Kornimate/medical-research-clean huggingface dataset:
effects of functional electrical stimulation cycling versus cycling only on walking and quality of life in ms

Conditions: Multiple Sclerosis

Summary: this study will seek to determine the benefits that fes-le cycling has over cycling alone on walking performance and quality of life in people with multiple sclerosis.

functional electrical stimulation (fes) is a rehabilitation tool that stimulates nerves via electrical current, causing muscles to contract. when fes is appled to leg muscles during stationary cycling the legs move in a fixed rhythmical pattern. previous studies have demonstrated that fes during cycling is a safe and effective exercise for individuals recovering from spinal cord injury or stroke, but few have applied this tool to a progressive disorder, such as multiple sclerosis (ms). the aim of this study is to assess the immediate and short-term effect of an 8-week training program comparing fes lower extremity cycling to cycling without fes. twenty volunteers with ms will participate. they will be randomly assigned to a training group. this study examine the effects of training on quality of life, endurance, walking speed, and step quality. participants will sign an informed consent and complete a questionnaire that includes medical history and demographic data. before training, immediately after training finishes and one month after training, self-report questionnaires, timed walking tests will be completed. during the walking tests, step quality and speed will be measured with a sensor that is worn on a belt

Eligibility criteria:
inclusion criteria: * medical diagnosis of ms * patient-determined disease steps score between 3.0 and 6.0 inclusive * ability to attend training sessions 3 times per week for an 8-10 week period * passing a submaximal exercise test * adequate hip range of motion (at least 110 degrees) * adequate knee range of motion (10-90 degrees) exclusion criteria: * cognitive deficits that would interfere in ability to sign consent and understand the procedures for the study. * history or presence of other neurological pathologies that interfere with movement * received physical therapy within the last 4 weeks prior to the study * history of an acute exacerbation of their ms symptoms within 4 weeks prior to the study * immunosuppressive or steroid therapy within the past 4 weeks * significant spasticity in the legs that interferes with the cycling motion * history of congestive heart failure * coronary artery disease * uncontrolled hypertension * history of epilepsy or seizures * cardiac demand pacemaker or implanted defibrillator * unhealed fractures in the legs * pressure sores or open wounds on the legs * pregnant or trying to conceive

Keywords: functional electrical stimulation cycling
hemodynamic effects of blood flow variation in continuous renal replacement therapy

Conditions: Acute Kidney Injury; End-stage Renal Disease

Summary: purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy.


Eligibility criteria:
inclusion criteria: * age 18-89 * acute renal failure or end-stage renal disease necessitating crrt * admitted to the micu service * if on vasopressor/inotropic agent, norepinephrine as only intravenous pressor * if on vasopressor/inotropic agent, at stable pressor dose for at least four hours * if on iv fluids, stable dose of crystalloids \<= 100cc/hour and is not receiving colloids for 4 hours or more prior to initiation of crrt * mean arterial pressure (map) \>= 65 * arterial catheter present for continuous blood pressure monitoring * crrt duration of 48 hours or less using nxstage system one dialysis system * successfully tolerated crrt for at least 4 hours without clotting or hemodynamic instability * no other procedures, blood products transfusion, or additional medication administration are anticipated during the study period exclusion criteria: * listed for organ transplant * atrial fibrillation, other irregular heart rhythm, unstable arrhythmia * need for more than one intravenous vasopressor agent * intravenous vasopressor/inotropic agent other than norepinephrine (ie dobutamine, dopamine, vasopressin, epinephrine) * therapeutic anticoagulation being administered * known acute myocardial infarction as defined by elevated troponin along with a documented clinical diagnosis during current hospitalization * known acute stroke, intracerebral hemorrhage, intracranial mass effect, or elevated intracranial pressure within the last 30 days. * dialysis catheter malfunction and unable to maintain target blood flow rate * fluid removal (ultrafiltration) rate \> 100ml/hour
non-invasive assessment of wound healing with optical methods

Conditions: Diabetic Foot Ulcers

Summary: the objective of this project is to further the development of a non-invasive optically based nir (near infrared) device to enable the quantitative diagnosis, monitoring and treatment optimization of chronic wounds (especially diabetic) in a clinical setting. the end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel. our animal studies have shown that the early healing of chronic wounds can be characterized by absorption and scattering of light at near infrared wavelengths ranging from 680 nm to 950 nm. if our project is successful we will be providing the clinician the ability to predict if a wound is healing and if a particular treatment is successful in accelerating healing before any changes are observed by wound size contraction or other visible clinical signs. our hope is that the fnir optical device will provide conclusive therapeutic treatment information as early as 5 weeks after initial evaluation, before it would be obvious on gross examination of the patient.


Eligibility criteria:
healthy subject inclusion criteria * subjects must be 18-65 years of age * subjects must have no history of diabetes * subjects must have no history of vascular disease * subjects must have no findings of vascular disease on physical examination * subjects who are not allergic to tegaderm patient subject inclusion criteria: * subjects must be 18-65 years of age * subjects must have documented diabetes mellitus for at least 6 months. * subjects must have at least one documented chronic wound for a minimum 8 weeks. * a chronic wound is defined as any wound that has not healed after 8 weeks and has a minimum surface area of 1cm2. there is no maximum wound size. * wound(s) must be secondary to the complications of diabetes, including vascular disease neuropathy, or both. * wounds must be on the ankles or feet * subjects who are not allergic to tegaderm exclusion criteria * subject must not be \ 65 years of age * subjects with major infections, abscesses, or untreated osteomyelitis will be excluded until appropriately treated. * subjects will not be excluded based upon the existence of other co-morbidities associated with chronic diabetes, including retinopathy, nephropathy, peripheral neuropathy, or cardiovascular disease except as follows: * subjects who have moderate to severe vascular insufficiency (defined as ankle brachial index \<0.75 or toe-brachial index \<0.5) * subjects who are unable to return for weekly follow-up appointments will not be included. * pregnant or lactating people will not be invited to participate. * subjects who are allergic to tegaderm
everolimus in combination with dhap in patients with relapsed or refractory hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the purpose of this trial is 1. to determine the recommended dose of everolimus for a subsequent phase ii trial 2. to determine the efficacy of everolimus plus dhap


Eligibility criteria:
inclusion criteria: * relapsed or refractory hodgkin lymphoma * age 18-60 * histology confirmed relapse exclusion criteria: * previous therapy with mtor inhibitor * current cns involvement * other primary malignant disease within the last 3 years
satisfaction, confidence and naturalness in men with psychogenic erectile dysfunction (ed)

Conditions: Erectile Dysfunction

Summary: context and objectives: erectile dysfunction severely compromises not only sexual satisfaction, which is well known to be closely linked to overall life satisfaction but is also associated with a lower quality of life, lower self-esteem, depression, anxiety and adverse effects on interpersonal relationships. the objective was to assess the efficacy of psychotherapy and/or sildenafil for psychogenic erectile dysfunction. design and settings: randomized controlled single-blind trial performed at institute of psychiatry of the medical school of at universidade de são paulo, são paulo, brazil methods: thirty patients with mild and moderate psychogenic erectile dysfunction (ed) were randomized to receive for six months: group psychotherapy (gp) plus 50mg sildenafil on demand, or 50mg sildenafil exclusively, on demand, or gp exclusively. changes in score from baseline for three questions of the erectile dysfunction inventory of treatment satisfaction (edits) were evaluated at end-point and after 3-months follow-up. results: satisfaction with the treatment, confidence and naturalness increased in gp plus sildenafil and gp exclusively groups (p=0.001) from baseline to endpoint. the treatment-by-time comparison was not significant at end point versus 3-month follow-ups, in the three groups. no difference was observed in the sildenafil group in the three study periods (p \>0.05) conclusions: patients with mild and moderate psychogenic ed had higher treatment satisfaction, confidence and naturalness in engaging in sexual activity when receiving gp plus sildenafil or gp exclusively, when compared with sildenafil exclusively, as assessed by these three edits questions after 6-months treatment


Eligibility criteria:
inclusion criteria: 1. exclusive diagnosis of psychogenic ed, using a checklist for dsm-iv criteria.morning erections, situational erections (masturbatory or with another partner), or acute onset are characteristics of psychogenic ed; 2. age between 25 and 50 years; 3. mild and moderate erectile dysfunction according to the international index of erectile function (iief); 4. stable heterosexual relationship for at least 1 year, and in accordance with inclusion criteria during short-time psychotherapy focused on sexuality; (f) informed consent from the patient. exclusion criteria: patients were excluded if presenting significant clinical diseases, major depressive disorder or other severe mental disorder, primary no erectile sexual disorder (e.g., hypoactive sexual disorder), penile anatomic defects; users of medications that could interfere with sexual function; patients with any kind of physical limitations for the use of sildenafil citrate (current use of nitrates, past history of retinitis pigmentosa, allergies); and significant drug, alcohol or tobacco use

Keywords: erectile dysfunction group psychotherapy sildenafil [substance name] patient satisfaction efficacy randomized controlled trial [publication type]
combined resection vs. separated resection after mobilization of splenic vein during distal pancreatectomy

Conditions: Pancreatic Neoplasms

Summary: eligible patients will be centrally randomized to either arm a (resection of the splenic vein after isolation from the pancreatic parenchyma) or arm b (co-resection of the vein together with the pancreas).

in distal pancreatectomy, it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. this is considered essential to prevent disruption of the stump of the splenic vein and the consequent intra-abdominal haemorrhage in the event of pancreatic fistula. this procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. the objective of this trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during distal pancreatectomy using a mechanical stapler.

Eligibility criteria:
inclusion criteria: * elective open or laparoscopic distal pancreatectomy for diseases of the pancreatic body and tail * ecog performance status (ps) = 0-1 * age ≥ 20 years old * maintenance of functioning of the major organs (bone marrow, liver, kidney, lung, etc.) (a) white blood cells ≥ 2,500/mm3 (b) haemoglobin ≥ 9.0 g/dl (c) platelets ≥ 100,000/mm3 (d) total bilirubin ≤ 2.0 mg/dl (e) creatinine ≤ 2.0 mg/dl (v) sufficient judgement to understand the study and to provide written informed consent exclusion criteria: * splenic vein-preserving distal pancreatectomy * superior mesenteric vein or portal vein invasion * pancreatic trauma * preoperative inflammatory pancreatic disease (pancreatitis) * requirement of anti-coagulant treatment during or after surgery. anti-coagulant treatment at 24 hrs after surgery is allowed. * severe ischemic cardiovascular disease * liver cirrhosis or active hepatitis * need for oxygen due to interstitial pneumonia or lung fibrosis * dialysis due to chronic renal failure * need for surrounding organ resection (stomach, colon, etc.), excluding the left adrenal gland and gall bladder * active multiple cancer that is thought to influence the occurrence of adverse events * difficulty with study participation due to psychotic disease or symptoms * inappropriate use of the stapler * inappropriate for the study objectives
dose-finding study of intranasal midazolam for procedural sedation in children

Conditions: Procedural Anxiety

Summary: dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims: specific aim #1: to determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each dose. specific aim #2: to determine the time to recovery and describe the adverse events associated with each dose.

intranasal midazolam is a common and effective sedative whose use in children presenting to emergency departments has been described. however, the doses of intranasal midazolam used have varied greatly, with no identified optimal dose. doses most commonly described in literature reviews, research studies, and clinical guidelines range from 0.2 to 0.5 mg/kg. there is only one study, retrospective, that compares doses and suggests that clinical efficacy is improved with higher doses, without any clear difference in safety. there is a need for a rigorously-conducted trial to determine the dose of intranasal midazolam that optimizes the adequacy of sedation state without leading to adverse events or compromising emergency department-centric outcomes such as time to onset of sedation and time to recovery. to fill this important and persistent gap in knowledge, the investigator will conduct a dose-finding study using an adaptive trial design to compare intranasal midazolam doses of 0.2, 0.3, 0.4, and 0.5 mg/kg in children undergoing laceration repairs, one of the most common types of minor trauma treated in emergency departments.

Eligibility criteria:
inclusion criteria: * ages 6 months to 7 years old (i.e. before their 8th birthday) * simple laceration * attending physician has decided intranasal midazolam indicated to facilitate repair exclusion criteria: * repair using tissue adhesive (e.g. dermabond) or staples * known or confirmed developmental delay * baseline motor neurological abnormality (e.g. motor deficit, cerebral palsy) * autism spectrum disorder * illness associated with chronic pain * known allergy to midazolam or any other benzodiazepine * eyelid laceration * tongue or intraoral lacerations * nasal obstruction that cannot be easily cleared * does not speak english or spanish * foster children, wards of the state

Keywords: intranasal midazolam pediatric laceration repair sedation anxiolysis adaptive trial design dose finding
a trial comparing a cellulose dressing to two standard of care dressings in treating split thickness donor sites in burn and wound patients.

Conditions: Donor Sites; Wound Heal; Wound Drainage; Pain Management

Summary: this is a three arm study, comparing the novadress, mepilex ag, and xeroform occlusive dressings for healing, drainage, and pain management. novadress is constructed of pure cellulose derived from tree pulp. mepilex ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. xeroform occlusive dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.


Eligibility criteria:
inclusion criteria: * is ≥18 years of age. * has been admitted to the joseph m. still burn center at doctors hospital augusta or the advanced wound clinic, needing a split-thickness skin graft and will undergo a subsequent donor site harvest. * subject is able to provide informed consent. * has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) if available or if stated by patient. exclusion criteria: * has a baux score of ≥130. * subject is intubated, unable to state pain levels. * has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study, * has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding. * vulnerable subjects who, in the opinion of the investigator, present with poor skin integrity (i.e. elderly), is a prisoner, non-english speaking, or is without means of follow-up or return to clinic (i.e. homeless). * is pregnant, plans to become pregnant, or is actively breastfeeding. * active illicit drug use. * is moribund, or in the opinion of the investigator is not expected to survive.
the endurance 1 trial

Conditions: Diabetic Macular Edema

Summary: the endurance trial is a phase iv open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year vista dme (vgft-od-1009) end-point. subjects will be treated with intravitreal aflibercept injections pro re nata (prn) based on the presence of cr-dme (clinically relevant-diabetic macular edema). in addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days.

the safety and tolerability of intravitreal aflibercept injections have been investigated in previous phase i, i/ii and iii studies in amd, rvo, and dme trials. potential safety issues associated with the route of administration or the pharmacology of aflibercept in the study population include decreased bcva, intraocular inflammation, intraocular infection, transient and/or sustained elevation of intraocular pressure (iop), cataract development or progression, retinal or intravitreal hemorrhage, macular edema, retinal break or detachment, and arterial thromboembolic events (ates). safety will be assessed by visual acuity, ophthalmic examinations, fluorescein angiograms, oct, intraocular pressure, vital signs, and adverse event documentation. to minimize the risks of intraocular infections, all injections will be performed employing sterile techniques as described in appendix a. study drug administration will be held for subjects who experience certain ocular events or infections. in the event any subject develops an adverse event in the study eye that is considered by the evaluating physician to be severe in intensity, serious consideration should be given to withdrawing the subject from the study. the pi or designated sub-investigators will review all adverse events on an ongoing basis to determine causality and relationship to study drug and/or study procedures.

Eligibility criteria:
inclusion criteria: 1. enrolled and completed vista dme (vgft-od-1009) clinical trial 2. willing and able to comply with clinic visits and study-related procedures 3. provide signed informed consent 4. enrollment in the trial within 12 weeks of trial activation. exclusion criteria: 1. prior treatment with anti-vegf therapy in the study eye within 28 days of baseline 2. pregnant or breast-feeding women 3. sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[iud\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly). * contraception is not required for men with documented vasectomy. \*\*postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
assessing impacts of static magnetic fields on peripheral pulses and skin blood flow

Conditions: Arterial Stiffness; Magnetic Field Exposure; Peripheral Arterial Disease

Summary: the purpose of this research study is to investigate and determine the effects of static magnetic fields produced by a small magnet on peripheral pulses and skin blood flow.

a specific neodymium magnet and sham device will be placed on certain sites near the ulnar and medial arteries and the effect of such placement on peripheral pulses assessed via ppg on fingers and on skin blood flow via laser doppler perfusion determined. these assessments will be made while healthy subjects are lying supine on a padded examination table over a time interval of about 45-60 minutes. in addition to the impact that either the magnet or the sham devices have, the pulse and skin blood flow patterns and features will be analyzed from the point of view of sequential variability with and eye toward developing related parameters to potentially improve such variability.

Eligibility criteria:
inclusion criteria: 1. age between 18-35 years 2. no known neurological deficit 3. no known cardiovascular condition exclusion criteria: 1. unable or unwilling to lie reasonably still for about 55 minutes 2. known to have diabetes of any type 3. having any metallic or wire implant
effects of prostate cancer on brain function

Conditions: Prostate Cancer

Summary: to explore whether the patients with prostate cancer have functional changes in specific brain areas and changes in psychological and mental characteristics compared with the patients without prostate cancer.

this study was intended to observe the functional changes of brain fmri in patients with and without prostate cancer enrolled in the cohort of patients who planned to undergo prostate biopsy, in an attempt to discover specific brain region changes in patients with prostate cancer, and lay a foundation for further clarifying the relationship and mechanism between brain region function changes and prostate cancer.

Eligibility criteria:
inclusion criteria: 1. between the ages of 18 and 80 2. patients with prostate biopsy; 3. no history of other malignant tumors; 4. exclude other malignant tumors; 5. fully understand the clinical trial protocol and sign informed consent; exclusion criteria: 1. magnetic resonance contraindications; 2. symptomatic acute or chronic inflammation of the prostate; 3. patients with brain trauma or brain disease; 4. patients who have died of other malignancies in the past or are currently suffering from other malignancies; 5. patients judged by the investigator to be unfit to participate in the clinical trial;

Keywords: prostate cancer functional magnetic resonance imaging(fmri) brain function