Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of novosis putty for interbody lumbar fusion cases

Conditions: Degenerative Disc Disease

Summary: efficacy and safety of novosis putty in transforaminal lumbar interbody fusion for patients with lumbar degenerative disc disease : a pivotal, randomized, prospective, multi-center study


Eligibility criteria:
inclusion criteria: * has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar confirmed by subject history and radiographic imaging (ct, mri, x-rays) with no more than a grade 2 (≤50% translation) spondylolisthesis. symptomatic lumbar degeneration (l1 to s1) that may be associated with a co-morbid condition. * has preoperative oswestry disability index score ≥ 40/100 at baseline * psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms * signed informed consent exclusion criteria: * previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level; * degenerative or lytic spondylolisthesis greater than grade 2 (50% translation); * active malignancy: a patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years; * any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to parkinson's disease, amyotrophic lateral sclerosis (als), or multiple sclerosis; * has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease; * lactating, pregnant or interested in becoming pregnant in the next 3 years; * is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study. * known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any bmp-2 type recombinant proteins or peptides.
role of matrix metalloproteinases (mmps) and tissue inhibitors of metalloproteinases (timps) in children with myocarditis

Conditions: Myocarditis

Summary: children can have or develop certain problems with their heart function, specifically with the heart muscle or myocardium. this problem can be caused by many things specifically by infection resulting in myocarditis (inflammation of the heart muscle) or dilated cardiomyopathy (caused by many factors including high blood pressure and heart attacks). the body goes through many processes to repair the injured tissue including using proteins that cause the muscle mass to increase called matrix metalloproteinases (mmps). the body also uses proteins that direct the mmps to stop increasing the muscle mass called tissue inhibitory of metalloproteinases (timps). currently, there are no published studies that explain or evaluate the relationship that mmps and timps have in myocarditis and dilated cardiomyopathy in children. the investigator wishes to perform a prospective study of the serum levels of these proteins and their regulators in children with myocarditis and/or dilated cardiomyopathy and compare them with children that have no heart disease.

all children who present with signs and symptoms of myocarditis and have laboratory findings consistent with cardiomyopathy will be eligible. after prospective consent, all subjects will receive: (1) a complete physical examination, (2) complete transthoracic echocardiogram to better characterize the disease process. follow-up echocardiograms will be performed at 24-72 hours after admission into the protocol and at discharge from the hospital. approximately 2 teaspoons of blood will be drawn at: (1) enrollment, (2) 24 hours after, (3) 72 hours after, (4) and at hospital discharge. those subjects that receive a heart transplant will have blood drawn at the time of transplantation. for those that have a cardiac catheterization or have a muscle biopsy as part of their standard of care, will also have a biopsy of their right ventricle performed. data to be collected: minimum patient demographic data (age, sex, ethnic origin), vital signs, clinical course events/data (i.e. need for dialysis, length of stay, surgical time points, etc), diagnostic test results (ekgs, echos, etc), significant medical history data, and standard of care laboratory results. the investigator wishes to evaluate the relationship of this data with the patient's diagnosis, clinical course, and serum levels of mmp and timp proteinases.

Eligibility criteria:
inclusion criteria: 1. evidence from diagnostic tests and physical exam that confirm inflammatory cardiomyopathy. exclusion criteria: 1. patients with structural heart disease other than septal defects or patent ductus arteriosus 2. patients with history of arrhythmia 3. patients with history of ventricular dysfunction diagnosed by echocardiograms 4. patients with history of chronic systemic illness
swedish pap in osteoarthritis - a rct study

Conditions: Osteoarthritis; Sedentary

Summary: the purpose of this study is to determine whether an intervention with physical activity on prescription (pap) to individuals in primary care with knee or hip osteoarthritis would result in effects on physical activity level, physical capacity and quality on life. the hypothesis is that patients with osteoarthritis in hip or knee will increase their level of physical activity significantly more with a pap intervention compared to patients who only get general advice about physical activity.

according to guidelines the recommended first-line management for people with osteoarthritis consist of exercise, information about osteoarthritis and if necessary, weight reduction. it is well documented that exercise has a positive effect on pain and physical function in these patients. therefore, it is important to have methods to increase physical activity levels in these patients. it is not explored whether an intervention with pap may lead to increased physical activity in patients with knee or hip osteoarthritis. the study will be a prospective, randomized, single-blind intervention study including 140 patients (70 patients/group). patients will in a parallel design be randomized to intervention or control group. both groups receive oral and written information about osteoarthritis and if necessary, advice on weight loss. the intervention group receives swedish physical activity on prescription. it is a patient-centered counselling about physical activity related to the disease. the counselling results in an individualized written prescription on physical activity including specific modes on physical activity. after three weeks, three months and six months they are offered a follow up which could be by telephone or personal meeting. during the follow up they discuss who the physical activity works out and plan new goals. the control group will receive an intervention with general advice about being active three times a week and do strength training functional during the day. patients in the control group see the physiotherapist once.

Eligibility criteria:
inclusion criteria: 1. patients with clinically verified osteoarthritis in knee or hip 2. sedentary (physical activity level, less than 150 minutes of moderate-intensity or less than 75 minutes of vigorous-intensity a week) includes exclusion criteria: 1. severe pain in hip or knee when walking 2. other serious disorders causing problems when walking 3. back injury causing pain in the leg 4. cruciate ligament injury in the knee which causes severe dysfunction 5. severe menisci injury 6. total joint replacement in hip or knee 7. unable to understand swedish and follow verbal visual instructions study population: patients who contact primary care center because of their hip or knee osteoarthritis and which is referred to the physical therapist. seven health centers in gävle include patients.

Keywords: osteoarthritis sedentary physical activity health related quality of life
experimental word learning in children with and without language impairment

Conditions: Developmental Language Disorders

Summary: the purpose of this study is to compare the performances of normally developing children and children with language impairment (li) in three different experimental settings designed to promote vocabulary acquisition. this comparison will also provide evidence to support different intervention approaches designed to increase vocabulary abilities, which has been proved to be one of the major deficits of young children with li.


Eligibility criteria:
inclusion criteria: * for gp subjects: - diagnosis of language impairment * enrolled in language therapy * age between 3:0 (years:months) and 3:11 * for gc subjects: - normal performance in a language screening procedure * normal performance in an expressive vocabulary test exclusion criteria: * for gp subjects: - hearing impairments * diagnosed neurological or behavioral conditions * major cognitive impairment * for gc subjects: - communication complaints from caregivers * history of previous enrollment in language therapy

Keywords: child language language therapy vocabulary
the management of erectile dysfunction with placebo only

Conditions: Impotence; Erectile Dysfunction

Summary: placebo-controlled randomized clinical trials (rct) are the gold standard to provide applicable evidence for clinical practice. a vast number of rcts for treatment of several disorders has shown a mean placebo effect of 30%. erectile dysfunction (ed) is a high prevalent disease and its first-line therapy is oral phosphodiesterase type-5 inhibitor (ipde5) (i.e., sildenafil, vardenafil and tadalafil). although the placebo effect in ipde5 rct occurred at a rate as high as 50%, in the last decade, with the revolutionary discovery of effective pharmacotherapy for ed, oral ipde5 has become one of the most common prescribed drugs for men. the objective of this study is to evaluate the influence of patients' awareness on the composition of the therapeutic drug in the outcomes of the oral treatment for ed.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * complaint of ed for at least 6 months prior the start of the study, according to medical history and to the questionnaires iief, sear and qeq. * a stable heterosexual relationship. * to be in good health prior the participation in the study, with no important clinical abnormalities, determined by: clinical history, physical examination, blood chemistry and hematology, urinalysis (if the standard values of the laboratory for these tests are not evidenced, subjects can be included if the researcher consider the changes as not clinically significant). exclusion criteria: * history of significant cardiovascular, pulmonary, gastrointestinal, hematological, neurological (including epilepsy), locomotor, immunologic, ophthalmic, metabolic, endocrine, thromboembolic, rheumatologic, cancer, kidney or liver disease. * diagnosis of psychiatric conditions, e.g. depression, anxiety, dysthymia, mania, panic, agoraphobia, social phobia, suicidal ideation, obsessive-compulsive disorder, post-traumatic stress, psychotic disorders, schizophrenia, alcoholism, dependence on psycho-active substances. * history of hiv, hepatitis b or hepatitis c. * hyperprolactinemia or untreated hypothyroidism. * any condition, which, in the opinion of the investigator, may interfere with the participation of the subject in the study (e.g. difficulty to meet the requirements of the study, attend the consultations, answer the questionnaires). * report of significant clinical problems by the subject's partner, such as decreased sexual interest, pain during relations or other forms of sexual dysfunction that interfere in the relationship with the sexual partner. * patient or partner willing to undergo a surgical procedure during the study period, which may interfere in the results. * peyronie's disease, which may lead to impossibility to penetrate or cause pain during the sexual intercourse. * use of nitrates. * illiterate patient.

Keywords: placebo placebo effect sexual dysfunction erectile dysfunction clinical trial
reliability of a masseter muscle prominence scale and lower facial shape classification

Conditions: Healthy Volunteers

Summary: this study will evaluate the inter-rater and intra-rater reliability of a masseter muscle prominence scale for evaluating a patient's muscle prominence and a lower shape classification for evaluating a patient's lower facial shape.


Eligibility criteria:
inclusion criteria: -sufficient visual acuity without the use of glasses or with contact lenses to self-assess lower facial shape in a mirror exclusion criteria: * infection of the mouth or gums, or facial skin infection requiring antibiotics * planned dental or facial procedure * unwillingness to be photographed and have the photos used for research, training, or educational purposes
virus shedding and environmental deposition of a novel influenza virus

Conditions: Novel (H1N1) Influenza

Summary: an influenza pandemic has recently been declared, involving the novel a(h1n1) 'swine flu' virus. this has spread to almost 100 countries worldwide in less than two months, causing widespread disease so far in mexico, usa and canada. it is highly likely that over the next 12 months, many countries including the uk will be affected by widespread illness. in the uk this wave of intense flu activity is most likely to occur in late autumn 2009. very little is known about the new h1n1 pandemic virus. for example we do not know how long the virus is excreted by infected humans and how much virus is spread to surfaces and carried in the air. this is very important to know as soon as possible because it affects the advice that will be given to healthcare workers about controlling the spread of infection to themselves and other patients. similarly we need this information so we can give good quality advice to families who will have to look after each other in their own homes. the best way to obtain this information is to ask patients who get pandemic flu soon (in august, september and october) to help us by agreeing to give a daily nose swab sample for just over one week so we can see how much virus is in the nose day by day and how quickly this disappears. at the same time we will take samples from hard surfaces in a patient's room or home and sample the air using a special filter device. we can then work out how much virus is being excreted, how long the 'danger period' is, whether surfaces are more or less important than the air that we breathe (in terms of catching the virus) and if we can advise on a 'safe distance' from the patient, beyond which there is relatively little chance of catching the illness.


Eligibility criteria:
inclusion criteria: * subject fulfils case definition * informed consent obtained (from parent/guardian where appropriate) * age \>1 month * near-patient test positive for influenza a or other substantive test positive for influenza a (including 'swine flu') * willing to participate and agrees to allow both nasal and environmental samples to be taken exclusion criteria: * illness for \>48h (community cases) * illness for \>96h (hospital cases) * existing case of ili in the household * a negative for swine flu (as part of nhs care) * has taken part in influenza research involving an investigational medicinal product within the last 3 months

Keywords: influenza virus shedding infection control swine flu
effect of niacin in the lipoprotein (a) concentration

Conditions: Hypercholesterolemia

Summary: objectives. * to evaluate the absolute and relative lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of niacin/laropiprant in subjects with normal lp(a) (\ 60 mg/dl). * to evaluate the absolute and relative lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of niacin/laropiprant depending on the number of kringle iv-2 repeated copies on the apo(a) gene. 2.1.1 hypotheses. * the lp(a) lowering effect of niacin is dependent of the pre-treatment lp(a) concentration, with higher absolute and relative reduction in lp(a) in subjects with hyperlipoproteinemia(a). * lp(a) size, throughout modifying hepatic synthesis of apo(a), is a major factor related to the lowering effect variability of niacin in human.

open-label 12-week study, 1g/20 mg day of niacin/laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day. subjects with normal lp(a) will be use as comparative group for the other two groups, so no placebo group is required is this study. subjects: volunteers from the lipid clinic of hospital universitario miguel servet of zaragoza, spain. subjects were selected according to their previously determined lp(a)concentration. all volunteers before any study procedure will have to give written inform consent to a protocol previously approved for the ethical committees of our institutions. biochemical determinations: lipids: total cholesterol and triglycerides; lipoproteins: hdl-cholesterol, lp(a); apolipoproteins: apo a1 and apo b and safety biochemical parameters (glucose, uric acid, creatinine, liver and muscle enzymes will be measured at baseline and at the end of the two treatment periods (weeks 4 and 8). an adverse experience questionnaire will be done in each visit. genetic analysis: apo(a) genetic polymorphism responsible of the lp(a) size variability will be analyzed by a pcr-based methodology (lanktree et al. j lipid res 2009; 50: 768-72 ).

Eligibility criteria:
inclusion criteria: 1. age \>18 and \< 80 years 2. ldl cholesterol between 70 and 190 mg/dl 3. triglycerides \< 500 mg/dl 4. at least 2 lp(a) determinations previous to the beginning of the study without differences \>20% or \> 20 mg/dl. 5. no lipid lowering therapy or on stable doses in the last 3 months exclusion criteria: 1. liver disease or liver enzymes \>2 times higher than reference values 2. creatinine \> 2 mg/dl 3. active peptic ulcer 4. clinical gout in the last year 5. uncontrolled diabetes (hba1c \>8%) 6. enrolment in other drug clinical trial in the previous 3 months.

Keywords: lipoprotein (a) lpa niacin kringle iv-2 repeats
antibiotic concentrations among critically ill patients

Conditions: Administration of Antibiotics in Intensive Care Units

Summary: the primary objective of the dali study is to compare antibiotic concentrations in patient blood samples with bacteriological objectives associated with maximum bactericidal activity. the antibiotics studied are certain lactams and glycopeptides.


Eligibility criteria:
inclusion criteria: * the patient (or his/her "trusted representative") must have given his/her informed and signed consent * antibiotic treatment is administered with beta-lactams or glycopeptides administered continuously or intermittently (can be of the following: amoxicillin-clavulanic acid, ampicillin, piperacillin-tazobactam, penicillin g, flucloxacillin, dicloxacillin, cloxacillin, cefazolin, ceftazidime, ceftriaxone, cefepime, meropenem, imipenem, doripenem, ertapenem; vancomycin, teicoplanin). * a vein or artery catheter is established to facilitate blood sampling (arterial catheter is preferred) exclusion criteria: * none of the above-mentioned antibiotics are administered * impossible to establish venous or arterial catheter * consent not given * patient is pregnant, parturient or breastfeeding * the patient is under tutorship or curatorship * the patient is participating in another study

Keywords: intensive care antibiotic levels in blood samples
health and wellness after preterm birth

Conditions: Preterm Birth; Health Care Utilization; Tobacco Use; Contraceptive Usage; Depression; Weight, Birth

Summary: this study continues an adaptation of the behavioral intervention care coordination after preterm birth (ccapb). this is a pragmatic pilot randomized controlled feasibility trial of ccapb with baseline and post-intervention assessments.

interventionists will be trained in care coordination strategies and motivational interviewing (mi) techniques. following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within 4 weeks of birth.the primary outcome of this study is acceptability and feasibility of the intervention and study procedures as measured by the acceptability of intervention measure, participant completion of study data collection, and interventionist completion of planned intervention modules.

Eligibility criteria:
inclusion criteria: * female * age 14 - 45 * history of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may including: low preventive care utilization, tobacco use, obesity, depression or anxiety, history of unmet contraceptive needs, chronic or pregnancy-associated hypertension or diabetes. ) * intention to seek pediatric care at one of two pediatric primary care sites * medicaid insurance exclusion criteria: * history of sterilization procedure. * plan to move away from the area or transfer pediatric primary care within six months of enrollment. * limited english proficiency. * history of organ failure or malignancies.

Keywords: preconception care interconception care postpartum care preventive health care care coordination motivational interviewing
evaluating naltrexone for use in conjunction with buprenorphine in adults with opioid use disorder transitioning from buprenorphine maintenance prior to first dose of vivitrol

Conditions: Opioid Use Disorder

Summary: this study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with opioid use disorder transitioning from buprenorphine maintenance prior to the first dose of vivitrol.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * willing and able to provide government-issued identification * has a body mass index (bmi) of 18.0-40.0 kg/m\^2 * has a history of opioid use disorder diagnosis for at least 6 months * has a history of prescribed buprenorphine (or buprenorphine/naloxone) maintenance for the prior 3 or more consecutive months and is currently buprenorphine-maintained * must be voluntarily seeking treatment for opioid use disorder and be motivated to receive antagonist therapy * willing to abide by the contraception requirements for the duration of the study * additional criteria may apply exclusion criteria: * is pregnant, planning to become pregnant or breastfeeding during the study * has a positive urine drug screen for opiates or oxycodone at screening * has used methadone within 30 days prior to study day -5 * has used naltrexone (oral or vivitrol) within the 90 days prior to day -5 * has a history of seizures or has received anticonvulsant therapy within the past 5 years for treatment of seizures (use of anticonvulsant during the past detoxification is not exclusionary) * has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments * has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder * is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification * has a history of hypersensitivity or adverse reaction to buprenorphine, naltrexone, vivitrol, or naloxone * additional criteria may apply

Keywords: naltrexone vivitrol buprenorphine opioid addiction