Kornimate/medical-research-clean huggingface dataset:
tapentadol versus tramadol analgesia post cardiac surgery

Conditions: Postoperative Pain; Surgery; Pain, Postoperative; Pain, Acute; Pain, Chronic; Pain, Procedural; Pain, Neuropathic; Analgesia

Summary: the aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain) in cardiac surgery patients

management of post-surgical pain is a daily challenge for every anaesthetist. undertreated post-surgical pain can result in cardiovascular, pulmonary and gastrointestinal complications, as well as chronic pain and negative psychological effects. a negative impact may be seen on immune function, coagulation and wound healing. opioids have been the cornerstone in the treatment of pain after cardiac surgery. however, opioids have a number of adverse effects such as respiratory depression, gastrointestinal alterations, dizziness, delirium, addiction. tapentadol is a new synthetic opioid with dual mechanism of action. it acts as a mu-receptor agonist, as well as norepinephrine reuptake inhibitor. it is used to treat moderate to severe pain and is associated with fewer adverse effects compared to other opioids. the aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain). patients undergoing cardiac surgery and being discharged from icu to ward within 30 hours of surgery, will be divided into 3 groups. group a will receive tapentadol 50mg p.o 3 times daily for two days, group b will receive tapentadol 75 mg p.o 3 times daily for two days and group c will receive tramadol 100 mg p.o 3 times daily for two days. pain level will be assessed with numeric rating scale (nrs), before drug administration and two hours after drug administration. overall patient satisfaction will be assessed with likert scale. brief pain inventory( short form) and dn4 questionnaire will be used to detect chronic pain and neuropathic pain respectively, 3 and 6 months after surgery.

Eligibility criteria:
inclusion criteria: * age \<75 years old * patients discharged from intensive care unit (icu) in less than 30 hours * elective cardiac surgery exclusion criteria: * hepatic failure (increased transaminase levels * renal failure (creatinine\> 2 mg/dl) * ileus * emergency surgery (hemorrhage, tamponade, aortic dissection) * readmission in icu * treatment with monoaminoxidase inhibitors, selective serotonine reuptake inhibitors or antiepileptics * age\>75 years old * communication or language barriers * lack of informed consent

Keywords: tapentadol tramadol
physical exercise, dietary counseling and cognitive behavioral training as a combined intervention to reduce weight and increase workability in health care workers

Conditions: Overweight; Physical Capacity; Musculoskeletal Diseases; Work Ability; Sick-leave

Summary: the purpose of this study is to evaluate whether a 1 year worksite based life-style intervention can reduce body weight and increase physical capacity and subsequently reduce musculoskeletal disorders and increase workability in overweight health care workers.

health care workers have a high rate of musculoskeletal disorders and sick leave and a poor workability and physical fitness. most studies have focused on increasing physical fitness in order to increase workability and to reduce musculoskeletal disorders and sick leave. studies however also show that many health care workers are obese and obesity has been linked to poor workability. limited research is available on the effect of reducing body-weight in this group in order to increase workability and to decrease musculoskeletal disorders and sick leave. this study introduces a combined worksite based lifestyle intervention consisting of physical exercise, dietary counseling and cognitive behavioral training aimed at reducing weight in health care workers. on specific worksites, health care workers are cluster randomized to either intervention or control group. effects on physical capacity, body composition, musculoskeletal disorders, workability and sick leave are evaluated before and after a 1 year intervention period

Eligibility criteria:
inclusion criteria: * overweight health care workers, working more than 15 hours pr week exclusion criteria: * pregnancy, angina pectoris and life-threatening diseases according to safty regulations for physical evaluation methods

Keywords: weight loss physical activity cognitive behavioral training
aimn multicenter study: 18 f-fdg pet-ct with or without contrast medium in the staging and radiation of lung cancer?

Conditions: Non Small Cell Lung Cancer

Summary: accurate staging of patients with non-small cell cancer (nsclc) is of fundamental importance both for the correct choice of treatment plan and for prognosis. numerous studies have demonstrated the added value of co-registration of functional pet images and anatomical ct images using hybrid pet-ct tomographs and the consequent benefits on the choice of treatment in patients with nsclc. currently in most pet centers ct is performed with a "low dose" technique and is used exclusively as a transmissive source for attenuation correction and anatomical localization. the availability of new generation hybrid tomographs allows for "diagnostic" ct examinations (contrast ct) to be performed with a standard dose of radiation and with the use of intravenous and/or oral iodinated contrast medium (contrast medium). little data is currently available on the added value of a pet-ct scan performed in a single session compared to pet-ct performed independently and, generally, subsequently to ct scan. the objective of the study is to evaluate the ability to correctly define the accuracy in localizing and characterizing lung "lesions" in patients with confirmed nsclc, in the staging or restaging phase, through the use of: pet-ct "low-dose" and pet contrast ct. the effects of the two procedures on the patient's quality of life and on the costs incurred by the patient and the healthcare service will also be evaluated.


Eligibility criteria:
inclusion criteria: * patients with histologically proven nsclc, undergoing staging or restaging; * plasma creatinine normal; exclusion criteria: * patients with lung microcytoma; * pregnant women
upside down, give me the handle

Conditions: Schizophrenic Disorders

Summary: in schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. a fragmentation of motor and sensory perceptions could be held responsible (fuchs, 2005). however, automatic integration between perception and action is the necessary condition to be in "relationship with the world." affordance is the experimental link between object perception and actions potentially associated (gibson (1977, 1979) explored by stimulus response compatibility (src) paradigm. the existence of visual motor neurons leads us to postulate that the affordance effect can be assisted by a visuomotor priming of a hand in a position to grasp. with tucker \& ellis sensory motor compatibility task, we study the capacity of affordance in schizophrenia, as well as the impact of perceptual motor priming on these affordance effects.

all participants will perform cognitive tasks: reaction time (alert tea, zimmermann and fimm, 2005), edinburgh laterality questionnaire (oldfield, 1971), iq test (iq: pm38, raven, 1960), and the panss (positive and negative syndrome scale, kay et al., 1987). controls will only have the first three tasks (cognitive spots alert and laterality). then all will perform all tasks in successive order (task 1 and task 2). for both tasks, photographs of 20 objects of everyday life typical grip with one hand are presented in 4 orientations. the instruction is to say if the object is presented upright or inverted; the second task differs from the first only by the introduction of a prime: presenting a hand in position "catching" before the picture of an object

Eligibility criteria:
inclusion criteria: for patients: * a dsm-iv diagnosis of schizophrenia (men or women), * no change in antipsychotic medication and clinical status within four weeks prior to the study exclusion criteria: * iq \< 70 for patients and control group inclusion criteria - age ≥ 18 years et ≤ 50 years exclusion criteria: * history of head trauma, * neurological disease with cerebral repercussion or not stabilized serious physical illness; * psychotropic medication, * disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);

Keywords: schizophrenia motor and sensory perceptions
the effect of remote ischemic preconditioning on postoperative cognitive dysfunction in total knee replacement

Conditions: Knee Osteoarthritis

Summary: the patients were allocated randomly to receive remote preconditioning group (ripc group, r) or not (control group, c) using sealed envelopes with the options inside the sealed envelope of r and c before anaesthesia induction. the registered nurse who did not participate in patient care and was blind to the study performed the all randomization process. all medical staffs who involved the patient care were blind to the study. all data were collected by trained observers who were blind to the study and did not participate in patient care

ripc was performed just after anesthesia induction and before the tourniquet application for the operation site. the tourniquet was applied at the opposite site of thigh in the both groups. the thigh was covered with blanket to conceal the tourniquet inflation and deflation. for r group, 3 cycles of tourniquet inflation for 5 minutes with 2 × systemic systolic arterial blood pressure of arrival at operation room and deflation were performed. for c group, the tourniquet was applied with same manner for r group except inflation pressure of 0 mmhg. the tourniquet pressure according to the randomization was set by the registered nurse who participated in the patients' allocation. the monitor of tourniquet pressure was sealed for blindness.

Eligibility criteria:
inclusion criteria: * patient who was planned to undergo total knee replacement surgery exclusion criteria: * emergency operation * underlying cerebrovascular disease * underlying peripheral vascular disease
arise: evaluation of the gore® ascending stent graft in the treatment of debakey type i/ii aortic dissection

Conditions: Aortic Dissection

Summary: assess the feasibility of the treatment of debakey type i/ii aortic dissections with the gore® ascending stent graft

this study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of debakey type i/ii aortic dissections with the gore® ascending stent graft.

Eligibility criteria:
inclusion criteria: 1. debakey type i/ii aortic dissection compatible with the treatment requirements of gore® ascending stent graft, including: * primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia * ascending aorta compatible with the gore® ascending stent graft including landing zone true lumen diameter between 24mm - 42mm and total aortic landing zone diameter ≤ 45 mm 2. able to undergo ct scan per protocol requirements to perform required case planning prior to endovascular procedure 3. high surgical risk, as determined by the implanting physician 4. adequate vascular access via transfemoral or retroperitoneal approach 5. an informed consent form signed by subject or legally authorized representative 6. able to comply with protocol requirements including follow-up exclusion criteria: 1. planned aortic valve repair or replacement or coronary artery intervention within 30 days 2. presence of mechanical heart valve in the aortic position 3. primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta 4. aortic insufficiency grade 3+ or 4+ 5. known irreversible neurological injury 6. known degenerative connective tissue disease, e.g. marfan's or ehler-danlos syndrome 7. participation in another drug or medical device study within 1 year of study enrollment 8. known history of drug abuse 9. pregnant female at time of informed consent signature 10. body habitus or other medical condition which prevents adequate visualization of the aorta 11. systemic infection that could increase the risk of endovascular graft infection 12. previous thoracic aortic surgery 13. life expectancy \<12 months due to associated non-cardiac co-morbid conditions 14. subject has known sensitivities or allergies to the device materials 15. previous instance of heparin induced thrombocytopenia type 2 (hit-2) or known hypersensitivity to heparin 16. patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment

Keywords: type a dissection
a trial of enteral colostrum on intestinal permeability in critically ill patients

Conditions: Critical Illness

Summary: the effects of colostrum on intestinal permeability in critical ill patients has not been investigated. in current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.

a randomized, double blind, controlled trial will be conducted in general intensive care unit (icu) in tehran, iran. after a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. intervention patients will be received 20 g/day of colostrum along with enteral formula and control patients will be received maltodextrin along with enteral formula. patients will be evaluated for plasma endotoxin and plasma zonulin.

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years old) admitted to icu * start of study intervention within 48 hours after icu admission * expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour * written informed consent of patient or written informed consent of legal representative exclusion criteria: * enrollment in a related icu interventional study * requiring other specific enteral nutrition for medical reason * death or discharge before 5th day * having any contra-indication to receive enteral nutrition * pregnant patients or lactating with the intent to breastfeed * bmi \ 40.0 kg/m2 * have life expectancy of \<6 mo * patients who are moribund * history of allergy or intolerance to the study product components * receiving colostrum during two weeks before start study product * have other reasons

Keywords: colostrum enteral nutrition intestinal permeability intensive care unit
xerostomia in head and neck cancer patients receiving radiation as the primary treatment versus patients who will not have such a procedure

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.


Eligibility criteria:
inclusion criteria: * patients with a histological diagnosis of squamous cell carcinoma * patients with unilateral or no neck involvement of the nasopharynx * the submandibular transfer will be done on the uninvolved side of the neck. * karnofsky score greater than or equal to 70 * expected survival greater than one year * a signed informed consent exclusion criteria: * bilateral neck nodes involvement. involvement of level 1 lymph nodes on the side of the proposed procedure.

Keywords: nasopharynx xerostomia prevention
renal denervation in end stage renal disease patients with refractory hypertension

Conditions: Kidney Failure, Chronic; Renal Dialysis

Summary: the purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of esrd patients with refractory hypertension.


Eligibility criteria:
inclusion criteria: * systolic blood pressure of 160 mmhg or greater * on 3 or more antihypertensive medications * on dialysis for more than 6 months exclusion criteria: * renal artery abnormalities * known secondary hypertension attributable to a cause other than sleep apnea * mi, angina, cva within 6 months * others
international multicenter prospective transtar registry

Conditions: Constipation

Summary: obstructed defecation syndrome (ods) describes a condition which is characterized by chronic constipation. the symptoms of ods include abdominal pain or cramping, irregular bowel frequency and the feeling of not having emptied the rectum. ods is usually associated with internal rectal prolapse and/or rectocele. for surgical treatment of ods, a plethora of surgical techniques have been described with no one method having been assessed as a gold standard.

a new surgical procedure - transtar - has been introduced in europe recently. the goal of this registry is to assess safety, effectiveness and patient quality of life, associated with transtar for chronic constipation due to morphological changes, such as internal rectal prolapse and rectocele.

Eligibility criteria:
inclusion criteria: * patients with obstructed defecation, fragmented defecation or incomplete evacuation as a presenting symptom documented by a standardized symptom score * confirmed internal rectal prolapse or rectocele on dynamic defecography * adequate external sphincter on rectal digital examination. exclusion criteria: * subjects with any other surgical procedure than starr for ods * subjects in whom starr is not performed with the contour transtar stapler * subjects with a physical or psychological condition which would impair participation in the registry.

Keywords: ods chronic constipation internal rectal prolapse rectocele stapled transanal rectal resection contour transtar starr
haploidentical transplant with nk cell infusion for pediatric acute leukemia and solid tumors

Conditions: Leukemia; Solid Tumors

Summary: this study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (all), aml and high risk or refractory solid tumors. in addition, the feasibility and safety of administering post-transplant nk cell infusions will be evaluated. data obtained from this study will help determine the efficacy of allogeneic hsct in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical hsct to treat acute leukemia in pediatric patients. this study will also further elucidate the role of nk cells in mediating a graft vs. tumor effect in allogeneic hsct. the main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. if feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.


Eligibility criteria:
inclusion criteria: * solid tumors that have failed auto transplant or are ineligible to receive auto transplant * relapsed aml in 1st relapse or 2nd or 3rd cr * relapsed all if they fail to attain an initial remission or if they relapse within 1 year following the discontinuation of chemotherapy. * greater than or equal to 6 months and \<26 years old * suitable haploidentical donor available exclusion criteria: * leukemia with \>25% blasts in bone marrow at the time of admission to the hsct unit. * serum bilirubin \>3 mg/dl * gfr \<40 ml/min/1.73 mw * cardiac left ventricular ejection fraction \<40% * hiv+ * pregnant

Keywords: recurrent or refractory leukemia or solid tumors in pediatrics
efficacy and safety of grazax in children

Conditions: Allergy

Summary: the purpose of this study is to investigate if immunotherapy with grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season


Eligibility criteria:
inclusion criteria: * boys and girls 5-16 years of age * a clinical history of grass pollen induced hayfever * positive skin prick test to phleum pratense * positive specific ige against phleum pratense exclusion criteria: * history of seasonal hayfever symptoms (and/or asthma) caused by another allergen than phleum pratense during or overlapping the grass pollen season * history of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed * history of severe asthma * current severe atopic dermatitis
als diagnosis from a saliva sample: a non-coding rna analysis approach

Conditions: Amyotrophic Lateral Sclerosis, Sporadic; Amyotrophic Lateral Sclerosis

Summary: rnals is a multicentre, transversal, diagnostic and non-interventional study carried out in als reference centers; in order to identify a diagnostic signature for amyotrophic lateral sclerosis by analyzing of coding and non-coding rna contained in patients saliva. the study population consists of patients with definite or probable amyotrophic lateral sclerosis (als) according to the el escorial criteria ("als subjects" group) and subjects with no neurological history (control group). the control group will be made up of caregivers of patients with als, and caregivers of patients with a pathology other than als. the als patients concerned by the study already benefit from routine medical care in als expert centers in france. the patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the recommendations of the has, cngof.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age, * patient from one of the 2 study populations: * diagnosis of definite or probable als according to el escorial criteria ("patients als" group) ; * control group * patient able to carry out a mouth rinse, * patient affiliated to the healthcare system, * patient has dated and signed the consent form, exclusion criteria: * recent (\<1 month) or ongoing bacterial or viral infection, * known active oral or digestive mycosis, * evolving, symptomatic or obvious oral pathology, * known pregnancy, * patient participating in another clinical research study, * patient deprived of liberty by administrative or judicial decision or under guardianship ; * subject refusing to take a saliva sample; * for the control group: direct relationship (siblings, descendants, ascendants) with a patient included in the study; * for control group: medical history of neurological disease (excluding migraine).

Keywords: als rna saliva sample