Kornimate/medical-research-clean huggingface dataset:
effects of pinta 745 in end stage renal disease (esrd) patients who require hemodialysis and have protein energy wasting

Conditions: End Stage Renal Disease; Kidney Disease; Protein Energy Wasting

Summary: this is a pilot study to assess the safety, pharmacokinetics and effectiveness of pinta 745 or placebo in treating protein energy wasting (pew) in patients receiving maintenance hemodialysis (mhd).

this is a randomized (participants will be assigned by chance to study treatments), double-blind (participants and study personnel will not know the identity of the study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in patients who receive maintenance hemodialysis. three participants will receive pinta 745 for every participant that receives placebo. pinta 745 or placebo will be taken intravenously once per week following dialysis. the study period will consist of screening, treatment for 12 weeks, and follow up for 8 weeks. evaluations will be performed to assess the safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of what a drug does to the body) and effectiveness in treating protein energy wasting (such as increasing muscle size and muscle function) throughout the study.

Eligibility criteria:
inclusion criteria: * esrd patient and on outpatient maintenance hemodialysis for ≥ 6 months * adequate dialysis with kt/v ≥ 1.2 on two occasions within 12 weeks of enrollment * undergoing dialysis at least 3 times per week, on average * serum albumin ≤ 3.8g/dl within 60 days of enrollment * able and willing to provide informed consent exclusion criteria: * presence of an indwelling central vascular catheter * current medical condition that would interfere with ability to perform physical function tests * active infection requiring hospitalization or antibiotics within the past month * major surgery within past 3 months, minor surgery within the past 4 months * dialysis access revision/angioplasty/replacement within the past 2 weeks * history of renal transplant, whether or not functional, within 2 years (however, if graft has been removed, patient will be considered eligible) or plans to undergo renal transplantation within 6 months * history of neoplasia, except non-melanoma skin cancers, with a 30% probability of recurrence within 12 months * current treatment with appetite stimulants, anabolic steroids or growth hormone * clinically significant heart disease * difficulty swallowing food or liquid * if female, currently breast feeding * if female, pregnant * if female or male, unwilling to use a highly effective method of contraception

Keywords: end stage renal disease esrd maintenance hemodialysis hemodialysis dialysis mhd protein energy wasting pew
a bioequivalence study comparing methylprednisolone suspension to methylprednisolone tablets under fed conditions

Conditions: Therapeutic Equivalency

Summary: a study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fed conditions.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects between the ages of 21 and 55 years. * body mass index (bmi) of 17.5 to 30.5 kg/m2 and a total body weight \> 45 kg (99 lbs). exclusion criteria: * any condition possible affecting drug absorption (eg, gastectomy). * a positive urine drug screen.

Keywords: bioequivalence study methylprednisolone suspension tablets fed
antidepressant use during pregnancy

Conditions: Depression

Summary: this study will determine the safety of antidepressant use during pregnancy for both the mother and the child.

symptoms of major depressive disorder (mdd) include persistent sad mood, feelings of hopelessness or guilt, decreased energy, irritability, and more. if untreated, mdd can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. mdd occurs most commonly in females between the ages of 25 and 44. this puts women of childbearing age at a particularly high risk for developing the disorder. however, very little research has been done to determine the safety of antidepressant use during pregnancy and how the medication may affect the baby. this study will determine the safety of antidepressant use during pregnancy for both the mother and the child. participants in this observational study will not receive medication or treatment of any kind. pregnant woman who are already taking medication for depression will be recruited, in addition to pregnant women who are not taking any medication. the participants will first undergo interviews to establish their psychiatric diagnoses. subsequent interviews will be held to monitor levels of depressive symptoms, exposure to other substances that could potentially harm the fetus, levels of antidepressants in the blood, and dietary intake during pregnancy. participants will report to the study site for these evaluations at weeks 20, 30, and 36 of pregnancy. from week 36 to week 40, interviews will be conducted over the phone. at birth, cord blood will be collected and the infant's cries will be recorded. the infant's development will be assessed at 2 weeks and 3, 6 ½, 12, 18, and 24 months postpartum. mothers who take selective serotonin reuptake inhibitors (ssris) and are breastfeeding their children will report to the study site with their children at 1 month postpartum to measure the level of ssris in the infant's blood. in addition, digital photographs of the infant's face, profile, hands, and torso will be taken at 2 weeks and 3, 12, and 24 months postpartum. additional face-only photographs of the infant will be taken at these times and at birth for further in-depth analyses of facial characteristics. mother-child interactions will be videotaped at all postpartum assessments.

Eligibility criteria:
inclusion criteria: * less than 24 weeks pregnant at the time of study entry * as of 12/1/2005, at significant risk for developing depression or currently taking ssris during pregnancy exclusion criteria: * history of or current psychosis, bipolar disorder, or schizoaffective disorder * current substance use disorder * any medical condition that may be related to outcomes (such as multiple births or insulin-dependent diabetes) * has not attended at least two prenatal visits at the 20-week intake point

Keywords: ssri exposure pregnancy infant development
effectiveness of exercise plus pain neuroscience education on brain function in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: a three-arm randomized controlled trial will be conducted. fifty-nine participants with koa will be recruited in a 1:1:1 ratio. assessor, and statistician will be blinded to group allocation. one experimental group (n=19) will receive nme plus pne, the other experimental group (n=19) will receive isolated nme and the control group (n=19) will continue with usual care. the pne will be adapted to the context of the participants. outcome measures will be brain activity, pressure pain threshold, pain intensity, disability, fear-avoidance beliefs, self-efficacy, and pain catastrophizing. outcome measures will be evaluated pre-intervention, immediately post-intervention, and four-month post-intervention. the investigators hypothesize that there will be significant differences in favor of the nme plus pne intervention group.


Eligibility criteria:
inclusion criteria: * women and men at least 45 years old radiologically diagnosed with unilateral or bilateral koa (kellgren-lawrence 1-3 grading scale) * pain duration greater than three months exclusion criteria: * patients who have received physical therapy or other conservative therapy in the previous three months and those who have a history of major knee trauma and surgery in the last six months * cardiac pathology * structural use of psychoactive medications, such as antipsychotics, antidepressants, antiepileptics, and anxiolytics, during the past year * neurological diseases * other musculoskeletal clinical conditions that generate pain

Keywords: neuromuscular exercise pain neuroscience education knee osteoarthritis chronic pain physical therapy
effect of enteral nutrition enriched in protein and based on indirect calorimetry measurement in chronically critically ill patients

Conditions: Critically Ill

Summary: this is a single-center, prospective, randomized, comparative, double-blind controlled clinical study intended to establish 1) the optimal method of determining calorie requirements and 2) the optimal amount of protein supply in chronically ventilated patients.

the study will be performed in a chronic ventilation department. enrolled patients will be randomly allocated to receive calories as dictated by: the harriss-benedict formula (group 1) or indirect calorimetry (group 2) after one week of admission to the hospital department and study enrollment we will review the first results of the study. after seven days of hospitalization and study enrollment patients who have not been weaned from the ventilator, will be divided into three groups. 1. patients in the first group will receive caloric support calculated by the harriss benedict equation and protein dose of 1.1 to 1.5 grams per kilogram weight. 2. patients in the second group will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight. 3. patients in the third group will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight. outcome of treatment results will be performed after one ,four and eight weeks: 1. length of hospitalization 2. weaning from mechanical ventilation 3. development and progression of pressure ulcers 4. infectious diseases incidence 5. amount of insulin needed for glucose control 6. length of mechanical ventilation 7. readmission to intensive care unit 8. mortality rate

Eligibility criteria:
inclusion criteria: * chronically mechanical ventilated patients (more than 21 days of mechanical ventilation) by tracheostomy, * between ages 65-90 exclusion criteria: * patient over age 90 and younger the age of 65 * ph level less than 7.3 due to metabolic causes. * a patient with blood albumin level less than 2.2 g / dl

Keywords: mechanical ventilation
aflibercept versus placebo in combination with irinotecan and 5-fu in the treatment of patients with metastatic colorectal cancer after failure of an oxaliplatin based regimen

Conditions: Colorectal Neoplasms; Neoplasm Metastasis

Summary: the main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with folfiri (irinotecan, 5-fluorouracil, and leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. the secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (iv) aflibercept, and to assess pharmacokinetics of iv aflibercept in both treatment arms.

participants were * randomized at baseline (treatment was initiated with 3 days of randomization) * administered treatment in cycles of 14-days till a study withdrawal criterion was met * followed up 30 days after discontinuation of treatment, and every 8 weeks until death or end of study. the criteria for discontinuation of study treatment for a participant are: * participant (or legal representative) chose to withdraw from treatment * the investigator thought that continuation of the study would be detrimental to the participants well-being due to * disease progression * unacceptable aes * intercurrent illnesses * non-compliance to the study protocol * participant was lost to follow-up * participant was unblinded for the investigational treatment

Eligibility criteria:
participants who met the following main selection criteria were included in the study. inclusion criteria: * histologically or cytologically proven adenocarcinoma of the colon or rectum * metastatic disease that is not amenable to potentially curative treatment * one and only one prior line of treatment for metastatic disease. this prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible) * prior treatment with bevacizumab is permitted. exclusion criteria: * prior therapy with irinotecan * eastern cooperative oncology group performance status \>2 the above information is not intended to contain all considerations relevant to participation in a clinical trial.

Keywords: colorectal cancer metastatic anti-angiogenic irinotecan 5-fu folfiri
efficacy of lung ultrasound in monitoring fluid resuscitation in chest trauma patients

Conditions: Contusions Pulmonary; Lung Injury; Chest Trauma; Fluid Overload Pulmonary Edema

Summary: efficacy of lung ultrasound in monitoring fluid resuscitation in chest trauma patients with lung contusions

trauma is a public health problem, associated to high morbidity and mortality, in egypt the mortality from road traffic crashes is about 12000 victims per year. * chest trauma represents from 10% to 15% of the total number of traumas worldwide. according to atls protocol , early diagnosis and management of chest trauma are essential. \*pulmonary contusion is found in 30-75% of cases of chest injury. * point of care ultrasound (pocus) is now a corner stone in emergency management it can predict lung contusions within the first 72 hours after trauma. * recently, lus play a major role in assessment of the volume status in trauma patients. * b-lines score (bls) has been validated as a lung ultrasound quantification of pulmonary congestion.the sum of all b-lines yields a score, b-lines score (bls), which assess the degree of lung contusion. so that lus may provide a valuable safety threshold to conduct fluid therapy.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * chest trauma patients either with or without other injuries. * any patient with either blunt or penetrating chest trauma. exclusion criteria: * - patients in cardiac arrest. * patient refusal to participate * pregnant females.
thrombus aspiration in heavy thrombus burden acute st-elevation myocardial infarction

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; ST Elevation Myocardial Infarction

Summary: recent guidelines for the management of st-elevation myocardial infarction (stemi) recommend against the routine use of thrombus aspiration (ta) during primary percutaneous coronary intervention (ppci) (class iii indication). yet, so far, there is limited data regarding its role stemi patients with heavy thrombus burden (tb). the aim of this trial is to evaluate the effects of manual ta and pci in comparison to conventional pci alone in a real-life clinical trial among heavy tb stemi patients undergoing ppci.

recent guidelines for the management of st-elevation myocardial infarction (stemi) recommend against the routine use of thrombus aspiration (ta) during primary percutaneous coronary intervention (ppci) (class iii indication). yet, so far, there is limited data regarding its role in stemi patients with heavy thrombus burden (tb). the aim of this trial is to evaluate the effects of manual ta and pci in comparison to conventional pci alone in a real-life clinical trial among heavy tb stemi patients undergoing ppci.

Eligibility criteria:
inclusion criteria: * stemi patients with heavy thrombus burden as assessed by timi score of 0-1 or thrombus burden classification 4-5 exclusion criteria: * stemi patients with low thrombus burden (timi 2-3 or tb 0-3) * history of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs. * symptomatic hypotension and/or an sbp \< 100 mmhg at the time of randomization.

Keywords: coronary artery disease myocardial infarction percutaneous coronary intervention
fear of childbirth (tokophobia) - etiology, essence and clinical implications

Conditions: Phobias

Summary: the purpose of this study is twofold: * to understand the etiology and the essence of fear of childbirth * to examine the implications and efficiency of several forms of psychological therapy.

fear of childbirth (tokophobia) is inconsistently defined in the research literature: some define it as an anxiety disorder while it is often defined as a form of phobia; some regard only the pre-pregnancy period, some regard the anxiety during pregnancy and some focus on the labor process. despite the high prevalence (between 13%-20% of fertile women), research in this area is scarce and the current findings are incohesive due to various conceptualizations of the phenomenon and to various measurement methods.

Eligibility criteria:
inclusion criteria: * subjective diagnosis of tokophobia exclusion criteria: * currently undergoing psychological therapy * major depression * acute anxiety * psychosis * bipolar disorder * suicidal * substance abuse * non-compliant personality disorder * health problems during pregnancy that affect perception

Keywords: fear of childbirth tokophobia anxiety labor pregnancy cognitive-behavioral psychoanalysis group therapy etiology
dead space monitoring with volumetric capnography in ards patients

Conditions: Acute Respiratory Distress Syndrome; Capnography

Summary: this studies´ objective is to describe how different peep levels affect dead space measured by bohr´s formula.

in ards patients peep has contradictory effects on ∆p (driving pressure of the airway) hat depends on the balance between lung recruitment and overdistension. some authors showed that incremental levels of peep did not much affect dead space in ards patients. these studies used different methods for the assessment of dead space. such technique also overestimates the dead space. we believe that the right way to measure dead space is applying the original bohr's equation using the mean paco2 value. therefore, the aim of this observational study was to describe the effect that peep has on bohr's dead space and its sub-components in mechanically ventilated patients with ards. this observational study was performed in the intensive care unit of a university hospital. protocol design the protocol started recording the data during baseline protective ventilation. after 15 minutes of data recording, we studied four levels of peep - 0, 6, 10 and 16 cmh2o - which were randomly assigned by a randomization table. respiratory, hemodynamic, arterial blood gas analysis and volumetric capnographic parameters were recorded. we analyzed the last 2 minutes of each protocol steps consisting in more than 30 breaths or data-points.

Eligibility criteria:
inclusion criteria: * age older than 18 years * requirement of invasive mechanical ventilation for more than 4 hours and less than 12 hours * severe hypoxemia (pafi \< 200) secondary to ards or post-operatory atelectasis exclusion criteria: -requirement of invasive mechanical ventilation prior to enrollment in this study
intensive versus standard one year monitoring on glycaemic control after initiating csii in children with dt1. deep study

Conditions: Diabetes Mellitus, Type 1; Pediatric ALL

Summary: more than half of type 1 diabetes (dt1) children are under csii (continuous subcutaneous insulin infusion). several studies showed that despite a patients' follow-up mostly by hospital-based paediatricians, there are still some concerns on long-term glycaemic control with inconstant results on glycaemic control either due to csii adherence or nutrition management issues. consequently, this real life study aims to compare two monitoring methods (standard versus intensive) in children initiating a csii treatment and assess the impact on glycaemic control after one year.

as csii becomes more and more the gold standard therapy in children with type 1 diabetes, there have been some questions regarding the long-term effect of these treatments with some concerns on the inconstant results on glycaemic control either due to csii adherence or nutrition management issues. the dcct (diabetes control and complications trial) study has already shown in diabetic adults that intensification of treatment and follow-up could result in significative improvement of glycaemic control. this study aims to test this hypothesis of significant improvement after one year following csii initiation on glycaemic control. two parallel arms will be compared in real life conditions; one with standard recommendations-based follow-up by both diabetologists/pediatricians and service provider and the other with intensive follow-up with higher frequency of provider's nurses visits and personalization of patient status transferred to the physician for each diabetologists/pediatricians visit. thus, investigators could determine after one year if the glycaemic control is better with one or the other of these follow-up procedures. glycaemic control will be assessed both by the evolution of hba1c during the study period and its last level at the end of the study. its evaluation will be completed by counting of all symptomatic hypoglycemia occurence during the study.

Eligibility criteria:
inclusion criteria: * children (\<18 yo) with not controlled type 1 diabetes seen by diabetologists/paediatricians immediately following the initiation of csii. * children for whom it is the first initiation of csii. * children (or their parents if necessary) having read the information note and having dated and signed the informed consent form. exclusion criteria: * children with a history of diabetes less than 12 months. * children with hba1c values below 7.5 or above 10 before csii initiation. * children treated by csii for more than 3 months.