Kornimate/medical-research-clean huggingface dataset:
comparison of harmonic scalpel to conventional diathermy in perforator flap elevation for head and neck reconstruction

Conditions: Cancer

Summary: this study is to compare the efficacy of harmonic scalpel with conventional diathermy technique in terms of reducing elevation time and perioperative complications of perforator flaps for head and neck reconstruction.


Eligibility criteria:
inclusion criteria: * head and neck reconstruction with perforator flap * informed consent from the patient exclusion criteria: * coagulation problem * refused to participate

Keywords: cancer reconstruction free flap surgery
role of cerebral oximetry in reducing postoperative morbidity following cardiac surgery

Conditions: Postoperative Complications

Summary: cerebral oximetry employing near-infrared spectroscopy (nirs) is a non-invasive modality used to estimate regional cerebral oxygen content saturation (rso2). near-infrared spectroscopy has increasingly been used in perioperative setting of heart surgery and many studies have outlined an increased incidence of postoperative morbidity in patients with significant perioperative reductions in rso2. although a relationship between rso2 reductions and adverse outcomes has been reported, there is not compelling evidence that interventions to correct rso2 during cardiac surgery lead to improved clinical outcomes. hypothesis of the study is that interventions to normalize intraoperatively decreased cerebral rso2 would reduce the overall incidence of postoperative complications in high-risk cardiac surgery patients.


Eligibility criteria:
inclusion criteria: high-risk cardiac surgery patients as determined by at least one of the followings: * the age greater than or equal to 75 years on the day of screening; * left ventricle ejection fraction less than 35%; * use of a preoperative intraaortic balloon pump; * combined valve and coronary artery surgery or multiple valve surgery in patients who have congestive heart failure, or renal insufficiency (creatinine clearance \< 60 ml/min) exclusion criteria: * refusal of consent

Keywords: cerebral near-infrared spectroscopy monitoring postoperative complications cardiac surgery
noninvasive ventilation bundle in postoperative respiratory failure

Conditions: Respiratory Insufficiency

Summary: the investigators assessed the efficacy and safety of this noninvasive ventilation (niv) bundle strategy compared with a conventional treatment in postoperative patients with arf.

this is a randomized, prospective, open-label study. postoperative patients with arf included in the study were randomly assigned to intervention group or conventional treatment group. in the intervention group, niv was early used for treatment of postoperative respiratory failure, if patients were inability to spontaneously clear airways from excessive secretions during niv, fiberoptic bronchoscopy (fbo) was used for suction of secretions , if patients showed intolerance or inadequate patient cooperation during the niv session, they were sedated (ramsay scale 2-3) by a continuous perfusion of propofol during the niv session. patients assigned to the control group received supplemental oxygen, respiratory therapists delivered this intervention using conventional masks or venturi oxygen, and adjusted fio2 to achieve arterial o2 saturation of more than 92%. the application of noninvasive ventilation was considered, if patients failed the supplemental oxygen and met at least two of the following criteria:(1) severe respiratory distress with dyspnoea, respiratory rate\>30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing, or intercostal indrawing), (2) respiratory acidosis (arterial ph of 7.35 or less with paco2 of 45 mm hg or more) ;(3) arterial o2 saturation by pulse oximetry less than 90% or pao2 less than 60 mm hg at an fio2\> 0.5 or breathing at least 10 l/min oxygen. all the patients were continuous monitored of vital signs.whereas arterial blood gases were analyzed before niv and 1h after niv, before and after fbo, and once a day and in the case of any change either in the ventilatory settings or in the fio2; duration of noninvasive ventilation, the rate and cause of endotracheal intubation, icu and hospital mortality and length of stay in the icu and in hospital, study procedure related complications.

Eligibility criteria:
inclusion criteria: * postoperative patients with acute respiratory failure (arf) were included in the study,who had to meet one of the following criteria * respiratory acidosis (arterial ph of 7.35 or less with paco2 of 45 mm hg or more) * partial pressure of arterial oxygen (pao2)/fraction of inspired oxygen (fio2) ratio less than 250 * dyspnoea with respiratory rate \> 25 breaths/min or use of accessory respiratory muscles or paradoxical abdominal breathing exclusion criteria: * cardiac or respiratory arrest; loss of consciousness * facial trauma or surgery or deformity sufficient to preclude mask fitting * active upper gastrointestinal bleeding * haemodynamic instability or unstable cardiac arrhythmia * multiple organ failure
self-management and glycemic control in adult haitian immigrants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Patient Engagement; Patient Education

Summary: the objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult haitian immigrants.

this is a two-arm randomized trial. participants will be randomized to the culturally tailored diabetes self-management education program or standard care condition in a 1:1 allocation. all participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. the culturally tailored diabetes education program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (tbd) by aim 1 (e.g., in-person, video/telephone conference call).

Eligibility criteria:
inclusion criteria: * self-described haitian immigrant aged 21 and older * known diagnosis of type 2 diabetes for at least one year * have lived in the us for at least one year * have an hba1c of 7.5% * willing and able to participate in an individual interview exclusion criteria: * having a diagnosis of type 1 diabetes * unable to comprehend, consent and or fully participate in the study

Keywords: immigrant health diabetes mellitus, type 2 metabolic diseases self-management behaviors haitian americans
decompressive cervical surgery and hypertension

Conditions: Myelopathy, Compressive; Hypertension

Summary: there is a relationship between csm and hypertension, probably a cause/effect relationship, and investigators term this type of hypertension "cervicogenic hypertension". abnormally functioning serotonergic pacemaker cells in the dorsal raphe nucleus inappropriately activate and inhibit parts of the central and autonomic nervous systems as part of a chronic stress response, which causes hypertension and migraine. this theory is now being expanded to encompass both csm and essential hypertension, the idea being that these two conditions are intimately related.

cervical spondylotic myelopathy (csm) and hypertension are both very common diseases in the general population.investigators have also observed previously hypertensive patients with csm become normotensive following decompressive cervical surgery and no longer need antihypertensive medications. both observations are difficult to explain according to current theories of the two diseases.

Eligibility criteria:
inclusion criteria: * established diagnosis of cervical spondylosis myelopathy * be at least 18 years of age * office-measured systolic bp≧140mmhg * ability to adhere to study protocol * have signed an approved informed consent form for participation in this study exclusion criteria: * have hypertension secondary to a treatable cause * have prior cervical spine surgery * are pregnant or contemplating pregnancy during the 3-month follow-up period * people deny to join the study * are unable to comply with protocol requirements * are unlikely to survive the protocol follow-up period * are enrolled in another concurrent clinical trial * visual analogue scale≥4
a study to compare pk, pd and safety of the ad-213-a and ad-2131

Conditions: Gastroesophagus Reflux Disease

Summary: a study to compare safety, pharmacokinetics and pharmacodynamics of ad-213-a to ad-2131 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy adults over 19 years of age. * weight is more than 50kg and bmi is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2. * subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials. * subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing. exclusion criteria: * a subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug. * as a result of laboratory tests, the following figures: alt or ast or total bilirubin \> 1.5 times upper limit of normal range. * as a result of laboratory tests, the following figures: creatinine clearance \< 80ml/min. * subjects who judged ineligible by the investigator.
a study on assessment of stelara and tumor necrosis factor alpha inhibitor therapies in participants with psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with stelara or tumor necrosis factor alpha inhibitor (tnfi) therapies in relation to effectiveness, safety, benefit/risk and to examine clinical response.

this is a prospective, observational, cohort study to collect data on adult participants who have a confirmed diagnosis of psoriatic arthritis (psa) and are starting either stelara or a new tnfi as a new therapy in a first, second, or third line of biologic disease-modifying antirheumatic drug (bdmard) therapy. approximately 1,400 participants will be enrolled into this study, with 700 participants who are receiving stelara at study entry and 700 participants who are receiving a new tnfi therapy at study entry. recruitment into the study will continue for approximately 2 years (with the possibility to extend this period if the patient enrollment target is not reached), with a 3-year follow-up period. for each participant, the follow-up period will continue for 3 years (36 months) after inclusion into the study. participants will primarily be assessed for parameters of treatment retention, clinical response, effectiveness and safety over an observational period of 36 months.

Eligibility criteria:
inclusion criteria: * must have a confirmed diagnosis of psoriatic arthritis (psa) as determined by a rheumatologist according to classification criteria for psoriatic arthritis (caspar) criteria * must be starting either stelara or any new approved tumor necrosis factor alpha inhibitor (tnfi) (including tnfi biosimilar) as a new biologic disease-modifying antirheumatic drug (bdmard) therapy in a first, second or third line of bdmard therapy for psa at the time of enrollment into the observational study or within a maximum 2-month window after the baseline visit * must sign a participation agreement/informed consent form (icf) allowing data collection and source data verification in accordance with local requirements exclusion criteria: * participant is starting stelara or a tnfi therapy as fourth or further line of biologic treatment * participant is unwilling or unable to participate in long-term data collection * participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point * participant is currently enrolled in an interventional study

Keywords: stelara psoriatic arthritis ustekinumab
interoception and sense of movement in the patient with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: to evaluate the effectiveness of an experimental rehabilitative protocol with specific tasks for the improvement of body awareness and the motor scheme in the patient with multiple sclerosis (edss \<2.5). primary outcome: improvement of the interoception (awareness of the body) and of the related motor capacity secondary outcomes: improvement of balance and postural self-correction control

multiple sclerosis (ms) is a chronically progressive, disabling, autoimmune disease that affects the central nervous system causing a wide spectrum of sensory, motor, and neuropsychiatric signs and symptoms. in the great part of patients with ms, there is a cognitive deficit that can start already in the early stages of the disease. disability related to the disease is usually investigated through the expanded disability status scale (edss), however, the scale does not evaluate some very disabling aspects of the disease such as diplopia, fatigue and the impact of cognitive disorders. the posture and postural self-correction are dependent on the image that anyone have of his own body and on the perception of it in the space, both internal and external. in multiple sclerosis proprioception and interoception are often altered due to motor and cognitive impairment. the investigators propose a rehabilitative protocol that combine postural rehabilitation with specific visual-spatial tasks, relaxation sessions with self-awareness improvement and cognitive rehabilitation.

Eligibility criteria:
inclusion criteria: * bmi\<30 * diagnosis of multiple sclerosis for less than 10 years * course of relapsing remitting type * relapse-free for at least 30 days * edss score \<2,5 * fda-approved disease-modifying therapy for at least 6 months * mmse\>24 * public health guidelines for participating in physical activity exclusion criteria: * other concurrent neurological and psychiatric diseases (like schizophrenia, bipolar disorder i or ii and substance abuse disorders) * oncological diseases * cardiovascular disease, pacemaker carrier * diabetes * rheumatological diseases * scoliosis \>20° cobb * previous surgery on the spine * pregnancy * other physiotherapy in progress

Keywords: interoception sense of movement posture body scheme
a phase ii study of single-agent lenalidomide in subjects with relapsed or refractory t-cell non-hodgkin's lymphoma

Conditions: T-cell Non-Hodgkin's Lymphoma

Summary: this is a phase ii, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory t-cell lymphoma. this study will be conducted in two phases: a treatment phase and a follow-up phase. subjects who qualify for enrollment into the study will enter the treatment phase and receive single-agent lenalidomide 25 mg once daily on days 1-21 every 28 days (28-day cycles). subjects may continue participation in the treatment phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop. all subjects who discontinue the treatment phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the follow-up phase. objectives: primary: • to determine the efficacy of lenalidomide monotherapy in relapsed or refractory t-cell non-hodgkin's lymphoma (nhl). efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival. secondary: • to evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory t-cell nhl.

study was terminated. study data assessment revealed that study drug is active, but is not likely to be sufficiently active as a single agent in this population for registration purposes.

Eligibility criteria:
inclusion criteria: * must understand and voluntarily sign an informed consent form. * must be ≥ 18 years of age at the time of signing the informed consent form. * must be able to adhere to the study visit schedule and other protocol requirements. * biopsy-proven t-cell non-hodgkin's lymphoma, either: * peripheral t-cell lymphoma (ptcl) whatever the subtype, or * cutaneous t-cell lymphoma (ctcl), but only the subtype mycosis fungoides. * relapsed or refractory to previous therapy for t-cell non-hodgkin's lymphoma. * must have received at least one prior combination chemotherapy regimen. there is no limit on the number of prior therapies. exclusion criteria: * cutaneous t-cell lymphoma of subtype sézary syndrome.

Keywords: nhl, non-hodgkin's lymphoma, t-cell lymphoma
physical activity and bariatric surgery

Conditions: Bariatric Surgery Candidate

Summary: bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (wolfe et al., 2016) and improves functional physical abilities (herring et al., 2016). because these benefits are related to decreased energy intake, the investigators aim to optimize them by combining them with supervised adapted physical activity practice. so, the aim of this clinical trial is to measure the effects of a physical training program on physical fitness, body composition and quality of life of obese women who have undergone bariatric surgery.

upon hospitalization for their bariatric surgery (bypass or sleeve), subjects will sign their informed consent and be included in the study. six weeks' post-surgery, the subjects will be randomized in one of the 2 groups (control group cg or adapted physical activity group apag). patients in both groups will have 3 postoperative visits one at 6 weeks (v1), one at 18 weeks (v2) and one at 30 weeks (v3). during these visits, they will undergo the same assessments (body composition, physical condition, quality of life). patients in the cg will receive standard hospital management. patients in apag will follow the same management and will also follow a 3-month physical activity program 3 times a week between v1 and v2. then, between v2 and v3, no apa program will be offered to both groups. the subjects will evaluate during each visit v1, v2 and v3: * body composition, * physical condition, * quality of life * daily physical activity

Eligibility criteria:
inclusion criteria: * women between 18 and 55 years old * undergoing bariatric surgery (a "bypass gastric" or a "sleeve") * not practicing a supervised physical activity * having read and signed an informed consent prior to the start of the trial * being affiliated to a social security system exclusion criteria: * women with a contraindication to physical activity * any medical contraindication to the practice of stress tests. * unable to go to the hospital regularly * having a significant functional limitation that does not allow her to perform the 6-minute walk test * with an intellectual disability and/or psychiatric illness * does not speak and/or understand french * pregnant woman * under guardianship or curatorship * participating in another clinical research

Keywords: physical activity bariatric surgery physical fitness quality of life body composition
ultrasound guided ganglion impar block

Conditions: Coccydynia; Chronic Pain

Summary: the aim of this study is to evaluate feasibility, reliability and short term effectiveness of ganglion impar block with ultrasound in patients with chronic coccygodinia.

ganglion impar blocks have long been used for coccydynia, either with a landmark-based technique or fluoroscopic guidance. with the growing use of ultrasound, ultrasound-guided ganglion impar block has become a viable alternative. despite its frequent use in clinical practice, ultrasound has limitations in visualizing structures behind the bone, while fluoroscopy remains the gold standard. further research is needed to evaluate its feasibility, safety, and efficacy. this study primarily aims to assess the feasibility and safety of ultrasound-guided ganglion impar block in coccydynia. additionally, it will examine its short-term (1-month) efficacy.

Eligibility criteria:
inclusion criteria: * age between 18-65 years. * coccydynia persisting for at least three months. * being scheduled for a ganglion impar block in the pain medicine outpatient clinic. * having inadequate response to medical and conservative treatments. * aggreeing to undergo the interventional procedure and participate in the study. exclusion criteria: * local infection at the injection site. * bleeding disorders or diseases and drugs that may cause bleeding diatesis (e.g. renal failure, liver failure, anticoagulant treatments) * history of allergic reaction to the medications to be used. * pregnancy

Keywords: coccydynia pain ultrasound guided injection ganglion impar
effect of semet (80 and 160 mcg) versus placebo in euthyroid patients with ait

Conditions: Thyroiditis Autoimmune

Summary: over the past 10 years, several clinical studies have suggested that selenium supplementation may influence the natural history of ait. recently, interferon gamma (ifnγ)-inducible chemokines (cxcl-9, -10 and -11) were shown to be elevated in the ait patients. the aim of this prospective, randomized, controlled study is to evaluate the effect of two different doses of selenomethionine (80 or 160 mcg) versus placebo in euthyroid women with ait, in terms of reduction of anti-thyroid antibodies and improvement of thyroid hypoechogenicity, over 24 months. serum levels of selenium, cxcl-9, -10 and -11 and their regulators, tumor necrosis factor alpha (tnfα) and infγ, thyroid function and volume and the quality of life of ait patients are also evaluated.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic autoimmune thyroiditis defined by positivity of anti thyroperoxidase and/or anti thyroglobulin antibodies (\> or = 100 u/l) and thyroid hypoechogenicity exclusion criteria: * presence of other thyroid disease but micronodules * history of the malignancy in the past 5 years * drugs affecting immune system and/or thyroid function * pregnancy detected during screening or follow-up.
quality in patients with permanent hypoparathyroidism after total thyroidectomy

Conditions: Permanent Hypoparathyroidism

Summary: quality of life study. the study with include all patients operated with total thyroidectomy between 2005-2015 in uppsala-örebro healthcare region, sweden. the study population has been identified in a previous study and includes close to 1700 patients, of which about 200 developed permanent hypoparathyroidism after surgery. quality of life will be assessed using sf-36 health surgery and the outcome for patients with and without permanent hypoparathyroidism will be compared.


Eligibility criteria:
inclusion criteria: * total thyroidectomy between 2005-2015 in uppsala-orebro healthcare region. exclusion criteria: * malignancy * sternotomy * previous thyroid surgery * previous or concurrent parathyroidectomy