Kornimate/medical-research-clean huggingface dataset:
preoperative (pre-amputation) cryoanalgesia to improve post-amputation phantom limb pain

Conditions: Postoperative Pain

Summary: investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on those outcomes and to investigate the potentiality of conducting a future larger randomized controlled trial, which the investigators will assess quantitatively the benefits of cryoanalgesia.

primary aim: to determine preoperative cryoneurolysis improves phantom limb pain compared with no cryoneurolysis. estimate the standard deviation of phantom limb pain score at baseline and post-treatment (day 0), days 1 and 2; weeks 1, 2, 3, and months 1, 2 and 3. the investigators will consider using the upper limit of the 75% confidence interval to plan the sample size of future larger trial. hypothesis 1: preoperative cryoneurolysis reduces phantom limb pain over 3 month after surgical leg amputation compared with no cryoneurolysis. secondary aim 1: to determine if preoperative cryoneurolysis improves mobility after lower limb amputation compared with no cryoneurolysis. hypothesis 1: preoperative cryoneurolysis improves mobilization (as measured with accelerometer) over 3 the month after surgical leg amputation compared with no cryoneurolysis. secondary aim 2: to determine if preoperative cryoneurolysis improves general physical and emotional disability after lower limb amputation compared with no cryoneurolysis. hypothesis 2: preoperative cryoneurolysis reduces general physical and emotional disability (as measured with the world health organization disability assessment) over the 3 month after surgical leg amputation compared with no cryoneurolysis. secondary aim 3: to determine if preoperative cryoneurolysis decreases opioid use after lower limb amputation compared with no cryoneurolysis. hypothesis 3: preoperative cryoneurolysis reduces opioid consumption over the 3 month after surgical leg amputation compared with no cryoneurolysis. exploratory aims: hypothesis 1: preoperative cryoneurolysis reduces residual limb pain over the 3 months after surgical leg amputation compared with no cryoneurolysis.

Eligibility criteria:
inclusion criteria: * adults at least 18 years of age. * scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone. exclusion criteria: * pregnancy * incarceration * morbid obesity (body mass index greater than 40 kg/m2 * contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria, or reynaud's syndrome. * investigator opinion that the potential subject is a poor candidate for this trial.

Keywords: postoperative pain phantom limb syndrome postoperative movilization lower limb amputation
virtual reality, debriefing and chronic pain

Conditions: Chronic Pain

Summary: this study will determine if occupational therapy or the combination of occupational therapy and virtual reality is the better treatment for chronic low back pain (clbp)patients.

chronic musculoskeletal pain is defined as persistent or recurrent pain lasting more than 3 months. chronic pain is a complex and disabling physiological and psychosocial disorder that does not provide an adaptive or protective purpose. in chronic pain, the precipitating event (e.g., fracture, sprain, trauma) is healed, and yet excessive pain remains. in immersive virtual reality (ivr) people experience a three-dimensional, computer-generated environment via a computer headset. ivr has been used to treat acute pain, but there have been few focused studies on the effects of ivr on chronic pain. when people with chronic pain are in ivr, they become unaware of their body and tend to move normally. we would like to test to see if ivr has a lasting effect in this study. thus, ivr has strong potential as an additional tool in an arsenal of treatments for chronic pain. this study will examine if ivr can reduce pain and other symptoms in people with chronic pain.

Eligibility criteria:
inclusion criteria: * ages 18 and older * referred for chronic pain occupational therapy services at the upmc centers for rehab services centre commons site. exclusion criteria: * had a seizure, loss of awareness, or other symptom linked to an epileptic condition * had virtual reality intervention within the last 3 months * has sensory insensitivity such as hearing loss or low vision, as assessed by the pi * has contagious disorder on the face, such as pink eye, that could be transmitted via the vr headset or has open areas on the face that would come in contact with the headset * has a pacemaker or defibrillator * insufficient upper extremity coordination to operate ivr controls, as assessed by the pi * insufficient cognitive ability to answer questionnaires or learn to use the ivr, as assessed by the pi * have a diagnosis of asd (autism spectrum disorder) or unable to understand and/or respond in english

Keywords: chronic pain virtual reality occupational therapy debriefing self-efficacy fear of movement
nalbuphine as an adjuvant to intravenous regional anesthesia

Conditions: Postoperative Pain

Summary: the effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia


Eligibility criteria:
inclusion criteria: * adult patients * american society of anesthesiologists (asa) physical status i-ii * age between 20 and 50 years old * scheduled for elective unilateral short hand surgery exclusion criteria: * allergy to study medications * body mass index \> 35 kg/m2 * patients with sickle cell disease or reynaud disease * patient refusal
a close examination of patient experiences in glioblastoma multiforme clinical research

Conditions: Glioblastoma Multiforme

Summary: clinical research can sometimes favor certain demographic groups. additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative. the goal is to identify the obstacles and challenges that prevent participation in glioblastoma multiforme clinical study, as well as the reasons for withdrawal or discontinuation. insights gained from this study will ultimately benefit those with glioblastoma multiforme who may be invited to participate in clinical trial in the years to come.


Eligibility criteria:
inclusion criteria: * diagnosis of glioblastoma multiforme * no prior treatment for glioblastoma multiforme * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * female patients who are currently pregnant or nursing * enrolled in another research study * patients who are currently receiving any other investigational drug.

Keywords: glioblastoma multiforme
indocyanine green or trypan blue for delamination of the internal limiting membrane in macular hole surgery

Conditions: Idiopathic Macular Hole

Summary: to evaluate the anatomical and visual outcomes after vitrectomy and internal limiting membrane (ilm) peeling with indocyanine green (icg) or trypan blue (tb) for idiopathic macular hole repair in a prospective randomized trial.

in several clinical trials the positive effect of inner limiting membrane peeling (ilm) on anatomical and functional outcome in macular hole surgery has been reported. controversies, however, exist regarding the application and possible toxicity of dyes, facilitating the surgical procedure. since dyes were introduced for ilm peeling several authors reported on the use of indocyanine green and trypan blue (tb) for membrane peeling or ilm removal. recent experimental and clinical reports raise concern about the safety of icg-assisted membrane peeling. morphological and functional damage was described in an animal model, in human donor eyes, in cultured human pigment epithelial cells and in clinical studies using icg in macular surgery. the intraocular tolerance of tb has been demonstrated in rabbit eyes and in retinal pigment epithelium cell viability studies. higher concentrations of tb (0.6 or 4 mg/ml) lead to toxicity on cultured rpe cells, but the application of lower clinically relevant levels did not show any significant effect. a recent retrospective comparative analysis indicates that tb may be the safer dye. they found better anatomical and functional results than with the use of icg. therefore, the aim of this study was to compare the anatomical and functional outcome after dye-assisted peeling of the ilm in patients with idiopathic macular holes using icg or tb in a prospective and randomized trial.

Eligibility criteria:
inclusion criteria: * patients with idiopathic macular holes stage ii-iv according to the classification proposed by gass and a visual acuity of at least 20/200 entered this study. exclusion criteria: * patients with secondary macular holes, previous intraocular surgery, except for uneventful cataract extraction and patients with ocular disorders that might interfere with vision such as severe cataract, exudative age-related macular degeneration or diabetic retinopathy.

Keywords: macular hole surgery indocyanine green trypan blue internal limiting membrane
high resolution optical coherence tomography

Conditions: Retinal Disease; Retinal Detachment; Retinal Vein Occlusion; Retinal Dystrophy; Retinal Artery Occlusion; Retinal Edema; Retinal Neovascularization; Uveitis; Diabetic Retinopathy; Diabetic Macular Edema; Macular Edema; Macular Degeneration; Macular Disease; Glaucoma; Optic Nerve Diseases; Hypertensive Retinopathy

Summary: comparison of high-resolution optical coherence tomography (high-res-oct) to conventional imaging modalities for the diagnosis of eye diseases

the high resolution optical coherence tomography (high-res-oct) is an improvement of a non-invasive routinely used imaging technique, the optical coherence tomography (oct), with a light-source capable of providing an increased axial resolution. the routinely used spectral-domain oct has a center wavelength of 880 nm and a spectral bandwidth of 40 nm, resulting in an axial resolution of approximately 7 μm in the eye and is used routinely worldwide. the high-res oct works with a central wavelength of 840 nm and an increased bandwidth of 130 nm, making it possible to improve the optical axial resolution in tissue from 7 to 3 µm, without increasing the maximum laser exposure limit. the improved axial resolution of the high-res oct results in clearer and more detailed images. the technique is routinely used in clinical practice and the device used for high-res-oct (heidelberg, spectralis® high-res oct- dmr001) has received ce mark (european conformity in the extended single market in the european economic area) approval in march 2021. we plan to compare high-res-oct as an imaging modality to conventional imaging modalities used in clinical routine, such as the spectral-domain-oct (sd-oct)

Eligibility criteria:
inclusion criteria: * patients from the department of ophthalmology, university hospital bern requiring conventional imaging for eye disease and willing to sign informed consent patients of 18 years or older exclusion criteria: * patients not willing or able to sign informed consent * patients younger than 18 years * patients with epilepsy. * vulnerable subjects (except the objectives of the investigation concern vulnerable subjects specifically), * inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject * participation in another investigation with an investigational drug or another md within the 30 days preceding and during the present investigation * enrolment of the pi, his/her family members, employees and other dependent persons

Keywords: optical coherence tomography diagnostic techniques, ophthalmological high resolution optical coherence tomography
single or triple uterine tourniquet at myomectomy

Conditions: Uterine Myoma

Summary: the aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.


Eligibility criteria:
inclusion criteria: 1. three or more uterine myoma 2. at least one myoma ≥ 8 cm, if there is less than three myoma exclusion criteria: 1. pedunculated myoma, 2. broad ligament myoma

Keywords: leiomyoma of uterus hemostasis, surgical prevention of surgical blood loss mechanical uterine tourniquet
a placebo-controlled study for spm 962 in early parkinson's disease patients

Conditions: Early Parkinson's Disease

Summary: to investigate superiority of spm 962 over placebo in early parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of spm 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)


Eligibility criteria:
inclusion criteria: 1. subject diagnosed as having parkinson's disease in accordance with "diagnostic criteria established by the research committee of mhlw-specified intractable neurodegenerative diseases (1995)" 2. subject is 30 years \ 80 years at the time of informed consent 3. hoehn \& yahr stage 1- 3 4. total of each sum score of updrs part 2 and 3 is over 10 at screening test exclusion criteria: 1. subject has previously participated in a trial with spm 962 2. subject is on l-dopa treatment for total of over 6 months at the time of informed consent 3. subject has psychiatric symptoms, e.g. confusion, hallucination, delusion, excitation, delirium, abnormal behavior at screening test and baseline 4. subject has orthostatic hypotension 5. subject has a history of epilepsy, convulsion and other 6. subject has a complication of serious cardiac disorder/arrhythmia or has the history 7. subject has arrhythmia and treated with class 1a anti-arrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 anti-arrhythmic drugs (e.g. amiodarone, sotalol etc.) 8. subject has serious ecg abnormal at screening i.e.; 1) subject has more than 450 msec of qtc values both in two measurements at screening test 2) subject has more than 470 msec for females and more than 450 msec for males of mean qtc values of two measurements at baseline 9. subject has congenital long qt syndrome 10. subject has serum potassium of less than 3.5 meq/l at screening test. 11. subject has total bilirubin of 3.0 mg/dl and above or ast(got), alt(gpt) greater than 2.5 times (or 100 iu/l and above) of the clinical laboratory's upper limit of the reference range at screening test 12. subject has 30 mg/dl and above of bun or 2.0 mg/dl and above of serum creatinine at screening test 13. subject has a history of allergy to topical medicine, e.g. transdermal patch 14. subject is pregnant, nursing, or is child bearing potential while the trial 15. subject is receiving therapy with prohibited drug specified in the study protocol 16. subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant 17. subject has dementia 18. subject is unable to give consent 19. subject is participating in another trial of an investigational drug or done so within 12 weeks prior to the initial treatment 20. investigator judges that subject is inappropriate as a study subject with other reasons

Keywords: spm 962 rotigotine parkinson's disease monotherapy
deep tms for the treatment of patients with parkinson's disease and progressive supranuclear palsy

Conditions: Progressive Supranuclear Palsy; Parkinson's Disease

Summary: background: progressive supranuclear palsy (psp) is a rare neuro-degenerative disease, counted among atypical parkinsonism (ap). medical treatment and rehabilitation are extremely limited in ap, therefore it would be very useful to find new ways to improve motor and non motor symptoms in psp. the brainway deep transcranial magnetic stimulation (dtms) is a new technology of tms using a particular coil, i.e. h-coil, able to stimulate deeper regions of the brain. only few studies in literature have evaluated the efficacy of dtms in parkinson's disease and parkinsonism; in particular in psp patients, a case report showed an improvement in language.

materials and methods: this study was a pilot, randomized, cross-over, double blind trial. it was designed to evaluate the efficacy of deep tms in terms of recovery of motor functions, freezing of gait, and cognitive decline in patients with psp. nineteen subject underwent 14 session of high frequency dtms over a 4 weeks period. the target were the left broca and dorsolateral prefrontal cortex.

Eligibility criteria:
inclusion criteria: * outpatients with psp according to ninds-spsp criteria exclusion criteria: * contraindications for dtms (history of seizures, pacemakers, or any other electric device)

Keywords: progressive supranuclear palsy deep transcranial magnetic stimulation
turkish translation of sportsconcussion assesment tool 6

Conditions: Sports Injury; Concussion, Mild; Concussion, Brain; Concussion, Severe; Concussion, Intermediate

Summary: concussions, a significant type of sports injury caused by head, face, or neck trauma, are common in contact sports and require serious attention due to potential fatal consequences of mismanagement. the sport concussion assessment tool (scat), developed by the concussion in sport group (cisg) and updated in 2023, provides a standardized approach to assess head injuries and manage athletes' return-to-sport process. while scat has been adapted into various languages, no turkish version exists. this study aims to translate and culturally adapt scat 6 into turkish, contributing to the accurate evaluation and management of concussion injuries among turkish-speaking athletes.

concussions constitute an important part of sports injuries. concussion is a head trauma caused by blows to the head, face and neck. head injuries are common in contact sports. they are usually minor injuries. however, injuries should be taken seriously. because mismanagement can be fatal in cases of misdiagnosis. therefore, it is among medical emergencies . a sports concussions group has been established for the correct management of concussions seen in sports. in 2022, the group met in amsterdam, renewed the existing consensus and published it in the british journal of sports medicine in 2023 . the sport concussion assessment tool (scat), developed by the sports concussion group (cisg), is a valid and reliable approach to assessing sports-related head injuries ('sport concussion assessment tool 6 (scat6),' 2023). the main purpose of scat is to assess head injuries with a standardised method and to manage the return to sport process of athletes. scat is an assessment tool that evaluates adult athletes over the age of 13 in terms of physical, mental and cognitive aspects and includes different sections. in the literature, there are adaptations of previous and current versions of scat in different languages (korean, chinese, persian, arabic). however, no turkish translation and adaptation study of any version has been conducted before. turkishisation of this assessment tool is an important step in terms of accurately evaluating concussion injuries in turkish-speaking athletes and managing the return to sport process correctly. the aim of this study is to translate the scat 6 into turkish and to provide intercultural adaptation of the scat 6 to the literature.

Eligibility criteria:
inclusion criteria: to be 13 years old * talking in turkish * being a professional athlete exclusion criteria: * athletes who experience any injury during the test, retest process will be excluded from the study.
intra-abdominal sepsis and relationship between cumulative fluid balance and serum sodium and chloride levels and in-hospital mortality

Conditions: Intraabdominal Infections; Fluid Balance; Disorder; Sodium Disorder; Chloride Disorder

Summary: intra-abdominal sepsis and septic shock in critically ill surgical patients have a high mortality rate. fluid therapy is one of the initial resuscitation measures, but it can contribute to poor treatment outcomes through fluid overload and accumulation of sodium and chloride. this study aimed to examine an association among cumulative fluid balance and serum sodium and chloride levels in the intensive care unit (icu) and in-hospital mortality in critically ill surgical patients with intra-abdominal sepsis after emergency surgical treatment. the study was designed as a retrospective, cohort study.

data were collected and analyzed from 100 critically ill surgical patients with intra-abdominal sepsis, consecutively admitted to the icu of a university medical center. patients were immediately subjected to surgical treatment for intra-abdominal sepsis upon hospital admission. postoperative care continued in the icu for at least seven days. patients who were hospitalized in the icu for less than seven days, immunocompromised, and patients with intra-abdominal sepsis as a result of previous abdominal surgery were not included in the study. data related to daily fluid intake and loss were taken from medical records where these data are recorded daily. intake included both enteral and parenteral, while fluid losses from the body included urine, losses through drains, and nasogastric tube. the cumulative fluid balance was calculated for the periods from days 1 to 3 of treatment, and from days 1 to 7 of treatment. data on serum sodium and chloride levels were recorded at the same time points as for cumulative fluid balance. the impact of variables on treatment outcomes was determined using binary logistic regression. the predictive quality of the variables on the outcome was assessed using roc curves.

Eligibility criteria:
inclusion criteria: * critically ill surgical patients with intra-abdominal sepsis/septic shock consecutively admitted to a university medical center * patients who were immediately subjected to surgical treatment for intra-abdominal sepsis/sepstic shock upon hospital admission and postoperative care continued in the icu for at least seven days exclusion criteria: * patients who were hospitalized in the icu for less than seven days * immunocompromised * patients with intra-abdominal sepsis as a result of previous abdominal surgery were not included in the study

Keywords: sepsis intra-abdominal sepsis in-hospital mortality fluid therapy sodium disorder chloride disorder critically ill patients