Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the bioequivalence of single oral dose of esomeprazole capsule and tablet formulation in healthy participants

Conditions: Healthy Participants

Summary: the purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.

the drug being tested in this study is called esomeprazole. esomeprazole is being tested in healthy participants in order to evaluate the bioequivalence between a single oral dose of esomeprazole tablet and capsule. the study will enroll 52 participants. participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment sequences: * esomeprazole 40 mg capsule + esomeprazole 40 mg tablet * esomeprazole 40 mg tablet + esomeprazole 40 mg capsule all participants will be asked to take one capsule or tablet on day 1 of each intervention period based on the treatment sequence to which the participant has been assigned. this single center trial will be conducted in the united states. the overall duration to participate in this study is 36 days. participants will visit the clinic on day -1 and remained confined until day 1 of intervention period 1 and 2. a washout period of minimum 6 days will be maintained between the dose in each intervention period.

Eligibility criteria:
inclusion criteria: 1. is a healthy adult male or female participant. 2. is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose. 3. weighs at least 50 kilogram (kg) and has a body mass index (bmi) from 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive at screening and day -1. exclusion criteria: 1. has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results. it is the responsibility of the investigator to assess the clinical significance; however, consultation with the takeda medical monitor may be warranted. 2. has a history of significant gastro intestinal (gi) disorders manifested with persistent, chronic or intermittent nausea, vomiting, diarrhea, or has a current or recent (within 6 months) gi disease that would influence the absorption of drugs (example, a history of malabsorption, severe esophageal reflux, peptic ulcer disease or erosive esophagitis), or any gastrointestinal-related surgical intervention.. 3. has a known hypersensitivity to any component of the formulation of esomeprazole capsules or tablets or compounds with the same mechanism of action (dexlansoprazole, lansoprazole, omeprazole, rabeprazole, pantoprazole), or related compounds.

Keywords: drug therapy
utility of fallopian tube cocultures in assisted reproductive technology

Conditions: Infertility

Summary: prospective feasibility study: fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during their surgical evaluation of infertility. of note, these patients are already scheduled to undergo surgery as part of their standard of care.

the surgical technique will involve laparoscopic brush and tissue biopsies of the fallopian tube lumen. a small piece of the fallopian tube lining will be removed during the surgery.the biopsy is a minimally invasive and relatively pain free procedure. co culture blood serum will be drawn at least one day prior to the biopsy and during the ivf cycle. the fallopian tube sample is sent to the center for reproductive medicine (crm) lab where it is treated, purified and frozen. the next month or whenever the physician deems appropriate, the patient will then undergo a typical ivf cycle and will be given standard medication protocol determined by her physician to stimulate egg growth in her ovaries. the patient's eggs will be retrieved and mixed with sperm. at this time, the lab will begin to thaw and grow the fallopian tube cells. once fertilization is confirmed, the patient's embryos will be placed on top of her own (now thawed) fallopian tube cells and allowed to grow. subsequently, the embryos will be placed on top of her uterus for implantation and pregnancy.

Eligibility criteria:
inclusion criteria: * women undergoing assisted reproductive technology at weill cornell medical college (wcmc) and are scheduled to undergo surgery as part of their standard of care * women who had a prior failed ivf cycle * women with normal hysterosalpingogram (hsg) or a prior laparoscopy confirming normal tubal status * both the patient (potential subject) and her partner must sign the consent form exclusion criteria: * pregnancy * undiagnosed vaginal bleeding * fallopian tube disease
performance evaluation of reusable contact lenses when worn for one month by habitual soft contact lens wearers

Conditions: Myopia; Hyperopia

Summary: the purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

this study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. duration of involvement for each participant was approximately 3 months.

Eligibility criteria:
inclusion criteria: 1. were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer; 2. had read and signed an information consent letter; 3. were willing and able to follow instructions and maintain the appointment schedule; 4. self-reported having had a full eye examination in the previous two years; 5. had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator; 6. anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week; 7. habitually wore spherical soft contact lenses, for the past 3 months minimum: it was preferred that all participants were habitual frequent replacement lens wearers. however, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers; - for the frequent replacement wearers: no more than 3 could be habitual wearers of the avaira vitality™/ serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of air optix® plus hydraglyde® can be enrolled at each site; 8. had refractive astigmatism no higher than -0.75dc in each eye; 9. could be fit and achieve binocular distance vision of at least 20/30 snellen (available lens parameters are sphere +6.00 to -6.00d, 0.25d steps). exclusion criteria: 1. were participating in any concurrent clinical or research study; 2. had any known active ocular disease and/or infection that contraindicated contact lens wear; 3. had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable; 4. were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable; 5. had known sensitivity to the diagnostic sodium fluorescein used in the study; 6. self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. had undergone refractive error surgery or intraocular surgery.
a study to assess the effectiveness of an atrial fibrillation (af) risk prediction algorithm and diagnostic test in identifying patients with af.

Conditions: Atrial Fibrillation

Summary: this is a trial to assess the effectiveness of an atrial fibrillation (af) risk prediction algorithm and diagnostic test for the identification of patients with atrial fibrillation


Eligibility criteria:
inclusion criteria: practice inclusion criteria for the trial are as follows; * gp practices within national institute for healthcare research (nihr) clinical research network: west midlands (crn: wm) crn: wm * gp practices using emis as their electronic medical record system of choice. patient inclusion criteria for the trial are as follows; * patients registered at a participating practice, aged ≥30 years and without an af diagnosis. * patients with a valid index date (see section 3.3) participant inclusion criteria for participation in the intervention arm are; * as above, and who have provided written consent to: attend a research clinic, af diagnosis check using a 12-lead ecg, and for access to medical records participant inclusion criteria for participation in further af remote diagnosis with an alivecor heart monitor are; * as above, and those with a negative or indeterminant ecg * as above, and those with access to a smartphone exclusion criteria: * patients \<30 years * patients with an existing diagnosis of af * patients for whom the healthcare professional feels the study is unsuitable
vzv-specific tissue resident memory t-cells after shingrix vaccination

Conditions: Varicella Zoster Virus Infection

Summary: to evaluate the effect of intramuscular rzv vaccine on vzv-specific skin trm and circulating t-cells

this is an interventional study of vaccination related to infection with varicella zoster virus. we will enroll participants of two age groups. cohort 1 will be persons between the ages of 30-40; cohort 2 will be persons who are 70 years of age or older. all participants will receive the fda-approved recombinant zoster (rzv) vaccine (shingrix) given at the approved dose and schedule.

Eligibility criteria:
inclusion criteria: * cohort 1: 30-40 years of age * cohort 2: 70 years of age or older * hiv seronegative exclusion criteria: * previous vaccination with shingrix (rzv), zostavax (zvl, zoster vaccine live), or with the chickenpox vaccine * vzv seronegative * active hepatitis c infection or active hepatitis b infection. persons with serologic evidence of hepatitis c infection that has cleared spontaneously, or with a history of treated hepatitis c with a sustained virologic response, can be enrolled. persons with a history of resolved hepatitis b infection (negative for hepatitis b surface antigen) can be enrolled * history of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to any component of the vaccine * history of receipt of an organ transplant or hematopoietic stem cell transplant * significant autoimmune disease such as rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, scleroderma, dermatomyositis, or other condition which in the past has required significant immune modifying medication or which has a clinical course that is characterized by relapses * has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy. * has long-term use of oral or parenteral steroids (\>7 days), or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed) * women of child-bearing potential only: pregnant, breastfeeding, or planning to become pregnant 3 months post vaccination * has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe * history of coagulopathy or taking medication that may cause bleeding (long term high dose aspirin, heparin, coumadin). aspirin doses \<100 mg daily allowed * history of keloid formation or excessive scarring * history of frequent cellulitis or boils (\>3 episodes in past 2 years) requiring antibiotic therapy * allergy to lidocaine, silver nitrate, or mupirocin * has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
a study of subcutaneous ky1005 in healthy volunteers

Conditions: Immune System Diseases

Summary: single centre, open-label, single dose, parallel group study to investigate the pk, safety and tolerability of ky1005 after subcutaneous (s.c.) and intravenous (i.v.) administration, with i.v. ky1005 as a reference treatment.


Eligibility criteria:
inclusion criteria: * male, aged 18-45 years at screening * body weight 60-120 kg * body mass index (bmi) in the range 18.0-30.0 kg/m\^2 (inclusive) * deemed healthy on the basis of a clinical history, physical examination, ecg, vital signs and laboratory tests of blood and urine exclusion criteria: * clinically relevant abnormal findings at the screening assessment; acute or chronic illness; clinically relevant abnormal medical history or concurrent medical condition; positive tests for hepatitis b, hepatitis c, human immunodeficiency virus (hiv) * drug or alcohol abuse * use of over-the-counter medication (with the exception of paracetamol \[acetaminophen\]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication * participation in other clinical trials of unlicensed medicines within the 3 months or 5 half-lives, whichever is longer, before admission to this study * loss of more than 400 ml blood, within the previous 3 months
efficacy, safety and tolerability of magnesium sulfate with low-volume polyethylene glycol for colonoscopy cleansing

Conditions: Bowel Preparation for Colonoscopy

Summary: magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. magnesium sulfate combined with polyethylene glycol is less used in the world. this multicenter, randomized, controlled trial is aimed at to evaluate the efficacy and safety of magnesium sulfate combined with low-volume polyethylene glycol for preoperative bowel preparation for colonoscopy.


Eligibility criteria:
inclusion criteria: * 18-75 years old, male or female * to undergo screening, surveillance and diagnostic colonoscopy * signed written informed consent exclusion criteria: * subjects with therapeutic colonoscopy for colorectal polyps * subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding * subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon * subjects with renal or liver dysfunction, congestive heart failure or rhabdomyolysis * subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration * subjects with constipation (\<3 times a week, difficult defecation, dry stool, less amount) * subjects with serious cardiac and cerebrovascular diseases,suffering from metabolic disease or endocrine disease * subjects who had previously undergone colorectal resection * women with positive pregnancy tests or pregnancy plans, and women in lactation or allergic to the investigational drugs and their ingredients * subjects who are participating in other clinical trials or receiving special drugs * subjects with any other conditions that the investigator considered inappropriate for inclusion

Keywords: magnesium sulfate colonoscopy bowel preparation adenoma detection rate
evaluation of a diabetes self-management education program for non-intensified insulin therapy in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: a new diabetes education program for the initiation of non-intensive insulin therapy in type 2 diabetic patients (medias 2 ct) was developed. in the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. it is expected that the new developed program (medias 2 ct) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. if non-inferiority can be demonstrated superiority of this program will be tested.

the medias 2 ct program is based on a self-management/empowerment approach. it is conducted as a group program comprising 6 lessons of 90 minutes each. medias 2 ct was designed to help patients perform conventional insulin therapy. in addition, medias 2 ct focused on controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk of late complications, and reducing the emotional burden of diabetes and its treatment. the active comparator condition (acc-ct) consisted of an established patient education program for type 2 diabetic patients with conventional insulin treatment. this education program was developed in the 1980s and 1990s and is more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes. both treatment arms (medias 2 ct and acc) consisted of 6 lessons, which were conducted as group sessions.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * two years diabetes duration with oral treatment * bmi \> 20 and \< 40 kg/m² * written informed consent exclusion criteria: * current psychiatric disease * dementia or other severe cognitive impairment * severe complications * severe conditions (e.g., cancer) * gestational diabetes.

Keywords: diabetes self-management education insulin therapy
autologous antigen-activated dendritic cells in the treatment of patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy method on the basis of autologous antigen-activated dendritic cells in the treatment of patients with colorectal cancer. this technology is intended for complex treatment of patients with colorectal cancer and is aimed at preventing the occurrence and treatment of secondary foci. the need for this technology is justified by the widespread occurrence of colorectal cancer, a decrease in the average age at onset of the disease, and the chemoresistantness of locally advanced forms of cancer.

currently, technologies are being developed to improve the clinical outcomes of patients with complex treatment of colorectal cancer. many patients are immunosuppressed after surgical, radiation and chemotherapeutic treatment, which leads to dysfunction of t cells, resulting in tumor cells avoiding immune surveillance. restoration of antitumor immunity during immunotherapy is one of the modern approaches in the treatment of colorectal cancer, which contributes to the formation of an effective specific immune response, the destruction of tumor cells while minimizing toxicity. dendritic cells (dc) and the lymphocytes induced by them are one of the most effective methods for the destruction of residual cancer cells, which are the leading cause of relapse and metastasis.

Eligibility criteria:
inclusion criteria: 1. for the first time established morphologically confirmed diagnosis of colorectal cancer 2. patients with ii a, ii b, ii c, iii a, iii b, iii c stages of colorectal cancer; 3. patients with progressive or primary iv stage of colorectal cancer with cytologically confirmed and accessible soft tissue metastases; 4. absence of severe somatic pathology in which medical intervention (at the stage of obtaining biological material or the stage of immunotherapy) will only worsen the patient's condition, 5. the patient's desire. exclusion criteria: 1. pregnancy at any time, 2. impossibility of correction of therapy of concomitant diseases, if the taken preparations are proved to influence the immune status, 3. rapid progression of the underlying disease, in which the use of immunotherapy is deontologically unjustified, 4. individual intolerance to the components of the vaccine and / or the development of severe side effects on any of the components, 5. refusal of the patient to participate in the study in oral or written form. 6. patient involvement in any other clinical study (including those that the patient has not been informed by the direct oncologist who has been treated, but which has become known already after the beginning of any stage of the study).

Keywords: dendritic cell, il-12, il-18, cytotoxicity
comparing the qor of pecs block and ga in breast-conserving surgery with sentinel lymph node biopsy

Conditions: Breast Cancer; Pectoral Nerves Block; Breast-Conserving Surgery; Sentinel Lymph Node Biopsy

Summary: the aim of this randomized controlled trial (rct) is to assess the quality of recovery (qor) in breast-conserving surgery (bcs) with sentinel lymph node biopsy (slnb) using pectoral nerves (pecs) block and general anesthesia (ga). the primary objectives are as follows: first, to determine if the pecs group exhibits better qor; second, to investigate if the pecs group experiences less postoperative pain and complications; third, to examine if the pecs group demonstrates more stable hemodynamics.

this study is a randomized controlled trial, with a 1:1 ratio for grouping. the experimental group is the t group, receiving pecs ii combined with intercostal nerve block, while the control group is the c group, receiving general anesthesia. the primary outcome measure is the qor-15 score of the subjects 6 hours after surgery. based on preliminary results, the control group had a qor-15 score of 133±8 (n=6), and the experimental group needs to improve by at least 8 points (which is generally considered clinically significant, pmid:27159009). with a two-sided α=0.05 and a power of 99%, accounting for a 20% dropout rate, the final required sample size was calculated to be 96 cases, with 48 cases in each group. if the proportion of dropout cases is less than 5% and considered "completely random missing," the missing records generated by the dropout cases will be directly excluded. depending on the specific circumstances, either single imputation or multiple imputation methods will be used.

Eligibility criteria:
inclusion criteria: * patients scheduled for breast-conserving surgery with sentinel lymph node biopsy. * age between 18 and 70 years. * body mass index (bmi) \< 30 kg/m2. * american society of anesthesiologists (asa) classification grade i-iii. exclusion criteria: * contraindications to regional anesthesia: site infection at the puncture site, allergy to local anesthetics, coagulation disorders, or bleeding risks. * impaired liver or kidney function. * pregnancy, lactation, possibility of pregnancy, or planned pregnancy. * preoperative use of analgesic drugs, history of chronic pain, or history of opioid abuse. * mental illness. * patients who refuse to participate. * patients deemed unsuitable for the clinical trial by the researchers.

Keywords: pectoral nerves block ii intercostal nerve block dexmedetomidine breast-conserving surgery sentinel lymph node biopsy quality of recovery