Kornimate/medical-research-clean huggingface dataset:
the role of adrenomedullin on the outcome of severe heart failure: a clinical randomized study

Conditions: Heart Failure

Summary: 1. study hypothesis: * the decrease of plasma adrenomedullin (adm) concentration by ultrafiltration and isovolumetric hemofiltration in patients with acute iii and iv class new york heart association functional(nyha) heart failure is more pronounced than a standard diuretic treatment and is related with clinical improvement. 2. outcome measurements: to correlate the adrenomedullin plasma levels with clinical treatment, ultrafiltration and hemofiltration related to: * brain natriuretic peptide (bnp) level * angiotensin ii level * sympathetic nervous activity * oxydative stress * clinical outcome at the beginning, at discharge and 90 days after randomization.

testing the hypothesis that adrenomedullin (adm) is a important peptide in severe heart failure and that is related to clinical condition, we will study the effects of 3 different treatments (clinical usual treatment,ultrafiltration and isovolumetric hemofiltration with diuretics) to participants are followed until discharge to adrenomedullin level and clinical outcomes,and also their relationship with angiotensin ii level, brain natriuretic peptide(bnp), sympathetic nervous system and oxydative stress. the patients will be randomized in three different treatment group and analyzed in three moments: on the randomization, at discharge and 90 days after randomization(plus or minus 3). the clinical treatment will be optimized, the ultrafiltration will be done until clinically adequate fluid removal or until hematocrit increased 10% from basal level, and isovolumetric hemofiltration will be done for 8 hours- dose of 35 ml/kg/h in association with diuretic. all this dialytic procedures will be done with paes membrane- filter hf1400 and automatic machine.

Eligibility criteria:
inclusion criteria: * more than two item: * more than eighteen years of age * orthopnea * chest rx with cardiomegaly and pulmonary infiltration * edema * diuretic resistance exclusion criteria: * insulin dependent diabetes * hepatic cirrhosis * vascular access problems * creatinine more than 2,5 mg/dl before acute heart failure * systemic infection * aortic stenosis and heart transplantation * radiologic contrast up to 72 hours prior randomization * advanced neoplasia

Keywords: adrenomedullin heart failure ultrafiltration hemofiltration
mk0462 5 mg, sumatriptan 50 mg, and placebo comparison study (0462-029)

Conditions: Migraine Headache

Summary: a study to compare rizatriptan (mk0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.


Eligibility criteria:
inclusion criteria: * participant had at least a 6-month history of migraine, with or without aura * participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions * participant was judged to be in good health, apart from migraine exclusion criteria: * participant was pregnant or a nursing mother * participant had a history or current evidence of drug or alcohol abuse * participant had a history or clinical evidence of cardiovascular disease * participant had a clinically significant electrocardiography (ecg) abnormality * participant had a resting systolic blood pressure of greater than 145 mm hg or diastolic of less than 95 mm hg at screening * participant had received treatment with an investigational device or compound within 30 days of the study * participant typically suffered from less then 1 or more than 8 attacks of migraine per month * participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches * participant was currently taking monoamine oxidase inhibitors, methysergide or lithium
vagus nerve injury post radiofrequency catheter ablation for atrial fibrillation

Conditions: Atrial Fibrillation; Gastrointestinal Tract; Radiofrequency Catheter Ablation

Summary: this study is an observational study designed to determine the extent of gastrointestinal (gi) post-procedure complications after radiofrequency catheter ablation (rfca) for atrial fibrillation (af). this exploratory study will evaluate patient symptoms prior to the rfca procedure, at 1 month post rfca procedure, and at 3 months post rfca procedure, through the administration of a questionnaire. the purpose of this study is to determine if vagus nerve injury resulting from rfca for af increases the risk of post-procedure gi complications that may present as temporary or permanent symptoms.


Eligibility criteria:
inclusion criteria: * patients with a verified medical history of atrial fibrillation. * male or female \>18 years of age. * patients scheduled for an rfca procedure, subsequent to failure of one antiarrhythmic drug (aad class i, iii or iv), or ablation. * ability to answer questions posed by the questionnaire. * ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. exclusion criteria: * none
e07-001: safety and efficacy extension study of eculizumab in paroxysmal nocturnal hemoglobinuria patients

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the objective of this study was to assess the long-term safety and efficacy of eculizumab in hemolytic pnh patients who completed the 4-week screening and 12-week treatment period of the c07-001 study. in addition, pharmacokinetic and pharmacodynamic assessments of eculizumab were conducted.


Eligibility criteria:
inclusion criteria: * patients must have fully completed c07-001 study 12-week treatment period exclusion criteria: * patients who terminated early from the c07-001 study

Keywords: hemolytic paroxysmal nocturnal hemoglobinuria eculizumab pnh
comparison of 30 units of ti (technosphere® insulin) prepared with insulin from two different suppliers

Conditions: Healthy Volunteers

Summary: a phase 1, open-label randomized crossover trial in healthy volunteers to evaluate the pk/pd of ti (technosphere® insulin) prepared with insulin from two different suppliers.


Eligibility criteria:
inclusion criteria: * men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis * hnvs with a screening blood pressure less than 140/90 mm hg * subjects who have hypertension controlled with up to 1 medication and who have a blood pressure less than 140/90 mm hg * note: for subjects with blood pressure at or above 140/90 mm hg; two additional readings 5 minutes apart are allowed but the last blood pressure reading must be in range * subjects who have hypercholesterolemia controlled with up to 1 medication and who have a low-density lipoprotein value less than 160 mg/dl * good venous access for blood draws * no smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine cotinine testing \< 100 ng/ml * body mass index (bmi) \< 32 kg/m2 * completion of informed consent form exclusion criteria: * blood donation (500 ml) within the last 8 weeks * fasting blood sugar \>100 mg/dl * history of coronary artery disease, peripheral vascular disease, or congestive heart failure * allergy to study drug, components of boost and boost plus, or other study material * clinically significant active or chronic illness * history of asthma, copd, or any other clinically relevant chronic lung disease * respiratory tract infection within 4 weeks before screening * history of drug or alcohol abuse within the past 5 years * positive urine drug screen * clinically significant screening ecg, physical examination, laboratory test, or vital sign abnormality * exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism * history of malignancy within the 5 years before screening (other than basal cell carcinoma) * history of human immunodeficiency virus (hiv) infection or hepatitis b or c * women who are pregnant, lactating, or planning to become pregnant during the clinical study period * women of childbearing potential (premenopausal who have not undergone hysterectomy or bilateral tubal ligation, or postmenopausal for fewer than 2 years) not practicing adequate birth control. adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile. * any subject who, in the opinion of the pi or a designee, appears not to be qualified for this study
intrapleural bupivacaine for ipsilateral shoulder pain after thoracotomy

Conditions: Post Thoracic Surgery

Summary: while thoracic epidural could control incisional pain after thoracotomy, an excruciating ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy patients. it is often difficult to manage and relatively resistant to opioids. the investigators postulate that in the presence of a functioning thoracic epidural, intrapleural bupivacaine administered through the chest tube could be effective in reducing post thoracotomy ipsilateral shoulder pain.


Eligibility criteria:
inclusion criteria: * male and female, between 18 and 80 years, asa 1-3, scheduled for open thoracotomy exclusion criteria: * asa \>3, morbid obesity bmi\>40, previous cardiac or ipsilateral thoracic surgery, renal or hepatic failure, anemia, allergy to local anesthetics, contraindications to receive regional anesthesia, patient refusal, reiteration due to complication
validating a self-fitting hearing aid

Conditions: Hearing and Vision Loss

Summary: eargo, inc. has developed a hearing aid that contains self-fitting gain software that allows adults with mild-to-moderate hearing loss to test their hearing sensitivity and program hearing aids to match their measured hearing loss. traditionally, hearing aids are custom programmed by a hearing health professional based on a professional hearing test. this technology has the potential to improve affordability and accessibility of hearing aids for adults with mild-to-moderate hearing loss. we propose to validate eargo's self-fitting software in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by a professional following usual clinical best practice for fitting hearing aids.

the study will recruit 30-50 adults age 18 and over with mild-to-moderate hearing loss in both ears. we will aim to recruit a sample with roughly equal number of males and females and new and experienced hearing aid users (defined by any hearing aid use within the previous 6 months). hearing loss will be measured using the results of a standard clinical hearing test. we will use a within-subject, crossover design in which all participants will complete both field trial hearing aid conditions (self-fit and clinically fit hearing aids). the order of the field trials will be randomized across participants to account for any potential order effects. after each field trial, participants will visit the lab to complete study outcome measures, including hearing aid benefit, subjective sound quality, and speech in noise intelligibility testing.

Eligibility criteria:
inclusion criteria: * mild to moderate hearing loss ability to follow written directions, exclusion criteria: * inability to use software during first visit

Keywords: hearing aids, self-fitting
medication adherence in older people with psychosis

Conditions: Psychotic Disorders; Schizophrenia

Summary: this study will determine whether medication adherence therapy (mat) can improve medication adherence and lower the risk of rehospitalization in older patients with psychosis.

psychoses are among the most common and serious psychiatric disorders. currently, the most effective treatment for psychoses involves the use of antipsychotic or neuroleptic medications. unfortunately, pharmacologic regimens often do not achieve their goals because of poor medication adherence. nonadherence to antipsychotic treatment is a considerable public health problem that leads to myriad clinical and economic burdens, including psychotic relapse, increased clinic and emergency room visits, and rehospitalization. participants in this study are randomly assigned to receive either mat or supportive treatment for 12 weeks. mat is given in 15 sessions and consists of motivational interviewing, education, and social skills and behavior modification. individual mat sessions are held in weeks 1 and 12; small group sessions take place in weeks 2 through 11. three monthly booster group sessions begin in week 16. participants are assessed at baseline and at 3, 6, and 12 months. medication adherence, psychopathology, quality of life, medication side effects, health beliefs, and functioning are assessed.

Eligibility criteria:
inclusion criteria: * dsm-iv criteria for schizophrenia or schizoaffective disorder * outpatient status at the time of enrollment * currently prescribed maintenance treatment with antipsychotic medication (typical or atypical, oral or depot)
ymca produce prescription project (yprx)

Conditions: Pre-diabetes

Summary: in this randomized control study, participants will be randomized 1:1 to either participate in the ymca's produce prescription program (yprx) and receive weekly deliveries of fresh produce bags for their household or to receive yprx plus participate in the diabetes prevention program (dpp). the investigators hypothesize that participants randomized to receive yprx plus dpp will have greater weight loss, increased physical activity, improved diet quality and behaviors, increased food security, improved self-rated health assessment, decreased healthcare utilization from baseline to endline (12 months) compared to those randomized to receive yprx produce deliveries only. we will also collect data on process measures for implementation purposes.

this study is a randomized control trial testing the impact of adding disease-specific, evidence-based health education (dpp) to produce prescriptions (yprx) on participants' health. dpp is a 12-month diabetes prevention behavioral weight loss program developed by the centers for disease control and prevention and implemented nationwide. in this study, investigators will test whether the addition of health education, coaching, and peer support through dpp improves the effectiveness of yprx. this trial will take place in the washington d.c. metropolitan area in collaboration with the ymca of metropolitan washington, a provider of dpp and yprx, hungry harvest, a purveyor of produce deliveries, and amerigroup/elevance health, a medicaid managed care organization. participants will be randomized 1:1 to either participate in yprx only or to participate in yprx plus the dpp. the length of the trial will be 12 months for each participant, and outcomes will be measured at baseline, 4 weeks, 3 months, 6 months, 9 months, and 12 months.

Eligibility criteria:
inclusion criteria: * over the age of 18 * recipient of medicaid through amerigroup * has never been diagnosed with type i or type ii diabetes * access to laptop, computer, or phone with internet, or willing to use a provided device * district of columbia resident * available to attend dpp classes at the scheduled recurring day and time * not pregnant exclusion criteria: * under the age of 18 * not a recipient of medicaid through amerigroup * has been diagnosed with type i or type ii diabetes * no access to laptop, computer, or phone with internet * not a resident of the district of columbia * cannot attend dpp classes at the scheduled recurring day and time * pregnant

Keywords: diabetes prevention program produce rx program produce prescription
a pilot study on the effect of vitamin d treatment in patients with statin-associated myalgia

Conditions: Hyperlipidemia

Summary: the purpose of this study is to measure the effect vitamin d has in alleviating muscle pain or aches that may be caused by taking certain medications for treating high cholesterol.

participation in this study will consist of at least two study visits, expected to occur over a period of up to four weeks. study-related medication will be provided at no cost to participants. participants will receive either vitamin d or placebo (sugar pill).

Eligibility criteria:
inclusion criteria: * men and women who are between the ages of 18 and 88 years old * a muscle symptom defined as any of the following: myalgia (muscle aches with normal ck); myopathy (muscle aches with increased ck up to 5 times above the upper limit of normal); or myopathy for the purpose of further evaluation (muscle aches with increased ck up to 5 times the upper limit of normal) exclusion criteria: * women who are pregnant, breastfeeding or planning to become pregnant * morbidly obese with a bmi \>40 kg/m2 * travel to southern states, areas near the equator, etc., or use of artificial tanning beds, such that study participants have increased sunlight/uv rays exposure in the past 30 days or at any point during the trial * currently (within the last 2 weeks) using any of the following supplements: vitamin d-3 (cholecalciferol) of more than 400 iu orally daily, which would not exclude typical multi-vitamin use; vitamin d-2 (ergocalciferol); calcitriol; or coenzyme q10 * documented to be hyperglycemic or laboratory results show hyperglycemia prior to randomization * renal dysfunction defined as glomerular filtration rate less than 60 ml/min. * documented to have parathyroid abnormalities or parathyroid hormone laboratory results show the study participant is outside of the normal limits

Keywords: statin-related myalgia high cholesterol
the effect of pramlintide on meal time insulin bolus

Conditions: Type 1 Diabetes

Summary: the primary objective is to establish the mean percentage of change in the insulin-to-carbohydrate ratio due to pramlintide treatment once a maximum tolerated dose or 6 mcg before each meal is reached. the secondary objective is to establish which insulin bolus wave form is associated with the lowest post-bolus without hypoglycemia in subjects treated with maximum pramlintide dosage.

pramlintide. an amylinomimetic, is effective in reducing post-meal glucose by non-insulin means. as such, when patients requiring insulin treatment are treated with pramlintide, the bolus insulin does must be reduced. current recommendations suggest a 50% reduction but in our experience and that of a recent study this appears excessive. by using continuous glucose monitoring(cgm) to guide pre-meal insulin treatment, we will determine the percentage reduction in meal time insulin bolus comparing pre-pramlintide to maximum pramlintide treatment. we anticipate that the reduction in bolus dosage will be about 25%. in addition, the secondary aim of this study is to determine which bolus pattern, standard, square or dual wave, provides the best post-meal glucose control with pramlintide therapy.

Eligibility criteria:
inclusion criteria: * age: \>17 * type i diabetes * onset of diabetes \>3 months * use of insulin pump \>3 months * hb a1c \<8.9% * demonstrated compliance to clinic visits * demonstrated knowledge and use of bolus dosing calculations, carbohydrate counting, use of insulin pump and blood glucose meter * monitor blood glucose \>4/day exclusion criteria: * pregnancy or nursing * recent (within last 3 months) factor that may cause change in insulin sensitivity, e.g. severe emotional or physical stress, recent significant infection or surgery. etc. * renal failure (creatinine \>1.5 mg/dl * symptomatic gastroparesis * using a medication that would interfere with insulin sensitivity * treatment with extenatide or dpp iv inhibitor within the last 4 weeks * hba1c change \>0.9 % within the last 3 months * significant change in eating or activity pattern * weight change of \>1.9 kg within the last 3 months * alt \>3 times upper limits of normal

Keywords: type i diabetes insulin pump continuous glucose monitoring insulin to carbohydrate ratio correction factor pramlintide
the role of 18f-fdg-pet for staging and prognostication

Conditions: Mantle Cell Lymphoma

Summary: a retrospective, multicenter, non-interventional, imaging study ancillary to fil_mcl0208 clinical trial (nct02354313) in untreated adult patients with mantle cell lymphoma.

this is a retrospective, multicenter, non-interventional, imaging study devoted to patients diagnosed with mcl and enrolled in the mcl0208 international randomized, phase iii clinical trial (nct02354313). the study is aimed at addressing a number of prognostic issues that still need to be clarified in mcl patients, by taking advantage of the pet performed within the mcl0208 trial and available for the analysis, and the clinical records and molecular data generated in the context of the trial. in the clinical trial pet was optional at baseline (b-pet), before asct (i-pet) and after-asct (eot-pet), and none of the exams was used in the decisionmaking strategy. all the pets available will be collected and considered for analysis. the study will not require additional treatment or procedures except those required for the mcl0208 trial. the participation of the patient to the mcl0208 trial is a pre-requisite to be involved in this study.

Eligibility criteria:
inclusion criteria: * enrollment of the patient in the mcl0208 clinical trial documented by the signature of the study informed consent; * patient's treatment in one of the centers that participated in the mcl0208 trial and that has joined the mcl0208-pet study as well; * evidence of signed informed consent for the mcl0208-pet study.

Keywords: prognostic issues pet review mcl
open versus laparoscopic appendectomy

Conditions: Appendicitis

Summary: the aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. the investigators especially focused on the postoperative recovery and long-term complications.


Eligibility criteria:
inclusion criteria: * age over 15 years * suspected acute appendicitis * suitability for laparoscopy exclusion criteria: * patients refusal to participate * lack of a laparoscopic surgeon

Keywords: acute appendicitis