Kornimate/medical-research-clean huggingface dataset:
study of celecoxib or diclofenac and omeprazole for gastrointestinal (gi) safety in high gi risk patients with arthritis

Conditions: Osteoarthritis; Arthritis, Rheumatoid

Summary: to determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (gi) events in high gi risk subjects with osteoarthritis and/or rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * subjects with a clinical diagnosis of oa or ra and who are expected to require regular anti-inflammatory therapy for arthritis symptom management * subjects must be aged 60 years or older with or without a history of gastroduodenal (gd) ulceration; or be of any age 18 years or older and have had documented evidence of gd ulceration 90 days or more prior to the screening visit exclusion criteria: * active gd ulceration or gd ulceration within 90 days of the screening visit. * concomitant use of low dose aspirin * previous mi, stroke or significant vascular disease.

Keywords: gi events in high risk gi arthritis patients
crave crush neuroimaging study

Conditions: Obesity

Summary: the purpose of the research is to test whether a gymnemic acids (ga) lozenge will reduce reward region response to intake of high-sugar food and ad lib candy intake and whether the ga lozenge reduced reward region response to anticipated intake of high-sugar food and high-sugar food pictures relative to a placebo lozenge.

test the hypothesis that an acute dose of crave crush will produce greater reductions in reward region response to a taste of a high-sugar/high-fat beverage and anticipated receipt of this beverage than a placebo dose. test the hypothesis that a dose of crave crush will result in reduced ad lib candy intake while the participants complete a survey after the fmri scan. participants will receive a second dose of crave crush or placebo. they will then be placed in a room to complete a few surveys. a bowl of candy will be placed on the table. participants will be told that the candy is left over from their assessment and that they are free to have as much as they like, because the candy must be discarded after each participant.

Eligibility criteria:
inclusion criteria: * between 18 and 50 years old * report having a sweet tooth * report desire to lose weight * body mass index between 18 and 40 exclusion criteria: * major psychiatric disorders * serious health problems (e.g., diabetes) * habitual use of psychoactive drugs or medications * contraindications for mri scanning (e.g., ferromagnetic braces) * gluten or lactose intolerance * a vegan diet.
cavity shaving in breast conserving surgery for breast cancer patients

Conditions: Breast Cancer

Summary: this randomized controlled trial is to evaluate the impact of additional cavity shaving (cs) on pathological cavity margin (cm) status in breast cancer patients. patients receiving standard breast-conserving surgery (bcs) will be randomized to intra-operative cm assessment versus intra-operative cs followed by cm assessment. the primary objective of this study is to assess the impact of cs on intra-operative cm status, intra-operative re-excision rate, post-operative cm status and re-excision rate, cosmetic outcomes, and on intraoperative time and medical costs.

after stratified and blocked randomization, the patients' name, admission id and treatment assignment will be written on a slip of paper, and will be placed in a sealed envelop. a label with the patients' name and admission id will be placed on the sealed envelop, which will be kept in a locked file. on the day of surgery, a research coordinator will bring the sealed envelope to the operation room. during the standard-of-care bcs, the tumor was excised with a rim of grossly normal tissue. additional resections are allowed when any of the margins of the tumor-containing specimen were suspected to be inadequate on the basis of standard gross evaluation by surgeons. prior to intra-operative cm assessment, the research co-ordinator will unseal the envelop and determine which procedure has been designated to the patient. the cosmetic outcome and the quality of life will be evaluated at the day of discharge, after completion of radiotherapy and one year by the patient herself, her partner and a research co-ordinator.

Eligibility criteria:
inclusion criteria: * female * at least 18 years of age and no more than 65 years of age * able to understand and willing to sign an informed consent document * willing and planning to undergo the breast-conserving surgery * ecog≤ 2 exclusion criteria: * inflammatory breast cancer * preference for mastectomy instead of breast-conserving surgery * necessity to undergo oncoplastic breast surgery * prior surgical treatment, including ultrasound-guided vacuum-assisted biopsy and excision biopsy. * prior systemic therapy for this diagnosis, including neoadjuvant chemotherapy, neoadjuvant endocrine therapy. * history of prior breast/axillary radiation therapy * known metastatic disease * diagnosed as bilateral breast cancer or dcis * history of other malignancy ≤ 5 years previous * preoperation evaluation indicates tumor size\>5cm * preoperation evaluation indicates multicenter or multifocal breast cancer(including suspicious calcification on mammography) * undergoing other clinical trials * with sever liver disfunction(child-pugh c) * with sever cardiac insufficiency * with sever renal disfunction * pregnancy

Keywords: breast-conserving surgery(bcs) cavity shave margin proportion of positive margins
immunological tolerance after frequent rabies booster vaccinations

Conditions: Rabies

Summary: to study immunological tolerance effect after frequent rabies booster vaccination

previous studies had shown lower antibody titers among those who received frequent rabies booster vaccination, compared to ones who had got primary immunization. we study immunological cells i.e., regulatory t cell, regulatory b cell, t follicular helper cell, and cytokines in those who received frequent rabies booster vaccination.

Eligibility criteria:
inclusion criteria: * healthy adults * previously received rabies vaccination exclusion criteria: * had immunocompromised conditions * received blood or blood product within 3 months * received anti-malarial drugs

Keywords: rabies vaccination
yttrium y 90 ibritumomab tiuxetan and rituximab in treating patients with previously untreated marginal zone lymphoma

Conditions: Marginal Zone Lymphoma

Summary: zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (mzl).

this phase ii study will assess the clinical response rate to ibritumomab tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal mzl as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (malt) gastric lymphoma.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old with previously untreated, histologically confirmed marginal zone lymphoma (non-gastric extranodal mzl, splenic mzl and nodal mzl) or gastric mzl that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months) * measurable and evaluable disease * all stages are eligible * eastern cooperative oncology group (ecog) performance status score of 0, 1, or 2 (appendix b) * willing and able to provide written informed consent * women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment * life expectancy of at least 6 months exclusion criteria: * prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment. * ≥ 25% lymphoma bone marrow involvement * platelet count \< 100,000 cells/mm³ * neutrophil count \< 1,500 cells/mm³ * known history of hiv infection * pregnant or lactating (pregnancy test is required for all female patients of childbearing potential) * woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection. * physical or mental condition that makes patient unable to complete specified follow-up assessments

Keywords: marginal zone lymphoma non-gastric extranodal marginal zone lymphoma splenic marginal zone lymphoma nodal marginal zone lymphoma gastric marginal zone lymphoma mzl non-gastric extranodal mzl splenic mzl nodal mzl gastric mzl
lidocaine infusion versus magnesium infusion in decreasing fentanyl requirements in endoscopic sinus surgeries

Conditions: Enhanced Recovery; Functional Endoscopic Sinus Surgery; Lidocaine; Magnesium Sulphate; Perioperative Pain

Summary: enhanced recovery after ear, nose and throat surgery is based on multimodal and multidisciplinary perioperative interventions to decrease postoperative pain. functional endoscopic sinus surgery is a surgical management for chronic rhinosinusitis. although a common procedure, there is a lack of knowledge about perioperative pain and specific pain management after such a procedure. most of recommendations given in guidelines for postoperative pain management in nasal surgery and sinus surgery are subsumed under head and neck surgery. head and neck surgery is a wide field covering widely variable surgical procedures. so, postoperative pain management guidelines may not meet the requirements for pain management during and after endoscopic sinus surgery. various medications have been used to improve the surgical field and postoperative pain including intravenous clonidine, dexmedetomidine, lidocaine, and magnesium. lidocaine has been used considering its analgesic, immuno-modulating, and anti-inflammatory properties. the opioid sparing effect of lidocaine is supported by a high level of evidence. the effectiveness of lidocaine infusion in obtaining reduction of postoperative pain, gastrointestinal recovery time, postoperative nausea and vomiting, and shortening the hospital length of stay, was demonstrated principally in major gastro-intestinal surgery. magnesium sulfate is a good option in multimodal analgesia, as it stabilizes the cell membrane and intracytoplasmic organelles by mediating the activation of na+-k+ atpase and ca++ atpase enzymes, which have an important role in transmembrane ion exchange during the depolarization and repolarization phases. moreover, magnesium inhibits the release of norepinephrine by blocking the n-type ca++ channels at nerve endings. many studies were designed to prove the role of the analgesic effect of lidocaine and magnesium infusion. however, this is the first randomized controlled study to assess the effect of lidocaine infusion versus magnesium sulphate infusion on decreasing total fentanyl requirements in patients undergoing functional endoscopic sinus surgery. this randomized controlled trial was designed to compare the efficacy of lidocaine hydrochloride infusion versus magnesium sulphate infusion in controlling perioperative pain in patients undergoing functional endoscopic sinus surgery.


Eligibility criteria:
inclusion criteria: * age from 21 to 60 years. * both genders. * american society of anesthesiologist (asa) physical status i-ii * scheduled for functional endoscopic sinus surgery under general anesthesia. exclusion criteria: * patients with prolonged qt interval. * patients with renal disease. * patients with a history of allergy to lidocaine or magnesium sulfate. * american society of anesthesiologists class higher than ii. * patient refusal
antioxidant treatment of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.


Eligibility criteria:
inclusion criteria: subjects with a known diagnosis of type 2 diabetes - exclusion criteria: none, except known intolerance to n-acetylcysteine -

Keywords: type 2 diabetes
u/s-guided continuous quadratus lumborum block iii in percutaneous nephrolithotomy

Conditions: Analgesia; Surgery; Renal Stone

Summary: percutaneous nephrolithotomy (pcnl) is considered to be the first choice and a more conservative procedure than open stone surgery. not only postoperative pain related to dilatation of the renal capsule and parenchymal tract, but also patient's discomfort \& nephrostomy tube-related stress are reported to delay recovery time and increase the complication rates. this study is designed to provide postoperative analgesia by using ultrasound-guided continuous quadratus lumborum block (qlb) iii in patients undergoing pcnl and to assess pain scores \& side effects with less opioids consumption.


Eligibility criteria:
inclusion criteria: * asa i-ii. * scheduled for percutaneous nephrolithotomy (pcnl). exclusion criteria: * patient refusal. * coagulation disorders. * skin lesions or infection at site of needle insertion. * known allergy to local anesthetics or opioids. * patients suffering from neurological or mental disease. * procedure turned into open stone surgery. * failure of identification by u/s. * urinary tract malignancies. * opioid consumption 48 hours before the operation.

Keywords: quadratus lumborum block iii ultrasound-guided percutaneous nephrolithotomy analgesia
the effect of a weight management program during treatment with olanzapine

Conditions: Schizophrenia

Summary: the study is a prospective, randomized, open-label study.

the principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.

Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for schizophrenia * ages between 18 and 65 * informed consent * weight gain of at least 1.5 kg in the first 4 weeks * a sufficient understanding to participate adequately in the weight management program * patients must agree to cooperate with all tests and examinations required by the protocol. * each patient must understand the nature of the study and must sign an informed consent document. exclusion criteria: * serious, unstable somatic illnesses * illnesses associated with weight gain including renal and endocrine diseases * weight change greater than 3 kg in the preceding three months * weight gain less than 1.5 kg in the first 4 weeks

Keywords: schizophrenia, weight management programme
phase iv trial to collect safety data and sera for immunogenicity testing in healthy children given fluzone® vaccine

Conditions: Influenza

Summary: to provide centers for biologic evaluation and research (cber) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine fluzone® for further study.


Eligibility criteria:
inclusion criteria: * participant is aged ≥ 6 months (24 weeks) to \< 36 months (3rd birthday). * participant is considered to be in good health on the basis of reported medical history and limited physical examination. * participant is available for the duration of the study. * parent/legal acceptable representative is willing and able to provide informed consent. * parent/legal acceptable representative is willing and able to meet protocol requirements. * born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs). exclusion criteria: * reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. * an acute illness with or without fever (for infants/toddlers: temperature ≥ 100.4°f rectal; for children: temperature ≥ 99.5°f oral/axillary) in the 72 hours preceding enrollment in the trial (enrollment may be deferred). * clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). * participation in any other interventional clinical trial within 30 days prior to enrollment or planned participation in the study. * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth. * personal or immediate family history of congenital immune deficiency. * developmental delay, neurologic disorder, or seizure disorder. * chronic medical, congenital, or developmental disorder. * known human immunodeficiency virus (hiv)-positive mother. * prior personal history of guillain-barré syndrome. * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. * received any vaccinations within the preceding 14 days (enrollment may be deferred).

Keywords: influenza vaccine influenza virus orthomyxoviridae infections fluzone®
a research study to look at how semaglutide affects gastric emptying in people with obesity

Conditions: Overweight; Obesity

Summary: this study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine. in addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake. participants will either get semaglutide or "dummy" medicine - which treatment any participant gets is decided by chance. participants will take 1 injection per week. the study medicine is injected with a thin needle in the stomach, thigh or upper arm. the study will last for about 27 weeks (from first treatment to last check-up). participants will have 8 visits at the clinic with the study doctor.


Eligibility criteria:
inclusion criteria: * male or female, aged between 18 to 65 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 30.0 and 45.0 kg/m\^2 (both inclusive) exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method * any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions
osmotin plant protein for progressive multiple sclerosis

Conditions: Progressive Multiple Sclerosis

Summary: the aim of this study is to explore the anti-inflammatory and neuroprotective effects of a novel nutraceutical product (commercial name forza™️), consisting of the plant osmotin protein, in patients with progressive multiple sclerosis (pms). the potential effect on brain metabolism and microstructure will be evaluated by magnetic resonance imaging (mri) performed six months before starting treatment, at baseline, and after one and six months of treatment. at the same timepoints, electrophysiology, neurofilaments (nfl) quantification, optical coherence tomography (oct) and clinical assessments will be performed.


Eligibility criteria:
inclusion criteria: * signed written informed consent * diagnosis of progressive multiple sclerosis (pms) * expanded disability status scale edss ≤ 6.5 exclusion criteria: * contraindications to mri * pregnancy * hiv positivity * severe renal, hepatic, oncological, hematological and psychiatric diseases

Keywords: osmotin
effectiveness of a hand-held fan for breathlessness

Conditions: Primary Lung Cancer or Secondary Lung Metastases; COPD III/IV

Summary: breathlessness is a common and distressing symptom in advanced disease. a hand-held fan is a simple device which has shown, when directed to the patients face, to be effective in relieving breathlessness. this phase ii trial aims to determine the potential effectiveness of a hand-held fan to relieve breathlessness over time and to evaluate the recruitment into the study and the acceptance of the intervention and the control. the intervention to be tested is a hhf directed to the area of the face innervated by the second and third trigeminal nerve branches. a wristband was chosen as control under the assumption that distraction could serve as a placebo. the main outcomes for this study are uptake into the trial (proportion of patients from the longitudinal study participating in the rct), adherence to the study, and use and acceptance of the intervention and the control. the main outcome for assessing the effect of the hand-held fan is change of severity of breathlessness between baseline and one month and two months, respectively.


Eligibility criteria:
inclusion criteria: * patients were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions: * advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer) * copd stage iii (severe) and iv (very severe) according to gold criteria.\[7\] exclusion criteria: * unable to provide informed consent * too ill to be interviewed and not fluent or illiterate in german

Keywords: breathlessness dyspnea hand-held fan palliative care
effect of an anterior chamber infusion system on trabeculectomy outcomes

Conditions: Glaucoma

Summary: in the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. the flow through the surgically created fistula determines the intraocular pressure. titrating suture tightness is important to achieving the desired post-operative intraocular pressure. this process is not straightforward and intraocular pressures are often too high or too low post-operatively.

the use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes. thus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.

Eligibility criteria:
inclusion criteria: * 18 years of age * one of the following diagnoses: * primary open angle glaucoma * chronic angle closure glaucoma * pseudo exfoliation glaucoma * pigment dispersion glaucoma exclusion criteria: * unable to provide consent or return for follow up

Keywords: glaucoma trabeculectomy anterior chamber maintainer anterior chamber infusion