Kornimate/medical-research-clean huggingface dataset:
efficacy study of switching stabilized schizophrenic patients from conventional to atypical antipsychotic treatment

Conditions: Schizophrenia

Summary: the objective of this study is to demonstrate that there is a benefit in switching chronic schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy, neurological safety and patient's outcome.


Eligibility criteria:
inclusion criteria: schizophrenic patient meeting the dsm-iv diagnostic criteria more than one year ago and treated with antipsychotic for at least 1 year. outpatient (or patient admitted to hospital for social or logistic reasons). patient receiving a stable dose of the same conventional antipsychotic for at least 8 weeks before visit 1. patient presenting a panss score equal or greater than 49 at visit 2. patient considered by the investigator as possible candidates for a switch, owing to inadequate efficacy or poor safety of the current treatment. exclusion criteria: patient presenting a schizophreniform or a schizo-affective disorder according to the dsm-iv diagnostic criteria, or any other disorder from axis i of the dsm-iv, or a disorder from axis ii (limit personality), substance dependence or substance abuse. administration of an atypical antipsychotic drug during the 8 weeks preceding v1. history of resistance to antipsychotic drugs hospitalization in a psychiatric unit or in a psychiatric emergency department within the 8 weeks preceding the beginning of the study. presence of serious unstable disease, such as a fatal outcome or hospitalization in an intensive care unit, is foreseeable within a period of 6 months.
ezetimibe and statins on postprandial lipemia in type 2 diabetes

Conditions: Postprandial Lipemia; Type 2 Diabetes

Summary: the purpose of this study is to determine whether ezetimibe in association with statins is more effective than statins alone on postprandial lipemia in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetes since at least two years * stable metabolic control (hba1c\<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period. * bmi\<30 kg/m2 and body weight stable during the last six months. * both sexes; only post-menopausal women. * ldl-cholesterol \>130 mg/dl, plasma triglycerides \<400 mg/dl. * no use of hypolipidemic drugs in the last three months. exclusion criteria: * patient with renal (serum creatinine \>1.5 mg/dl) or hepatic (serum transaminases \>three times upper normal values) impairment. * patients with history of cardiovascular disease. * pre-menopausal women. * any other acute or chronic degenerative disease. * anemia (hb\<12 g/dl). * uncontrolled blood pressure. * use of any drugs able to interfere with the study medications

Keywords: postprandial lipemia type 2 diabetes ezetimibe hypercholesterolemia
bms-790052 (daclatasvir) plus peg-interferon alfa-2a and ribavirin in treatment-naive black/african-americans, latinos and white/caucasians with hepatitis c

Conditions: Hepatitis C

Summary: the purpose of this study is to compare the rates of sustained virologic response in each cohort (black-african americans, latinos) in this study to historical rate.


Eligibility criteria:
inclusion criteria: * participants chronically infected with hepatitis c virus (hcv) genotype 1 * hcv rna viral load of ≥10,000 iu/ml at screening * no previous exposure to interferon formulation, ribavirin or hcv direct antiviral agent * self-described as black-african american, latino or white-caucasian * results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with hcv liver biopsy from any time prior to first treatment. compensated cirrhotics were capped at approximately 25% exclusion criteria: * evidence of decompensated liver disease * documented or suspected hepatocellular carcinoma (hcc) * positive for hepatitis b or hiv 1/hiv 2 antibody at screening
a study of intravenous mircera in participants with chronic renal anemia who are on dialysis

Conditions: Anemia

Summary: this single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (cera/mircera) for the maintenance of hemoglobin (hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in hungary. participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of mircera, with the starting dose derived from the erythropoiesis-stimulating agent (esa) dose they had been receiving.


Eligibility criteria:
inclusion criteria: * adults greater than or equal to (≥) 18 years of age * chronic renal anemia * continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month * regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months exclusion criteria: * transfusion of red blood cells during previous 2 months * poorly controlled hypertension * significant acute or chronic bleeding
use of a vacuum mattress during laparoscopic sleeve gastrectomy to reduce the concentration of rhabdomyolysis markers and acute renal failure

Conditions: Rhabdomyolysis; Acute Kidney Injury; Bariatric Surgery Candidate

Summary: this prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy (lsg) in the reduction of levels of rhabdomyolysis markers (myoglobin, creatine kinase, creatinine) and incidence of rml and aki in the postoperative period. method patients a prospective clinical trial has been conducted between january 2015 and december 2022 in a tertiary referral university hospital (krakow, poland). it is designed as a single-center, prospective trial with two intervention arms. during the study, we specified 3 periods: * january 2015 - december 2016 - only standard mattresses were used * january 2017 - december 2019 - both types of mattresses were used * january 2020 - december 2022 - only vacuum mattresses were used participants patients aged ≥18 were qualified for lsg due to obesity and divided the first group (vacuum mattress group) are those laid on vacuum mattresses during the surgery. the control group consisted of patients for whom a standard operating mattress was used during the surgery. patients with preoperative chronic renal failure were excluded from the study. other exclusion criteria were perioperative complications which required postoperative hospitalization at the intensive care unit and compliance with enhanced recovery after bariatric surgery (erabs) protocol \< 85%. procedures and perioperative care all patients underwent lsg. patients were operated in the beach chair position. in the study group, the patient was laid on vacuum mattresses during the surgery. in the case of control group patients, a standard operating mattress was used during the surgery. perioperative care for all patients was in accordance with the erabs protocol adopted in our center\[\]. blood samples were collected on the first postoperative to measure rml markers (myoglobin, creatine kinase, creatinine). symptoms of rml, aki, and other complications were monitored for 30 days after surgery. end point criteria the primary endpoint is the incidence of postoperative aki or biochemical or clinical diagnosis of rml which required additional treatment. secondary endpoints is the concentrations of rml markers (myoglobin, creatine kinase, creatinine) on the first postoperative day


Eligibility criteria:
inclusion criteria: patients aged ≥18 which will be qualified for lsg due to obesity exclusion criteria: patients with preoperative chronic renal failure will be excluded from the study. other exclusion criteria are perioperative complications which require postoperative hospitalization at the intensive care unit and compliance with enhanced recovery after bariatric surgery (erabserabs ) protocol \< 85%.
study of trofinetide for the treatment of girls and women with rett syndrome (lavender™)

Conditions: Rett Syndrome

Summary: to investigate the efficacy of treatment with oral trofinetide versus placebo in females with rett syndrome


Eligibility criteria:
inclusion criteria: 1. female subjects 5 to 20 years of age, inclusive, at screening 2. body weight ≥12 kg at screening 3. can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube 4. has classic/typical rett syndrome (rtt) 5. has a documented disease-causing mutation in the mecp2 gene 6. has a stable pattern of seizures, or has had no seizures, within 8 weeks of screening 7. subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter or must agree to use acceptable methods of contraception. subject must not be pregnant or breastfeeding. 8. the subject's caregiver is english-speaking and has sufficient language skills to complete the caregiver assessments 9. subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to screening exclusion criteria: 1. has been treated with insulin within 12 weeks of baseline 2. has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study 3. has a history of, or current, cerebrovascular disease or brain trauma 4. has significant, uncorrected visual or uncorrected hearing impairment 5. has a history of, or current, malignancy 6. has a known history or symptoms of long qt syndrome additional inclusion/exclusion criteria apply. patients will be evaluated at screening to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).
study of edecesertib in participants with cutaneous lupus erythematosus (cle)

Conditions: Cutaneous Lupus Erythematosus

Summary: the primary objective of this study is to evaluate the safety and tolerability of edecesertib (formerly gs-5718) in participants with cutaneous lupus erythematosus (cle) with or without systemic lupus erythematosus (sle).


Eligibility criteria:
key inclusion criteria: * either fulfill the european league against rheumatism (eular)/ american college of rheumatology(acr) 2019 classification criteria for systemic lupus erythematosus (sle) or have biopsy-proven cutaneous lupus erythematosus (cle). * must have active acute cutaneous lupus erythematosus (acle)/ subacute cutaneous lupus erythematosus (scle); individuals with mixed skin presentations of lupus skin disease (including dle) are allowed to enter. * cle disease area and severity index (clasi) activity score of ≥ 6 during screening and day 1, excluding the alopecia component. * presence of at least 1 representative lupus skin lesion amenable to punch biopsy and willingness to undergo skin biopsy at 2 time points. * protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents for the treatment of cle/sle (eg, antimalarials, methotrexate (mtx), or other conventional synthetic disease-modifying antirheumatic drug (csdmards)) must maintain stable dose(s) for ≥ 60 days prior to randomization through week 4 of the study. key exclusion criteria: * dermatologic disease other than cutaneous manifestations of sle or cle that may interfere with assessment of lupus-specific skin lesions. * ongoing or active clinically significant bacterial, fungal or viral infection. * history of or positive for human immunodeficiency virus, hepatitis c virus, or hepatitis b virus. * uncontrolled health conditions including highly active sle (e.g. lupus nephritis, neuropsychiatric sle, vasculitis etc.). * history of malignancy. note: other protocol defined inclusion/exclusion criteria may apply.
effects on the diagnostic accuracy of magnetic imaging angiographies of the supra-aortic vessels by three different magnetic resonance contrast agents in patients

Conditions: Headache; Epilepsy; Dizziness

Summary: angiographies of the supra-aortic vessels by magnetic imaging have become common recently. so it was the purpose of this study to evaluate the imaging potential of different contrast agents. three contrast agents for magnetic resonance imaging are compared in angiographies of the supra-aortic arteries in a intraindividual study of 10 patients. all applications of these contrast agents are performed with a flow of 2 ml/s. one contrast medium is applicated a second time with a reduced flow of 1 ml/s. the angiographies of the supra-aortic vessels are evaluated by two experienced readers in a consensus reading. the signal/noise- and contrast/noise-ratio of anatomic vessel segments of the carotic and vertebral arteries are measured and compared to each other.


Eligibility criteria:
inclusion criteria: * headache * epilepsia * dizziness exclusion criteria: * pregnancy * metal implants (e.g. pacemaker) * contraindication for contrast agent * multiple allergies

Keywords: magnetic imaging angiography contrast agent signal/noise ratio contrast/noise ratio vessel
recurrent s. aureus infections in osteoarticular infections

Conditions: Staphylococcus Aureus Infection; Bone and Joint Infection

Summary: staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side. the aim of this study is to improve knowledge on persistence of mechanisms of s. aureus


Eligibility criteria:
inclusion criteria: * patients having had an osteoarticular infection with or without material due to s. aureus presenting a recurrence of s. aureus infection exclusion criteria: -

Keywords: staphylococcus aureus infection bone and joint infection relapse
treatment study investigating new cognitive behavioral therapy treatment manual for body dysmorphic disorder

Conditions: Body Dysmorphic Disorder; Somatoform Disorders

Summary: in an earlier phase of this study, a cognitive behavioral therapy (cbt) manual to treat body dysmorphic disorder (bdd) symptoms was developed. we are currently implementing this manual-based treatment to validate its effectiveness in patients with bdd.

bdd is a disease that involves preoccupation with imagined or minor physical flaws. the condition often begins in adolescence and, if left untreated, can cause significant social, emotional, and occupational distress. within the last decade, bdd has received increased attention, and various modes of treatment have been utilized and evaluated. cbt has been found to be a more effective form of treatment than other types of psychotherapy. in this study, we have created a new cbt treatment manual and are currently implementing it to evaluate its effectiveness in patients with bdd. the utility of this manual for different populations will also be evaluated, and adherence and competence measures to assess cbt delivery will be developed. this study will last 24 weeks. participants will be randomly assigned (like the flip of a coin) to either start cbt treatment immediately or to a waitlist group, which would require a 3-month wait without treatment before beginning treatment for this study. participants have a 50-50 chance of being in either group. participants will receive a total of 22 sessions of individual, manual-based cbt. the cbt sessions will occur weekly during the course of the study. during the sessions, participants will receive education about bdd and cbt, engage in activities that help them confront their bdd, learn new ways of thinking about body image, and learn relapse prevention techniques. self-report scales will be used to assess participants.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of bdd for at least 6 months prior to study entry * score higher than 23 on bdd yale-brown obsessive compulsive scale * live within driving distance of boston, ma or providence, ri exclusion criteria: * any psychiatric diagnoses other than bdd * alcohol abuse or dependence within 3 months prior to study entry * suicidal or homicidal * psychotropic medication within 2 months prior to study entry

Keywords: cognitive behavioral therapy cbt bdd body dysmorphic disorder
a study to monitor the use of an amino acid-based infant formula

Conditions: Cow's Milk Protein Allergy; Eosinophilic Gastrointestinal Disorders; Malabsorption/Maldigestion; Short Bowel Syndrome; Multiple Food Allergies

Summary: to assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.

prospective, post-market surveillance program to be conducted in the united states (us). infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula

Eligibility criteria:
inclusion criteria: * infants who use a free amino acid based infant formula during their first year of life including: * those that are currently consuming the formula at the time of enrollment * those for whom consumption of the formula is planned * at least one parent/guardian is willing to provide written informed consent form (icf) for participation in the surveillance program exclusion criteria: - infants \<37 weeks of corrected gestation age (cga) at time of enrollment
impact of anti-platelet drug exposure on platelet mrna splicing in healthy subjects

Conditions: Thrombosis; Artery

Summary: the purpose of this pilot study is to determine how the anti-platelet drug, ticagrelor, impacts platelet mrna splicing after a single loading dose in 10 healthy participants. these results will be valuable in that they will help inform our analysis of platelet rna splicing after a thrombotic event.

there is nothing known on how differential splicing in platelets is impacted by of p2y12 inhibition by anti-platelet agents. consequently, the focus of this longitudinal pilot study will be to determine the impact of a single ticagrelor loading dose (180 mg), our "model" anti-platelet drug, on platelet rna splicing in 10 healthy individuals. it will test the hypothesis that ticagrelor exposure does not significantly alter platelet mrna splicing. it will involve administering a single loading dose (180 mg) of ticagrelor to healthy volunteers.

Eligibility criteria:
inclusion criteria: * 18 - 70 years-old * speak and understand english exclusion criteria: * history of blood clotting/bleeding disorders * current medications that are cyp3a4 inhibitors/inducers * current medications that their pharmacokinetics is impacted by ticagrelor (i.e. simvastatin, lovastatin, digoxin) per fda recommendations. * diagnosed with arterial or venous thrombosis * active cancer diagnosis * pregnant * hepatic impairment including active hepatitis infection or cirrhosis * current hormonal contraception * currently taking aspirin or anti-platelet drugs. if patient has recently taken an nsaid, the last dose should have been discontinued based established criteria
energy content and energy density of pre-portioned entrees

Conditions: Obesity

Summary: pre-portioned entrées are commonly consumed to help control portion size and limit energy intake. few studies, however, have investigated the influence of the characteristics of pre-portioned entrées on energy intake. this study investigates how the characteristics of solid pre-portioned entrées, specifically, variations in their energy content and energy density influence energy intake over a day. the investigators hypothesize that reducing the energy content and energy density of compulsory entrées will act independently and add together to reduce daily energy intake.

this experiment uses a crossover design with repeated measures within subjects. one day a week for four weeks, participants are provided with all of their foods and beverages for breakfast, lunch, and dinner meals. across test days, the entrée at each meal is varied in both energy content and energy density between a standard level (100%) and a reduced level (64% of the standard). following consumption of a compulsory entrée, a variety of unmanipulated foods will be served for ad libitum consumption. the order of experimental conditions is counterbalanced across the subjects.

Eligibility criteria:
inclusion criteria: * regularly eat three meals per day * do not smoke * do not have any food allergies or restrictions * are not athletes in training * are not dieting * are not taking medications that would affect appetite * are willing to consume the foods served in the test meals exclusion criteria: * a score \> 40 on the zung scale * a score \> 20 on the eating attitudes test * reported known health problems * weight not maintained within 10 lb during the 6 months before the start of the study

Keywords: energy content energy density energy intake pre-portioned entrees