Kornimate/medical-research-clean huggingface dataset:
the effects of pregabalin on postoperative pain after cardiac surgery

Conditions: Postoperative Pain

Summary: the purpose of this study is to determine whether pregabalin is effective in the treatment of acute postoperative pain after cardiac surgery if administered before the surgery.

pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and anxiolytic properties and was also used to treat neuropathic pain. in recent years it has been used as part of a multimodal management of acute postoperative pain after various types of surgery. we study the effect of pregabalin administered before cardiac surgery on acute and chronic postoperative pain. post cabg syndrome is well known since 1980 and various analgesic methods have been used from time to time (opioids, regional analgesia, non-steroidal anti-inflammatory drugs). in our research patients will be divided into three groups. the control group will receive a placebo capsule before surgery. the second group will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of pregabalin. after the surgery all patients will be connected to an intravenous pca morphine pump for 48 hours. the postoperative pain will be assessed with the visual analogue scale (0-10) every day. total morphine consumption by the patients as well as any other pain medications administered supplementary will be registered and compared between the different groups. remaining postoperative pain will be assessed after 3 months. the results will be statistically analyzed in order to determine whether there is significant difference in pain management between the groups.

Eligibility criteria:
inclusion criteria: * patients' age 18-85years who are undergoing cardiac surgery exclusion criteria: * chronic pain syndromes * renal failure * age \>85 * allergy to pregabalin * patients already taking pregabalin

Keywords: cardiac surgery pregabalin postoperative pain
efficacy on volume reduction and tolerance of progressiv' medical compressive therapy (mct) v0322 bc in patients with chronic venous oedema

Conditions: Chronic Venous Insufficiency (CVI)

Summary: elastic mct is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (cvi).efficacy evidence level is often insufficient (grade b or c), or based on studies carried prior to ceap classification (2004). item c3 of this classification relates to patients suffering from chronic venous disease and permanent oedema. literature mentions only one study in which volume reduction in venous-induced oedema was primary endpoint. indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (sem) after 12 weeks with a class 2 compression sock (15-20 mm hg at ankle). volume is an accurate and reproducible quantitative measure considered nowadays as being gold standard when objectifying oedema variation. it is therefore particularly relevant in a c3-patient trial (ceap classification). the main objective of the current study is to evaluate the clinical effect of progressiv' mct on volume reduction in permanent cvi-oedema after 3 months of treatment.


Eligibility criteria:
inclusion criteria: * age 18 years and above * permanent chronic oedema of venous origin (c3 based on ceap classification) confirmed by doppler or duplex ultrasound examination with reflux and/or obstruction on superficial, deep or perforator veins * pitting oedema * have given and signed written informed consent * registered with or benefiting from health insurance (mandatory for france) exclusion criteria: * use of compression therapy in the last 5 days before inclusion * common contraindications for mct (arteriopathy, decompensated heart failure, infectious dermatitis * isolated lipoedema * isolated lymphoedema (kaposi- stemmer sign * severe systemic disease (heart failure, renal failure, hepatic failure, thyroid dysfunction untreated, malnutrition with hypo-proteinemia ...) * known hypersensitivity to any component of mct * important limitation of ankle movement requiring a specific therapy * following treatment initiated or dose-modified 1 month prior to inclusion: nsaid, corticosteroids, calcium blockers, ace inhibitors, angiotensin ii inhibitors, vasoconstrictors or vasodilators * hormonal treatment initiated or dose-modified 1 month prior to inclusion * diuretic and/or phlebotonic treatment initiated or dose-modified 1 month prior to inclusion * pregnancy, breast feeding, planning to become pregnant, or not using any form of contraception * patient linguistically or psychologically unable to understand the information given or who refuses to give his/her consent in writing * participation in another clinical trial * deprived of liberty for administrative, medical and legal reasons * may not be compliant with the constraints imposed by the protocol
residence time evaluation of systane ultra lubricant eye drops vs. hialid and saline

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to evaluate the ocular retention time of systane ultra compared to hialid and saline.


Eligibility criteria:
inclusion criteria: * diagnosed with mild to moderate dry eye as defined in the protocol. * able and willing to follow instructions. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any medical condition that may affect the results of the study. * history or evidence of ocular or intraocular surgery within the past six months. * history of intolerance or hypersensitivity to any component of the study medications. * use of concomitant topical ocular medications during the study period. * ocular conditions that may preclude safe administration of the test article. * unwilling to discontinue contact lens wear during the study period. * participation in an investigational drug or device study within 30 days of enrollment. * other protocol-defined exclusion criteria may apply.

Keywords: dry eye ocular retention time
temocillin vs meropenem for the targeted treatment of bacteraemia resistant to third gen cephalosporins

Conditions: Bacteremia

Summary: a phase 3, multicenter, randomised, controlled, open-label study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product imp in spain, but authorized in belgium and uk) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant enterobacteriaceae. the duration of treatment will be between 7 and 14 days. from the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.

the objective of the trial is to demonstrate the non-inferiority of temocillin (2g each 8 hours, intravenous) to carbapenems (meropenem 1g each 8 hours, intravenous) in terms of efficacy and safety in the targeted treatment of bacteraemia due to enterobacteriaceae resistant to third-generation cephalosporins, and therefore provide evidence for the use of temocillin in these infections. the duration of treatment will be between 7 and 14 days. from the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.

Eligibility criteria:
inclusion criteria: * adult patients with monomicrobial bacteremia due to enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (mic \>2 mg/l) and/or ceftazidime (mic \>4 mg/l), and sensible to temocillin (mic ≤8 mg/l, except in bacteremia only of urinary origin, for which the criterion is mic ≤16 mg/l ) and meropenem (mic ≤2 mg/l). * duration of intravenous treatment is planned to be at least 4 days. * the patient signed informed consent form. exclusion criteria: * \<18 years * pregnancy * breastfeeding * palliative care * allergy to betalactams * polymicrobial bacteraemia * infections typically needing prolonged \>14 days of therapy (e.g., endocarditis, prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis) or meningitis * active empirical treatment\> 96 hours after initial blood culture extraction * delay in inclusion\> 48 h * recruited in another clinical trial with active treatment * peritoneal dialysis or continuous hemofiltration * extreme gravity or imminent death

Keywords: bacteraemia enterobacteriaceae temocillin third-generation cephalosporin-resistant enterobacteriaceae.
effects of subconscious memory extinction in patients with alcohol dependence and its mechanism

Conditions: Alcohol Use Disorder

Summary: in this study, the subconscious memory extinction therapy based on very brief exposure is used to intervene to reduce the alcohol craving of alcohol-dependent patients, prevent relapse, and observe the psychological craving, heart rate, skin conductance, and pupil diameter changes of the patients during the brief exposure extinction. the main questions it aims to answer are: 1. whether subconscious extinction intervention would reduce psychological craving and alcohol relapse? 2. what is the mechanism of subconscious extinction intervention in alcohol dependence?

after being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. patients who meet the eligibility requirements will be randomized in very brief extinction, clearly visible extinction, or very brief neutral extinction. this study will recruit alcohol-dependent participants aged 18-60 in the ward, observe reported subjective scores during the extinction, and record the heart rate, skin conductance, pupil diameter, and erp changes.

Eligibility criteria:
inclusion criteria: 1. adopt dsm-iv alcohol dependence diagnostic criteria; 2. complete detoxification treatment without obvious withdrawal symptoms; 3. informed consent, voluntary participation. exclusion criteria: 1. acute alcohol dependence withdrawal period; 2. patients who meet the dsm-ⅳ diagnosis of psychoactive substances or non-psychoactive substances other than alcohol (except nicotine); 3. previous acceptance experienced similar exposure therapy;

Keywords: alcohol craving extinction training subconscious
recurrent pterygium surgery using mitomycin c with limbal conjunctival or amniotic membrane

Conditions: Recurrent Pterygium

Summary: to compare the outcomes of limbal conjunctival autograft (lcag) versus amniotic membrane graft (amg) when combined with intraoperative 0.02% mitomycin c (mmc) after pterygium removal in patients with recurrent pterygium.

excision alone for treating recurrent pterygium was reported to be at risk of high recurrence again. as one of adjunctive methods, intraoperative application of a single dose of mitomycin c (mmc) seems to be the most commonly used method for preventing recurrence of pterygium. additionally, closure of conjunctival defect after excision of pterygium by limbal conjunctival autograft or amniotic membrane have also become popular in recent years. there are a few reports in which mmc combined either limbal conjunctival autograft (lcag) or amniotic membrane graft (amg) for the treatment of recurrent pterygium. to assess the effectiveness and safety of these two combined approaches, the investigator plans to work on a randomized comparative and prospective trial of recurrent pterygium extensive excision with intraoperative 0.02% mmc application comparing lcag to amg.the patients enrolled in this study will be followed for at least 12 months after the surgery. recurrence was defined as fibrovascular tissue crossing the limbus on to the clear cornea in the area of previous pterygium excision.

Eligibility criteria:
inclusion criteria: * the patients had one or two eye(s) with unilateral recurrent pterygium. * recurrent pterygium：be defined as of fibrovascular tissue onto the cornea for any distance in the position of a previous pterygium. * willingness to participate in research project and to attend research time. exclusion criteria: * poor general health. * pregnant or lactating women. * patients with collagen vascular diseases or other autoimmune diseases. * patients with any evidence of stem cell deficiency. * patients with glaucoma who might require future filtering surgery. * patients with ocular infection. * patients with an allergy to mitomycin c, tobramycin or dexamethasone.

Keywords: amniotic membrane limbal conjunctival autograft limbal conjunctival mitomycin c recurrent pterygium pterygium
research on new diagnosis and treatment technologies for early lung cancer

Conditions: Lung Cancer, Peripheral Pulmonary Nodules

Summary: to verify the clinical effectiveness and safety of the airway tree navigation system constructed by artificial intelligence (ai) in the navigation diagnosis of peripheral pulmonary nodules (ppls).

early diagnosis and treatment of lung cancer is of great significance, in which navigated tracheoscopic biopsy is an important tool for confirming the diagnosis of early lung cancer. conventional navigation software realizes airway reconstruction and guides biopsy by recognizing differences in hu values on computed tomography scans. it is difficult for conventional navigation software to recognize the reconstruction due to the special characteristics of small airways that are susceptible to interference and collapse. therefore, an ai deep learning approach can realize accurate construction of small airways and guide accurate biopsy. this study intends to validate the clinical effectiveness and safety of the ai-constructed airway tree navigation system in the navigational diagnosis of peripheral pulmonary nodules (ppls).

Eligibility criteria:
inclusion criteria: 1. aged 18 years or above. 2. patients with one or more peripheral lung nodules suspected to be lung cancer or poorly absorbing lesions on conventional anti-infective therapy. 3. patients with nodule diameters ≤30 mm (diameters mentioned in the text are the average of the maximum and minimum diameters). 4. the nodules were pure ground glass nodules, partially solid nodules, or solid nodules. 5. the nodule is surrounded by lung parenchyma and is not visible in the bronchial lumen above the segment. exclusion criteria: 1. preoperative judgment that it is difficult for the patient to benefit from bronchoscopic biopsy (e.g., high risk of bleeding due to perivascular encasement of the lesion, difficulty in reaching the airway adjacent to the lesion due to previous lung surgery, etc.). 2. those with incomplete clinical data. 3. those with missing visits after biopsy.

Keywords: lung cancer peripheral pulmonary nodules ai-constructed airway tree navigation system diagnosis effectiveness and safety
assessment of hypoxia before radioembolization treatment with 18f-fmiso pet

Conditions: Radioembolization; Radiotherapy; Cancer; Positron Emission Tomography

Summary: hypoxia is a known factor for resistance to radiotherapy in tumors. response to transarterial radioembolization is known to be variable between different patients even if the same dose of radiation was delivered. in this study the investigators aim to quantify the hypoxia in the primary and secondary tumors of liver with 18f-fmiso pet before radioembolization and to prove any effect of the hypoxia, if present, on the dose that should be delivered to tumor to ensure treatment response.


Eligibility criteria:
inclusion criteria: * diagnosed with colorectal carcinoma with liver metastasis or hepatocellular carcinoma. * is not eligible for surgery * above 18 years old * the patients who are referred for transarterial radioembolization treatment to ankara university school of medicine department of nuclear medicine. exclusion criteria: * patients with ecog performance score \>1 * claustrophobia * life expectancy shorter than 3 months * pregnant or breast-feeding patients
spring: scio-469 patients with rheumatoid arthritis not receiving methotrexate

Conditions: Arthritis, Rheumatoid

Summary: the primary objective of this study is to determine the efficacy of oral scio-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (dmards).

this is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral scio-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (dmards). the patient will participate in the study for approximately 183 days. safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). the patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.

Eligibility criteria:
inclusion criteria: * patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (dmards) * patients taking hydroxychloroquine (plaquenil) must be on a stable or consistent dose prior to entering study exclusion criteria: * patients using enbrel, remicade, kineret, humira, or an experimental biologic agent within the past 3 months * lab tests revealed elevated liver enzymes within the past 6 months * medical history of tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy * hiv positive * abnormal electrocardiogram * chronic or acute infection

Keywords: rheumatoid arthritis dmards methotrexate p38 kinase
exploratory study to access the metabolic effects of ranolazine in subjects with type 2 diabetes mellitus when added to ongoing non-insulin antidiabetic therapy

Conditions: Diabetes Mellitus, Type 2

Summary: this study enrolled participants with inadequately controlled type 2 diabetes mellitus (t2dm) despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have benefited from additional control of blood glucose levels. the study assessed the metabolic effects of ranolazine, including its effect in lowering glycosylated hemoglobin a1c (hba1c), and lowering glucose while fasting, and following a meal (postprandial). participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were stratified by hba1c ≤ 7.5% or \> 7.5%. enrollment was to include no more than two-thirds of participants with baseline hba1c ≤ 7.5%. other than glucose values, efficacy endpoint results remained blinded during the study; for safety purposes, the investigator was to be alerted of severe hyperglycemia or hypoglycemia. participants were instructed to maintain logs of their physical activity/exercise (subject activity assessment) and study drug dosing (dosing log).


Eligibility criteria:
inclusion criteria: * participant with t2dm on stable non-insulin antidiabetic therapy in addition to diet and exercise * body mass index (bmi) ≥ 25 kg/m\^2 and ≤ 40 kg/m\^2 * hba1c 7 - 11% * ability and willingness to maintain a complete and accurate subject activity log during the course of the trial * female of child-bearing potential must have agreed to use effective methods of contraception * ability to understand and willing to sign written informed consent exclusion criteria: * type 1 diabetes mellitus (t1dm) * t2dm with history of or current insulin therapy. prior use during pregnancy or gestational diabetes was acceptable. * history of ketoacidosis or ketosis-prone diabetes * clinically significant complications of diabetes that in the judgment of the investigator would have made participant unsuitable to participate in this trial * history of a severe episode of hypoglycemia * change in non-insulin antidiabetic therapy in addition to diet and exercise \< 2 months prior to screening * any clinically significant cardiovascular event \< 2 months prior to screening * clinically significant, inadequately controlled or unstable hypertension * hospitalization \< 2 months prior to screening * major surgery \< 3 months prior to screening * weight loss medication (prescription or non-prescription) \< 2 months prior to screening

Keywords: type 2 diabetes mellitus t2dm ranolazine ranexa hba1c
safety, pharmacokinetics and efficacy of proellex® (telapristone acetate) administered vaginally in the treatment of premenopausal women with uterine fibroids who have completed zpv-200

Conditions: Uterine Fibroids

Summary: to further determine the safety and efficacy of proellex in premenopausal women with uterine fibroids who have previously completed study zpv-200.

this is an open label, extension study of zpv-200 applicable to multiple study sites. subjects will chose to administer 12 mg proellex vaginal doses once or twice daily (morning and evening). total study participation for zpv-200 ext may be up to 120 days of drug treatment separated from zpv-200 by an off-drug interval and a 30 day follow up visit. subjects already enrolled in zpv-200ext and the remainder of the subjects who enroll will have the option of administering 12 mg vaginal capsules once or twice daily. this choice will be provided to new subjects at visit 1. the first 4 subjects who chose to administer 12 mg proellex twice daily, will have additional study procedures during the baseline visit and the day after. once a subject has selected a dosing regimen the subject must remain on that dose for the remainder of the study. all subjects entering the zpv-200ext study will have completed the zpv-200 study and will complete an off-drug interval prior to the start of their first dosing cycle. in the off-drug interval, subject must have a menses prior to resumption of the dosing cycle in the luteal phase. efficacy measurements will consist of ufs-qol (uterine fibroid symptom quality of life survey) sub-scores and total score, and number of bleeding days per drug treatment cycle as recorded in subject diaries. fibroid size will be assessed by mri (magnetic resonance imaging) at the end of treatment (visit 5), and changes in size of uterine fibroids will be compared to mri results from visit 2 and visit 10 of zpv-200. safety measurements for this study will include adverse events (aes), clinical laboratory tests, hormone tests, physical examinations (including breast examination and pelvic examination with pap smear) and vital signs.

Eligibility criteria:
inclusion criteria: * have a negative pregnancy test at the baseline visit * subject has successfully completed zpv-200 and demonstrated a return of menses exclusion criteria: * women with abnormally high liver enzymes or liver disease. alanine aminotransferase(alt) or aspartate aminotransferase (ast) exceeding 1.5x upper limit normal (uln and)total bilirubin exceeding 1.5x uln at baseline and confirmed on repeat). * clinically significant abnormal findings on baseline examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study