Kornimate/medical-research-clean huggingface dataset:
mortality analysis of st elevation myocardial infarction (stemi) patients in belgium

Conditions: Acute Myocardial Infarction

Summary: the purpose of this observational study is to assess predictors of in-hospital mortality in patients with acute myocardial infarction admitted to belgian hospitals.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute myocardial infarction with st elevation or left bundle branch blok pattern on ecg exclusion criteria: * acute myocardial infarction as an acute complication of coronary intervention

Keywords: acute coronary syndrome myocardial infarction predictors of mortality reperfusion therapy
exhaled hydrogen peroxide as a marker of lung disease (exhale) pilot study.

Conditions: Asthma; Chronic Obstructive Pulmonary Disease

Summary: this pilot study evaluates the use of a new device called inflammacheck and whether it can consistently measure hydrogen peroxide levels in exhaled breath condensate. it will also assess whether exhaled breath condensate hydrogen peroxide levels as measured by inflammacheck can differentiate people with asthma and copd from healthy individuals.

hydrogen peroxide levels in exhaled breath condensate (ebc) is a direct biomarker of oxidative stress from the airway epithelium. levels have been shown to be raised in asthma and chronic obstructive pulmonary disease (copd) both in stable and exacerbating states. previously it has been difficult to measure this volatile compound away from a laboratory based setting. however a new device has been developed to measure hydrogen peroxide levels in exhaled breath by the patients side. this pilot study will test this new device in a clinical setting. it will assess whether the device can monitor levels consistently and reliably and whether it can distinguish disease from healthy individuals.

Eligibility criteria:
inclusion criteria: * subject has a clinician made diagnosis of asthma with symptoms for ≥ 3 months supported by objective evidence of airflow variability, reversibility or airway hyper-responsiveness * subject has a confirmed, clinician made diagnosis of copd for ≥ 3 months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of fev1/fvc \<0.7) recorded at any time * subject has no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease). * subject is willing and able to give informed consent for participation in the study. exclusion criteria: * subject has existing co-morbidities that may prevent them from performing spirometry, feno or other study measurements (at the discretion of the clinical investigator). * subject has known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry. * subject has received treatment for an exacerbation of their respiratory disease within the last 2 weeks. * in the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures. * subject is unable to comprehend the study and provide informed consent, e.g. insufficient command of english in the absence of someone to adequately interpret.
the effects of performing a motor imagery task on cortical excitability during acute experimental muscle pain and acute itch

Conditions: Itch; Pain

Summary: the aim of this project is to determine the effects of performing a motor imagery task on cortical excitability during acute experimental muscle pain (induced by hypertonic saline), acute histaminergic itch (induced by histamine), and non-histaminergic itch stimulation (triggered by cowhage). we hypothesize that motor imagery will counteract the alterations in cortical excitability observed during experimental muscle pain and both itch models.

itch and pain share many similarities and dissimilarities in terms of the mechanisms and molecules involved. many studies have been conducted to explain all the neurophysiological aspects involved in the pain process, and cortical adaptations have been provoked in healthy individuals using experimental pain models. unfortunately, all these aspects still need to be clarified regarding itch. has been previously demonstrated that motor imagery can counteracted the pain-induced decrease in corticospinal excitability observed during acute pain, and it has also been proposed as a potential intervention for individuals with pain to restore maladaptive neuroplasticity. however, whether motor imagery can similarly counteract the itch-induced cortical changes remains unclear. therefore, the aim of this project is to investigate whether motor imagery would counteract the reduction in cortical excitability during acute itch, similar to the effects observed in the context of acute pain.

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids, or other addictive drugs * previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis), musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder (e.g., heart stroke), or psychiatric diagnoses (e.g. depression) that may affect the results * current use of medications that may affect the trial, such as antihistamines, antipsychotics, and painkillers, as well as systemic or topical steroids * skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis) * moles, scars, or tattoos in the area to be treated or tested. * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * unable to pass the "transcranial magnetic stimulation adult safety screen" (subproject 1 and 2) * contraindications to transcranial magnetic stimulation (tms) application (history of epilepsy, metal implants in head or jaw, etc.) * presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos * participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials) * lack of ability to cooperate
acetazolamide's headache inducing characteristics and effects on the cerebral arteries and blood flow

Conditions: Headache; Migraine

Summary: in this study the investigators will research the hypothesis that the drug acetazolamide induce headache and dilation of cerebral arteries and increase the cerebral blood flow in the areas of the brain supplied by these arteries.

to investigate headache score and accompanying symptoms during and after infusion of acetazolamide. with magnetic resonance imaging the investigators will investigate changes in regional cerebral blood flow (rcbf) in the area supplied by middle cerebral artery (mca), diameter of mca, the internal carotic artery (ica), the superficial temporal artery (sta) and the medial meningeal artery (mma).

Eligibility criteria:
inclusion criteria: * healthy volunteers * aged 18-40 * 50-100 kg * fertile women must use safe contraceptives (iud, oral contraceptives, surgical sterilisation and long lasting gestagen. exclusion criteria: * tension type headache more than once/month * other primary headaches * daily medication except contraceptives * drug taken within 4 times the halflife for the specific drug except contraceptives * pregnant or lactating women * exposure to radiation within the last year * headache within the last 24 hours before start of trial * hypertension * hypotension * respiratory or cardiac disease

Keywords: acetazolamide headache migraine
concurrent chemo-radiotherapy for limited disease small cell lung cancer (ld-sclc) on basis of fdg-pet-scans

Conditions: Small Cell Lung Cancer

Summary: our group has shown that the omission of elective nodal irradiation on the basis of ct scans in patients with ld-sclc lead to a higher than expected isolated nodal recurrence in the ipsilateral supraclavicular area. we have previously also shown that selective mediastinal nodal radiation on basis of fdg-pet scans in nsclc is safe and reduces the radiation fields and hence toxicity. as the accuracy of fdg-pet scans is also in sclc higher than ct, we will investigate the safety of selective nodal irradiation in ld-sclc patients treated with concurrent chemo-radiation.

eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on fdg-pet scan to a dose of 45 gy in 30 fractions in 3 weeks (1.5 gy bid with minimum 6 h interfraction interval). dose-constraints: mld \> 20 gy. in that case, ct-based replanning will be done after 1 week of treatment and shrinking field techniques will be used if appropriate. the radiation doses will be specified according to icru 50. lung density corrections will be applied, as well as all standard qa procedures. technical requirements are the same as in standard practice at maastro clinic. radiotherapy shall start during the first cycle of carboplatin and etoposide chemotherapy. chemotherapy (standard schedule in the comprehensive cancer centre limburg region): * carboplatin auc 5 day 1 * etoposide 120 mg/m2 days 1-3 q 3 weeks; 5 cycles in patients with no progression and a who ps 0-2, after the completion of chemotherapy, pci will be given (25 gy in 10 fractions, qd)

Eligibility criteria:
inclusion criteria: * histological or cytological proven sclc * uicc stage i-iii, "limited disease" * performance status 0-2 * fev 1 and dlco at least 30% of the age-predicted value exclusion criteria: * not sclc or mixed sclc and other histologies (e.g. non-small cell lung carcinoma) * uicc stage iv * performance status 3 or more * fev 1 and dlco \< 30% of the age-predicted value

Keywords: radiotherapy ld-sclc stage i-iii small cell lung cancer
study in patients with copd

Conditions: COPD; Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of copd compared to the control drug


Eligibility criteria:
inclusion criteria: * diagnosis of copd * history of cigarette smoking exclusion criteria: * clinical diagnosis of asthma * significant pulmonary disease other than copd * other significant major organ disease(s)

Keywords: copd chronic obstructive pulmonary disease formoterol fumarate formoterol
a single-patient clinical trial of mas825 in a patient with xiap deficiency

Conditions: X-linked Lymphoproliferative Syndrome Type 2 (XLP-2)

Summary: mas825 is a bi-specific igg1 monoclonal antibody that simultaneously targets il-1 beta and il-18, thereby neutralizing both cytokines that are thought to be integral to the pathogenesis of xlp-2. clinical trials are currently examining its efficacy in other diseases associated with elevations of these cytokines, including nlrc4-associated disease and hidradenitis suppurativa. this study proposes to assess the effectiveness of mas825 in a single patient with xlp-2, who has previously demonstrated response to blockade of il-1 beta and il-18. given the lack of alternative pharmaceutical options for xlp-2, this represents the only known medication option that avoids the toxicity associated with high-dose corticosteroids and the morbidity associated with hematopoietic stem cell transplantation.


Eligibility criteria:
inclusion criteria: * known patient with xiap genetic defect under the care of the investigator exclusion criteria: * n/a
conservative therapy versus epidural steroids for cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: the main objective of this study is to determine whether interventional treatment (i.e. epidural steroids), conservative therapy, or the combination, is superior for cervical radiculopathy. one hundred and sixty eight patients with radicular neck pain will be randomized in a 1:1:1 ratio to receive either cervical epidural steroid injections (cesi), non-interventional management with physical therapy and medications, or a combination of the two. the first follow-up visit will be at 1-month. in patients who obtain some benefit but continue to report significant pain, either a 2nd cesi can be done, the patient's medications can be adjusted, or both in the combination group. those patients who fail to obtain any benefit will exit the study to receive another treatment or alternative care. the second follow-up visit will be at 3-months. similar to the 1-month follow-up, the doctor may elect to change nothing in patients who are satisfied, adjust medications, schedule the patient for another cesi, or do both in the combination group. patients who fail to obtain any benefit can exit the study to receive alternative treatment. the final follow-up visit will be at 6 months.


Eligibility criteria:
inclusion criteria: 1. cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, spurling's test etc.) 2. nrs arm pain score \> 3 3. mri evidence of disc pathology consistent with symptoms exclusion criteria: 1. untreated coagulopathy 2. previous spine surgery 3. no mri study 4. arm pain \> 4 years duration 5. epidural steroid injection within past 3 years 6. radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor) 7. signs or symptoms or myelopathy or spinal cord compression 8. previous failed trials with gabapentin or pregabalin, and nortriptyline or amitriptyline 9. allergic reactions to gabapentin or nortriptyline 10. referrals from surgery for diagnostic injections for surgical evaluation 11. serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome 12. pregnancy

Keywords: epidural steroid injection neck pain pharmacotherapy radiculopathy
sensing ventricular arrhythmias by his bundle leads

Conditions: Heart Failure

Summary: the purpose of this trial is to determine if implantable cardiac device leads implanted in the his bundle are capable of detecting ventricular arrhythmias.

during routine testing of implanted leads, the his bundle lead will be connected to a separate device with all therapies disabled. testing will be done to see if the his bundle lead can detect ventricular arrhythmias.

Eligibility criteria:
inclusion criteria: * individuals undergoing routine defibrillation threshold testing of a right ventricular implantable cardioverter defibrillator lead who also have previously placed his bundle lead or who are undergoing placement of a his bundle lead. exclusion criteria: * individuals with contraindications to defibrillation threshold testing
the clinical relevance of micro rnas in mild traumatic brain injury

Conditions: Brain Injuries, Traumatic

Summary: the aim of this study is to investigate the early serum measurement (\<6h after injury) of mrna mir let-7i, mir-16 and mir-92 in patients with mhi and intracranial traumatic lesions (cct pos.) as compared to those in patients with mhi without intracranial traumatic lesions (cct neg.). s100b serum levels will be measured in both groups. the usual risk factors for the occurrence of an intracranial hematoma (diagnostic algorithm) will be recorded. additionally, a group of healthy individuals will serve as a control group.

patients and methods the investigators plan to include 60 patients with minor head injury (mhi) admitted to our hospital within one year (1-2 each week): 1. 30 patients in the cct pos. group, i.e. patients with an intracranial hematoma on emergency ct scan. 2. 30 patients with mhi in the cct neg. group, i.e. patients without an intracranial traumatic lesion on emergency ct-scan. 3. additionally, 30 healthy volunteers will be included. patients with multiple injuries i.e. polytraumatized patients, patients with severe traumatic brain injury, patients with open fractures and fractures of the long bones, as well as pregnant patients and patients \<18 years, are excluded from the study. patients with a gcs (glascow coma scale) of 13-15 are usually able to consent to be enrolled in the clinical trial. generally, their reasoning and judgment is not impaired. the objective of the study is to compare 3 groups on the microrna serum levels. the investigators plan to draw blood from a peripheral catheter in the patients of groups 1 and 2 (within 6 hours) after arrival at the hospital together with the routine laboratory investigations. additionally, blood will be obtained from healthy volunteers (group 3).

Eligibility criteria:
inclusion criteria: * tbi with gcs 13-15 exclusion criteria: * patients with multiple injuries i.e. polytraumatized patients, patients with severe traumatic brain injury, patients with open fractures and fractures of the long bones, as well as pregnant patients and patients \<18 years, are excluded from the study.

Keywords: tbi microrna s-100b
a dose escalation trial evaluating safety, efficacy, and pharmacokinetics of transcon cnp administered once weekly in prepubertal children with achondroplasia

Conditions: Achondroplasia

Summary: the trial is a multicenter, double-blind, randomized, placebo-controlled, dose escalation trial of weekly transcon cnp administered subcutaneously in prepubertal children 2 to 10 years old, inclusive, with achondroplasia.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of ach with genetic confirmation 2. age between 2 to 10 years old (inclusive) at screening visit 3. prepubertal (stage 1 breasts for girls or testicular volume \< 4ml for boys) at screening visit 4. able to stand without assistance 5. caregiver willing and able to administer subcutaneous injections of study drug exclusion criteria: 1. clinically significant findings at screening that: * are expected to require surgical intervention during participation in the trial or * are musculoskeletal in nature, such as salter-harris fractures and severe hip pain or * otherwise are considered by investigator or medical monitor/medical expert to make a participant unfit to receive study drug or undergo trial related procedures 2. have received treatment (\>3 months) of human growth hormone (hgh) or other medications known to affect stature or body proportionality at any time 3. have received any dose of medications intended to affect stature or body proportionality within the previous 6 months of screening visit 4. have received any study drug or device intended to affect stature or body proportionality at any time 5. history or presence of injury or disease of the growth plate(s), other than achondroplasia, that affects growth potential of long bones

Keywords: achondroplasia dwarfism
safety and anti-tumor study of oral epi-506 for patients with metastatic castration-resistant prostate cancer

Conditions: Prostatic Neoplasms; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases

Summary: the study will consist of 2 parts: part i (dose escalation) and part ii (dose expansion). in part i, patients will participate in single, multiple, and long-term dosing periods using epi-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumor activity. part i is an open-label, adaptive 3 + 3 design, dose-escalation study. approximately six dose levels of epi-506 will be studied, beginning at 80 mg/day. enrolled patients may be allowed to escalate to a subsequent dose cohort after their initial twelve weeks. additional patients may be enrolled at any safe dose level prior to or concurrent with enrolling patients in part ii. in part ii, 3 patient populations; post-abiraterone metastatic castration-resistant prostate cancer (mcrpc) but enzalutamide-naïve, post-enzalutamide mcrpc but abiraterone-naïve, and post-abiraterone and enzalutamide mcrpc will be studied at the recommended phase 2 dose (rp2d) determined in part i over 12 weeks of daily dosing. approximately 120 patients (40 in each cohort) will be enrolled.


Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate * metastatic disease with at least one lesion on bone scan and/or soft tissue on ct/mri * demonstrated progression on abiraterone and/or enzalutamide * demonstrated psa progression within 12 weeks of study participation * castrate testosterone levels at screening with continued luteinizing hormone-releasing hormone (lhrh) therapy * eastern cooperative oncology group (ecog) score between 0-1 * asymptomatic or mildly symptomatic exclusion criteria: * candidates for cytotoxic chemotherapy * received more than one line of chemotherapy * received more than one treatment course of enzalutamide or abiraterone * inadequate washout of prohibited hormonally active agents or other prior treatments for prostate cancer (pca) * known intra-cerebral disease or brain mets * spinal cord compression within 6 months * prior treatment with investigative androgen receptor (ar) agents

Keywords: prostate cancer metastatic castration-resistant prostate cancer
tenelia elderly cgms study(teddy)

Conditions: Type 2 Diabetes Mellitus

Summary: to assess the efficacy and safety of teneligliptin in patients aged 65 and older with inadequately controlled type 2 diabetes.

to assess the efficacy and safety of teneligliptin in patients aged 65 and older with inadequately controlled type 2 diabetes.

Eligibility criteria:
inclusion criteria: * patients who are 65 years or older on screening * patients with type 2 diabetes mellitus * patients with 7.0% ≤ hba1c ≤ 9.0% at the screening visit * patients with fpg \< 270mg/dl on screening visit exclusion criteria: -
retrospective study on radiological factors predictive of psoas impingement

Conditions: Hip Impingement Syndrome; Prosthetic Complication

Summary: the purpose of this study is to identify radiological factors on tc of the hip that could lead to prediction of development of symptomatic psoas impingement in patients with protruding acetabular cup after primary total hip arthroplasty.


Eligibility criteria:
inclusion criteria: * primary total hip arthroplasty * execution of a postoperative ct scan for pain, noises or planning of the contralateral tha * 5 years minimum follow-up for the control group, tenotomy of the iliopsoas muscle in the cases group * complete clinical and radiological data exclusion criteria: * patient's refusal to participate * non adequate ct scans or made for periprosthetic fractures, component mobilization, periprosthetic infection or wearing of the prosthesis * incomplete clinical and radiological data * inadequate follow-up or regression of the iliopsoas impingement symptoms with non-operative treatment

Keywords: iliopsoas impingement overhanging cup
group treatment for insomnia in primary health care

Conditions: Insomnia

Summary: the aim of this study is to analyze if group treatment is effective to treat insomnia in primary healthcare.

insomnia is a common health problem. untreated insomnia may lead to decreased physical and mental health. the patients turns to primary health care when daytime symptoms decrease social and occupational function. previous studies have shown that cognitive and behavioral therapy have effects on insomnia and recommends as first line treatment but is not widely available in primary health care. the purpose is to test the effect of group intervention in primary health care for patients with insomnia. the outcomes is insomnia severity, sleep habits, use of hypnotics, fatigue, general health and health related quality of life. characters with insomnia visiting in primary health care.

Eligibility criteria:
inclusion criteria: * insomnia symptoms regarding dsm-v * motivated to group treatment. exclusion criteria: * insomnia severity index less than 7 points * presence of acute life crises, acute psychiatric illness, bipolar disorder * shift work * linguistic or cognitive difficulties causing inability participate in group or fill in forms * insomnia directly caused by medical illness. other sleep disorder.

Keywords: insomnia primary health care