Kornimate/medical-research-clean huggingface dataset:
abuse potential assessment of intranasally administered embeda compared to morphine sulfate controlled release and placebo

Conditions: Narcotic Abuse; Opioid-related Disorders; Analgesia; Chronic Pain

Summary: this was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed embeda® compared to morphine sulfate cr tablets and placebo in healthy male and female, non-dependent, recreational opioid users. an appropriate dose of morphine sulfate cr (i.e., 30 mg, 60 or 90 mg) was to be selected during part a of the study (dose selection phase). each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects 18 to 55 years of age, inclusive. * subject is a recreational opioid user who is not dependent on opioids based on diagnostic and statistical manual of mental disorders-fourth edition-text revision (dsm-iv-tr) criteria and the naloxone challenge. a recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the screening visit (visit 1). * subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the screening visit. exclusion criteria: * diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the investigator using the dsm iv-tr criteria. * has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine). * has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus. * allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose. * history or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the investigator. * history or current pulmonary disease including asthma, chronic obstructive pulmonary disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.

Keywords: abuse liability abuse potential morphine intranasal administration snorting opioid abuse pharmacodynamic recreational drug use
18776 - human photoallergy test

Conditions: Sunscreening Agents

Summary: to evaluate the potential of a test material to produce a photoallergic response.


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a health insurance portability and accountability act (hipaa) authorization form in conformance with 45cfr parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator; exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; * have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products. * subjects who are employees of the cro and/or bayer or is a household member of an employee
cardiac troponin t after transcatheter closure of the interatrial septum

Conditions: Congenital Heart Disease

Summary: to examine retrospectively whether transcatheter closure of the interatrial septum leads to myocardial injury and to determine the mechanism.

in a prospective study in adults troponin t (tnt) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (asd) or patent foramen ovale (pfo).

Eligibility criteria:
inclusion criteria: * transcatheter asd and pfo closure at the university hospital of lund, sweden exclusion criteria: * missing tnt values
clinical trial for the treatment of chronic chagas disease with posaconazole and benznidazole

Conditions: Chagas Disease

Summary: the investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of chagas disease chronical infection. exploratory trial of posaconazole antiparasitic activity against trypanosoma cruzi.


Eligibility criteria:
inclusion criteria: * consenting patients with serological evidence of chagas infection and positive pcr real time exclusion criteria: -
sunphenon epigallocatechin-gallate (egcg) in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the aim of this multicentre, prospective, double blind, placebo controlled, randomized pilot study is to investigate safety and tolerance of epigallocatechin-gallate (egcg, the major polyphenol in green tea) in patients with muscular dystrophy of the duchenne type. in a second step the investigators want to investigate the effect of egcg on the course of the duchenne condition.

duchenne muscular dystrophy (dmd) is the most frequent neuromuscular condition to occur in childhood and youth. the course of the disease is progressive, and life expectancy is severely curtailed by the participation of the respiratory muscles and/or by progressive cardiomyopathy. dmd derives from mutations in the dmd gene which leads to a loss of the protein dystrophin. secondary inflammatory/immunological reactions contribute to the progressive course of the disease (1,2). no curative therapy yet exists. administration of steroids is the only established medical treatment. symptomatic measures are also available, such as orthopaedic operations, the treatment of cardiomyopathy or, in advanced stages, home mechanical ventilation. in studies involving experiments on cells and animals, epigallocatechin-gallate (egcg, the major polyphenol in green tea) has shown a neuroprotective effect. the neuroprotective mechanism of action is probably based on several factors, including egcg's modulation of several signal transduction pathways, its influence on the expression of genes regulating cell survival or programmed cell death, as well as its modulation of mitochondrial function. the mdx mouse is the best-investigated animal model of a dystrophin-negative muscular dystrophy. administration of egcg in the mdx mouse led to both a reduction in the proportion of fibre necroses as well as to a less pronounced proliferation of connective tissue in the muscle (3,4), and also to an improvement in clinical symptoms (5,6). therefore, the investigators want to investigate safety and tolerance of egcg in a dosage of up to 10mg/kg in patients with muscular dystrophy of the duchenne type in this multicentre, prospective, double blind, placebo controlled, randomized pilot study.

Eligibility criteria:
inclusion criteria: * duchenne muscular dystrophy * age 5-10 years * ability to walk without support * informed consent by the parents exclusion criteria: * another serious organic disease * further primary psychiatric or neurological diseases * long-term intake of liver-toxic medicines

Keywords: duchenne muscular dystrophy epigallocatechin-gallate green tea extract
safety and immunogenicity of a naked dna-based vaccine therapy in patients with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study was to investigate whether hbv-dna vaccination is safe and could restore immune responses in patients with chronic hepatitis b non responder to available therapies.

* despite the availability of effective hepatitis b vaccines for many years, over 370 million people remain persistently infected with hepatitis b virus (hbv). persistent infection is associated with chronic liver disease that can lead to the development of cirrhosis and hepatocellular carcinoma in some patients. viral persistence is thought to be related to poor hbv-specific immune responses. * interferon (ifn)-alpha treatment significantly decreases hbv replication in only one third of patients with hepatitis b e antigen (hbeag)-positive chronic active hepatitis b. nucleoside analogues, such as lamivudine and adefovir dipivoxil, inhibit hbv replication and improve histological signs of liver disease,but their use is limited by the risk of relapse after treatment discontinuation and the emergence of drug-resistant viral variants. * patients with acute self-limited hepatitis b display detectable polyclonal and multispecific cytotoxic t lymphocyte and t helper (th) responses to viral antigens,whereas these responses are weak or absent in chronic hbv carriers. * increasing the strength of hbv-specific t-cell responses to the levels found in patients recovering from infection is therefore a goal in the treatment of patients with chronic hepatitis. * immunization with a nucleic acid vaccine (dna vaccine) usually elicits antibody responses and t lymphocytes with a th1 cytokine profile. in animal models of chronic hepatitis b infection, including nonhuman primates, intramuscular injection of a plasmid encoding hbv envelope proteins induces rapid, strong, and sustained humoral and cell-mediated immune responses. clinical trials of dna vaccines for hepatitis b conducted in healthy adult volunteers using a plasmid encoding hepatitis b surface antigen and the gene gun as a delivery system showed good tolerance. * we carried out a phase i trial of a hbv dna vaccine in patients with chronic active viral hepatitis, aiming to restore hbv-specific immune responses and to assess safety regarding liver disease.

Eligibility criteria:
inclusion criteria: * chronic hbv carriers * biopsy proven chronic hepatitis * active hbv replication for \> 6 months * non responding to interferon-alpha or lamivudine treatment exclusion criteria: * co-infection with hiv, hcv, delta hepatitis virus * alcohol consumption\> 40g/day * decompensated liver disease * hla dr2

Keywords: hepatitis b dna vaccine immunotherapy
intensive psychotherapy for chronic depression

Conditions: Chronic Depression; Persistent Depressive Disorder; Recurrent Major Depression

Summary: the study evaluates whether intensive psychotherapy show superior effect on chronic depression over tau

background: accumulating evidence indicates that intensive psychotherapy (i.e., greater number of treatment sessions per time unit) improves outcomes for patients with mental health problems. however, few studies have investigated whether patients with chronic depression (cd) benefit from treatment with higher intensity. the main purpose of this study is to investigate if intensive psychotherapy could improve treatment for patients with chronic depression (cd). the primary research question is whether two intensive psychodynamic inpatient treatments, affect phobia therapy (apt) and vita, are superior to low intensity treatment (tau) at completion of treatment. to indicate if a potential difference between intensive treatment and tau is due to the intensity of the therapy, the study contrasts two therapies with similar intensity, but different theoretical rationales. methods: 280 patients with cd are included in a naturalistic study. patients are assessed at four time points; assessment, start of therapy, end of therapy and 1-year follow-up. three comparisons are performed with patients matched across groups; intensive treatment (apt + vita) vs tau during treatment, apt vs vita during treatment and apt vs vita during follow-up. the outcome measure is the bdi-ii.

Eligibility criteria:
inclusion criteria: inclusion criteria will be liberal and similar to clinical practice criteria at the treatment site which includes patients with the characteristics of chronic depression (cd), thus including patients with * persistent depressive disorder as defined by the diagnostic and statistical manual of mental disorders (dsm5) * recurrent depressive disorder as defined by the international classification of diseases-10 (icd-10) exclusion criteria: * not having utilized reasonably available treatment in proximity to their residence * a psychotic disorder * cluster a or b personality disorder * bipolar disorder, * ongoing substance abuse, * physical brain disorder * not having access to tau while on the 12 week wait-list period.
shockwave therapy and platelet rich plasma for the treatment of erectile dysfunction

Conditions: Erectile Dysfunction

Summary: the purpose of this research study is to evaluate whether the combination of shock wave therapy (swt) with platelet rich plasma (prp) is synergistic and can reverse the pathology of microvascular erectile dysfunction (ed) and enhance erectile function by improving vasodilation, and endothelial function


Eligibility criteria:
inclusion criteria: 1. be male 2. be 30 to 80 years of age (inclusive). 3. be able to provide written informed consent. 4. have a diagnosis of ed due to organic origin for at least 6 months prior to consent. 5. sexually active in a stable, heterosexual relationship of more than three months duration. 6. iief-ef score 12-25 at screening 7. agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs. 8. agree to comply with all study related tests/procedures. exclusion criteria: 1. previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting. 2. previous history of priapism or penile fracture 3. abnormal morning serum testosterone level defined as a value lower than 300 ng/dl (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dl (±5%). 4. current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (subjects with prior or current use of hormonal treatment for prostate cancer are also excluded. 5. psychogenic ed as determined by study investigator. 6. anatomical (peyronie's disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area. 7. patients using intracavernosal injection (ici) for management of ed 8. patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or parkinson's disease. 9. have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study. 10. history of consistent treatment failure with phosphodiesterase type 5 (pde5) inhibitors for therapy of ed. 11. any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. patients who are currently using selective serotonin reuptake inhibitors (ssri) or psychotropic medications. 12. hemoglobin a1c \>9%.
safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising doses of bi 10773 tablets

Conditions: Diabetes Mellitus, Type 2

Summary: to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of bi 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of bi 10773 after multiple dosing, including dose proportionality and assessment of steady state.


Eligibility criteria:
inclusion criteria: 1. male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less. 2. glycosylated haemoglobin a1 (hba1c) £ 8.5 % at screening. 3. age \>21 and age \ 60 and age \<70 years (postmenopausal female patients) 4. body mass index (bmi) \>18.5 and \<40 kg/m2 5. signed and dated written informed consent prior to admission to the study in accordance with gcp and the local legislation exclusion criteria: 1. antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose) 2. fasted blood glucose \> 240 mg/dl (\>13.3 mmol/l) on two consecutive days during washout. 3. glycosylated haemoglobin a1 (hba1c) \>8.5% at screening 4. clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as: * any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot) * renal insufficiency (calculated creatinine clearance \< 80 ml/min/1.73m²) * cardiac insufficiency nyha ii-iv, myocardial infarction, other known cardiovascular diseases including hypertension \> 160/95mmhg (measured at training visit and each of the timepoints of day -1), stroke and tia (transistoric ischaemic attack) * neurological disorders (such as epilepsy) or psychiatric disorders * acute or relevant chronic infections (e.g. hiv, repeated urogenital infections) * any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder 5. history of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval \>450 ms) 7. a history of additional risk factors for tdp (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)
the role of micrometastasis and isolated tumor cells (itcs) in endometrial and cervical cancer. a multicenter study.

Conditions: Endometrial Cancer; Cervical Cancer; Sentinel Lymph Node; Micrometastasis; Sentinel Lymph Node Biopsy; Endometrium Tumor; Endometrial Neoplasms; Cervical Neoplasm; Cervical Tumor; Lymph Node Metastases; Lymph Node Disease

Summary: the role of small-volume lymph node disease (itc and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (sln) procedure is not clearly defined. this study was designed to create a dataset of patients with lymph nodal disease. data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (dfs, os, recurrence rate) will be collected and analyzed. this will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.


Eligibility criteria:
inclusion criteria: * early stage endometrial cancer scheduled for sln procedure * early stage cervical cancer scheduled for sln procedure * pathological evaluation of slns with standard ultra-staging or one-step nucleic acid amplification (osna) for the detection of metastasis * presence of lymph nodes metastasis (macrometastasis or low volume disease \[micrometastasis and isolated tumor cells\]) exclusion criteria: * previous (\<5 years) or concomitant malignancy other than non-melanoma skin cancer * advanced/metastatic endometrial cancer * locally advanced/metastatic cervical cancer

Keywords: endometrial cancer cervical cancer sentinel lymph node low volume disease survival recurrence rate adjuvant therapy micrometastases isolated tumor cell macrometastases ultrastaging one-step nucleic acid amplification (osna)
a 12 week study to confirm the effectiveness of 8mg of fesoterodine compared to 4mg of fesoterodine

Conditions: Overactive Bladder

Summary: this study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. in addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. the study also assesses the side effects and safety of the two doses.


Eligibility criteria:
inclusion criteria: * 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours. exclusion criteria: * other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.
a randomized controlled trial of impact of wearable, wireless breast pumps on frequency and efficacy of milk expression in mothers of premature infants

Conditions: Premature Birth

Summary: a randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump.

randomized, controlled crossover study design. non-blinded. mother of infants born at or below 29+6 weeks of gestation will be eligible once their infant is 28 or more days old. mothers will be provided with a wearable, wireless breast pump in addition to their usual hospital grade pump. wireless pumps can be used while cuddling their baby, driving too and from the hospital, caring for other children, etc.

Eligibility criteria:
inclusion criteria: * mother of infant born at 29+6 weeks or below * mother still pumping at 4 weeks since birth exclusion criteria: * current use of mothers own wearable pump

Keywords: premature birth lactation
study to investigate the safety and efficacy of high dose of symbicort® smart in japanese patients

Conditions: Asthma

Summary: the primary objective of the study is to compare the tolerability of symbicort® turbuhaler® 160/4.5 μg 10 inhalations with terbutaline turbuhaler® 0.4 mg 10 inhalations for 3 days on top of symbicort® turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * a minimum of 6 months documented history of asthma according to the jgl2006/gina2006 definition * fev1\> 70% of predicted normal value pre-bronchodilator exclusion criteria: * having a known or suspected allergy to study therapy (active drugs or additive) * having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure * having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months * respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks

Keywords: asthma symbicort turbuhaler
the role of interleukin-1 beta targeted therapy for patients suffering from allergic contact dermatitis

Conditions: Allergic Contact Dermatitis

Summary: the study will investigate if anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy


Eligibility criteria:
inclusion criteria: * aged at least eighteen years old. * able to provide written informed consent. * have a medical diagnosis of nickel allergy with at least a +2 reaction on the * icdrg scoring system when challenged with nickel. * fitzpatrick skin type 1-4. * able to speak and understand danish. exclusion criteria: * received any topical immunomodulating or immunosuppresive treatment on the lower back two weeks prior, or applied crème/lotion on the lower back 24 hours prior to day 0. * received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0. * any skin lesions at the area of interest such as nevi, scar tissue or pigment changes. * dermatitis and/or infection. * recent (3 months or less) administration of a live virus vaccine. * women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating. * taking part in any other intervention study. * has any other condition which would, in the investigator's opinion, deem the patient unsuitable for participation in the study (e.g. condition requiring long term or frequent oral steroid use). * presence of any condition or use of any medication which precludes the use of the study drug. * allergy to any of the ingredients in the drug.