Kornimate/medical-research-clean huggingface dataset:
pegylated arginine deiminase in treating patients with metastatic melanoma that cannot be removed by surgery

Conditions: Melanoma (Skin)

Summary: rationale: pegylated arginine deiminase may stop the growth of tumor cells by taking away an amino acid needed for cell growth. purpose: this phase ii trial is studying how well pegylated arginine deiminase works in treating patients with metastatic melanoma that cannot be removed by surgery.

objectives: primary: * determine the clinical response (complete and partial response) in patients with unresectable metastatic melanoma treated with pegylated arginine deiminase. secondary: * determine the toxicity profile of this drug in these patients. * determine the pharmacokinetics and pharmacodynamics of this drug in these patients. * determine the progression-free survival and overall survival of patients treated with this drug. outline: patients receive pegylated arginine deiminase intramuscularly once or twice a week in weeks 1-4. courses repeat every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. blood samples are acquired at baseline and every 2 weeks thereafter for pharmacokinetic and pharmacodynamic studies. after completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 5 years, and annually thereafter. projected accrual: a total of 43 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic melanoma, meeting any of the following criteria: * progressive disease after chemotherapy, radiotherapy, surgery, or immunotherapy * no longer responding to standard therapy or have refused standard therapy * unresectable disease * measurable or evaluable disease * no clinical ascites * no symptomatic pleural effusion patient characteristics: * life expectancy ≥ 12 weeks * karnofsky performance status 70-100% * bilirubin ≤ 3.0 mg/dl * albumin ≥ 3.0 g/dl * alkaline phosphatase \< 5 times upper limit of normal (uln) * serum glucose \> 60 mg/dl * amylase \< 1.5 times uln * absolute neutrophil count \> 1,500/mm³ * platelet count \> 100,000/mm³ * no new york heart association class iii-iv heart failure * no serious infection requiring treatment with antibiotics * no known allergy to e. coli drug products (e.g., sargramostim \[gm-csf\]) * not pregnant or nursing * negative pregnancy test * fertile patients must use 2 forms of effective contraception prior concurrent therapy: * see disease characteristics * at least 4 weeks since prior anticancer therapy * at least 4 weeks since prior surgery and recovered * no concurrent participation in another investigational drug study

Keywords: recurrent melanoma stage iv melanoma
a study of the safety of oral elsubrutinib capsules and oral upadacitinib tablets given alone or in combination (abbv-599) for adult participants with moderately to severely active systemic lupus erythematosus to assess change in disease state

Conditions: Systemic Lupus Erythematosus (SLE)

Summary: systemic lupus erythematosus (sle) is an immune-mediated disease associated with inflammation of multiple organ systems. this study will evaluate how well elsubrutinib and upadacitinib given alone or as the abbv-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study m19-130. this study will assess the change in disease symptoms. abbv-599 is an investigational drug being developed for the treatment of systemic lupus erythematosus (sle). this study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. study doctors put the participants into 1 of 4 groups called treatment arms. each group receives a different treatment. adult participants with a diagnosis of sle will be enrolled. around 260 participants will be enrolled in the study in approximately 100 sites worldwide. participants will receive the following for up to 56 weeks: participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. participants who were receiving elsubrutinib and/or upadacitnib in m19-130 will continue to receive the same treatment in this study. participants who were receiving placebo in m19-130 will be re-randomized to one of the 2 combination treatment arms in this study. arm 1: elsubrutinib dose a and upadacitinib dose a arm 2: elsubrutinib dose a and upadacitinib dose b there may be higher burden for participants in this trial compared to their standard of care. participants will attend monthly visits during the course of the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * completed study m19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and abbv-599 \[elsubrutinib/upadacitinib\] combination or matching placebo) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study. * on stable background treatment for sle throughout the study. exclusion criteria: * active, chronic, or recurrent viral, or bacterial infection. * active tuberculosis (tb) * history of gastrointestinal (gi) perforation, diverticulitis, or a significantly increased risk for gi perforation per investigator assessment. * participant require vaccination with live vaccine during study participation.

Keywords: systemic lupus erythematosus abbv-599 abbv-105 abt-494 elsubrutinib upadacitinib
sequential changes of serum kl-6 predict progression in interstitial lung disease

Conditions: Interstitial Lung Disease, Desquamative

Summary: interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly variable clinical process.thence it is significant for the patient to search a convenient and accurate prediction method. the objective of this study was to determine whether peripheral blood biomarkers can predict disease .

the median follow-up period was 12 months, each patient received 4 or 5 follow-ups in our center, 336 person-times in study enrollment totally. the patients with interstitial lung disease had significantly higher serum baseline kl-6 and mmp-7 levels compared with healthy control.they divided into progressive group and non-progressive group according to disease change. serum kl-6 and mmp-7 levels were elevated in patients if disease progression, but baseline level of biomarkers in progressive group were not significant higher compare with non-progressive group .binary logistic regression showed △kl-6 and △mmp-7 were significant predictors for disease progression. multivariate cox analysis showed kl-6 and mmp-7 were significantly associated with survival along with other variables. the serum levels of kl-6 and mmp-7 were elevated in the individuals with interstitial lung disease compared with healthy controls. the rate of poor prognosis and mortality more associated with the variability increased biomarker concentrations，rather than the baseline concentration.therefore，serial measurements of biomarkers contribute to the disease monitoring in clinical management.

Eligibility criteria:
inclusion criteriar: * clinical diagnosis of interstitial lung disease exclusion criteria: * diagnosise of interstitial lung disease acute excerbation * combined pulmonary embolism, pulmonary edema, pulmonary tuberculosis, and peumonias

Keywords: kl-6 disease progression predict biomarkers mmp-7
greek study on work productivity and sleep in patients with rheumatic diseases treated with adalimumab

Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Summary: treatment with tumor necrosis factor (tnf) inhibitors, especially adalimumab, demonstrated an improvement in work productivity in participants with rheumatic diseases: rheumatoid arthritis (ra), psoriatic arthritis (psa), and ankylosing spondylitis (as). limited data was available for the effect of adalimumab treatment on sleep in all three diseases (ra, psa, and as) and no data was available for the effect of adalimumab treatment on work productivity in psa. this long term health-related quality of life (hrql) observational study was conducted to evaluate the effect of treatment with adalimumab on work productivity and sleep disturbance in greek participants with moderate to severe rheumatic diseases (ra, psa, and as).

this was a multi-center, uncontrolled, prospective, observational study in participants with moderate to severe rheumatic disease (ra, psa, or as) who received adalimumab under normal clinical practice in accordance with summary of product characteristics (smpc), with or without other anti-rheumatic treatments.

Eligibility criteria:
inclusion criteria: 1. participants with moderate or severe active rheumatic disease, who received adalimumab under normal clinical practice in accordance with the approved local smpc. 2. participants who provided their consent for data collection and use by abbvie. exclusion criteria: 1. contraindications according to the smpc. 2. participants who did not participate in other observational studies conducted by abbvie.

Keywords: ankylosing spondylitis sleep psoriatic arthritis work productivity rheumatoid arthritis
0.9% saline versus balanced solutions in severe diabetic ketoacidosis

Conditions: Metabolic Ketoacidosis; Ketoacidemia; Acetonemia; Acetonuria

Summary: severe diabetic ketoacidosis (dka) is a potentially serious complication of diabetes mellitus. the treatment regimen is based on insulin and rehydration. the choice of rehydration solution is a question that remains open. we sought to compare the effect of sodium chloride 0.9% (sc) versus ringer lactate (rl) in the resolution of severe dka as well as on the variation of electrolytes.

we design an open randomized trial in adult patients admitted to our icu for severe dka. the insulin therapy protocol was identical and the randomization concerned the rehydration solution either by sc or rl. the primary endpoint was resolution of dka at h48 defined by a composite endpoint (glycemia \ 15 mmol/l or ph\>7.30 and anion gap \<16). the secondary endpoints were resolution of dka at h24, change in base excess to ≥ -3 meq/l at 48 h and h24 and change in electrolytes, insulin requirements, length of stay and mortality. blood gases, ionogram with chloride and lactate were performed at baseline, h6, h12, h24 and h48.

Eligibility criteria:
inclusion criteria: - all patients aged 16 and over hospitalized in intensive care for severe ketoacidosis defined as arterial ph ≤ 7.25 (or serum bicarbonate ≤ 15 mmol/l) and blood glucose ≥ 14 mmol/l and need for icu. exclusion criteria: * \< 16 y

Keywords: severe diabetic ketoacidosis, sodium chloride 0.9% ringer lactate base excess
mothers and caregivers investing in children

Conditions: Obesity, Childhood; Parenting

Summary: the incidence of childhood obesity in the united states has steadily increased over the past 30 years but has begun to level off in recent years. epidemiological evidence indicates that obesity may transmitted across multiple generations. the current study seeks to: 1) evaluate the extent to which mothers and other important caregivers affect their mothers' parenting; 2) examine whether an intervention aimed at improving diet quality and enhancing responsive feeding to improves parental responsivity and feeding behavior and infants' weight trajectories over time; 3) examine the effects of early life feeding and caregiver sensitivity on health and development; and 4) examine feasibility of food distribution along with the feeding intervention.

the incidence of childhood obesity in the united states has steadily increased over the past 30 years, but has begun to level off in recent years. children from minority groups may be disproportionately affected, such that hispanic and non-hispanic black children have greater weight for recumbent length compared to white children. similarly, socioeconomic status (ses) may affect child weight status. epidemiological evidence indicates that obesity may transmitted across multiple generations. genetics are a factor in determining weight status, but parents are largely responsible for regulating children's dietary environments. grandparents increasingly provide care for their grandchildren, yet few studies have examined grandparent involvement or the role that grandparents or other significant caregivers play in feeding the child. the objective of the current study is two-fold: 1) to evaluate the extent to which mothers and other caregivers affect mothers' parenting surrounding feeding their infant, beginning when the infant is first introduced to solid foods; and 2) to examine whether an intervention aimed at providing both mothers and and other important caregivers with hands-on training regarding healthy foods and responsive and sensitive feeding behaviors improves mothers' and other caregivers' responsive and sensitive behaviors and infants' weight trajectories over time. the researchers will collect both self-report data on diet, child temperament, mothers and caregiver mental health, stress and support. observational assessments will be obtained to code co-caregiver behavior and caregiver responsiveness during feeding.

Eligibility criteria:
inclusion criteria: * mothers with babies aged 4 to 5 months * other caregivers assisting the mother with the baby. * babies aged 4 to 5 months exclusion criteria: * babies with metabolic or feeding issues. * mothers younger than 16 years of age.

Keywords: nutrition parenting intergenerational feeding influences sensitive feeding
model 4296 left ventricular (lv) lead chronic performance study

Conditions: Heart Failure

Summary: lead survivability will be summarized.

the purpose of this study is to evaluate long-term performance of the 4296 lv lead. this evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. the leads will be followed for 5 years after implant. this study is required by fda as a condition of approval of the model 4296 lv lead. this study is conducted within medtronic's post-market surveillance platform.

Eligibility criteria:
patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. inclusion criteria * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has or is intended to receive an attain ability model 4296 lv lead * patient within 30 day post implant enrollment window exclusion criteria * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
measuring menstrual iron loss using the iron isotope dilution technique

Conditions: Iron-deficiency; Menorrhagia; Anemia

Summary: it is very difficult to quantify menstrual blood loss, the reference method is a tedious one. this is a problem, as it is not conducive to objectively measuring menstrual blood loss and understanding the contribution of menstrual iron loss to iron deficiency anemia. with this study, the investigators aim to investigate iron loss during the menstrual cycle and aim to validate a much simpler technique.

anemia reduction efforts have largely focused on increasing iron intakes such as improving diet quality, food fortification with iron, iron supplementation, biofortification. there is little information on the contribution of menstrual iron loss to iron deficiency anemia. indeed, the accurate measurement of menstrual blood loss volume and iron loss is difficult. self-perception of heavy menstrual blood loss poorly predicts actual blood loss, and the objective measurement of menstrual blood loss remains a tedious method. various methods have been used to objectively measure menstrual blood loss volume including radioisotopes, but these methods are invasive. the investigators aim to validate a much simpler technique, namely the stable iron isotope dilution methodology. this is a promising new method for quantifying long-term body iron balance, absorption, and loss which has not been applied previously to measure menstrual iron losses. validating this new method against the alkaline hematin reference method would be an important step to encourage menstrual blood loss measurements and shed light on the contribution of menstrual blood loss to iron deficiency and iron deficiency anemia.

Eligibility criteria:
inclusion criteria: * female, 18-30 years old * already labelled with stable iron isotopes at least 12 months prior to study start * weight \<70 kg * normal body mass index (18.5 - 25kg/m2) * regular menstrual cycle (self-reported cycle length between 28 and 35 days in the past 6 months) * signed informed consent * able to read and understand english exclusion criteria: * use of hormonal contraceptives within a 3-month recall period * anemia (hemoglobin \< 117 g/l) * any known major metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer, or cardiovascular diseases (according to the participants own statement) * women with severe menstrual cramps * consumption of iron-containing supplements within 1 month prior to the start of study * known difficulties with blood sampling * pregnancy (serum human chorionic gonadotropin (hcg) \< 5 miu/ml) * current smoking (\>1 cigarette per week over a 1-month recall period) * women who are planning to get pregnant * inability to follow the study protocol

Keywords: anemia menstruation alkaline hematin iron isotope dilution blood loss menorrhagia
zone 2 flexor tendon repair with conextions tr implant system

Conditions: Tendon Injury - Hand

Summary: prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated zone 2 flexor digitorum profundus tendons.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. willing and able to provide a signed and dated informed consent form 3. stated willingness to comply with all study procedures 4. available for the duration of the study 5. have one or two fully lacerated digital fdp tendon(s), with or without a concomitant injury of the flexor digitorum superficialis, in zone 2 of the index, middle, ring, or small finger 6. tendon laceration occurred within the previous 14 days exclusion criteria: 1. pregnant or planning to become pregnant during the follow-up period 2. autoimmune disorder(s) 3. type 1 diabetes mellitus or clinical history of poorly controlled type 2 diabetes mellitus 4. lack of proper cutaneous coverage at repair site 5. concomitant fracture 6. amputated digit(s) 7. arthritis of the hand 8. prior hand trauma with residual impact to function 9. congenital hand defect 10. conditions that would affect comparative measurements in the uninjured hand 11. tendon laceration caused by a crush injury 12. prior sensory impairment in digits of either hand. note: participants with nerve injuries associated with the trauma causing the current flexor tendon injury are eligible for enrollment 13. vascular injuries that require revascularisation procedures 14. ischemia and/or blood supply compromise 15. prior or current infections at or near the intended implant site 16. active sepsis, mrsa, or other conditions that may prevent healing 17. history of foreign-body sensitivity to 316 l stainless steel or uhmwpe 18. implantation of conextionstr implant would result in physical contact with other metal implants made of material other than implant grade stainless steel such as titanium, titanium alloys, cobalt chromium, or other dissimilar metals 19. any condition(s) which, in the opinion of the investigator, may impact the participant's ability to properly follow-up or otherwise be at-risk for following protocol instructions 20. currently participating in another clinical/device trial the following criteria, determined during the surgical procedure, will also cause an individual to be excluded from the study: 21. surgical site access less than 20 mm in total or less than 10 mm on either side of intended implant site 22. injured tendon is outside of the width range (3.0-7.0 mm) and thickness range (1.5-4.0 mm) specified for the conextionstr implant system.

Keywords: flexor tendon zone 2
outcomes of surgery of aortic valve

Conditions: Aortic Valve Disease

Summary: overall goal: to study the outcomes of patients undergoing aortic valve surgeries, different approaches such as standard aortic valve replacement, aortic valve repair, novel techniques as ozaki's procedure and their subsequent results and complications. * objective 1: identify predictors of complications following different types of aortic valve surgery accordingly. * objective 2: determine the value of each type in terms of advantages and disadvantages. * objective3: assess outcomes such as postoperative life expectancy, hospital stay, prognosis and quality of life.


Eligibility criteria:
inclusion criteria: 1. patients with severe symptomatic aortic valve lesion. 2. asymptomatic aortic insufficiency patients with left ventricular dysfunction or significant left ventricular dilatation (lv end diastolic diameter\>70 mm or lv end systolic diameter\>50 mm. 3. patients with aortic regurgitation caused by: * a dilated aortic annulus * conjoined cusp prolapse in bicuspid aortic valves (bav) * single cusp prolapse in tricuspid aortic valves * aortic valve cusp perforation from endocarditis exclusion criteria: * patients with previous aortic root or valve surgery.
treatment of rumination by biofeedback - a randomized controlled trial

Conditions: Rumination Disorders

Summary: rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. in a previous study the investigators showed that rumination is produced by an unperceived, somatic response to food ingestion. after having identified the key mechanisms of rumination, the investigators developed an original emg guided biofeedback technique with specific targets for correction, based on emg-guided control of abdomino-thoracic muscular activity, and in a pilot study the investigators showed the potential effectivity of this treatment. the current aim is to validate this previous uncontrolled observation by a formal placebo-controlled, randomized trial.

abdomino-thoracic muscle activity after a challenge meal will be recorded by emg and the signal displayed on a monitor and front in the patients: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will receive a pill of placebo. in each patient 3 sessions will be performed over a 10-day period. physiological (muscular activity by emg) and clinical outcomes (number of rumination events by questionnaires administered daily for 10 days) will be measured before and after treatment.

Eligibility criteria:
inclusion criteria: * rumination syndrome exclusion criteria: * relevant organic disease

Keywords: rumination síndrome regurgitation vomiting biofeedback electromyography abdominal accommodation