Kornimate/medical-research-clean huggingface dataset:
transcranial magnetic stimulation in the treatment of addiction

Conditions: Alcohol Addiction

Summary: the investigators hypothesize that repetitive transcranial magnetic stimulation (rtms) on the right side of the head will make craving towards alcohol less severe in recently detoxified alcohol addicted patients. although there are successful treatment option to detoxify patients form their alcohol use, many patients tend to relapse. this relapse is mainly caused by a high level of (uncontrollable) craving towards alcohol. this aspect of addiction is with the existing options hard to treat, there is a great need of new successful treatment modalities. rtms is a fda approved treatment method for depression. recently some small scale studies have shown promising results on rtms in the treatment of addiction. in this study the investigators focus on alcohol addiction since it is the addiction with the highest morbidity and mortality in the netherlands.

in this study the investigators focus on three levels of interest: the biological level, the functional level and the clinical level. the investigators will measure the effect of rtms directly on brain activity through eeg recording. the investigators investigate its effects on cognitive performance through the use of neuropsychological computer tasks. the investigators will address clinical behavior (craving and alcohol use) with questionnaires.

Eligibility criteria:
inclusion criteria: * right-handed males between 23-65 years of age * a primary diagnose of alcohol dependence (meeting the dsm-iv-tr criteria 303.90/icd-10 f10.2) * written consent for participation of the study. exclusion criteria: * mate outcome \<4 (as extracted from part 4 mate at enrollment phase)mate= dutch screening instrument on (among others) addiction severity * presence of a current or past relevant somatic or neurological disorder * meeting the dsm-iv-tr criteria for a current bipolar disorder, schizophrenia, anxiety disorder or moderate to severe depressive disorder. these disorders would be a possible great confounder. measured with the mini-plus. * meeting the dsm-iv-tr criteria for current (in the past 2 weeks) dependence of substances other than alcohol, nicotine or caffeine. information present in mate. * participant-bound factors that may endanger participants or may jeopardize study adherence, because of failure to understand and/or comply with instructions (e.g. current, disruptive symptoms such as psychotic symptoms or severe cognitive impairment) * contra-indications resulting from the use of rtms: * epilepsy, convulsion or seizure * serious head trauma or brain surgery * large or ferromagnetic metal parts in the head (except for a dental wire) * implanted cardiac pacemaker or neurostimulator

Keywords: alcohol addiction tms craving use rtms eeg lpp p300 ern sst cct aaat
mucorales pcr screening in at-risk hematology patients

Conditions: Mucormycosis

Summary: patients with leukemia are treated with intensive chemotherapy and often have to undergo a stem cell transplantation which makes their immune system extremely vulnerable. this puts them at risk for invasive fungal infections, of which invasive mucormycosis (im) is one of the most dangerous ones. treatment of im is complex and mortality rates are still extremely high, ranging from 40% to 80% and sometimes even higher if the central nervous system is involved. mucormycosis requires immediate intervention due to the rapidly progressive and destructive nature of the infection. but the diagnosis is often made too late... better survival can be achieved with a faster diagnosis. a new test has recently been developed for detection of mucorales dna by pcr. the polymerase chain reaction (pcr) is a method that allows to quickly make millions of copies of, for example, mucorales dna in order to detect it in the blood at an early stage. because blood can easily be obtained, without an additional burden on the patient, the test could be interesting for screening for these infections, which then offers the opportunity to start an adequate treatment more quickly. however, the test is now only performed if there is a clinical suspicion of im. but at that point, precious time has already been lost, and often the patient can no longer be cured. in this study the utility of the mucorales pcr as a possible screening test in at-risk patients is assessed. the participants, hospitalised patients with leukemia, will be screened twice weekly with a mucorales pcr test during their most vulnerable period. if the study shows that the test helps in diagnosing im faster, this could have an important impact on the treatment and survival of these at-risk patients.


Eligibility criteria:
inclusion criteria: * underlying disease: * start of remission induction chemotherapy for acute myeloid leukemia (aml) or myelodysplastic syndrome (mds) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months; or * start of myeloablative conditioning regimen to prepare for a first allogeneic hematopoietic cell transplantation (hct). * expected prolonged neutropenia (anc\< 0.5 x 109 /l for ≥ 7 days). * planned hospital admission for the duration of the neutropenic phase.

Keywords: invasive mycosis neutropenia leukemia stem cell transplant complications invasive mucormycosis
oral paricalcitol in renal transplant recipients for reducing albuminuria

Conditions: Proteinuria

Summary: the main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. about 50% of graft losses are related to interstitial fibrosis. paricalcitol is a vitamin d receptor activator indicated for treatment of secondary hyperparathyroidism. paricalcitol is known to exert an anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. paricalcitol is also shown to be renoprotective by reducing proteinuria. no randomized controlled trials with paricalcitol are performed in renal transplant patients examining the effect on proteinuria and graft fibrosis.

77 randomized, 37 paricalcitol, 40 no treatment

Eligibility criteria:
inclusion criteria: * kidney transplant patients exclusion criteria: * previously transplanted

Keywords: kidney transplant patients albuminuria
antimicrobial therapy as adjunct to periodontal treatment: effect of timing

Conditions: Chronic Periodontitis

Summary: it is common practice to carry out the therapy of periodontal diseases in two phases. in a first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are removed using a cleaning method called "scaling and root planing" (srp). after three to six months the case is evaluated and, if necessary, further treatment is provided, usually taking a more aggressive, surgical approach. beneficial effects of adjunctive systemic antibiotics on clinical outcomes have been shown repeatedly but specific indications for antibiotics in subgroups of diseased patients, and the optimal timing of antimicrobial therapy, continue to be issues of a long lasting controversy.this study assessed the differential outcomes of periodontal therapy supplemented with amoxicillin-metronidazole during either the non-surgical or the surgical treatment phase.

single center, randomized placebo controlled crossover clinical trial with a one-year follow-up. eighty participants with aggregatibacter actinomycetemcomitans-associated chronic or aggressive periodontitis were randomized into two treatment groups. a: antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase of periodontal therapy (t1), and placebo during the second, surgical phase (t2). b: placebo during t1, and antibiotics during t2. persistence of sites with a probing depth (pd) \>4 mm and bleeding on probing (bop) was the primary outcome. evaluations were made three months after t1, as well as 6 and 12 months after t2.

Eligibility criteria:
inclusion criteria: * untreated moderate to advanced periodontitis (at least 4 teeth with a probing pocket depth (pd) \>4 mm, clinical attachment loss of at least 2 mm and radiographic evidence of bone loss) * presence of at least 12 scorable teeth (not including 3rd molars, teeth with orthodontic appliances, bridges, crowns or implants) * aggregatibacter actinomycetemcomitans-positive exclusion criteria: * systemic illnesses (i.e. diabetes mellitus, cancer, hiv, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy) * pregnancy or lactation * systemic antibiotics taken within the previous two months * use of non-steroid anti-inflammatory drugs * confirmed or suspected intolerance to 5-nitroimidazole-derivatives or amoxicillin subgingival srp or surgical periodontal therapy in the last year

Keywords: periodontitis amoxicillin metronidazole case management
measure of pharmacokinetic parameters and adherence with mems in naive hiv infected patients treated with reyataz once daily combined with norvir and truvada

Conditions: HIV Infections

Summary: the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. all drugs will be delivered in mems electronic device to monitor dosing history.

the trial is a phase ii, open label, non-randomized, prospective multicenter trial to assess the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. all drugs will be delivered in mems electronic device to monitor dosing history.

Eligibility criteria:
inclusion criteria: * naïve of treatment hiv -1 infected patients * cd4 above 100/mm3 exclusion criteria: * pregnancy * renal failure * hepatitic disease * ongoing opportunistic disease * hb under 8g/dl; platelets under 50 000/mm3; neutrophils under 750/mm3; prothrombin index under 80%, ca or ph \> 2.5 n * drugs interacting with investigational drugs

Keywords: hiv infections atazanavir pharmacokinetics treatment naive
contingent incentives plus bupropion for smoking in people with schizophrenia

Conditions: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder

Summary: there is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. the aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.

there is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. in this study, we are investigating whether the combination of bupropion (also called zyban and wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. this is a 3-week study aimed to investigate the feasibility of this treatment approach. participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. after one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. they also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. participants in the control behavioral treatment group receive gift cards regardless of cotinine level. any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. if we have favorable results from this trial, we will expand it into a smoking treatment program.

Eligibility criteria:
inclusion criteria: diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications exclusion criteria: pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of mao inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, da agonists, anorectics, stimulants

Keywords: tobacco
supraspinal contributions to the control of human locomotion: clinical and fundamental aspects

Conditions: Post-stroke Gait Assessments

Summary: many neurological patients express enhanced deficits while walking in a dark room (or during the night): the supraspinal structures involved in this navigational deficit have not been identified yet. in this project, the investigators will study post-stroke gaits of human patients and compare them to those of a control population during a goal-oriented task performed in different visual conditions. the investigators want to test the hypothesis that during simple goal-oriented locomotor tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express navigational deficits.


Eligibility criteria:
inclusion criteria (for matching controls): * adult male and female subjects (18--\>85 years old) exclusion criteria (for matching controls): * persons with history of an acquired or congenital neurological disorder, e.g. stroke, multiple sclerosis, parkinson disease, increased intracranial pressure, etc.; * persons injured at the time of the experiments (fractures,...); * persons having reported repetitive spatial troubles/disorders; * persons with eye disorders and non-corrected vision problems; * pregnant women.
study of the effects of testosterone in frail elderly men

Conditions: Frailty; Sarcopenia

Summary: the study aims to determine the effects of testosterone on muscle function, mobility, activities of daily living and overall quality of life

ageing-associated loss of muscle mass and strength is a major cause of physical frailty, disability, morbidity and dependency in the elderly. this is associated with increased falls, fractures, loss of mobility, restricted activities of daily living and increased utilisation of healthcare resources. it is well known that serum testosterone levels fall with advancing age and this may be an important cause for muscle wasting and weakness (sarcopenia). testosterone replacement increases muscle mass and improves muscle strength in young hypogonadal men. in relatively healthy elderly men, some short-term studies have also shown that testosterone can improve muscle strength. the potential beneficial effects of testosterone supplementation on muscle strength and functional capacity of frail elderly men has so far not been studies and forms the basis of this research. we hypothesise that testosterone supplementation is an effective, safe and economic anabolic intervention in frail elderly men with low circulating testosterone.

Eligibility criteria:
inclusion criteria: * frail elderly men (as defined by freid's criteria of frailty) * community - dwelling men aged 65 years and above * total testosterone ≤12.0 nmol/l or calculated free t≤0.25nmol/l exclusion criteria: * carcinoma of prostate * carcinoma of breast * psa \>4ng/ml * severe symptomatic benign prostatic hypertrophy (ipss \>21) * active liver disease * renal impairment (serum creatinine \>180 mmol/l) * congestive heart failure * unstable ischaemic heart disease * polycythaemia * evidence of systemic disease which may affect muscle/joint function * moderate to severe peripheral vascular disease * moderate to severe chronic obstructive airways disease * alcohol consumption over 30 units per week * medications that interfere with sex steroid metabolism * history of stroke causing persistent motor deficit * cognitive deficit * major psychiatric illness * hospital admission in the past 6 weeks * sleep apnoea

Keywords: frailty muscle strength physical performance bone mineral density quality of life
a study to assess the efficacy and safety of apremilast in japanese pediatric participants with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * japanese participants aged 6 to 17 years at screening * participants must have a weight of ≥ 15 kg * diagnosis of chronic plaque psoriasis for at least 3 months prior to screening * has moderate to severe plaque psoriasis at screening and baseline as defined by: * pasi score ≥ 12; and * bsa ≥ 10; and * spga ≥ 3 (moderate to severe) * disease inadequately controlled by or contraindicated for ≥ 1 topical therapy for psoriasis * candidate for systemic therapy or phototherapy exclusion criteria: * psoriasis flare or rebound within 4 weeks prior to screening * evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments * other than psoriasis, history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease * prior history of suicide attempt at any time in the participant's lifetime prior to screening or baseline in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent * guttate, erythrodermic, or pustular psoriasis at screening and baseline

Keywords: plaque psoriasis apremilast amg 407 moderate to severe plaque psoriasis pediatric plaque psoriasis
a comparison of exenatide and insulin glargine

Conditions: Type 2 Diabetes

Summary: this is a 16-week, single-center, randomized, open label, parallel controlled group comparison of the comprehensive glycemic control of exenatide and insulin glargine on type 2 diabetes patients inadequately controlled with metformin monotherapy.

screening will be made to select eligible patients, then 44 patients receiving a stable dose of metformin (≥1500 mg daily) will be randomized (1:1) to receive exenatide or insulin glargine for 16 weeks. exenatide will be administered twice daily by subcutaneous injection 30- 60 minutes before breakfast and dinner; the dose was 5 μg twice-daily for the first 4 weeks of treatment and 10 μg thereafter. insulin glargine will be administered once daily at bedtime by subcutaneous injection. the dose of insulin glargine will initiate at ≥8 iu once-daily, and titrate based on a dosing algorithm targeting fasting blood glucose (fpg)\<6.1 mmol/l. titration is only allowed in first 4 weeks. at the end of the study, data will be collected and analyzed.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures 2. type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks) 3. male or female age ≧ 18 years and ≦70 years old 4. hba1c ≧7.0 and ≦10% 5. bmi ≧ 24 kg/m2 exclusion criteria: 1. known or suspected allergy to trial products or related products. 2. impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 133 umol/l). 3. acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock. 4. abnormal liver function, alanine transaminase or aspartate aminotransferase ≥ 3 fold normal upper limit, total bilirubin ≥ 2 normal upper limit, acute alcohol intoxication, alcoholism. 5. subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (mi), arrhythmias or conduction delays on ecg, unstable angina, or decompensated heart failure (new york heart association-class ⅲ and ⅳ). 6. proliferative retinopathy or muscular oedema requiring acute treatment. 7. pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods). 8. treatment with systemic corticosteroids within the past two months prior to screening. 9. type 1 diabetes mellitus. 10. receipt of any investigational drug within 1 month prior to this trial.

Keywords: exenatide insulin glargine
phase i/ii dose-escalation study to investigate safety and pharmacokinetics/ pharmacodynamics of wx-554 in patients with solid tumours

Conditions: Advanced Solid Tumours

Summary: the aim of part 1 of this study is to determine the optimal biological dose (obd) and maximum tolerated dose (mtd) for wx-554 and the recommended dose/dose schedules for the chronic treatment in part 2. the aim of part 2 is to further determine the safety and tolerability of chronic treatment with wx-554.


Eligibility criteria:
inclusion criteria: 1. patients with advanced, metastatic and/or progressive solid tumours for whom there is no effective standard therapy available. 2. evaluable or measurable disease 3. has normal organ functions; is no greater than 2 on the ecog performance scale 4. life expectancy of \>3 months 5. negative hcg test in women of childbearing potential exclusion criteria: 1. patients who received an investigational anti-cancer drug within 4 weeks of starting the study 2. patients who received major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study 3. clinically significant, unresolved toxicity from previous anti-cancer therapy patients 4. patients who previously received a mek inhibitor 5. presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs. 6. known medical history of retinal vein occlusion, intraocular pressure greater than 21 mm hg or patient considered at risk of retinal vein thrombosis. 7. known hiv positivity or active hepatitis b or c infection. 8. history of clinically significant cardiac condition
efficacy of canrenone as add-on treatment in moderate to severe ards in covid-19

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Summary: the main aim of the study is to estimate the potential efficacy of i.v. canrenone as add-on therapy on maximal medical treatment versus maximal medical treatment alone in treating moderate-to-severe ards due to sars-cov-2.


Eligibility criteria:
inclusion criteria: * age 18 - 80 y.o. since over eighties are very fragile patients, a lot of confounding unpredictable events may interfere with the trial analyses; thus, these patients will be excluded from this exploratory proof-of-concept trial; * covid-19 diagnosis through swab within 14 days from the beginning of symptoms * hospitalization for moderate to severe ards (as determined by pao2/fio2 ≤300 mmhg at admission) * serum concentration of potassium ≤4.5 meq/l * consent to participate exclusion criteria: * invasive mechanical ventilation * i.v. hydratation with darrow's solution or half-strength darrow's solution underway * acute cardiovascular event (acute myocardial infarction, acute ischaemic stroke) * current malignant disease * creatinine \>1.8 mg/dl (for women) and \>2.0 mg/dl (for men) or glomerular filtration rate \<50 ml/mm * systolic blood pressure \<110 mmhg and/or diastolic blood pressure \<60 mmhg * known or suspected hypersensitivity to canrenone * hyponatremia * anuria * familial history of porphyria * pregnancy and breastfeeding * known or suspected hypersensitivity to canrenone * inclusion in any other pharmacological clinical trials

Keywords: covid-19 potassium canrenoate