Kornimate/medical-research-clean huggingface dataset:
impact of a telerehabilitation program with technology enhancement on post-burn recovery

Conditions: Burns

Summary: the purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.

this is a prospective single center randomized trial comparing a traditional approach to physical therapy to a technology-enhanced approach following a burn. we hypothesize that with the implementation of a novel telerehabilitation program incorporating technology enhancement, range of motion and quality of life can be improved. to test the hypothesis in future grant applications, this pilot study will be used to determine feasibility, collect preliminary data, vet endpoints, and gain patient feedback. to achieve these necessary goals, we will compare two methods of supporting home performance of prescribed physical and occupational therapy: standard (s): patients will be equipped with paper instructions for their physical therapy exercises; and technology-enhanced (te) support: patients will be given paper instructions, set up with a habit and productivity application (avocation) that gamifies tasks and tracks achievements, a fitbit activity tracker, a logbook, and have virtual movement therapy once weekly with an exercise physiologist for a total of four weeks. specific aim 1: to determine whether range of motion is altered with te. range of motion in the affected joint(s) will be measured by goniometry (self-reported by patient and measured by study staff in the clinic) specific aim 2: to determine whether te with prescribed movement affects scar, pain, and quality of life.

Eligibility criteria:
inclusion criteria: * adults: ≥18 to ≤79 years of age * not participating in another interventional trial * admitted to the blocker burn unit for treatment of initial burn * subject is able and willing to follow the protocol requirements * burn wound / scar / contracture occurring across at least one joint. * has regular access to smart phone, tablet, or computer with internet access. exclusion criteria: * any medical condition that, in the opinion of the investigator or physician, would place the subject at increased risk for participation. * concurrent participation on another interventional clinical trial * history of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions. * patients without internet access.
the efficacy and safety of a chinese herbal medicine for long covid associated fatigue

Conditions: Long COVID

Summary: this is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a chinese herbal medicine (shenlingcao oral liquid) for treating long covid associated fatigue.

this is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a chinese herbal medicine (shenlingcao oral liquid) for treating long covid associated fatigue. our target population is adults (18-65 years old) with a covid-19 infection history and have moderate to severe fatigue symptom at least 4 weeks after infection. the total sample size is 152. all participants will be randomly attributed to treatment group or placebo group in 1:1 ratio. the treatment duration is 4-week, and the follow-up period is also 4 weeks. shenlingcao oral solution has been registered and marketed in mainland china, it is a safe product and pervious studies suggested it has anti-fatigue function. the primary efficacy outcome is the change of scores of chalder fatigue scale (0-33 points) after 4-week treatment. the primary safety outcome is the number of adverse events. this study will be conducted in hong kong baptist university mr. \& mrs. chan hon yin chinese medicine specialty clinic and good clinical practice centre.

Eligibility criteria:
inclusion criteria: 1. 18-65 years adults 2. fulfill the long covid diagnostic criteria by centers for disease control and prevention (cdc) 3. chalder fatigue scale (0-11) not less than 4 exclusion criteria: 1. have any medical history that may cause fatigue before covid-19 infection, which include but not limited to cardiovascular diseases, chronic lung diseases, dyspnea, cognitive diseases, psychological diseases, chronic liver or renal diseases, cancer, etc. 2. must chronically taking medicines that may affect the study results. 3. severe obesity (bmi not less than 45) 4. alcoholism or drug abuse 5. allergy to chinese medicine 6. pregnancy, or plan to be pregnant, or lactating women

Keywords: fatigue chinese herbal medicine
first-in-man study of the cerebrovascular interventional procedural control system

Conditions: Acute Ischemic Stroke

Summary: the objective of this study the first human use of a new device in treatment of acute ischemic stroke, which to evaluate the feasibility, safety, and efficacy of the cerebrovascular interventional procedural control system.


Eligibility criteria:
inclusion criteria: 1. age 18-80. 2. diagnosed with acute ischemic stroke. 3. arterial occlusion in the anterior cerebral circulation that was confirmed by cta or mra. 4. subject could be treated intraarterially within 8 hours after symptom onset. 5. prestroke modified rankin score ≤ 1. 6. national institutes of health stroke scale (nihss) ≥6 and ≤20. 7. patients or their legally authorised representatives provided signed, informed consent. exclusion criteria: 1. ncct aspect score \<6，or the infarct volume exceeded 1/3 of the middle cerebral artery blood supply area. 2. ct/mr showed midline shift or cerebral hernia, and ventricle occupying effect. intracranial hemorrhage. cta/mra shows carotid artery dissection, severe stenosis, or complete occlusion, which requiring carotid stent implantation during thrombectomy; bilateral acute stroke or multiple intracranial large vessel occlusion. 3. females who are pregnant or lactating. 4. severe allergy to contrast agents, nickel-titanium metal or its alloys. 5. drug-resistant hypertension (defined as sustained systolic blood pressure \>185mmhg or diastolic blood pressure \>110mmhg). 6. hemorrhagic tendency (including but not limited to platelet \ 1.7). 7. surgery or biopsy of parenchymal organs within the last 1 month 8. any active or recent bleeding (gastrointestinal, urinary, etc.) within the last 1 month 9. undergoing hemodialysis or peritoneal dialysis; exist of severe renal insufficiency (serum creatinine \>220umol/l or 2.5mg/dl) 10. previous intracranial hemorrhage, subarachnoid hemorrhage, brain tumor. 11. life expectancy of less than 1 year. 12. enrollment in another clinical trial evaluating other devices or drugs during the same period. 13. abnormalities or diseases that the investigator considers to be excluded from the study's coverage.
study of the tolerability of different sar153191 drug products, that differ with respect to manufacturing processes and formulation, at different concentrations and doses in healthy male subjects

Conditions: Rheumatoid Arthritis

Summary: primary objective: to determine the tolerability of different sar153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects. secondary objectives: to determine the pharmacokinetic profile of the different sar153191 drug products administered subcutaneously. to assess the safety of the different sar153191 drug products administered subcutaneously.

up to 35 days

Eligibility criteria:
inclusion criteria: * having given written informed consent prior to any procedure related to the study. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * any subject who, in the judgment of the investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study of barzolvolimab in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with atopic dermatitis

this is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (cdx-0159) in adult participants with atopic dermatitis. there is a screening period of up to 28 days, a 16-week double-blind, placebo-controlled treatment period, a 16-week double-blind, active treatment period, and a 16-week follow-up period. on day 1, participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (cdx-0159) by subcutaneous injections of 150 mg every 4 weeks (q4w) after an initial loading dose of 450 mg \[arm 1\], 300 mg q4w after an initial loading dose of 450 mg \[arm 2\], or placebo q4w \[arm 3\]. at week 16, participants on placebo will be re-randomized on a 1:1 ratio to receive barzolvolimab by subcutaneous injections of 150 mg every 4 weeks (q4w) after an initial loading dose of 450 mg, 300 mg q4w after an initial loading dose of 450 mg. participants on arms 1 and 2 will undergo a mock re-randomization at week 16 to maintain the blind.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age 2. diagnosis of chronic atopic dermatitis (ad) for at least 1 year 3. onset of symptoms at least 1 year prior and current symptoms consistent with moderate to severe ad as defined by: 1. easi ≥ 12 at visit 1 and easi ≥ 16 at visit 2 2. body surface area of involvement (bsa) ≥ 10% at visit 1 and visit 2 3. iga score ≥ 3 at visit 1 and visit 2 4. severe itch, defined by weekly average of daily pp-nrs score of ≥ 5, during the 7 days prior to treatment 4. documented history of inadequate response to treatment with topical medications or for whom topical medications are otherwise medically inadvisable. 5. willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule. exclusion criteria: 1. any other active pruritic skin diseases that would confound ad assessments based on the investigator's clinical judgment. 2. phototherapy with ultraviolet (uv) a or uvb within 4 weeks of visit 1. 3. planned or anticipated use of any prohibited medications at any time during the study. 4. prior receipt of barzolvolimab or other anti-kit therapy. there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Keywords: ad atopic dermatitis eczema barzolvolimab cdx-0159 cdx0159-15
comparison of glycemic control achieved with 2 different needles

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the 29 gauge x 12.7 mm needle in obese subjects with diabetes.


Eligibility criteria:
inclusion criteria: * diabetes mellitus * current treatment with insulin or insulin analogues for the last 6 months * bmi greater than or equal to 30.0 kg/m2 * currently injecting in the thigh or abdomen * hba1c below 10% exclusion criteria: * severe, uncontrolled hypertension * self-mixing insulin * unwillingness to monitor blood glucose * pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures
rotation of hydrophobic acrylic lenses - rayner ra0800c & alcon clareon & hoya nanex & hoya vivinex xy1-em & rayone emv toric & podeye toric

Conditions: Age Related Cataracts; Astigmatism

Summary: the investigational devices are approved intraocular lenses (iol) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. within the study, three different iols will be investigated and separately evaluated. cataract surgery with iol implantation will be performed in subjects who have signed an informed consent form. postoperative examinations will be postoperative refraction, visual acuity, slitlamp examination, and rotation of the iol within 1 hour, 1 week, 1 month and 4-7 months. in the alcon clareon toric, rayone emv toric and podeye toric group, patients receive a toric iol according to their preoperative astigmatism


Eligibility criteria:
inclusion criteria: * uni- or bilateral age-related cataract necessitating phacoemulsification extraction and posterior iol implantation * age: 45 to 95 * need for spherical iol correction between 10.00 and 30.00 d * need for spherical iol correction between +6.00 and +30.00 d (alcon clareon toric group) * need for spherical iol correction between +10.00 and +25.00 d (rayner rayone emv toric group) * preoperative pupil dilation in mydriasis ≥ 7.0 mm (hoya, rayner groups) * astigmatism of at least 1.0 diopters (alcon clareon toric and rayner rayone emv toric groups and podeye toric) * pupil dilation \>5.5mm (alcon clareon toric rayner rayone emv toric group) exclusion criteria: * preceding ocular surgery or trauma * recurrent intraocular inflammation of unknown etiology * uncontrolled glaucoma * uncontrolled systemic or ocular disease * blind fellow eye * microphthalmus * corneal abnormality (corneal scaring) * history of uveitis/iritis * iris neovascularization * proliferative diabetic retinopathy * pregnancy * lactation * females of childbearing age will be asked if pregnancy is possible
a pilot study of vitamin k2 (menaquinone-7, soloways ™) in patients with osteopenia/osteoporosis carrying a vdr gene variant

Conditions: Osteoporosis; Osteopenia

Summary: this pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of vitamin k2 (menaquinone-7, mk-7) supplementation in patients with low bone mineral density (osteopenia or osteoporosis) who carry a specific "unfavorable" variant in the vitamin d receptor (vdr) gene (e.g., bsmi or apai polymorphisms). the trial will compare improvements in bone health and related biomarkers between two cohorts: (1) homozygous carriers of the vdr variant and (2) non-variant carriers (wild-type). investigators hypothesize that mk-7 supplementation will lead to greater improvements in bone mineral density (bmd) and bone turnover markers in the homozygous variant group due to their potentially reduced baseline response to vitamin d signaling.

vitamin d receptor (vdr) polymorphisms have been associated with varying responses to vitamin d and calcium supplementation, ultimately influencing bone health. menaquinone-7 (vitamin k2) is crucial for carboxylation of osteocalcin, facilitating calcium deposition in bone. this study investigates whether individuals with an "unfavorable" vdr gene variant - who might have lower basal responsiveness to vitamin d - experience enhanced benefit from mk-7 supplementation in conjunction with a standard vitamin d3 regimen. by focusing on this genotype-stratified approach, the study aims to generate preliminary data supporting the role of personalized supplementation strategies in skeletal health.

Eligibility criteria:
inclusion criteria: * adults aged 40-75 years with a confirmed dxa-based diagnosis of osteopenia or osteoporosis (t-score ≤ -1.0). * stable dietary habits and willingness to maintain current exercise regimen throughout the study. * willingness to undergo genotyping for the vdr variant. for the vdr variant cohort: confirmed homozygous "unfavorable" variant (e.g., bsmi or apai). * for the non-variant cohort: confirmed absence of the "unfavorable" allele (wild-type). exclusion criteria: * current or recent (last 3 months) use of high-dose bisphosphonates, anabolic agents (e.g., teriparatide), or selective estrogen receptor modulators (serms). known allergy or hypersensitivity to vitamin k or vitamin d supplements. * severe renal or hepatic dysfunction, uncontrolled hyperthyroidism, or other significant comorbidities that could confound bone metabolism assessments. * pregnancy or breastfeeding. * inability or unwillingness to provide informed consent or to comply with study procedures.

Keywords: osteopenia osteoporosis supplements vitamin k2 vitamin d
a study of the effects of sitagliptin (mk0431) and metformin on incretin hormone concentrations (0431-050)(completed)

Conditions: Type 2 Diabetes

Summary: this study will determine the effect of concomitant administration of sitagliptin and metformin on post-meal incretin hormone concentrations in healthy adults.


Eligibility criteria:
inclusion criteria: * subject is in good health * subject has been a nonsmoker for at least 6 months * subject is willing to avoid strenuous activity from the screening visit until the end of the study * subject agrees not to consume grapefruit products during the study and to avoid all fruit juices 24 hours before and after study drug administration exclusion criteria: * any history of stroke or neurological disorder * subject has a history of cardiovascular, blood, endocrine or liver diseases * subject has a history of cancer
effects of electric massage on the cervical region in subjects diagnosed with temporomandibular disorders

Conditions: Temporomandibular Disorders

Summary: to know the short-term effects of electric massage applied on the cervical region combined with local techniques on the temporomandibular joint versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders.

this study aims to know the short-term effects of electric massage applied to the cervical region combined with local techniques on the temporomandibular pain versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders. this is a prospective, controlled, single-blind clinical trial of 46 subjects randomly divided into two groups: group 1 manual therapy=21; group 2 interferential massage plus manual therapy=25. group 1 will receive manual therapy consisting of techniques of ischemic compression on masseter muscles and soft-tissue release technique over the temporal región. group 2, in addition to the intervention in group 1, will receive electric massage with interferential currents at the cervical level. pain related measures (visual analogue scale oral, pressure pain threshold (ppt)), vertical mouth opening as primary outcome measures and cervical range of motion as secondary outcomes were assessed. the assessments were made before the intervention, immediately after and after 4 weeks of follow-up.

Eligibility criteria:
inclusion criteria: * consent of the subject to participate in the study. * a primary diagnosis of myofascial pain according to axis i, category ia and ib (i.e. myofascial pain with or without limited opening) of the research diagnostic criteria for tmd (rdc ⁄ tmd) (schiffman e, ohrbach r, truelove e, et al. diagnostic criteria for tempormandibular disorders (dc(tmd) for clinical and research applications: recommendations of the international rdc/tmd consortium network\* and orofacial pain special interest group. j oral facial pain headache. 2014;28(1):6-27"). * bilateral pain involving the masseter and temporal regions; presence of at least one trigger point (trp) in the masseter muscle. * pain symptoms history of at least the 3 months previous to the study. * intensity of the pain of at least 30 mm on a 100 mm visual analogue scale (vas). * a score of less than 45 points on the personal psychological apprehension scale (ppas). it has been validated in the scope of physiotherapy, and represents a simple-to-handle tool in studies where subjects may undergo electrotherapy as a treatment option. exclusion criteria: * surgical intervention of the temporomandibular joints (tmj). * suffering some intra-articular damage (arthritis) or some vestibular disorder diagnosed. * inflammation of the tmj. * having received physiotherapy treatment in the last two weeks. * receive pharmacological treatment for analgesic, anti-inflammatory or that could cause alterations of equilibrium.

Keywords: temporomandibular disorders electric massage temporomandibular joint local techniques
g-csf+dac+bucy vs g-csf+dac+bf conditioning regimen for high-risk mds undergoing allo-hsct

Conditions: Myelodysplastic Syndrome; Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning

Summary: allo-hsct is the most effective way to cure high-risk mds patients. at present, the best conditioning regimen for high-risk mds patients undergoing allo-hsct remains in discussion. in this prospective study, the safety and efficacy of g-csf+dac+bucy and g-csf+dac+bf conditioning regimens in high-risk mds patients undergoing allo-hsct are evaluated.

allo-hsct is the most effective way to cure high-risk mds patients. at present, the best conditioning regimen for high-risk mds patients undergoing allo-hsct remains in discussion. a previous study by the investigators has showed that g-csf +dac+bucy conditioning regimen could reduce the relapse and improve the survival compared with bucy conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (nrm). several retrospective and prospective studies have demonstrated that bf conditioning regimen has a lower nrm compared with bucy conditioning regimen, while the relapse and survival are similar in patients undergoing bf and bucy conditioning regimens. based on the above, the investigators design the prospective randomized controlled study to evaluate the safety and efficacy of g-csf+dac+bucy and g-csf+dac+bf conditioning regimens in high-risk mds patients undergoing allo-hsct.

Eligibility criteria:
inclusion criteria: * had a diagnosis of raeb-1 or raeb-2 with ipss-r \>3 * age 18 to 65 years old * ecog performance status of 0-2 * hct-ci of 0-2 * were willing to undergo allo-hsct exclusion criteria: * therapy-related mds * previous allo-hsct * uncontrolled infections * liver or renal dysfunction * severe concomitant conditions not suitable for the trial
reliability of basdai and basfi applied by tele-assessment method in axial spa spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: the goal of this observational study is to investigate the reliability of basdai and basfi questionnaires applied via tele-assessment in axial spondyloarthritis patients.

telehealth is the provision of healthcare services and clinical practices remotely through information and communication technologies. in recent years, the use of telehealth applications has increased worldwide. telehealth is an umbrella term that covers practices such as telemedicine, telerehabilitation, and tele-assessment. tele-assessment has gained importance in terms of monitoring patients with chronic diseases. although basdai and basfi have been shown to be valid and reliable in as patients, there is no study in the literature examining the reliability of basdai and basfi applied via tele-assessment. the aim of our study is to investigate the reliability of basdai and basfi questionnaires administered via tele-assessment in axial spa patients.

Eligibility criteria:
inclusion criteria: * being diagnosed with axial spondyloarthritis according to the assessment in spondyloarthritis international society (asas) criteria * volunteering to participate in the study * being between the ages of 20-60 exclusion criteria: * having another systemic, orthopedic, neurological or cognitive disease other than axial spondyloarthritis * pregnancy * the patient wishes to withdraw from the study

Keywords: axial spondyloarthritis basdai basfi self assessment tele-assessment reliability