Kornimate/medical-research-clean huggingface dataset:
personalized management of body weight during pregnancy

Conditions: Weight Gain During Pregnancy

Summary: the purpose of this study is to determine how to help manage weight gain during pregnancy. this study is part of the national consortium 'life-moms: lifestyle interventions in expectant moms'. life-moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.

the study will last 22 months, from screening until study completion. the entire study will include 3 screening visits, receipt of weight management advice, second trimester testing, third trimester testing and three follow up visits during the first year after the baby is born. participants will randomly be assigned to 1 of 3 programs to help manage their weight during pregnancy: 1. physician directed group 2. smartmoms-clinic group 3. smartmoms-phone group

Eligibility criteria:
inclusion criteria: * are pregnant. * are between 18 and 40 years old. * have a bmi (a number calculated from your height and weight) equal to or above 25kg/m2. * establish prenatal care before 12 weeks of your pregnancy. * can read, speak and understand english. exclusion criteria: * do not plan to deliver your baby at woman's hospital, baton rouge, la * are pregnant with more than one infant. * have habitually smoked during the last 6 months. * currently abuse or have abused illegal or prescription drugs in the last 6 months. * consume more than 2 alcoholic drinks per week. * are unwilling to avoid pregnancy for 12 months following delivery. * are unwilling to enroll your baby in the 12 month follow-up testing planned in this study. * are planning to move out of the area within the next 2 years or plan to be out of the study area for more than 1 month in the next year. * are unwilling to be assigned at random to any of the intervention groups. * are planning to terminate your pregnancy. * are planning to give your baby up for adoption. * are pregnant with a baby who has a known fetal anomaly. * have a reason that exercising is unsafe (determined by your physician or study staff). * have had or plan to have bariatric surgery within 1 year of your expected delivery. * currently have or have a history of the following: * 3 or more first trimester miscarriages * high blood pressure * type 1 diabetes * diagnosis of pregnancy related diabetes during screening * hiv or aids * psychotic disorder, major depressive episode, bipolar disorder or eating disorder * any other pregnancy, blood, heart, lung, hormone, or digestive problem that your doctor considers unsafe for participation in this study

Keywords: pregnancy gestational weight gain
caffeine use in the management of preterm infants

Conditions: Apnea of Prematurity

Summary: this study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.

this study is a randomized, double-blinded, placebo-controlled trial. infants will be randomized to receive either caffeine or placebo for up to maximum of four additional weeks after meeting clinical criteria to discontinue caffeine. initiation of oral feeding will be based on standard of care as determined by a neonatal occupational therapist and clinical cues. oral feedings will be advanced by a standardized 5 step oral feeding protocol. the time it takes to achieve full oral feeds between the treatment and control groups will be compared.

Eligibility criteria:
inclusion criteria: • infants born at equal to or less than 32 weeks and 0 days gestational age and * equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment. * off respiratory support for at least 2 days (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (cpap), mechanical ventilation). * on caffeine and meet criteria to discontinue caffeine. * no significant cardiopulmonary events for at least 5 days (apnea \> 20 seconds, apnea with heart rate (hr) \< 80 beats per minute (bpm), hr \< 80 bpm with desaturation \< 85% or color change). exclusion criteria: * infants with critical congenital heart disease. * infants with neuromuscular conditions affecting respiration. * infants with overt brain injury (i.e. severe grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding. * infants with major genetic disorders. * infants with anatomic anomalies that will hinder oral feeding. * infants who have already progressed to step 3 (of 5) of our institution's oral feeding protocol (oral feeds 4 times per day). * infants who develop necrotizing enterocolitis after enrollment. * failure to obtain consent or declined by parents.

Keywords: feeding caffeine
effects of fasting mimetic diet on nephropatic patients

Conditions: Renal Insufficiency, Chronic

Summary: fasting mimetic diet (fmd) showed positive effects on cardiovascular risks. purpose of the trial is to evaluate fmd effects on patients affected by chronic kidney disease (ckd), through the stimulation of kidney stem cells and improving cardiovascular and metabolic status. from april 2018, the investigators enrolled 13 patients (7 male) with an history of primary glomerulonephritis (gmn) and an egfr between 60 ml/min and 30 ml/min. exclusion criteria are: age \ 65 y.o., secondary gmn, severe heart failure (nyha iv),ongoing infectious diseases, ongoing neoplasia, hepatic diseases, copd, inflammatory bowel disease, history of stroke, history of acute coronary disease less than 3 months, pregnancy, refuse informed consent.


Eligibility criteria:
inclusion criteria: * history of primary glomerulonephritis * egfr between 60 ml/min and 30 ml/min * age between 18-65 years old exclusion criteria: * secondary gmn * severe heart failure (nyha iv) * ongoing infectious diseases * ongoing neoplasia, * hepatic diseases * copd, * inflammatory bowel disease * history of stroke * history of acute coronary disease less than 3 months * pregnancy * refuse informed consent.

Keywords: chronic kidney disease fasting mimetic diet kidney stem cells
effect of physiologic insulin administration on cognition

Conditions: Alzheimer Disease

Summary: in humans, insulin is secreted in pulses from the pancreatic beta-cells, and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range. these pulses become disrupted in the presence of insulin resistance. some people have referred to alzheimer's disease as type 3 diabetes because the glucose uptake in the brain is reduced by 30%. clinical observations in clinics that treat patients with insulin pulses every 5 minutes for 3 hours twice a week for 2 weeks followed by once a week for 6 weeks and followed by less frequency treatments suggest an improvement in type 2 diabetes control, reduction in insulin resistance and an improvement in diabetes complications. a patient with parkinson's disease was treated with this pulsed insulin paradigm and experienced dramatic improvement that has now been maintained over years. parkinson's disease has been reported to have a decreased glucose uptake in the brain, so pulsed insulin treatment was tried in a small number of patients with alzheimer's disease and there was an impression that they showed improvement. clinics that use pulsed insulin treatment change more than one parameter of the insulin pulses which makes it difficult to determine what is giving the improvement. the euglycemic hyper-insulinemic clamp, also called a clamp, is a well-standardized test that measures insulin resistance and involves intravenous insulin infusion. this single patient study will enroll one patient with early alzheimer's disease and insulin resistance. the subject will have one standard clamp test with continuous insulin followed by 4 clamps over a 2-week period using the same amount of insulin over the same period of time but administered in pulses every 5 minutes. this was the number of pulsed insulin treatments needed to see a dramatic improvement in parkinson's disease. the cognition in the alzheimer's disease patient will be thoroughly evaluated with questionnaires and walking on a special mat while doing arithmetic tasks before and after the 4 pulsed insulin clamps. if this study demonstrates an improvement in cognition, one will know that the only thing that changed from the standard clamp was the pulse nature of the insulin delivery.

the purpose of this research study is to test the effect of an insulin treatment on alzheimer's disease.

Eligibility criteria:
inclusion criteria: * early alzheimer's disease * insulin resistance exclusion criteria: * inability to walk * unable to read, understand or inability to complete questionnaire * belong to a vulnerable group like prisoners
efficacy of topical versus intravenous tranexamic acid in controlling blood loss

Conditions: To Calculate Total Blood Loss Immediately Postoperative

Summary: total laryngectomy with bilateral block neck dissection is considered one of the major head and neck surgeries. intraoperative bleeding is considered a risk factor for this operation specially that the population of this operation are elder with multiple comorbidities. intravenous administration of tranexamic acid reduces bleeding during surgery.we design this study aiming to prove the role of topical tranexamic acid in controlling the intraoperative bleeding in patients undergoing total laryngectomy operation avoiding the risk of intravenous administration.

45 patients undergoing total laryngectomy operation will be enrolled in this study. the patients will be divided into 3 equal groups, 15 patients in each group. group (a), tranexamic acid will be given 1 hr preoperatively. group (b), topical tranexamic acid will be given as an irrigation to the surgical site. group (c), control group.one hour preoperatively, a wide bore cannula will be inserted to all patients. tranexamic acid 1mg/kg will be given intravenously to patients in group (a). normal saline will be given to group (b) and group (c) .on arrival to the operating room, a pulse oximetry, continuous electrocardiogram (ecg), and non-invasive blood pressure measurement device will be connected to the patient. pre-medications will be given; metoclopramide (10mg) and dexamethasone (8mg) preoperatively. induction will be done by sevoflurane, propofol 1mg/ kg, succinyl choline 0.5mg/kg. after intubation, fentanyl 2mic/kg and atracurium 0.5mg/kg will be given , followed by 0.8 mg/kg morphine sulphate . anesthesia will be maintained by isoflurane 1.5% and atracurium 0.1mg/kg/ 30min. after flap elevation ( using local infiltraton of epinephrine 1/100000), the surgical site will be irrigated by 40 ml of tranexamic acid 2mg/kg dissolved in 200ml normal saline every 1 hour for the first 5 hours in group (b), and by normal saline in group (a) and group (c).

Eligibility criteria:
inclusion criteria: - patients of either sex, aged between 18-70 years old, asa physical status i, ii undergoing total laryngectomy exclusion criteria: * patients with coagulopathy, a history of thromboembolism or a history of tranexamic acid allergy or complication will be excluded.
non-invasive diagnostic and functional evaluation of cardiac involvement in patients with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the aim of this study was to assess serum n-terminal probnp (nt-probnp) in systemic sclerosis patients and to establish whether it reflects the severity of rv overload.

elevated serum brain natriuretic peptide (bnp) levels released from myocytes of ventricles upon stretch have been found in patients with isolated right ventricular (rv) pressure overload. however, limited data suggest that serum bnp may be elevated in patients with systemic sclerosis (ssc), especially with rv dysfunction. the aim of this study was to assess serum n-terminal probnp (nt-probnp) in ssc patients and to establish whether it reflects the severity of rv overload.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of systemic sclerosis exclusion criteria: * cardiovascular disorders other than pulmonary hypertension * significant pulmonary function abnormalities * impaired renal function

Keywords: systemic sclerosis pulmonary hypertension echocardiography n-terminal probnp
haematopoietic stem cell transplantation (hsct) in comparison to conventional consolidation therapy for patients with acute myeloid leukemia (aml) (intermediate risk) </= 60y. after first cr

Conditions: Leukemia, Myeloid, Acute

Summary: hematopoietic stem cell transplantation in patients with newly diagnosed aml ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy


Eligibility criteria:
inclusion criteria: * aml in first remission * cytological standard risk, i.e. karyotype not listed under exclusion criteria * identification of hla-identical sibling or hla-compatible related or unrelated donor (9/10 hla-alleles matched, high resolution typing for hla-a, b, cw, drb1 and dqb1) * age: 18 - 60 years * medically fit for allogeneic stem cell transplantation * cr / cri after induction therapy exclusion criteria: * core-binding factor leukemia (t(8;21), inv16) * acute promyelocytic leukemia (t(15;17) * complex aberrant karyotype * karyotypes: -7; -5; del5q; t(3;3); t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration * pregnancy / nursing * non-compliance

Keywords: aml, leukemia acute myeloid leukemia hsct stem cell transplantation tx chemotherapy
comparison of continuous positive airway pressure (cpap) and non-invasive positive pressure ventilation (nippv) in preterm newborns with respiratory distress syndrome.

Conditions: Respiratory Distress Syndrome (RDS)

Summary: primary objective: to evaluate safety and efficacy of two different non-invasive respiratory support modalities in preterm neonatal patients with respiratory distress syndrome. secondary objective is to compare different respiratory support mode performance in different gestational age groups. primary endpoint is treatment failure. with this study, the following hypotheses will be tested: hypothesis 1: nippv has a lower failure rate compared to cpap mode. hypothesis 2: nippv complication rate is non-superior compared to cpap.

treatment failure is defined as any of the following: * fio2\>0.6 to maintain spo2\>88% * respiratory acidosis (ph\ 65 mmhg) * recurrent apnea (\>4 episodes/h) or apnea requiring bag and mask ventilation * silverman andersen respiratory severity score (sas score) ≥6 and does not improve by \> 20% within 4-8 hours secondary endpoints: * mortality rate * intubation rate * late onset sepsis (los) rate * treatment duration * complication rates: pneumothorax rate bronchopulmonary dysplasia (bpd) necrotizing enterocolitis (nec) persisting ductus arteriosus (pda) intraventricular hemorrhage (ivh) retinopathy of prematurity (rop) nasal trauma: * i° - nasal/septal redness * ii° - nasal/septal redness + indent * iii° - nasal/septal redness + indent + skin breakdown abdominal distension: * visible abdominal distension (defined by attending clinician) and one of the following: * feeding intolerance (defined by clinician) or * \>3 desaturation episodes or \>20% fio2 increase in 1 hour after feed. with this study, the following hypotheses will be tested: hypothesis 1: nippv has a lower failure rate compared to cpap mode. hypothesis 2: nippv complication rate is non-superior compared to cpap.

Eligibility criteria:
inclusion criteria: 1. gestational age (ga) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings). 2. need of respiratory support (deemed by a clinician). exclusion criteria: 1. major congenital anomalies 2. cardiovascular instability 3. consent refused or not provided
retrospective study of adult patients with inborn errors of metabolism in switzerland

Conditions: Inborn Errors of Metabolism

Summary: this is a retrospective study aimed at establishing a database of the current health of adult patients with iem in the french-speaking part of switzerland. .

background inborn errors of metabolism (iems) are a group of rare disorders caused by genetic mutations that affect enzymes of intermediary metabolism. because adult with iems has become an emerging and challenging group in switzerland, this study is intended to assess the actual situation of adult patients with iem in the french-speaking part of switzerland, namely their age, their sex, their diagnosis, age at disease onset and their clinical outcome including complications of the disease. all adult patients with a biochemical and/or genetic diagnosis of iem followed at the adult metabolic clinic from the lausanne university hospital and geneva university hospital between 01.10.2013 to 31.12.2017 will be included in the study. in addition, investigators will also include the patients referred to the clinic for suspicion of iem and determinate if the investigation confirmed an iem disease. electronic and paper patient charts will be reviewed for clinical features, biochemical investigations, molecular genetic testing, diagnostic imaging, treatment and long-term outcome. all data will be entered in an excel database.

Eligibility criteria:
inclusion criteria: * all iem adult patients who were transitioned from the pediatric clinic to the adult metabolic clinic (the centre for molecular disease in lausanne and the division of endocrinology, diabetology, hypertension and nutrition of the hug) since its creation in 2013 and those who were referred to our clinic for suspicion of iem and requiring further investigation. exclusion criteria: * age \< 16 years . any document attesting a refusal to participate will exclude the data entry of the concerned patient.

Keywords: inborn errors of metabolism adulthood clinical characteristics
local infiltration analgesia vs adductor canal block for analgesia after anterior cruciate ligament reconstruction

Conditions: Rupture of Anterior Cruciate Ligament; Infiltration; Regional Anesthesia Morbidity

Summary: early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. regarding this latter, different options have emerged recently such as the adductor canal block, performed before the surgery by the anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of the intervention. no trial has compared these two approaches. as practice of medicine should be based on evidence, we decided to undertake this randomised controlled trial where we compared the adductor canal block with the local infiltration analgesia technique in terms of pain and functional outcomes

patients scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be randomly allocated to two groups: local infiltration analgesia or adductor canal block. the local infiltration analgesia will be performed by the surgeon at the end of surgery with 20 mls of ropivacaine 0.5%. the adductor canal block will be performed by the anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient, using the same solution (20 mls ropivacaine 0.5%) postoperative analgesia will include intravenous patient-controlled analgesia of morphine (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3x400 mg) and acetaminophen (4x1000 mg). a research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.

Eligibility criteria:
inclusion criteria: * patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction exclusion criteria: * peripheral neuropathy * pre-existing femoral neuropathy * diabetes mellitus * alcoholism * drug addiction * cancer with chemotherapy * chronic pain state
a study to evaluate raptiva in adults with plaque psoriasis previously enrolled in study acd2390g

Conditions: Psoriasis

Summary: this is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly sc (subcutaneous) doses of 1.0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in study acd2390g.


Eligibility criteria:
inclusion criteria: * signed informed consent * previous participation in study acd2390g * for women of childbearing potential, continued use of an acceptable method of contraception for the duration of their participation in the study * willingness to continue to hold sun exposure reasonably constant and to avoid use of tanning booths or other uv light sources throughout the study exclusion criteria: * any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab * systemic therapy for psoriasis (et day 0 through fu day 84 or upon relapse or unusual presentation of psoriasis in the fu period, whichever occurs first) * systemic immunosuppressive drugs for other indications (et day 0 through fu day 84) * topical therapies for psoriasis (et day 0 through et day 84) * live virus or bacteria vaccines (et day 0 through fu day 84) * other vaccines or allergy desensitization (it is recommended that these be scheduled after fu day 84) * other experimental drugs or treatments (et day 0 through fu day 84) * beta-blockers, ace inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between et day 0 and tt day 84)

Keywords: plaque psoriasis topical
budesonide for immunosuppression after liver transplantation to reduce side effects

Conditions: Acute Cellular Graft Rejection; Liver Transplant Rejection

Summary: our hypothesis is that budesonide will provide effective hepatic isp that will replace prednisone and allow lower systemic drug levels of fk, thus reducing the steroid- and calcineurin-associated complications often observed in the olt population. this study is intended to investigate the therapeutic potential of this isp combination.

this study will be a randomized, open-label non-inferiority trial to assess the efficacy, safety and tolerability of budesonide in combination with low-dose fk and standard-dose mmf as post-olt isp in comparison to standard isp (s-isp). subjects will include olt patients age 18 years and older receiving their first single-organ living- or deceased-donor liver transplant. subjects must have post-operative recovery of graft function and be able to take oral medications before beginning treatment according to the study protocol. subjects will be randomized to receive either (1) investigational oral isp including budesonide 9mg by mouth in three daily divided doses, fk with an initial target trough level of no greater than 5-6ng/ml, and mmf (i-isp); or (2) s-isp including prednisone, calcineurin antagonist, and mmf. after randomization, subjects will be followed for a total of 52 weeks and assessed for adequacy of graft function, and complications of therapy, particularly acr

Eligibility criteria:
inclusion criteria: adult patients age 18 years or older who undergo initial single-organ living- or deceased-donor liver-transplant surgery. research participants are required to have satisfactory post-operative recovery of graft function and no post-operative renal-replacement therapy prior to starting medication according to protocol. they must also be able to take oral medications. - exclusion criteria: patients will be excluded from the study if they are: (1) undergoing retransplantation; (2) have fulminant hepatic failure as an indication for liver transplantation; (3) have surgical complication(s) potentially affecting post-operative graft function (i.e., hepatic artery thrombosis); or have delayed initial recovery of graft function (primary non-function) requiring non-standard induction therapy. furthermore, patients with a contraindication to budesonide (i.e., hypersensitivity) will not be included in the study -

Keywords: graft loss renal failure infection diabetes hypertension