Kornimate/medical-research-clean huggingface dataset:
dutch randomised endovascular aneurysm management (dream-) trial

Conditions: Abdominal Aortic Aneurysm

Summary: the purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (aaa) is an adequate substitute of the conventional aaa repair.

after the introduction of endovascular repair of abdominal aortic aneurysms (aaa), both benefits and drawbacks of this new technique have been reported. to assess whether the new technique is an adequate substitute of conventional aaa repair, a randomised study is required. the dream trial is a randomised multicenter trial enrolling patients eligible for elective treatment of infrarenal aaas. the primary endpoint is combined operative mortality and morbidity. secondary endpoints and additional assessments include event-free survival, quality of life,and costs.

Eligibility criteria:
inclusion criteria: * asymptomatic, infrarenal aaa that requires surgery * adequate infrarenal neck * other aortic-iliac anatomical configuration suitable for evar according to the criteria of the device to be used * patient having a life expectation of at least 2 years and cleared for transabdominal intervention * signed informed consent exclusion criteria: * ruptured aaa or symptomatic aaa, which requires emergency surgery * maximum aneurysm diameter\< 5.0 cm * suprarenal aaa * inflammatory aaa (more than minimal wall thickening) * infrarenal neck unsuitable for endovascular fixation or aortic-iliac anatomic configuration otherwise unsuitable for evar according to criteria of the device to be used * bilateral retroperitoneal incision required for evar * sacrifice of both hypogastric arteries required * anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation * patient unsuitable for laparotomy * administration of contrast agent not possible: proved, severe systemic reaction to contrast agent * active infection present * transplantation-patients * limited life expectation due to other illness (\< 2 year) * non-iatrogenic bleeding diathesis * connective tissue disease

Keywords: abdominal aortic aneurysm aaa randomised controlled trial endovascular repair conventional open repair
seton or glue for trans-sphincteric anal fistulas

Conditions: Anal Fistulas

Summary: surgical treatment of perianal fistulas frequently affects fecal continence. sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap have been advocated to minimize the risk of sphincter injury, but patients often complain of a prolonged healing period and major discomfort. furthermore, the healing rate varies widely according to the type of fistula and the surgeon's experience.in the early '90s the treatment of perianal fistulas by autologous or commercial fibrin glue was suggested and the american fda approved the use and marketing of a human fibrin glue in 1998. since then, several studies have evaluated the effectiveness of human fibrin glue in the treatment of different types of perianal fistulas, reporting a wide range of success rates ranging from 31 to 85%. primary aim of this study is to conduct a prospective randomized trial evaluating the effectiveness of glue treatment of perianal fistulas as compared with the classical seton treatment. secondary aims are to compare postoperative faecal incontinence, postoperative anal pain, healing time and length of hospitalization.

background: fibrin glue treatment of anal fistulas has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because clear data in literature are lacking. we will run a prospective randomised trial comparing commercial fibrin glue treatment with classical seton treatment, taking into account the healing rate, hospital stay, healing time, faecal incontinence and postoperative pain. patients and methods: 130 homogeneous patients with trans-sphincteric anal fistulas referred to 7 colorectal units will be randomised to undergo fibrin glue or seton treatment. permanent healing of the fistula will be defined as absence on any discharge from the fistula and healing of the secondary fistula orifice after at least 1 year of follow up. post operative pain (on a vas scale) and hospital stay will be recorded and compared in the two groups

Eligibility criteria:
inclusion criteria: * medium or high trans-sphincteric fistulas of cryptoglandular origin, no previous treatments exclusion criteria: * crohn's disease * anal abscesses * complex fistulas (horse-shoe type or multiple secondary tracts) * immunosuppression * diabetes, * anal fissures * pregnancy * anti-coagulant treatments, * any allergic reaction to the bioglue components.

Keywords: fibrin glue transsphincteric anal fistulas seton incontinence prospective randomised trial
effects of dexmedetomidine on respiratory mechanics and oxygenation during one lung ventilation with chronic obstructive lung disease

Conditions: COPD, One Lung Ventilation

Summary: copd is often associated with the airflow limitation and the pulmonary hyperinflation. during the one-lung ventilation (olv), copd patients' physiologic dead space increases and hypercapnia may develop. in addition, an alveolar overdistention by the pulmonary hyperinflation would divert pulmonary blood flow and impair arterial oxygenation. dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. the investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as bronchodilator in copd patients when administered during surgery with the one lung ventilation. if result successfully shows the effect of dexmedetomidine as a predominantly a vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to anesthetic agents in copd patients during the olv.


Eligibility criteria:
inclusion criteria: 1. above 40 years of age 2. american society of anesthesiologists (asa) physical status i, ii, iii. 3. copd diagnosed , criteria ( on preop. pft : fev1 \< 80%, fev1 / fvc \< 70% after bronchodilator) 4. thoracic surgical procedure exclusion criteria: 1. severe functional liver or kidney disease 2. diagnosed hf ( nyha class \>3) 3. arrhythmia or received treatment with antiarrythmic drug . 4. exceed bmi \> 30 kg/ m2 5. bradycardia (hr \<50 bpm)
reprogramming energy homeostasis in overweight individuals via exercise, cognitive, and social training

Conditions: Obesity and Overweight; Leptin Resistance; Childhood Obesity

Summary: the resilient project is a clinical trial investigating leptin sensitivity in both children and adults with overweight or obesity. the study examines the additive effects of cognitive training (ct) and social training (st) on leptin sensitivity, compared to stand-alone intensive health behaviour treatment (ihbt), which includes diet and physical activity (pa). the intervention will last for 8 weeks, followed by a 12-week washout period. a multilevel assessment will be conducted, evaluating in vivo leptin sensitivity (through the ratio of leptin levels to caloric intake) as well as ex vivo molecular analysis of leptin signaling in peripheral blood mononuclear cells (pbmcs). additionally, clinical, psychological, cognitive, and physiological assessments will be performed to assess the efficacy of each intervention. by investigating leptin resistance as a potential molecular bridge between metabolic dysregulation and cognitive dysfunctions, this study may contribute to the development of more effective, long-term treatments for obesity and overweight. additionally, in vivo investigation of leptin sensitivity may be particularly important for providing evidence of the metabolic and cognitive effects necessary for developing novel anti-obesity treatments.


Eligibility criteria:
inclusion criteria: * a condition of overweight or obesity * intelligence quotient (iq) ≥ 85 exclusion criteria: * genetic or syndromic obesity; * reduced mobility; * systemic diseases; * ongoing pharmacological treatment for chronic conditions.

Keywords: childhood obesity cognitive training social training environmental enrichment leptin lifestyle modification overweight obesity energy expenditure thermogenesis physical activity leptin sensitivity leptin resistance
extension to study 200952 to evaluate the long-term safety, tolerability and pharmacodynamics of albiglutide liquid drug product in type 2 diabetes mellitus subjects

Conditions: Diabetes Mellitus, Type 2

Summary: albiglutide has been developed for the treatment of type 2 diabetes mellitus (t2dm) as an adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and has been approved by the united states (us) food and drug administration (fda), the european medicines agency (ema) and other regulatory agencies. this is a 26 week, open-label, single group, multicenter, extension study to study 200952. this extension study will provide extended safety, tolerability and immunogenicity data for the albiglutide liquid drug product. this extension study will comprise 2 study periods: treatment (26 weeks) and post-treatment follow-up (8 weeks). a maximum of 300 subjects will be eligible to take part in this extension study.


Eligibility criteria:
inclusion criteria: * subjects who have completed the 26 week treatment phase of study 200952 * male or female * able and willing to provide informed consent. exclusion criteria: * subject meets one or more of the withdrawal stopping criteria at visit 1 (week 26)

Keywords: extension long-term safety pharmacodynamics albiglutide type 2 diabetes mellitus
study using eculizumab in transfusion dependent paroxysmal nocturnal hemoglobinuria (pnh) patients

Conditions: Hemoglobinuria, Paroxysmal

Summary: the primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic pnh.


Eligibility criteria:
inclusion criteria: * must have required at least 4 transfusions in the past 12 months * pnh type iii red blood cell (rbc) clone by flow cytometry of \>10% * lactate dehydrogenase (ldh) level \> 1.5 x upper limit of normal * platelet count \> 100,000/mm3 * patient taking erythropoietin must be on a stable dose for at least 26 weeks * patient taking immunosuppressants must be on a stable dose for at least 26 weeks * patient taking corticosteroids must be on a stable dose for at least 4 weeks * patient taking coumadin must be at a stable inr for at least 4 weeks * patient taking iron supplements or folic acid must be on a stable dose for 4 weeks * willing and able to give written informed consent * must avoid conception exclusion criteria: * mean hemoglobin level prior to transfusion over the previous 12 months is \>10.5 gm/dl * absolute neutrophil count \<500/ul * active bacterial infection * hereditary complement deficiency * participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures within 30 days * pregnant, breast-feeding, or intending to conceive * history of meningococcal disease * history of bone marrow transplantation
transdermal fentanyl patch for postoperative analgesia after abdominal surgery: a randomized placebo-controlled trial

Conditions: Postoperative Pain Relief

Summary: abdominal surgery causes severe postoperative pain. multi-modal pain therapy is usually applied but there is no perfect choice. it depends on physician's skill and situation. the best regimen is patient-controlled analgesia, but it requires an expensive equipment. transdermal fentanyl patch, usually used in chronic pain relief, can steadily release fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours. hypothesis: if transdermal fentanyl patch is applied 10-12 hours before surgery, it may provide good analgesia for 72 hours.


Eligibility criteria:
inclusion criteria: * age =\>18 years * scheduled for abdominal surgery exclusion criteria: * asa class \> 3 * known allergy to fentanyl or morphine * history of substance or alcohol abuse, and tolerance or dependence on opioids * combined epidural block * can't use pca, abnormal renal / liver function

Keywords: transdermal fentanyl patch, postoperative pain,
a retrospective study of covid-19 treatments

Conditions: Covid19; COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Acute Bronchitis; COVID-19 Acute Respiratory Distress Syndrome; COVID-19 Lower Respiratory Infection; SARS-CoV2 Infection; SARS-CoV-2 Acute Respiratory Disease

Summary: surveys administered to subjects who have recovered from covid-19 to assess how effective their treatment was.

subjects who have recovered from covid-19 will answer questions regarding the severity of their illness, symptoms experienced, what treatment they received, and how long they were ill.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female of 18 years of age or older 3. diagnosis of covid-19 infection by rt- pcr 4. recovery from covid-19 exclusion criteria:
[11c]-pbr28 positron emission tomography study to evaluate the effect of abt 555 in subjects with relapsing forms of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this open-label positron emission tomography (pet) study is designed to determine the effect of abt-555 on translocator protein expression level in participants with relapsing forms of multiple sclerosis.


Eligibility criteria:
inclusion criteria: diagnosis of relapsing-remitting ms (rrms) or relapsing secondary progressive ms (spms) neurologically stable at screening, in the investigator's judgment and not actively experiencing or recovering from a recent relapse in the 30 days preceding the screening visit a kurtzke expanded disability status scale (edss) score of 1.0 to 6.0, inclusive at the screening visit high or mixed affinity binder of the tspo, as determined by rs6971 polymorphism genotyping at screening exclusion criteria: diagnosis of primary progressive or non-relapsing secondary progressive ms smoking more than 10 cigarettes per day or use of a nicotine patch known history of, or positive screening test result for hepatitis c virus or hepatitis b virus varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening any type of live virus vaccine from 4 weeks before randomization history of abnormal laboratory results

Keywords: relapsing multiple sclerosis
a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer

Conditions: Breast Cancer

Summary: after breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.

after breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. the frequency of follow-up varies between and within different institutions. to date, no de-escalation strategy has appropriately evaluated patient reported outcomes such as quality of life or perception of care. there has been a growing body of evidence that de-intensification of follow-up is safe, effective and reduces costs for both patients and the health care system. therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.

Eligibility criteria:
inclusion criteria: * being referred to the wellness beyond cancer program (wbcp) for routine follow-up after completion of acute phase of treatment for invasive breast cancer exclusion criteria: * history of prior invasive breast cancer, recurrent brest cancer or metastatic breast cancer * currently receiving zoledronate, lhrh (gonadotropin-releasing hormone) or abemaciclib

Keywords: well follow-up follow-up interval
pharmacokinetic properties of various modified release tablet formulations of lu af11167

Conditions: Schizophrenia

Summary: the purpose of this study is to investigate the pharmacokinetic (pk) properties of various modified release tablet formulations of lu af11167 (part a) and to investigate the pharmacokinetic (pk) properties of a modified release tablet formulation of lu af11167 in a fed and fasted state and following multiple dosing (part b).


Eligibility criteria:
inclusion criteria: * healthy men and women ≥18 and ≤45 years of age with a body mass index (bmi) of \>18.5 and \<30.0 kg/m2. * women of child-bearing potential will have a confirmed non-pregnant and non-lactating status. * other pre-defined inclusion and exclusion criteria may apply.
feasibility study for imaging of peripheral tumors with a high-resolution pet imaging system

Conditions: Solid Tumors; Cancer

Summary: the goal of this clinical research study is to learn if using the pemflex solo ii, a high-resolution camera for pet scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine pet/ct. researchers will compare the images taken using the pemflex solo ii to the images taken during your scheduled routine pet/ct scan, as well as any additional routine ct scan(s), magnetic resonance imaging (mri) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.

if you agree to take part in this study, right after your already-scheduled routine pet/ct scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine pet/ct scan was just performed. you will then sit in a chair as a study staff member positions the pemflex solo ii on either side of the area being checked for cancer. it will take about 20 minutes to set up the pemflex solo ii and take the pet scan images. length of study: after the pet scan images have been taken using the pemflex solo ii, your participation in this study will be over. this is an investigational study. the pemflex solo ii is commercially available and designed for pet scan imaging of the breast. the use of the pemflex solo ii for imaging other parts of the body is investigational. up to 20 patients will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1. a signed informed consent. 2. known or suspected primary or metastatic lesion of the extremities, head or neck as determined by biopsy, physical examination or noninvasive imaging studies including plain films, ct, mr, ultrasound or nuclear medicine imaging. 3. scheduled for routine clinical imaging at the acb pet/ct facility. 4. participant must be at least 18 years of age. exclusion criteria: 1. uncontrolled blood glucose levels (\>200 mg/dl). 2. patient is unable to comprehend the requirements of the study. 3. patient is unable to undergo scanning of the known or suspected lesion with the high-resolution pem (pet) scanner (due to body habitus, inability to comply with positioning requirements, etc.).

Keywords: peripheral tumors arm leg head neck hr pet imaging system high-resolution pet pet/ct pemflex solo ii positron emission tomography/computed tomography (pet/ct)
efficacy and safety of methylphenidate hcl er capsules in children and adolescents with adhd

Conditions: Attention Deficit Hyperactivity Disorder; ADHD

Summary: this multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (er) capsules of four dose levels compared with a placebo group in pediatric patients with attention deficit hyperactivity disorder (adhd) who are between 6 and 18 years old.

this is a parallel, randomized, double-blind, multi-center, placebo-controlled, forced dose, phase 3 study to evaluate the safety and efficacy of biphentin® methylphenidate hydrochloride (hcl) extended release (er) capsules in the treatment of attention deficit hyperactivity disorder (adhd) in pediatric and adolescent patients aged 6 up to 18 years. the primary objective was to assess the efficacy of biphentin compared to placebo, in the clinic setting, as measured by the clinician-administered parent version of the adhd-rs-iv. subjects who met study entry criteria were enrolled in the double-blind phase and were randomized to either a fixed dose of biphentin (!0, 15, 20, or 40 mg/day) or placebo capsule taken daily in the morning for 1 week. subjects then continued into an open-label phase that included dose optimization with doses starting at 10 mg and allowed up to 60 mg. the open-label period following the one double-blind fixed dose week provides additional opportunity for subjects to receive treatment with biphentin. extra unscheduled dose optimization visits are allowed as needed for additional dose titration visits during the open-label period. the safety and tolerability, and efficacy assessments will be conducted throughout the study. biphentin® is designed to be a single daily dose alternative to separate doses of immediate release methylphenidate by providing a biphasic plasma profile. it achieves a first cmax more similar to immediate release methylphenidate.

Eligibility criteria:
inclusion criteria: * males and females ages 6 up to 18 * adhd diagnosis with adhd rating scale - 4th edition scores ≥ 90th percentile * in need of treatment for adhd and able to have 2-day washout from previous medication * females of child-bearing potential not pregnant and practice birth control * subject and parent/guardian willing to comply with protocol * signed consent and assent exclusion criteria: * estimated full scale intellectual level below 80 using wechsler abbreviated scale of intelligence (wasi) * current primary psychiatric diagnosis of other listed disorders * chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma * use of psychotropic central nervous system (cns) meds having effect exceeding 14 days from screening * planned use of prohibited drugs * is pregnant or breast-feeding * significant ecg or laboratory abnormalities * experimental drug or medical device within 30 days prior to screening * hypersensitivity to methylphenidate * inability or unwillingness to comply with protocol * well controlled on current adhd treatment * inability to take oral capsules

Keywords: inattention impulsivity hyperactivity adhd