Kornimate/medical-research-clean huggingface dataset:
combining pet/ct and ebv dna to evaluate the hazard of progression in the follow-up of locally advanced npc

Conditions: Nasopharyngeal Carcinoma

Summary: pet/ct and ebv dna are important in diagnosis of npc. we consider that combining post-treament pet/ct and plasma ebv dna may be effective in evaluating the hazard of progression in the follow-up of locally advanced nasopharyngeal carcinoma. hence we establish this prospective cohort study.

newly-diagnosed patients with stage iii or iv non-metastatic nasopharyngeal carcinoma (ajcc 7th) will be recruited. all subjects receiving chemoradiotherapy will undergo a baseline integrated \[18f\]fluoro-2-deoxy-d-glucose (fdg) positron emission tomography/computed tomography (pet/ct) scan or traditional follow-up examination and plasma ebv dna test before the start of chemoradiotherapy. patients receiving imrt treatment will receive a dedicated fdg pet/ct protocol 12 weeks after the end of chemoradiotherapy (primary endpoint).plasma ebv dna test will be performed 4, 12, 24 weeks after the end of imrt treatment. in patients with negative pet/ct results, 2 follow-up visits are required to complement nasopharyngoscope examination and plasma ebv dna test in the frist year. all patients will undergo annual pet/ct or traditional follow-up examination and plasma ebv dna test 1 year after completing chemoradiation unless recurrent/residual disease is histopathologically-confirmed. patients with a pet/ct result suspecting for residual/recurrent/metastatic tumor must have pathological and/or clinical evidence of tumor existence before salvage therapy is started.

Eligibility criteria:
inclusion criteria: * patients must be informed of the investigational nature of this study and given written informed consent. * aged between 18-65, male/female. * staged iii or iv (ajcc 7th) npc patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, who ii and iii). * received induction chemotherapy and/or concurrent chemoradiotherapy. * ecog scale 0-1. * fertile women should practice contraception during the study period. * hgb ≥90g/l ,wbc ≥4\*109/l , plt ≥100\*109/l, * with normal liver function test (alt and ast ≤2.5\*uln, tbil ≤2.0\*uln) * with normal renal function test (serum creatinine ≤1.5\*uln) exclusion criteria: * women in pregnancy or lactation * prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ. * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×uln), and emotional disturbance. * already involved in other clinical trial. * mental disorder, civil disability, limited capacity for civil conduct.

Keywords: pet/ct ebv dna predicting predicting
comparison of topical ketorolac 0,4% versus placebo in cataract surgery

Conditions: Cystoid Macular Edema Following Cataract Surgery, Bilateral

Summary: the purpose of this study is to compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery. patients scheduled to undergo phacoemulsification will be randomized to receive either topical prednisolone acetate 1% 4 times daily (qid) plus dextran 70/hypromellose qid (placebo group) or topical prednisolone 1% qid plus ketorolac tromethamine 0.4% qid (ketorolac group) for three days preoperatively and four weeks postoperatively. the primary outcome 5 weeks after surgery will be angiographic cystoid macular edema.

purpose: to compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery. methods: this will be a masked single-center, randomized clinical study comprising 80 patients undergoing phacoemulsification cataract surgery. patients scheduled to undergo phacoemulsification and with no recognized cystoid macular edema (cme) risks (diabetic retinopathy, retinal vascular disease or macular abnormality) will be randomized to receive either topical prednisolone acetate 1% 4 times daily (qid) plus dextran 70/hypromellose qid (placebo group;n=40) or topical prednisolone 1% qid plus ketorolac tromethamine 0.4% qid (ketorolac group;n=40) for three days preoperatively and four weeks postoperatively. in both groups topical gatifloxacin will be administered to the treated eye qid, starting three days before surgery and continuing for seven days. the primary outcome 5 weeks after surgery will be angiographic cystoid macular edema. other included outcomes will be best corrected visual acuity (bcva), intraocular pressure (iop), cme incidence, retinal thickness as measured by spectral-domain optical coherence tomography (oct).

Eligibility criteria:
inclusion criteria: * subjects with nuclear cataract, density 1 and 2 classified by locs ii, scheduled to undergo phacoemulsification cataract surgery. exclusion criteria: * patients with: * diabetes, * hypertension, * uveitis, * macular disease, * congenital ocular abnormalities, * cataract density 0 and 3 by locs ii, * pseudoexfoliation syndrome. patients under treatment with nonsteroidal antinflammatory drugs or topical eye drops were excluded.

Keywords: cataract surgery cystoid macular edema angiography
home-based training in obese individuals

Conditions: Obesity

Summary: generally, the enhancement of physical fitness depends on the optimal modulation of different physiological, technical or psychological stimuli and within the factors the would contribute to a decrease performance level, obesity is one of them. in this context, ample evidence shows that obesity is associated with an augmented cardio-metabolic risk, lowered postural control, functional performance and strength-related variables. international guidelines suggests to counteract obesity to respect a minimum dosage of 150 min a week of physical activity at moderate intensity performed with resistance training exercises with a frequency of 2-3 days/week. however, in the aforementioned guidelines there is a little consideration for what concern the quality of motor execution (i.e., "how" an individual performs each movement pattern). in addition, the available literature demonstrates the effectiveness of a "movement-quality" training intervention on fitness parameters and postural control, compared to a mere conventional exercise, in normal-weight individuals . in account to this, the purpose is to evaluate whether a quality of movement protocol would be more effective than a traditional strength training exercise in improving postural control and fitness parameters in subjects with obesity.


Eligibility criteria:
inclusion criteria: * physical activity frequency at least 1 days per week * bmi index more than 30 kg/m2 * informed consent signature exclusion criteria: * aged more than 70 years * patients with knee pain (visual analogue scale \> 7 a.u.) * history of hip or knee replacement * severe hip or knee osteoarthrosis * cardiac or neurological condition contraindicating physical activity

Keywords: obesity functional performance postural control muscular strength
performance comparison of two monthly replacement silicone hydrogel multifocal lens types

Conditions: Presbyopia

Summary: to evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

this was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. each lens type was worn for approximately 4-6 weeks: the lens prescription of each lens type was optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.

Eligibility criteria:
inclusion criteria: 1. were at least 42 years of age and had full legal capacity to volunteer; 2. had read and signed an information consent letter; 3. self-reported having had a full eye examination in the previous two years; 4. anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week; 5. were willing and able to follow instructions and maintain the appointment schedule; 6. habitually wore spherical multifocal soft contact lenses, for the past 3 months minimum: * maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses, * maximum of 4 participants (out of 12) per site could be habitual wearers of biofinity multifocal, * maximum of 4 participants (out of 12) per site could be habitual wearers of either total30 multifocal or airoptix plus hydraglyde multifocal 7. had refractive astigmatism no higher than -0.75dc; 8. is presbyopic and requires a reading addition of at least +0.75d and no more than +2.50d; 9. could be fit and achieve binocular distance vision of at least 20/30 snellen which participants also deem to be 'acceptable', with the available study lens parameters (distance sphere +4 to -6; near addition as per study design). 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.
fluorescent lymphography-guided lymphadenectomy in laparoscopic proctectomy

Conditions: Rectal Cancer

Summary: the purpose of this study is to compare the number of lymph nodes retrieved with or without the use of intraoperative fluorescence lymphography in laparoscopic radical resection of rectal cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of rectal carcinoma. * without multiple primary cancer. * without receiving neoadjuvant chemoradiotherapy. * sufficient organ function. * able to provide written informed consent. exclusion criteria: * younger than 18 years or older than 75 years * synchronous or metachronous malignancy within 5 years. * patients with intestinal obstruction or perforation or bleeding who require emergency surgery. * patients with a history of pelvic irradiation. * asa (american society of anesthesiologists) grade iv or v. * women who are pregnant (confirmed by serum β-human chorionic gonadotropin in women of reproductive age) or breast feeding. * severe mental illness. * patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery. * patients who received steroid therapy within one month. * patients or family members misunderstand the conditions and goals of this study.
absorbable interface screw clinical trial

Conditions: Anterior Cruciate Ligament Rupture

Summary: validation of the safety and efficacy of absorbable interface screws for clinical use

interface screws are divided into metal screws and absorbable screws. since metal screws cut tendon grafts, absorbable interface screws are now mostly selected. at present, the materials of absorbable screws are mainly polylactic acid and polyglycolide. the test product is composed of two kinds of polylactic acid and bioactive glass fiber, which can reduce the adverse stimulation to the surrounding bone, promote the absorption of the screw and the bone grow into.estimated enrollment for 4 months, follow-up for 14 months, a total of 18 months.

Eligibility criteria:
inclusion criteria: * ① before surgery, subjects or guardians are willing and able to sign the informed consent; * patients aged 18 to 80 (including 18 and 80 years old), regardless of gender; * patients who meet the diagnostic criteria for anterior cruciate ligament rupture of the knee joint and have no contraindications to implantation; * the patient's bones are mature; * good compliance, willing and able to conduct follow-up observation as required. exclusion criteria: * ① subjects who have participated in other clinical studies of drugs, biological agents or medical devices before being selected and did not reach the primary study endpoint; * the patient is known to have a history of allergy to one or more implanted materials; * those who are physically weak or cannot tolerate surgery due to other diseases of the body; * active infection in the knee joint or other parts of the body; ⑤ those with other ligament injury and/or meniscus injury in the affected knee joint; ⑥ those who need to perform simultaneous meniscus repair and other surgeries on the ipsilateral knee joint; ⑦ obese bmi\>35;

Keywords: anterior cruciate ligament absorbable interface screws
neonatal infection surveillance database

Conditions: Neonatal Infection

Summary: neonin is a is a neonatal infection surveillance database which will facilitate active surveillance for bacterial infections through a network of neonatal units, using standardised definitions, proformas and microbiological techniques. the centralised and secure web-based database will allow real-time entry of data and rapid and timely analysis of results.

the neonin surveillance network captures data on episodes of invasive neonatal infection on a web-based database (www.neonin.org.uk). over 25 uk neonatal units currently contribute to this database in real-time. an episode of neonatal infection is defined as a positive culture collected from a normally sterile site such as the blood, cerebrospinal fluid (csf) or urine (via catheter or suprapubic aspirate) for which clinicians prescribed at least five days of appropriate antibiotics. clinical, demographic and microbiological data (including antimicrobial susceptibilities) are collected using a standardised online questionnaire, and denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit.

Eligibility criteria:
inclusion criteria: * infants on participating neonatal units who have an episode of infection with a positive culture exclusion criteria: -
spectacle lens visual acuity assessments study

Conditions: Myopia; Myopia Progression; Juvenile Myopia

Summary: this is a two-arm parallel group, non-dispensing study. participants will be existing active cypress extension (cpro-1802-002) subjects. subjects will undergo additional visual performance assessments.


Eligibility criteria:
inclusion criteria: * existing subject from the cypress extension study (cpro-1802-002) * ability to comply with study assessments * the subject's parent(s) or legal guardian(s) must read, understand and sign the statement of informed consent and receive a fully executed coy of the form exclusion criteria: * any current ocular infection, inflammation or irritation likely to affect vision
efficacy of cognitive behavior therapy in the treatment of chronic pelvic pain in women

Conditions: Chronic Pelvic Pain Syndrome

Summary: this will be the pilot study trial. the target population will be 30 individuals with chronic pelvic pain (ccp). there will be 02 groups, experimental group and control group. the primary outcome measure will be impact of female chronic pelvic pain questionnaire (if-cppq). the experimental group will receive cbt spread over 12 sessions.


Eligibility criteria:
inclusion criteria: 1. women of reproductive age. 2. women with chronic pelvic pain having no pathological or anatomical causes. 3. women with overactive bladder syndrome. 4. women with vulvodynia. - exclusion criteria: 1. women experiencing perimenopause or menopause. 2. women with medical, or gynecological or hormonal abnormalities. 3. women with mental disorders. 4. women who use substances. -

Keywords: chronic pelvic pain, pelvic pain, women
the effect of oral carnitine supplementation on mrs-derived mitochondrial function

Conditions: Elderly; Pre-diabetic

Summary: this is a longitudinal study supported by pfizer and is a collaboration between dmpi (duke molecular physiology institute) and dial (duke image acquisition laboratory) to measure the effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin sensitivity in the plasma. this pilot study seeks to explain why moderate intensity exercise provides more improvements in glucose control for pre-diabetic patients than vigorous intensity. the investigators hypothesize that moderate intensity exercise might be beneficial for elderly individuals who are overweight or obese, specifically by: 1. reducing damaging excess protein acetylation (measured in muscle biopsy), 2. improving the acylcarnitine/carnitine ratio (measured by mrs), 3. improving overall mitochondrial function as reflected in reduced phosphocreatine recovery time (measured by mrs) and 4. increasing insulin sensitivity as measured by a 4-hour oral glucose tolerance test. investigators intend to use the results of this study to show feasibility in measuring mitochondrial function at duke for a larger federal grant submission. investigators hypothesize that carnitine insufficiency might contribute to mitochondrial dysfunction and obesity-related impairments in glucose tolerance and insulin action.


Eligibility criteria:
inclusion criteria: * age: 60-80 years * moderately overweight: bmi - 25.0 - 35.4 * sedentary - exercise ≤ 1 day/week * fasting plasma glucose: \> 100 - \< 126 mg/dl * readings from two separate days exclusion criteria: * orthopedic limitations, musculoskeletal disease and/or injury * allergic to xylocaine * inability to give blood continuously through an intravenous catheter * have a confounding medical condition that is progressive and unstable such as hiv, hepatitis c, active cancer, and/or taking medications for those conditions that are likely to confound the assessment of pre-diabetes * prior surgical operation within the past 6 months * prior injury to the eye involving metallic objects or fragments * prior injury involving a metallic object or foreign body (eg. bb, bullet, shrapnel, etc.) * tattoos from the waist down to the feet * any of the following implants or devices * aneurysm clip * cardiac pacemaker * implanted cardioverter defibrillator (icd) * electronic implant or device * magnetically activated implant or device * neurostimulation system * spinal cord stimulator * internal electrodes or wires * bone growth/bone fusion stimulator * cochlear, otologic or other ear implant * insulin or other infusion pump * implanted drug infusion device * eye implants * vascular access port and/or catheter * wire mesh implant or stent * other implant * claustrophobia * prior knee replacement surgery * pregnant or intending to become pregnant during the study

Keywords: carnitine acylcarnitine exercise exercise intensity insulin sensitivity
fontan imaging biomarkers (fib) study

Conditions: Single-ventricle; Congenital Heart Disease

Summary: the goal of the fontan imaging biomarkers (fib) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.

this study has the following research questions: 1. what is the reproducibility of ventricular systolic function measurements (including ventricular strain) in fontan patients using echocardiography (echo) and cardiac magnetic resonance imaging (cmr)? 2. what is the reproducibility of ventricular diastolic function measurements (including tissue doppler and strain rate) in fontan patients using echo and cmr? 3. is there a correlation between ventricular function measurements and circulating biomarkers (including galectin-3 levels, nt-probnp, st2, and meld-xi score)?

Eligibility criteria:
inclusion criteria: * all patients with fontan circulation undergoing clinically indicated cmr at boston children's hospital will be considered for the study exclusion criteria: * inadequate imaging quality to perform proposed analysis * patients \<15 kg will be excluded to simplify compliance with bch minimal risk research blood draw volume guidelines (minimal risk is defined as \< 5% total blood volume)

Keywords: biomarkers fontan operation single ventricle congenital heart disease
pre-sleep protein supplementation in british army recruits

Conditions: Protein-energy; Imbalance; Recovery; Body Weight

Summary: dietary protein has been shown to be important to support physical training. for occupational demands such as military training, new recruits often fail to meet the recommended protein intake during basic training (bt), with negligible amounts consumed in the evening. as such, individuals undertaking bt may require higher intakes than the general population.this study assessed the influence of a daily bolus of protein prior to sleep on performance adaptations, body composition and recovery in british army recruits.

dietary protein is crucial for optimising physical training adaptations such as muscular strength and mass, which are key aims for athletic populations, including british army recruits. new recruits fail to meet the recommended protein intake during basic training (bt), with negligible amounts consumed in the evening. this study aimed to assess the influence of a daily bolus of protein prior to sleep on performance adaptations, body composition and recovery in british army recruits. the study will recruit a mixed cohort of \>120 new recruits from the united kingdom (uk) british army who will be randomised into a dietary control (con), carbohydrate placebo (pla), moderate (20g) protein (mod) or high (60g) protein (high) supplementation group. supplements will be isocaloric and consumed daily on weekday evenings between 2000 and 2100h for 10 weeks during bt, alongside standardised dietary intake and bt activities. performance tests (mid-thigh pull, medicine ball throw, 2km run time, maximal push-up and maximal vertical jump) and body composition will be assessed at the start and end of bt under standardised conditions. dietary intake, energy expenditure, salivary hormones, urinary nitrogen balance, perceived muscle soreness, rating of perceived exertion, mood and fatigue will be assessed at the start, middle and end of bt. the underlying aim of this study is to assess whether inclusion of nocturnal protein supplementation will influence performance adaptations, body composition changes or acute recovery in british army recruits.

Eligibility criteria:
inclusion criteria: * enrolled into british army basic training * medically fit to start army training exclusion criteria: * not taking any other nutritional supplement * not currently pregnant * not dairy or lactose intolerant or have any specific dietary requirements .