Kornimate/medical-research-clean huggingface dataset:
muscle mass via ultrasound in cirrhosis (mmuscle)

Conditions: Sarcopenia; Cirrhosis; Malnutrition

Summary: the goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. the main question\[s\] it aims to answer are: * what is the prevalence and development of sarcopenia in cirrhosis? * what is the role of malnutrition? participants will * undergo a muscle ultrasound of the lower and upper limb muscles * handgrip strength will be measured * malnutrition screening and assessment * complete a questionnaire to assess quality of life

in this study, the investigators will assess the prevalence and development of sarcopenia in the large in- and outpatient population with cirrhosis (n= 1346) of the university hospital of antwerp, using ultrasound assessment of muscle mass and quality in the lower as well as the upper limb muscles. handgrip strength will be tested for muscle functional status. findings will be correlated with clinical outcome (meld, survival, decompensating events). the etiology of the cirrhosis and its underlying activity will be taken into account as dependent variables, e.g. whether there is a difference between compensated vs. decompensated cirrhosis. the investigators will screen for malnutrition using the rfh-npt and compare with the glim criteria. the effect of sarcopenia on the quality of life will be evaluated using the validated "sarqol®" (sarcopenia quality of life) questionnaire.

Eligibility criteria:
inclusion criteria: * diagnosis of cirrhosis and follow-up in the university hospital of antwerp exclusion criteria: * known patient will against participation in the study or against the measures applied in the study * a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours * no complete remission of malignancy including hepatocellular carcinoma within the past 12 months

Keywords: sarcopenia cirrhosis malnutrition skeletal muscle ultrasound
dara-rvd induction for newly diagnosed multiple myeloma with autologous stem cell transplantation

Conditions: Newly Diagnosed Multiple Myeloma; Multiple Myeloma; Autologous Stem Cell Transplantation

Summary: this phase ii hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (ndmm) who are eligible for standard-of-care autologous stem cell transplantation (asct). daratumumab, lenalidomide, bortezomib, and dexamethasone (dara-rvd) have recently become a standard induction regimen for patients with ndmm who are eligible for asct in the united states. as implemented in clinical trials, dara-rvd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists. this study examines the efficacy of an attenuated dara-rvd schedule involving once-weekly bortezomib dosing.


Eligibility criteria:
inclusion criteria: 1. written informed consent was obtained to participate in the study and hipaa authorization for release of personal health information. subjects are willing and able to comply with study procedures based on the judgment of the investigator. 2. age ≥18 years at the time of consent. 3. eastern cooperative oncology group (ecog) ≤ 2 4. subjects with multiple myeloma. exclusion criteria: 1. active infection requiring systemic therapy or other serious infection within 14 days prior to study treatment. 2. pregnant or breastfeeding.

Keywords: daratumumab lenalidomide bortezomib dexamethasone
women with polycystic ovary syndrome are at high risk for cardiac insults

Conditions: Cardiac Disease

Summary: objectives: evaluation of the cardiovascular (cv) risk in a sample of cv asymptomatic infertile women with polycystic ovary syndrome (pcos). patients \& methods: 100 infertile pcos women older than 30 years (pcos group) and 50 fertile non-pcos women (non-pcos group) underwent gynecological and laboratory diagnosis and then underwent a diagnostic protocol consisting of determination of body mass index (bmi), homeostasis model assessment of insulin resistance (homa-ir) scoring and cardiologic evaluation using echocardiography, estimation of carotid artery intima-media thickness (cimt), coronary artery calcium (cac) score using multi-slice non-contrast cardiac ct and cardiac risk ratio (crr). study outcomes included the incidence of abnormal cardiac risk parameters and the determination of the best minimally invasive modality to be used as a screening test for these women.

women attending the infertility clinics at tanta and benha university hospitals were eligible for evaluation for pcos as a cause of infertility. gynecological evaluation entails data concerning present and past history of menstrual regularity, previous pregnancy for married women, previous investigations or therapies for pcos or infertility. pcos was diagnosed depending on the presence of at least two of the rotterdam criteria

Eligibility criteria:
inclusion criteria: infertile pcos women older than 30 years and free of exclusion criteria were enrolled in the study as pcos group. fifty non-pcos women of age- and bmi cross-matched to the enrolled pcos women with regular menstrual cycles or fertile if married were collected as control (non-pcos) group. only women who signed the written informed consent will be enrolled in the study. exclusion criteria: * age younger than 30 years old, bmi\>35 kg/m2, presence of acute or chronic inflammatory diseases, diabetes mellitus, hyperprolactinemia, thyroid dysfunction, cushing's syndrome, congenital adrenal hyperplasia, adrenal tumor or ovarian tumor, autoimmune disease, malignancy, central nervous system disease, current or previous use of oral contraceptives within 6 months of enrollment were excluded from the study. patients had congenital cardiac lesions, manifestations of atherosclerosis or family history of cardiac or cerebrovascular insults, ejection fraction \<50%, regional wall motion abnormalities and significant valvular diseases were excluded.
cost-effectiveness of different treatment options for lower calyceal stones

Conditions: Renal Calculi

Summary: the aim of the present study to perform a full cost analysis for the complete clearance of calyceal stones by retrograde intrarenal surgery (rirs) and percutaneous nephrolithotomy (pnl) for the treatment of lower calyceal stones between 1 and 2 centimeters (cm) in size.

the lifelong prevalence of urinary system stone disease is approximately 15%. the lower calyx is the most common location where renal calculi occur. because anatomical factors preclude spontaneous passage in this area, the need for treatment is more likely in lower calyceal stones. the european association of urology (eau) suggests percutaneous nephrolithotomy (pnl) for stones larger than 2 centimeters (cm) and shock wave lithotripsy (swl) or retrograde intrarenal surgery (rirs) for stones smaller than 1cm as a first option, but controversy continues regarding the best treatment option for medium-sized lower calyceal stones of between 1cm and 2cm. medical costs are divided into two components: direct and indirect. direct costs encompass all medical expenditures (e.g., drugs, hospital bed, all consumable and non-consumable materials used during the operation), while indirect costs include loss of working days for the patient. the stone-free rates (sfr) are reported as approximately 60% and 90% for one session of rirs and pnl, respectively; however, no physician can guarantee a 100% sfr for one session. for this reason, a full cost analysis must include the direct and indirect costs of both the first and all auxiliary procedures. the aim of this study was to perform a full cost analysis for the complete clearance of calyceal stones by rirs and all pnl types for the treatment of lower calyceal stones between 1cm and 2cm in size.

Eligibility criteria:
inclusion criteria: * patients who had a lower calyceal stone between 1cm and 2 cm in size exclusion criteria: * solitary or anomaly (horseshoe or pelvic kidney) kidney, * renal insufficiency, * pregnancy, * patient younger than 18 or older than 75 years, * non-interrupted antithrombotic medication before surgery, * urinary tract infection, * double-j or nephrostomy insertion before surgery

Keywords: lower calyceal stone cost-effectiveness percutaneous nephrolithotomy retrograde intrarenal surgery
adjuvant effect of chloroquine on gemcitabine

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the safety by defining the maximum tolerated dose (mtd) of choloroquine when combined with gemcitabine, and to evaluate preliminary efficacy of combined systemic gemcitabine and chloroquine. in addition, the influence of the treatment on the anti-cancer immunity and the value of golph2 as serum marker for pancreatic cancer will be assessed within a translational objective. * trial with medicinal product


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-resectable locally advanced or metastatic adenocarcinoma of the pancreas. assessment is done within 21 days before enrolment. * age = 18 years * adequate liver function or kidney function tests, including any of the following: bilirubin \ 40 ml/min (using the cockroft formula) * adequate haematological values: haemoglobin \> 80 g/l, leukocytes \>3.00 g/l, neutrophils \> 1.00 g/l, platelets \> 100 g/l * written informed consent * biliary decompression is mandatory before inclusion into the study in case of bilirubin levels \> 50 µmol/l. * women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during the 12 months thereafter. a negative pregnancy test before inclusion into the trial is required for women of childbearing potential, defined as having not reached the menopause, last menstrual period occurred less than 12 months ago, no surgical sterilization performed, and fallopian tubes and/or uterus have been not surgically removed. * men who agree not to father a child during participation in the trial or during the 12 months thereafter. patient compliance and geographic proximity allow proper staging and follow-up. patient not eligible for folfirinox treatment. who ps 0-2 exclusion criteria: * life expectancy \< 3 months * severe medical or psychiatric co-morbidity prohibiting the planned treatment or the giving of informed consent * any prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy. * any prior radiotherapy or combined radio-chemotherapy for pancreatic cancer if completed less than 12 months prior to study inclusion. * known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs. * known glucose-6-phosphate dehydrogenase deficiency. * concurrent use of other experimental drugs, treatment within a clinical trial within 30 days prior to trial entry. * active heart disease defined as congestive heart failure \> nyha class 2 * past or current history (within the last 2 years prior to treatment start) of other malignancies except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix * inability or unwillingness to comply with the study protocol * no understanding of the german language
the comparative efficacy of standard treatment plus ribavirin vs standard treatment alone in preventing clinically significant hemorrhage in patients with dengue fever

Conditions: Dengue Fever; Dengue Hemorrhagic Fever; Severe Dengue

Summary: this study investigates the comparative efficacy of standard treatment plus ribavirin versus standard treatment alone in preventing clinically significant hemorrhage among patients diagnosed with dengue fever. it is a double-blind, randomized control trial aimed at determining whether the addition of ribavirin improves clinical outcomes, particularly reducing bleeding events.

dengue fever, a significant public health concern, presents varying severity from asymptomatic to life-threatening complications such as hemorrhage or shock. this study evaluates the effectiveness of ribavirin when combined with standard treatment in mitigating severe bleeding complications in dengue patients. conducted at multiple public sector hospitals in khyber pakhtunkhwa, the trial employs a rigorous methodology, including block randomization, double-blinding, and predefined eligibility criteria. outcomes include changes in bleeding grades, platelet counts, acute-phase reactants, and hospital stay length. the findings aim to inform policy decisions and enhance dengue fever management protocols.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 years and above. * hospitalized patients diagnosed with dengue fever, confirmed via: * positive dengue ns1 antigen test * dengue igm antibodies * dengue rna pcr. * patients presenting with various severities of illness, as classified by the who dengue severity classification. exclusion criteria: * patients taking antiplatelet or anticoagulant medications. * patients with known bleeding disorders (e.g., hemophilia, von willebrand disease, end-stage renal disease, or liver cirrhosis). * patients with hiv undergoing antiviral therapy. * pregnant women. * patients with hypersensitivity to ribavirin. * patients with who grade 1 bleeding (few petechiae without clinical significance).

Keywords: dengue hemorrhage randomized controlled trial antiviral therapy
very low ketogenic diet and energy expenditure

Conditions: Energy Metabolism

Summary: this study aimed at evaluating the effectiveness of the active phase of a very low-calorie ketogenic diet in females with obesity lasting 28 days on body weight, body composition and energy metabolism using a metabolic chamber.

patients were recruited at the obesity and lipodystrophy center, university hospital of pisa. enrolled subjects underwent active phase of very low-calorie ketogenic diet within the metabolic chamber from day 0 for a duration of 4 weeks (day 0-28). on days 0, 7, and 28, patients underwent a 24-hour measurement of energy metabolism using the metabolic chamber. on the day of exit from the chamber measurement of body composition was conducted using total-body densitometry (lunar idxa; ge healthcare).

Eligibility criteria:
inclusion criteria: * overweight and obesity exclusion criteria: * type 1 and type 2 diabetes mellitus * endocrine disorders * asthma or pulmonary conditions * cardiovascular disease * gastrointestinal disease * liver disease * kidney diseases * anemia (hemoglobin \< 11 g/dl) * leucopenia (white blood cells \< 4,000/mcl) * thrombocytopenia (platelets \< 150,000/mcl) * central nervous system disorders * neurodegenerative diseases * psychiatric disorders * eating disorders * alcohol abuse and substance dependence * pregnancy * lactation.
safety evaluation of a new preservative in a lubricating eye drop

Conditions: Dry Eye Syndromes

Summary: this study is to evaluate the safety of a new preservative in a lubricant eye drop used four times a day in healthy adults and subjects diagnosed with dry eye.

single-site, open-labeled study. twenty two subjects will be enrolled into the healthy adult group and twenty two subjects into the dry eye group. each subject will be in the study for approximately 2 weeks (treatment) and seen at three study visits: visit 1 (day 0, baseline), visit 2 (day 7 +/- 1) and visit 3 (day 14 +/- 1). dosing regimen is 1-2 drops into each eye, four times daily, for two weeks. assessments will be comprised of visual acuity, slit lamp biomicroscopy, fluorescein corneal staining, and product comfort.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * able to follow all study instructions and attend all required study visits * provide written informed consent * visual health and eye comfort within protocol-specified parameters * women of child-bearing potential must have a negative urine pregnancy test at screening, not be breast-feeding, and agree to use a protocol-specified acceptable form of birth control throughout the study exclusion criteria: * any medical condition or history, or ocular scores, or use of any drug, device or medication that, per protocol or in the opinion of the investigator, might compromise the safety of the subject or analysis of the study results. * use of contact lenses outside protocol allowance * self-reported pregnancy, positive urine pregnancy test, breast-feeding; intends to become pregnant or breast-feed during the duration of the study, refuses protocol-specified urine pregnancy testing, and/or does not use protocol-specified birth control methods and agree to continue doing so for the duration of the study. * participated in an investigational drug or device trial within 30 days of entering the study.

Keywords: preservative eye drops
effect of adding zirconium oxide nanoparticles to printable implant overdenture

Conditions: Prosthesis Durability

Summary: this clinical study will be conducted to evaluate and compare non-modified printable acrylic resin base material and modified printable acrylic resin base material with zirconia oxide nanoparticles for a 2-implant retained complete overdenture regarding:surface roughness; microbiological assessment of denture base microbiological analysis peri-implant soft tissue health around used implants


Eligibility criteria:
inclusion criteria: * 1. patients are healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. this will be achieved through medical history and clinical examination by physician. 2. they will have completely edentulous jaws for at least 1 year. 3. they will be of angle's class i maxillo-mandibular relationship and have upper and lower completely edentulous arches. 4. residual alveolar ridges covered with healthy firm mucosa. 5. all included patients will have sufficient available length and width of mandibular bone to accommodate conventional implant. (at least 5 mm buccolingual width and 12 mm vertical height of bone. exclusion criteria: * patients with chronic systemic diseases that affect bone metabolism * uncontrolled diabetic patients * patients with tmj dysfunction * smokers
oxytocin effects on food motivation pathways

Conditions: Overweight and Obesity

Summary: oxytocin is a peptide hormone produced in the brain that regulates food intake. however, the mechanisms for this effect in humans is not yet clear. in this study, the investigators will therefore examine the effect of a single dose of intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and functional magnetic resonance imaging activation of areas of the brain involved in food motivation.


Eligibility criteria:
inclusion criteria: * age 18-45 years old * bmi 25-40 * regular breakfast eater (at least 4 times per week) * stable weight within the past three months exclusion criteria: * psychiatric disease, use of psychotropic medications * history of eating disorder * history of excessive exercise within the last three months (having run more that 25 miles in any one week or having exercised more than ten hours in any one week) * history of diabetes mellitus * active substance abuse * hematocrit lower than the normal range * gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection) * history of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms) * untreated thyroid disease * tobacco use * cardiac pacemaker, surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in body/eyes, nitroglycerin patch, severe claustrophobia
assessing the response rate of neo-adjuvant taxotere and trastuzumab in nigerian women with breast cancer

Conditions: Breast Cancer; Breast Cancer Female; HER2-positive Breast Cancer; Breast Cancer Stage II; Breast Cancer Stage III

Summary: this is a one stage phase ii study with a single arm design. it will be conducted in her-2 positive breast cancer patients in nigeria who are chemotherapy/hormonal treatment naive.


Eligibility criteria:
inclusion criteria: 1. women ages of 18 to 70 years old 2. biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm) 3. patients with histologically confirmed carcinoma of the female breast with 3+ positive her2 status by ihc 4. clinical stages iia -iiic (ajcc 2009) 5. chemotherapy-naïve patients (for this malignancy) 6. performance status: ecog performance status 0-1 (appendix a) 7. non-pregnant and not nursing. women of childbearing potential must take the pregnancy test and must commit to receive lhrh agonist zoladex (goserelin) for two years starting from the commencement of the study medications 8. required initial laboratory data. adequate hematologic, renal and hepatic function, as defined by each of the following: 1. granulocyte ≥ 1,500/μl 2. platelet count ≥ 100,000/μl 3. absolute neutrophil count (anc) ≥ l500/μl 4. hemoglobin ≥ 10g/dl 5. bilirubin ≤ 1.5 x upper limit of normal 6. sgot and sgpt \< 2.5 x upper limit of normal 7. creatinine within institutional normal limits or glomerular filtration rate ≥ 30 ml/min/1.73 m2 by ckd epi equation (see http://mdrd.com/ for calculator) 9. echo: baseline left ventricular ejection fraction of ≥ 55% exclusion criteria: 1. pregnant or lactating women. women of childbearing potential not using a reliable and appropriate contraceptive method. postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. patients of childbearing potential will agree to continue the use of acceptable form of contraception for 24 months from the date of last herceptin administration. 2. patients with distant metastasis (brain and/or visceral metastasis) 3. serious, uncontrolled, concurrent infection(s). 4. treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (ccis) 5. participation in any investigational drug study within 4 weeks preceding the start of study treatment 6. other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, hiv-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements. 7. patients with her2-negative disease

Keywords: breast cancer breast cancer stage ii breast cancer stage iii docetaxel herceptin neoadjuvant treatment nigeria