Kornimate/medical-research-clean huggingface dataset:
a clinical evaluation of an esterified hyaluronic acid matrix in burn patients for stsg

Conditions: Burn Wound

Summary: burn patients meeting inclusion criteria will receive the esterified hyaluronic acid matrix as the matrix for their wound, in conjunction with the standard of care for managing these types of wounds. the study will be divided into two phases. phase i will entail intervention with the wound matrix and will continue until one of the following occur, sufficient granulation has occurred and the patient can receive a stsg and proceed to phase ii, the patient's physician determines an stsg is no longer necessary or two applications with the wound matrix occur and no stsg is approved. phase ii will begin following the stsg procedure. in this phase, the wound will be monitored and proportion of stsg take will be evaluated but no application of the wound matrix device will take place. this phase will continue for 28 days or if the physician deems the patient no longer needs regular care to monitor the wound, whichever occurs earlier.


Eligibility criteria:
inclusion criteria: * has a wound originating from a thermal or electrical burn * target burn area is less than 20% of tbsa * target burn wound is greater than 0.5% of tbsa * patient has undergone escharectomy procedure or will undergo escharectomy on the target burn and resulting wound will likely need a split thickness skin graft, but wound site is not immediately ready for grafting * for patients with diabetes, an a1c hemoglobin level between 11 percent (taken within 90 days) exclusion criteria: * current active diagnosis of substance abuse, per the investigator * patient currently taking non-inhaled corticosteroids * patient needs or is likely to need negative pressure wound therapy of the target wound after application of hyalomatrix wound device * patient is pregnant, planning to become pregnant during study period, or breastfeeding * unstable medical condition as determined by the site investigator * patients with known sensitivities to hyaluronan, hyaluronan derivatives, silicone, or any other ingredients of the hyalomatrix wound device
the influence of hyperbaric oxygen in patients with perianal crohn's disease already treated with tnf alpha blockers treated with tnf alpha blockers

Conditions: Crohn's Disease; Perianal Fistulas

Summary: the aim of this study is to evaluate the effect of hyperbaric oxygen therapy (hbot) on patient suffering from residual crohn's disease related perianal fistulas already treated with tnf alpha blockers

this study is a prospective open-label study that consists three periods: screening, treatment and follow-up. after signing an informed consent, subjects will be assessed by a gastroenterologist, a surgeon (for the diagnosing the perianal disease and assessing the need for surgery) and a hbot specialist for assessing the capability of the subject to undergo hbot treatment.after the screening period, eligible subjects will enter an 8 weeks hbot treatment period, combined with tnfalpha blocker treatment. this period will be followed by a 4 months follow-up period in which treatment with tnfalpha blocker will continue. all patients will have an mri and trus examinations to assess the fistulas and also blood tests for cbc, chemistry, inflammatory markers and cytokine analysis. same evaluation will be repeated at the end of the study.

Eligibility criteria:
inclusion criteria: patients aged 18 and above that suffer from crohn's disease one or more perianal draining fistulas for at least 3 months currently receiving a tnfalpha blocker for at least 3 months (without improvement of the perianal disease) exclusion criteria: pregnancy or plans to conceive during the next year inability (such as previous adverse effects, tuberculosis, concurrent infection etc.)or unwillingness to start or continue with tnf alpha blockers treatment. any past or current malignancy treatment with hbot in the last year claustrophobia middle ear problems inability to equalize pressure in the middle ear medical status that precludes treatment with hbot such as chest x-ray abnormality, epilepsy, severe congestive heart failure, uncontrolled diabetes or uncontrolled hypertension any perianal surgery in the last 6 months any change in crohn's disease medications in the last 3 months

Keywords: crohn's disease perianal fistulas tnf alpha blockers hyperbaric oxygen therapy
southwest german interventional study in acute myocardial infarction iii

Conditions: Acute Myocardial Infarction

Summary: siam iii was a multicenter, randomized, prospective, controlled trial in patients with st-elevation myocardial infarction receiving fibrinolysis \<12 hours after onset of symptoms. patients of the early pci group were transferred within 6 hours after fibrinolysis for pci. the conservative group received elective pci two weeks after fibrinolysis.

siam iii was a multicenter, randomized, prospective, controlled trial in patients with st-elevation myocardial infarction receiving fibrinolysis \<12 hours after onset of symptoms. all patients received reteplase, aspirin in combination with ticlopidin, and heparin. patients of the early pci group were transferred within 6 hours after fibrinolysis for pci. the conservative group received elective pci two weeks after fibrinolysis. in total 197 patients were included, 163 were treated by pci. the primary end point was the composite of ischemic events, death, reinfarction, and target lesion revascularization.

Eligibility criteria:
inclusion criteria: * symptoms of mi present for 12 h * st segment elevation of at least 1 mm in two or more limb leads, * st segment elevation of at least 2 mm in the precordial leads, * or new bundlebranch block * patients eligible for thrombolysis * informed consent for participation exclusion criteria: * secondary or iatrogenic infarction * chronic renal insufficiency requiring dialysis * coronary anatomy unsuitable for stent placement * anticipated indication for surgical coronary revascularization within 6 months * previous mi in the area of the infarct related vessel * infarct related lesion not clearly defined

Keywords: acute myocardial infarction thrombolysis percutaneous coronary interention
the diagnostic value of autoimmune antibody detection in newly onset and chronic epilepsy

Conditions: Epilepsy

Summary: multi-central and prospectively study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy, and provide reference for clinical practice

multi-centrally recruit patients with newly onset or chronic epilepsy and hoping to find whether there exist an autoimmune cause. whether the patients receive immune therapy or not will depend on the type and titter of the autoimmune antibody as well as the severity of the symptom. at 3 and 6 months later, all patients will be followed-up, and the positive autoimmune antibody will be redetected. the clinical manifest, clinical data, medication and treatment outcome will be recorded and analyzed, to study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy

Eligibility criteria:
inclusion criteria: * patients diagnosed with epilepsy according to the diagnostic criteria of international league against epilepsy (ilae) 2017 * age from 16 to 70 years old * the etiology of patients with epilepsy is unknown * the patient or guardian signs an informed consent and can cooperate with the inspection and follow-up for six months exclusion criteria: * patients with hereditary, infectious, and metabolic epilepsy * the investigation and follow-up cannot be completed due to vision, hearing, language expression, disturbance of consciousness, and impaired understanding, and the guardian cannot replace the completed * patients with other progressive or systemic diseases

Keywords: epilepsy autoimmune antibody diagnose
a study of single dose of abt-333 in healthy male adults

Conditions: HCV Infections

Summary: the objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of abt-333 under nonfasting conditions in healthy male adult in japan.


Eligibility criteria:
inclusion criteria: * subject has provided written consent. * subject is in general good health. exclusion criteria: * see above for main selection criteria.

Keywords: healthy volunteers
chemotherapy, hormone therapy, and surgery to remove the prostate gland in patients with high risk prostate cancer

Conditions: Prostate Cancer

Summary: in men with prostate cancer who do not have evidence of spread to bone or other sites on computed axial tomography (cat) scan/bone scan but are still at significant risk of failing treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy is being given for 6 months followed by surgery to remove the prostate.


Eligibility criteria:
inclusion criteria: * high risk prostate cancer without evidence of bone metastasis.

Keywords: prostate cancer chemotherapy hormone therapy surgery psa gleason score
spinal cord stimulation for restoration of arm and hand function in people with subcortical stroke

Conditions: Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases

Summary: the goal of this study is to verify whether electrical stimulation of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. participants will undergo a surgical procedure to implant a system which provides epidural electrical stimulation (ees) of the cervical spinal cord. researchers will quantify the ability of ees to recruit arm and hand muscles and produce distinct kinematic movements. the implant will be removed after less than 30 days. results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neurorehabilitation programs to restore upper limb motor function in people with subcortical strokes, thereby increasing independence and quality of life.

specifically, researchers will 1) quantify the motor potentials in arm and hand muscles generated by single pulses of electrical stimulation of the spinal cord using fda-cleared devices 2) characterize optimal stimulation parameter ranges to maximize induced arm and hand movement, 3) measure neural changes that could be induced by the system, 4) characterize potential clinical effects by assessing patient mobility, spasticity, and neurophysiology with standard clinical tests and simple motor tasks.

Eligibility criteria:
inclusion criteria: 1. single, ischemic or hemorrhagic stroke resulting in upper extremity hemiparesis more than 6 months prior to the time of enrollment. (prior strokes that did not cause upper extremity motor deficits are not exclusionary.) 2. participants must be between the ages of 21 and 70 years old. 3. scores higher than 7 and lower than 50 on the fugl-meyer scale exclusion criteria: 1. serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect the ability to participate in study activities. 2. pregnancy or breast feeding. 3. receiving anticoagulant, anti-spasticity or anti-epileptic medications throughout the duration of the study. 4. presence of any implanted medical devices. 5. severe claustrophobia. 6. presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities 7. results from the brief symptoms inventory (bsi-18) and additional discussions with the principal investigator and a study physician that deem participant inappropriate for the study. 8. evaluation to sign consent form score \<12.
structured home-based exercise versus walking advice in claudication patients: a randomized-controlled trial

Conditions: Peripheral Artery Disease

Summary: a recent position paper calls for effective home-based exercise program for patients with peripheral artery disease (pad) and claudication to be implemented in real-world care. this randomized-controlled trial aims to test the effects on mobility, hemodynamics and cardiovascular outcomes of a structured home-based exercise program (shb) compared to walking advice (wa) recommendation intended as usual care, in pad patients. male and females pad patients at leriche-fontaine's stage ii and aged more than 60 years old will be enrolled. patients will be randomized in shb or wa groups. patients of shb group will receive a prescription of a home-based walking program during serial testing sessions at the hospital. the program will include two 10-minute sessions/day (6 days/week) of intermittent walking (1-minute work and 1-minute rest while seated) at a prescribed speed converted into a walking cadence and followed at home using a metronome. two follow-up visits (at weeks 8 and 16) will be performed to evaluate patient adherence and to update the exercise program by increasing the walking speed. patients randomized in wa group will receive the advice to walk as suggested by the guidelines. in particular, patients will be recommended to gather almost 30 minutes of walking at least 3 times per week; when they will face claudication pain, they will be allowed to rest and restart walking as soon as possible. outcome measures will be performed at the entry prior to randomization, at the end of exercise programs (6-month) and after 12-month follow up. primary outcomes will be the pain-free walking distance and the 6-minute walking distance collected during the 6-minute walking test secondary outcomes will include ankle-brachial index, quality of life, lower limb strength and long-term clinical outcomes including revascularization and mortality.


Eligibility criteria:
inclusion criteria: * male and females aged \> 60 years old * peripheral artery disease at leriche-fontaine's stage 2a or 2b * cognitive functioning to give informed consent identified by a mini mental status examination score ≥18/30. exclusion criteria: * peripheral artery disease at leriche-fontaine's stage 1 * peripheral artery disease at leriche-fontaine's stage 3 or more * severe cardio-respiratory conditions (e.g. unstable angina; severe heart failure identified by new york heart association class iii or iv) * neurological or musculoskeletal conditions (e.g. above knee amputation) contraindicating or inhibiting exercise training. * very good exercise capacity determined by a 6-minute walking distance \> 500 meters.

Keywords: exercise rehabilitation exercise testing
effects of osteopathic manual therapy on infant colic

Conditions: Colic, Infantile

Summary: infant colic (cl) is a common disorder that affects approximately 8-33% of newborns during the first months of life. typically defined as "crying that lasts at least 3 hours a day, and occurs at least 3 days a week over a 3-week period." osteopathic manual therapy is presented as an effective and safe alternative to cl treatment. the main objective of the study is to quantify possible changes in daily crying hours and hours of sleep, the severity of cl, the frequency of episodes, changes in stool and possible adverse effects. the study hypothesis argues that the application of osteopathic manual therapy in babies with cl produces an improvement in the hours of daily crying, the frequency of episodes, the severity of colic and the hours of sleep. a controlled rct will be performed where the evaluator and the parents will be blinded with respect to the allocation group for each subject. subjects who meet the inclusion and exclusion criteria will be randomly assigned to the experimental group (eg) and control group (cg) using a table of random numbers by a person from outside the research. the eg diagnosis treatment using techniques of osteopathic manual therapy, vertebral mobilization, cranial techniques and visceral mobilization, according to the diagnostic criteria of the therapist. the cg has no treatment. a total of 3 procedures were performed, one per week, problems with the chronology in all groups (days 0, 7 and 14 if required). the therapist in charge of performing the operations will be a physiotherapist and osteopath with more than 10 years of experience. the evaluations will be carried out by a healthcare professional with more than 10 years of experience. the evaluator will be blinded. parents blinded with respect to the allocation group of each subject until the end of the study. to analyze the main variable of the study (total hours of excessive crying per day), use the crying diary completed by the parents. the infantile colic severity questionnaire (icsq) will be applied to evaluate the secondary variables (sleep, feces, frequency of episodes and severity of colic).


Eligibility criteria:
inclusion criteria: * inconsolable crying for more than 3 hours a day, at least 3 days a week for at least 3 weeks. * age 2 - 12 weeks. * gestation equal to or greater than 38 weeks. * birth weight equal to or greater than 2,500 grams. * weight gain of at least 150 grams. per week. * appropriate pediatric general physical examination (height, weight, head circumference and psychomotor development). * sign the informed consent. exclusion criteria: * signs and / or symptoms of other pathologies. * signs of lactose intolerance. * having had benefits with the withdrawal of milk from maternal feeding or the use of milk with hydrolyzed casein. * having received the subjects and / or siblings, previous treatment with osteopathy and / or chiropractic. * contraindication to the treatment and / or some of its techniques; presence of congenital malformations.
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for sci

Conditions: Spinal Cord Injuries

Summary: this trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of spinal cord injury.

studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (sci). this patient funded trial aims to study the safety and efficacy of intravenous and intrathecal delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of sci. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of spinal cord injury * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur * anticoagulation medicine use

Keywords: spinal cord injury sci stem cell treatment
1% metformin in moderate and severe periodontitis

Conditions: Periodontitis

Summary: this study evaluates the efficacy of 1% metformin gel in treatment of moderate and severe periodontitis subject.

metformin (mf) has stimulating effect of osteoblastic lineages. in the present study seventy subjects were categorized into two treatment groups: scaling and root planing (srp) plus 1% mf and srp plus placebo. clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (pi), modified sulcus bleeding index (msbi), probing depth (pd), and clinical attachment level (cal). radiologic assessment of intra bony defect (ibd) and percentage defect depth reduction (ddr%) was done at baseline, 6 months and 9 months interval using computer-aided software. pd, cal and defect depth reduction was evaluated in initial pocket depth of ≥5mm and ≥7mm subgroup within placebo and mf group. mean probing depth reduction and mean clinical attachment level gain was found to greater in mf group than placebo group at all visits. significantly greater mean percentage of defect depth reduction was found in mf group than the placebo sites in both ≥5mm and ≥7mm of initial periodontal pocket depth. in mf group improvement in clinical parameter were similar in both the sites, with slightly better improvement in clinical parameters in initial pocket depth ≥7mm with respect to cal, ibd and ddr% while pd was significantly reduced in initial pocket depth of ≥7mm. there was greater decrease in msbi and pd and more cal gain with significant ibd depth reduction at the sites treated with srp plus locally delivered mf in chronic periodontitis subjects with intrabony defects as compared to placebo and effect of mf was similar in initial moderate periodontal pockets and deep pocket depths.

Eligibility criteria:
inclusion criteria: * systemically healthy subjects, pocket depth ≥ 5 mm, clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months. exclusion criteria: * subjects allergic to mf, those on systemic mf therapy, subjects with aggressive periodontitis, immunocompromised subjects, use of tobacco in any form, alcoholics, lactating and pregnant females.

Keywords: metformin pocket depth moderate periodontitis severe periodontitis
study of tdcs for mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the primary objective of this study is to investigate whether the transcranial direct current stimulation (tdcs) improves the cognitive function in patients with mild cognitive impairment (mci)

twenty-four patients were recruited and randomized to receive either real- or sham-tdcs over the left (anode) and right (cathode) dorsolateral prefrontal cortex (dlpfc). their legally responsible caregivers were provided with mobile tdcs device, and were instructed to use it on the patients at the hospital. 30-minute session of the stimulation were applied 3 times a week for 12 weeks. the patients were evaluated at baseline and at week 12.

Eligibility criteria:
inclusion criteria: * subjects who have a subjective memory impairment * subjects who have korean version of mini mental status examination score 22 or more * subjects who have svlt and rcft delayed recall test scores lower than 1.5sd * subjects who have had other cognitive impairments besides memory * subjects who have seoul-instrumental activities of daily living score (s-iadl) of 8 or lower * subjects who are not dementia of alzheimer's type * subjects who are right-handed * subjects who are able to read and write * subject or legally responsible caregiver has provided informed consent exclusion criteria: * subjects who have a history of stroke and seizures * subjects who have any illnesses that may disturb the patients completing the trials, including stroke, parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a treatment ischemic attack. * subjects who have neurologic problems on physical examination that cuase memory disturbances * subjects who have a history of dsm-iv axis i disorders * subjects who have extremely sensitive skin * subjects who have suffered from the cancer in 3 years * subjects who have had a cerebrovascular neurosurgery in medical history * subjects who have dyspnea in sitting position * subjects who have problems with memory, language and problem-solving for 2 hours after the heart attack. * subjects who have a history of drug or alcohol abuse (in the past 5 years) * subjects who have a history of mental or emotional disorders (in the past 5 years) * subjects who have been lapsed into unconsciousness for an hour because of other reasons than general anesthesia * subjects who have a history of hospitalization due to head injury * subjects who are unable to read even with glasses * subject who are unable to understand the conversation due to the hearing defect (even with the hearing aid)

Keywords: transcranial direct current stimulation tdcs mild cognitive impairment mci