Kornimate/medical-research-clean huggingface dataset:
central nervous system amplification in lumbar failed back surgery syndrome

Conditions: Chronic Pain

Summary: the purpose of this study is to learn whether or not certain risk factors and patient characteristics are linked with and possibly can predict the development of chronic pain after lumbar spine surgery.


Eligibility criteria:
inclusion criteria for all participants: * ability to read and speak english to allow for written informed consent, phenotyping, and patient-reported outcomes measures exclusion criteria for all participants: * individuals receiving or applying for compensation or disability and other aspects associated with potential secondary gain * inability to provide written informed consent * severe physical impairment * co-morbid medical conditions that may significantly impair physical functional status * illicit drug or unreported opioid use * medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study * pregnant or nursing * liver failure * self-reported liver cirrhosis * self-reported hepatitis * severe cardiovascular disease inclusion criteria for candidates for lumbar spine surgery: * deemed to be a candidate for primary lumbar spine surgery including but not limited to: lumbar laminectomy, discectomy, and fusion/instrumentation * diagnostic clinical and radiographic findings including but not limited to: lumbar degenerative disc disease, lumbar disc protrusion, herniation, or extrusion, lumbar spondylosis, lumbar spinal stenosis, lumbar spondylolisthesis or spondylolysis * willingness to participate in longitudinal follow-up or 6-months after their surgery. exclusion criteria for candidates for lumbar spine surgery: * history of previous lumbar spine surgery * indication for lumbar spine surgery is due to spinal cancer-related diagnosis * need for urgent or emergent lumbar spine surgery inclusion criteria for candidates with lumbar failed back surgery syndrome: * chronic low back pain (+/- leg pain) for \>= to 6 months duration after lumbar spine surgery (with or without instrumented fusion) * low back pain severity is moderate to severe (numerical rating scale \[nrs\] score \>=4) exclusion criteria for candidates with lumbar failed back surgery syndrome: * have a structural spinal lesion that would make them a current candidate for a revision lumbar spine surgery inclusion criteria for healthy volunteers: * no major diseases or diagnoses influencing pain or function exclusion criteria for healthy volunteers: * no chronic pain condition * score 3 or greater on the 2011 fm survey criteria (i.e. individuals with very mild fatigue or sleep problems will be allowed to participate as this is extremely common in the general population)

Keywords: lumbar spine surgery lumbar failed back surgery syndrome
non-inferiority of gsk biologicals' dtpw-hbv/hib compared to two formulations of gsk biologicals' dtpw-hbv/hib

Conditions: Whole Cell Pertussis; Haemophilus Influenzae Type b; Tetanus; Diphtheria; Hepatitis B

Summary: the purpose of this observer-blind study is to generate immunogenicity data with one formulation of gsk biologicals' dtpw-hbv/hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of gsk biologicals' dtpw-hbv/hib vaccine with respect to the anti-prp antibody response. additionally to assess the reactogenicity and safety of gsk biologicals' dtpw-hbv/hib vaccine. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * born after a gestation period of 36 to 42 weeks inclusive. * administration of one dose of hepatitis b vaccine at birth exclusion criteria: * use of any investigational or non-registered product (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 with the exception of opv. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of opv). * bacille calmette-guérin (bcg) vaccine received after the first 2 weeks of life. * hepatitis b vaccine received after the first week of life. * previous vaccination against diphtheria, tetanus, pertussis, haemophilus influenzae or hepatitis b (except hepatitis b at birth). * history of diphtheria, tetanus, pertussis, haemophilus influenzae or hepatitis b diseases. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * acute disease at the time of enrolment. * other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Keywords: hepatitis b tetanus diphtheria pertussis haemophilus influenzae type b vaccines
omega-3 fatty acids and insulin sensitivity

Conditions: Insulin Resistance

Summary: this study is being done to understand the effects of dietary omega-3 fats on insulin sensitivity in adult men and women.

dietary omega-3 polyunsaturated fatty acids (n-3 pufa), which include eicosapentaenoic acid (epa) and docosahexaenoic acid (dha) from fish oil, prevent insulin resistance in rodents, but data in humans is ambiguous. no existing studies have systematically evaluated the influence of n-3 pufas on insulin sensitivity and beta cell function in insulin resistant, non-diabetic humans. the investigators hypothesize that 6 months of oral supplementation of purified epa/dha (3.9g/day) will significantly improve hepatic and peripheral insulin sensitivity and beta cell responsiveness in insulin-resistant, non-diabetic individuals. based on recent work in mice, the investigators also hypothesize that epa/dha will increase the content and function of mitochondria in skeletal muscle, measured using a combination of in vivo and in vitro methods. overall, the investigators hypothesize that epa+dha supplementation will improve hepatic and peripheral insulin sensitivity in insulin resistant humans, and this improvement will be associated with mitochondrial biogenesis and attenuated lipid accumulation in skeletal muscle and liver. a sub-study was added in which participants receiving dietary omega-3 fatty acids or placebo supplements underwent abdominal subcutaneous adipose tissue biopsies to measure the content of total, pro- (m1) and anti- (m2) inflammatory macrophages (immunohistochemistry), crown-like structures (immunohistochemistry), and senescent cells (β-galactosidase staining), as well as a two-step euglycemic, pancreatic clamp with a stable-isotope labeled precursor ((u-13c)palmitate) infusion to determine the insulin concentration needed to suppress palmitate flux by 50% (ic50(palmitate)f).

Eligibility criteria:
inclusion criteria: 1. age 18-65 years 2. insulin resistant (homeostasis model assessment (homa) insulin resistance (ir) ≥2.6) exclusion criteria: 1. current use of omega-3 nutritional supplements 2. fasting plasma glucose ≥126 mg/dl 3. active coronary artery disease 4. participation in structured exercise (\>2 times per week for 30 minutes or longer) 5. smoking 6. medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants) 7. renal failure (serum creatinine \> 1.5mg/dl) 8. chronic active liver disease (ast\>144 iu/l and alanine transaminase (alt)\>165 iu/l) 9. anti-coagulant therapy (warfarin/heparin) 10. international normalized ratio (inr) \>3 11. use of systemic glucocorticoids 12. chronic use of nsaids or aspirin 13. pregnancy or breastfeeding 14. alcohol consumption greater than 2 glasses/day 15. hypothyroidism 16. fish or shellfish allergy
stem cell therapy for type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus

to evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.

Eligibility criteria:
inclusion criteria: 1. free will taking part in the study and ability to provide written informed consent. 2. confirmed diagnosis of type i diabetes for at least 2 years 3. insulin-dependent. 4. age 18-50 years, male/female. 5. fbg≥7.0 mmol/l, and hbac1≥7％. 6. not pregnant or nursing. 7. negative pregnancy test. 8. fertile patients will use effective contraception. exclusion criteria: 1. presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (cva) or acute renal failure. 2. severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction). 3. active infection requiring treatment. 4. known immunosuppressive disease, e.g. hiv infection, or hepatitis b or c infection.

Keywords: stem cells; diabetes mellitus; treatment.
a multi-centre, randomized, double-blind, placebo controlled pilot trial to assess the efficacy, safety, and tolerability of spm 927 in subjects with postherpetic neuralgia (phn).

Conditions: Postherpetic Neuralgia

Summary: the objective of the trial is to investigate the analgesic efficacy of spm 927 in subjects with moderate to severe neuropathic pain due to postherpetic neuralgia (phn)


Eligibility criteria:
inclusion criteria: * subject has clinically diagnosed painful postherpetic neuralgia present at least six months after healing of a herpes zoster skin rash and has at least one form of allodynia * subject must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on likert scale). exclusion criteria: * subject has other conditions that cause pain at least as severe as the postherpetic neuralgia. * subject has had any surgical treatment or any neurolytic injections for phn * subject has clinically significant ecg and laboratory abnormalities. * subject is receiving treatment with anti-epileptic drugs (aeds), muscle relaxants, mexiletine, topical analgesics, antidepressants, opioids, non-steroidal anti-inflammatory drugs (nsaids), paracetamol, benzodiazepines, and antiviral agents. * subject has liver function tests (ast, alt, alkaline phosphatase, total bilirubin and ggt out of the reference range) \> 1,5 x uln (upper limit of normal) at visit 1 * subject has serum creatinine ≥ 2 times the upper limit of reference range at visit 1.

Keywords: lacosamide, vimpat®
effect of simethicone on screening colonoscopy

Conditions: Adenoma Colon

Summary: this study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.

a proper bowel preparation is key to a thorough and safe colonoscopy. several factors affect the mucosal visualization during colonoscopy, and consequently the quality of such evaluation. undoubtedly, this can have unfavorable implications like missed lesions. one of the most commonly encountered scenarios is the presence of multiple bubbles that interfere with mucosal visualization. when this occurs, simethicone (an antifoam agent used to reduce bloating when ingested orally) is injected through the colonoscope to eliminate the bubbles and get a clear view of the mucosa. a few studies have used oral simethicone in conjunction with oral preparation agents (peg, magnesium citrate, sodium phosphate) in an attempt to improve the quality of the preparation. unfortunately these studies have not used the exact same preparation agent with and without simethicone, making it difficult to draw conclusions on its efficacy. however, it is important to understand that simethicone is not intended to decrease the amount of stool in the colon, and it's purpose is to decrease the amount of bubbles interfering with the visualization of the mucosa provided that there is no stool present . furthermore, it is unclear if adding simethicone to a standard bowel preparation makes a significant difference in key aspects of screening colonoscopy such as adenoma detection rate or withdrawal times. this prospective randomized controlled, observer blinded study at texas tech university health sciences center in el paso, aims at studying the effect of simethicone on the overall colon preparation as well as on adenoma detection rate and withdrawal times.

Eligibility criteria:
inclusion criteria: 1. patients between the ages of 30-80 scheduled for screening colonoscopy. 2. male and female patients 3. ambulatory patients 4. signed informed consent form exclusion criteria: 1. previous colonic surgery 2. patient with mental/physical condition that impairs oral ingestion of preparation 3. allergy or hypersensitivity to simethicone 4. patients with limited mobility (bedridden patients) 5. patients with gastrointestinal obstruction 6. patients with gastroparesis

Keywords: screening adenoma detection rate simethicone
antioxidant therapy to reduce inflammation in sickle cell disease

Conditions: Anemia, Sickle Cell

Summary: the purpose of this study is to determine whether alpha-lipoic acid and acetyl-l-carnitine will lower systemic inflammation in patients with sickle cell disease by reducing oxidative stress, which will result in a decrease in the frequency of vaso-occlusive pain episodes and improve their quality of life.

people with sickle cell disease have more inflammation (a response of body tissues to injury or irritation) than people without sickle cell disease. this inflammation can be measured in the blood by checking the level of a protein called c reactive protein as well as other changes we see in blood due to inflammation (such as changes in platelets and other cells). there is even more inflammation during sickle-related complications (like pain or acute chest syndrome). we want to test if inflammation in people with sickle cell disease can be reduced by the use of antioxidant compounds. antioxidants are nutrients (certain vitamins, minerals and enzymes) that can counteract the effects of oxidative stress arising from free radicals in our cells. the formation of free radicals is a normal cell process, but uncontrolled oxidative stress can cause problems for us. one such harmful problem is inflammation. we know from other research studies that antioxidants help with some conditions related to inflammation. in this study the antioxidant being tested is a combination of alpha-lipoic acid and acetyl-l-carnitine, both of which are natural parts of many of the foods we eat and are needed by our cells to make energy from food.

Eligibility criteria:
inclusion criteria: * proven diagnosis of sickle cell disease, either homozygous sickle disease or hb s beta zero thalassemia genotype * age at entry at least 14 years. younger children will not be included since the combination alpha-lipoic acid and acetyl-l-carnitine tablets are not available in a smaller dose at this time. exclusion criteria: * more than 3 packed red blood transfusions in the past 12 months * coexisting illness that could contribute to inflammation. these include chronic hepatitis, lupus, arthritis, inflammatory bowel disease, chronic osteomyelitis, and other similar conditions. * acute sickle cell disease related symptoms requiring a hospital visit in the past 4 weeks * women who are pregnant, attempting to get pregnant, or breast feeding * active participation in other investigational drug or device studies * participants who start hydroxyurea or regular transfusion therapy during the course of the study on the recommendation of their primary hematologist will be ineligible for further participation.

Keywords: antioxidant inflammation sickle cell disease oxidative stress cytokines anti-inflammatory acetylcarnitine
atx-ms-1467 in patients with relapsing forms of multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: phase 1 study to assess the safety and biological activity of atx-ms-1467 in patients with relapsing forms of multiple sclerosis. this will be an open label upward dose titration involving injections on 9 occasions, each two weeks apart. after dosing is complete there will be a 22 week follow up period. blood samples will be drawn throughout the study to monitor safety and the body's response to the injections and mri scans will be performed on several occasions to follow the course of the multiple sclerosis during the trial.


Eligibility criteria:
inclusion criteria: * 1. patients who have definite relapsing multiple sclerosis disease as defined by the mcdonald criteria (mcdonald et al., 2001 and 2005) and as assessed by a neurologist. 2. hla drb1\*15 positive. 3. high baseline levels of t-cell proliferation in response to myelin basic protein, defined as \>1000 cpm with a \>3 stimulation index compared to background. 4. disease duration equal to or less than 10 years (from the first clinical event). 5. at least one documented relapse in the previous 12 months or two relapses within the previous 24 months prior to screening. 6. must be in a clinically stable or improving neurological state during the 28 days preceding screening. 7. edss score \< 5.5. exclusion criteria: * 1. subjects treated with β-interferon, plasma exchange, intravenous gamma globulin within the 3 months prior to study day 1 2. subjects treated with glatiramer acetate at any time in the past 3. subjects who have been treated with parenteral steroids or adrenocorticotropic hormone within 3 months days prior to study day 1 4. prior treatment with: cytotoxic agents (including but not limited to cladribine, mitoxantrone, cyclophosphamide, azathioprine, methotrexate), fingolimod, laquinimod, teriflunomide, total lymphoid irradiation, stem cell or bone marrow transplantation, or monoclonal antibody therapy (including natalizumab, daclizumab, alemtuzumab) 5. prior use of disease related t-cell vaccine or peptide-tolerising agent to treat ms 6. use of any investigational drug or experimental procedure within 6 months prior to study day 1 including cytokine or anti-cytokine therapy

Keywords: multiple sclerosis immunomodulation phase 1
intracoronary analysis of cardiac allograft vasculopathy by means of optical coherence tomography

Conditions: Intimal Proliferation; Immunosuppression

Summary: randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (everolimus (certican®) or mycophenolate mofetil (cellcept®)) on cardiac allograft vasculopathy (cav) in heart transplanted patients. maximal intima-thickness will be visualized by optical coherence tomography (oct) to assess the progression of cav.

in summary, the aim of the study is to examine the effect of the immunosuppressive agent everolimus (certican) on the development of cardiac allograft vasculopathy (cav). therefore the study is divided in three sections: substudy 1: evaluation of morphological differences between between cad and cav. substudy 2: analysis of cardiovascular risk factors (e.g. hypertension) under a specific immunosuppressive protocol in patients with cav. substudy 3: prospective, randomized analysis of the influence of different immunosuppressive protocols in patients with cav. primary endpoint of the study will be the adaption of intimal thickness after 10 years, analysed by means of optical coherence tomography. in addition to the explanations above the most important in- and exclusion criteria are listed below: inclusion criteria: * patients after heart transplantation * patients with coronary artery disease (cad) * age 18-80 years exclusion criteria: * contraindication of everolimus/sirolimus or adjuvants * renal insufficiency (creatinine \> 265 µmol/l) * cardiogenic shock or patients with killip\*-class iii or iv (\*name) * pregnant or breast feeding females * insufficient contraception (only for substudy 3)

Eligibility criteria:
inclusion criteria: * patients with heart transplantation * patient with coronary artery disease * age between 18 and 80 years exclusion criteria: * renal insufficiency (\> 265 µmol/l) * incapability to give informed consent * cardiogenic shock of patient with killip iii or iv * pregnant or breast feeding females * insufficient contraception (only for substudy 3)

Keywords: intima thickness transplantation cardiology immunosuppression
the effect of physical exercise in reducing pain in women undergoing mammography

Conditions: Pain; Side Effects

Summary: mammography is a systematic way in the main programs of screening for breast cancer in women over 40 or 50 years old, according to screening programs, but most research has shown a frequency of discomfort and pain during the examination mammography. this study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. it is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination.

this research aims to evaluate the relationship of pre-mammography guided physical activity and pain after the examination, evaluating the impact of the intervention in a group of patients undergoing upper limb exercise (sle), compared to another group women not subject exposure (mne), and another group with lower limb exercise (lle). this study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. it is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination. the results will be checked by study association between the level of physical activity, body mass index, breast density and reducing the pain effect between groups for comparison of means and variances of values of the visual analogue scale (vas).

Eligibility criteria:
inclusion criteria: * women: 20 to 69 years old exclusion criteria: * cardiovascular disease * mental diseases * pulmonary diseases * steroids use