Kornimate/medical-research-clean huggingface dataset:
foster teens' risk during transition

Conditions: School Adjustment; Foster Care Disruptions

Summary: the purpose of this study is to conduct a randomized effectiveness trial to determine whether adding a preventive intervention at the transition from elementary to middle school is effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use, participation in hiv- risking sexual behavior, delinquency, mental health problems, and school failure for young adolescents in foster care. the proposed links intervention marries the goals of child welfare and educational systems. the aims are: a) to determine the effectiveness of the links intervention on key behavioral health and school adjustment outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to examine cost effectiveness and cost avoidance of links.


Eligibility criteria:
inclusion criteria: * the focal youth will be transitioning into middle school * the focal youth is in either a foster or kinship care home * the focal youth has been in the home for a minimum of 30 days (including those who are newly placed in care and those moving from another type of placement). exclusion criteria: * youth who are are considered medically fragile (i.e., severely physically or mentally handicapped)

Keywords: foster care school adjustment
vitamin d supplementation enhances immune response to bacille-calmette-guerin (bcg) vaccination in infants

Conditions: Tuberculosis

Summary: the purpose of this study is to determine whether a single oral dose of vitamin d given to infants prior to bacille-calmette-guerin (bcg) vaccination will enhance the immune response to bcg vaccination.

in 2000, there were an estimated 884,000 cases of tuberculosis (tb) in children with many developing severe, disseminated disease. widespread immunization with bacille-calmette-guerin (bcg) vaccine has not been effective in preventing primary tb infection or in halting the progression from latent to active disease. poor vaccine efficacy has prompted investigators to develop novel tb vaccines and to experiment with enhancing the immune response to the current bcg vaccine. increasing data indicate that children with low vitamin d levels and specific genetic variants that lower functional levels of vitamin d are at increased risk for severe tuberculosis. elegant studies investigating mycobacterium tuberculosis (mtb) infection have shown that mycobacteria are able to reside in endosomes within macrophages by preventing endosome-lysosome fusion; a critical step in autophagy, a cellular process used to recycle cytoplasmic organelles and proteins, and to degrade microbial organisms including mtb. in-vitro studies have shown that vitamin d increases autophagy and triggers the production of antimicrobial peptides including cathelicidin. this leads to increased intracellular killing of mtb and increased mtb antigen presentation to the immune system. anti-tuberculous vaccines that over-express mtb antigens generate a stronger immune response than wild type bcg vaccine. the investigators hypothesis is that a single oral dose of vitamin d3 (cholecalciferol) given to infants prior to bcg administration will enhance the immune response to vaccination through improved mhc class i and class ii presentation of the vaccine.

Eligibility criteria:
inclusion criteria: * healthy mothers \> 18 years of age * term, healthy infants eligible to receive the bacille-calmette- guerin (bcg) vaccine exclusion criteria: * recent maternal history of tuberculosis (within 1 year) or active tuberculosis * known maternal human immuno-deficiency virus (hiv) infection * maternal fever or chorio-amnionitis * maternal use of vitamin d, steroids or immuno-regulatory medications * household member with active tuberculosis

Keywords: bcg vaccine vitamin d cholecalciferol tuberculosis
hormone deficiency in heart failure with preserved ejection fraction

Conditions: Heart Failure; Hormone Deficiencies

Summary: the objective of this study is to describe the prevalence of multiple hormone deficiencies in heart failure with preserved ejection fraction.

despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. there is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive. consistent data coming from several independent groups have documented the reduced activity of most anabolic axes in hf with reduced ejection fraction. to date, no study has addressed the prevalence the presence and the prevalence of the multiple hormone deficiencies in heart failure with preserved ejection fraction.

Eligibility criteria:
inclusion criteria: * male patients of affected by chf, secondary to ischemic or idiopathic dilated cardiomyopathy * left ventricle ejection fraction \> 50% or more exclusion criteria: * severe liver disease * serum creatinine levels \>2.5 mg/dl * history of active cancer with life expectancy below 1 year acute coronary syndrome in the previous 6 months

Keywords: heart failure heart failure with preserved ejection fraction gh deficiency testosterone deficiency low- t3 syndrome multiple hormone deficiencies
scalp acupuncture for dyskinesia after ischemic stroke

Conditions: Ischemic Stroke

Summary: scalp acupuncture formed by combining traditional chinese acupuncture techniques and modern theories in medical anatomy has been widely used to treat ischemic stroke in china, but effective clinical trials that verify its efficacy are lacking. this study proposes to verify the effects of lu's scalp acupuncture on ischemic stroke by comparing differential improvement of motor function between conventional rehabilitation alone and conventional rehabilitation with lu's scalp acupuncture.

a randomized, controlled, parallel, clinical trial. 116 ischemic stroke patients will be collected with dyskinesia from longhua hospital, shanghai university of traditional chinese medicine and huashan hospital, fudan university in china. all patients will be equally randomized into either a control group (conventional rehabilitation) or an experimental group (scalp acupuncture + conventional rehabilitation). in the control group, patients will receive conventional rehabilitation according to the guidelines for stroke rehabilitation in china. in the experimental group, conventional rehabilitation will be supplemented with oblique acupuncture at approximately 15° and an insertion depth of 25-35 mm in the motor areas of the scalp. twisting speed will be 200 times per minute. acupuncture will be performed six times per day in 1-minute bouts, with a 4-minute rest following each bout. patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks. the primary outcome will be the difference in fugl-meyer motor function score between posttreatment (4 weeks, 8 weeks, and 6 months of follow-up) and baseline. the secondary outcomes will be differences in the modified barthel index, stroke-specific quality of life, and stroke syndrome of traditional chinese medicine.

Eligibility criteria:
inclusion criteria: * meet to criteria for diagnosis and efficacy evaluation of stroke, formulated by the state administration of traditional chinese medicine encephalopathy emergency cooperative group in 1996 (trial implementation) * guidelines for the diagnosis and treatment of acute ischemic stroke in china in 2014 (neurology branch of chinese medical association and cerebrovascular disease association of neurology branch of chinese medical association, 2015) * ischemic stroke diagnosed by ct or magnetic resonance imaging (mri), with the presence of stable vital signs and awareness * an age of 40-70 years onset within 1-6 months * motor dysfunction in the extremities * a mini-mental state examination (pangman et al., 2000) score \> 24 points exclusion criteria: * consciousness disorder or severe cognitive impairment * severe parkinson's disease, heart disease, cancer, epilepsy, or chronic alcoholism * hepatic or renal impairment * hemorrhagic tendency * sensitivity to acupuncture * congenital disability * pregnancy * currently participating in other clinical trials
chronic limb-threatening ischemia treated with intravascular lithotripsy observational study

Conditions: Chronic Limb-Threatening Ischemia

Summary: calcio is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular lithotripsy (ivl) with the shockwave ivl system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (clti). the primary objective of calcio is to understand the effectiveness of ivl in promoting wound healing and preventing amputation. the secondary objectives of calcio are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.


Eligibility criteria:
inclusion criteria: * patient with chronic limb-threatening ischemia (rutherford category ≥4) * femoropopliteal and/or crural calcified lesions visible on fluoroscopy; * treatment with ivl using the shockwave medical ivl system. exclusion criteria: * \< 18 years old; * incapacity or refusal to give informed consent; * ongoing pregnancy; * endovascular procedure(s) on the treatment site within 4 weeks before the planned ivl treatment.

Keywords: clti
effect of acetazolamide on sleep related breathing disturbances in patients with respiratory disease at altitude

Conditions: Chronic Obstructive Pulmonary Disease

Summary: in this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances at altitude in patients with copd.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances in lowlanders with chronic obstructive pulmonary disease travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3200 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo), will be administered 24 hours before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3200 m. sleep related breathing disturbances will be evaluated by respiratory polygraphy. an interim analysis will be carried out when 90 patients will have completed the study or after the first year. the peto's method will be used to correct the p-values.

Eligibility criteria:
inclusion criteria: * male and female patients, age 18-75 yrs. * copd diagnosed according to gold, fev1 40-80% predicted, spo2 ≥92% at 750 m. * born, raised and currently living at low altitude (\<800m). * written informed consent. exclusion criteria: * copd exacerbation, very severe copd with hypoxemia at low altitude (fev1/fvc \<0.7, fev1 \<40% predicted, oxygen saturation on room air \<92% at 750 m). * comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; osa; pneumothorax in the last 2 months. * internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day) * known renal failure or allergy to acetazolamide and other sulfonamides

Keywords: sleep related breathing disturbances respiratory polygraphy airway disease emphysema acetazolamide altitude nocturnal pulse oxymetry
treatment of the human anti-tnf monoclonal antibody adalimumab in moderate to severe crohn's disease with previous exposure to infliximab (choice)

Conditions: Crohn's Disease

Summary: the primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active crohn's disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety


Eligibility criteria:
inclusion criteria: * patient diagnosed with moderate to severe crohn's disease. * failed prior infliximab therapy. * patient is judged to be in generally good health as determined by the principal investigator. exclusion criteria: * previous treatment with adalimumab. * patient considered by the investigator, for any reason, to be an unsuitable candidate
effects of hyperprolactinemia induced by antipsychotic drugs on bone metabolism

Conditions: Schizophrenia

Summary: the study is aimed to assess the severities of hyperprolactinemia caused by antipsychotic drugs and the effects of the duration of hyperprolactinemia on bone metabolism in schizophrenia patients.

hyperprolactinemia is a common adverse effect of antipsychotic drugs. studies have shown that hyperprolactinemia may affect bone metabolism through direct and indirect effects and increase the risk of osteoporosis and fracture.the investigators assess the duration, the severity of hyperprolactinemia and its effects on bone metabolism in schizophrenics taking antipsychotic drugs through analyzing the correlation between prolactin levels and biochemical markers of bone metabolism and the correlation between the duration of hyperprolactinemia and abnormal bone metabolism. meanwhile, the investigators aims to obtain the boundary value of prolactin levels in patients with abnormal bone metabolism.

Eligibility criteria:
inclusion criteria: * 1. diagnosis of the disease meets the icd-10 diagnostic criteria for schizophrenia 2. subjects intend to use atypical antipsychotics 3. age between 18 and 50 years of age exclusion criteria: * 1. pregnant and breast feeding women 2. abnormal lipid metabolism 3. the level of serum alanine aminotransferase or aspartate aminotransferase is two times higher than the upper limit of the normal 4. patients with diabetes or impaired fasting glucose 5. the level of prolactin is higher than normal 6. patients taking drugs that affect bone metabolism (e.g. selective serotonin reuptake inhibitors antidepressants, antiepileptic drugs) 7. the level of creatinine is 1.2 times higher than the upper limit of the normal value

Keywords: antipsychotic drugs hyperprolactinemia bone metabolism
budesonide treatment for lymphocytic colitis

Conditions: Microscopic Colitis

Summary: the purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

the purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Eligibility criteria:
inclusion criteria: * lymphocytic colitis * diarrhea * effective contraception * written informed consent exclusion criteria: * other forms if ibd * celiac disease * infectious colitis * history of colonic surgery * use of budesonide, 5-asa, steroids within th previous 4 weeks * pregnancy, lactation

Keywords: lymphocytic colitis microscopic colitis budesonide
combined tdcs and tms on subjective tinnitus and combined depression

Conditions: Tinnitus; Depression

Summary: the investigators combined transcranial direct current stimulation (tdcs) and transcranial magnetic stimulation (tms) to increase the effective response of a single session of neuromodulation in subjective tinnitus.

to treat motor and psychiatric disorders, transcranial direct current stimulation (tdcs) and transcranial magnetic stimulation (tms) are world-widely in use in clinics. the investigators combined these two types of neuromodulation techniques to increase the effective response of a single session of neuromodulation in subjective tinnitus. experimental groups with 80 tinnitus subjects consisted of four different treatment groups which are tdcs, tdcs with sham tms, tdcs-tms and tms group. subjects were given 1.5milliampere (ma) tdcs on the bi-frontal area and tms stimulated contralateral single side of the temporoparietal cortex with 200 pulses at 1herz (hz) stimulation.

Eligibility criteria:
inclusion criteria: * research volunteers who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the department of otorhinolaryngology head-and-neck surgery, seoul national university bundang hospital exclusion criteria: * psychoactive drug user * implanted material * pacemaker user

Keywords: tinnitus, tdcs, tms
orthobiologic treatment for knee osteoarthritis

Conditions: Osteoarthritis Knee

Summary: the goal of this randomized clinical trial is to compare treatment for osteoarthritis in the knee using platelet rich plasma (prp) or adipose stem cells (ads). the main questions it aims to answer are: * will the patients clinically benefit from the treatment, and if so, which treatment is better? * will there be radiological findings to support this? participants will be randomized into one of four groups: prp, ads, prp + ads or placebo treatment (saline) and will be examined and get an x-ray and mri of the knee taken at inclusion and after 1 and 2 years.

patients will be randomized into one of four treatment groups and then be followed up at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after intervention. they will fill out scores and be clinically evaluated, as well as radiologically examined at inclusion and at the final check up (x-ray and mri).

Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis in the knee grade i-iii using the kellgren-lawrance grading scale * age 40-70 years * minimum vas 3 * no use of nsaids or steroids the last 14 days * no injections of hyaluronic acid the last three months * varus/valgus deformity \&lt;5 degrees as evaluated on x-ray imaging exclusion criteria: * pregnant or breastfeeding women * cancer * other etiologies of knee pain (refered pain, pain from the back, dislocated meniscus on mri, osteoarthritis grade iv using the kellgren-lawrance grading scale) * previous knee surgery on the affected knee * secondary osteoarthritis in the knee * previous infection in the knee * other diseases (rheumatoid arthritis, diabetes, systemic diseases or corticosteroid-demaning disease) * patients with a high risk of deep vein thrombosis * patients who cannot cooperate/are low compliance (psychiatric disease) or has contraindications for mri

Keywords: osteoarthritis knee platelet rich plasma adipose tissue
presternal bupivacaine plus magnesium sulfate infusion after cardiac surgery

Conditions: Pain; Postoperative Pain

Summary: effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures. magnesium is the fourth most plentiful cation in our body. it has antinociceptive effects in animal and human models of pain.

effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. a major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days. the most often used analgesics in these patients are parenteral opioids which can lead to undesirable side-effects as sedation, respiratory depression, nausea, and vomiting. infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures. magnesium is the fourth most plentiful cation in our body. it has antinociceptive effects in animal and human models of pain. it has been mentioned in a systematic review that it may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising. these effects are primarily based on physiological calcium antagonism, that is voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism of n-methyl-d-aspartate (nmda) receptors. postoperative pain control will be by 1gm paracetamol / 6 hr, ketorolac tromethamine 30 mg / 8:12 hour in control group vs bupivacaine 0.125% plus magnesium sulfate 5% through a single catheter after parasternal block in in study group after cardiac surgery. the investigators primary outcome is pain scores assessment , the secondary outcomes are extubation time, postoperative respiratory parameters, serum cortisol level

Eligibility criteria:
inclusion criteria: * 18-60 years old * american society of anesthesiologists physical status ii and iii * patients scheduled for open heart surgery with sternotomy exclusion criteria: * emergency surgery * clinically significant kidney or liver disease * patients allergic to local anesthetic * patients with prolonged cpb time (\>120 min) * patients required intra-aortic balloon pump

Keywords: sternotomy , cardiac surgery , pain
extended-release naltrexone for alcohol dependence in primary care

Conditions: Alcohol Dependence

Summary: naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. the efficacy of extended-release naltrexone (vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. however, the feasibility of implementing this united states food and drug administration approved treatment in the front-line settings in which it is most needed has not been demonstrated. this is an open-label pilot feasibility study of implementing treatment with vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.


Eligibility criteria:
inclusion criteria: * current alcohol dependence * age 18 or older * english or spanish-speaking * without untreated severe mental illness * liver enzymes (alanine aminotransferase and aspartate aminotransferase) ≤ 3x normal * kept 2 of last 3 clinic primary care appointments and/or has a working telephone number at which can be contacted directly * either a) currently abstinent (e.g., referred from an inpatient 'detox' setting) or b) with the ability, in the clinician's judgment, to achieve and maintain abstinence * if female of child-bearing potential, must be using adequate contraception * able to understand study procedures exclusion criteria: * currently opioid dependent or requiring ongoing treatment with opioids for any indication

Keywords: alcohol dependence
effects of gene polymorphism after transcranial cranial direct current stimulation on the corticobulbar excitability

Conditions: Healthy

Summary: this study aims to examine the effects of transcranial direct current stimulation at corticobulbar excitability in individuals with different gene polymorphism.

the effects of tdcs on corticobulbar excitability of the brain after inhibitory pre-conditioning will be compared in patients with different bdnf phenotypes

Eligibility criteria:
inclusion criteria: * age 19-40 years * informed consent exclusion criteria: * history of epilepsy * presence of cardiac pacemaker * previous brain surgery * previous swallowing problems * current use of medication which acts on the central nervous system * presence of implanted metal intracranially