Kornimate/medical-research-clean huggingface dataset:
treatment study using depot naltrexone (1/6) philadelphia coord/data mgmt site

Conditions: Opiate Addiction

Summary: the aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (tau) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to tau alone. participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. the effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. the primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.

this site serves as the coordinating center for five sites conducting the trial under the same ind and same protocol.

Eligibility criteria:
inclusion criteria: * be between the ages of 18 and 60; * have dx of opioid dependence according to dsm-iv criteria * be in good general health as determined by complete physical and laboratory tests; * under some form of criminal justice supervision for at least 12 months; * have a negative result for urinary opioids and no sign of opiate withdrawal after iv (or im) injection of 0.8 mg of naloxone; and * express a goal of opiate free treatment rather than agonist maintenance exclusion criteria: * current drug or alcohol dependence that requires medical supervision; * untreated psychiatric disorders that might make participation hazardous (e.g. untreated psychosis, bipolar disorder with mania, significant suicide risk). adequately treated psychiatric disorders and appropriate psychotropic medications would be allowed. 3. active medical illness that might make participation hazardous (e.g., untreated hypertension, hepatitis with ast or alt \>3 times upper limit of normal, unstable diabetes or heart disease). adequately treated medical conditions are acceptable; 4. female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestriel implant); 5. liver failure or liver function test levels greater than three times normal; 6. history of allergic reaction to naltrexone; 7. history of a drug overdose in the past 3 years; and 8. current diagnosis of chronic pain disorder for which opioids are prescribed for pain relief.

Keywords: depot naltrexone parolees opioid addiction prevention medication treatment alternatives prevention of relapse to opioid addiction
programming strategy of vfs for gait impairments in pd

Conditions: Parkinson's Disease; Deep Brain Stimulation; Gait Disorders, Neurologic

Summary: variable frequency stimulation(vfs) is a stimulation pattern applied in deep brain stimulation(dbs) therapy for parkinson's disease(pd). peking union medical college hospital was the first centre conducting research on vfs. the studies in the past have resembled conclusion that vfs provides improvement not only in the major symptoms such as tremor and rigidity, but also in gait and balance disorder. however, the best programming strategy of vfs has not met agreement. the random-controlled double blinded crossover study is designed for participants who underwent dbs surgery in bilateral subthalamic nucleus for parkinson's disease. the investigators study several strategies on programming and observe the improvement of symptom to look for the best one. a 4-month follow-up is designed to observe a relatively long-term effectiveness of vfs. the study intends to gather more clinical evidence to guide further studies on vfs application.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (according to the movement disorder society clinical diagnostic criteria for parkinson's disease); * 18-75 years of age; * hoehn \& yahr ≤ 3 (in best off-medication condition)； * implanted bilateral subthalamic nucleus dbs for over 1 year； * gait impairments in off-medication condition； * high frequency stimulation provides significant improvement； * in off-medication on-stimulation condition, capable of walking ≥ 10m. exclusion criteria: * mental disorder or dementia; * pregnant women, lactating mothers or women who are unable to take effective measures to prevent pregnancy; * with other diseases that can affect walking distance, such as joint diseases of the lower body, spinal diseases, neuropathy, or serious heart or lung diseases; * in severe health condition, such as diseases associated with heart or liver; * epilepsy; * lead off target; * unable to willingly sign written informed consent; * disagree or unable to cooperate with follow-up sessions.

Keywords: parkinson's disease deep brain stimulation variable frequency stimulation movement disorder freezing of gait crossover study
effectiveness of rotarix™ against rotavirus severe gastroenteritis (rv sge) in infants in panama

Conditions: Infections, Rotavirus

Summary: this study aims to estimate the effectiveness of rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (epi), in preventing rv sge among hospitalised children born after 1 march 2006, which corresponds to the date of introduction of rotarix™ in the national immunization program.


Eligibility criteria:
inclusion criteria for enrolled subjects and cases : * a male or female child born after 1 march 2006 (which corresponds to the date of introduction of rotarix™ in the epi) and at least 12 weeks of age. * subject admitted to the study hospital for sge (refer to the glossary) during the study period. * onset of sge \<= 14 days prior to admission. * laboratory confirmed (i.e. by elisa at the hospital laboratory) rv positive stool sample at hospital admission or during the first 48 hours of hospitalisation. note: this criterion is applicable only for cases. * written informed consent obtained from the parent or guardian of the subject. inclusion criteria for controls: * admitted for non-ge causes at the same hospital as the case. note: this criterion is applicable to hospital controls only. * living in the same neighbourhood as the case for at least three consecutive months. note: this criterion is applicable to neighbourhood controls only. * at least 12 weeks of age and being born within ± 2 weeks from the date of birth of the case. if the list of children born within ± 2 weeks is exhausted, then the range would be extended to ± 4 weeks. * written informed consent obtained from the parent or guardian of the child. exclusion criteria for enrolled subjects and cases: * subject has previously participated as case or control in this study. * hospitalisation is unrelated to ge. * onset of sge \> 48 hours after admission to the hospital (nosocomial infections). exclusion criteria for controls: * for hospital controls: child who has symptoms of ge during current hospitalisation or on the day of interview of his/her parent or guardian. or * for neighbourhood controls: child who has symptoms of ge on the day of interview of his/her parent or guardian. * exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive haemophilus influenzae type b (hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis b. * child has participated in the past as a case or control in this study. * child living in the same house as the case. note: this criterion is applicable to neighbourhood controls only

Keywords: rotavirus severe gastroenteritis (rv sge)
sphenopalatine ganglion nerve block vs. elavil for treatment of transformed migraines

Conditions: Transformed Migraine; Chronic Daily Headache

Summary: this study will compare a local anesthetic technique that has been used to treat subjects suffering from transformed migraines (chronic migraines) versus medical management with traditional antidepressant amitriptyline / elavil. subjects will be randomized into one of two treatment groups to compare the safety and efficacy of the therapies. subjects will recieve either sphenopalatine ganglion nerve block with 5% lidocaine gel into the nasopharynx or medical management with traditional antidepressants, elavil, to produce a reduction in the frequency and severity of the headache. we propose that there will be a difference in the outcomes when comparing the two methods of treating transformed migraines and that one research arm will result in more patient satisfaction and greater efficacy in the treatment of subjects

arm one will receive sphenopalatine ganglion nerve block weekly for 4 weeks arm two will receive amitriptyline / elavil daily for 30 days

Eligibility criteria:
inclusion criteria: 1. male and female age 18-90 2. subject have formal medical diagnosis of migraine headache 3. subjects currently require treatment for headache 4. subjects who have received optimal medical management from migraines including triptans (imitrex, amerge and relpax) 5. subjects who have recieved optimal medical management for migraines including anticonvulsants (depakote, lamictal, klonopin exclusion criteria: 1. less than 18 years of age 2. subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain 3. untreated heart failure 4. pregnancy 5. individuals unwilling to comply with study procedures and follow-up

Keywords: migraine headache menstrual migraine vascular headache temporal lobe seizure
a study to evaluate the epidemiology of anemia associated with chronic kidney disease in patients in primary care using the stockholm creatinine measurement (scream) register

Conditions: Chronic Kidney Disease

Summary: the objectives of this analysis is to determine the incidence of anemia occurring in patients with chronic kidney disease (ckd) in primary care (i.e. prior to any eventual referral to nephrology care). this analysis also evaluates patient characteristics, anemia treatment and associated cardiovascular risk.

data will be derived from the stockholm creatinine measurement (scream) cohort, a repository of laboratory data of individuals residing and accessing healthcare in the region of stockholm and who underwent a creatinine assessment between 2012 - 2018.

Eligibility criteria:
inclusion criteria: * patient entered in scream between 2012 and 2018 * with two consecutive plasma-creatinine test(s) indicating an estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73 m\^2 * with at least one eligible hb after egfr \< 60 ml/min/1.73 m\^2. the date of the first eligible hb test is the study entry point/index date of the study. exclusion criteria: * patient who has had a recent pregnancy or childbirth (issued diagnosis within 2 years prior to index date). * patient with ongoing/recent cancer (diagnosed within the previous 3 years), haematological diseases or leukaemia. * patient with chronic infections (hepatitis, tuberculosis, or human immunodeficiency virus \[hiv\]); note by definition chronic infections are chronic and look back period will be to 1997. * patients with anemia at baseline (index date), defined by an anemia diagnosis in the year prior, a baseline hb value within the anemia range according to the who definition, or the presence of a recent dispensation of esa or iron (up to six months prior). * patient referred to nephrologist within the previous 2 years from cohort entry/ index date.

Keywords: chronic kidney disease scream database
comparative effectiveness research of electroacupuncture and tens in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the aim of this pilot study is to compare the effectiveness of electroacupuncture or transcutaneous electrical nerve stimulation in reducing the tenderness in the patients with rheumatoid arthritis. the study adopted a pragmatic, randomized, patient-centered approach to investigate the effectiveness of clinical symptoms and quality of life.

a total of 80 volunteers of patients with rheumatoid arthritis will be recruited from the chinese medicine or western medicine clinics in china medical university hospital and dalin tzu-chi hospital. these patients will be randomized to receive electroacupuncture (40 participants) or transcutaneous electrical nerve stimulation (40 participants) treatment two sessions per week and for 10 treatments in total. the investigators expect that electroacupuncture or transcutaneous electrical nerve stimulation can reduce the severity of pain in the patients with rheumatoid arthritis. the effectiveness of electroacupuncture or transcutaneous electrical nerve stimulation can be detected by visual analogue scale, simplified disease activity index, and disease activity score and be used to improve the clinical symptoms and quality of life.

Eligibility criteria:
inclusion criteria: * 20-70 years old * met the american college of rheumatology criteria (2010) for ra * classification of x-ray : stage i\~iii * the participants' ra medication regimen (dmard, nsaid, steroid)were eligible if they were on a stable dose for at least 3 months before entry into and throughout the study. * all patients were instructed not to make any changes in their background therapies during the study. * intra-articular or pulse steroid were not permitted during the study exclusion criteria: * be treated with biological agents, such as antagonist of tnf-alpha, il-6, jak, and cd20 mono antibody in the last 3 months * having history of serious drug allergy * pregnancy or breastfeeding * bleeding or coagulation disorders * localized skin infections * uncontrolled or ill-controlled blood pressure with diastolic pressure≥110 mmhg * any other acupuncture treatment or herbal medication for ra within 2 weeks before screening * needle phobia * intra-articular corticosteroid or pulse steroid within 4 weeks preceding the study * any severe chronic or uncontrolled comorbid disease

Keywords: comparative effectiveness research electroacupuncture transcutaneous electrical nerve stimulation rheumatoid arthritis: randomized clinical trial
meloxicam for pain management after total joint arthroplasty (tja)

Conditions: Total Knee Replacement; Total Hip Replacement

Summary: the purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee and hip arthroplasty could be observed with the substitution of intravenous meloxicam for ketorolac in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).


Eligibility criteria:
inclusion criteria: 1. patients over the age of 18, 2. patients undergoing primary total knee or primary total hip replacement at the university of miami hospital, 3. patients that have capacity to provide medical consent exclusion criteria: 1. all patients under the age of 18 2. prisoners, diabetics, increased risk of bleeding, and pregnant women. 3. patients with prior surgery or history of infection on the joint of interest. 4. patients with an estimated glomerular filtration rate (egfr) \<50 ml/min 5. patients on dialysis or renal transplant. 6. patients on steroid preoperatively. 7. allergy to sulfas 8. inability to provide medical consent. 9. any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.
attr expanded access program (eap) by ionis

Conditions: Amyloidosis, Hereditary

Summary: the purpose of this program is to provide expanded access to inotersen for up to 100 patients with hereditary transthyretin amyloidosis (httr).

the program is intended to provided expanded access to inotersen for eligible patients with hattr who have limited or no available treatment options.

Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age with a diagnosis of hattr * symptoms consistent with polyneuropathy * meet polyneuropathy disability (pnd) stage i-iii requirements exclusion criteria: * known primary amyloidosis, leptomeningeal amyloidosis or monoclonal gammopathy of undetermined significance or multiple myeloma * have inadequate cardiac function * have low platelet counts * have inadequate renal function
promise registry: a prostate cancer registry of outcomes and germline mutations for improved survival and treatment effectiveness

Conditions: Prostate Cancer

Summary: promise aims to create a comprehensive nationwide registry of prostate cancer patients with germline pathogenic variants by prospectively screening approximately 5,000 subjects with a confirmed prostate cancer diagnosis, either through tissue biopsy, psa greater than 100 ng/dl and/or radiographic evidence of disease and receiving systemic therapy for prostate cancer. patients at all stages of disease will be welcome to participate in the promise registry. participants will be recruited \& screened over a five-year period. study participants will be asked to provide a saliva sample to be tested for germline cancer risk variants through color health. if the results identify a pathogenic or likely pathogenic variant, an appointment with a genetic counselor from color health will be scheduled to discuss the results. participants will complete a baseline demographic survey that includes self-reported health history, family history of cancer and standardized patient reported outcome (pro) measures. promise registry staff will request medical records from the participant's cancer care provider(s) for the purpose of obtaining clinical data. participants will receive bi-annual newsletters offering information on new developments in treatment and research opportunities, including clinical trials, associated with genetic variants. eligible participants (those with target germline mutations) will be followed every 6 months to obtain updated health records data and patient-reported outcomes data. participants will be followed for a minimum of 15 years. the promise registry will help identify prostate cancer patients with pathogenic variants to learn more about how these variants affect patient outcomes. ultimately, we hope to help patients learn more about their disease and the treatments that they may derive the most benefit from, including the germline genetic biomarker-based clinical trials they may be eligible for. for more information, visit the study website at: prostatecancerpromise.org


Eligibility criteria:
inclusion criteria: * have prostate cancer (any stage of disease or survivorship) diagnosed or documented through one of the following: * tissue biopsy, and/or * psa greater than 100 ng/dl (1ng/ml), and/or * clear radiographic evidence of disease * live in the united states (including puerto rico, guam, american samoa, us virgin islands, northern mariana islands) exclusion criteria: * unable or unwilling to provide all of the necessary information for eligibility * incomplete inclusion criteria

Keywords: prostate cancer genetics registry germline mutation genetic testing germline testing
combined treatment with pulsed light and photobiomodulation before laser refractive surgery

Conditions: Dry Eye; Dry Eye After LASIK-Laser in Situ Keratomileusis

Summary: ametropia is the first cause of reversible visual trouble. recently, laser refractive surgery has increased in popularity. unfortunately, dry eye is a common side effect, representing about 25% of patients after lasik and 20% after smile. even if symptoms are usually released by artificial tears, there can be very uncomfortable for patients, decrease productivity and quality of life and be the source of unsatisfaction after surgery. the goal of our study is to study the efficiency of a preventive associated treatment by intense-pulsed-light and low-level-light therapy with eye-light® device before laser refractive surgery. recent study confirmed the efficacity of this treatment in meibomian glund dysfunction, the predominant dry eye mecanism.

monocentric, randomized, simple bling, controlled study

Eligibility criteria:
inclusion criteria: * ametropia without progression for almost one year * pachymetry \>480 um * myopia \< -8 dioptre * hyperopia \< +6 dioptre * astigmatism \< -5 dioptre exclusion criteria: * other ocular disease (such as keratoconus, cataract, glaucoma, amd, diabetic retinopathy, etc.) * infectious or systemic pathology (e.g.: epilepsia, migraine) * pregnancy, fitzpatrick v or vi (eye-light contraindication)

Keywords: dry eye laser refractive surgery smile lasik presbylasik photorefractive keratectomy intense-pulsed light low-level-light therapy photobiomodulation
leap2 on postprandial glucose metabolism and food intake n obese males

Conditions: Obesity

Summary: the study aims to delineate the effects of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (leap-2) on postprandial glucose metabolism and food intake in obese volunteers. the overall objective is to investigate the physiological importance of leap-2 in obese subjects.

in a recent study, the molecular phenotype of enteroendocrine cells in the small intestine before and after roux-en-y gastric bypass (rygb) surgery in obese individuals was examined. enteroendocrine cells were identified and isolated from intestinal biopsies and analysed for differentially expressed genes by illumina high throughput rna-sequencing. it was discovered that the gene encoding liver-enriched antimicrobial peptide 2 (leap-2), a naturally occurring peptide in humans, was significantly upregulated compared to baseline expression. interestingly, leap-2 was recently shown to antagonize ghrelin function in response to feeding in mice. moreover, the mature murine leap-2 peptide is identical in mice and humans. thus, leap-2 has been identified as an endogenous peptide that may be able to alter feeding behaviour and maintenance of glucose levels during calorie restriction. our group recently found a 12 % relative reduction in ad libitum food intake and reduced postprandial glucose excursions. the present study hypothesis is that leap-2 alters postprandial glucose metabolism and decreases appetite as well as food intake in relation to a liquid mixed meal and a standardised ad libitum meal compared with saline (placebo) in obese subjects.

Eligibility criteria:
inclusion criteria: * caucasian men * age between 18 and 25 years * body mass index between 30-50 kg/m2 * informed consent exclusion criteria: * anaemia (haemoglobin below normal range) * alanine aminotransferase (alat) and/or aspartate aminotransferase (asat) \>2 times normal values) or history of hepatobiliary and/or gastrointestinal disorder(s) * nephropathy (serum creatinine above normal range and/or albuminuria) * allergy or intolerance to ingredients included in the standardised meals * first-degree relatives with diabetes and/or glycated haemoglobin (hba1c) \>48 mmol/mol * regular tobacco smoking or use of other nicotine-containing products * any ongoing medication that the investigator evaluates would interfere with trial participation. * any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses