Kornimate/medical-research-clean huggingface dataset:
impact of ketogenic diets in preventing relapse in obesity management

Conditions: Obesity

Summary: low-carb ketogenic diets have become extremely popular because of large weight loss in the short-term. yet their potential benefits in preventing long-term weight regain have not been assessed in large scale studies. the aim of this study is to determine the effect of a low-carbohydrate (cho) ketogenic diet, compared with an isocaloric balanced diet, on the maintenance of weight loss. the secondary aim is to investigate the impact of both diets on appetite. adults with obesity (30\<bmi\<40 kg/m2), will first undergo 4 weeks of a very-low energy diet aimed at inducing 5-10% weight loss and then will be randomized to two different weight maintenance diets for 1 year. one will be a low-cho ketogenic diet (50 g cho/day) plant-based (e.g. with less animal protein and more plant-based), and the other a diet following the norwegian health directorate recommendations. only conventional foods will be used in both diets.


Eligibility criteria:
inclusion criteria: * weight stable over the last three months (\<2 kg) * not currently dieting to lose weight * inactive lifestyle (less than 150 min of physical activity weekly. * given that some of the variables of interest have been shown to be affected by the phase of menstrual cycle in normally ovulating women, namely appetite and resting metabolic rate, only women taking oral contraceptives, with regular menstrual cycles or post-menopausal will be included in the study exclusion criteria: * pregnancy * breast-feeding * drug or alcohol abuse within the last two years * clinically significant illness including diabetes, gastrointestinal (particularly cholelithiasis), kidney (gfr \<60) or liver disease, osteoporosis (t-score \<-2.5) and osteopenia (t-score \<-1.5) * treatment with antiosteoporotic drug * depression or other psychological disorders * eating disorders * milk intolerance * current medication known to affect appetite/metabolism or induce weight loss. * a planned surgery during the study period * participating in another research study

Keywords: diet, ketogenic weight loss body weight
same-day radioembolization for large hcc

Conditions: Hepatocellular Carcinoma (HCC)

Summary: in patients who has no sign suggesting high lung shunt fraction (tips, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel), planning angiography, maa scan, and radioembolization are performed in a single day with sir-spheres. this prospective registry will prove that the selection criteria is accurate and same-day radioembolization is feasible and safe.

sir-spheres (sirtex): a mother vial containing ≥7 gbq is delivered to the hospital, and the treatment team divides it into daughter vials with specific radiation activities tailored to the target vessels. this allows for same-day tare, in which lung shunt evaluation, vessel identification, dose calculation, and microsphere injection are all conducted on the same day. this approach is referred to as same-day tare. to implement same-day tare effectively, it is crucial to carefully select patients who are expected to have a low lung shunt fraction. this helps minimize the waste of pre-ordered sir-spheres vials that would otherwise go unused. factors associated with a high lung shunt fraction include large tumor size, hepatic vein invasion, the presence of a transjugular intrahepatic portosystemic shunt (tips), and dysmorphic intratumoral vessels. in patients with tumors larger than 5 cm, the lung shunt fraction is likely to be low if there is no hepatic vein invasion, no tips, and no dysmorphic intratumoral vessels. therefore, by selecting patients without dysmorphic intratumoral vessels for same-day tare, it is possible to avoid wasting sir-spheres vials and perform the procedure without delays in treatment. furthermore, by defining safe and effective dose ranges for lung dose, tumor dose, and perfused liver dose, a standardized tare protocol can be established. through this study, we aim to establish appropriate patient selection criteria for same-day tare and to standardize tare dosimetry.

Eligibility criteria:
inclusion criteria: * hcc can be diagnosed by aasld guideline * hepatocellular carcinoma 5cm or larger * dysmorphic intratumoral vessels 3mm or smaller * child-pugh class a * ecog 0 or 1 * the following lab should be met. a. leukocytes ≥ 1,000/µl and ≤ 20,000/µl b. hemoglobin ≥ 6.0 g/dl (transfusion allowed to meet this criterion) c. total bilirubin ≤ 2.0 mg/dl d. platelet ≥ 40,000/µl e. international normalized ratio (inr) ≤ 2.0 for patients not taking anticoagulants f. aspartate transaminase (ast) ≤ 800 iu/l (i.e., ≤ 20x upper normal limit) g. alanine transaminase (alt) ≤ 800 iu/l (i.e., ≤ 20x upper normal limit) h. creatinine ≤ 2.5 mg/dl (if patient is receiving hemodialysis, no upper limit of creatinine) exclusion criteria: * hepatic vein invasion on ct/mri * hepatic vein enhancement on arterial phase of ct/mri * tips * dysmorphic intratumoral vessels \> 3mm * main portal vein invasion * significant copd or interstitial lung disease
effectiveness of fascial manipulation for chronic low back pain

Conditions: Low Back Pain

Summary: the purpose is to evaluate the effectiveness of a physiotherapy program for chronic low back pain. we'll randomize more about 35 patients in two groups. both groups will receive an 8 physioterapy intervention in 4 weeks, in particular the first group (study) will receive 4 fascial manipulation treatment combined with 4 session of a standard approach (mobilization and stretching exercises); whereas the second (control) will receive only the standard approach.

all patients were assessed and randomised by a physician. the control group intervention concerned of: relaxation of lumbar and respiration muscles, stretching for posterior muscular chain and hip flexors, assisted/active mobilization of lumbar region in sagittal plane and rotation, exercises to improve proprioception of lumbar spine, active and progressive movement of lumbar spine in anterior flexion, extension, lateroflexion and rotation, active exercise for lumbar stabilizers muscles, occupational training for activity of daily living, indications and recommendations for correct postures. the study group intervention received 4 manual intervention on deep fascial tissues, according to fascial manipulation tecnique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.

Eligibility criteria:
inclusion criteria: * patients with a chronic low back pain (more than 7 weeks) * age between 20 to 60 years old exclusion criteria: * presence of neurological red flags * continuative assumption of drugs for low back pain * no positive imaging for spine lesions (fractures, spondilolistesi, * vascular desease (aneurism abdominal aorta) * secondary lesions (oncological desease) * rheumatic systemic desease * any other neurological desease which could compromise the partecipation to the program exercise

Keywords: low back pain fascial manipulation physioterapy physical activity
anticoagulation and antiplatelet management during perioperative period

Conditions: Anticoagulants and Bleeding Disorders

Summary: the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. in some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.

the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. in some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation. the investigators want to investigate these transitions: how were they understood by patients, how were they performed, and how does this affect surgery, postoperative morbidity and mortality? anticoagulation for prevention of thromboembolic events will not be studied in this study. the anesthesia team will not be particularly trained in anticoagulants and antiplatelets management to be close to actual care. in the hospital the investigators have a guide written in 2013 in order to describe all the cases possible. the "control/ goal group" will be the patients who have undertaken strictly the protocol described for their cases in the guide.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * able to consent * taking anticoagulants or antiplatelet drugs in the long term. exclusion criteria: * incapacitated adults * minor patients
quorn in community health experiment

Conditions: Overweight and Obesity

Summary: in overweight individuals (bmi \> 27.5 kg/m2), does daily consumption of mycoprotein containing quorn food products lower blood cholesterol compared with daily meat/fish consumption?


Eligibility criteria:
inclusion criteria: * 18-70 years old * bmi \>27.5 kg/m2 * non allergic to penicillin/mycoprotein * moderate levels of physical activity or below (self-identified; ndns servey) * omnivores * not currently using cholesterol lowering medication exclusion criteria: * \ 70 years old * bmi \<27.5 kg/m2 * allergies to penicillin/mycoprotein * heavy exercisers (self idenfiied) * vegetarian/vegans * currently using cholesterol lowering medication
use of ranibizumab with mitomycin c during trabeculectomy

Conditions: Glaucoma

Summary: the purpose of the study is to study the safety of the combination of ranibizumab and mmc vs monotherapy mmc vs intravitreal ranibizumab injection in patients with glaucoma.

a common problem after undergoing trabeculectomy surgery to create a bleb (blister or bubble) to reduce intraocular pressure, is scarring of the opening. this scarring prevents fluid drainage and interferes with the proper functioning of the bleb. mmc (mitomycin c) is usually administered intraoperatively, to reduce scarring and increase filtration. however, the failure rate of trabeculectomy remains high. anti-vegf (vascular endothelial growth factor) agents have been used successfully in cases requiring bleb needling. the purpose of the study is to determine the safety of the combination of ranibizumab and mmc vs monotherapy mmc in patients with glaucoma. this is an open-label, phase i/ii safety study of 30 patients randomized to either treatment with ranibizumab 0.5 mg intravitreally injected (n=10), combination ranibizumab 0.5mg intravitreally injected and mmc (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) or mmc therapy alone (n=10). for the ranibizumab groups, a repeat injection of ranibizumab 0.5mg may be given prn (as needed) at 1 month if hypervascularity or neovascularization of the conjunctiva exists.

Eligibility criteria:
inclusion criteria: * glaucoma * undergoing trabeculectomy * 21 years of age or older exclusion criteria: * pregnancy or lactation * any condition the investigator believes would impose a significant hazard to the patient if investigational therapy were initiated * history of ocular surface disease * cataract surgery in the past 6 months * history of active inflammatory, infectious or idiopathic keratitis

Keywords: trabeculectomy glaucoma ranibizumab
cpap and glucose metabolism in non-diabetic osa subjects

Conditions: Obstructive Sleep Apnea; Pre-diabetes

Summary: the purpose of the current study is to investigate whether alleviation of osa by cpap positively impacts glucose metabolism in non-diabetic patients.

glucose metabolism in patients newly diagnosed with moderate-severe osa and without diabetes will be monitored for two weeks prior to commencement of cpap using a cgm. they will consume a 75g oral glucose drink fasted on waking twice during the two-week monitoring period, having consumed a standardised meal the evening prior. after establishing cpap use for at least four weeks they will undergo the same protocol as for the observation period prior to commencing cpap. glucose metabolism will be monitored using an interstitial (skin based) glucose monitor.

Eligibility criteria:
inclusion criteria: 1. community dwelling adult males and females aged 18-65 years 2. polysomnography confirmed moderate to severe osa with apnea hypopnea index (ahi) ≥15/hr within the past 60 months 3. able to give written informed consent 4. proficient in english 6. diagnosed non-diabetic as defined by the american diabetes association as any of the following recent (\<3 months) findings: 1. fasting glucose with a bgl \<7.0 mmol/l 2. glucose tolerance with a 2-hour bgl of \< 11.1 mmol/l after a formal 75g oral glucose tolerance test (ogtt) 3. hba1c of ≤ 6.5% 7. possession or regular access to a mobile telephone with capability to download and run the withings sleep anlayser app. exclusion criteria: 1. clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury) 2. severe mental health disorders (e.g. current major depressive disorder, schizophrenia, bipolar disorder) that in the opinion of the investigator is not adequately treated or will significantly affect their participation in the study. 3. regular (\>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants) 4. regular night shift work or travel overseas within the last 2 weeks 5. sleep physician has advised against cpap withdrawal 6. pregnancy 7. active smoking or routine alcohol use (more than 2 standard drinks a day) or excessive caffeine intake (\>300 mg a day) or recent (in the past month) use of illicit drugs 8. current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded) 9. current or recent (\<3 months) use of hypoglycaemic agents 10. undergoing a weight loss programme 11. contraindications for use of the freestyle libre pro sensor. e.g. known hypersensitivity to skin adhesives such as those used to attach the sensor to the arm.
pilot study of contrast-enhanced ultrasound of transplanted kidney

Conditions: Transplant; Failure, Kidney

Summary: to check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with pathologic results from ultrasound guided biopsy of transplanted kidney

to check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images and to verify the correlation with pathologic results from ultrasound guided biopsy of transplanted kidney. ten patients scheduled to perform ultrasound guided biopsy of transplanted kidney will be enrolled. the patients who have previous medical history of cardiac problem or who do not recover renal function over three days after graft surgery will be excluded. before ultrasound guided biopsy of transplanted kidney, we will perform conventional, sonoelastography and real-time contrast-enhanced ultrasound using sonovue for acquisition of parameters and data, respectively. we will check the possibility of the acquisition of a number of parameters through real-time contrast-enhanced ultrasound and sonoelastography images using analyzing program (vuebox, bracco, swiss). and we will verify the correlation of acquired data and parameters with pathologic results from ultrasound guided biopsy of transplanted kidney. from perfusion images, several regions of interest (rois) will be marked including main renal artery, segmental artery and renal medulla. a number of time-intensity curves (tics) are acquired from rois using vuebox. the parameters acquired from time intensity curve (tic) (i.e. arrival time, mean transit time, time to peak, basal intensity, peak intensity, area under curve, slope rate of ascending and descending curves), the date acquired from spectral doppler ultrasound (i.e. restive index, pulsatility index) and values of shear wave velocities of the several regions of interest acquired from sonoelastography will be analyzed to find statistical significance in assessment of allograft nephropathy such as acute rejection or chronic allograft nephropathy. pathologic conditions such as acute rejection may show the decrease in arrival time, peak intensity, area under curve suggesting total blood flow and accelerating slope rate, compared with non-pathologic condition.

Eligibility criteria:
inclusion criteria: * 1)patients to perform ultrasound guided biopsy of transplanted kidney exclusion criteria: * 1)patients to have the medical histories of heart such as acute failure, arrhythmia, ischemia, infarction and angioplasty 2)patients to show poor graft function which does not recovery within three days after transplantation

Keywords: ultrasound perfusion imaging elasticity imaging techniques kidney transplantation graft rejection chronic allograft nephropathy
study of adjuvant topotecan and cisplatin with concurrent radiation therapy for advanced cervical cancer

Conditions: Cervical Cancer

Summary: a phase i study of adjuvant topotecan and cisplatin with concurrent radiation therapy for advanced cervical cancer.

examines the effects of topotecan and cisplatin with radiation for advanced cervical cancer

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed advanced cervical carcinoma who, following optional surgical staging, are not deemed to be curable by either surgery or radiotherapy alone. this includes patients with stages iib, iiia, iiib or iva and stages ib or iia who in addition have one of the following risk factors: * primary tumor \> 6 cm * positive pelvic and/or para-aortic lymph nodes (resected or unresected) * positive surgical margins * depth of invasion greater than 50 % and positive capillary-lymphatic space involvement * eligible cell types include squamous, adenosquamous and adenocarcinoma of the cervix * patients may have measurable disease (defined as lesions which can be measured in at least two (2) dimensions by physical examination or any medical imaging technique). inability to measure disease will not constitute exclusion criteria. * patients with gog performance status of 0, 1, or 2. * patients will have recovered from the effects of recent surgery and should be free of clinically significant infection. * patients must have adequate: * bone marrow function: wbc greater than or equal to 3,000 cells/mm3, platelet count greater than or equal to 100,000 cells/mm3, and granulocyte count greater than or equal to 1,500 cells/mm3. * renal function: creatinine less than or equal to 2.0 mg/dl. * hepatic function: bilirubin less than or equal to 1.5 x institutional normal, sgot and alkaline phosphatase less than or equal to 3 x institutional normal. * patients must have signed an approved informed consent. * patients have met the pre-entry requirements specified in section 7.0 exclusion criteria: * patients with gog performance of 3 or 4. * patients with another malignancy, prior or concomitant, other than skin (excluding melanoma). * patients with septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction. * patients with anatomic abnormalities requiring modification of radiation fields (pelvic kidney, renal transplant, etc.). * patient with recurrent cervical cancer * patients who have received prior pelvic radiation * pregnant women and women of childbearing potential not using an effective form of contraception. * history of thrombus (10/28/02) * history of unstable angina or mi within the past six months. patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months. (10/28/02)

Keywords: cancer cervix
west philadelphia consortium randomized control trial

Conditions: Cancer; Cardiovascular Disease (CVD)

Summary: the investigators will evaluate the effects of an integrated risk counseling program on behavioral and psychological outcomes in african american men and women in a randomized trial that is implemented and evaluated collaboratively through the west philadelphia consortium to address disparities. the specific aims of this research are as follows: 1. to evaluate the effects of integrated versus disease specific counseling on risk exposure behaviors. the investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater intake of fruits and vegetables and increased rates of physical activity. 2. to evaluate effects of integrated versus disease specific counseling on psychological outcomes. the investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater risk comprehension related to cancer and cardiovascular disease and will be more motivated to make behavioral changes. 3. to identify the mechanisms through which integrated risk counseling leads to behavioral change. the investigators predict that changes in risk exposure behaviors (e.g., diet and physical activity) will be mediated by increased risk comprehension and self-efficacy for diet and physical activity.


Eligibility criteria:
inclusion criteria: * african american * age 18-75 * resident of philadelphia exclusion criteria: * previous or current cancer diagnosis * previous or current diagnosis of a cvd * cognitive disorder

Keywords: cancer cvd african american health education intervention intervention rct study focus is to examine the influence of health education regarding either cvd or cvd and cancer on health behaviors.
comparison atomoxetine hydrochloride and comparator in pediatric outpatients with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of the study is to compare atomoxetine hydrochloride and methylphenidate hydrochloride in pediatric patients with adhd.


Eligibility criteria:
inclusion criteria: * be at least 6 years of age and not more than 16 years of age at visit 1 * must meet dsm-iv criteria for adhd * must be of normal intelligence (that is, without a general impairment of intelligence and likely, in the investigator's judgement, to achieve a score of greater than or equal to 70 on an iq test) * must be able to swallow capsules * must have laboratory results that show no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation) exclusion criteria: * weigh less than 20 kg or more than 60 kg at study entry * have a history of bipolar i or ii disorder, psychosis, or pervasive developmental disorder * meet dsm-iv criteria for an anxiety disorder * have a history of any seizure disorder (other than febrile seizures)or prior ecg abnormalities related to epilepsy, or subjects who have taken or are currently taking anti-convulsants for seizure control * have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions,including a hypersensitivity to methylphenidate