Kornimate/medical-research-clean huggingface dataset:
the effect of human prostate tissue on platelet activation

Conditions: Prostate Hyperplasia; Coagulation; Intravascular; Thrombotic Disorder

Summary: transurethral resection of the prostate (turp) is a common and standard urological surgical procedure for managing benign prostatic hyperplasia (bph). although surgical technology improved in recent decades, severe complications such as turp syndrome, hematuria, and postoperative hemorrhage were still considerable. coagulopathy is one of rare but devastating complication which may contribute to bleeding during and after turp. although the exact pathophysiological condition of coagulopathy is not clear, there are several possible mechanisms of turp associated coagulopathy including: urokinase- (u-pa) and tissue-type plasminogen activator (t-pa)-related fibrinolysis; absorption of irrigating fluid associated dilutional coagulopathy; release of prostatic particles rich in tissue thromboplastins into the circulation causing secondary ﬁbrinolysis and disseminated intravascular coagulopathy (dic); sepsis with dic associated with bacteria entering the circulation due to prostatic venous sinuses opening and the using of high pressure irrigation. on the other hand, platelet are essential to hemostasis and thrombosis and its activation also contributes to leukocyte recruitment and dic. furthermore, previous studies demonstrated that activated platelets could express tlr4, cd40l, p-selectin and induce platelet-leukocyte aggregation (pla), which were considered important for systemic inflammatory responses and dic development. currently, no study investigating the association of prostate particle and platelet activation. here, we tested the hypothesis that prostate tissue may induce inflammatory responses through platelet activation by measuring the expression of tlr4, cd40l, p-selectin and pla on platelets.


Eligibility criteria:
inclusion criteria: * scheduled for turp surgery exclusion criteria: * morbid obesity, bedridden, thromboembolic disease, sepsis, nephrotic syndrome, trauma, malignant tumor, disease associated with increasing blood viscosity.

Keywords: turp coagulopathy dic thrombotic disorder
bosentan use in patients with diabetic nephropathy

Conditions: Type 2 Diabetes

Summary: there is little doubt of the necessity for further improvement in the prevention and therapy of end-stage renal disease. despite the success of arb in treating diabetic nephropathy, not all patients obtain satisfactory control of blood pressure, albuminuria and decline in renal function. experimental data have provided us with a rationale for the potential added benefits of et receptor blockade to the aii inhibition in diabetic renal protection. considering the nephroprotective effect of bosentan in diabetic rats, clinical studies are warranted to assess whether et receptor antagonism has additive renoprotective effects on top of aii inhibition.


Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years of age with a body weight of ≥ 40 kg; * for female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using intrauterine devices (iuds); * patients diagnosed type 2 diabetes with overt nephropathy (urinary albumin excretion ≥ 300mg/24h); * patients on current treatment with angiotensin ii receptor blockers for ≥ 3 months; * patients stable for at least 3 months prior to screening (no change in medications for diabetic nephropathy); * provide written informed consent; exclusion criteria: * patients with a history of pulmonary chronic obstructive disease, cardiac failure or coronary artery disease; * patients with documented cancers, acute infections or chronic inflammatory diseases; * patients who are pregnant or breast-feeding; * patients with known hepatic disorders or ast and ∕or alt upper than normal limit; * patients with hemoglobin or hematocrit that is ≥ 30% below the normal range (patients with secondary polycythemia are permitted); * patients with systolic blood pressure \< 110mm hg; * patients with plasmatic albumin level \< 30g/l; * patients with a documented creatinine clearance ≤ 60ml/min; * patients on anticoagulants or anti-inflammatory drugs, including cyclooxygenase inhibitors, ains, prednisone and immunosuppressive drugs, platelet aggregation inhibitors, except low dose aspirin, ace inhibitors, antidiabetic agents (rosiglitazone, pioglitazone) and antioxidants (vitamin e)(except statins or low-dose aspirin ≤ 80mg/day); * patients on treatment or planned treatment with another investigational drug; * patients who are receiving an endothelin receptor antagonist, phosphodiesterase type 5 inhibitor, or with a prostanoid (excluding acute administration during a catheterization procedure to test vascular reactivity) within 2 months of inclusion; * patients who are receiving calcineurin-inhibitors (i.e., cyclosporine a and tacrolimus), fluconazole, glibenclamide (glyburide) at inclusion or are expected to receive any of these drugs during the study; * patients with a known hypersensitivity to bosentan or any of the excipients;
a pilot observational study to assess the ability of continuous 'home' eeg to accurately diagnose narcolepsy and demonstrate response to treatment

Conditions: Narcolepsy Type 1; Hypersomnia

Summary: the goal of this pilot observational study is to assess the ability of continuous 'home' eeg to accurately diagnose narcolepsy in children and young people with hypersomnia. the main question\[s\]it aims to answer are: * can ambulatory home monitoring using a dreem headband with a 'life as usual' unrestricted protocol allow accurate diagnosis of narcolepsy, compared to gold standard in-patient psg and mslt * which eeg derived sleep parameters and study duration yield most diagnostic accuracy participants undergoing investigation for hypersomnia will additionally be asked to wear a dream headband at night for weeknights, then continuously for 48 hours over the weekend. the data from the headband will then be analysed to see if it can predict the results of the polysomnography and mslt that form routine clinical care.


Eligibility criteria:
inclusion criteria: * participants already under investigation within gstt children and adult sleep service for hypersomnolence * age 12 to 25 years of age at recruitment * participants able to understand patient information (information including dh instructions written only in english for this initial observational study) and who can provide written informed consent or assent. exclusion criteria: * any physician diagnosed sleep disorder (e.g. sleep apnea) * any physician diagnosed medical or psychiatric disorder that could explain their excessive daytime sleepiness * regular use of either prescribed or recreational medication that affects sleep * participation in another concurrent research study
a study of orally administered pimodivir in adult participants with hepatic impairment

Conditions: Hepatic Impairment

Summary: the purpose is to evaluate the pharmacokinetics (pk) of a single oral dose of 600 milligram (mg) pimodivir in adult participants with impaired hepatic function compared to adult participants with normal hepatic function.


Eligibility criteria:
inclusion criteria: * participant must have a stable hepatic function as confirmed by albumin levels, prothrombin time (pt), international normalized ratio (inr), and platelet count measured during screening and those measured within 24 hours prior to study drug administration. participants with a transjugular intrahepatic portosystemic shunt procedure will be allowed to participate in the study * participant must have a body mass index (bmi; weight \[kilogram {kg}/height\^2 \[meter {m}\^2\]) between 18.0 and 38.0 kg/m\^2, extremes included, and body weight not less than 50 kg at screening * participant must have a 12-lead electrocardiogram (ecg) consistent with normal cardiac conduction and function at screening, including: (a) sinus rhythm; (b) pulse rate between 45 and 100 beats per minute (bpm); (c) qt interval corrected for heart rate (qtc) according to fridericia formula (qtcf) less than or equal to (\<=) 450 millisecond (ms) for male participant and \<= 470 ms for female participant; (d) qrs interval of less than (\<) 120 ms; (e) pr interval \<= 220 ms and (f) electrocardiogram morphology consistent with healthy cardiac conduction and function. participant with pacemaker is eligible as long as all criteria mentioned above are met * a woman, except if postmenopausal, must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[beta-hcg\]) at screening and a negative urine pregnancy test on day -1 * contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies exclusion criteria: * participant has known allergies, hypersensitivity, or intolerance to pimodivir or its excipients * participant has donated blood or blood products or had substantial loss of blood (more than 500 milliliter \[ml\]) within 3 months before administration of the study drug or intention to donate blood or blood products during the study * participant has received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before administration of the study drug is scheduled * participant has preplanned surgery or procedures that would interfere with the conduct of the study * participant is a woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or a woman of childbearing potential who is unwilling to use an acceptable method of contraception
clinical performance of three universal adhesives in posterior restorations

Conditions: Recurrent Caries

Summary: this study was designed to evaluate and compare the two-year clinical performance of three universal adhesives in posterior composite restorations, based on international dental federation (fdi) criteria.

the description of the experimental design will follow the consolidated standards of reporting trials (consort) statement. the present study will be a double blinded (patients and examiner) randomized clinical trial anticipating the split-mouth design. 30 adult patients seeking dental treatment in operative department clinic at faculty of dentistry, mansoura university will be enrolled in the current study with a total of 90 teeth with class i or ii posterior composite restorations. no advertisement will be made for participant recruitment, forming a sample of convenience. each patient will sign a consent form before participating in the current study. the study will be conducted from november 2022 to november 2024 as a part of doctoral dissertation. mansoura university institution's ethics committee approved the form and protocol before conducting the study. the sample size was calculated based on a previous study with a similar study design. parameters including a significance level of 5% (p \< 0.05) and a power of 80% were used to calculate an appropriate sample size of 28 cases. allowing for a 20% drop-out rate, the total sample size was set at 30 cases.

Eligibility criteria:
inclusion criteria: * patients will have at least 3 posterior teeth with carious lesions of icdas score 4, or 5. * the teeth will have to be vital, without spontaneous pain and/or mobility. * patients must have a good oral hygiene. * patients with normal and full occlusion. exclusion criteria: * high caries risk patients with extremely poor oral hygiene. * patients with abutments. * patients with heavy bruxism habits and clenching.
temozolomide in treating patients with recurrent oligodendroglial tumors

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors.

objectives: i. assess the therapeutic activity of temozolomide as first line chemotherapy in patients with recurrent oligodendroglial tumors after radiation therapy. ii. assess the objective response and duration of response of these patients given this treatment. iii. characterize the acute side effects of temozolomide in this patient population. outline: this is an open label, multicenter study. patients receive oral temozolomide on days 1-5. courses are repeated every 28 days. treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. patients are followed every 3 months until disease progression. projected accrual: a total of 15-33 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven oligodendroglioma or oligoastrocytoma with at least 25% oligodendroglial elements recurrent or progressive disease following radiotherapy at least 3 months since prior radiotherapy measurable disease by mri or ct scan lesion must have a diameter of at least 1 cm no progressive neurological deficits from the present recurrence no new neurological deficits interfering with daily activities no tumor causing midline shift or brain stem compression due to which a rapid deterioration is to be expected in case of no response no signs of increased intracranial pressure no extracranial disease patient characteristics: age: 18 to 70 performance status: who 0-2 life expectancy: at least 3 months hematopoietic: neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.25 times upper limit of normal (uln) ast/alt no greater than 2 times uln alkaline phosphatase no greater than 2 times uln renal: creatinine clearance at least 60 ml/min creatinine no greater than 1.25 times uln neurologic: see disease characteristics other: not pregnant or nursing fertile patients must use effective contraception no other malignant or nonmalignant diseases interfering with follow-up no psychological, familial, sociological, or geographical condition potentially hampering compliance with the study and follow-up prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: see disease characteristics surgery: not specified other: no other concurrent investigational drugs no other concurrent antitumor agents

Keywords: adult oligodendroglioma adult mixed glioma
task-oriented upper limb training in ms

Conditions: Multiple Sclerosis

Summary: an adequate upper limb function is crucial to independently perform activities of daily living (adl). persons with neurological diseases often experience upper limb dysfunction. upper limb function in multiple sclerosis (ms) is highly prevalent, increasing with overall disability level, while the detrimental impact on adl is higher than in stroke, given that symptoms often occur bilaterally. in contrast to stroke, it is unknown whether similar rehabilitation principles and effect sizes apply in ms given that this progressive neurodegenerative disease is characterized by multiple lesions and atrophy of brain structures. to date, optimal therapy dosage of upper limb rehabilitation programs are not known in the ms literature neither were characteristics of responders identified. the aim of this explorative study is to investigate the intensity dependent clinical effects of a task-oriented upper limb training in persons with ms with different upper limb disability levels.


Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosis of ms (mcdonald criteria) * progressive type of ms (primary or secondary progressive ms) * a score 1 or more on the performance scale: item hand function exclusion criteria: * a relapse or relapse-related treatment within the last 3 months prior to the study * complete paralysis of both upper limbs * marked or severe intention tremor (fahn's tremor rating scale \> 3) * other medical conditions interfering with the upper limb function (ortopaedic or rheumatoid impairment) * severe cognitive or visual deficits interfering with testing and training

Keywords: multiple sclerosis upper limb rehabilitation
a study to assess the anti-viral activity, safety, tolerability and pharmacokinetics of tmc435350 in participants infected with hepatitis c-virus (hcv)

Conditions: Hepatitis C

Summary: the purpose of this study is to assess anti-viral activity (inhibition of viral growth) of tmc435350 in genotype 2,3,4,5 and 6 hepatitis c virus infected participants who have never received treatment for their hepatitis c infection.

this is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of tmc435350 hereafter referred to as tmc435. approximately 40 participants will be divided in 5 groups as per the genotype (8 participants each group). the study will include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase (30-35 days after the last dose of study medication). safety evaluations will include assessment of adverse events, clinical laboratory tests and cardiovascular safety.

Eligibility criteria:
inclusion criteria: * participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis c virus (hcv) infection * participants who have never received treatment for their hcv infection * participants with either no cirrhosis or up to child pugh a liver disease * participants with plasma hcv genotype level of more than or equal to 100, 000 iu/ml at screening exclusion criteria: * evidence of child pugh b or c liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices * participants with diagnosed or suspected hepatocellular carcinoma * participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis a or b virus infection or active tuberculosis at screening * participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening

Keywords: hepatitis c tmc435
studies in porphyria i: characterization of enzyme defects

Conditions: Porphyria

Summary: objectives: i. characterize enzyme defects in patients with known or suspected porphyria and their family members. ii. determine whether selected patients are eligible for other porphyria research protocols. iii. provide blood, urine, and fecal samples from well characterized patients and their family members to investigators studying the nature of specific mutations in genes for heme biosynthetic pathway enzymes.

protocol outline: all patients are evaluated for porphyria type and factors contributing to the clinical expression of their particular form of the disease. testing includes erythrocyte porphobilinogen deaminase, erythrocyte protoporphyrin, plasma porphyrins, and urinary and fecal porphyrins and precursors. selected patients are entered into other porphyrin research protocols in this and other institutions, including analysis of dna to identify specific mutations in genes for heme biosynthetic pathway enzymes.

Eligibility criteria:
* suspected or confirmed porphyria * adults, children, and family members eligible

Keywords: inborn errors of metabolism porphyria rare disease
mindfulness for intense emotions: a feasibility trial

Conditions: Borderline Personality Disorder

Summary: this study explores the feasibility of a mindfulness-based intervention for people with a diagnosis of borderline personality disorder.

this is an uncontrolled feasibility trial of an eight-week mindfulness-based intervention for people with a diagnosis of borderline personality disorder. a battery of measures will be administered at baseline, in a time window of six to zero weeks prior to the start of the intervention. outcome measures will be repeated in the two weeks after the end of the eight-week intervention, along with a qualitative interview.

Eligibility criteria:
inclusion criteria: * are on the caseload of a united kingdom national health service assessment and treatment service in the recruitment area and have had contact with that service in the past three months * have received the diagnosis of borderline personality disorder from a suitably qualified health care professional, and continue to meet criteria for this diagnosis according to the scid-ii (structured clinical interview for dsm disorders version ii) at their screening assessment * have sufficient english language speaking and comprehension abilities to access group discussions and hand-out materials * have not previously engaged in a mindfulness-based intervention. as in other similar trials, a minimum dose has been operationally defined as having undertaken 50% or more of a mindfulness-based intervention delivered face-to-face by a suitably qualified health care professional * are not currently receiving, nor have plans to receive any other form of psychological therapy during the course of the study exclusion criteria: * have psychosis * misuse alcohol or drug to a level that requiring detox * have a intellectual disability * present a high level of risk requiring inpatient management at the time of their screening assessment

Keywords: mindfulness
efficacy of epa-enriched supplement in malnourished head and neck cancer patients undergone surgery

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to study the effects of epa-enriched supplement compared with conventional supplement in malnourished head and neck cancer patients undergone surgery. primary outcome is perioperative weight changing.

to study the effects of epa-enriched supplement compared with conventional supplement in malnourished head and neck cancer patients undergone surgery. the patients are divided into 2 groups receiving the different formula supplements. the both supplements are isocaloric. the patients receive the supplement for 3 weeks (1 week prior to surgery and 2 weeks post surgery) primary outcome is perioperative weight changing. secondary outcomes are body compositions, hospital stay days, complication and co-morbidity.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed as head an neck cancer with pathological confirmation 2. receiving surgery as a primary treatment 3. malnutrition screening tool(mst) is 2 or more exclusion criteria: 1. previously irradiated patient in the head and neck region 2. previously receiving chemotherapy 3. renal insufficiency with serum creatinine \> 2.5 mg/dl 4. liver function abnormality with total serum bilirubin \> 3.0 mg/dl 5. pregnancy

Keywords: malnourished head and neck cancer surgery
study of a pandemic influenza vaccine

Conditions: Influenza

Summary: the world health organisation has warned that an influenza pandemic is inevitable. the avian influenza h5n1 virus strain is the leading candidate to cause the next avian influenza pandemic. this study will test the safety and immunogenicity of a h5n1 pandemic influenza vaccine in healthy adults.


Eligibility criteria:
inclusion criteria: * healthy adults exclusion criteria: * history of guillain-barre syndrome or active neurological disease

Keywords: pandemic influenza prevention vaccine prevention of pandemic influenza