Kornimate/medical-research-clean huggingface dataset:
evaluation of the safety & efficacy of a combination of niacin er & simvastatin in patients with dyslipidemia (oceans)

Conditions: Hypercholesterolemia

Summary: the purpose of this 24 week study is to compare the effectiveness and safety of different doses of niacin er/simvastatin (ns) in subjects with elevated fat levels in their blood (dyslipidemia). at least 600 subjects with a similar medical condition will take part in this study.

objectives: to evaluate the safety and efficacy of the combination product niacin er and simvastatin (ns) in patients with primary type ii dyslipidemia and to descriptively compare flushing rates between two titration schedules for ns.

Eligibility criteria:
inclusion criteria: * patient has primary type ii hyperlipidemia or mixed dyslipidemia. * if the patient is currently taking a lipid modifying medication other than zocor \& he/she is willing to discontinue this medication * ldl-c levels and/or non hdl-c levels above normal. * reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study. exclusion criteria: * patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives. * hba1c ≥ 9% in diabetic patients

Keywords: niacin statin zocor simvastatin coronary heart disease dyslipidemia atherosclerosis hypercholesterolemia stroke high-density lipoprotein cholesterol low-density lipoprotein cholesterol lipoprotein lipid niacin er/simvastatin total cholesterol triglycerides
extended drug utilization study among patients exposed to ticagrelor, clopidogrel and prasugrel

Conditions: Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout

Summary: the purpose of the study is to describe patient characteristics and drug usage among patients that are prescribed ticagrelor for the first time and to compare them with patients who are prescribed clopidogrel and prasugrel for the first time. a further purpose is to ascertain and estimate the crude incidence rate of bleeding, arrhythmias, heart failure, acute renal failure, acute liver failure, dyspnoea and gout among new users in the three cohorts of ticagrelor, clopidogrel and prasugrel.


Eligibility criteria:
inclusion criteria: * first time users of ticagrelor, clopidogrel and prasugrel, respectively exclusion criteria: * individuals with more than one of above three antiplatelet drugs dispensed the same day

Keywords: acute coronary syndrome, thienopyridine, epidemiology
university of wisconsin hmsc cell bank: bone marrow donor protocol

Conditions: Graft Versus Host Disease (GVHD); Acute Myocardial Infarction (AMI)

Summary: the objective of this protocol is to use established standard criteria and methods for the collection of hmsc (human mesenchymal stromal cells) from healthy bone marrow donors. the hmsc collected from the donors will use to develop well-defined and reproducible cell banks. standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. after the cell banks are created, these cell products will be used in future translational or clinical research.

cell banks will be manufactured and cellular products used for future translational or clinical research.

Eligibility criteria:
inclusion criteria: * age 18 to 35 years * willingness to provide written informed consent exclusion criteria: * presence of risk factors for or clinical evidence of human immunodeficiency virus (type 1 and 2), hepatitis b, hepatitis c, human t-lymphotrophic virus (type i and ii), human transmissible spongiform encephalopathy (including creutzfeldt-jakob disease) treponema pallidum, * presence of communicable disease risk associated with xenotransplantation. * test positive for human immunodeficiency virus (type 1 and 2), hepatitis b, hepatitis c, human t-lymphotrophic virus (type i and ii), cytomegalovirus (cvm), west nile virus, treponema pallidum. * use of investigational drug within 30 days or 5 half lives which ever is longer. use of investigational implanted device. * history of malignancy. * pregnancy * in the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide bm donation.

Keywords: msc allogeneic bone marrow cells healthy subject donors collection of msc from bone marrow aspirate bronchiolitis obliterans syndrome (bos)
efficiency of the hepatitis b sci-b-vac vaccine in hiv positive patients

Conditions: HIV

Summary: hbv vaccination is of paramount importance among hiv positive persons due to an increased risk of infection and disease progression. the most widely used engerix b vaccine reaches a lower rate of vaccination (20-70%) among hiv positive vaccinees (compared to over 90% in the normal population). sci-b-vac is novel vaccine containing 3 antigens and is therefore more immunogenic (as opposed to one in engerix b). its use has been associated with higher and more rapid vaccination rates. therefore, it has a theoretical advantage in hiv positive individuals.

a cohort of 100 hiv positive, hbv negative individuals who have not been vaccinated against hbv before will be prospectively given 3 doses of sci-b-vac at 0, 1 and 6 months. hbv antibodies will be checked one month after every dose given.

Eligibility criteria:
inclusion criteria: * hbv negative * hiv positive individuals * above the age of 18 * treated at the tasmc aids clinic, who have signed and informed consent and have never been vaccinated against hbv before exclusion criteria: * pregnant women * hbv positivity * previous hbv vaccination

Keywords: hbv hiv immunization hbv immunization rate among hiv positive individuals
behavioral therapy combined with carbidopa/levodopa for the treatment of cocaine dependence

Conditions: Cocaine Abuse; Cocaine-Related Disorders

Summary: cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. the purpose of this study is to examine the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. in addition, this study will examine the effects of incentive rewards for treatment compliance.

cocaine is a strong central nervous system stimulant that is widely abused throughout the united states. due to its widespread use, it is important to develop an effective treatment for cocaine dependence. levodopa is a medication that is used alone or in combination with carbidopa to treat parkinson's disease. the purpose of this study is to determine the possible interactions between behavioral interventions and carbidopa/levodopa in order to treat cocaine dependent individuals. this study will last 12 weeks and will involve two phases. the first phase will include three therapy conditions: 1) clinical management only, 2) clinical management and relapse prevention therapy, and 3) clinical management, relapse prevention therapy, and contingency management. all of the conditions in the first phase will be evaluated incrementally under active and placebo conditions while participants receive carbidopa/levodopa. the second phase of the study will examine the contingency management procedure applications. each of the three contingency management procedure applications targets specific behaviors that, when reinforced, may interact with carbidopa/levodopa to produce clinical benefits. participants will receive relapse prevention therapy combined with a contingency management procedure that targets clinic attendance, medication compliance, and cocaine abstinence. study visits will occur weekly throughout the study. in addition, participants will complete a one-year follow-up visit.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for current cocaine dependence * provides at least one positive urine test for cocaine during study screening * good general health, based on a physical exam, lab tests, and an electrocardiogram * reads and writes english at a sixth grade level exclusion criteria: * current axis i depressive, psychotic, or anxiety disorder * currently in jail * pregnant or breastfeeding * requires certain medications

Keywords: cocaine addiction cocaine treatment
application of a mindfulness and self-compassion program in patients with schizophrenia. randomized controlled trial.

Conditions: Schizophrenia

Summary: this is a randomized clinical trial to check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (msc) programme.

main aim to check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (msc) programme, compared with those participating in an active control programme or those following usual treatment. design randomized clinical trial, three parallel groups: 1. experimental, which will receive the msc together with the usual treatment (tau). 2. active control, which will receive an alternative programme with cognitive, behavioural and psychoeducational components (cbtg) together with the tau. 3. passive control, which will receive the tau. study disorder schizophrenia. data from the intervention under study program developed by kristin neff and christopher germer, after observing in diverse investigations the inverse correlation between levels of self-pity and diverse pathological clinical variables. population under study patients from telde's mental health unit who have been diagnosed with schizophrenia. total number of subjects 150

Eligibility criteria:
inclusion criteria: * diagnosis of schizohrenia exclusion criteria: * drug addict

Keywords: psychosis quality of life mindfulness compassion self-compassion schizophrenia
mobile coach for parents of children and adolescents with chronic pain

Conditions: Parents; Chronic Pain; Pediatric Disorder

Summary: chronic pain is estimated to affect 20% to 35% of children and adolescents around the world, and is associated with increased risk of anxiety and depression among children and adolescents, as well as coping challenges, anxiety, depression, and anger in their parents. for parents, learning to manage stress is critical, as parents play a significant role in a child's experience of pain. parental behaviors such as over-involvement, solicitousness and rejection are associated with decreased functioning, including higher school absenteeism in children and teens. a number of interventions demonstrate that teaching skills to parents can have a direct and positive impact on the health of children and adolescents with chronic pain. the investigators propose to create and test the bodimojo parent buddy which will provide parents with real-time, tailored and adaptive coping and stress management support and will provide a curriculum of skills for responding to a child in pain in order to promote child functioning. thirty parents of children ages 8-18 who have been diagnosed with a non-cancer chronic pain condition will participate in this user-testing study. parents will complete a brief set of questionnaires before and after the intervention, and will be instructed to open and use the app each day for 30 days. participants will complete audio mindfulness exercises, watch brief video clips, and read psychoeducational information about pain, coping, and communication skills. post-intervention questionnaires will also include an acceptance test to assess participants' opinions about the helpfulness and usability of the app. parent participation is expected to take around 3.5 hours total over the 30 day study period.


Eligibility criteria:
inclusion criteria: * parents who self-report parenting a child or adolescent ages 8-18 with non-cancer chronic pain. * daily use of a smartphone (ios, android, or windows) or tablet. * ability to speak and understand english. exclusion criteria: * inability to provide consent * inability to speak and understand english
ozonized olive oil in the treatment of periodontal pockets

Conditions: Periodontal Pocket

Summary: a randomized controlled clinical trial was conducted on 16 patients (8 males and 8 women) who were diagnosed chronic periodontitis. all the patients has been divided by randomization in two groups: control group treated with placebo gel and experimental group treated with gel based on ozonated evo olive oil. both group after the evaluation of inclusion and exclusion criteria during the first visit, were subjected to hygiene treatment of removal tartar deposit, considered as standard of therapy for periodontitis. after 15 days the hygiene treatment, patients were been randomized in two groups following the flow chart (t0) starting with: periodontal probing, microbiological samples and the first administration of gel. next week (t1), has been collected the compliance and did the second administration of gel; the procedures will be the same also for another week (t2), until the last week (t3) when has been registered the second periodontal probing and did the second microbiological samples. data were collected to software microsoft excel and all the data analysis were conducted on this software to highlight significant differences between both groups. as the primary outcome was continuous variable and assuming normal distribution bilateral parametric test t-student was performed. an alpha error of 5% was considered, beta error was not calculated as this was a pilot study.


Eligibility criteria:
inclusion criteria: * patients with stage ii, iii, or iv periodontitis according to the new 2017 world workshop periodontal classification * patients of either sex and older than 18 years of age * probing pocket depth (ppd) greater than or equal to 4 mm at 3 sites * patients who have signed consent to the study * collaborating patients exclusion criteria: * age \< 18 years and/or inability to provide written informed consent; * absence of family or social welfare support; * non-drug-induced gingival hypertrophy, * severe smokers (more than 20 cigarettes per day), * consumers of high levels of alcohol, * patients on corticosteroid treatment, * diabetic patient, * immunodepressive therapies, * chemotherapies, * radiotherapies, * pregnancy states; * lack of collaboration for ongoing postoperative reevaluations.

Keywords: ozonated olive oil periodontal pocket periodontal disease
mbcp safety and performance in the osteonecrosis of femur head

Conditions: Osteonecrosis

Summary: the aim of this pilot study is to evaluate mbcp performance in bone regeneration after osteonecrosis biopsy of the femur head. this technic may prevent the neck of the femur bone weakness following the healthy area drilling, thanks to a bone reconstruction at the expense of the biomaterial.

twelve patients will be enrolled in this study and evaluation of infection and inflammation of the drilled area, pain and hip function will be assessed during a one year follow up. bone reconstruction will be evaluated with scanner and radiography.

Eligibility criteria:
inclusion criteria: * femur head osteonecrosis (1 to 2 level in arco scale) * signed informed consent exclusion criteria: * primary bone infection * femur head sphericity loss * cancer, diabetes, tuberculosis previous history * hiv, hepatitis b, hepatitis c infection * drepanocytosis * current corticotherapy * current immunosuppressive therapy * innate or acquired immune deficience * pregnancy or lack of efficient contraception * current participation in an other study

Keywords: femur head aseptic osteonecrosis bone reconstruction macroporous biphasic calcium phosphate granules
open label safety and efficacy study of pregabalin in subjects with nerve pain asociated with human immunodeficiency virus (hiv) neuropathy

Conditions: Peripheral Neuropathy; HIV Infections

Summary: to evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with hiv neuropathy


Eligibility criteria:
inclusion criteria: * participation in the preceding a0081066 double-blind trial met the entry criteria for that trial and completed a0081066 study through visit 7 exclusion criteria: * experienced serious adverse event during the a0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor * non-compliant during a0081066 trial * clinically significant or unstable medical condition both hiv-related and non-hiv related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study
surgical treatment of chronic neuropathic pain

Conditions: Chronic Neuropathic Pain

Summary: observational registry study assessing the subject's pain history and the impact of surgery for the treatment of chronic neuropathic pain by comparing post-operative outcomes (pain level, pain medication usage, quality of life outcomes, and nerve functional outcome) to pre-operative levels.

this observational registry will evaluate the subject's healthcare journey and pain history through detailed medical history and record review. for patients who undergo surgical treatment for pain, the registry will capture standardized outcomes measures to assess key factors such as post-operative pain, pain medication usage, quality of life outcomes, and functional outcome of associated nerves as compared to pre-operative levels.

Eligibility criteria:
inclusion criteria: 1. be age ≥ 18 years 2. have a documented diagnosis of chronic neuropathic pain 3. in the opinion of the investigator, be considered at the time of screening a likely candidate for surgical treatment of their neuropathic pain according to institutional standard of care. 4. be willing to participate in data collection and all follow-up assessments throughout and for the entire duration of follow-up exclusion criteria: 1. subjects who, in the opinion of the investigator, have not or likely will not complete the required follow-up assessments. 2. subjects who are currently enrolled in another clinical trial; 3. subjects who have undergone previous surgical treatment of pain from symptomatic neuroma in the target nerve(s); 4. subjects who are undergoing treatment(s)/intervention(s) for other condition(s) which, in the opinion of the investigator, may confound assessment of pain or interfere with the study measurements.

Keywords: peripheral nerve injuries peripheral nervous system disease neuropathic pain neuroma chronic pain symptomatic neuroma
comparasion of autogenic inhibition and reciprocal inhibition muscle energy techniques (mets) in piriformis syndrome

Conditions: Piriformis Syndrome

Summary: to compare the effects of autogenic inhibition and reciprocal inhibition muscle energy techniques (mets) in piriformis syndrome

piriformis syndrome is when the piriformis muscle, located in the buttock region, spasms and causes buttock pain. the piriformis muscle also can irritate the nearby sciatic nerve and cause pain, numbness, and tingling along the back of the leg and into the foot (similar to sciatic pain). the functional limitations experienced by hip pain patients in the lower limb profoundly impact their quality of life. this study aims to investigate the effectiveness of an integrated approach that compares the effects of autogenic inhibition versus reciprocal inhibition muscle energy techniques on pain, range of motion, and disability in patients with piriformis syndrome. this randomized clinical trial will be conducted at dhq hospital jhang over six months. the sample size will consist of 32 participants. participants who meet the inclusion criteria will be taken through a non-probability convenience sampling technique, that will be randomized through a sealed envelope method. 16 participants will be assigned to group a that will be treated with the autogenic inhibition muscle energy technique, 16 participants will be assigned to group b and will be treated with reciprocal inhibition muscle energy technique at the frequency of 1 set and 3 repetitions per session for two sessions per week and total six sessions for three weeks with follow up at one month. the duration of contraction is 7-10 seconds. pre and post-intervention values will be taken on the 1st day in the 3rd week and at one-month follow-up. data will be collected using various assessment tools, including the fair test, freiberg test, lasegue test, beatty test, pace sign, numeric pain rating scale (nprs), and universal goniometer. pre-intervention assessments will be conducted for all two groups. the effects of the interventions will be measured either by parametric or non-parametric tests after assessing the normality of data by the shapiro-wilk test independent t-test. data analysis will be performed by using spss 25 software.

Eligibility criteria:
inclusion criteria: * both genders with ages between 25-45 years. * patients diagnosed with piriformis syndrome using the piriformis fair test, freiberg test, lasegue test, beaty test, and pace sign. * hip pain with a threshold of nprs 3-6. * limited rom of hip internal rotation and abduction measured using a goniometer. * buttock pain ≥ 3 months. * pain with prolonged sitting (more than 20 minutes) exclusion criteria: * hip degenerative changes. * history of trauma or fracture * other systemic conditions * postural abnormality/deformity * diagnosed psychological disorders * pregnancy

Keywords: exercise manipulative therapies pain piriformis syndrome range of motion sciatic nerve
circulating tumor dna for the early detection of hpv-positive pelvic cancer relapses

Conditions: HPV Positive Pelvic Cancer

Summary: ctdna detection in patients with previously treated, hpv-induced, stage ii or iii invasive pelvic cancer and who are currently in post-treatment follow-up.

patients with previously treated, hpv-induced, stage ii or iii invasive pelvic cancer and who are currently in post-treatment follow-up will be included. these patients will be followed up during 30 months (2.5 years) (if no relapse occurred before) with ctdna detection performed at each hospital visit. at each visit, clinical, biological (squamous cell carcinoma (scc) serum marker will be done systematically) and radiological/pathology (if any) results will be prospectively collected in the study. for the patients who have a relapse or new hpv-induced invasive cancer before 30 months, the follow-up will be discontinued at the date of the relapse. for the patients who will have completed their follow-up for the study (2.5 years) with no relapse or new hpv-induced invasive cancer, they will be followed up for 6 months (+ 14 days), to collect any late relapse (if any). none specific study procedure will be performed during this period.

Eligibility criteria:
inclusion criteria: 1. 1) patient curatively treated within the past 3 years for: * a hpv-induced stage ib3, ic, ii or iii cervix cancer * a hpv-induced stage ii or iii anal canal, vagina, vulva or penis cancer 2. patient with no evidence of any invasive tumor at inclusion (clinical and, if any, radiological exams). 3. age ≥ 18 years 4. availability of hpv genotyping of the treated cancer and/or archived tumor tissue available. 5. patient who a follow-up visit is scheduled in the including center at least twice a year. 6. patient being affiliated to the french social security. 7. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. patient presenting with active invasive tumor masses (e.g. stage iv cancer). 2. patient deprived from ability to decide on her own or placed under the authority of a tutor. 3. patient unable to have a regular follow up for geographical, social or psychological reasons.

Keywords: hpv positive pelvic cancer circulating tumor biomarker