Kornimate/medical-research-clean huggingface dataset:
a study to evaluate a quality improvement intervention to reduce wound separation rates in obese gynecologic oncology service patients undergoing abdominal surgery

Conditions: Wound Complications; Wound Infection; Wound Separation

Summary: approximately 500,000 surgical site infections occur annually in the us. these lead to worse patient quality of life, more outpatient and emergency room visits, readmissions and home services, with an estimated increase in costs of at least $3500 per complication. surgical site infections are associated with increasing body mass index. there is limited and conflicting data of the utility of multiple surgical interventions to decrease the risk of surgical site complications. the investigators explored the effect of a prospective care pathway for closure of vertical abdominal wounds on patient's wound complications.


Eligibility criteria:
inclusion criteria: women were eligible if they were between the ages of 18-89, with a bmi ≥ 30 kg/m2 undergoing a gynecologic procedure via a vertical abdominal incision. - exclusion criteria: planned laparoscopic surgery, planned panniculectomy or other plastic surgery procedure at the time of laparotomy, prior history of hernia repair with mesh or planned mesh hernia repair at the current procedure, enterotomy or intestinal surgery, a history of prior radiation to the abdomen or pelvis, concurrent pregnancy, current incarceration, or inability to provide informed consent, including inability to understand spoken english.

Keywords: wound complications wound infection wound separation
floatation-rest and anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the study proposed in this protocol aims to document the effect of floatation-rest (reduced environmental stimulation therapy) on symptoms of anorexia nervosa.

flotation-rest (reduced environmental stimulation therapy) alters the balance of sensory input by systematically attenuating signals from the visual, auditory, thermal, tactile, vestibular, and proprioceptive systems. previous research has shown that this heightens interoceptive awareness and reduces anxiety in clinically anxious populations. anorexia nervosa (an) is characterized by elevated anxiety, distorted body image, and disrupted interoception, raising the question of whether floatation therapy might positively impact these symptoms. a recent safety study found that floatation-rest was well tolerated by individuals weight-restored outpatients with current or prior an. additionally, participants reported improvements in affective state and body image disturbance following floating, raising the possibility that this intervention might be investigated for clinical benefit in more acutely ill cases. the primary aim of this study is to begin to examine the effect of floatation-rest on body image disturbance in inpatients with an. secondary aims including determining whether floatation-rest has an impact on anxiety, emotional distress, eating disorder severity, functional ability, and interoception.

Eligibility criteria:
inclusion criteria: * primary clinical diagnosis of anorexia nervosa * receiving inpatient treatment for eating disorder * body mass index greater than or equal to 16 * no new medication prescription in the week prior to study randomization * independently ambulatory * no current evidence of orthostatic hypotension * ability to lay flat comfortably * possession of a smartphone with data plan * english proficiency exclusion criteria: * active suicidal ideation * active cutting or skin lacerating behaviors * orthostatic hypotension (defined as a drop of ≥ 20 mm hg in systolic bp or a drop of ≥ 10 mm hg in diastolic bp when measured shortly after transitioning from lying down to standing) * comorbid schizophrenia spectrum or other psychotic disorder

Keywords: anorexia nervosa floatation therapy
diaphragm structure and function in childhood cancer survivors

Conditions: Childhood Cancer; Cancer Survivors

Summary: the purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in childhood cancer survivors.

during the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. the participants will then perform a training program for the breathing muscles at home for 6 weeks. the research team will follow up each week via telehealth visits to support training. after the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Eligibility criteria:
inclusion criteria: * completed medical treatment (chemotherapy, chemotherapy/surgery, chemotherapy/radiation or any combination of cancer treatment) for any type of cancer, except for cancer of the central nervous system, at least 1 year ago exclusion criteria: * history of neuromuscular, cardiac, or pulmonary disease prior to the diagnosis of cancer * recent injury or condition (less than 6 months ago) that precludes strength testing or walking * dyspnea with minimal activity (4 on the modified medical research council dyspnea scale)

Keywords: inspiratory muscle training diaphragm control of breathing muscle dysfunction dyspnea
validation study for an unobtrusive online sleep measurement system

Conditions: Apnea; Restless Legs Syndrome; Sleep Fragmentation

Summary: the purpose of the study is to determine the precision of an unobtrusive sleep measurement system. the system measures a force sensor signal under the mattress and analyzes sleep quality. the system measures: time in bed, sleep stages, sleep fragmentation, heart rate, respiration rate, sleep related breathing disorders, and limb movements.


Eligibility criteria:
inclusion criteria: * age 18-80 * finnish-speaking
a multi-center study to evaluate the efficacy and safety of pep005 (ingenol mebutate) gel, when used to treat actinic keratoses on the head (face or scalp)

Conditions: Actinic Keratosis

Summary: this phase iii study is designed to assess the efficacy and safety of pep005 gel, 0.015% when applied to an area of skin containing 4-8 ak lesions on the face or scalp.


Eligibility criteria:
inclusion criteria: * patient is male or female and at least 18 years of age * female patients must be of either: * non-childbearing potential, post-menopausal * childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy exclusion criteria: * cosmetic or therapeutic procedures within 2 weeks and 2cm of the selected treatment area * treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks * treatment with 5-fu, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area

Keywords: peplin actinic keratosis pep005
effect of epinephrine on post-polypectomy pain

Conditions: Colonic Polyp

Summary: epinephrine is widely used in endoscopic mucosal resection of large polyps to prevent post-polypectomy bleeding. no previous studies looked at increase in immediate post-polypectomy pain with the use of epinephrine.


Eligibility criteria:
inclusion criteria 1. patients aged 18 years and over 2. patients scheduled for treatment of large (≥ 20 mm) colorectal polyps 3. able to sign informed consent exclusion criteria 1. patients previously enrolled in the study 2. pedunculated polyps 3. polyps not amenable to endoscopic resection 4. patients allergic or sensitive to epinephrine 5. patients with coronary artery disease who have had a myocardial infarction in the past year, or had coronary stenting in the past year, or had angina in the past year. 6. patients electing anesthesia other than monitored anesthesia care with propofol (mac) for colonoscopy
linksymphoknee (lsk) total knee replacement system study - ultra-congruent (uc)

Conditions: Osteoarthritis (OA) of the Knee; Fracture; Rheumatoid Arthritis

Summary: to collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the linksymphoknee total knee replacement system with ultra-congruent tibial bearing surface.

the study will collect outcomes data on up to 600 patients from up to 3 sites using a legally marketed device according to its labeled intended use. the study will collect: 1. koos-jr 2. knee society score (kss), 2011 3. promis global health 4. promis physical function 5. promis pain interference 6. surgery satisfaction 7. forgotten joint score 8. radiographic findings 9. revisions. radiographic evaluations will be done through postoperative year 2. other outcomes will be evaluated up to postoperative year 5.

Eligibility criteria:
inclusion criteria: * 18 years or older, and skeletally mature; and * undergoing a primary tka for one or both knees using the cemented linksymphoknee knee system as part of the surgeon's standard of care. * able to read and understand english (because patient-reported outcome questionnaires are not validated for all potential other languages). exclusion criteria: * 80 years of age or older, * women who are pregnant at the time of surgery, * history of joint sepsis, * bone defect that requires grafting, * previous history of bone disease (e.g., severe osteoporosis or osteomalacia) which in the surgeon's opinion is severe enough to compromise device fixation, * systemic conditions affecting bone density (e.g., inflammatory arthritis or renal disease) which in the surgeon's opinion are severe enough to compromise device fixation, * a poorly functioning contralateral total knee replacement or a contralateral revision regardless of function.

Keywords: primary total knee arthroplasty
a simple cognitive task to reduce the build-up of flashbacks after a road traffic accident

Conditions: Post-traumatic Stress Disorders

Summary: this research study is designed to investigate the effects of a simple cognitive task (a memory reactivation cue following by playing the computer game "tetris") on flashbacks and other post-traumatic stress symptoms after a road traffic accident. patients presenting to a hospital emergency department soon after a road traffic accident will be randomly allocated to either the simple cognitive task intervention or usual care. participants will be followed up at one week and one month. it is predicted that participants given the simple cognitive task intervention will develop fewer flashbacks and less severe clinical symptoms than those who are not. this will inform the potential future development of a simple technique to prevent distressing psychological symptoms after a traumatic event.


Eligibility criteria:
inclusion criteria: * aged 18 or over * experienced or witnessed a road traffic accident (as a driver, passenger, motorcyclist, cyclist or pedestrian) * met the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criterion a1 for post-traumatic stress disorder (ptsd) ("experienced, witnessed, or confronted with actual or threatened death or serious injury) * can be seen in the emergency department within 6 hours of leaving the scene of the accident * report memory of the accident * fluent in written and spoken english * alert and orientated, glasgow coma scale score (gcs) = 15 * have sufficient physical mobility to play a computer game on the intervention platform (a nintendo ds) at the point of taking informed consent * willing and able to provide informed consent and complete study procedures * willing and able to be contacted following discharge to complete follow-up assessments exclusion criteria: * loss of consciousness of \> 5 minutes * current intoxication * report a history of severe mental illness * current substance abuse or neurological condition * currently suicidal
electrical muscle stimulation effect versus myofascial release on quality of life in female fibromyalgia

Conditions: Electric Stimulation; Myofascial Release; Fibromyalgia

Summary: the study was done to investigate the effect of electrical muscle stimulation as muscle strengthening versus the effect of myofascial releasing on quality of life in female fibromyalgia patients while following mediterranean diet.

fibromyalgia is a chronic pain condition characterized by unrefreshing sleep, physical exhaustion, and cognitive difficulties. it affects all populations worldwide and requires a diagnosis of widespread pain for at least three months. people with fibromyalgia show abnormal endogenous pain modulation, including reduced conditioned pain modulation and exercise-induced hypoalgesia. exercise is considered a first-line treatment for fibromyalgia. electrical myostimulation has been shown to improve pain, sleep subscales, and quality of life. a potential causal link between fibromyalgia and micronutrient deficiency has been suggested. the study focuses on fibromyalgia, which affects mostly females and is difficult to diagnose easily. electrical myostimulation and myofascial release are effective treatments for fibromyalgia.

Eligibility criteria:
inclusion criteria: 1. sixty females have diagnosed suffering from fibromyalgia syndrome. 2. their ages will be ranged from 45 to 55 years old. 3. their body mass index will be ranged from 25 to 34 ( overweight and obese type 1) 4. they have willingness to participate in this study. exclusion criteria: 1. peripheral vascular diseases. 2. drug abuse. 3. smokers. 4. chest disease. ( either obstructive or restrictive ). 5. clinical signs of sever cardiac events ( eg. congestive heart disease).
efficacy and safety study of simeprevir in combination with sofosbuvir in participants with genotype 1 chronic hepatitis c virus infection and cirrhosis

Conditions: Hepatitis C Virus Infection

Summary: the purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis c virus (hcv) genotype 1 infected men and women with cirrhosis who are hcv treatment-naïve or treatment-experienced.

this is a open-label (all people know the identity of the intervention), single arm, multicenter study. the study will consist of a screening phase up to 4 weeks, open-label treatment phase of 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. approximately 100 participants will receive 150 mg simeprevir in combination with 400 mg sofosbuvir once dailyfor 12 weeks. safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. the maximum study duration for each participant will be approximately 40 weeks.

Eligibility criteria:
inclusion criteria: * hepatitis c virus (hcv) genotype 1 infection (confirmed at screening). * hcv ribonucleic acid (rna) greater than 10,000 iu/ml at screening * treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin * participants must have an hepatic imaging procedure (ultrasound, computerized tomography scan or magnetic resonance imaging scan) within 6 months prior to the screening visit (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma * participant must be willing and able to comply with the protocol requirements * participants with liver cirrhosis exclusion criteria: * evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy) * infection/co-infection with hcv non-genotype 1 * co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening) * co-infection with hepatitis b virus (hepatitis b-surface-antigen positive) * previously been treated with any direct acting anti-hcv agent (approved or investigational) for chronic hcv infection

Keywords: hepatitis c virus infection simeprevir sofosbuvir hcv cirrhosis
efficacy of symbicort versus its monocomponents - spruce 80/4.5

Conditions: Asthma

Summary: the purpose of this study is to compare symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults


Eligibility criteria:
inclusion criteria: * at least 6 years of age * diagnosis of asthma * baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol exclusion criteria: * severe asthma * has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers * had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Keywords: asthma symbicort budesonide/formoterol budesonide formoterol
scoliosis and quality of life of adolescents

Conditions: Scoliosis

Summary: around the scoliosis surgery, the pain (pre or post operative, physical, psychological, fantasy or real) is a major concern for adolescents and their families. she is also a key concern of caregivers, both its assessment and management is complex. this pain involved predominantly in the quality of life of these teenagers today who will become the adults of tomorrow. to date in france, no study aims to describe and evaluate the effect of a multidisciplinary approach and its impact on the quality of life of these young people made. the present study wish to prevent, anticipate and limit the short, medium and long-term morbidity. focus will be on pain and its management, on preparing for surgery, hospitalization, follow-up after surgery, rehabilitation until recovery. help teens reclaim their bodies after the changes caused by the intervention is a major issue. this study believe that support good quality, adapted to patient needs will limit operating and postoperative pain in the medium and long term. medical team developed special attention around the teenagers that are operated for scoliosis (teen groups and parent groups, interview before the operation and counseling, physiotherapy support ...). the present study would systematize data collections in order to have a comprehensive and accurate assessment of the care. the qualitative research will focus on the multidisciplinary care in an effort to evaluate the whole course of these teenagers, their experience and to identify efforts to put in place to optimize the current care.


Eligibility criteria:
inclusion criteria: * patients followed for idiopathic scoliosis with indication for surgery * patients monitored and operated at the children hospital of toulouse exclusion criteria: * opposition to the participation * spine deformations other than scoliosis * non idiopathic scoliosis

Keywords: teenagers multidisciplinary approach pain surgery
the efficacy and safety of batroxobin combined with anticoagulation in cerebral venous sinus thrombosis

Conditions: Cerebral Venous Sinus Thrombosis; Batroxobin

Summary: our previous clinical case observations showed that batroxobin combined with anticoagulation therapy can improve the sinus recanalization rate in patients with cvst, shorten the hospital stay, and increase the neurological score of patients. its main mechanism is to inhibit thrombosis after reducing fibrinogen, and to dissolve thrombus. to further explore the safety of batroxobin combined with anticoagulation therapy for cvst, an open-label, randomized controlled (1: 1), single-center, prospective study was used. further study on the safety and effectiveness of batroxobin combined with anticoagulation for cvst.


Eligibility criteria:
inclusion criteria: 1. cerebral venous thrombosis, confirmed by cerebral angiography (with intra-arterial contrast injection), magnetic resonance venography or computed tomographic venography. 2. severe form of cvst with a high chance of incomplete recovery, as defined by the presence of one or more of the following risk factors 1. intracerebral hemorrhagic lesion due to cvst 2. mental status disorder 3. coma (glasgow coma scale \< 9) 4. thrombosis of the deep cerebral venous system 3. uncertainty by the treating physician if et or standard heparin therapy is the optimal therapy for the patient. exclusion criteria: 1. conditions associated with increased risk of bleeding 2. any thrombolytic therapy within last 7 days 3. cerebellar venous thrombosis with 4th ventricle compression and hydrocephalus, which requires surgery 4. contraindication for anti-coagulant or batroxobin treatment 1)documented generalized bleeding disorder 2)concurrent thrombocytopenia (\ 120 mm hg) 6)known recent (\< 3 months) gastrointestinal tract hemorrhage (not including hemorrhage from rectal hemorrhoids) 5. any known associated condition (such as terminal cancer) with a poor short term (1 year) prognosis independent of cvst 6. clinical and radiological signs of impending transtentorial herniation due to large space-occupying lesions (e.g. large cerebral venous infarcts or hemorrhages) 7. recent (\< 2 weeks) major surgical procedure (does not include lumbar puncture) or severe cranial trauma 8. previously legally incompetent prior to cvst 9. severe renal impairment 10. active liver disease 11. pregnancy, nursing or planning to become pregnant while in the trial 12. further exclusion criteria apply 13. no informed consent.

Keywords: cerebral venous sinus thrombosis
depth of anesthesia in cardiac surgery

Conditions: Heart Valve Diseases

Summary: the aim of our study was to evaluate the significance of monitoring anesthetic depth for the conduct of anesthesia and the early postoperative period in patients subjected to surgical correction of combined valvular disorders.

our aim was to evaluate the effect of monitoring anesthetic depth on duration of postoperative mechanical ventilation and icu stay after surgical correction of combined valvular disorders.

Eligibility criteria:
inclusion criteria: * requirement of surgical correction of two or more valves exclusion criteria: * no

Keywords: depth of anesthesia valve surgery