Kornimate/medical-research-clean huggingface dataset:
isoprinosine in hiv patients with viral load > 50 y < 200 copies/ml

Conditions: HIV Infections

Summary: virological failure is a complication of treatment in patients with hiv, and it can be as high as 42% to first line treatment or around 18% in second line treatment. the reasons behind this phenomenon are several, including adherence to treatment (self-patient) or those related to the drugs (kinetics, interactions) and the virus itself (resistance patterns). people living with hiv needs treatment for all their lives, another factor to facilitate virus resistance and poor adherence to treatment. for that reason, it is necessary to look for additional therapeutic options to minimize this problem, and the use of immunomodulatory drugs is an interesting topic now. among those drugs, isoprinosine hs been reported not only improve the immune response, it also has the capability to inhibit the replication of rna virus. then, we propose an open label clinical trial to evaluate the effect of isoprinosine in hiv patients with a virological load between 50 and 200 copies/ml.


Eligibility criteria:
inclusion criteria: * older than 18 years old. * patients with a viral load (rna of vih) between \> 50 and \< 200 copies/ml after 24 weeks of antiviral therapy or after scheme change. * informed consent signature exclusion criteria: * younger than 18 years old. * no virologic failure or rna of vih \> 200 copies/ml. * presence of a serious opportunistic infection. * renal failure (including litiasis) or presence of gout. * pregnancy.
medicare anti-aβ mab coverage with evidence development (ced) study

Conditions: Mild Alzheimer's Disease; Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Summary: the anti-aβ mab ced study is a prospective, longitudinal coverage with evidence development (ced) study using clinical data, patient assessments, and administrative claims data of the medicare population, conducted in accordance to the national coverage determination (ncd) on monoclonal antibodies directed against amyloid for the treatment of alzheimer's disease (ad).

the anti-aβ mab ced study is conducted in accordance with the coverage criteria specified in the ncd for patients who have a clinical diagnosis of mild cognitive impairment (mci) due to ad or mild ad dementia. the complete ncd decision memorandum is available on our website (https://www.cms.gov/medicare-coverage-database/view/ncacal-decisionmemo.aspx?proposed=n\&ncaid=305). study overview: 1. clinicians will conduct a neurocognitive evaluation to determine patient eligibility by confirming a clinical diagnosis of mci due to ad or mild ad dementia, and the presence of amyloid using biomarker testing including imaging (amyloid pet), cerebral spinal fluid (csf) studies, and/or blood tests. 2. for all medicare beneficiaries receiving anti-aβ mab treatment for mci due to ad or mild ad dementia, the prescribing clinician will assess the patient's baseline clinical status by cognition and function assessments using validated tools appropriate for use in the mci with ad and mild ad dementia populations and submit these data to the registry via the dedicated cms ced submission portal every six months for up to 24 months (five total assessments). 3. in addition to performing the required cognition and function assessments, prescribing clinicians will need to report on the patient's use of anti-platelet and/or anti-coagulation therapy and whether the patient has developed new amyloid related imaging abnormalities (aria) since the last assessment data submission.

Eligibility criteria:
inclusion criteria: * medicare patients with a clinical diagnosis of mild cognitive impairment due to alzheimer's disease (ad) or mild ad dementia, both with confirmed presence of amyloid beta pathology consistent with ad. exclusion criteria: * none
exercise-induced improvements of inflammatory status in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary aim of the study is to investigate if 10 weeks of high intensity interval training improve inflammatory status in patients with rheumatoid arthritis.

rheumatoid arthritis (ra) is a chronic, systemic inflammatory disorder that may affect many tissues and organs, but principally attacks synovial joints. although the cause of rheumatoid arthritis is unknown, autoimmunity plays a role in both the chronicity and progression, and ra is considered as a systemic autoimmune disease. due to chronic inflammatory status, ra-patients are at higher risk of developing cardiovascular disease (cvd) compared to the general population. accumulating evidence indicates that regular physical activity has beneficial effects on ra. the mechanisms behind exercise-induce improvements are none the less unclear and more research is needed to better understand the beneficial effects of exercise training in this patient group. recently, promising results from gene expression studies of blood cells have revealed unexplored fields of biomarker discovery and gene expression profiling of disease. due to easy accessible and minimally invasive sample collection, gene expression profiling of whole blood might turn out to be a promising tool in molecular diagnostics and clinical medicine. to our knowledge, whole-genome transcriptional changes have not previously been studied in ra-patients undergoing a high-intensity exercise program. hypothesis: ten weeks of high intensity interval training improves the inflammatory status, quality of life, and known risk factors for cardiovascular diseases. in addition to measure traditionally inflammatory markers in the blood, whole genome analysis will be made.

Eligibility criteria:
inclusion criteria: * ability to exercise * written consent exclusion criteria: * inability to exercise * known ischemic cardiovascular disease * severe pulmonary disease * high activity level * pregnancy * drug/alcohol abuse * unstable ra * diagnosis before 2000

Keywords: high intensity exercise cardiovascular risk factors
zonisamide for weight reduction in obese adults

Conditions: Obesity

Summary: the primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.

this rct compares two doses of zonisamide and placebo for one year. a total of 225 subjects are randomly assigned to one of the three treatment interventions at duke university medical centre. the primary outcome measure is change in body weight in kilograms. secondary outcomes include changes in waist circumference, glycaemic and inflammatory markers, lipids, food craving, hunger and satiety, quality of life, blood pressure and heart rate.

Eligibility criteria:
inclusion criteria: age 18-65 years; bmi 30-50 exclusion criteria: secondary obesity; significant cardiovascular disease; stroke, seizure disorder or other significant neurological disease; significant liver or gallbladder disease; significant renal disease or history of kidney stones; hiv positive status; diabetes mellitus; untreated or unstable hypothyroidism malignancy in the past 5 years; concomitant medications that cause significant weight gain or weight loss; concomitant use of prescription or otc weight loss medications; had bariatric surgery or planning surgery in the next 1 year; weight change of more than 4 kg in the past 3 months; suicidal subjects; major depression in the past 6 months; history of psychosis, bipolar disorder, or severe personality disorders; subjects taking antipsychotics or mood stabilisers; alcohol or substance abuse in the past 6 months; currently taking zonisamide or other antiepileptic drugs; history of hypersensitivity to zonisamide or sulfonamides; pregnant or planning pregnancy in the next year, or breastfeeding; severe physical disability; current participation in a commercial weight loss program or planning to participate; currently following low-carbohydrate, high protein, high fat diet; use of investigational medications or devices (current or past 4 weeks) -

Keywords: obesity treatment weight loss antiobesity drugs zonisamide
investigation of the efficacy of quinine sulphate administered via taste-masked pellets to children with falciparum malaria

Conditions: Malaria

Summary: no pediatric formulations of quinine exist. therefore, quinine tablets are broken into 2 or 4 parts, according to the body weight. based on the body weight, 1/2 or 1/4 a tablet is administered to the child. at this moment, quinine sulphate pellets are developed. these pellets enable an adequate dosing according to the body weight. 56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body weight.


Eligibility criteria:
inclusion criteria: * malaria (falciparium malaria, uncomplicated) * informed consent exclusion criteria: -
pitavastatin pre-treatment study in patient with elective pci for stable angina pectoris (pipa)

Conditions: Percutaneous Coronary Intervention

Summary: patients who is scheduled elective pci are randomized to pitavastatin 4mg daily or without pitavastatin for 5 -7days before the procedure. creatine kinase-mb, troponin i, and myoglobin levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation). after pci, pitavastatin will be administered for additional 4 weeks(2nd evaluation).

procedural ischemic myocardial injury remains the most frequent complication after coronary angioplasty. recently it was reported that pretreatment with atorvastatin reduce the myocardial damage compared to placebo. thus, we will evaluate the difference of pretreatment of pitavastatin compared to standard therapy on the reduction of myocardial damage in patient who is scheduled elective pci for stable angina pectoris.

Eligibility criteria:
inclusion criteria: * patients with ldl ≥ 100mg/dl * patients who are scheduled an elective pci for stable angina exclusion criteria: * acute myocardial infarction (\<3 months) * unstable angina * previous treatment with statins (\<6 months) * increase in ck-mb above upper normal limit * increase in liver enzymes (ast/alt) above 2 times of upper normal limit * increase in serum creatinine above 2 times of upper normal limit * left ventricular ejection fraction \<30% * previous treatment with glycoprotein ⅱb/ⅲa receptor inhibitor (\<4 weeks)

Keywords: pitavastatin pci stable angina
to estimate relative bioavailability of 5 formulations of ronacaleret given to healthy postmenopausal females

Conditions: Osteoporosis

Summary: this study will examine the effects of formulation on the relative bioavailability of sb-751689 (400 mg) administered to healthy postmenopausal women. subjects will receive a single oral dose of each formulation, with five formulations of sb-751689 tested in total. blood samples will be taken up to 24 hours postdose after each dose administration. this study will provide information for future possible formulation development of sb-751689 for phase iii.


Eligibility criteria:
inclusion criteria: * healthy postmenopausal women * non-smokers * body weight \> or = 50 kg and bmi within the range 19-32 kg/m2 * capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form * qtcb or qtcf \< 450 msec; or qtc \< 480 msec in subjects with bundle branch block * hispanic or non-hispanic (caucasian) ethnicity exclusion criteria: * any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study * positive urine drug screen at screening * positive urine test for alcohol at pre-dose * positive for hiv or hepatitis b or c virus at screening * urinary cotinine levels indicative of smoking at screening * history of smoking or use of nicotine containing products within one year of the study or \>10 pack-year history of smoking overall * history of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening * history of drug abuse within 6 months of the study * participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of the current study medication. * exposure to more than four new chemical entities within 12 months prior to the first dosing day. * use of prescription or non-prescription drugs * consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication * donation of blood in excess of 500 ml within 56 days prior to dosing * evidence of renal, hepatic or biliary impairment * history of serious gastrointestinal disease * history of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. * history of clinically significant cardiovascular disease * medical conditions that might alter bone metabolism * serum parathyroid hormone (ipth) test levels outside the reference range at screening * liver function tests, parathyroid hormone test or cpk outside the reference range at screening

Keywords: formulation drug study, healthy postmenopausal
a study of rucaparib in patients with metastatic castration-resistant prostate cancer and homologous recombination gene deficiency

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: the purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.


Eligibility criteria:
inclusion criteria: * be 18 years old at the time the informed consent form is signed * have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate * be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dl (1.73 nm) * experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease * have a deleterious mutation in brca1/2 or atm, or molecular evidence of other homologous recombination deficiency exclusion criteria: * active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer * prior treatment with any parp inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy * symptomatic and/or untreated central nervous system metastases * pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib

Keywords: crpc parp inhibitor parpi brca atm hrd triton homologous recombination dna repair dna defect dna anomaly bard1 brip1 cdk12 chek2 fanca nbn palb2 rad51 rad51b rad51c rad51d rad54l germline somatic mcrpc
safety and pharmacokinetics of intravenous and oral posaconazole in immunocompromised children (mk-5592-097)

Conditions: Neutropenia

Summary: this study aims to evaluate the pharmacokinetics of posaconazole (pos) administered intravenously (iv) or orally to immunocompromised pediatric participants.


Eligibility criteria:
inclusion criteria: * have documented or anticipated neutropenia expected to last for at least 7 days, following treatment in at least one of the following clinical situations: acute leukemia, myelodysplasia, severe aplastic anemia, recipients of autologous hematopoietic stem cell transplant (hsct), high risk neuroblastoma, advanced stage non-hodgkin's lymphoma, hemophagocytic lymphohistiocytosis * have a central line in place prior to iv study therapy * participants of reproductive potential agree to remain abstinent, or use a medically accepted method of birth control exclusion criteria: * has a proven or probable invasive fungal infection * has received any formulation of pos within prior 10 days * is receiving any prohibited drugs * has laboratory results that are outside of normal limits at screening, as follows: a) moderate or severe liver dysfunction, as defined as: aspartate aminotransferase (ast) \> 5 times the upper limit of normal (uln), or alanine aminotransferase (alt) \> 5 times the uln, or serum total bilirubin \>2.5 times the uln, or ast or alt \> 3 times uln with total bilirubin \> 2 times uln; b) calculated creatinine clearance \<30 ml/min. * has qtc (qt interval corrected for rate) prolongation defined as: a) symptomatic qtc prolongation \>450 msec (males) or \>470 msec (females) or b) any qtc prolongation of \>500 msec * is pregnant, intends to become pregnant during study, or is breastfeeding * has a history of anaphylaxis attributed to the azole class of antifungal agents * is not expected to receive a minimum of 10 days of pos iv solution * has participated in any phase 1 investigational new drug (ind) study within prior 30 days or expects to do so within the following 60 days * is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial
safety & immunogenicity study of 10-valent pneumococcal conjugate vaccine when administered as a 2-dose schedule

Conditions: Infections, Streptococcal

Summary: assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with dtpa-hbv-ipv/hib or dtpa-ipv/hib (according to national recommendations)

total anticipated: 300 subjects (150/group). 2-dose group - 10-valent pneumococcal vaccine + dtpa combined vaccine (2, 4, 11 months); comparator group - 10-valent pneumococcal vaccine (2, 3, 4, 11 months) + dtpa combined vaccine (2, 4, 11 months). the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * a male or female between, and including, 8 and 16 weeks (56-120 days) of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * born after a gestation period of 36 to 42 weeks. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) and ending 30 days after the last dose, with exception of bcg vaccination which can be given after the 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule) blood sampling and a minimum of 30 days before the pre-booster dose blood sampling. * previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis b, haemophilus influenzae type b, and/or s. pneumoniae. * history of or intercurrent diphtheria, tetanus, pertussis, hepatitis b, polio, haemophilus influenzae type b disease, and/or invasive pneumococcal diseases. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * history of any neurologic disorders or seizures. * acute disease at the time of enrolment. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * a family history of congenital or hereditary immunodeficiency. * major congenital defects or serious chronic illness. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Keywords: primary vaccination pneumococcal disease safety booster vaccination immunogenicity pneumococcal vaccine dose comparison
comparison of two nn1250 formulations in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two nn1250 (insulin degludec, ideg) formulations in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
behavioral expressions in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: behavioral expressions, such as agitation and aggression, affect up to 90% of persons with dementia and are a major source of patient and caregiver distress, nursing home placement, anti-psychotic medication use, restraints, and increased health care costs. the purpose of the research study is to investigate whether reducing pain reduces behavioral expressions of alzheimer's disease (agitation and aggression).

the research study will investigate if routine analgesic use will reduce behavioral expressions of dementia and pain in older adults with alzheimer's disease or other dementias. using a randomized, placebo-controlled, double-blind, cross-over design, the investigators will compare effects of a routine acetaminophen intervention (650 mg administered routinely by mouth three times per day for 4 weeks) to those of routine placebo (methylcellulose), also given for 4 weeks. the maximum dose to be administered will be 1,950 mg per 24 hours, which is below the current fda recommendations (maximum dose of 3,000 mg/day). participants will be randomly assigned to either treatment or placebo group. the initial treatment phase will last for 4 weeks. at the end of the first 4 weeks, the treatment will be reversed after a 3 day washout period. during the 2nd intervention period, the study drug will be reversed (those receiving acetaminophen will receive the placebo drug and vice versa). the second treatment phase will last for 4 weeks. at the end of 2nd treatment phase, all study treatments will be discontinued

Eligibility criteria:
inclusion criteria: * documented diagnosis of alzheimer's disease or other dementia * history of a typically painful condition, such as osteoarthritis, back pain, or other chronic musculoskeletal pain * able to swallow oral medication * history of aggressive or agitated behavior (defined as score of \> 39 on the cohen-mansfield agitation inventory), * mini mental state exam (mmse) score \< 23 exclusion criteria: * currently taking acetaminophen or opioid medication on a routine (regularly-scheduled, round the clock) basis * receiving hospice care * history of liver or renal disease * drinks more than 3 alcoholic beverages per day * known allergy or adverse reaction to acetaminophen * bed-ridden or comatose * currently taking warfarin