Kornimate/medical-research-clean huggingface dataset:
does dairy benefit bone & body composition in overweight girls undergoing a weight management program?

Conditions: Overweight; Obesity; Children

Summary: the purpose of this study is to examine whether increased dairy intake, at the level recommended by canada's food guide, combined with healthy eating and exercise, will improve body composition and bone turnover over 12 weeks in overweight and obese girls.

three groups will participate in this study. participants must be low dairy consumers (0-1 svgs/d) and do little to no structured physical activity at study entry. each participant will be assigned to a group; one of two experimental groups or a control group. the two intervention groups will differ only in the amount of dairy consumed (4 svgs vs. 0-1 svg/d). both will undergo the same exercise program (3x/wk) and will be counseled on healthy eating by a trained nutritionist-dietitian every month. the control group will be tested at the beginning and end of the study to help account for any growth-related changes during the study but will not receive any formal intervention. in each group, the investigators will assess body composition (muscle mass, fat mass, % body fat and regional fat mass) and bone (bone turnover markers). the investigators will also measure various metabolic and inflammatory markers, hormones as well as dietary intake, strength and fitness. this study will determine whether increased intake of dairy products improve bone and body composition during a 12-week weight management intervention. the investigators expect the two groups participating in the intervention to show significant changes in body weight and body composition and greater gains in fitness compared to the control group. the investigators expect those consuming dairy to show greater improvements in body composition and bone health compared to those not consuming added dairy. the investigators also anticipate better vitamin d status and less whole-body inflammation in those consuming dairy. both intervention groups should show improvements in fasting insulin, glucose and cholesterol.

Eligibility criteria:
inclusion criteria: * at or above the age appropriate cut-offs for overweight (ow) or obese (ob) on who growth charts: ≥85-97% for ow and \>97% for ob for bmi * between 10 and 18 years old * menarcheal * low dairy consumers (0-2 svgs/d and \<700 mg ca/d measured by baseline ffq) * otherwise healthy (i.e. no diagnosed disease or illness) * lower levels of physical activity (0-2 times/week) * no allergy to dairy foods or diagnosed lactose intolerance * not on medications related to a chronic condition or that affect bone health participants will be excluded from participation in the study if they do not meet one or more of the above inclusion criteria.

Keywords: bone health body composition dairy foods exercise inflammation nutrition intervention weight management
derazantinib and atezolizumab in patients with urothelial cancer

Conditions: Urothelial Carcinoma

Summary: the purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (fgfr) genetic aberrations (ga) of various clinical stages of disease progression and prior treatments.

the study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring fgfr ga (with the exception of substudy 2 which did not require a fgfr ga) who were treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. the study enrolled patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with fgfr inhibitors.

Eligibility criteria:
inclusion criteria: * histologically-confirmed transitional cell carcinoma of the urothelium of the upper or lower urinary tract * recurrent or progressing stage iv disease, or surgically unresectable, recurrent or progressing disease * documented central fgfr genetic aberration (fgfr1, fgfr2, or fgfr3 mutations / short variants and rearrangements / fusions) (note; substudy 2 started with patients requiring an fgfr ga, but this requirement was removed from the protocol later on) * measurable disease, as defined by the investigator using response evaluation criteria in solid tumors (recist) 1.1 criteria * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * adequate organ functions as indicated by screening visit local laboratory values exclusion criteria: * receipt of prior cancer treatment within specific interval periods * concurrent evidence of any clinically significant corneal or retinal disorder * history of clinically significant cardiac disorders * known cns metastases * concurrent uncontrolled or active infection with human immunodeficiency virus * active hepatitis b or chronic hepatitis b without current antiviral therapy * active hepatitis c * active tuberculosis * severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or iv medication at the time of first dose of study drug administration

Keywords: metastatic urothelial cancer bladder cancer fibroblast growth factor receptor fgfr genetic aberration targeted therapy derazantinib checkpoint inhibitor immune checkpoint blockade atezolizumab tecentriq solid tumor
prostatic artery embolization vs. conventional transurethral prostatectomy in the treatment of benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: benign prostatic hyperplasia (bph) is a prevalent entity, affecting over 50% of men older than 60 years. the clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. medical therapy is usually the first-line treatment. however, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration. in cases with moderate to severe lower urinary tract symptoms (luts) transurethral resection of the prostate (tur-p) is the standard treatment. turp, however, is limited to prostates smaller than 60-80ml and the procedure is associated with a complication rate. the cumulative short-term morbidity rate is around 11% and the necessity for surgical revision is as high as 6%. bleeding requiring transfusions and transurethral resection syndrome represent potentially serious threats to elderly and frail patients. prostatic artery embolization (pae) has been suggested as a minimal invasive alternative procedure, which can be performed in an outpatient setting with rapid recovery and low morbidity. the investigators hypothesize that pae is non-inferior in the treatment of symptomatic bph compared to conventional and established tur-p.


Eligibility criteria:
inclusion criteria: * men older than 40 * patient must be a candidate for turp * refractory to medical therapy or patient is not willing to consider (further) medical treatment * patient has a prostate size of at least 25 ml and not more than 80 ml, measured by ultrasound * ipss ≥8 * qol ≥3 * qmax\<12 and/or urinary retention * written informed consent exclusion criteria: * mild symptoms (ipss \<8) * severe atherosclerosis * severe tortuosity in the aortic bifurcation or internal iliac arteries * acontractile detrusor * neurogenic lower urinary tract dysfunction * urethral stenosis * bladder diverticulum * bladder stone with surgical indication * allergy to intravenous contrast media * contraindication for mri imaging * preinterventionally proven adenocarcinoma of the prostate * renal failure (gfr\<60ml/min)
post marketing surveillance study of biphasic insulin aspart 30

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.


Eligibility criteria:
inclusion criteria: * subjects with diabetes who did not have indications that are contraindicated in the product insert
alveolar ridge preservation techniques after tooth extraction

Conditions: Alveolar Bone Loss

Summary: the aim of the present randomized controlled trial (rct) was to evaluate the efficacy of different alveolar ridge preservation (arp) techniques on hard tissue dimensional alterations after tooth extraction, based on clinical measurements.

thrirty-six patients were randomly assigned in four treatment groups: a) freeze-dried bone allograft (fdba) covered with collagen sponge (cs), b) fdba covered with free gingival graft (fgg), c) demineralized bovine bone mineral xenograft (dbbm) covered with fgg and d) fgg without socket grafting. clinical measurements were performed immediately after tooth extraction and 4 months later. the related outcomes pertained to both vertical and horizontal assessment of bone loss

Eligibility criteria:
inclusion criteria: * systematically healthy patients * non-smokers * no use of antibiotics for the last 3 months * presence of a non-restorable single-rooted tooth in the maxilla. exclusion criteria: * patients were excluded when a bony wall loss of more than 50% was verified for the socket after the extraction
effect of simvastatin versus calcium hydroxide intracanal medications on post-operative pain and interleukin 6 and 8

Conditions: Periapical Periodontitis

Summary: comparing the effect of simvastatin versus calcium hydroxide used as an intracanal medicament on post-operative pain and total amount of il-6 and il-8 in periapical fluids of lower premolars in patients with symptomatic apical periodontitis:

lower premolars with symptomatic apical periodontitis will be selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using simvastatin or calcium hydroxide intracanal medication for 1 week. the endodontic treatment will be completed in two visits. postoperative pain will be assessed using the numerical rating scale at 6, 12, 24, 48 hours post-instrumentation and at 6, 12, 24, 48 hours post-obturation. periapical fluid sample will be collected immediately post-instrumentation and 1 week later pre-obturation. the periapical samples will be analyzed for total amounts of il-6 and il-8.

Eligibility criteria:
inclusion criteria: * patients who are free from any physical or mental handicapping condition with no underlying systemic disease. * lower single rooted premolars: * presence of pain with percussion. * widening in the periodontal membrane space or with small sized periapical radiolucency. * diagnosed clinically with symptomatic apical periodontitis. * patients' acceptance to participate in the trial. * patients who can understand pain scale and can sign the informed consent exclusion criteria: * medically compromised patients * pregnant women * patients who are allergic to non-steroidal anti-inflammatory drugs. * patients with two or more adjacent teeth requiring root canal therapy * if analgesics or antibiotics have been administrated by the patient during the past two weeks preoperatively. * patients reporting bruxism or clenching. * teeth associated with acute periapical abscess, swelling or a fistulous tract. * greater than grade i mobility or pocket depth greater than 5mm. * non restorable teeth. * immature teeth. * teeth with previous endodontic treatment. * radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
late clinical events associated with covid-19 infection

Conditions: Covid19

Summary: several publications document the occurrence of symptoms that persist or occur late. the identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of covid-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients. since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.

several publications document the occurrence of symptoms that persist or occur late, more than 3 weeks after the first clinical manifestations of an sars-cov2 infection. these manifestations may be related to thromboembolic or inflammatory complications, superinfections, or other mechanisms not yet well understood, including potentially related to the persistence of sars-cov2. the identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of covid-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients. since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed. in parallel, the prevalence of the main symptoms observed more than 3 weeks after the onset of a covid-19 will be estimated through partnerships with existing cohort studies in the general population or in the population followed for covid-19, still symptomatic or not at 3 weeks of infection. longitudinal implementation of bio-libraries will allow this cohort to also constitute a bridge between clinicians and researchers.

Eligibility criteria:
inclusion criteria: * history of symptomatic cov-2-sars infection as defined by : o positive rt-pcr sars-cov-2 rt-pcr result or positive sars-cov-2 serology o associated with at least one event : x anosmia occurring after february 2020 x or covid 19 evocative scanner x or ≥ 2 contemporary symptoms of the virological sample from: asthenia, cough, dyspnea, fever, myalgia, dysgeusia, diarrhea and not present prior to diagnosis * and persistence of at least one symptom present in the first 3 weeks of a covid-19, more than 8 weeks away from the first symptoms of covid-19. or late onset of at least one new symptom a minimum of 3 weeks and a maximum of 6 months after the first symptoms of a cov-2 sars infection. * first symptoms less than 6 months old on the day of inclusion * to benefit from a state health insurance or medical aid plan * have signed an informed consent for inclusion. exclusion criteria: * minor patient * patient under protection of justice * patient who required intensive care management : * more than 5 days * or requiring orotracheal intubation * or having required high flow ventilation (optiflow)
safety study of clinical cell transplant therapy using hearticellgram-ami for patients with acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to evaluate the safety of the previously conducted clinical trial cell transplant therapy using hearticellgram-ami for patients with acute myocardial infarction. this is a follow-up observational study and targeting the subjects who participated in the previously conducted clinical trial.

the safety evaluation in this clinical trial is performed with variables, such as occurrence and severity of adverse events, clinical laboratory tests, vital signs, physical examination, cardiac events, and cancer.

Eligibility criteria:
inclusion criteria: * patients who have elapsed for more than 2 years after onset of acute myocardial infarction among the patients who had received cell transplant therapy or drug treatment at least once in test and control group on the previously conducted clinical trial. * subjects agreed to participate in this follow-up study and signed the consent form. exclusion criteria: * n/a
assessment of effects on ovarian activity of a combined oral contraceptive pill when preceded by the intake of ellaone® or placebo.

Conditions: Emergency Contraception

Summary: the purposes of this study are to compare the effects on ovarian activity of quick starting a combined oral contraceptive pill (cocp) after ellaone® or placebo intake.


Eligibility criteria:
inclusion criteria: * healthy women aged 18-35 years old * bmi \< 30 kg/m2 * not at risk of pregnancy * no use of progesterone-only-pill for 3 months before start of treatment cycle * no use of implant hormonal contraception for 3 months before start of treatment cycle * no use of levonorgestrel intrauterine system for 3 months before start of treatment cycle * no use of depo provera for 12 months before start of treatment cycle * able to give informed consent.

Keywords: ella ellaone quickstart contraception combined oral pill microgynon
apotransferrin in patients with β-thalassemia

Conditions: β-thalassemia Intermedia

Summary: the aim of the trial is to study the effect of apotransferrin administration in patients suffering from β-thalassemia intermedia in order to restore the erythropoiesis as reflected by enhanced haemoglobin levels or reduced transfusion dependency.


Eligibility criteria:
inclusion criteria: * non-transfusion dependent β-thalassemia intermedia, defined as patients with microcytic anaemia in combination with an elevated hba2 (\>2.5%) and a haemoglobin of \<6.2 mmol/l, or transfusion dependent β-thalassemia treated with a regular transfusion schedule. * age above≥ 17 years. * adequate renal and hepatic function tests * who performance 0, 1 or 2. * signed informed consent. exclusion criteria: * known with allergic reactions against human plasma or plasma products. * concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease). * cardiac dysfunction as defined by: myocardial infarction within the last 6 months of study entry, unstable angina, or unstable cardiac arrhythmias. * pregnant or lactating females. * known with iga deficiency with anti-iga antibodies
predicting radiological extranodal extension in oropharyngeal carcinoma patients using ai

Conditions: Head and Neck Carcinoma

Summary: development and validation of a model that predicts rene from radiological imaging using annotated / labeled scans by means of deep learning

oropharyngeal squamous cell carcinoma (opscc) is a rare cancer (incidence \~700 per year in the netherlands), originating in the middle part of the throat. in opscc, nodal status is an important prognostic factor for survival. in the clinical tnm (tumor node metastases) system, nodal status is mainly defined by the size, number and laterality of nodal metastases. in surgically treated patients the pathological tnm classification includes the presence of pathological extranodal extension (pene). pene is a predictor for poor outcome and also an indication for the addition of chemotherapy to postoperative radiation. however, most patients with opscc are treated non-surgically by means of radiation or chemoradiation and thus information about pene is lacking. recently, extranodal extension on diagnostic imaging has been associated with prognosis in opscc patients. it is anticipated that in the near future radiological ene (rene) may be included in the ctnm classification system for refinement of outcome prediction in patients with nodal disease. the diagnosis of rene on radiological imaging is new and not trivial and we hypothesize that artificial intelligence (ai) may support the radiologist in detecting rene. in this study we aim to develop and validate a model that predicts rene from radiological imaging using annotated / labeled scans by means of deep learning

Eligibility criteria:
inclusion criteria: * non-metastatic (m0) node-positive hpv+ and hpv- oropharyngeal carcinoma * treated between 2008 to 2019 * curative intent * radiation only or concurrent chemoradiation * modern treatment modality: imrt / vmat * diagnostic/staging image scanning protocols available (contrast-enhanced ct with 2-3 mm slice thickness and/or mr with 3 mm slice thickness) exclusion criteria: * removal of lymph node (ln) (excisional biopsy or neck dissection \[nd\]) prior to staging ct/mr scan * no available imaging within 2 months prior to radiotherapy (rt)"
evaluation of protease inhibition for covid-19 in standard-risk patients (epic-sr).

Conditions: COVID-19

Summary: the primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted covid-19 signs and symptoms through day 28 between pf-07321332/ritonavir and placebo.

throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or at another non-clinic location, if available. the total study duration is up to 24 weeks.

Eligibility criteria:
inclusion criteria: * confirmed sars-cov-2 infection 5 days prior to randomization * initial onset of covid-19 signs/symptoms within 5 days of randomization * fertile participants must agree to use a highly effective method of contraception exclusion criteria: * has at least one underlying medical condition associated with an increased risk of developing severe illness from covid-19 * history of or need for hospitalization for the medical treatment of covid-19 * prior diagnosis of sars-cov-2 infection (reinfection) * known medical history of liver disease * receiving dialysis or have known renal impairment * known human immunodeficiency virus (hiv) infection with viral load \> 400 copies/ml or taking prohibited medications for hiv treatment * suspected or confirmed concurrent active systemic infection other than covid-19 * current or expected use of any medications or substances that are highly dependent on cytochrome p450 3a4 (cyp3a4) for clearance or are strong inducers of cyp3a4 * has received or is expected to receive monoclonal antibody treatment or convalescent covid-19 plasma * has received any sars-cov-2 vaccine within 12 months of screening * participating in another interventional clinical study with an investigational compound or device, including those for covid-19 * known prior participation in this trial or other trial involving pf-07321332 * oxygen saturation of \< 92% on room air * females who are pregnant or breastfeeding

Keywords: sars-cov-2 infection
musculoskeletal injuries' prediction tool for military combatants in the israeli defense force

Conditions: Cumulative Trauma Disorders

Summary: emerging evidences indicate that performance on a variety of functional movement screens can identify athletes/soldiers at risk for injury. these field expedient tests have not been validated in a military setting or across different military occupational specialties. in this prospective study the investigators plan to screen 300 combatants for a 1-year time frame in order to validate the suggested algorithm of a list of modifiable and non-modifiable risk factors which are hypothesized to predict injury risk during the military service.

injury data will be collected through physician exam, self-report, profile data, and healthcare utilization data. injury data will be collected at baseline and for six iterations, every 60 days, over the course of one year following baseline. based on the data collected, clinical prediction rules will be used to develop computerized algorithm to predict injury risk in these populations. moreover, these results will assist in creating individualized preventing physical training program.

Eligibility criteria:
inclusion criteria: * ages 18-21 years old * a combat medical profile according the idf medical corp regulations * hebrew speaking and reading. exclusion criteria: * currently seeking medical care for musculoskeletal injuries or has sought medical care for musculoskeletal injury in the last 30 days. * currently unable to participate in routine physical training due to injury in foot, ankle, knee, hip, neck, shoulder, elbow, wrist, or hand injury. * cardiac or pulmonary problems limiting physical activity. * known history of balance or visual impairment, neurological disorders, or chronic musculoskeletal conditions precluding their involvement in military training, physical training, or sports. * pregnancy, subjects that become pregnant during the course of the study will be excluded based on the different injury risk factors that are associated with musculoskeletal injury during pregnancy.

Keywords: fms functional movement screen