Kornimate/medical-research-clean huggingface dataset:
single site versus multi site robotic hysterectomy

Conditions: Rehabilitation; Pain, Postoperative; Wound Infection

Summary: robotic single site surgery (r-ssh) is a novel technique, which may be superior to multi site hysterectomy (r-msh) in select patients regarding cosmesis and postoperative pain. a randomized trial is performed to compare r-ssh with r-msh with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.

the study is scheduled to start november 2018 and compares robotic single site to multi site hysterectomy. procedures are performed on two locations, herning and herlev hospitals, by experienced surgeons. patients are randomized to either r-ssh (no.=62) or r-msh (no.=62). patient's satisfaction with body image and cosmesis is assessed at different time points pre- and postoperatively by means of validated cosmesis scales and body image questionnaire and photo-evaluations. postoperative pain and split times spent at the operation theatre will be registered as secondary outcome parameters. a follow-up at 1, 3 and 6 month include evaluation of the scar and registration of port-site hernias and vaginal dehiscence or other complications. interviews and diaries will include time of return to home and work, daily activities including sexuality the r-ssh is performed using da vinci, xi robotic system. one single port, diameter 2 cm is applied. applying an additional assistant port is defined conversion of procedure r-msh is performed using standard equipment and 4 trocars, 5 mm each. sample size calculation was based a previous study on fast track hysterectomy, which showed a difference in return to work of 4 days. 62 women in each group is needed with standard deviation ±8 and a power of 80%. to include those not working, the calculation was performed with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group and suggested that the sample was sufficient to detect of difference of 0.1 in visual analog pain score with a power of 80%. all calculation are based on two-sided testing with alpha of 0.05.

Eligibility criteria:
inclusion criteria: * hysterectomy on benign indication, * american society of anesthetists group 1 or 2, * bmi less than 30 kg/m2 * uterine size less than 300 g estimated by ultrasound, using ferraris formula. exclusion criteria: * adhesions * prior extensive abdominal surgery * prior midline incision * cutis laxa of abdomen surgery * endometriosis * more than 1 cesarean section * malignant disease

Keywords: return-to-work cosmesis visual analogue pain score
efficacy and safety of zingiber officinale roscoe extract on body fat

Conditions: Obesity

Summary: this study was conducted to investigate the effects of daily supplementation of zingiber officinale roscoe extract on body fat.

this study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. forty subjects were randomly divided into zingiber officinale roscoe extract 200 mg or placebo group. the investigators measured body fat mass, percent body fat, fat free mass, weight, and body mass index.

Eligibility criteria:
inclusion criteria: * age between 19 and 65 years, * bmi 25\~29.9 kg/m2 * subjects giving written informed consent exclusion criteria: * significant variation in weight(more 10%) in the past 3 months * cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker * history of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery * participation in any other clinical trials within past 2 months * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * pregnancy or breast feeding etc,.
effectiveness of pain neuroscience education and strength training in fibromyalgia

Conditions: Fibromyalgia

Summary: the main goal of this study is to get to know if applying both, pain neuroscience education (pne) plus strength training (st) will reduce the pain of fibromyalgia (fm). both therapies have shown evidence of improvement in fibromyalgia patients. however, there are no studies evaluating their efficacy in combination.

at present, the increase in knowledge about the neuroscience of pain has led to the integration of psychological factors, such as cognitions and beliefs about pain, fear-avoidance behaviors or catastrophism within the integrative perception of the concept . this has led to the development of therapeutic strategies aimed at the reconceptualization of pain through a treatment method called pain neuroscience education (pne), having shown evidence in the treatment of pain, disability, catastrophism and physical performance. but despite current advances in pain neuroscience, there are still pain syndromes, such as fibromyalgia, that are the subject of debate and controversy. fibromyalgia is a syndrome that causes generalized musculoskeletal pain, fatigue, sleep disorders, and physical disability. it is the main cause of chronic generalized musculoskeletal pain, with a prevalence of 1-5% of the world population. scientific research has provided new insight for the diagnosis of fibromyalgia patients, who are characterized by a central sensitization process. objectives: to assess the effectiveness of pain neuroscience education and strength training to decrease pain and disability; and increasing quality of life and functionality in patients with fibromyalgia.

Eligibility criteria:
inclusion criteria: * women diagnosed with fibromyalgia. * duration of pain greater than one year. * generalized or present pain in more than two body regions. * not having participated in pain neuroscience education program. * not having participated in physical exercise programs in the last three months. exclusion criteria: * presence of other diseases not related to the musculoskeletal system. * being under medical treatment not related to pain. * being under physiotherapeutic treatment related to pain. * unavailability to carry out a physical exercise program. * pregnant or puerperium women. * inability to perform or complete the necessary tests to measure the study variables.

Keywords: fibromyalgia education strength training
sequential core stability corrective exercise approach in lower crossed syndrome

Conditions: Low Back Pain

Summary: the objective of the study will be to determine the effects of sequential core stability corrective exercise approach for alignment and muscle function in lower crossed syndrome.

lower crossed syndrome is one of common postural disorder which occurs due to the muscular imbalance. it refers to specific altered muscle activation and movement patterns along with some postural deviations. alterations in muscle activation include overactivity of hip flexors and lower back muscles paired underactivity of abdominals and gluteus muscle. this pattern of imbalance creates dysfunction. postural correction exercise with inner and outer core muscles are necessary. there are different traditional structural approach, functional approach and biomechanics and are presumed to lead to adjustments in the length and strength of local muscles while ignoring other related malalignments and core stability. the objective of the study will be to determine the effects of sequential core stability corrective exercise approach for alignment and muscle function in lower crossed syndrome. it will be a randomized controlled trial. sample size will be collected after running the pilot study. the participants will be recruited through convenient sampling technique and then allocated randomly to groups. outcome measures will be alignment and muscle function. pre and post reading and after one month follow-up will be recorded. data will be analyzed using statistical package for social sciences software version 25. after assessing normality of data by shapiro-wilk test, it will be decided either parametric or nonparametric test will be use within a group or between two groups. keywords: alignment, core stability, diaphragm, muscular imbalance, muscle thickness pelvic floor.

Eligibility criteria:
inclusion criteria: * • age group between 18 to 28 years * no current incidence of low back pain or past history of low back dysfunction * kendall double leg lowering test: abdominal muscle weakness to the extent of not being able to maintain posterior pelvic tilt during a double leg lowering test in supine position. * diagnosed with lower cross syndrome through assessment criteria of janda muscle testing and assessment exclusion criteria: * • having any history of low back pain, spinal trauma, * joint dysfunction in past 3 months * congenital deformities at hip or lumbar region, * recent fracture to related joints in past 6 months * any family history of cardiopulmonary disease * any disease or urogenital tract * participants having bmi above 30. * recent history of hepatitis or fatty liver or * any athlete having high physical activity. * history of abdominal, hip or lumbar surgeries in past 3 months

Keywords: alignment core stability diaphragm pelvic floor dysfunction
two different exercise training in frozen shoulder treatment

Conditions: Adhesive Capsulitis

Summary: the aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders.

after being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double-blind manner in a 1:1 (participant and investigator) to graded motor imagery or exercise group.

Eligibility criteria:
inclusion criteria: * patients aged \>60 years * patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear; * patients with ability to follow simple orders; iii) * patients with ability to sign to provide informed consent exclusion criteria: * normal passive rom * external rom \< 30 * to have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint * pain \< 3 according to the numbered pain assessment scale

Keywords: frozen shoulder exercise graded motor imagery
medico-economic comparison of four strategies of radioiodine ablation in thyroid carcinoma patients

Conditions: Thyroid Cancer

Summary: in france, 3,700 new cases of thyroid cancer are diagnosed each year. differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. this favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7gbq (100mci) in case of significant risk of persistent disease. few centers investigated the possibility to administer lower doses of 131i (1gbq, 30 mci), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff. radio-iodine ablation requires tsh stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. during this period, patients suffered from symptoms of hypothyroidism. the recombinant human tsh (rhtsh, thyrogen®, genzyme therapeutics, cambridge, usa) was approved in europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. it allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). however, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.

this is a multicentric, randomized, controlled, open-label phase iii clinical trial involving 26 french centers. it aims at comparing four strategies of management of postoperative radioiodine ablation, each strategy combining a method of tsh stimulation (thyroid hormone withdrawal or rhtsh (thyrogen®, genzyme)) and an activity of 131i (low-dose (1gbq, 30 mci) or high-dose (3,7gbq, 100 mci)).

Eligibility criteria:
inclusion criteria: * 18 year or older * newly diagnosed differentiated papillary or follicular thyroid carcinoma who underwent total thyroidectomy between 30 and 60 days before randomization and treated by lt4 for at least one month. * patients are all staged pt1\ 1cm n0 n1 nx or pt2 n0 * the performance status is 0 or 1. * all patients will provide written consent to participate. exclusion criteria : * partial thyroidectomy * patients treated by lt4 less than one month * time from thyroidectomy superior to 60 days at randomization * patients with hurtle cancer or aggressive histology * patients staged pt1\<1cm n0 or t2 n1 or t3 or t4 or m1 * patients for which the use of rhtsh is required for medical reasons * patients with major concurrent medical disorder (cardiac, renal, liver, respiratory) * patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission for at least 2 years) * patients with recent history of drugs affecting thyroid function, including iodine containing medications or radiocontrast agents * patients with recent history of 131i whole body scan * pregant women or breast-feeding
reporting of adverse events in patients treated with new oral anticoagulants

Conditions: Bleeding as Complication to Anticoagulation Therapy

Summary: serious adverse events in patients treated with new oral anticoagulants are underreported.

the study investigates if serious adverse events in patients treated with noac are reported to the health and medicines authority.

Eligibility criteria:
inclusion criteria: * patients admitted for gi bleeding while in treatment with noac exclusion criteria: * none

Keywords: bleeding anticoagulation
icbt for children with fapds - the child's pain regulation

Conditions: Functional Abdominal Pain Syndrome

Summary: functional abdominal pain disorders (fapds) in children are common (14%) and abdominal pain has increased rapidly in children during the last ten years in sweden. many children with fapds have low quality of life, missed school days, and about 30-40% suffer from psychiatric comorbidity. fapds are often sustained into adulthood and a large swedish cohort study showed that abdominal pain during childhood is an independent strong predictor anxiety and depression later in life. internet-cognitive behavioral therapy (internet-cbt) can improve fapd symptoms, but a significant number of children does not respond to the treatment. we will here determine the pain regulation in children with fapds, compared with healthy controls, and assess: what aspects of the child's pain regulation is related to improvement for children with fapds engaging in internet-cbt? does some aspects of the child's pain regulation change during treatment?


Eligibility criteria:
inclusion criteria: children 8-17 years with fapds: have been offered treatment at bup internetbehandling for fapds. children 8-17 years without fapds: not affected by recurrent (every week) or persistant pain during the last year. exclusion criteria: contraindication for mr (metal implant or metal object in body, claustrophobia, pregnancy)
aerobic exercise and neck exercises in pediatric migraine treatment

Conditions: Migraine in Children

Summary: this randomized controlled single-blind trial will include 60 pediatric migraine patients. participants will be divided into two groups: one performing aerobic exercise, and the other conducting neck exercises. assessments include attack frequency, severity, duration, and neck pain over three months.


Eligibility criteria:
inclusion criteria: - pediatric migraneurs, as per international classification of headache disorders-3 guidelines exclusion criteria: * individuals with any other concomitant headaches * those showing findings beyond nonspecific hyperintense areas on cranial magnetic resonance imaging * patients with systemic diseases other than migraine, such as fibromyalgia * individuals who had experienced treatment changes or required treatment changes within the last month * limited mental capacity or psychological illnesses that could hinder their participation in surveys and exercises * a history of increased attack frequency or severity with previous physical activity program involvement, or a history of trauma to the neck or face * individuals with a history of a herniated disc in the cervical region or symptoms of cervical radiculopathy
trial of sunitinib in advanced non-clear cell type renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma

Summary: to evaluate the efficacy and safety of sunitinib in non-clear cell type renal cell carcinoma with the exception of pure sarcomatoid carcinoma and collecting duct carcinoma

there have been no standard treatment in non-clear cell renal cell carcinoma. retrospective studies showed sunitinib or sorafenib might be active in non-clear cell renal cell carcinoma, especially papillary type and chromophobe type. this study is to evaluate efficacy and safety of sunitinib in this group of patients.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmation of renal cell carcinoma without a clear cell histologic component, e.g., papillary type, chromophobe type, or collecting duct type 2. patients with stage iv or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent. 3. measurable disease according to recist criteria 4. ecog performance status 1 or better 5. age 18 years or older 6. adequate cardiac function 7. adequate bone marrow, hepatic, and renal function 8. life expectancy of ≥ 3 months 9. singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment exclusion criteria: 1. clear cell type renal cell carcinoma or sarcomatoid carcinoma without any clue to the primary type 2. diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri 3. hypertension that cannot be controlled by medications (blood pressure \> 150/90 mmhg despite optimal medical therapy) 4. treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. low dose coumadin for dvt prophylaxis is permitted (up to 2 mg/day). 5. pregnancy or breast feeding. 6. other severe acute or chronic medical or psychiatric condition 7. prior treatment on sunitinib, sorafenib, or bevacizumab.
bariatric surgery and pharmacokinetics of hydrochlorothiazide

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on hydrochlorothiazide are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics hydrochlorothiazide
feasibility study of rapidpulsetm aspiration system as frontline approach for patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: a feasibility study to evaluate the initial safety and performance of the rapidpulsetm aspiration system in the treatment of patients with acute ischemic stroke (ais) due to large vessel occlusion (lvo) in the intracranial ica, m1, m2, basilar or vertebral arteries.

the purpose of this prospective, open label clinical trial is to assess the initial safety and performance of the rapidpulsetm aspiration system as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). the study will enroll up to a maximum of 50 subjects in 2 centers in georgia. subjects will undergo mechanical thrombectomy procedure and will have post-operative assessments completed at 24 hours and on day 5-7 or upon hospital discharge.

Eligibility criteria:
inclusion criteria: * age 18 years or older * clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours * large vessel occlusion (lvo) involving the intracranial internal carotid artery (ica), middle cerebral artery (mca) m1 or m2 segments, basilar or vertebral artery * target occlusion can be accessed by the medtronic react 71 aspiration catheter exclusion criteria: * known or suspected intracranial atherosclerotic disease (icad) * tandem occlusions

Keywords: stroke large vessel occlusion mechanical thrombectomy neurovascular intervention
daily magnesium-supplement for severe asthmatics

Conditions: Asthma

Summary: the present study is part of a project titled 'magnesium in asthma and chronic obstructive pulmonary disease'. the hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease. the aim of this part of the project is to reveal possible beneficial effects of daily magnesium supplement for severe asthmatics, refractory to conventional treatment.


Eligibility criteria:
inclusion criteria: * severe asthmatics, refractory to conventional treatment, including systemic steroid treatment; symptoms must be annual. exclusion criteria: * se-mg \> 2,00 mmol/l, * smoking cessation less than 1 year prior to study start, * major changes in eating habits within three months prior to study start and during the study period of approximately one year, * various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.

Keywords: steroid-resistant severe asthmatics annual symptoms daily magnesium supplement act (asthma control test)
effect of renal denervation on no-mediated sodium excretion and plasma levels of vasoactive hormones

Conditions: Essential Hypertension

Summary: catheter based renal denervation (crd) in humans represents a promising new treatment of resistant hypertension. crd is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in denmark (reset). in reset, patients are randomized to either crd or a sham procedure with 6 months follow up. the mechanisms by which crd reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (no) has not been investigated in humans. to study the interaction between no and renal sympathetic nerves, we designed the present substudy, where the effects of no-inhibition on renal, hemodynamic and hormonal variables are studied before and after crd.


Eligibility criteria:
inclusion criteria: * age 30-70 years * stable antihypertensive treatment for 1-month with at least 3 antihypertensive drugs including a diuretic * day-time ambulatory blood pressure \> 145/75 mmhg exclusion criteria: * non compliance * pregnancy/no-anticonception in fertile women * radiocontrast allergy * malignancy * congestive heart failure (ef \< 50) * egfr \< 45 * unstable angina pectoris * recent myocardial infarction or pci (\< 6 mdr) * secondary hypertension * renal artery stenosis or multiple renal arteries on ct * claudication

Keywords: essential hypertension nitric oxide renal denervation sodium gfr