Kornimate/medical-research-clean huggingface dataset:
effect of differently fed farmed gilthead sea bream consumption

Conditions: Cardiometabolic Health

Summary: the trial was a double-blind randomized dietary intervention study with a 1:1 allocation ratio, conducted in accordance with the declaration of helsinki. this study compared two treatments, i.e., farmed fish fed with olive pomace enriched diet (enriched fish; ef) versus farmed fish fed with fish oil diet (conventional fish; cf), using a crossover design. the study lasted 22 weeks; treatment period one (8 weeks, mid-january-end of march), washout period (6 weeks), and treatment period two (8 weeks, mid-may-end of july). the participants were equally distributed to the two treatments along treatment periods. eligible subjects were all adults aged between 30 and 65 years old with a body mass index (bmi) between 24.0 and 31.0 kg/m2 who met the eligibility criteria for habitual fish consumption (\<150 g of cooked fish per week). exclusion criteria were pregnancy, current or recent weight loss effort, use of dietary supplements and being under treatment for any medical disorder. subjects were allowed to use medical treatment for thyroid gland disorders, iron or folic acid supplements, contraceptives or hormone replacement therapy (hrt) for women, provided they would continue receiving their medication throughout the study. the aim of the study was to evaluate the effects of consumption of fillets from differently fed farmed gilthead sea bream on markers of cardiometabolic health such as platelet aggregation, circulating haemostatic markers, markers of inflammation and oxidative stress.


Eligibility criteria:
inclusion criteria: * age 30-65 years old * body mass index between 24-31 kg/m\^2 * habitual fish consumption: \<150 g of cooked fish per week exclusion criteria: * pregnancy * current or recent weight loss effort * use of dietary supplements * being under treatment for any medical disorder

Keywords: fish sea bream dietary intervention olive oil platelet aggregation thrombosis inflammation cardioprotection
diabetic gastroparesis study 05

Conditions: Gastroparesis

Summary: this open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the rlm-md-03 \[nct03420781\] or rlm-md-04 \[nct03383146\] study and to provide treatment for these participants until relamorelin becomes commercially available or the sponsor terminates development.


Eligibility criteria:
inclusion criteria: * successful completion of either study rlm-md-03 or study rlm-md-04 * ability to provide written informed consent (ic) prior to any study procedures and willingness and ability to comply with study procedures * demonstration of adequate compliance with the study procedures in study rlm-md-03 or rlm-md-04, in the opinion of the investigator. exclusion criteria: * participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during study 3071-305-020 * participant has an unresolved adverse event (ae) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ecg) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study * any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease * females who are pregnant, nursing, or planning a pregnancy during the study.

Keywords: diabetic gastroparesis
resting metabolic rate in chronic bed-ridden patients

Conditions: Chronic Disease

Summary: research objective: to measure resting metabolic rate (ree) in long term, bed ridden, chronically ill patients and to compare their measured energy needs to standard ree equations

are standard ree equations suitable for estimating resting metabolic rate in long term, bed ridden, chronically ill patients? research objective: to measure resting metabolic rate (ree) in long term, bed ridden, chronically ill patients and to compare their measured energy needs to standard ree equations

Eligibility criteria:
inclusion criteria: * age (years): 18-30, 31-60, 61-74, 75-100 * confinement to bed at least for a year exclusion criteria: * mechanical ventilation * tracheostomy

Keywords: resting metabolic rate bed ridden, vegetative low conscious minimal conscious state immobilized resting energy expenditure
study of individualized selection of chemotherapy in patients with advanced pancreatic carcinoma according to therapeutic targets

Conditions: Advanced Pancreatic Carcinoma

Summary: the purpose of this study is to determine the proportion of patients alive after 12 months of the beginning of the trial in patients with advanced pancreatic carcinoma individually selected and grouped according to the expression in tumor tissue for therapeutic targets.

phase ii, open two branches, in which conventional treatment is administered to patients diagnosed with metastatic pancreatic carcinoma. patients will be randomized (1:1) to a treatment arm or control arm of experimental treatment guided by the therapeutic targets. patients in the control treatment arm will be treated with any of the schemes used in the study according to the discretion of the physician responsible. patients will be analyzed as "intention to treat." in the experimental treatment arm (therapeutic targets) and within 15 days will determine the markers of therapeutic targets detailed in the protocol, either from pre-existing tumor sample or a fresh sample obtained by biopsy. based on the results of this analysis, we prescribe a chemotherapy treatment determined for possible treatments currently used in pancreatic carcinoma, gemcitabine, gemcitabine and capecitabine, gemcitabine and erlotinib, folfirinox, folfox, folfiri. treatment duration is indefinite .

Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of pancreatic carcinoma. * patients\> 18 years. * measurable or not measurable disease. * life expectancy\> 3 months at the discretion of the investigator. * good general condition determined by the ecog scale (score 0-1) * candidate for first-line systemic chemotherapy according to standard practice. * availability of tumor tissue or opportunity for tumor biopsy for the - determination of biomarkers and their correlation with treatment. * adequate hematologic function: anc\> 1.5 x 103 / l, absolute count of platelets\> 100 x 109 / l, normal values of inr and ptt. * adequate liver function: total serum bilirubin \<2 mg / dl, alt and ast \<3 times the upper limit established by the laboratory (lsr) or \<5 lsr in patients with liver metastases. * adequate renal function: serum creatinine \<1.5 lsr. exclusion criteria: * patients who have received prior chemotherapy for advanced pancreatic carcinoma. will not result excluding patients who had previously received adjuvant treatment with gemcitabine or fluoropyrimidines. also not will be excluded patients who had previously received preoperative neoadjuvant treatment for localized disease with chemotherapy and / or radiotherapy. * patients for whom is contraindicated the administration of either drug used in first-line treatment for pancreatic cancer: gemcitabine, 5'fluouracilo, leucovorin, capecitabine, oxaliplatin, irinotecan, erlotinib. * pregnant or breastfeeding women

Keywords: therapeutic targets in pancreas
a combination study of rucaparib and atezolizumab in participants with advanced gynecologic cancers and triple-negative breast cancer

Conditions: Gynecologic Neoplasms

Summary: this is a phase ib, open-label, non-randomized study in patients with previously treated advanced ovarian or endometrial cancer (part 1) and platinum-sensitive ovarian cancer or triple-negative breast cancer (tnbc) (part 2) to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of rucaparib in combination with atezolizumab. the study is conducted in 2 parts: a dose-finding phase (part 1) and a dose-expansion phase (part 2)


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * a life expectancy of at least 3 months * have disease that is measurable as according to recist v1.1 * have sufficient archival formalin-fixed paraffin-embedded (ffpe) tumor tissue available for planned analyses * for part 1, have a histologically confirmed diagnosis of ovarian or endometrial cancer, and have received at least one line of prior therapy for metastatic disease * for part 2 only, have disease that can be safely biopsied * for part 2 only, have a deleterious germline or somatic breast cancer susceptibility gene 1 (brca1) or brca2 mutation or tumors that are wild-type brca but show high levels of loss of heterozygosity (loh) (tbrcawt/lohhigh) signature * for part 2 cohort 1 (ovarian cancer), high-grade serous or grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (ppc) * for part 2 cohort 1, have received at least one and no more than two lines of prior platinum-containing therapy and progressed after the most recent platinum therapy in a platinum-sensitive timeframe * for part 2 only, cohort 1, have a ca125 measurement that is greater than 2 times the upper limit of normal (uln) * for part 2 cohort 2 (tnbc), metastatic, histologically confirmed estrogen receptor (er)-negative, progesterone receptor-negative, and her2-negative adenocarcinoma of the breast per local laboratory assessment * for part 2 cohort 2, radiologic/objective evidence of recurrence or disease progression after one line of chemotherapy for tnbc in the metastatic setting * have adequate organ function exclusion criteria: * history of prior malignancy except a) curatively treated non-melanoma skin cancer, b) solid tumor treated curatively more than 3 years ago without evidence of recurrence, c) for cohort 1 (ovarian cancer): breast cancer with no evidence of disease or inactive for at least 3 years, and d) synchronous endometrial cancer (stage 1a) with ovarian cancer * treatment with chemotherapy, radiation, hormones (except corticosteroids and megestrol acetate), or other anticancer therapies less than or equal to (\<=) 14 days prior to first dose of study treatment * preexisting duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib * symptomatic and/or untreated central nervous system metastases * prior treatment with any poly adenosine diphosphate-ribose polymerase (parp) inhibitor
a prospective, clinical investigation of the vanguard 360 revision knee

Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Post Traumatic Deformity; Complications; Arthroplasty; Deformity of Limb

Summary: the purpose of this study is to evaluate performance of the vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

this investigation is being conducted on a new complete revision knee system, vanguard 360, which incorporates: * fixed bearing knee - vanguard ssk360 with ps bearing and psc bearing * fixed bearing knee - vanguard ssk360 tinbn femur with ps bearing and psc bearing * mobile bearing knee - vanguard da360 (only being collected in europe) the purpose of this study is to evaluate performance of the vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship. the efficacy and performance of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured pre-operatively and post-operatively. secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates. surgical techniques and patient care are to be standard for the surgeon participating in the protocol. there will be no experimental or investigational devices used. there will be no experimental or investigational surgical techniques used. the devices and products will be used in accordance with their instructions for use and/or approved labeling.

Eligibility criteria:
inclusion criteria: * painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * correction of varus, valgus or post-traumatic deformity * correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure * ability and willingness of the patient to attend follow-up visit. * willing to give written informed consent * patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity. exclusion criteria: * infection * sepsis * osteomyelitis relative contraindications: * an uncooperative patient or a patient with neurologic disorders who is incapable of following directions * osteoporosis * metabolic disorders which may impair brain function * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, neuromuscular disease * incomplete or deficient soft tissue surrounding the knee additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.

Keywords: revision surgery
can birthly, an online childbirth education platform, reduce pregnancy-related anxiety compared to usual care

Conditions: Pregnancy, High Risk

Summary: a pilot randomized, controlled trial comparing birthly, (an online platform for live group prenatal classes taught by childbirth educators, nurses, and lactation consultants) plus standard prenatal care versus standard prenatal care alone among women with high risk pregnancies.


Eligibility criteria:
inclusion criteria: * women over 18 * willing and stable to give consent * english-speaking * have access to high-speed internet available on a computer or mobile device * nulliparous women have a confirmed single, live intrauterine gestation and are \<20 weeks gestational age at their prenatal visit * women without indications for a scheduled cesarean delivery at the time of their index prenatal visit * women who have a high-risk pregnancy, as defined by all maternal conditions including hypertension, diabetes, auto-immune disorders, seizure disorder, substance use, etc * agree to participation in birthly * obtaining prenatal care in the university of pennsylvania health system exclusion criteria: * women who do not speak at least conversational english * women without internet access * multiparous women * women receiving group prenatal care
combining tsdcs and exoskeleton gait training on spinal excitability in sci

Conditions: Spinal Cord Injury

Summary: the purpose of the study is to determine whether transcutaneous spinal direct current stimulation (tsdcs) is safe for individuals with spinal cord injury (sci). tsdcs is an electrical current applied to the skin. the plan is to also study the potential neurophysiological changes (changes in speed and excitability of the nerves) and functional improvements in gait (for example, gait quality, speed and walking distance) for individuals with sci after combined application of tsdcs and exoskeleton assisted gait training.

subjects will participate in two baseline visits, 4 days apart. each baseline visit will last 1 hour and will include assessment of soleus h-reflex and 10 meter walk test on arrival and 40 minutes after the initial assessment. subjects will be asked to minimize their activity between assessments by either sitting in a chair or lying on a mat. each training visit will involve either an exoskeleton intervention or a combined exoskeleton and tsdcs intervention. each training visit will include assessment of soleus h-reflex and 10 meter walk test before and after the exoskeleton intervention or before and after the combined exoskeleton and tsdcs intervention.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female * ≥18 years of age * able to achieve adequate fit within exoskeleton * diagnosis of spinal cord injury (sci), t10 level and above (t11 and 12 may participate if no clinical signs of lower motor neuron lesion present) * minimum of 6 months post injury * sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit * weight \<220 pounds * intact skin on all surfaces in contact with device and load bearing surfaces * ability to perform informed consent exclusion criteria: * pregnancy * spinal instability * unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs * presence of peripheral neuropathy or any pathology that could influence reflex excitability * diagnosis of other neurological injury other than sci such as stroke/cerebrovascular accident (cva), multiple sclerosis (ms), acquired brain injury (abi), cerebral palsy (cp) * uncontrolled spasticity (≥3 on modified ashworth scale) * colostomy * decreased range of motion or contractures in legs (\>10° at hips, knees or ankles) * uncontrolled autonomic dysreflexia * unresolved deep vein thrombosis * inability to tolerate standing due to cardiovascular issues or orthostatic hypotension * severe comorbidities: active infections, heart, lung, or circulatory conditions * pressure sores, impaired skin integrity * use of mechanical ventilation for respiratory support * presence of any of the following contraindications to electrical stimulation: cardiac pacemaker, deep brain stimulator, or evidence of cancerous (malignant) tissue * presence of metal in thoracic spine or region of electrode placement
improving informed consent process for trauma patients in the emergency department

Conditions: Trauma; Surgery

Summary: this study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing trauma patients in emergency department (ed) about risks, benefits, and alternatives to receiving surgery.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * scheduled to receive the surgery exclusion criteria: * clinically unstable * refuse to participate * unable to understand the consent process for this study

Keywords: trauma surgery informed consent
mace and pe in elective primary tka & tha

Conditions: Cardiovascular Complication; Pulmonary Embolism; Stroke; Transient Ischemic Attack; Death

Summary: this study ought to identify the occurence of the major adverse cardiovascular events (mace) and the pumonary emoblism (pe) in patients undergoing elective primary tha \& tka

the study included 220 consecutive patients undergoing elective primary tha \& tka from january 2018 to december 2018. the occcurence of major adverse cardiovascular events (mace) and the pumonary emoblism (pe) were recorder. under the term mace the following were included; non fatal cardiac arrest acute myocardial infraction congestive cardiac failure cardiac arrhythmia agnina stroke cardiovascular death cerebrovascular death

Eligibility criteria:
inclusion criteria: * all consecutive patients age 18 years or older, with a diagnosis of primary osteoarthritis of the hip or knee, who underwent elective, primary, unilateral tka or tha. exclusion criteria: * previous tka or tha within 3 months * revision surgery * surgical procedures related to a previous complication * asa ps iv * recent history (6 months) of unstable acute coronary syndrome or decompensated heart failure

Keywords: total joint arthroplasty total hip arthroplasty total knee arthroplasty major adverse cardiovascular events pulmonary embolism
periapical bone healing after apicectomy with and without retrograde root filling

Conditions: Stomatognathic Disease; Mouth Disease; Periapical Disease; Alveolar Bone Loss

Summary: ph.d project: periapical bone healing after apicectomy with and without retrograde root filling. the aim of this study is to assess periapical bone healing after apicectomy without a filling and apicectomy combined with a retrograde filling material, mta. further, we will estimate risk factors in non-healing cases. study hypothesis: there is no difference in treatment outcome between: periapical bone healing after apicectomy with retrograde root filling and periapical bone healing after apicectomy without retrograde root filling

ph.d project: periapical bone healing after apicectomy with and without retrograde root filling. 60 patients have been selected from a group of 490 patients, who had a full mouth radiographic status taken in connection with a population study of apical periodontitis in aarhus community. the selection criteria for the 60 patients were patients with a persisting apical periodontitis, periapical index (pai) score 3-5, on front teeth and premolars in the upper jaw. the orthograde root filling in the tooth must be at least 2 years old and sufficient regarding density and length. the 60 patients will be randomised into the two groups of apicectomy with and without filling. a radiograph will be taken just before the operation and 6 and 12 months after the operation. in the assessment of bone healing, we will use two different techniques, subtraction radiography and the periapical index (pai). we will also evaluate the benefits of using the operation microscope during the operation, and if clinical photos can be useful as documentation of treatment result.

Eligibility criteria:
inclusion criteria: healthy person age 18 or above sufficient root filling sufficient coronal restauration apical infection for at least 2 years pai score3, 4, or 5 exclusion criteria: boneless more than 50 % communication between pocket and apical infection no visible root filling material after apicectomy facial bone less than 3 mm

Keywords: apicoectomy retrograde mta
hypomagnesemia and diabetic nephropathy

Conditions: Diabetic Nephropathies

Summary: to find if there is a corrolatation between microalbuminurea and diabetic retinopathy, in daibetic patients

40 daibetic patients with microalbuminurea will be subjeted to full clinical examination and fundus examination,20 control diabetics with out microalbuminurea will also be included for comparison,patients will be selected from the outpatient clinic 0f fayoum university hospital.

Eligibility criteria:
inclusion criteria: * diabetics on oral treatment,diabetics on insulin exclusion criteria: * healthy volunteers,,hypertensive patients with normal blood glucose