Kornimate/medical-research-clean huggingface dataset:
polysomnography study of pregabalin and pramipexole versus placebo in patients with restless legs syndrome and associated sleep disturbance

Conditions: Restless Legs Syndrome

Summary: the purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.


Eligibility criteria:
inclusion criteria: * diagnosis of restless legs syndrome with a total score of 15 or more points on the international rls rating scale (irls). * rls symptoms interfering with sleep on 3 or more nights per week for at least 6 months. * psg confirmation of waso of at least 60 min, plmi of 10 or more, and total sleep time of at least 3 hrs and less than 6.5 hrs. exclusion criteria: * secondary rls. * daytime rls symptoms requiring treatment. * primary sleep disorder. * sleep apnea. * night or shift work. * concurrent medical disorder that could interfere with efficacy assessment or present a safety concern. * pregnant or lactating women. * women of child-bearing potential not using acceptable method of birth control. * use of prohibited medication.

Keywords: restless legs syndrome rls polysomnography psg sleep disturbance patient reported outcome
sep and the impact of portion size on daily energy intake

Conditions: Diet, Healthy; Eating Behavior; Obesity

Summary: reducing food portion size is a potential strategy to reduce energy intake. there is some evidence to suggest that individuals with lower socioeconomic position (sep) intend to eat more from larger portions, suggesting that the effect of portion size on food intake might vary by sep. however, no study has tested this by measuring actual food intake. this study examines whether reductions to the portion size of components of a main meal will reduce daily energy intake, and whether and how socioeconomic position (higher vs lower) moderates the portion size effect. in a crossover experiment, participants will be served all meals in the lab on two separate days, with the portion size of main meal components at lunch and dinner manipulated (i.e. smaller on one day vs larger on the other day). all other foods offered are identical. food intake from the portion-manipulated lunch and dinner, as well as all other meal components (breakfast, dessert, seconds, snacks) will be measured, and any additional food consumed by the participant will be measured using self-report, giving total daily energy intake (kcal).

see attached protocol document.

Eligibility criteria:
inclusion criteria: * female * uk (united kingdom) residents, aged 18 or over * fluent in english * willing to consume the test foods * self report liking of test foods * bmi between 22.5 - 32.5kg2 exclusion criteria: * taking medication which affects appetite * currently pregnant * history of eating disorders * currently on a diet to lose weight * food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan) * participated in 2018 mood study * currently participating in another study where meals are provided

Keywords: portion size socio-economic position eating behaviour
digital home-based prehabilitation before surgery

Conditions: Cancer Colorectal; Frailty; Surgery

Summary: this clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. the prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.

patients are randomized to either a digital home-based program, a physical hospital-based program or no-organized prehabilitation. the eligible patients are anyone scheduled for colorectal cancer surgery who are fluent in norwegian able to consent and to understand questionnaires. the main question the study aims to answer is whether a digital home-based program is non-inferior to a hospital-based program in terms of improved physical capacity and maintenance of life-quality. in addition, blood samples will be drawn at three time points, at inclusion, after intervention (prior to surgery) and 6 weeks after surgery to analyze and search for biomarkers reflecting patients' individual surgical risk profile and response to prehabilitation. participants randomized to intervention, will be given psychological coaching and support, individualized nutritionist counselling, coached, structured and repeated 60 minutes daily exercises for three weeks prior to surgery. the control group will receive no organized prehabilitation in the period of time between diagnose and surgery.

Eligibility criteria:
inclusion criteria: * planned for major gastrointestinal cancer surgery * fluent in norwegian and able to consent and to understand questionnaires exclusion criteria: * inability to walk for six minutes or to rise independently from a chair * inability to comprehend exercise program or to comply with written and oral instructions * presence of a cardio-pulmonary condition that precludes exercise * living in very remote areas making a hospital-based intervention group impossible to implement * being without a permanent address * admittance to a hospital facility for \> 50% of the time from diagnosis to surgery

Keywords: prehabilitation colorectal cancer frailty
safety and efficacy of therapeutic hypothermia in acute ischemic stroke

Conditions: Stroke, Ischemic

Summary: therapeutic hypothermia (th) in stroke has demonstrated robust neuroprotection in animals especially after ischemia-reperfusion injury, but its safety and efficacy remain controversial. the investigators propose this trial to study the clinical and radiological effects of therapeutic hypothermia in acute ischemic stroke patients treated with intravascular thrombectomy (ivt).

the study intervention is therapeutic hypothermia. after intubation, patients assigned to therapeutic hypothermia will receive central venous catheterization through right jugular vein or femoral vein depending on the cooling application and the unique needs, a flexible catheter will be inserted and iced saline will be circulated through the multiple balloons of the catheter in a closed-loop design to induce therapeutic hypothermia. this system also has a hydrophilic coating with heparin and a triple-lumen central venous catheter to satisfy the need of fluid or drug infusion, blood draw and central venous pressure monitoring. after central venous catheterization, patients assigned to th will receive intravascular temperature management to achieve the target temperature of 34-35 °c, which is superior to surface methods in cooling performance in terms of faster rate of cooling, shorter induced cooling time, precise control during maintenance. thereafter, hypothermia will be maintained for 24 hrs from the start of hypothermia. the patients will be rewarmed slowly at a rate of no greater than 0.5 °c every 4 h. what's more, patients in th group will execute anti-shivering protocol during awaking and extubation.

Eligibility criteria:
inclusion criteria: 1. aged 18-85 years(inclusive); 2. patients have clinical signs consistent with acute ischemic stroke, 3. patients with acute large vessel occlusion including internal carotid artery and middle cerebral artery m1 and m2 demonstrated by cta，mra or dsa 4. the possibility to receive arterial thrombus removal treatment （within6 or24 hr of large vessel occlusion ）; 5. provide the informed consent form of the patient or the patient's agent. exclusion criteria: 1. coma or altered vigilance defined as a score ≥2 on the level of consciousness 1a subscale of the nihss. 2. associated cerebral hemorrhage. 3. there is dysfunction before the onset, mrs score \>= 2 points; 4. accompanied by severe comorbidities (such as severe cardiopulmonary insufficiency, the expected survival period of advanced malignant tumors is less than 90 days); 5. multi-mode ct/mri examination of the corresponding contrast agent use contraindications (such as contrast agent allergy, etc.); 6. women during pregnancy or lactation; 7. patients currently participating in other clinical research trials; 8. other conditions judged by the investigator as not suitable for inclusion in the clinical study.

Keywords: therapeutic hypothermia, ais, neurological function prognosis
metabolic syndrome and long-term survival following liver resection

Conditions: Survival

Summary: although hepatitis c virus (hcv) infection remains one of the main causes of hepatocellular carcinoma (hcc) worldwide, metabolic syndrome, with its increase in prevalence, has become an important and significant risk factor for hcc

hepatocellular carcinoma (hcc) represents the sixth most common cancer worldwide. in egypt, it represents the fourth common cancer. many hospital-based studies reported increasing the incidence of hcc. the reason for increased incidence could be attributed to (1) improvement in screening programs and diagnostic tools, (2) increasing the survival rate of cirrhotic patients that increases the chance of developing hcc, and (3) increasing the incidence and complications of hepatitis c virus (hcv) which is the most important risk factor in developing liver cancer including hcc in egypt precise staging of hcc initially is very useful for determination of the therapeutic options and the overall prognosis of the disease. there are certain clinical features upon which most staging systems use for hcc assessment. these clinical features are size and local extent of the tumor, metastasis of the tumor, severity of the liver disease, and the overall patient performance status several studies in the united states, europe, taiwan, hong kong , and new zealand have examined the potential relationships between various metabolic factors and hcc risks, mostly focusing on type 2 dm and obesity. diabetes , or even prediabetes, has been observed to be a major metabolic factor related to an increased risk of hcc in individuals with hbv infections. there is paucity in literature about effect of metabolic syndrome on long-term survival following liver resection for hepatocellular carcinoma among patients with chronic hepatitis c virus infection

Eligibility criteria:
inclusion criteria: - all patients with hcc secondary to hcv infection underwent hepatic resection exclusion criteria: hbv patients other modalities of therapy

Keywords: metabolic syndrome, survival, hepatocellular carcinom
daaoi-1 treatment for treatment-resistant schizophrenia

Conditions: Schizophrenia

Summary: pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. according to the n-methyl-d-aspartate (nmda) hypothesis, adjuvant nmda-enhancing agents may have therapeutic benefit. daaoi-1, a d-amino acid oxidase (daao) inhibitor, is a nmda-enhancing agents. the aim of this project is to examine the effectiveness and safety of daaoi-1 adjuvant treatment for clozapine-resistant refractory schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. among schizophrenia patients, around 20-25%are treatment-resistant. according to the n-methyl-d-aspartate (nmda) hypothesis, many clinical trials on nmda-enhancing agents were studied. adjuvant nmda-enhancing agents, including glycine, d-amino acids (d-serine, d-alanine), and sarcosine (a glycine transporter i inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms. the investigators recently started to study the potential of daaoi-1, a d-amino acid oxidase (daao) inhibitor which can elevate synaptic concentration of d-amino acids. the aims of this project is to examine the effectiveness and safety of daaoi-1 adjuvant treatment for clozapine-resistant refractory schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Eligibility criteria:
inclusion criteria: * fulfilled the dsm-iv criteria of schizophrenia * poor responder of clozapine: a 12-week treatment without satisfactory response: a minimal total score of 70 on the positive and negative syndrome scale (panss) (kay 1987), and a minimal total score of 40 on the scale for the assessment of negative symptoms (sans) (andreasen 1983). * agree to participate in the study and provide informed consent exclusion criteria: * meet dsm-iv criteria of other axis i disorder, current substance dependence or mental retardation * serious medical or neurological illness * pregnancy or lactation * use of depot antipsychotic in the past 6 months * inability to follow protocol.

Keywords: schizophrenia nmda daaoi clozapine resistant schizophrenia
investigation of the effects of motor imagery and action observation in people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: it was planned to examine the effects of motor imagery and action observation applied in addition to standard rehabilitation in individuals with multiple sclerosis on walking, fatigue, and muscle oxygenation.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * a definitive diagnosis of ms by a neurologist according to the 2017 mcdonald criteria * expanded disability status scale (edss) score of 4.0 and below (it is determined routinely by the physician during the examination) * not having an attack in the last 3 months * a minimum score of 4 in each motor imagery ability (internal visual imagery, external visual imagery, and kinesthetic imagery) on the movement imagery questionnaire-3 (miq-3) exclusion criteria: * cognitive impairment, defined as a mini-mental state examination (mmse) score of less than 24 * having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study. * having severe vision and hearing problems

Keywords: multiple sclerosis motor imagery action observation walking fatigue muscle oxygenation
chemotherapy and whole-brain radiation therapy in treating patients with primary central nervous system non- hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining radiation therapy with chemotherapy may kill more tumor cells and may be an effective treatment for non-hodgkin's lymphoma. purpose: phase ii trial to study the effectiveness of combination chemotherapy and whole-brain radiation therapy in patients with primary central nervous system non-hodgkin's lymphoma.

objectives: i. assess the response to chod (cyclophosphamide/doxorubicin/vincristine/ dexamethasone) and bvam (carmustine/vincristine/cytarabine/methotrexate) plus whole-brain radiotherapy in patients with primary central nervous system non-hodgkin's lymphoma (pcnsl). ii. assess the toxic effects associated with this treatment. iii. assess the survival of patients with pcnsl receiving this treatment. iv. investigate the frequency of systemic involvement at follow-up. v. identify factors that appear to be associated with outcome.

Eligibility criteria:
disease characteristics: primary central nervous system non-hodgkin's lymphoma (pcnsl) clinically diagnosed intracranial space-occupying lesion pathology consistent with non-hodgkin's lymphoma and reviewed by ncctg biopsy optional if characteristic history, pathognomonic neuroimaging, and cytology are consistent with malignant lymphocytes from vitrectomy, csf, or both no occult systemic lymphoma or prior lymphoma no post-transplant lymphoproliferative disorder disease measurable or evaluable on postoperative contrast-enhanced ct or mri postoperative therapy must start within 6 weeks of definitive diagnosis patient characteristics: age: 18 to 70 performance status: ecog 0-3 hematopoietic: wbc at least 4,000/mm3 platelet count at least 120,000/mm3 hepatic: bilirubin no greater than 2 times normal ast no greater than 2 times normal renal: creatinine no greater than 1.5 times normal cardiovascular: no heart failure no uncontrolled arrhythmia pulmonary: no severe pulmonary failure other: no serious uncontrolled infection no active bleeding no aids or hiv-positive serology no prior organ transplant no pregnant or nursing women negative pregnancy test required of fertile women adequate contraception required of fertile patients prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: corticosteroids allowed if dose fixed or decreasing for at least 1 week prior to baseline scan radiotherapy: no prior radiotherapy surgery: not specified

Keywords: primary central nervous system non-hodgkin lymphoma
closed-loop control of postprandial glucose levels after meals with different macronutrients content in adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: carbohydrates are the main determinant of post-meal glucose excursion. however, fat and protein have been shown to also impact the postprandial glucose control, adding to the complexity of meal insulin calculation. few studies have looked at the effect of macronutrients other than carbohydrates on postprandial glucose excursions with the closed-loop strategy. the objective of this study is to test whether the single-hormone closed-loop strategy can achieve similar post-meal glucose control with meals with a fixed carbohydrate content, but high in protein and/or fat when compared to a meal with a fixed carbohydrate content only.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years old. 2. clinical diagnosis of type 1 diabetes for at least one year. 3. the subject will have been on insulin pump therapy for at least 3 months and currently using fast-acting insulin analog (lispro, aspart or guilisine). 4. last (less than 3 months) hba1c ≤ 10%. exclusion criteria: 1. clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator. 2. recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. 3. ongoing pregnancy. 4. severe hypoglycemic episode within 1 month of screening. 5. agents affecting gastric emptying (motilium®, prandase®, all glp-1 analogs) as well as oral anti-diabetic agents (metformin, sglt-2 inhibitors and dpp-4 inhibitors) if not at a stable dose for 3 months. otherwise, these medications are acceptable and will be kept stable during the entire protocol. 6. oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone cortef®). inhaled steroids at stable dose in the last month are acceptable. 7. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. unstable psychiatric condition). 8. failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).

Keywords: closed-loop system artificial pancreas glucose control meal
effect of acupuncture on postoperative nausea and vomiting

Conditions: Anesthesia; Nausea and Vomiting, Postoperative

Summary: in this study, the hypothesis that bilateral acupuncture needling at the neiguan (pc6) point during the intraoperative period, in addition to the 0.15 mg/kg dose of ondansetron (5-ht3 antagonist) frequently used for postoperative nausea and vomiting (ponv) prophylaxis in patients undergoing lumbar disc herniation surgery, would reduce the incidence of ponv was investigated. ponv was defined as the presence of nausea and vomiting within 24 hours postoperatively.

the study will include patients aged 18 years and over, with (american society of anesthesiologists) asa physical status i to ii, and scheduled for one or two-level lumbar disc herniation surgery under general anesthesia. patient characteristics (age, gender, body mass index, etc.) and postoperative nausea and vomiting (ponv) risk factors such as history of ponv, motion sickness, and history of not smoking will be recorded. the primary outcome parameter will be the incidence of ponv within 24 hours postoperatively. the severity of nausea in patients who develop nausea in the postoperative period will be assessed using a likert scale between 0 and 10. ponv will be defined as vomiting, significant nausea (numerical rating scale \[nrs\] ≥4), and/or need for rescue medication. patients will be assessed for ponv at 0, 2, 4, 12, and 24 hours using a likert scale. emetic attacks, pain and severity of pain, nausea and severity of nausea, need for additional analgesics, and administration of antiemetic rescue medication will be assessed as secondary outcome parameters. the severity of pain and nausea in patients who develop postoperative pain will be assessed using an 11-point numerical rating scale, where '0' indicates the absence of symptoms and '10' indicates the maximum severity. ponv within the first two hours will be defined as 'early', and within 2-24 hours after awakening will be defined as 'late'. nausea will be defined as the desire to vomit, and vomiting will be defined as the forceful expulsion of stomach contents.

Eligibility criteria:
inclusion criteria: * age 18 and above * asa physical status i to ii * one or two level lumbar disc herniation surgery under general anesthesia exclusion criteria: * body mass index \>35 kg/m²) * history of drug use * nausea and vomiting before surgery * psychiatric disorders * use of antipsychotic or antiemetic drugs * severe heart disease * central nervous system diseases * vertebrobasilar artery insufficiency * cytostatic therapy * vestibular diseases * renal and/or hepatic dysfunction * presence of fistula, neuropathy and paralysis in the extremity to be treated * patient's refusal to accept acupuncture * pregnant patients * presence of bleeding diathesis * patients in a condition where cooperation cannot be established in the post-operative period (mental retardation etc.)

Keywords: acupuncture postoperative nausea vomiting apfel score
effect of pharmacological anti-lipolysis on ffa and vldl-tg metabolism before and during exercise

Conditions: Diabetes; Obesity

Summary: this study will investigate free fatty acid and vldl-tg metabolism before and during exercise with and without pharmacological antilipolysis by the niacin antagonist acipimox. main focuses will be vldl-tg and free fatty acid metabolism as well as expression of membrane proteins in fat- and muscle biopsies.

insulin resistance in liver and skeletal muscle is of central pathogenic significance in the development of type 2 diabetes. the molecular connections are unresolved but high levels of free fatty acids and triglyceride is probably involved. diabetic subjects and to a lesser extent obese subjects have increased triglyceride levels, this could be due to an abnormal turnover of vldl-tg. it is not yet investigated whether vldl-tg kinetics changes during pharmacological antilipolysis. using the aseptic ex-vivo labeling technique (developed in our laboratories) we will investigate this issue in sedentary healthy men. after a 3 hour basal period subjects will exercise on a bike for 60 minutes at 60% of vo2max. in both basal and exercise period one muscle and one fat biopsy will be obtained, further blood samples will be drawn to examine ffa and vldl-tg metabolism etc.. this new knowledge will contribute to the understanding of metabolic disorders like type 2 diabetes and obesity.

Eligibility criteria:
inclusion criteria: - healthy, untrained males exclusion criteria: * medication * history of malignancy, alcohol abuse or drug abuse * participation in isotope trials in the last 6 months

Keywords: vldl-tg metabolism exercise free fatty acids