal Cancer

Summary: this study aims to evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals

intestinal parasitic infections continue to be characterized as a significant cause of morbidity worldwide, and according to world health organization (who) statistics, more than a quarter of the world's population, mostly in developing countries, are infected acquisition of infection, clinical severity, and outcome of a parasitic disease depend on innate and acquired host immunity as well as on the parasite's response against the host when the infection is established chronic infections and inflammation along with unhealthy diet, stressful lifestyle, cell damage, constant exposure to radiation, and harmful chemicals are risk factors for the development of cancers as infectious factors, the blastocystis hominis and cryptosporidium spp. are opportunistic protozoa isolated from the human host gastrointestinal tract, these prevalent enteric parasites may cause serious challenges in people undergoing colorectal cancer treatment (chemotherapy)

Eligibility criteria:
inclusion criteria: * intestinal cancer patients (colorectal cancer, intestinal lymphoma, gastrointestinal stromal tumors, and other malignant variants) exclusion criteria: * patient took antibiotics within the previous four weeks and anti-parasitic drugs within the previous two weeks
a study of shr-4602 in subjects with advanced malignant solid tumors

Conditions: Advanced Solid Tumor

Summary: this is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of shr-4602 and preliminary anti-tumor efficacy in her2 expressing or mutated advanced malignant solid tumor subjects.


Eligibility criteria:
inclusion criteria: 1. advanced/unresectable or metastatic solid tumor with her2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; 2. at least one measurable lesion based on recist v1.1 criteria; 3. ecog ps score: 0-1 points; 4. expected survival period ≥ 3 months; 5. adequate organ function; 6. must take one medically approved contraceptive measure; 7. patients voluntarily joined the study and signed informed consent. exclusion criteria: 1. patients with known cns metastasis or hepatic encephalopathy; 2. suffering from peripheral neuropathy; 3. history of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period; 4. patients with any active, known or suspected autoimmune disorder; 5. with known severe allergic reactions to any other monoclonal antibodies; 6. patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose; 7. patients with other malignancies currently or within the past 5 years; 8. uncontrolled cardiac diseases or symptoms; 9. with known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs); 10. patients with other potential factors that may affect the study results.