Kornimate/medical-research-clean huggingface dataset:
transcutaneous spinal cord stimulation for parkinson disease

Conditions: Parkinson Disease; Gait, Rigid

Summary: spinal cord stimulation has been used to treat gait problems in parkinson's disease, with positive results along some studies. the use of non-invasive stimulation can be an alternative to stimulate the spinal corn.

spinal cord stimulation has been used to treat gait problems in parkinson's disease, with positive results along some studies. the use of non-invasive stimulation can be an alternative to stimulate the spinal corn. in this pilot trial, the investigators recruit participants with parkinson' disease and freezing of gait. the aim of the study is to explore the safety along the non-invasive magnetic thoracic spinal cord stimulation as well the effect on gait problems, especially freezing of gait, prospectively, in an open-label fashion.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced idiopathic parkinson's disease * significant freezing of gait despite optimized treatment with medications and rehabilitation program exclusion criteria: * psychiatric symptoms * dementia * cardiac pacemaker
trial evaluating the benefit of a fitness tracker based workout during adjuvant radiotherapy of breast cancer

Conditions: Breast Cancer

Summary: this randomized three-arm trial will test the benefit in terms of cancer related fatigue of an activity tracker based exercise training during adjuvant radiotherapy in breast cancer patients.

this monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in breast cancer patients on the fatigue syndrome during adjuvant radiotherapy. quality of life and the intensity of fatigue will be documented with the fatigue subscale of the facit questionnaire three months after adjuvant radiotherapy.

Eligibility criteria:
inclusion criteria: * capacity for consent * minimum age 18 * presence of breast cancer * ecog 0-2 * indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery or ablatio mammae exclusion criteria: * participation in any other interventional study * pregnancy * contraindication against physical activity/sport and others * severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy in the last 6 months, congestive heart failure nyha \> i°) * preexisting diseases with are relevantly accompanied by a limited mobility in patients (e.g. paraparesis of the lower limbs) * ecog status 3-4 * prior use of activity trackers

Keywords: fatigue activity tracker radiotherapy exercise
prospective evaluation of ct guided ablation of cardiac ganglionated plexi

Conditions: Atrial Fibrillation

Summary: despite progress made in treating atrial fibrillation with catheter ablation, outcomes remain suboptimal with pulmonary vein isolation alone. ablation of ganglionated plexi (gp) has been shown to be beneficial in patients with atrial fibrillation although optimal strategies of localization of these regions have yet to be determined. the investigators aim to develop a novel strategy of ct guided gp localization to guide ablation in patients with atrial fibrillation. the investigators also aim to clarify the network of innervation between gp to clarify the optimal ablation strategy. this is an observational, single-center study evaluating feasibility and efficacy of ct and high frequency stimulation (hfs) guided gp mapping and ablation in patients with af undergoing catheter ablation with pulmonary vein isolation. patients will undergo hfs and ct guided mapping of gps followed by allocation into one of 8 different gp ablation approaches in a non-randomized fashion.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 18 years 4. history of af with plan to undergo catheter ablation exclusion criteria: 1. contraindication or unwillingness to undergo ct imaging or catheter ablation. 2. pregnancy or lactation

Keywords: atrial fibrillation ganglionated plexus cardioneural ablation
tobacco cessation intervention study for oral diseases

Conditions: Smoking Cessation; Mouth Diseases; Periodontal Diseases; Leukoplakia; Lichen Planus; Keratosis; Implant

Summary: this study is to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial. tobacco cessation intervention is implemented for 12 weeks. during the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. improvement of each disease is evaluated between smoking cessation intervention group and non-cessation intervention group.

it has been concluded that available evidence suggests that behavioral interventions for tobacco cessation conducted by oral health professionals incorporating an oral examination component in the dental office or community setting may increase tobacco abstinence rates among both cigarette smokers and smokeless tobacco users (cochrane database syst rev.6:cd005084.) however, efficacy of tobacco cessation for oral diseases by oral health professionals are not elucidated. there are few studies on tobacco cessation intervention by dentists but none in terms of reduction of oral diseases or further disease prevention. association for the japanese academy of maxillofacial implants, association for the japanese society of oral and maxillofacial surgeons, association for the japanese society of oral implantology, japanese society of oral medicine, japanese society of periodontology, japanese academy of clinical periodontology, japanese society for oral health, japanese society of dentistry for medically compromised patient and japanese society of oral oncology conduct a study to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial.

Eligibility criteria:
criteria inclusion criteria: * current smokers with periodontitis; 30% or more of the teeth where periodontal pocket depth (ppd) is 4mm or more and 3 or more sites in 6mm or more of the ppd * current smokers in patients about to receive implant placement * current smokers with oral mucosal diseases clinically diagnosed for nicotine stomatitis, oral leukoplakia, erythroplakia and oral lichen planus exclusion criteria: * already having any cessation intervention * periodontitis with having anti-inflammatory drug or steroid use and have had periodontal treatment within 6 months * oral mucosal diseases having had surgical resections or other interventional treatments

Keywords: smoking cessation mouth diseases periodontal diseases leukoplakia keratosis implant lichen planus
surgery and convergence insufficiency intermittent exotropia

Conditions: Complications

Summary: this trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia.

surgery can give better results,

Eligibility criteria:
inclusion criteria:convergence insufficiency type intermittent exotropia * no stereopsis * good visual acuity exclusion criteria: * amblyopia * anisometropia \> 2.5d * vertical deviations
lymphedema in endometrial cancer

Conditions: Lower Extremity Lymphedema; Endometrial Cancer

Summary: objectives: (1) to determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo staging surgery. data analysis and risk/safety issues: the proposed study will consist of a convenience sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period. the investigators anticipate enrollment of 75 to 100 women. frequency tables and difference with its 95% exact confidence intervals between pre-and post-operative lower extremity lymphedema measurements and quality of life questionnaires will be estimated.


Eligibility criteria:
inclusion criteria: 1. women older than 18 years old, 2. endometrial cancer, 3. suitable candidates for surgery, 4. scheduled to undergo laparoscopy or robotic-assisted (ra) laparoscopy for endometrial cancer at duke university medical center (dumc), 5. no severe physical or mental comorbidity exclusion criteria: 1. metastatic disease, 2. laparotomy
surgical versus nonsurgical treatment for spinal stenosis

Conditions: Spinal Stenosis

Summary: lumbar spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) is a condition that occurs frequently, particularly in the elderly. this condition can lead to significant pain and limit a person's ability to function. moreover, doctors disagree about the best way to treat people with lumbar spinal stenosis. in this study we will compare surgical treatment of lumbar spinal stenosis with nonsurgical treatment using physical therapy. the results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.

lumbar spinal stenosis is a frequently encountered condition, particularly in the elderly, which can lead to significant pain and functional limitations. the prevalence of this condition is growing as the population continues to age. substantial controversy exists regarding the management of lumbar spinal stenosis. surgery has traditionally been the treatment of choice, although physicians typically recommend a trial of nonsurgical care prior to surgery. the most effective means of nonsurgical treatment has not been identified, although a "standard" regimen has been developed. there is presently no evidence in the literature regarding the relative effectiveness of surgical versus nonsurgical treatment of lumbar spinal stenosis, or the efficacy of the standard nonsurgical treatment approach. this randomized clinical trial will compare surgical decompression versus nonsurgical treatment (i.e., physical therapy) of lumbar spinal stenosis. the results of this study should help clarify which treatment strategies are the most effective for patients with lumbar spinal stenosis.

Eligibility criteria:
inclusion criteria: * imaging evidence of stenosis * unable to walk more than 1/4 of a mile * no prior surgery for stenosis * consents to surgery * speaks english exclusion criteria: * presence of dementia or organic brain syndrome * coronary artery disease, recent myocardial infarction, pulmonary or vascular disease * spondylolisthesis (\> 5 mm slippage) * severe osteoporosis * metastatic cancer

Keywords: human therapy evaluation orthopedics physical therapy nonsurgical treatment surgical decompression surgery lumbar spine disorder spinal stenosis gender difference medical rehabilitation
identification of specific modulation frequencies in hepatitis b carriers with and without hepatocellular carcinoma

Conditions: Hepatitis; Hepatocellular Carcinomas

Summary: the propose of this study is to identification of a group of specific amplitude-modulated frequencies of low intensity electromagnetic fields that is associated with biofeedback upon exposure to in patients with hepatitis b carries with or without hepatocellular carcinoma.

patients will be exposed by different specific amplitude-modulated frequencies of low intensity electromagnetic fields for 30 min. during the exposure, autonomic response with be recorded in order to identify biofeedback response. differences in group of frequencies is expected in patients with hepatitis b carries with or without hepatocellular carcinoma.

Eligibility criteria:
inclusion criteria: * hepatitis b carriers patients * hepatitis b carriers patients with hepatocellular cancer patients exclusion criteria: * other tumor types * other hepatitis types

Keywords: biofeedback response
anaesthetic management guided by comet measurements

Conditions: Mitochondrial Oxygenation Measurement; Surgical Site Infection

Summary: surgical site infection (ssi) is a significant cause of morbidity and mortality, prolonged hospital stays and healthcare costs. perioperative low tissue oxygen tension is associated with a high risk of ssi. standard anaesthetic management guided by continuous monitoring of oxygen delivery with a non-invasive method of measuring mitochondrial oxygenation tension (mitopo2) using the cellular oxygen metabolism (comet) monitor may benefit the intraoperative oxygenation on the tissue level. this randomised, controlled, single-centre, parallel-arm, patient-blinded trial aims to investigate if standard anaesthetic management guided by mitopo2 monitoring results in higher tissue oxygen tension including patients undergoing elective abdominal surgery. anaesthetists in the intervention group strive to a minimum mitopo2 of 66 mmhg. patients in the control group receive standard care. the primary outcome is the difference in means of the mean mitopo2 during surgery.


Eligibility criteria:
inclusion criteria: * patients are at least 18 years old * patients undergo elective open or laparoscopic abdominal surgery with an expected minimal total incision size of 5 cm * patients are able and willing to give written informed consent exclusion criteria: * known photodermatoses of varying pathology and frequency * mitochondrial disease * porphyria * skin lesions on the upper arm which impede measurements * hypersensitivity to the active substance or the 5-ala medicated plaster material * emergency surgery * reoperation for complications from recent surgery (within last three months) * participation in another study with interference with this study * pregnancy or breastfeeding

Keywords: mitochondria mitochondrial oxygenation tissue oxygenation microcirculation surgical site infection wound infection abdominal surgery
assessment of efficacy of cr8020 and cr6261, monoclonal antibodies, against influenza infection

Conditions: Influenza

Summary: the purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with influenza a infection

this is a randomized, placebo-controlled, double-blind phase iia proof-of-concept study, designed to evaluate the effect of cr8020, cr6261, or placebo in hospitalized patients with influenza a infection that are receiving standard of care. up to 262 participants will be randomized to receive 30 mg/kg of cr8020, 30 mg/kg of cr6261, or placebo. the study duration will be approximately 117 days for each participant. prior to enrollment, participants will be screened to assess their eligibility. eligible participants will be randomized to cr8020, cr6261, or placebo and study drug will be administered on day 1. participants will be followed up for 115 days in 9 visits on days 2 to 8, day 29, and day 116 (end of study). after hospital discharge, the remaining follow-up visits will be performed as outpatient visits.

Eligibility criteria:
inclusion criteria: participant requires hospitalization/ each participant or his or her legally acceptable representative must sign an informed consent form/ participant must be able to start the infusion within 36 hours from the time the screening specimen was collected/ a woman must either be not of childbearing potential or of childbearing potential and agrees to practice two forms of highly effective method of birth control/ a woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[beta hcg\]) at screening/ a man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control/ exclusion criteria: participant is a female who is pregnant or breastfeeding/ participant undergoing peritoneal dialysis, hemodialysis or hemofiltration/ participant has presence of any pre-existing illness that, in the opinion of the investigator, would place the participant at an unreasonably increased risk through participation in this study/ participant has prior treatment with an experimental mab; or receipt of igg within 3 months or on chronic mab treatment prior to enrollment/ participant has known or suspected hypersensitivity to any of the cr8020 or cr6261 excipients (sucrose, l-histidine l-histidine monohydrochloride, polysorbate 20)/ participant received an investigational product (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment, is currently enrolled in an interventional investigational study, or is an employee of the investigational site/

Keywords: influenza virus monoclonal antibody immunization treatment
balance control in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of this study is to investigate how sensory information processing affects balance ability in children with cerebral palsy (cp). an additional goal is to determine if a subsensory electrical stimulation called stochastic resonance (sr) stimulation, can improve balance in children with cp. children with cp and children with typical development will participate and complete a series of clinical and balance assessments. they will also be tested in a sensor fusion paradigm to investigate potential deficits in the dynamic integration of visual, vestibular and proprioceptive information during upright stance. sr stimulation will then be used to potentially improve these deficits and subsequently their balance ability.


Eligibility criteria:
inclusion criteria: * diagnosis of spastic diplegia cp (gmfcs i- iii)\* * ability to stand independently for approximately 2 min exclusion criteria: * lower extremity surgery or fractures in the year prior testing * joint instability or dislocation in the lower extremities * botulinum toxin injections in the lower extremities within the past 6 months\* * marked visual or hearing deficits * uncontrolled seizure disorder * implanted medical device that may be contraindicated with application of sr stimulation * asterisk indicates the eligibility criteria that should be met only by children with cp

Keywords: sensor fusion stochastic resonance stimulation sensory deficits postural control
post-marketing registry study of infliximab for injection in chinese pediatric crohn's disease patients

Conditions: Crohn Disease

Summary: post-marketing registration of infliximab for injection in chinese pediatric crohn's disease patients.

this is a prospective, multicenter registry study in chinese pediatric crohn's disease patients. a total of 30 subjects were planned to be enrolled and treated with infliximab. subjects were observed for 102 weeks after administration to evaluate the clinical efficacy and safety of infliximab in the treatment of children with crohn's disease in a real diagnostic setting.

Eligibility criteria:
inclusion criteria: 1. age ranged 6 to 17 years (both inclusive), no gender limitation. 2. a clear diagnosis was made in children with moderate to severe active stage (pcdai≥30) crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition). 3. patients and/or their guardians must sign icf, and the research agreement/icf for data collection and data verification shall comply with local laws and regulations. 4. the patient received infliximab for the first time. exclusion criteria: 1. patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product. 2. those who accept other anti-tnf-α any biological drugs or any other biologicals. 3. patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period 4. those who have been or being enrolled in other clinical studies within 3 months prior to signing icf 5. the investigator judges the subject inappropriate to be included in this study.
pharmacodynamics and non-clinical inferiority of heparin sodium (cristália) compared with the product liquemine (roche) in chronic renal failure

Conditions: Chronic Renal Failure

Summary: the primary objective of the study was to assess the safety in use of the drug heparin sodium, produced by cristália laboratory, compared drug liquemine ®, manufactured by roche laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and ttpa anti-xa in patients with chronic renal failure in treatment of hemodialysis.


Eligibility criteria:
inclusion criteria: * adults of both sexes, regardless of color or social class * age over 18 years with a good clinical medical criteria * patients who agreed to participate and signed the informed consent * insufficient patients in chronic renal dialysis schedule (3 times per week) * patients with creatinine clearance \<30ml/min * patients with indication for anticoagulation during hemodialysis exclusion criteria: * patients with sensitivity to heparin sodium; * patients with hypersensitivity to benzyl alcohol * patients with a history of bleeding or illness that can change the blood coagulation aggravate or terminate the clinical picture, such as tables of gastric ulcer * patients with a history of peptic ulcer * patients with body mass index greater than 30 * cancer patients because of the possibility of compromising the function of the variable coagulation * patients in period of pregnancy or after delivery * patients with genetic abnormality of the clotting system * polytraumatized patients * patients using glucocorticoids for at least 1 month * patients using other anticoagulants * patients with high rate of bleeding * patients undergoing any surgery performed less than 15 days due to the risk of training of hematoma at the site of surgery * hypertension above 140/90 mmhg * patients using medications that could affect hemostasis * patients using the following medicines: hormonal anti not including ketorolac; dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein iib / iiia.

Keywords: ttpa anti-xa adverse reactions