Kornimate/medical-research-clean huggingface dataset:
exercise therapy during radiotherapy

Conditions: Breast Cancer; Exercise Therapy; Radiotherapy; Upper Extremity Problem

Summary: the main purpose of our study is to investigate the effects of exercise therapy on upper extremity functions in patients receiving radiotherapy to the axillary region after breast cancer surgery.

our study will take in place in radiation oncology clinic. in routine the patients which will receive axillary area radiotherapy will randomized into 2 groups will explained in study arms section later. there are papers explained about radiotherapy side effects to upper extremity functions. but there is lack of evidence about exercise therapy during radiotherapy protocol to cope with its side effects to upper extremity functions. in this study we will compare two groups upper extremity function related outcomes at the end of the radiotherapy sessions and also before and after results for two groups.

Eligibility criteria:
inclusion criteria: * patients i̇n the age range of 18-65 * receiving radiotherapy to the axillary region after surgery with breast cancer diagnosis exclusion criteria: * radiotherapy area to contain only the chest wall * any orthopedic injury or trauma involving the upper extremity prior to or during the cancer diagnosis * the presence of metastases in any area other than breast tissue

Keywords: breast cancer exercise therapy radiotherapy
effect of intrathoracic pressure regulation on traumatic brain injury

Conditions: Head Injury

Summary: the purpose of this study is to demonstrate proof of clinical concept that application of the intrathoracic pressure regulator (itpr) will result in an increase in cerebral perfusion pressure (cpp) and a decrease in intracranial perfusion pressure (icp) in patients with head injury and elevated icp, and to determine the optimal ventilation tidal volume (tv).


Eligibility criteria:
inclusion criteria: * ≥15 years of age * intubated and mechanically ventilated on a volume controlled mode * head injury or other intracranial pathology with icp of ≥15 mmhg * arterial line in place * spo2 ≥95% * map \>60 * in icu or about to undergo neurosurgery with planned placement of an icp monitor * inclusion presents no significant delays to planned emergent neurosurgery * prior written informed consent exclusion criteria: * cardiac or pulmonary injury impacting intrathoracic pressure * confirmed pneumothorax or hemothorax * pao2/fio2 \<300 * serious neck injury resulting in neck swelling with jugular venous compression * evidence of ongoing uncontrolled bleeding * respiratory disease such as copd, interstitial lung disease, or other parenchymal or pulmonary vascular disease * congestive heart failure

Keywords: traumatic brain injury tbi itpr intrathoracic pressure regulator hepatic encephalopathy pseudotumorcerebri obstructive hydrocephalus intracranial hemorrhage
early recognition and dynamic risk warning system of multiple organ dysfunction syndrome caused by sepsis

Conditions: Sepsis; MODS

Summary: background sepsis still the main challenge of icu patients, because of its high morbidity and mortality. the proportion of sepsis, severe sepsis, and septic shock in china were 3.10%, 43.6%, and 53.3% with a 2.78%, 17.69%, and 51.94%, of 90-day mortality, respectively. besides, according to the latest definition of sepsis- "a life-threatening organ dysfunction caused by a dysregulated host response to infection. ", it is a disease with intrinsic heterogeneity. sepsis as a syndrome with such great heterogeneity, there will be significant differences in the severity of sepsis. as a result, there will be significant differences in the treatment and monitoring intensity required by patients with severe sepsis and mild sepsis. no matter from the economic perspective or from the risk of treatment, a proper level of treatment will be the best chose of patient. however, the evaluation of the sepsis severity was not satisfied. such of sofa, the auc of predict patients' mortality was only 69%. weather these patients occurred multiple organ dysfunction syndrome (mods) may had totally different outcome and needed totally different treatment. all these treatments need early interference, in order to achieve a good prognosis. hence, early recognition of mods caused by sepsis became an imperious demand. study design on the base of regional critical medicine clinical information platform, a multi-center, sepsis big data platform (including clinical information database and biological sample database) and a long-term follow-up database will be established. thereafter, an early identification, risk classification and dynamic early warning system of sepsis induced mods will be established. this system was based on the real-time dynamic vital signs and clinical information, combined with biomarker and multi-omics information. and this system was evaluated sepsis patients via artificial intelligence, machine learning, bioinformatics analysis techniques. finally, optimize the early diagnosis of sepsis induced mods, standardized the treatment strategy, reduce the morbidity and mortality of mods through this system.


Eligibility criteria:
inclusion criteria: * patients diagnosed with sepsis3.0 exclusion criteria: * patients' data missing is greater than 20%

Keywords: sepsis mods big data artificial intelligence
evaluation of an advanced lower extremity neuroprostheses

Conditions: Spinal Cord Injuries; Stroke; Paralysis; Tetraplegia; Paraplegia

Summary: the purpose of this study is to evaluate a surgically implanted functional electrical stimulation (fes) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

protocol outline: patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. electrode leads are connected to an stimulator/telemeter. following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. a prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. home-based training follows prior to discharge for home use of the system. patients are followed at 6 and 12 months after discharge and then annually thereafter.

Eligibility criteria:
phase i inclusion criteria 1. skeletal maturity and ability to sign informed consent (\>18 years) 2. non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (c4 or below) spinal cord injuries, poststroke hemiparesis, tbi, or ms, affecting the trunk and/or lower limbs 3. innervated and excitable lower extremity and trunk musculature 4. adequate social support and stability 5. willingness to comply with follow-up procedures phase i exclusion criteria 1. non-english speaking 2. females who are pregnant 3. current pressure injuries that would be exacerbated by study activities 4. severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities 5. history of spontaneous fractures or other evidence of excessively low bone density 6. history of vestibular dysfunction, balance problems, or spontaneous falls 7. acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.

Keywords: neurologic disorders rare disease spinal cord injuries stroke paraplegia tetraplegia
efficacy and safety study of mdv9300 in patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl)

Conditions: Lymphoma, Large B-Cell, Diffuse; Primary Mediastinal Large B-cell Lymphoma; Transformed Indolent Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of mdv9300 in patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) that have achieved either stable disease or a partial remission following definitive salvage therapy. two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (asct), and a cohort of patients who have received asct following salvage chemotherapy.


Eligibility criteria:
inclusion criteria: * age 18 years or older and willing and able to provide informed consent; * histologically confirmed relapsed or refractory cd20+ dlbcl, transformed indolent lymphoma (follicular or other), or primary mediastinal large b-cell lymphoma; * received prior treatment with a standard anthracycline and therapeutic anti-cd20 monoclonal antibody-based regimen; * for transplant-ineligible patients, salvage therapy just prior to mdv9300 treatment must have resulted in a pr or stable disease; * for post autologous stem cell transplant (asct) patients, salvage therapy plus asct just prior to mdv9300 treatment must have resulted in a pr or stable disease; * adequate bone marrow reserve as defined per protocol; * eastern cooperative oncology group (ecog) performance status ≤ 1. patients with stable ecog scores of 2 may be allowed with medical monitor approval. exclusion criteria: * burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma * history of serious autoimmune disease; * history of central nervous system involvement of lymphoma; * prior therapy with agents targeting immune coinhibitory receptors.
a study to observe characteristics of rheumatoid arthritis in patients using infliximab (study p04250)

Conditions: Rheumatoid Arthritis

Summary: this 14-week non-interventional study will observe patients with rheumatoid arthritis (ra) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. patients in this study will be treated for ra with infliximab and in a usual manner as decided by their physician.


Eligibility criteria:
inclusion criteria: * subject has been diagnosed with ra * physician has decided, with the subject's consent, to begin treatment with infliximab * written informed consent form signed by both the subject and the physician. exclusion criteria: * subjects who have previously been exposed to infliximab
corneal crosslinking in patients with keratoconus and post-refractive ectasia

Conditions: Keratoconus; Post-Refractive Ectasia

Summary: the purpose of this study is to evaluate the effectiveness of using riboflavin and uv light to treat progressive keratoconus or post-refractive corneal ectasia.

the primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive ectasia.

Eligibility criteria:
inclusion criteria: 1. 10 years of age or older 2. having documented ectasia on topography or tomography after previous refractive surgery or progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization: 1. an increase of ≥ 1.00 d in the steepest keratometry value (or sim k) 2. an increase of ≥ 1.00 d in regular astigmatism evaluated by subjective manifest refraction 3. a myopic shift (decrease in the spherical equivalent) of ≥ 0.50 d on subjective manifest refraction 4. documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia. 3. subjects with keratoconus diagnosis only: a. axial topography consistent with keratoconus b. presence of central or inferior steepening on the pentacam map. c. presence of one or more slit lamp findings associated with keratoconus, such as: i. fleischer ring ii. vogt striae iii. corneal thinning iv. corneal scarring 4. contact lens wearers only: removal of contact lenses for the required period of time prior to the screening refraction: contact lens type minimum discontinuation time soft 3 days soft extended wear 1 week soft toric 2 weeks rigid gas permeable 2 weeks 5. signed written informed consent exclusion criteria: * 1. any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity. 2. patients with excessively thin corneas. 3. previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example: a. history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. clinically significant corneal scarring in the proposed treatment zone 4. a history of chemical injury or delayed epithelial healing in the eye(s) to be treated. 5. a known sensitivity to treatment medications. 6. patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing. 7. pregnancy (including plan to become pregnant) or lactation during the course of the study

Keywords: keratoconus ectasia cross linking collagen cross linking
a study on the safety of hakim programmable shunt system

Conditions: Hydrocephalus

Summary: this study aimed to collect safety information from subjects implanted with a shunt system (trade name: hakim shunt programmable system) produced by codman \& shurtleff, inc. of the united states. device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.


Eligibility criteria:
inclusion criteria: 1. the informed consent was exempted by the ethics committee of a research center. either a subject or his/her legal representative signed the informed consent form (icf) prior to enrollment. 2. subject had an indication suitable to use hakim shunt programmable system. 3. subject received a hakim shunt programmable system at least one year ago. exclusion criteria: 1. subject didn't have an indication suitable to use the product. 2. subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing and other components. 3. according to the comprehensive judgment of an investigator, subject had an infection of the implant site when the shunt system was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection. 4. subject was simultaneously implanted with another shunt system different from hakim shunt programmable system. 5. subject had a contraindication of the shunt operation. 6. subject had uncorrected coagulopathy or any bleeding disorder.
motor-assisted cycling and fes cycling for postprandial glucose in diabetic patients with adl disability

Conditions: Type2 Diabetes; Disability Physical

Summary: exercise has been the cornerstone of diabetes management. however, many diabetic patients have adl disabilities and experience substantial difficulty in performing usual exercises, such as brisk walking and upright cycling. there is an urgent need to provide alternative exercise modalities for diabetic patients with adl disabilities. in this study, investigators will investigate the effects on the glucose of three exercise modalities, including motor-assisted cycling (i.e., cycling on a motor-driven bike) and functional electrical stimulation (fes) cycling, during which the investigators will use electrical current to facilitate cycling movements.


Eligibility criteria:
inclusion criteria: * age above 60 years. * physician-diagnosed type 2 diabetes. * adl disability (self-reported). exclusion criteria: * fasting glucose ≥ 250 mg/dl. * symptomatic hypoglycemic events in the past three months. * insulin injection or infusion * systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥ 100 mmhg * diagnosis of nyha class i-iv heart failure * myocardial infarction in the past 6 months * recent or current angina, shortness of breath, or other symptoms suggestive of heart failure * diagnosed cancer * unable to consent due to impaired cognitive function * bone fracture, joint dislocation, or joint stiffness * local skin disorders at the fes cuff area or cgm sensor area * implantable electronic or metallic devices, such as cardioverter defibrillator and pacemaker

Keywords: exercise fes
pilot study: oral treatment of american tegumentary leishmaniasis (cutaneous and mucosal forms) in the elderly

Conditions: Leishmaniasis; Brazilian; Leishmaniasis, Mucocutaneous

Summary: randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis


Eligibility criteria:
inclusion criteria: * active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis * use of highly effective contraceptive method and a negative serologic pregnancy test (beta - hcg), if female in fertile phase * agree and sing informed consent form exclusion criteria: * previous treatment with leishmanicidal drugs in the last 6 months * pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin b (qtc greater than 450ms) * serum creatinine or urea 1.5 times the upper limit of normal * patients with severe or decompensated liver, kidney, heart disease, diabetes mellitus * history of any hypersensitivity reaction to liposomal amphotericin b, miltefosine and/or pentoxifylline * pregnant and breastfeeding women * patients with acquired immunodeficiency syndrome (aids) or other immunodeficiency

Keywords: elderly miltefosine leishmaniasis pentoxifylline liposomal amphotericin b treatment
virtual reality analgesia during pediatric physical therapy

Conditions: Burn

Summary: we would like to determine whether virtual reality (vr) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).

this study is done in a hospital for inpatients pediatrics. by randomization some subjects will immersive virtual reality (vr) during a painful procedure on daily basis up to 10 days to see whether this will reduce the pain and anxiety.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 8 years up to 20 yrs old * compliant and able to complete subject evaluation * a minimum of 3 days of physical therapy, one physical therapy session per day * no history of psychiatric (dsm-iv-r axis i) or developmental disorder that would interfere with decisional capacity * not demonstrating delirium, psychosis, or any form of organic brain disorder that would interfere with decisional capacity * able to communicate verbally * able to take oral medications * english-speaking exclusion criteria: * - age less than 8 years, or greater than 20 years. * not capable of indicating pain intensity * not capable of filling out study measures * hospitalization of fewer than 3 days * evidence of traumatic brain injury * history of psychiatric (dsm-iv-r axis i) disorder as evidenced in the admitting rn and md admission notes, if interfering with decisional capacity * demonstrating delirium, psychosis or any form of organic brain disorder and associated memory problems that would interfere with decisional capacity * unable to communicate verbally * unable to take oral medications * history of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment that would interfere with treatment or decisional capacity * receiving prophylaxis for alcohol or drug withdrawal * developmental disability that would interfere with decisional capacity * face/head/neck injuries preventing helmet use * non-english-speaking * extreme susceptibility to motion sickness * seizure history

Keywords: virtual reality peds
precise transvaginal tape placement trial

Conditions: Stress Urinary Incontinence; Urinary Incontinence

Summary: this purpose of this study is to study is to see if intra-operative urethral length measurement with the foley catheter will improve the placement of a synthetic sling in the mid-urethra.

this study will assess the effect of intraoperative measurement of the urethral length with the foley catheter in optimization of sling placement in the mid female urethra. of note, the foley catheter is well-tolerated, placed routinely during surgery to drain the bladder and has no complications associated with it. women who have chosen to undergo trans-vaginal tape sling (tvt) for stress urinary incontinence will be asked to enroll in this randomized trial by the study team during their clinic visit. randomization will be performed by the fpmrs study nurse coordinator after a woman has given her informed consent and meets the study criteria. twenty women will be randomized to undergo measurement of the urethral length by marking the foley catheter at the urethral meatus when it is placed at the start of the surgical case. when the catheter is removed, the length from the end of the foley balloon to the marking at the urethra will be measured as urethral length, the mid urethral point will then be determined by dividing the urethral length be two where the incision of sling placement will be made and twenty women will have our usual pre-operative assessment (which does not include intraoperative measurement of the urethral length with the foley catheter) for the treatment of symptomatic stress urinary incontinence all women participating in the study will receive an intra-operative 3-d trans-vaginal ultrasound (bk flex focus ultrasound with the 8838 transvaginal probe). the image will be stored and reviewed for; urethral length, urethral sphincter complex length and width. all women in the study will have an ultrasound at the end of their surgical procedure and a follow-up ultrasound at 2 weeks post operatively to assess for sling migration. of note, transvaginal ultrasound is well-tolerated and has no complications associated with it. all ultrasound measurements will be done by a four qualified surgeons, dr. elizabeth mueller dr. ahmed akl, dr. tanaka dune, and dr. susanne taege who have been trained on ultrasound measurements. in addition, women will complete questionnaires assessing their pelvic floor symptoms pre-operatively and at 2 week following surgery. instruments used will be the pelvic floor disorders inventory (pfdi), medical epidemiologic and social aging (mesa) and the patient global impression of improvement (pgii) \[11, 12\].

Eligibility criteria:
inclusion criteria: * candidates for tvt * \>=18 years of age to participate exclusion criteria: * inability to give informed consent * previous sui(stress urinary incontinence) treatment including tvt, burch or urethral bulking agents * previous bladder, urethral malignancies or vaginal/pelvic radiation treatment. * pregnant women cannot participate

Keywords: tvt stress urinary incontinence
use of fdg pet as predictor of residual disease and subsequent relapse in patients with nhl and hd undergoing hdc and asct

Conditions: Lymphoma, Non-Hodgkin; Hodgkin Disease

Summary: cytogenetic analysis of bone marrow specimen prior to high dose chemotherapy and autologous stem cell transplantation in patients with non-hodgkin's lymphoma or hodgkin's disease


Eligibility criteria:
inclusion criteria: * patients with nhl and hd undergoing hdc and asct

Keywords: nhl and hd