Kornimate/medical-research-clean huggingface dataset:
impact of sarcopenia on postoperative outcomes of patients undergoing liver resection

Conditions: Liver Neoplasms; Sarcopenia; Postoperative Complications

Summary: the investigators will investigate the impact of different biometric parameters (body mass index, sarcopenia, lean muscle mass, hand-grip strength, gait speed, fat composition) on the postoperative outcomes of patients undergoing liver resections. major and minor liver resections will be considered as well as open and minimally invasive techniques. benign and malignant indications will be included. patients characteristics and perioperative variables will be considered for analysis. short-term outcomes will be evaluated focusing on 90-days morbidity and mortality and readmission rate.

according to the null hypothesis, no difference in postoperative morbidity between the two groups would be expected. to calculate sample size, a 42% morbidity rate would be expected in sarcopenic patients while a 22% rate would be expected in the non-sarcopenic group. considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve statistical significance was 224 subjects. considering a 10% drop-out rate of patients undergoing explorative laparoscopy or laparotomy without parenchymal resection a total of 249 patients will be required for completion of the study

Eligibility criteria:
inclusion criteria: 1. patients undergoing open or laparoscopic liver resection 2. patients undergoing major or minor liver resection 3. patients undergoing liver resection for primary or secondary liver malignancies 4. patients undergoing liver resections for benign diseases (cysts, adenoma, focal nodular hyperplasia, hemangioma) - exclusion criteria: 1. patients undergoing extrahepatic resection 2. patients undergoing cyst fenestration or biopsies without liver resections 3. patients with extrahepatic metastases 4. patients undergoing explorative laparoscopy or laparotomy without parenchymal transection -

Keywords: hepatocellular carcinoma colorectal liver metastases non-colorectal liver metastases focal nodular hyperplasia liver hemangioma liver cysts surgical morbidity surgical mortality sarcopenia
a phase iii safety study of ferumoxytol compared to ferric carboxymaltose for the treatment of iron deficiency anemia (ida)

Conditions: Iron Deficiency Anemia

Summary: to evaluate the safety of 1.020 grams (g) of intravenous (iv) ferumoxytol compared to 1.500 g of iv ferric carboxymaltose (fcm).


Eligibility criteria:
key inclusion criteria include: * participants with ida and in whom iv iron treatment is indicated and defined as: * participants with documented hemoglobin \<12.0 g per deciliter (dl) for females and \<14.0 g/dl for males within 60 days of dosing and * participants with documented transferrin saturation (tsat) ≤20% or ferritin ≤100 nanograms (ng) per ml within 60 days of dosing * documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire) * all participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study key exclusion criteria include: * known hypersensitivity reaction to any component of ferumoxytol or fcm * history of allergy to an iv iron * history of multiple drug allergies * participants with dialysis-dependent chronic kidney disease * hemoglobin ≤7.0 g/dl * female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)

Keywords: iron deficiency anemia ida ferumoxytol ferric carboxymaltose fcm injectafer feraheme ferinject
a study on estimated risks of certain adverse events in adults with von willebrand disease (vwd) treated with veyvondi

Conditions: Von Willebrand Disease (VWD)

Summary: the main aim of this study is to estimate the risks of certain adverse events in adults with von willebrand disease treated with veyvondi. no study medicines will be provided to participants in this study. data from medical records of participants diagnosed with von willebrand disease and treated with veyvondi will be evaluated during this study.


Eligibility criteria:
inclusion criteria: 1. participants with 18 years of age or older 2. participants with diagnosis of congenital vwd. 3. participants received veyvondi with or without a fviii concentrate. 4. participants must have at least 7 days of observation time after the index dose. 5. provides informed consent, if required, in accordance with local ethical and institutional requirements. all medical record data will be abstracted retrospectively; therefore, an exemption or waiver of informed consent will be sought from all associated independent ethics committees (iecs) and institutional review boards (irbs). exclusion criteria: 1. history of any other coagulation or platelet disorder (including acquired vwd). 2. history of neutralizing antibodies / inhibitors to vwf or fviii.
sharp dissection versus monopolar electrocautery in primary total knee arthroplasty performed under tourniquet

Conditions: Osteo Arthritis Knee; Arthroplasty, Replacement, Knee

Summary: this study compares the use of sharp dissection with diathermy for the approach to a total knee replacement. half of the patients will be randomly assigned each intervention.

the approach to the knee to carry out a total knee replacement (tkr) can either be carried out using a scalpel, sharp dissection, or using an electric current to divide tissue, monopoly electrocautery. reducing blood loss is important. blood loss can result in anaemia, which has a number of effects including shortness of breath, chest pain and lethargy. blood loss into a newly replaced knee can also result in pain and stiffness in the joint. total knee replacements are routinely carried out with a tourniquet inflated, which reduces the blood flow into to leg during the operation. diathermy is applied to areas of bleeding to stop them from doing so during operations. with the tourniquet inflated, some areas that would bleed when this was deflated may not be noticed and continue to bleed. using diathermy for the approach would be expected to reduce this bleeding compared to using a scalpel.

Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis requiring tka (total knee arthroplasty) * planned for cruciate retaining prosthesis without patella resurfacing * patient is able to give informed consent * patient resides locally and will be available for follow up exclusion criteria: * cardiac pacemaker * inflammatory arthropathy * tourniquet contraindicated * thrombophilia/haemoglobinopathy * spinal anaesthetic not possible
malaria in pregnancy: nutrition and immunologic effects

Conditions: Malaria; Low Birth Weight; Anemia; Perinatal Mortality

Summary: the purpose of this study is to determine the efficacy of zinc and/or vitamin a supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes.

malaria accounts for a major proportion of the disease burden in tanzania with 14 to 18 million new malaria cases being reported each year resulting in 100,000-125,000 deaths. malaria results in impaired productivity for those between 15-55 years and lost learning opportunities in the 5-25 year age group. dar es salaam is characterized as an area with endemic and perennial malaria, with transmission occurring during the entire year. p. falciparum accounts for more than 95% of malaria infections. a number of interventions have contributed to reducing the burden of the disease in some settings in tanzania and beyond, including vector control measures, bed nets, and prophylaxis and treatment of malaria. however, malaria remains a serious problem among pregnant women and children. we will examine the efficacy of micronutrient supplements as a means of enhancing immune response to malaria in pregnancy and reducing the risks of associated adverse clinical outcomes. if successful, such a low-cost intervention would be added to the armamentarium against this disease. note: the time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. this record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. due to an oversight, we did not update this record when this protocol change took effect at the start of the study.

Eligibility criteria:
inclusion criteria: * primigravida or secundigravidae * at or before 13 weeks of gestation * hiv-negative * intend to stay in dar es salaam until delivery and for at least 6 weeks thereafter exclusion criteria: * not primigravida or secundigravidae * after 13 weeks of gestation * hiv-positive * do not intend to stay in dar es salaam until delivery and for at least 6 weeks thereafter

Keywords: malaria low birth weight anemia perinatal mortality vitamin a zinc
application of 68ga-labeled cd73 targeting probe pet/ct imaging in the diagnosis of breast cancer

Conditions: Breast Cancer

Summary: the investigators plan to conduct a 68ga-dota-dpne pet/ct imaging study in breast cancer patients to observe the binding of the tracer to tumor lesions and evaluate cd73 expression. as part of the study design, a subset of patients will initially undergo dynamic pet/ct imaging to evaluate the safety profile and pharmacokinetic distribution of the radiotracer in vivo. subsequently, static pet/ct imaging will be performed on additional patients to assess the diagnostic effectiveness of 68ga-dota-dpne. imaging results will be correlated with relevant clinical indicators to evaluate the potential of this tracer in diagnosing breast cancer, guiding therapeutic decisions, and predicting responses to targeted therapies.


Eligibility criteria:
inclusion criteria: female patients aged ≥18 years with an expected survival of at least 12 weeks no prior radiotherapy or chemotherapy; surgery or biopsy is feasible for pathological diagnosis at least one measurable target lesion as defined by recist v1.1 able to provide written informed consent and comply with follow-up requirements exclusion criteria: severe hepatic or renal dysfunction pregnant, breastfeeding, planning to become pregnant, or planning to have children during the study period; women of childbearing potential must use effective contraception during the study unable to lie flat for 30 minutes history of claustrophobia or other psychiatric disorders any other condition deemed unsuitable for participation by the investigator refusal to participate in the clinical study
implementation of a habit-ile intervention at william lennox neurological hospital (neureha)

Conditions: Acquired Brain Injury

Summary: using a randomized controlled trial design, in an hospital environment, possible changes induced by the "hand-arm bimanual intensive therapy including lower extremities (habit-ile)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of children with acquired brain injury.

the aim is to investigate, for the first time, the effectiveness of habit-ile therapy in a hospital setting in the treatment of a population representative of the clinical population with children with acquired brain injuries. the hypothesis is that an in-hospital habit-ile protocol will be more effective than conventional therapies usually given to children with acquired brain injury, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods. the aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (habit-ile) on body functions and structures, activity and participation in children with acquired brain injury.

Eligibility criteria:
inclusion criteria: * children with acquired brain injury of school * age 5 to 18 years inclusive exclusion criteria: * unstable seizure * programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time * severe visual or cognitive impairments likely to interfere with intervention or testing session completion

Keywords: motor skill learning executive function activity of daily living intensive therapy acquired brain injury
a study to evaluate intravaginal ejaculation time in men with and without premature ejaculation

Conditions: Erectile Dysfunction

Summary: the purpose of the study is to characterize intravaginal ejaculatory latency time (time between the start of vaginal intercourse and the start of intravaginal ejaculation) in men with and without premature ejaculation (pe) and to assess the validity of patient-reported outcomes.

this is a multinational, multicenter, observational study in men with and without pe. the study consists of three visits: one visit for screening and enrollment, and two visits for observation after 1 and 2 months (total duration of 8 weeks). no study treatment for pe is administered to patients during the course of the study. patients and their partners are expected to attempt sexual intercourse at least 2 times a week during the 8-week study period and to use a stopwatch to record the intravaginal ejaculatory latency time (ielt) during intercourse. at visits during the observation period "patients" (and/or partners if partners are responsible for completing questionaires) also provide patient-reported outcomes (pros) by answering several questionnaires that include the topics of control over ejaculation, satisfaction with sexual intercourse, personal distress, interpersonal difficulty, and self-esteem. the study will estimate the distribution of the average ielt values for men with pe and men without pe.

Eligibility criteria:
inclusion criteria: * must be in a stable, monogamous, sexual relationship with the same woman (18 years of age or older) for at least 6 months, who plan to maintain their relationship for the duration of the study * must be in good general health * patient and partner willing to avoid situations or activities that may have an effect on their sexual activity (eg, refrain from any preplanned surgery) exclusion criteria: * has history of drug abuse within the past 2 years * has history of or current major psychiatric disorder such as mood disorders, anxiety disorders, schizophrenia, other psychotic disorders, or alcoholism * must have erectile dysfunction * patient who has decreased interest in sexual intercourse or has other forms of sexual dysfunction * patient whose partner has decreased interest in sexual intercourse, painful intercourse, or other forms of female sexual dysfunction * patient whose partner is more than 3 months pregnant

Keywords: erectile dysfunction dapoxetine premature ejaculation ejaculation sexual dysfunction orgasmic disorder
signature acetabular posterior/lateral data collection

Conditions: Noninflammatory Degenerative Joint Disease; Avascular Necrosis; Rheumatoid Arthritis

Summary: the primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: cutting guide and conventional instrumentation.

using a more advanced surgical technique may assist surgeons and patients in a variety of ways including identifying a specific-size for the prosthesis prior to surgery, increasing operating room efficiency, and reducing the number of traditional instruments needed. this may reduce cost associated with the instrument inventory and instrument sterilization. operating time may also be reduced, potentially decreasing the patient's risk of infection. however, before these hypotheses can be tested, it is important to fully understand the efficacy and accuracy of signature custom guides and their use in total hip arthroplasty.

Eligibility criteria:
inclusion criteria: * subjects with one of the following indication: * noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * rheumatoid arthritis. * correction of functional deformity. * treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. additional inclusion criteria include: * subjects requiring primary total hip arthroplasty * 20 to 75 years of age * subjects with a diagnosis of osteoarthritis or traumatic arthritis * subjects willing to return for follow-up evaluations. * subjects who can read, understand study information and give written consent without representation of a legally authorized representative. * bilateral patients are included if staged. * only posterior lateral approach can be used for inclusion in this study exclusion criteria: - exclusion criteria should be in accordance with contraindications for the biomet primary acetabular cup. absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement. additional contraindications include: * subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard implants. specific examples of these are total dislocation of the hip, severe coxa vera deformity, and severe forms of multiple epiphyseal dysplasia * subjects unable to cooperate with and complete the study * dementia and inability to understand and follow instructions * neurological conditions affecting movement * pregnancy additional exclusion criteria include: * surgical approach other than posterior lateral. * simultaneous bilateral procedures

Keywords: hip signature
a study to assess safety of canagliflozin and metformin hydrochloride combination given as a supplement to diet and exercise to improve blood sugar level in indian adult participants with diabetes

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate release (ir) fixed-dose combination.


Eligibility criteria:
inclusion criteria: * participant willing to adhere to diet and exercise regimen as recommended by the investigator * type 2 diabetes mellitus (t2dm) with inadequate glycemic control on diet and exercise, who in investigator's opinion are eligible to receive study drug as per prescribing information along with standard care for management of t2dm * women must be postmenopausal, defined as greater than (\>) 45 years of age with amenorrhea for at least 18 months, or \> 45 years of age with amenorrhea for at least 6 months and less than (\ 40 international units per liter (iu/l), or surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal occlusion), or otherwise be incapable of pregnancy, or sexually active and practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, tubal ligation, intrauterine device, double-barrier method (example, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization, and consistent with local regulations regarding use of birth control methods for participant participating in clinical studies, for the duration of their participation in the study, or not sexually active * women of childbearing potential, regardless of age must have a negative serum beta-human chorionic gonadotropin (beta-hcg) pregnancy test at screening and negative upt at baseline (predose, day 1) * treatment naive participants or participants on stable antihyperglycemic agent (aha) therapy (for at least 12 weeks before screening) and have a screening visit glycosylated haemoglobin (hba1c) of greater than or equal to (\>=) 7.0 percent (%) and less than or equal to (\<=) 10.0 % exclusion criteria: * history of liver or renal insufficiency (estimated creatinine clearance below 45 milliliter per minute \[ml/min\]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * known allergies, hypersensitivity, or intolerance to canagliflozin, metformin or canagliflozin + metformin hydrochloride immediate release (ir) fixed dose combination (fdc) or its excipients * use of any other sodium glucose cotransporter 2 (sglt2) inhibitor within 12 weeks before the screening visit * if female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after last dose of study medication; or intending to donate ova during such time period * history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
a phase 3 evaluation of daclatasvir and asunaprevir in treatment-naive subjects with chronic hepatitis c genotype 1b infection

Conditions: Hepatitis C

Summary: the purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * patients chronically infected with hcv genotype 1b * no previous exposure to any interferon formulation, ribavirin (rbv), and hcv direct acting antiviral agent * hcv rna viral load ≥ 10,000 iu/ml at screening * seronegative for hiv and hbsag * bmi of 18-35 kg/m2, inclusive * patients with compensated cirrhosis are permitted exclusion criteria: * infection with hcv other than genotype (gt) -1b * evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy * evidence of a medical condition contributing to chronic liver disease other than hcv * diagnosed or suspected hepatocellular carcinoma or other malignancies * uncontrolled diabetes or hypertension * history of moderate to severe depression. well-controlled mild depression is allowed * confirmed alanine aminotransferase (alt) ≥ 5x upper limit of normal (uln) * confirmed platelet count \< 50,000 cells/mm3 * confirmed hemoglobin \< 8.5 g/dl