Kornimate/medical-research-clean huggingface dataset:
irdye800cw-bbn pet-nirf imaging guiding surgery in patients with glioblastoma

Conditions: Glioblastoma

Summary: this is an open-label positron emission tomography/near infrared (pet/nirf) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68ga-bbn-irdye800cw in glioblastoma (gbm) patients. a single dose of 40μg/111-148 mega-becquerel (mbq) and 1.0 mg/ml 68ga-bbn-irdye800cw will be injected intravenously before the operation and intraoperative respectively. visual and semiquantitative method will be used to assess the pet images and real-time margins localization for surgical navigation.

non-invasive preoperative pet imaging evaluation and real-time fluorescence-guided surgery would be of great help in gbm patients. bbn, with the amino acid sequence of gln-trp-ala-val-gly-his-leu-met-nh2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (grpr), a member of the g protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioblastoma multiforme. for interests in clinical translation of grpr targeting dual modality probe, an open label dual modality imaging pet/ nifr study was designed to investigate the safety and imaging guiding performance of 68ga-bbn-irdye800cw in patients with gbm.

Eligibility criteria:
inclusion criteria: * must be able to provide a written informed consent * mri imaging and/or pathological evidence of newly diagnosed or recurrence gbm exclusion criteria: * consisted of conditions of mental illness * severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μμ) * any hepatic enzyme level 5 times or more than normal upper limit * severe allergy or hypersensitivity to iv radiographic contrast * claustrophobia to accept the pet/ct scanning * pregnancy or breast feeding

Keywords: gbm grpr irdye800 nirf surgery
on-eye evaluation of contact lens rotation marks

Conditions: Refractive Error

Summary: the purpose of this study was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks.

participants wore the test and control products contralaterally (in each eye separately) for 2 hours, during which the investigator assessed the various molded rotation marks for visibility. each participant was assessed by 10 investigators.

Eligibility criteria:
inclusion criteria: * sign informed consent document. * best corrected distance visual acuity (va) greater than or equal to 20/25 in each eye. * other protocol-defined inclusion criteria may apply. exclusion criteria: * history of any ocular surgery or ocular injury within 12 weeks of study enrollment. * any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (cl) wear. * history of herpetic keratitis. * slit-lamp findings greater than grade 2 at baseline. * any use of systemic or ocular medications for which cl wear could be contraindicated. * inactive corneal neovascularization greater than 1 millimeter of penetration. * a clinically significant dry eye not responding to treatment. * history of refractive surgery. * participation in a clinical study within the previous 30 days. * other protocol-defined exclusion criteria may apply.

Keywords: astigmatism toric contact lenses daily disposable contact lenses molded mark rotation mark
study of dupilumab in adult patients with extrinsic moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the primary objective was to assess the clinical efficacy of repeated subcutaneous (sc) doses of dupilumab in adult participants with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: the inclusion criteria included, but were not limited to the following: 1. male or female, 18 years or older; 2. chronic atopic dermatitis (ad) for at least 3 years; 3. history of inadequate response to a stable (\>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for ad within 3 months before the screening visit. exclusion criteria: 1. prior treatment with regn668; 2. presence of certain laboratory abnormalities at the screening visit; 3. treatment with an investigational drug within 8 weeks ; 4. treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit; 5. certain treatments and medical procedures, undertaken within a particular time-frame prior to the baseline visit, preclude eligibility for participation in the study; 6. known history of human immunodeficiency virus (hiv) infection; 7. history of malignancy within 5 years before the baseline visit, with certain exceptions; 8. planned surgical procedure during the length of the patient's participation in this study; 9. history of clinical parasite infection; 10. any medical or psychiatric condition which in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results; 11. pregnant or breast-feeding women.
the earlens system long term safety and efficacy definitive multi-center study

Conditions: Hearing Impairment

Summary: the earlens system is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. the purpose of this multi-center definitive study is to assess the safety and efficacy of the earlens system for subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully activated system in their daily lives for a 4 month period of time. this study is designed to support us and international marketing applications to commercialize the earlens system. the main efficacy hypothesis is that the earlens system will be shown to improve speech understanding in quiet.


Eligibility criteria:
inclusion criteria: * age 18 to 85 years * mild to severe hearing impairment between 125 to 4000 hz * no significant conductive hearing impairment * able and willing to commit to travel and time demands of the study exclusion criteria: * must not have known or active medical issues that would preclude having a device including: 1. an abnormal tympanic membrane 2. an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes 3. an ear canal anatomy that prevents physicians from seeing adequate amount of the tympanic membrane * must not have other known or active medical issues including: 1. history of chronic and recurrent ear infections in the past 24 mouths 2. history of dizziness and/or vertigo in the past 24 months 3. taking medications/treatments with known ototoxic effects 4. a rapidly progressive or fluctuating hearing impairment 5. having been diagnosed with having a compromised immune system * must not fit the definition of a vulnerable subject, as per fda regulations 21 cfr parts 50 and 56 * must not have an ear canal anatomy that preclude manufacture of the device as determined by earlens manufacturing personnel

Keywords: hearing impairment hearing loss
prevention of post-exercise muscle fatigue and effect on exercise training in severe patients with copd.

Conditions: Obstructive Lung Diseases

Summary: in patients with severe chronic obstructive pulmonary disease (copd), exercise tolerance is severely impaired due to a ventilatory limitation, levelling off the intensity of exercise. this reduces the physiological benefit of pulmonary rehabilitation. in these patients, it is then proposed to add an inspiratory pressure support (ips) in order to increase the intensity and the duration of every training session. in a preliminary study, the investigators showed that ips applied during an exhaustive cycling exercise allowed to prevent the onset of post-exercise quadriceps fatigue evaluated by the endurance time to isotonic quadriceps contractions (tlimq). the aim of this study is to determine the relationship between the prevention of post-exercise fatigue (tlimq) and the change in training load (intensity x time x number of sessions) during a pulmonary rehabilitation programme. at the beginning of the training programme, 25 patients will be evaluated for tlimq after a cycling exercise (70% maximal workload) with and without ips in random order. the training load was then monitored at every exercise session of the programme.


Eligibility criteria:
inclusion criteria: * severe copd patients in stable condition (gold class 3 or 4) * ventilatory limitation to exercise during the incremental cardiopulmonary exercise test (at least one of the following criteria) : * no breathing reserve * exercise hypoventilation (increase arterial pco2\> 5 mmhg) * maximal workload \<50 watts exclusion criteria: * ips not tolerated during a preliminary cycling exercise test * enable to perform the exercise tests or the rehabilitation programme * decline to participate
sensimed triggerfish

Conditions: Glaucoma

Summary: the purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

60 subjects will be enrolled in total. enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. patients in the device arm will receive one session of 3-to 24-hour continuous iop monitoring with sensimed triggerfish®. sensimed triggerfish® monitoring will begin at 18h ± 2 hours for all patients. sensimed triggerfish® will be installed randomly on right or left eyes. during sensimed triggerfish® monitoring on one eye, gat and/or perkins iop measurements will be taken in the fellow eye every 3 hours. outside this time they will receive gat and/or iop measurements every 3 hours in both eyes until the end of the 24-hours period. patients in the control group will receive gat and/or icare pro iop measurements every 3 hours for 24 hours in both eyes.

Eligibility criteria:
inclusion criteria: * signed informed consent for the investigation * confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes * age 18-85 * stable anti-glaucomatous therapy 4 weeks before and throughout the investigation exclusion criteria: * patients not able to understand the character and individual consequences of the investigation * patients with contraindications for silicone contact lens wear * wear of full frame metallic glasses during sensimed triggerfish® monitoring * diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma * severe dry eye * patients who have had ocular surgery within the last 3 months * corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation * allergy to corneal anaesthesia * simultaneous participation in other clinical research
mandibular implants in elderly patients

Conditions: Edentulous Complete Denture Wearers

Summary: the purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (iod) in very old edentulous patients who depend on help for activities of daily living (adl) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.


Eligibility criteria:
inclusion criteria: * 75 years or older * living institutionalized or receiving help for the adl * edentulous * wearing complete dentures * the lower denture had to cause discomfort to the degree that the patients were seeking treatment exclusion criteria: * severe clinical depression * dementia * poorly controlled diabetes * immunosuppression * treatment with bisphosphonates * condition precluding the surgical intervention for implant placement

Keywords: edentulous complete denture
clinical and laboratory parameters associated with different degrees of dehydration among children with diabetic ketoacidosis

Conditions: Diabetic Ketoacidosis

Summary: diabetic ketoacidosis (dka) is a common acute complication of type 1 diabetes mellitus (t1dm). dka is characterized by hyperglycemia, metabolic acidosis, increased levels of ketone bodies in blood and urine. this leads to osmotic diuresis and severe depletion of water and electrolytes from both the intra- and extracellular fluid (ecf) compartments. estimation of the degree of dehydration for children admitted with dka is of great clinical importance. the calculation of the amount of deficit therapy depends on the estimated degree of dehydration. however, the degree of dehydration present during dka is difficult to be clinically assessed. hyperosmolality tends to preserve intravascular volume with maintenance of peripheral pulses, blood pressure, and urine output until extreme volume depletion occurs. metabolic acidosis leads to hyperventilation and dry oral mucosa as well as decreased peripheral vascular resistance and cardiac function . consequently, hyper-osmolality may lead to an underestimation of the degree of dehydration, whereas metabolic acidosis may lead to an overestimation of the degree of dehydration. this makes the physical findings unreliable in this setting. several clinical and biochemical markers were suggested to assess and stage the degree of dehydration at hospital admission. the blood urea nitrogen , hematocrit , plasma albumin are useful markers of the degree of ecf contraction.however, several previous studies demonstrated that there was no agreement between assessed and measured degree of dehydration which is calculated according to change in body weight at admission and after correction of dehydration. there were tendencies to overestimated or underestimate the degree of dehydration between different physicians. the assessment of the magnitude of dehydration in dka is of major interest and continues to be a subject of research. this study aims to assess the association between different clinical and laboratory parameters in children with diabetic ketoacidosis and the degree of dehydration at hospital admission among those children.


Eligibility criteria:
inclusion criteria: * children with t1dm aged 0-12 years admitted to the pediatric emergency department with dka criteria (blood glucose level \> 200 mg/dl, ph \< 7.3, and /or bicarbonate level in blood \< 15 mmol/l and positive ketones in urine by dipstick method) will be included. exclusion criteria: * children with dka who are referred to sohag university hospital after starting treatment for dka at another hospital.
baclofen versus gabapentin in preventing postoperative pain after laparoscopic sleeve gastrectomy

Conditions: Post Operative Pain

Summary: the aim of this study is to compare the possible efficacy of baclofen and gabapentin on postoperative pain in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.


Eligibility criteria:
inclusion criteria: * - age between 18-60 years old. * both male and female patients will be included. * morbidly obese patients scheduled for sleeve gastrectomy with bmi ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes. * morbidly obese patients scheduled for sleeve gastrectomy with bmi ≥ 40 kg/m2 without comorbidity. * patients fit for anesthesia and surgery. exclusion criteria: * patients with bmi \>55 kg/m2. * patients with previous procedures for the treatment of obesity. * pregnant females and lactating women. * patients with psychological or psychiatric disease * administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery * patients who experienced vomiting within 24 hours before surgery. * patients with history of alcohol or drug abuse. * patients with hypersensitivity or contraindications to any of the drugs used in this study.
acupuncture for anxiety in women with breast cancer: a feasibility study

Conditions: Breast Cancer

Summary: to assess the efficacy of acupuncture treatment in reducing symptoms of anxiety in women recently diagnosed with cancer. • to assess the efficacy of acupuncture treatment on improving perceived quality of life in women recently diagnosed with cancer.

this is a feasibility study of acupuncture for anxiety reduction in women with breast cancer. ten patients will be recruited at the unm cancer research treatment center via the breast clinic and screened for anxiety. treatment will consist of 10 acupuncture sessions over 5 weeks. measures (hopkins symptom checklist, sheehan disability index) will be administered and analyzed for treatment effect on scores.

Eligibility criteria:
inclusion criteria: * woman age 18 years or older excluding the need for parental/guardian permission. * histologic diagnosis of breast cancer. * having a minimum anxiety score of 1.75 on the hopkins symptom checklist (hscl) with sufficient english language proficiency for the investigators to make this determination. * able to give informed consent. * willingness to participate in the study and receive 10 acupuncture treatments in 5 weeks. * ability to fill out questionnaires and communicate with the research staff exclusion criteria: * males with breast cancer * psychoses or a major personality disorder * current use of opiates,
comparing no mechanical bowel preparation with oral antibiotics alone in patients undergoing elective colon surgery

Conditions: Elective Colon Surgery

Summary: the react nsqip will compare oral antibiotics vs. no antibiotics, which are two standards of care treatments for preoperative preparation of the bowel prior to colorectal surgery

the divergence of clinical practice guidelines, in addition to observation from the large north american retrospective studies, suggest that surgeons and centers have not established a standard of care for the preoperative preparation of the bowel prior to colorectal surgery. specifically, some centers are employing no preparation, others are administering a mechanical bowel preparation (mbp) and oral antibiotics and still others are using oral antibiotics alone. recently, the canadian society of colorectal surgeons was unable to come to a consensus when attempting to update their preoperative guidelines because of the lack of agreement on best practice (personal communication). this is an important yet controversial topic in colorectal surgery and a clinical trial comparing two standard of care therapies will impact current practice in canada. the react-nsqip study compares post-operative surgical infectious complications, length of stay, incidence of c. difficile rates, patient quality of life and cost-effectiveness in patients undergoing elective colorectal surgery with either no preparation or oral antibiotics. data will be collected from the national surgical quality improvement program (nsqip) and from patient quality of life questionnaires preoperatively and 30 days postoperatively in this study, it is hypothesized that it is the oral antibiotics, and not the mbp, that is responsible for the reduction in postoperative infectious surgical complications (deep or superficial surgical site infection (ssi)) in patients undergoing elective colorectal resections. this improvement in postoperative infectious complications is not anticipated to result in a clinically significant increase in postoperative c. difficile infections or antibiotic resistant hospital-acquired infections.

Eligibility criteria:
inclusion criteria: * patients undergoing elective, non-emergency colon, resection surgery or abdominal perineal resection and no other requirements exists for a mechanical bowel preparation (as determined by the operating surgeon) * 18 years of age or older * able to provide oral consent exclusion criteria: * contraindication to the oral antibiotics, including allergies or adverse reactions to either metronidazole or neomycin * undergoing a rectal resection with a planned anastomosis (these patients will all receive mbp) * emergency surgery where no opportunity to administer preoperative oral antibiotics exists * requirement for a mbp (i.e. rectal resection with pelvic anastomosis, intraoperative colonoscopy, or at the discretion of the treating surgeon

Keywords: oral antibiotics preoperative mechanical bowel preparation surgical site infection c. difficile
randomized, masked comparison of bromfenac and besifloxacin bid with either prednisolone bid or loteprednol 0.5% bid for prevention of retinal thickening and cme following phacoemulsification

Conditions: Pseudophakia; Cataract Surgery

Summary: the purpose of this study is to determine if lotemax eye drops are at least as effective as pred forte eye drops, which are the standard of care after cataract surgery.

prednisolone 1%, a topical steroid, is considered standard of care following cataract surgery to reduce inflammation. we aim to determine if lotemax is at least as effective as prednisolone. if so, these findings would demonstrate that physicians have other treatment options to consider.

Eligibility criteria:
inclusion criteria: * male or female \>18 years of age scheduled to undergo cataract surgery * patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams) * expected visual outcome of bcva (best corrected visual acuity)\> 20/25 postoperatively, as determined by potential visual acuity testing and review of preoperative corneal topography and oct (optical coherence tomography). * ability to provide informed consent, take study medications as directed, and likely to complete all study visits exclusion criteria: * known contraindication to any study medication or any of their components * required use of ocular medications other than the study medications during the study * evidence of macular disease (epiretinal membrane, vitreomacular traction syndrome, macular hole) on preoperative oct (optical coherence tomography) * presence of significant dry macular degeneration that may impact postoperative visual results. * history of retinal vein occlusion or diabetic macular edema, uveitis or any macular disease predisposing them to cystoid macular edema or prolonged intraocular inflammation. * posterior capsule rupture, vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome * anticipated need for mechanical iris dilating devices * presence of epithelial basement membrane dystrophy, significant dry eye, significant blepharitis, or any other corneal condition that may impact bcva (best corrected visual acuity) postoperatively

Keywords: prevention of retinal thickening and cme following phacoemulsification pseudophakia following cataract surgery