Kornimate/medical-research-clean huggingface dataset:
confocal laser probe to treat barrett's esophagus

Conditions: Barrett's Esophagus

Summary: the purpose of this study is to further validate the use of probe-based confocal laser endomicroscopy (pcle) for the evaluation of barrett's esophagus and associated neoplasia in a larger patient base.

subject population approximately 100 subjects will be recruited, age greater than 18 years. subjects will be recruited from ocf, omc kenner who are undergoing egd for either 1) screening for barrett's esophagus because of long-standing gerd of greater than 5 years; 2) surveillance of known barrett's esophagus; or 3) therapy for known barrett's esophagus. they will be asked to volunteer for participation at the time of their egd. these subjects are being recruited because of a high suspicion or known diagnosis of barrett's esophagus in this cohort. procedures patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. this dose of 2.5 mg of iv fluorescein will be administered during their egd. probe-based microscopy will be used to evaluate the mucosa of the esophagus and ge junction. photographs will be taken and digitally stored. biopsies (which are part of the routine diagnosis and surveillance of barrett's) will be targeted based on the microscopic images. the histologic findings on the biopsy specimens will be compared to the microscopic images to determine the accuracy of the probe-based microscopy in predicting pathology. the time commitment for the patient is included in the time to undergo endoscopy and is roughly 30 minutes to an hour, including recovery time. the research will occur at omc, jefferson highway and ochsner medical center, kenner.

Eligibility criteria:
inclusion criteria: * must be greater than 18 years of age * currently undergoing egd * previous diagnosis of barrett's esophagus * long-standing gerd of greater than 5 years * undergoing therapy for previously diagnosed barrett's esophagus exclusion criteria: * under 19 years of age
phase 3 study of bk1310 in healthy infants

Conditions: Immunization; Infection

Summary: the purpose of this study is to: * (cohort 1) evaluate safety and immunogenicity (haemophilus influenzae type b, hib) of bk1310. * (cohort 2) evaluate efficacy and safety of bk1310 using acthib® and tetrabik as a control in healthy infants.

\ * arm: bk1310-high. intervention: dpt-ipv-hib-high(combined vaccine) 0.5ml, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. * arm: bk1310-low. intervention: dpt-ipv-hib-low(combined vaccine) 0.5ml, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. \ * arm: bk1310-high or low. intervention: dpt-ipv-hib-high(combined vaccine) or dpt-ipv-hib-low(combined vaccine) 0.5ml, subcutaneous injection, 3 times with the 3-8weeks intervals. * arm: acthib® and tetrabik. intervention: hib vaccine and dpt-ipv 0.5ml, subcutaneous injection, 3 times with the 3-8weeks intervals.

Eligibility criteria:
inclusion criteria: * healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months). those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. infants who developed fever within 2 days after any previous vaccination. infants with history of convulsions. * written informed consent is obtained from a legal guardian (parent) exclusion criteria: * with past diagnosis of immunodeficiency or currently under immunosuppressive treatment * have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency * possibility of anaphylaxis due to food or pharmaceuticals * with experience of hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis * with experience of hib, diphteria, pertussis, tetanus or polio vaccination. * administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination * administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation * administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) * participated in other studies within 12 weeks before obtaining consent * with the gestational age \<37 weeks or weighed less than 2500 grams at birth. * considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.

Keywords: haemophilus influenza type b adsorbed diphteria-purified pertussis-tetanus-inactivate poliovirus combined vaccine hib dpt-ipv
hippotherapy to improve the balance of children with movement disorders

Conditions: Neuromuscular Diseases; Cerebral Palsy; Down Syndrome; Autism; Developmental Coordination Disorder

Summary: the purpose of this study is to determine if adding hippotherapy treatment will improve balance for children ages 5-17 who have disabilities such as cerebral palsy and down syndrome. we also want to find out if by improving their balance the children increase their participation in age appropriate activities.

the primary purpose of this study is to determine the effects of hippotherapy on the balance of children with developmental disorders that cause mild to moderate balance problems. the secondary purpose is to determine if the use of hippotherapy also improves perceived functional abilities and thus quality of life as measured by the pediatric balance scale and activities scale for kids (respectively)

Eligibility criteria:
inclusion criteria: * between the ages of 5 and 17 * have a neuromuscular diagnosis or confirmed difficulties with balance * be able to stand 4 seconds without an assistive device * be able to follow testing instructions * must be under 250 pounds * be able to attend a minimum 10/12 sessions. exclusion criteria: * any compounding orthopedic or medical condition not related to the primary developmental diagnosis. * previous hippotherapy intervention or therapeutic riding experience * allergies or aversion to horses. * refusal of parents to sign the therapeutic riding center's liability release form * any new treatments (includes therapies, drugs, or other complementary treatments) within one month of the start of the study or plans for new treatments during the intervention period * lack of a physician referral for physical therapy

Keywords: hippotherapy neuromuscular disorders balance deficits participation
a clinical trial of yh14642 in patients with chronic periodontal disease

Conditions: Chronic Periodontitis

Summary: this study is designed to evaluate the efficacy and the safety of yh14642 in korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.


Eligibility criteria:
inclusion criteria: * subjects must be 20 years of age or older * have at least 18 natural teeth * four or more clinical attachment level(cal) ≥ 3mm * four or more periodontal pockets with a probing depth (pd) ≥ 4mm * have bleeding on probing * provide informed consent and willingness to cooperate with the study protocol exclusion criteria: * forbidden history of panax notoginseng and rehmanniae radix preparata * hypersensitivity of doxycycline * hypersensitivity of zea mays l. extract * critical diseases such as hiv previous three years * patients with mental retardation and dementia * systemic diseases such as diabetes and hypertension * patients who take anticoagulants or antiplatelet agents * patients who have malignant tumor * smoker * continually use for 2weeks of phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month * patients who need malignant tumor * patients who received periodontal treatment within the last 6 months * pregnant or lactating females
way to cure hcv adherence

Conditions: Hepatitis C

Summary: this is a 3-arm, multi-center, patient-randomized, field evaluation of the "way to cure" behavioral interventions on medication adherence in hcv.

this 3-arm trial will field test the efficacy of "way to cure" intervention on medication adherence in hepatitis c for 12 weeks. as part of routine clinical care all patients will receive medication counseling regarding proper use and side effects by trained nurses or pharmacists depending on the clinical site. arm 1: control (n=20) - monitoring pill box will be set into "quiet mode". this mode sends daily adherence data to the way to health platform each time the participant opens the pill bottle, however, does not remind the participant to take the medication. in the event no electronic signal is received by the platform for 96 hours, the ra will call the participant to assess any usability or connectivity issues. arm 2: intervention - reminders/feedback (n=20) - patients will receive tailored text message reminders to take the medication if in case the interval from last box opening is \>30 hours (greater than 6 hours overdue). patients will receive weekly text messages with summary cumulative adherence scores. arm 3: intervention - reminders/feedback and financial incentives (n=20) - in addition to reminders with missed doses and weekly adherence feedback, patients in this arm will be eligible to receive a financial incentive each week they demonstrate perfect \>85% adherence. the weekly adherence feedback message will also alert patients whether they earned the incentive for the past week.

Eligibility criteria:
inclusion criteria: a) age 50 older, b) prescribed a fixed dose combination hcv regimen containing sofosbuvir/ledipasvir for 12 weeks, and 3) willing to receive text message communications. exclusion criteria: a) non-english speaking, b) have severe vision, hearing impairment precluding study participation, c) no text messaging capability, d) decompensated cirrhosis requiring hospitalization in the past 30 days, e) medication primarily given by a caregiver/facility
salvage therapy with amprenavir, lopinavir and ritonavir in hiv-infected patients in virological failure.

Conditions: HIV Infections

Summary: hiv infected patients are treated with highly active antiretroviral therapy (haart). side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. in order to maintain efficacy of haart, new combination is evaluated. the aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in hiv-infected patients in whom multiple antiretroviral regimens had failed.

hiv infected patients are treated with highly active antiretroviral therapy (haart). side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. in order to maintain efficacy of haart, new combination is evaluated. the aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors (nrti), over a 26-week period in hiv-infected patients in whom multiple antiretroviral regimens had failed. 100 patients with cd4 cell count below 300/mm3 and plasma hiv rna over 30,000 copies/ml are to be included in four groups: amprenavir, lopinavir, nrti, with ritonavir 200 mg.d or not (patients previously treated by additional ritonavir 200 or 400 mg/d).

Eligibility criteria:
inclusion criteria: * documented hiv infection * cd4 cell count below 300/mm3 * plasma hiv rna over 30,000 copies/ml * previously treated with 2 protease inhibitors and 1 non nucleoside analogue (except amprenavir, lopinavir) * written informed consent exclusion criteria: * biological abnormalities * pregnancy * alcool abuse * history of pancreatitis, hepatic failure * acute hiv related infection * chemotherapy

Keywords: hiv infections salvage therapy amprenavir lopinavir ritonavir
effects of guiding catheter on ffr and nhpr for the assessment of coronary artery stenoses (disengage@rest)

Conditions: Coronary Artery Disease

Summary: the disengage@rest study is a prospective registry carried out at federico ii university of naples with the aim to evaluate the influence of the guiding catheter engagement within the coronary ostium on both ffr and non-hyperaemic pressure ratios values (such as pd/pa and the resting full-cycle ratio -rfr), as well as the corresponding clinical impact on decision-making strategies. consecutive patients with at least one intermediate stenosis (40%-90% by visual estimation) in any of the 3 main coronary arteries will be included.


Eligibility criteria:
inclusion criteria: * age \> 18 years; * patients provides informed consent; * documented coronary artery disease: * chronic coronary syndromes * acute coronary syndromes presenting with at least one stenosis with indication for invasive functional assessment. exclusion criteria: * patients unable to provide informed consent; * pregnant women; * any contraindication to perform angiographic study or functional evaluation with pressure wire; * patients with aorto-ostial stenosis * target vessel diameter \< 2mm

Keywords: fractional flow reserve resting full-cycle ratio
a study to investigate the influence of hepatic impairment on mk-8189 treatment (mk-8189-012)

Conditions: Hepatic Impairment

Summary: the purpose of this study is to compare the pharmacokinetics (pk) of mk-8189 in participants with moderate hepatic impairment (based on the child-pugh classification) to healthy participants. this is part 1 of the study; following review of the safety and pk data from part 1, a decision will be made as to whether part 2 of the study will be initiated. if done, part 2 of the study will compare the pk of mk-8189 in participants with mild hepatic impairment to healthy participants.


Eligibility criteria:
inclusion criteria: * is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or equivalent) * female participant is not pregnant or breastfeeding and is not woman of childbearing potential (wocbp) or is a wocbp using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 14 days after the last dose of study intervention * (for hepatically impaired participants) has a diagnosis of chronic (\>6 months), stable (no acute episodes within the previous 2 months due to deterioration in hepatic function) hepatic impairment exclusion criteria: * has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases * has a history of cancer; exceptions include (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated malignancies * has a history of significant multiple and/or severe allergies or has had significant intolerability to prescription or non-prescription drugs or food * is positive for hepatitis b, hepatitis c or human immunodeficiency virus (hiv) * has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit * consumes greater than 3 glasses of alcoholic beverages per day * consumes greater than 6 servings (1 serving is \~120 mg of caffeine) caffeinated beverages per day * (for hepatically impaired participants) is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medications during study
the use of optical oximetry in determining gastrointestinal complications after the hybrid procedure

Conditions: Congenital Heart Disease

Summary: this project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. regional saturation monitoring is a standard of care in many institutions, including nch. advances in the technology and recent approval of the use of casmed devices for this purpose will allow us to use this technology more effectively. we aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and post operative period for the hybrid procedure and the balloon atrial septostomy procedure (bas).


Eligibility criteria:
inclusion criteria: * diagnosis of single ventricle and undergoing the hybrid procedure pathway. exclusion criteria: * none
glucose-dependent insulinotropic polypeptide: effect on bone remodelling and cell activity (ginebra)

Conditions: Bone Disease, Metabolic; Diabetes Mellitus, Type 2; Obesity and Obesity-related Medical Conditions

Summary: glucose-dependent insulinotropic polypeptide (gip) is released by the intestines in response to food intake and increases insulin secretion. although short-term (\< 3 hours) stimulation with gip decreases bone resorption in humans, the effect may vanish following continuous administration within 24 hours, at least in patients with type 1 diabetes. whether the anti-resorptive effect of gip can be maintained if the hormone is non-continuously administrated is unclear. as the first gip receptor (gipr) agonist, tirzepatide was recently approved for the treatment of obesity and type 2 diabetes in the usa and type 2 diabetes alone in the eu, there is a need to establish knowledge about the long-term effects of gip on bone health, including if different exposure times to gip have different skeletal effects. this project will investigate whether gip maintains its anti-resorptive potential if given as intermittent compared to continuous infusion in healthy men and women aged 18-40 years. administration cycles involve intermittent (8 hours daily) and continuous (24 hours daily) injection of gip for three days each. the effect of gip will be measured by bone markers in blood samples, as well as in vitro activity and genetic alterations of bone cells (osteoclasts and osteoblasts) using bone marrow aspirates and bone marrow biopsies. each participant will receive both administration cycles using a crossover design with a 14-28 days washout period between administrations of gip.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * pre-diabetes or diabetes (hba1c \>42mmol/mol) * bmi \>28 * fractures with \< 6months * comorbidities/treatments that may influence bone metabolism or procedures - -- pregnancy * inability to provide informed concent

Keywords: gip ctx p1np glucose-dependent insulinotropic polypeptide bone remodelling
effect of global postural correction exercises on stress urinary incontinence during pregnancy: a randomized controlled trial

Conditions: Stress Urinary Incontinence

Summary: background: one of the many consequences of pregnancy that may negatively affect a woman's quality of life is stress urinary incontinence caused by activities of daily living especially those associated with increased intraabdominal pressure. objective: this study aimed to investigate the effect of global postural correction exercises on stress urinary incontinence among pregnant women. participants and methods: forty primigravida women (aged between 30-39 years), with a single fetus, diagnosed with stress urinary incontinence participated in the study. participants were assigned randomly into two groups: study group (group a; n=20) and control group (group b; n=20). the participants were tested twice, before and after a 12-week period, during which group a received global postural correction exercises in addition to kegel exercises, while group b performed only kegel exercises. a perineometer was used to evaluate the change in vaginal squeeze pressure both before and after conducting the study. urogenital distress inventory questionnaire (udi-6) was used to assess changes in incontinence severity symptoms.


Eligibility criteria:
inclusion criteria: * forty primigravida women with singleton fetus in their third trimester and diagnosed with pregnancy related sui participated in this study. all participants suffered from a mild to moderate grade of sui identified by clinical grading (ingelman-sundberg) (wlazlak et al., 2015) as follows: grade i (mild), the leakage of urine occurs on straining; and grade ii (moderate), the leakage occurs following abrupt movement exclusion criteria: * females were excluded from the study if they had severe grade sui; infections in their lower urinary tract; neurological conditions; gestational diabetes; and chronic chest diseases. females who smoked, used any medications or medical/surgical interventions for sui, or who suffered any other type of urinary incontinence were also excluded from the study

Keywords: kegel exercise postural correction stress urinary incontinence
comparison of ultrasound-guided bilateral esp block and wound infiltration for spinal surgical analgesia

Conditions: Pain, Postoperative; Spinal Disease; Anesthesia, Local; Anesthesia, Regional

Summary: the aim of our study is to determine the superior procedure in analgesia management by comparing the traditional wound infiltration technique with the ultrasound-guided bilateral erector spina plan block technique in spinal surgery patients.

patients in asa i-ii-iii risk group aged 18-80 who will undergo spinal surgery by trakya university faculty of medicine, brain and nerve surgery will be included. in this study, patient data will be collected in the form of file scanning. intra-operative; hemodynamic data of patients; heart rate, blood pressure values, anesthetic and other drugs applied, surgery and anesthesia durations will be written from the anesthesia document after the operation is over. in the study, the application preferred by the anesthesiologist for the patient will not be intervened. the patients will be divided into three groups; wound infiltration technique was applied, ultrasound-guided bilateral erector spina plan block technique was applied and both techniques were applied together. after the operation; pain values will be calculated by vas at the 1st, 2nd, 4th, 6th, 12th and 24th hours of the patients. the patient's length of stay, satisfaction (excellent, good, moderate, poor) and methods used for analgesia will be recorded. with the results collected in our study, it will be determined which procedure is superior in pain management for spine surgery.

Eligibility criteria:
inclusion criteria: * undergoing elective spine surgery * no contraindication to the technique to be applied * not pregnant * being over the age of 18 exclusion criteria: * undergoing emergency spine surgery * there is an obstacle to the technical process to be applied * pregnant patients * patients younger than 18 years old

Keywords: ultrasound-guided bilateral erector spina plane block wound infiltration analgesia spinal surgery