Kornimate/medical-research-clean huggingface dataset:
a randomized trial measuring the effect of decision aids on patients' satisfaction, conflict of decision-making and clinical outcome

Conditions: Trapeziometacarpal Arthrosis; Carpal Tunnel Syndrome; Cubital Tunnel Syndrome; Distal Radius Fractures; Trigger Finger

Summary: the investigators plan a prospective randomized controlled study that compares the treatment decisions made by patients who receive decision aids, as compared to patients treated with usual care and the american society for surgery of the hand brochures. the investigators expect to enroll 126 patients.

decision aids are tools that help patients participate in making decisions by providing detailed, specific, and personalized information regarding the benefits and risks of various potential treatment options for a diagnosis. decision aids can reduce the level of uncertainty and mental anguish associated with choosing a particular course of action, i.e. 'decisional conflict'. the most common manifestations of decisional conflict include verbalized uncertainty about choices or undesired consequences of alternatives, vacillation between choices, and delayed decision making. besides the advantages of decision aids in the process of decision-making, the literature is not conclusive about the effect of decision aids on patient satisfaction. of the 86 randomized controlled trials identified by authors stacey et al., eleven studies measured satisfaction. of these, four studies reported that people exposed to decision aids had higher satisfaction with their choice compared to usual care, and the remaining seven reported no statistically significant difference. studies that have directly investigated the effect of decision aids in orthopaedic practice are limited and further study is necessary to determine the best way to implement decision aids in a clinical orthopedic practice. 7-12 randomized trials evaluating the impact of decision aids on patient knowledge, decisional conflict, satisfaction, and outcomes may have substantial impact in hand surgery where most treatments are elective and address quality of life.

Eligibility criteria:
inclusion criteria: * age 18 and above * diagnosis of moderate or severe: 2.) carpal tunnel syndrome (cts) 5.) trigger finger (tf) exclusion criteria: * patients with previous interventions for cts or tf * inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
vitamin d deficiency in obese adolescent girls and influence of vitamin d on insulin secretion and sensitivity

Conditions: Vitamin D Deficiency; Obesity; Insulin Resistance

Summary: sub-clinical vitamin d deficiency is a commonly unrecognized disorder in obese adolescents. the investigators hypothesize vitamin d deficiency will be highly prevalent in obese adolescents and those who are vitamin d deficient will be more insulin resistant.

this is a cross-sectional study of obese female adolescents matched for age, sex and pubertal staging. serum 25-oh vitamin d, intact pth , lipid profile, serum crp measurements and oral glucose tolerance tests (with glucose and insulin level measurements) will be done to assess the prevalence of vitamin d deficiency and to assess the insulin sensitivity- resistance indices.

Eligibility criteria:
inclusion criteria: * female adolescents * obese: bmi \> 95th percentile * menarchal * tanner stage ≥ 4 exclusion criteria: * children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications

Keywords: vitamin d deficiency obesity insulin resistance glucose tolerance
attentional bias modification treatment in ocd

Conditions: Obsessive-compulsive Disorder

Summary: obsessive-compulsive disorder is a chronic condition. even with proper treatment, no significant improvement is reached in about 30% to 40% of patients. thus, the development of new treatment strategies is necessary. the attentional bias - ability to aversive stimuli in capturing the attention of an individual compared to a neutral stimulus - has been extensively studied. already training attentional bias modification has been shown effective in reducing anxiety present in other anxiety disorders.this project aims to: 1 - generate knowledge on attentional bias in individuals with ocd through the use of a standardized protocol developed for ocd; 2 - available to the scientific community the first specific paradigm for the study of attentional bias in ocd patients, 3 - test the effectiveness of a training protocol for reversing attentional bias in individuals with ocd.


Eligibility criteria:
inclusion criteria: - 30 patients with obsessive-compulsive diagnosis according to dsm-v (with cleaning and or symmetry dimensions) * 30 health controls exclusion criteria: - doing any kind of behavioral therapy in the moment

Keywords: attentional bias attentional bias modification treatment
hemodynamic response to intubation

Conditions: Intubation

Summary: this study investigates the effects of dexmedetomidine and esmolol given intravenously before intubation on sympathetic response caused by intubation itself. half the patients will recevice dexmedetomidine and the other half will receive dexmedetomidine. ischemia modified albumine levels will be measured


Eligibility criteria:
inclusion criteria: * patients undergoing elective surgery under general anesthesia exclusion criteria: * patient refusal * morbid obesity (bmi\>30) * advanced systemic disease * hypoalbumiemia * beta-blocker usage * anticipated difficult ventilation and/or intubation

Keywords: intubation, ischemia modified albumine, dexmedetomidine, esmolol
amelioration of adverse ocular side effects of glaucoma medications in glaucoma patients using topical gl101

Conditions: Ocular Surface Disease

Summary: to evaluate the safety and efficacy of 0.5% gl101 topical gel administered twice daily for 28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with glaucoma medications.

the study is to assess the safety and efficacy of a new treatment for ocular surface disease associated with the use of glaucoma medications.

Eligibility criteria:
inclusion criteria: 1. male or female of any race, at least 18 years of age at visit 1 screening. 2. has provided verbal and written informed consent. 3. be able and willing to follow instructions, including participation in all study assessments and visits. 4. currently being treated for glaucoma using at least two medications, and be willing to continue on the same regime. 5. suffers from at least two of the symptoms in the glia™ glaucoma medication ocular side effect symptoms questionnaire at a severity of 2 (moderate) or more. 6. if a woman of childbearing potential, have a negative urine pregnancy test at visit 1 and be using an adequate method of birth control throughout the study period. exclusion criteria: 1. comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as corneal opacities and scars, dystrophies, epithelial scarring, infections, blood clots, etc. 2. best corrected visual acuity (bcva) at baseline \<20/200. 3. has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study. 4. a woman who is pregnant, nursing an infant, or planning a pregnancy. 5. has a known adverse reaction and/or sensitivity to the study drug or its components. 6. routine use (more than twice a week) of a chlorinated swimming pool. 7. unwilling or unable to cease using the following medications during the study period: topical ocular cyclosporine (e.g. restasis®), anti-histamines, antipsychotics, or eye gels. 8. currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to visit 1.

Keywords: ocular surface disease glaucoma medications
safety and efficacy of strategy to prevent drug-induced nephrotoxicity in high-risk patients

Conditions: Health Care Associated Pneumonia; Osteomyelitis/Septic Arthritis; Endocarditis; Bacteremia; Acute Bacterial Skin and Skin Structure Infections

Summary: for more than fifty years, vancomycin has been cited as a nephrotoxic agent. reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or vin), have waxed and waned throughout the years for various reasons. recently, vin has reemerged as a clinical concern. this may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. this study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * receiving intravenous vancomycin for the treatment of healthcare associated pneumonia, osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and skin structure infections * expected to receive vancomycin for at least 72 hours and are within the first 72 hours of therapy * have at least two or more of the following risk factors for drug-induced nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e. aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous contrast dye) d) pre-existing renal dysfunction (i.e. scr greater than or equal to 1.5 mg/dl). exclusion criteria: * pregnancy * end-stage renal disease * receipt of more than 4 grams of vancomycin prior to enrollment on current admission * absolute neutrophil count \< 1000/mm3
safety and effectiveness of giving lamisil to hiv-positive subjects with thrush who have not responded to fluconazole treatment

Conditions: Candidiasis, Oral; HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give lamisil to hiv-positive patients with thrush (a fungal infection) that has not responded to fluconazole.

this is an open-label, dose-escalating study with up to 2 sequential cohorts. the first 15 patients receive lamisil for 2 weeks. after 2 weeks, patients considered clinically cured (i.e., absence of removable, white plaques) are removed from treatment; patients not considered clinically cured receive an additional 2 weeks of treatment. at the end of 4 weeks, treatment is discontinued, regardless of clinical cure outcome. if less than 80% of patients are clinically cured after the 4 weeks of treatment, a second cohort of 15 patients receive lamisil on the same treatment regimen as first cohort (i.e., initial 2-week treatment period, with an additional 2 weeks of treatment for those patients who are not considered clinically cured after 2 weeks of treatment).

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are at least 18 years old. * have thrush that has not responded to at least 10 days of fluconazole treatment. * are hiv-positive. * are expected to live at least 4 weeks. * are able to take oral medication. exclusion criteria you will not be eligible for this study if you: * have liver or kidney disease. * have received certain medications. * have a history of serious diarrhea or digestive problems. * are pregnant or breast-feeding.

Keywords: aids-related opportunistic infections dose-response relationship, drug fluconazole antifungal agents candidiasis, oral drug administration schedule terbinafine
gaining real-life skills over the web

Conditions: Traumatic Brain Injury

Summary: gaining real-life skills over the web (grow) is an online parenting-skills intervention for caregivers of children aged 0-4 who sustained traumatic brain injuries. grow is designed to promote family and child coping and adjustment for caregivers.

this project develops and evaluates an online learning environment of web-based intervention modules designed to promote family and child coping and adjustment (grow: gaining real-life skills over the web) based on a comprehensive needs assessment of children aged 0 to 14 years old, who experienced a traumatic brain injury (tbi) between the ages of 0 to 4 years, and their families. the incidence of tbi peaks between the ages 0 to 4 years, yet there are no evidenced-based interventions to facilitate neurocognitive development and socio-emotional functioning of children injured during this critical development period. to address the unmet need of caregivers of infants and toddlers with tbi, the project uses a three-phase development process to generate proof of concept and initial proof of product. phase 1 involves a comprehensive needs assessment that includes quantitative assessment of family and child needs, qualitative assessment through focus groups and interviews of families, feedback from family and professional advisory boards, and consultation with professionals implementing interventions with similar populations (e.g., families of children with very low birth weight). during phase 2, the project develops the content and manual for the intervention modules, designs the online learning environment, and conducts intensive, iterative usability testing. phase 3 involves a pilot of the grow program with 20 families to evaluate its usability, acceptability, and qualitative and quantitative impact on stakeholder identified outcomes.

Eligibility criteria:
inclusion criteria: 1. age at injury and enrollment: ages 0-4, inclusive 2. overnight hospitalization for traumatic brain injury 3. mechanism of injury: non-penetrating traumatic brain injury; abusive head trauma (aht) will be included 4. language: english must be the primary spoken language in the home exclusion criteria: 1. does not reside with the caregiver at least half-time 2. the caregiving situation is not stable (i.e., there must be no scheduled custody hearings) 3. english is not the primary language spoken in the home 4. families of children who are non-responsive or in a persistent vegetative state will also be excluded 5. caregivers with a psychiatric hospitalization in the past year will be ineligible to participate 6. if aht is the suspected injury mechanism, the child must not reside with the suspected abuser, must have been in the current living situation for at least 6 months, and must be anticipated to remain in this living situation for the next 6 months. the study team will only recruit non-abusing caregivers (including foster parents) to participate.

Keywords: traumatic brain injury parent-child relations parenting
immunomodulation therapy for urinary tract infections

Conditions: Spinal Cord Injuries; Urinary Tract Infections

Summary: urinary tract infections (uti) represent one of the most common morbidities in individuals with spinal cord injury (sci) and reason for re-hospitalization. the consequences of recurrent uti are a decrease in quality of life and considerable health costs. immunomodulation therapy with urovaxom is a very promising method for the prevention of uti, however data in individuals with sci are very limited. the primary objective of this pilot study is to evaluate the feasibility (recruitment rate, patient attrition, compliance, assessment procedures etc.) of a main trial. a secondary objective is to collect data for an informed sample size calculation. furthermore, the clinical and biological changes after immunomodulation therapy will be investigated. this is a randomized, placebo-controlled, mono-centric pilot study investigating the feasibility of a main trial regarding the effectiveness of immunomodulation with urovaxom in the prevention of uti and the effect on the immune system in individuals with acute sci during primary rehabilitation. there will be two parallel groups of 12 participants each. group allocation will be based on a block-randomization stratified according to sex. study participants and outcome assessors will be blinded to the group allocation. the nursing staff will be unblinded and will administer the treatment and the placebo. study participants will either receive uro-vaxom (one tablet / day) or an off-the-shelf placebo for 90 days. after termination of the treatment, the study participants will be followed for 12 months. blood and urine samples will be taken before and 90 days, 6 months and 12 months after treatment start.


Eligibility criteria:
inclusion criteria: * acute sci (within 8 weeks after sci) * onset of sci within 72h * age from 18 to 70 years * informed consent as documented by signature exclusion criteria: * known hypersensitivity to investigational product, * other immunomodulation therapy, * immunosuppressant therapy, * oncological condition or therapy, * autoimmune diseases, nephropathy, bladder stones, * women who are pregnant (pregnancy test) or breast feeding, * participation in another study with an investigational drug within the 30 days preceding and during the present study

Keywords: spinal cord injury neurogenic lower urinary tract dysfunction urinary tract infection immunotherapy immunomodulation immunostimulation e. coli uro-vaxom
ctp imaging of lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: investigators hope to learn more about how to use computed tomography (ct) scans to measure blood flow in lung tumors and how it may change in response to treatment. this measurement technique is called computed tomography perfusion (ctp). ct scanners use x-rays to produce 3-dimensional images of the body. currently, doctors determine the response to treatment by measuring the size of the tumor. investigators are trying to find out if measuring the blood flow in the tumor is equal to or better than measuring the size of the tumor.

this is an experimental study of ct perfusion (ctp) imaging in subjects with non-small cell lung cancer. the objectives of this study are to demonstrate the feasibility of ct blood flow measurements in lung cancer, to develop a foundation for the use of ct blood flow measurements in lung cancer to assess the response to treatment, and to develop an optimized ctp imaging protocol for evaluating blood flow in solid body tumors. in this study, tumor blood flow will be evaluated at baseline and follow-up routine ct examinations of patients with non-small cell lung cancer, and the response of tumor blood flow will be recorded as a secondary endpoint. this research study will entail two study visits - one required and one optional - which will coincide with regularly scheduled standard of care ct scans.

Eligibility criteria:
inclusion criteria: adult patients with non small cell lung cancer who receive, or are considered for, systemic therapy exclusion criteria: renal failure pregnancy known contrast allergy -

Keywords: lung cancer computed tomography blood flow
vertical ramus osteotomy with iliac graft versus sagittal split osteotomy

Conditions: Mandibular Deficiency

Summary: * patients will be collected from faculty of dentistry * bilateral vertical ramus osteotomy (vro )with iliac graft group (group i):- 10 patients will be treated via vro and iliac crest or * bilateral sagital spilt osteotomy (bsso) group (group ii):- 10 patients will be treated via bsso * all patients will be studied by comprehensive clinical oral and maxillofacial examination and lateral cephalometric radiographic analyses, within 1 week before the surgery (t0), immediately after the surgery (t1), and 6 months after surgery (t2). * all lateral cephalometric radiographs and clinical photographs must be standardized for all cases. * after pre-surgical orthodontic treatment , a lateral cephalograph will be obtained for planning the surgical movement of both jaws * surgical models and surgical stent will be fabricated. * all surgical procedures will be performed under nasal intubation and general anesthesia to surgically reposition the maxilla in standard lefort i setback fosteotomy; the bsso group will be underwent bsso, and vro group will be underwent vro * the bony segments will be fixed in the new position with the use of custom made plates (specific for each patient )


Eligibility criteria:
inclusion criteria: * patients with age above 18 years old suffered from skeletal class ii with severe mandibular deficiency exclusion criteria: * patients with chin deviation, * severe temporomandibular joint (tmj) symptoms. * sever periodontal disease * pregnancy, * previous mandibular surgery, * inability to follow-up for the study protocol
mechanism of action of ocrelizumab in multiple sclerosis

Conditions: Multiple Sclerosis; Immune System Diseases

Summary: ocrelizumab is fda approved for therapy of multiple sclerosis (ms). it depletes b cells and stops ms inflammation.

the study will investigate immune cell subsets, and how the cells are modified by this therapy over a 1-year period in 25 subjects. blood will be drawn at baseline, 2 weeks, 6 mo, and 12 mo. immune subsets will be analyzed by flow cytometry. data are analyzed with anova with repeated measures.

Eligibility criteria:
inclusion criteria: * all patients who are eligible for ocrelizumab therapy based on fda criteria exclusion criteria: * all patients who are ineligible for ocrelizumab therapy based on fda criteria. * prior treatment with alemtuzumab or stem cell therapy, or immune abnormalities that would interfere with planned tests. * hepatitis b and hiv infections. * pregnant or lactating women. * hypersensitivity to trial medications.
can acupuncture benefit surgical patients with haemorrhagic stroke?

Conditions: Stroke

Summary: the purpose is to establish whether acupuncture in addition to conventional rehabilitation programme can improve the functional outcome and quality of life of surgical patients with haemorrhagic stroke, as compared to conventional rehabilitation programme alone.

the investigators aim to recruit 60 patients over a 30 month period. each patient will have six week of acupuncture treatment (either early within the first six week, or delayed after the first six week of observation and assessment of primary outcome). primary outcome measures: clinical outcome at the end of week 6 acupuncture treatment: glasgow outcome score extended. secondary outcome measures: modified rankin score, functional independence measure (fim) score, modified aschoff score, neurocognitive state examination (ncse) score, barthel index, modified rivermead mobility index (mrmi), modified functional ambulation category (mfac) and motor scores of upper limb and lower limb with fugl-meyer scale at the end of week six acupuncture treatment.

Eligibility criteria:
patient inclusion criteria: 1. patients after acute hemorrhagic stroke; 2. within the first month after acute presentation; 3. premorbid mobility level: independent indoor or outdoor walker; 4. co-operative and willing to comply with the rehabilitation program; patient exclusion criteria: 1. cardiac pacemaker; 2. patient who is apprehensive to acupuncture; 3. clotting abnormality; 4. poor local skin conditions.

Keywords: acupuncture,intracerebral hemorrhage, stroke
ipilimumab 12-month intensive pharmacovigilance protocol

Conditions: Melanoma

Summary: the primary objective of the protocol is to identify and describe observed adverse events (aes) while on treatment with ipilimumab for advanced melanoma in venezuela during the study period


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * age of 18 years or older on date of first dose of ipilimumab * subjects who received at least 1 dose of ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in venezuela exclusion criteria: * subjects who received ipilimumab as part of a clinical trial * subjects who received ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma)