Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study comparing abt-143 to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides

Conditions: Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

Summary: the primary purpose of this study is to test the effect and safety of three different doses of abt-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

there are 4 treatment groups in the study: abt-143 capsules 20/135 mg, abt-143 capsules 10/135 mg, abt-143 5/135 mg, and simvastatin capsules 40 mg. the primary outcome measure only compares 2 of these groups: abt-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . secondary outcome measure (mean percent change in ldl-c comparing abt-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: abt-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. secondary outcome measure (mean percent change in ldl-c comparing abt-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: abt-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. for the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in hdl-c from baseline to the final visit for the full analysis sets, all 3 abt-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures.

Eligibility criteria:
inclusion criteria * participants with hypercholesterolemia and hypertriglyceridemia. * participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the screening visit(s)): * triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dl) and less than 400 milligrams/deciliter, and * low-density lipoprotein cholesterol greater than or equal to 160 milligrams/deciliter and less than or equal to 240 milligrams/deciliter. exclusion criteria * participants with certain chronic or unstable medical conditions. * participants receiving coumarin anticoagulants, systemic cyclosporins, or certain other medications. * pregnant or lactating women, or women intending to become pregnant. * participants with diabetes mellitus that is poorly controlled. * participant was of asian ancestry (having filipino, chinese, japanese, korean, vietnamese, or asian-indian origin).

Keywords: dyslipidemia hypercholesterolemia hypertriglyceridemia
treatment of anemia in subjects with non-myeloid malignancy receiving multicycle chemotherapy

Conditions: Anemia; Non-Myeloid Malignancies

Summary: the purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.


Eligibility criteria:
inclusion criteria: * subjects with non-myeloid malignancy * at least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule * hemoglobin concentration less than 11.0 g/dl within 24 hours before randomization * adequate serum folate and vitamin b12 * eastern cooperative oncology group (ecog) performance status of 0 to 2 * of legal age at the time written informed consent is obtained exclusion criteria: * known history of seizure disorder * known primary hematologic disorder causing anemia other than non-myeloid malignancies * unstable/uncontrolled cardiac condition * clinically significant inflammatory disease * other diagnoses not related to the cancer which can cause anemia * inadequate renal and liver function * iron deficiency * known positive test for hiv infection * previously suspected of or confirmed to have neutralizing antibodies to rhuepo * received more than 2 red blood cell (rbc) transfusions within 4 weeks of randomization; or any rbc transfusion within 14 days before randomization; or any planned rbc transfusion between randomization and study day 1 * received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1 * other investigational procedures * currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s) * pregnant or breast feeding * not using adequate contraceptive precautions * previously randomized into this study * known hypersensitivity to any products to be administered * concerns for subject's compliance

Keywords: non-myeloid malignancy chemotherapy-induced anemia
a study of patients hospitalized with acute heart failure with reduced ejection fraction (hfref)

Conditions: Heart Failure

Summary: a study of participants hospitalized with acute heart failure with reduced ejection fraction


Eligibility criteria:
inclusion criteria: * an average left ventricular ejection fraction (lvef) \< 40% over the entire index hospitalization * age 18 years or older on the index date * at least 6 months of activity in the databaseprior to the index date exclusion criteria: * any code for myocardial infarction (icd-9 diagnosis code: 410.xx, icd-10 diagnosis code: i21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization other protocol defined inclusion/exclusion criteria could apply
communication with mechanically ventilated intensive care patients

Conditions: Critical Illness; Communication; Intensive Care Unit Syndrome

Summary: the overarching aim of this multicenter study is to develop a multimodule training intervention (commec-icu) for nurses working in icus, to increase nurses skills and knowledge and then improve communication for mechanically ventilated icu patients. the intervention will be implemented at the included icus and evaluated both on nurses in the icu and patients. patients with delirium will also be included.

the specific objectives of the research proposal are to: 1. investigate icu patients' perceptions of communication difficulties during mechanical ventilation, and evaluate the relationship between communication difficulties and symptom burden. 2. describe icu nurses' communication skills, communication techniques commonly used, and satisfaction with communication with patients. the results from objectives 1 and 2 are of relevance as such, but will also be used as a basis to develop the commec-icu and as a pre-intervention measure prior to implementation of the new program. 3. further develop and implement commec-icu in the selected icus. 4. evaluate the effect of commec-icu on a) icu nurses after receiving the training program b) former icu patients that have been treated in the icus with were the intervention have been implemented.

Eligibility criteria:
inclusion criteria patients: * patients over the age of 18 * first icu admission during the hospital stay * cognitively competent at the time of consenting to participate * invasive mechanical ventilation via endotracheal tube or tracheostomy for over 48 hours or more calendar days * patients must have been reported awake and communicative or with a richmond agitation and sedation scale over - 1. exclusion criteria patients: * patients who cannot understand norwegian * patients without an address * patients who have cognitive disabilities and are not able to consent or receive information about the study inclusion criteria nurses: having clinical experience from the icu for more than a year.

Keywords: mechanically ventilated patients delir symptoms self-efficacy
efficacy and safety of subcutaneous secukinumab for moderate to severe chronic plaque-type psoriasis for up to 1 year

Conditions: Moderate to Severe Plaque-type Psoriasis

Summary: this study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.


Eligibility criteria:
inclusion criteria: * moderate and severe plaque-type psoriasis diagnosed for at least 6 months. * severity of psoriasis disease meeting all of the following three criteria: * psoriasis area and severity index (pasi) score of 12 or greater, * investigator's global assessment (iga) score of 3 or greater, * total body surface area (bsa) affected of 10% or greater. * inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy. exclusion criteria: * current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate). * current drug-induced psoriasis. * previous use of secukinumab or any drug that targets il-17 or il-17 receptor. * significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject. * hematological abnormalities. * history of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis. * history of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years. * pregnant or nursing (lactating) women. * subjects not willing to limit uv light exposure during the study other protocol-defined inclusion/exclusion criteria may apply.

Keywords: psoriasis plaque plaque-type psoriasis il-17 blocker subcutaneous psoriatic arthritis injection ain457 ain457a secukinumab
development and validation of a prediction model for refeeding syndrome in icu patients undergoing enteral nutrition patients

Conditions: Development and Validation of a Prediction Model for Refeeding Syndrome in ICU Patients Undergoing Enteral Nutrition

Summary: this study intends to strengthen the discussion on the risk factors of rfs in critically ill patients, and construct an rfs risk prediction model which is easy for clinical medical staff to use and has a high sensitivity and specificity; in order to help medical staff to identify the high-risk groups of rfs in critically ill patients efficiently and accurately, and take targeted care and treatment for patients, so as to reduce the adverse consequences of rfs on critically ill patients.


Eligibility criteria:
inclusion criteria: * (1) age ≥18 years old; (2) patients with mechanical ventilation; (3) first admission to icu； (4) the time of receiving enteral nutrition support in icu was ≥ 3 days. exclusion criteria: * (1)ppregnant women or lactating patients;(2) patients with incomplete information;(3) there are other risk factors leading to hypophosphatemia, such as continuous hemodialysis , hyperphosphatemia treatment,parathyroid gland resection was performed within 3 months.

Keywords: refeeding syndrome;enteral nutrition;prediction;intensive care
expand access/assess safety and efficacy of paromomycin im injection for the treatment of visceral leishmaniasis

Conditions: Visceral Leishmaniasis

Summary: this modular program will first confirm the safety and efficacy of paromomycin im injection when given to an expanded population in the outpatient setting in experienced vl centers and subsequently evaluate the effectiveness of an expanded access model of providing paromomycin im injection to progressively more resource-constrained clinics in bihar, india.

safe, effective, and affordable treatments for visceral leishmaniasis (vl) that are widely available to the poorest population of rural india where the disease is endemic are urgently needed. resistance to antimonials, which have historically been the first line of treatment for vl in bihar and adjoining states, is a major problem. other available treatments are limited by their high cost, toxicity, or contraindications in certain populations. paromomycin im injection was approved for the treatment of vl in august 2006 by the drug controller general of india (dcgi). the study is designed to establish a phase 4 access program in a modular, stepwise fashion (modules 1 to 3). the study will first confirm the safety and efficacy of paromomycin im injection in an expanded vl population treated as an outpatient in experienced centers (module 1); and then progressively extend the network of treatment facilities, the number and reach of the trained staff, and the implementation of the requisite logistics systems to rural bihar (modules 2 and 3). an expanded network of healthcare workers will be trained and supervised to make a preliminary diagnosis of vl; to make appropriate referrals to confirm the diagnosis of vl; to treat with paromomycin im injection; and to assess patient safety and clinical response on an outpatient basis.

Eligibility criteria:
inclusion criteria: * confirmed, newly diagnosed or relapsed visceral leishmaniasis exclusion criteria: * hiv infection, tuberculosis * significant hematologic, renal or liver dysfunction * malaria * those unable to be treated as an outpatient.

Keywords: visceral leishmaniasis kala-azar bihar, india
a self-efficacy enhancing stroke self-management program for community-dwelling stroke survivors

Conditions: Stroke

Summary: the aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing stroke self-management program on recovery of community-dwelling stroke survivors.

previous systematic reviews showed that theory-based stroke self-management programs had potential benefits in improving stroke survivors' quality of life and self-efficacy. however there is a lack of evidence evaluating the effectiveness of a nurse-led theory-based stroke self-management program among community-dwelling chinese stroke survivors. this is a parallel group, single-blinded, randomized controlled trial to be held in a community center. all participants will be assessed at two time-points (baseline before randomization, and one month after program completion). eligible participants will be randomly allocated to either the control group (receiving usual care) or the intervention group (receiving the self-efficacy enhancing stroke self-management program). participants in the intervention group will receive an additional assessment on usefulness of the program immediately after program completion.

Eligibility criteria:
inclusion criteria: * aged 18 years or above * have a clinical diagnosis of stroke * currently live at home or will be discharged from hospital to home within one week * have a mini mental state examination score \>18 * speak cantonese * capable of giving informed consent * can attend sessions of the self-efficacy enhancing stroke self-management program * can use a phone exclusion criteria: * diagnosed with transient ischemic attack, subdural or epidural hemorrhage * have cerebrovascular events due to presence of malignancy or head trauma * have limited comprehension and receptive aphasia * have been diagnosed with schizophrenia, bipolar disorder, or dementia * have received a stroke self-management program in the past 12 months as reported by the participants

Keywords: stroke disease management self efficacy quality of life community integration
a new diet for patients with autosomal dominant polycystic disease (adpkd)

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: recent evidence has shown that kidney volume predicts the likelihood of developing renal insufficiency over a finite length of time in adpkd, suggesting a linkage between the growth of cysts and the harm they do to kidney function. recent studies indicate that the rate of kidney volume increase is hastened by excess dietary protein, salt, and potential net acid precursors, and slowed by increased water intake sufficient to lower plasma vasopressin levels. diets are commonly prescribed to treat adpkd and other renal patients with disease near the end-stage, but there is currently no specific diet prescription that takes potentially harmful dietary elements into account for adpkd patients in the earliest stages of the disease. this study will examine a novel diet for adpkd created by the researcher termed the adpkd diet.


Eligibility criteria:
inclusion criteria: * have not been prescribed dietary restrictions or enhancements * blood pressure \<135/85 mmhg with or without specific treatment * willingness to participate for at least one month * diet history consistent with the excretion of \>30 meq nae / day based on usual dietary intake exclusion criteria: * other active diseases requiring pharmacologic agents * unstable weight (+/- 2 kg) for 3 months prior to enrollment * food allergies * pregnancy or lactating * confounding medications, i.e. bicarbonate, citrate * individuals who do not consume meat for personal, religious, or health reasons.

Keywords: adpkd pkd kidney disease adpkd diet
hyperimmune convalescent plasma in moderate and severe covid-19 disease

Conditions: COVID-19

Summary: the clinical trial aims to study the safety and efficacy of transfusion of covid-19 convalescent hyperimmune plasma for the treatment of moderate and severe forms of covid-19 disease in comparison with non-convalescent fresh frozen plasma (standard plasma).

this is a study of the safety and efficacy of the use of covid-19 convalescent plasma (from subjects who have recovered from sars-cov-2) in the treatment of moderate and severe forms of the sars-cov-2 infection. currently, there are no registered drugs for the treatment of the sars-cov-2 infection in the world. the use of hyperimmune plasma is a well-known method used for many decades to treat many dangerous infections. the effectiveness of such a therapy for covid-19 patients has recently been demonstrated in a number of clinical studies in china. therefore, we plan to study the feasibility of administering multiple doses of covid-19 convalescent plasma in comparison with standard plasma to moderate and severe patients with covid-19.

Eligibility criteria:
inclusion criteria: 1. men or women aged 18-75 years. 2. the presence of covid-19 infection, confirmed by pcr testing 3. the presence of the covid-19 pneumonia pattern on the chest hrct with a damage to more than 25% of the lung parenchyma 4. morning fever ≥ 38.0 °c over the last three days 5. crp blood level ≥ 50 mg / ml or ferritin blood level ≥ 600 μg / ml 6. a signed informed consent exclusion criteria: 1. respiratory index ≤200 2. contraindications for the transfusion of donor immune plasma or history of prior reactions to blood transfusions 3. mechanical ventilation 4. the presence of chronic lung diseases with chronic respiratory failure. 5. the need for home continuous oxygen therapy before the onset of current disease. 6. serum creatinine level higher than 150 μmol / l 7. pregnancy or breastfeeding
analgesia for endometrial scratching

Conditions: Subfertility; Infertility

Summary: the aim of this study is to evaluate whether ibuprofen alone or combined with lorazepam reduce the pain associated with endometrial scratching/injury.


Eligibility criteria:
inclusion criteria: * women aged ≥ 18 years undergoing assisted reproduction (iui, ivf/icsi, frozen embryo transfer) * being submitted to endometrial scratching/injury with a pipelle on the first four days of the menstrual cycle. * not have performed endometrial scratching in the last 90 days. exclusion criteria: - none
safety study of apr-246 in patients with refractory hematologic cancer or prostate cancer

Conditions: Hematologic Neoplasms; Prostatic Neoplasms

Summary: the purpose of this study is to determine the highest feasible dose (hfd) of intravenous (iv) apr-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.


Eligibility criteria:
summary criteria for participant selection: inclusion criteria: * male or female ≥ 18 years of age. * any below mentioned advanced disease, which is not eligible for other therapies. the diagnosis should have been confirmed either histologically or cytologically: 1. acute myeloid leukemia. 2. acute lymphoid leukemia. 3. chronic lymphocytic leukemia. 4. chronic myeloid leukemia. 5. chronic myelomonocytic leukemia. 6. multiple myeloma. 7. non hodgkin's lymphoma. 8. hodgkin's lymphoma. 9. myelodysplastic syndrome. 10. myelofibrosis. 11. hormone refractory, metastatic prostate carcinoma.

Keywords: hematologic malignancy prostate carcinoma hematologic cancer prostate cancer
cytokine production and immunity to varicella zoster virus (vzv) in elderly recipients of zoster vaccine

Conditions: Immunity; Defect Due to Antibody or Cell Mediated Immune Defect

Summary: after immunization, particularly in older persons, some people are protected from disease by a vaccine and others are not. the investigators believe that this variable response may be due to overproduction of molecules that suppress development of immunity (antibodies and cell mediated immunity). normally, these molecules are produced to make sure that immunity is regulated in just the right way for the body as a whole, and to prevent autoimmune disease. however, with aging, the immune system may have difficulty in proper immune regulation. over production of immunosuppressive molecules after vaccination may interfere with the effects of a vaccine. for example when elderly individuals are immunized against zoster with a licensed vaccine, zostavax, the vaccine is effective in only about 50 to 60%. the investigators will compare blood levels of antibodies, cellular immunity, and immunosuppressive molecules in recipients of zostavax to see if there is a correlation between development low immunity and high levels of immunosuppressive molecules.

in order to determine whether there is a relationship between production of immunosuppressive cytokines (such as il-10) an lower levels of immunity to varicella zoster virus (vzv) after vaccination, the investigators will obtain blood samples before and 3-5 times after immunization to determine the immunity to vzv and the levels of certain cytokines. the first blood samples will be obtained before the vaccine is given, as baseline values. the vaccine being used is the licensed vaccine, zostavax, which is recommended by the food and drug administration (fda) and center for disease control and prevention (cdc) to be administered to all relatively healthy individuals over the age of 50. this study does not concern vaccine safety or effectiveness. as a benefit to vaccines, the vaccine is administered at no charge to the subject.

Eligibility criteria:
inclusion criteria: * relatively healthy and over 60 years old exclusion criteria: * having already received zostavax

Keywords: immune response varicella zoster virus (vzv) cytokine levels immunization
tens reduces movement-evoked pain in people with clbp

Conditions: Chronic Low-back Pain

Summary: in this cross-over study 25 patients with chronic low back pain (clbp) were tested for pain relief in 2 conditions: while using the transcutaneous electrical nerve stimulation (tens) application and without using it. primary outcome: movement-evoked pain (mep). this was measured using the back performance scale (bps) and a 5-minute walk test (5mwt). participants performed 5 functional tasks and were asked to rate their pain before, during, and after each movement on a numeric rating score scale. the same principle will be used for the 5mwt: for each walking-minute, 3 pain measurements will be assessed.


Eligibility criteria:
inclusion criteria: * chronic nonspecific lbp for at least 3 months' duration: non-specific lbp implies that patients are not allowed to have any evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy). exclusion criteria: * spinal surgery in the past 6 months * severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.), * pregnant or given birth in the preceding year, * having initiated a new lbp treatment in the 6 weeks prior to study participation