Kornimate/medical-research-clean huggingface dataset:
weight gain, eating patterns, and development of body composition during initiation of basal insulin therapy in patients with type 2 diabetes: a comparison of insulin detemir and insulin glargine

Conditions: Diabetes; Obesity

Summary: the main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today's standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine.


Eligibility criteria:
inclusion criteria: * age \> 18 years and \< 80 years * gender: female, male * type 2 diabetes * bmi: 20.0 - 38.0 * anti-gad antibody negative * fasting blood glucose \> 126 mg/dl * hba1c 7.0 - 11.0% * need for insulin therapy exclusion criteria: * previous therapy with insulin within the last 3 months prior to inclusion into the study * previous therapy with glitazones within the last 6 months prior to inclusion into the study * change in therapy with lipid-lowering or anti-hypertensive agent within one month prior to inclusion into the study (a stable lipid-lowering or anti-hypertensive therapy is allowed) * concomitant participation in other clinical trials * type 1 diabetes * cardiac and macrovascular disease * malignancy including leukaemia and lymphoma within the last 5 years * liver disease: cirrhosis or chronic active hepatitis, except fat liver * significant renal dysfunction * other endocrine disease * significant laboratory abnormalities * history of active substance abuse (including an average alcohol consume of \> 40g/day and drugs) within the past 2 years * female patients: pregnancy or childbearing potential without adequate contraception (for male patients contraception is not considered as medically important) * present therapy with systemic steroids * presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and ssris/snri´s * use of anti-obesity drugs 3 months prior or during the trial * potentially unreliable subjects, probably non compliant subjects, and those judged by the investigator to be unsuitable for the study * contraindications for mri scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia * known hypersensitivity to insulin detemir, insulin glargine or to any of the other components

Keywords: insulin therapy hepatic fat type 2 diabetes body composition comparison of insulin detemir and insulin glargine changes in hepatic fat obesity
autonomic dysfunction in temporal lobe epilepsy and sudep

Conditions: Temporal Lobe Epilepsy

Summary: the study aimed at detection of autonomic dysfunction among cases with temporal lobe epilepsy; using different electrophysiological techniques. moreover, it aimed at finding any correlation between electrophysiological tests and sudep risk.

temporal lobe epilepsy (tle) is the commonest focal form of epilepsy; representing 60% of all epilepsies . it has two major subtypes; neocortical (ntle) and mesial (mtle), each with different presentations. its diagnosis depends on detailed clinical history, neurological examination as well as neurophysiological (including eeg), and neuroimaging diagnostic tests which are mandatory in localizing the pathology. intimate connection between epileptic networks and the autonomic nervous system had been revealed. seizures could affect autonomic functions whether directly through activation of cortical autonomic centers or indirectly through the released catecholamines. the sudep is considered as one of the most serious complications of epilepsy and second most common cause of death from neurological diseases after stroke. autonomic dysfunction could have a potential role in the pathophysiology of sudden unexpected death of epileptic patients (sudep). attention has been focused on biomarkers that could assist in the detection and early stratification of sudep risk. such biomarkers include neurophysiological tests, imaging findings, laboratory findings. among the introduced neurophysiological biomarkers are electroencephalogram (eeg), sympathetic skin response (ssr) and heart rate variability (hrv). the hrv is considered as simple, sensitive index of cardiovagal function. reduced heart rate variability (hrv) is a strong predictor of sudden death in patients with heart disease. the electrodermal activity (eda )or ssr is referred as the most popular used test for assessment the sudomotor function . the eda had been proven to be a reliable biomarker for detecting generalized tonic-clonic seizures (gtcs) through a wearable device. frontal midline theta activity was studied using quantitative eeg (qeeg); that confirmed the presence of interactive relationships between activities of the peripheral autonomic system and the cortical network. the qeeg technique had been introduced in the thirties of the last century. yet, it had not been applied before on epileptic patients to assess either the central autonomic function or the sudep risk and thus, this is considered as the first study to address such issue.

Eligibility criteria:
inclusion criteria: * patients diagnosed as temporal lobe epilepsy(tle) depending on clinical semiology and eeg temporal inter-ictal epileptiform discharges exclusion criteria: * any identifiable disease that could affect autonomic nervous system function including diabetic patients. * any drug that could affect autonomic nervous system function including oral contraceptives

Keywords: temporal lobe epilepsy (tle) sudden unexpected death of epileptic patients (sudep) dysautonomia quantitative eeg (qeeg) sympathetic skin response (ssr) heart rate variability (hrv)
opioid withdrawal symptoms in critically ill patients

Conditions: Substance Withdrawal Syndrome; Critical Illness

Summary: most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (icu). opioids are principal analgesics that alleviate moderate to severe pain and facilitate patients to co-operate the course of treatment. however, prolong administration of opioids especially in mechanically ventilated patients can cause withdrawal symptoms if analgesics are rapidly weaning or acutely disruption. the opioid withdrawal symptoms (ows) are well reported in critically ill children that cause discomfort and prolong weaning from mechanical ventilation. weaning opioids and treatment of withdrawal symptoms are needed in order to decrease ventilator days, icu and hospital length of stay. conversely, there is lack of knowledge about incidence, clinical presentation, time course and appropriated assessment tool for withdrawal detection. therefore, we conduct the study to explore an incidence of ows, to identify factors associated ows, to establish the assessment tool for ows, and to report efficacy of the pharmacological treatment for ows, in adult critically ill patients.

the primary objective of the study is to explore incidence of ows in adult critically ill patients. the secondary objectives are 1) to identify factor associated ows, 2) establish the assessment tool for ows for adults and 3) to report efficacy of the pharmacological treatment in ows in adults patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years * on mechanical ventilator at least 24 hours * received continuous infusion of opioid at least 24 hours * patient or legal surrogate who is willing and able to provide written informed consent and comply with all protocol requirements exclusion criteria: * severely disturbed behavior pattern on account of underlying neurological disease (status epilepticus, encephalopathy, head trauma, brain injury, spinal cord injury) * preexisting psychiatric diagnosis * substance abuse prior to icu admission * chronic alcohol drinking * pregnancy * end-of-life care * death during icu admission or during opioid iv infusion
comparison of photorefractive keratectomy (prk) and sub-bowman's keratomileusis (sbk)

Conditions: Myopia

Summary: the objective of the study is to compare clinical outcomes from prk and sbk using fda-approved laser technology in the same patient

patients undergoing bilateral laser refractive surgery on the same day will be randomly assigned to have one eye treated with prk and the fellow eye treated with sbk.

Eligibility criteria:
inclusion criteria: * patients deemed to be suitable candidates for bilateral lasik surgery exclusion criteria: * patients who desire monovision correction rather than bilateral distance correction
personalized sequence for thoracic, esophageal, and h&n cancer

Conditions: Lung Cancer

Summary: the next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. the genome analysis needs systematic infra and database based on personal genetic information therefore, a big data of genome-clinical information is important.

to determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(pfs, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling.

Eligibility criteria:
inclusion criteria: * metastatic, histologically confirmed nsclc, head \& neck cancer, esophageal cancer exclusion criteria: -
extended release amantadine safety and efficacy study in levodopa-induced dyskinesia (eased study)

Conditions: Dyskinesia; Levodopa Induced Dyskinesia; Parkinson's Disease

Summary: this is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ads-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (lid) in subjects with parkinson's disease (pd). the novel pharmacokinetic profile of ads-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of pd are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.


Eligibility criteria:
inclusion criteria: * signed a current irb/iec-approved informed consent form * parkinson's disease, per uk parkinson's disease society (ukpds) brain bank clinical diagnostic criteria * on a stable regimen of antiparkinson's medications , including any levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation * experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia) * able to understand and complete a standardized pd home diary, following training exclusion criteria: * history of neurosurgical intervention related to parkinson's disease (e.g. deep brain stimulation) * history of seizures or stroke/tia within 2 years of screening * history of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer * estimated gfr \< 50 ml/min/1.73m2 * presence of cognitive impairment, as evidenced by a mini-mental status examination (mmse) score of less than 24 during screening * if female, is pregnant or lactating, or has a positive pregnancy test result pre-dose * if a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment * treatment with an investigational drug or device within 30 days prior to screening * treatment with an investigational biologic within 6 months prior to screening

Keywords: levodopa-induced dyskinesia parkinsonism
pcv13 in non-pregnant papua new guinean women

Conditions: Pneumococcal Infections

Summary: this is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in papua new guinea.


Eligibility criteria:
inclusion criteria: * healthy * non-pregnant * 18-45 years old exclusion criteria: * known hypersensitivity to any vaccine component * known/suspected to be immunocompromised * receipt of corticosteroids ≤30 days before * pregnant (pregnancy tests will be performed) * not being well at the time of vaccination * plan to travel out of the area in the month post-vaccination

Keywords: pneumococcal conjugate vaccine pcv reactogenicity immunogenicity women childbearing age
genetic polymorphisms associated with cad

Conditions: Coronary Artery Disease

Summary: the design and purpose of the current study is to expand and validate previous findings that the il-1 gene cluster composite genotype patterns potentiate the risk for coronary artery disease (cad) and cardiovascular events mediated by oxpl and lp(a). a secondary objective is to validate other, non il-1 genetic variants associated with cad.

the conclusions from an earlier study indicate that the contribution of oxpl/apob and lp(a) on angiographically documented cad and cad events is conditional on proinflammatory il-1 genotypes. this novel paradigm links the etiology of atherogenesis attributed to oxpl and lp(a) from genetics to clinical expression of cad. ili has also identified the functional il-1 gene variations that regulate the il1b gene in a haplotype context and appear to explain over-expression of il-1β, as well as the expression of other inflammatory biomolecules that are downstream of il-1β. the functional il-1 variants have been combined into patterns that have been associated with risk for more severe periodontal disease across multiple ethnic/racial populations. it is also important to test this functional genetic pattern for similar interactions with oxpl and lp(a) biomarker levels in association with angiographically documented cad and cad events. dna has been extracted from previously obtained subject blood samples (1173 subjects; 18 years to 90 years at entry (coronary angiography)) at the university general hospital of ioannina, greece study site. dnas will be labeled by anonymized subject id # (de-identified), and shipped to ili for genotyping and genetic analysis. phase ii will determine whether other gene variations (snps) previously shown in the literature to be associated with cad and/or cad-related secondary events can be validated in this study population.

Eligibility criteria:
inclusion criteria: diabetics and non-diabetics, with or without known cv disease, who are admitted in the department of cardiology in the university general hospital of ioannina and the catheterization laboratory of 1st ika hospital in athens and undergo coronary angiography at ages 18-90 for clinical purposes will be studied. the study includes subjects who; 1) have suspected cad and undergo a scheduled diagnostic angiogram for clinical reasons, and 2) are hospitalized because of an acute coronary syndrome and thus undergo diagnostic angiography (with or without previous history of cad). - exclusion criteria: patients \ 90 years old at time of coronary angiography. patients with a previous history of coronary revascularization procedure or moderate to severe stenosis will be excluded. -
evaluation of viral efficacy and safety of a reduced dose of stavudine (d4t): the phoenix study

Conditions: HIV

Summary: lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to stavudine at standard doses the aim of this study is to evaluate the efficacy of reduced doses of stavudine (30 mg b.i.d.) in hiv patients with controlled viral load and body weight \> 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b.i.d.

stavudine is a nucleoside inhibitor larged used in hiv treatments and has been associated to mithocondrial toxicity. as it is still largely used in developping countries,the evaluation of reducing dose is of importance. a single-arm open pilot 48 weeks study to evaluate the capacity of a switch from d4t 40 mg to 30 mg bid in patients with body weight \> 60kg to maintain full viral load suppression. clinical and biological evaluations were carried out at baseline, w24 and w48. primary end-point is viral load suppression (\<400 coies/ml) at w24. secondary end-points are : evolution of cd4 count at w24 and w48, neurological examination at baseline, w24 and w48, metabolic parameters and stavudine pk at w24.

Eligibility criteria:
inclusion criteria: * hiv patients * patients with an antiretroviral treatment containing stavudine at standard doses (40mg bid) for at least 3 months * patients with viral load \< 400 copies/ml for at least 3 months exclusion criteria: * patients receiving an antiretroviral therapy containing stavudine at 30mg bid * current opportunistic infection * current chemotherapy or under cytokines treatment (peg, inf, il2) * pregnant or feeding women

Keywords: stavudine reduced dose of stavudine viral load peripheral neuropathy treatment experienced
epigenetic regulation of altered t-cell immunity in sarcoidosis

Conditions: Sarcoidosis; Sarcoidosis, Pulmonary

Summary: sarcoidosis is a multi-system granulomatous disorder that is triggered and influenced by gene-environment interactions. although sarcoidosis predominantly affects the lungs in most cases, the clinical disease course is highly variable and any organ can be affected leading to end organ damage despite currently available therapeutics that unfortunately also have numerous and potentially devastating side effects. the environmental triggers of sarcoidosis are unknown but several occupational, environmental and infectious agents have been associated with sarcoidosis in susceptible hosts. exposure to these triggers result in inflammation, characterized by activation of cd4+ t-cells, cytokine production, subsequent recruitment of other immune cells, and granuloma formation. although several genetic markers have been associated with sarcoidosis, none fully explain individual susceptibility or clinical course variability, strongly implicating the environment and epigenetics. we have the ability to generate a map of the epigenetic histone modifications in immune cells via chromatin immuno-precipitation coupled with next generation sequencing (chip-seq) and a map of transcriptome profiles via rna-seq. the availability of histone and transcriptional signatures defining t cell activity in sarcoidosis will help identify the specific molecular programs affected by disease processes and can become the basis for future discovery of novel biomarker diagnostics in a clinical setting.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 85 * diagnosis of sarcoidosis confirmed by either biopsy or by manifestations consistent with acute sarcoidosis in absence of other known diagnosis. * have a suspected diagnosis of sarcoidosis and is scheduled to undergo a biopsy procedure to confirm a diagnosis of sarcoidosis. * able to tolerate and willing to undergo study procedures exclusion criteria: * current cigarette smoking or smoking within six months prior to the study * currently or recently (\<6months) on immunosuppressive therapy * pregnancy * patient inability to participate in the study, such as undergo venipuncture and or bal
a drug-drug interaction study of shr2150 on healthy chinese volunteers

Conditions: Human Immunodeficiency Virus Infection

Summary: the study is a single-centre, open-label, fixed-sequence, self-controlled clinical trial. it is planned to enroll 20 healthy adult subjects. subjects will take shr2150 on day 1 and day 21, and take efavirenz from day 7 to day 26.


Eligibility criteria:
inclusion criteria: 1. the subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent; 2. healthy subjects aged 18 \~ 45 (including the boundary value), male and female; 3. male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (bmi) within the range of 18 \~ 26 kg/m2 (including the boundary value) (bmi= weight (kg)/height 2 (m2)); 4. the physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal b-ultrasound, and chest radiograph are normal or have no clinical significance; 5. the subjects with reproduction ability must agree to take effective contraceptive measures after signing the informed consent form and within 7 months (for female) or 4 months (for male) until the last medication. exclusion criteria: 1. anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results; 2. those who have undergone surgery within 3 months before the trial, or plan to perform surgery during the study period; 3. those whose 12-lead ecg is abnormal with clinically significant or ecg qt interval (qtcf) ≥ 450 ms (for male) or \> 460 ms (for female) or \< 300 ms; 4. those who donated blood or suffered heavy blood loss (≥400 ml), received blood transfusions, or used blood products within 3 months before enrollment; 5. have a history of allergies to drugs, food or other substances; 6. those who have used soft drugs or hard drugs; or those with positive results in urine drug abuse screening; 7. those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration; 8. those who have taken any medicine within 1 month before the first administration (including prescription medicines, non-prescription medicines, chinese herbal medicines, vitamins, calcium tablets and other food supplements), especially the drugs which have any effect on cyp3a4; 9. regular drinkers within 3 months before the test, that is, drinking more than 15 g of alcohol per day (15 g alcohol = 450 ml of beer, or 50 ml of spirits, or 150 ml of wine), and any alcohol-containing products cannot be stopped during the study; 10. hepatitis b virus surface antigen is positive, or hepatitis c virus antibody is positive, or treponema pallidum antibody is positive, or human immunodeficiency virus antibody is positive; 11. women with pregnancy or within lactation period.