Kornimate/medical-research-clean huggingface dataset:
dynamic annuloplasty system with activation for the treatment of mitral regurgitation

Conditions: Mitral Valve Regurgitation

Summary: the device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.


Eligibility criteria:
inclusion criteria: 1. this patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement. 2. this patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair. 3. this patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively). 4. this patient is geographically stable and willing to return to the implant center for follow-up visits. 5. this patient has been adequately informed of his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol. exclusion criteria: 1. this patient is less than eighteen (18) years of age. 2. this patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months. 3. this patient has an ejection fraction \< 30%. 4. this patient has a heavily calcified annulus or leaflets. 5. this patient presents with active endocarditis or has had active endocarditis in the last 3 months. 6. this patient is pregnant (urine hcg test result positive) or lactating. 7. this patient is an intravenous drug abuser or alcohol abuser. 8. this patient has a previously implanted prosthetic mitral valve. 9. this patient requires mitral valve replacement. 10. this patient has a creatinine level \> 2.0 mg/dl 11. this patient has had congestive heart failure within the past 6 months requiring surgical treatment. 12. this patient has had a coronary artery ischemic event within the past 6 months. 13. this patient has a known life threatening, non-cardiac disease that will limit the patient's life expectancy to less than one year. 14. this patient is unable to take coumadin. 15. this patient has a known untreatable allergy to contrast media or nickel. 16. this patient has had a cerebral vascular event within the past 6 months. 17. this patient is a prisoner (u.s.a. only). 18. this patient is participating in concomitant research studies of investigational products. 19. this patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
feasibility study of a virtual reality cognitive-motor task based on positive stimuli for stroke rehabilitation

Conditions: Stroke

Summary: the purpose of this study is to determine whether it is feasible to use a virtual reality task for stroke rehabilitation for training motor and cognitive (attention and memory) domains based on the use of positive stimuli, and to evaluate the potential benefits in comparison to standard rehabilitation.

there is evidence that positive emotion stimuli can lead to improved performance in attention tasks and the investigators aim to understand the benefits of using this principle in cognitive and upper-limb motor rehabilitation following stroke. for this purpose, the investigators developed a vr attention task in which the user has to find a target image within a variable number of distractors by controlling a virtual arm. in some levels of the task the target has to be memorized, hence training both attention and memory. the target stimuli are positive images based on the individual preferences of each user. 40 participants within the first 6 months after stroke will be randomly allocated to one of two groups: 1) vr motor-cognitive task or 2) standard rehabilitation. the vr motor-cognitive task group will use the above described virtual task customized to each user in terms of the positive content. this also includes selected music that will be introduced in half of the sessions. the standard rehabilitation group will undergo conventional motor and cognitive rehabilitation. the intervention consists of 12 sessions of 45 minutes administered within a 4-6 weeks period. the participants will be evaluated using a number motor and cognitive assessment scales at baseline, end of the intervention and a 1-month follow-up.

Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke within the first 6 months post-stroke * motor impairment of the upper extremity but with a minimum score of 28 in the motricity index (elbow flexion and shoulder abduction domains combined score) * cognitive deficit but with enough capacity to understand the task and follow instructions with a minimum score of 11 over 17 in the token test (6-item version, portuguese population) * able to read exclusion criteria: * previous motor and/or cognitive deficits * normal cognitive functioning with a score above 26 points in the montreal cognitive assessment * unilateral spatial neglect * moderate to severe depressive symptomatology with a score above 20 points in the geriatric depression scale * vision disorders that may interfere with the execution of the task

Keywords: virtual reality motor and cognitive rehabilitation positive emotion stimuli
a study to determine the effect of 500 mg oral dose of kd025 in healthy male and post-menopausal female subjects

Conditions: Immune System Disorder (Healthy Volunteer)

Summary: the purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 500 mg oral bid dose of kd025 in healthy male and post-menopausal female participants.

up to approximately 58 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.

Eligibility criteria:
inclusion criteria: * healthy participants between the ages of 18 and 55 years, inclusive. * female who is not of reproductive potential. * able to provide written informed consent prior to the performance of any study specific procedures. * body mass index (bmi) range of 19-30 kilogram per square meter (kg/m2), inclusive. exclusion criteria: * past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pk evaluations. * known sensitivity to rho-associated coiled-coil containing serine/threonine protein kinases (rock2) inhibitor agents or to any of the constituents of the kd025 formulation. the above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
a study of ro 24-7429 in patients with hiv-related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to study the effects of ro 24-7429 on tumor growth in patients with hiv-related kaposi's sarcoma. to study the safety and tolerance, effects on hiv replication, and immunologic effects of ro 24-7429 in this patient population. to explore relationships between exposure to ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug toxicity.


Eligibility criteria:
inclusion criteria patients must have: * hiv seropositivity. * biopsy-proven mucocutaneous kaposi's sarcoma with fewer than 50 skin lesions and measurable disease. * no active opportunistic infection. note: * patients with cd4 count \>= 200 cells/mm3 must have no prior opportunistic infection, as well as no active opportunistic infection. * life expectancy of at least 24 weeks. * stable weight (+/- 2 kg) by 28 days prior to study entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * other active malignancies (except basal cell carcinoma of the skin and in situ cervical cancer). * known or suspected hypersensitivity to benzodiazepines. * evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease as determined by the investigator. * ongoing diarrhea (\> two liquid stools per day). * grade 2 or worse signs and symptoms of aids dementia complex. * alteration of mental status that may interfere with study compliance. concurrent medication: excluded: * azt, ddi, or ddc. * experimental antiretrovirals. * biologic response modifiers or immunomodulating agents (e.g., interferon). * colony stimulating factors (erythropoietin, gm-csf, g-csf). * ganciclovir. * foscarnet. * h-2 antagonists (cimetidine, ranitidine, famotidine, nizatidine). * omeprazole. * benzodiazepines. * any other investigational compound. * ongoing systemic treatment with corticosteroids (other than replacement therapy for adrenal insufficiency or short-term therapy of no more than 28 days for bronchial asthma). * cytotoxic chemotherapy (systemic and local). * drugs known to cause systemic toxicity, if avoidable (e.g., myelosuppressive, hepatotoxic, nephrotoxic, or neurotoxic drugs). * paromomycin sulfate. * chronic suppressive therapy for cmv and/or mai. patients with the following prior condition are excluded: history of serious adverse reactions to benzodiazepines. prior medication: excluded: * interferons or immune modulators within 4 weeks prior to study entry. * prior systemic cytotoxic chemotherapy (patients with cd4 counts \>= 200 cells/mm3 only). * benzodiazepines within 14 days prior to study entry. * intralesional chemotherapy for kaposi's sarcoma within 2 weeks prior to study entry. * therapy with antiretroviral drugs (including azt, ddi, ddc, d4t) or investigational drugs within 14 days prior to study entry. localized radiotherapy. radiotherapy (other than localized). active drug or alcohol abuse.

Keywords: sarcoma, kaposi acquired immunodeficiency syndrome antineoplastic agents gene products, tat
platelets indices and its role to predict liver fibrosis in patients with chronic hepatitis b infection

Conditions: Fibrosis, Liver

Summary: platelets indices and its role to predict liver fibrosis in patients with chronic hepatitis b infection

patients with chronic hepatitis b infection will be collected and will do liver fibroscan to predict the degree of liver fibrosis and correlate between the role of platelets count and degree of liver fibrosis in patients with chronic hepatitis b virus

Eligibility criteria:
inclusion criteria: * age from 18 to 70 years * without a history of clinical illness exclusion criteria: * with other hepatitis virus infection; (b) with alcoholic liver disease; (c) with any disease related to fibrosis (such as connective tissue diseases, chronic obstructive pulmonary disease, kidney failure, tumors, and so on); (d) have received any anti-fibrosis therapy; and (e) pregnancy
intensive gait training rehabilitation protocol after surgery in cerebral palsy

Conditions: Cerebral Palsy

Summary: in the context of cerebral palsy, rehabilitation post single-event multi-level surgery (semls) is a long process. one year after surgery and rehabilitation, the functional benefits are usually less improved than the gait pattern. this may be caused by a lack of intensity in the final rehabilitation steps. thus we created an intensive gait training rehabilitation protocole. this protocole associates 4 weeks of intensive rehabilitation in a healthcare center followed by 2 weeks of intensive rehabilitation at home. the objective of this study is to evaluate the efficiency of this protocol to improve walking speed and endurance, gross motor function et muscular strength.


Eligibility criteria:
inclusion criteria: * cerebral palsy * age between 10 and 20 years * single-event multi-level surgery more than one year ago * gmfcs i to iii * capacity to understand simple instructions * volontary consent exclusion criteria: * injuries or pain in lower limbs * toxines or surgery less than one year before the study
exploring the therapeutic effects of creatine supplementation for long covid-19

Conditions: Long COVID Fatigue

Summary: individuals living with long covid often experiencing a degree of undue fatigue after physical or cognitive exertion secondary to the condition, timed post-exertional malaise 9pem). this trial aims to explore the efficacy of creatine monohydrate in managing pem

cognitive dysfunction, and post-exertional malaise are common complaints of those living with post-covid condition (pcc), a sequelae of symptoms that persist beyond acute infection. similar to other types of post-viral fatigue, the diagnosis and treatment of pcc are challenging due to the lack of a valid biomarker for the condition. though the etiology of pcc is not well understood, recent research has found reduced skeletal muscle creatine concentration in those with pcc, which may contribute to fatigue. the objective of this study is to determine if eight weeks of creatine monohydrate supplementation (8g/day) improves symptoms of fatigue, cognition, exercise capacity, and pem in individuals living with pcc. participants will complete two cardiopulmonary exercise tests 24-hours apart on a cycle ergometer before and after an eight-week intervention period. venous blood samples will be collected before and after exercise on both days to assess changes in mitochondrial function. during the intervention, participants will be randomly assigned to supplement with 8g/day of either creatine monohydrate or a control (maltodextrin). cognition will be indirectly assessed via self-report of cognitive symptom frequency and severity at baseline, mid-intervention (i.e., 4 weeks) and post-intervention.

Eligibility criteria:
inclusion criteria: * experiencing symptoms at least 3 months after a covid-19 diagnosis confirmed by positive polymerase chain reaction (pcr) test * experiencing post-exertional malaise, as per the depaul symptom questionnaire exclusion criteria: * allergy or intolerance to creatine monohydrate or maltodextrin * supplemented with creatine in the past eight weeks * orthopaedic injury or condition that would prevent exercise testing * change in medication related to long covid symptom management in the past month.

Keywords: creatine post-exertional malaise exercise nutraceutical
use of low-level laser therapy in the treatment of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer; Diabetic Foot

Summary: diabetes mellitus (dm) is currently an important cause of morbidity and mortality. global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. the diabetic foot ulcers (dfu) present as sore wounds with disintegration of the skin. the dfu affect 15% of diabetic patients. several studies have been conducted aiming to find therapeutic strategies for the healing of dfu, among the reported therapeutic methods the low-level laser therapy (lllt) has been highlighted. the aim of this study is to investigate the effects of different doses of lllt in the treatment of dfu. methods: this study is characterized as a double-blind randomized clinical trial (rct), consisting of four groups, the control group will have only dressing and placebo lllt application and the other three groups will have dressing and real lllt gaas 904 nm application. expected outcomes: to elucidate the effects of different doses of lllt gaas 904 nm on the treatment of dfu, beyond to identify the most effective dose.

all groups will perform the same procedures twice weekly. volunteers will be comfortable with the affected foot exposed. the diabetic foot ulcers (dfu) will be cleaned using saline solution and gauze, then the ulcer temperature will be checked using the digital infrared thermometer. diabetic wounds will be measured and photographed at baseline and every 10 visits until the study is completed, the images will be analyzed using the imagej program for follow-up throughout the intervention. the dfu will be ranked according to the wagner scale. afterwards the volunteers will receive lllt application and conventional treatment in the form of helianthus annuus oil dressing. both therapist and participant will be instructed on precautions to be observed when using lllt. goggles will be provided prior to administration. the lower cylinder of the laser probe will be placed perpendicular to the dfu, the floor and edges of the ulcer will be irradiated using punctual and scanning techniques, respectively. once a week blood glucose levels will be obtained for patient screening. all data will be recorded until the end of the visits in a control form prepared.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients with diabetic foot ulcers; * patients aged 18 and over. exclusion criteria: * type 2 diabetes mellitus patients with ulcers in parts of the body other than the feet; * patients with infected diabetic foot ulcers.
the safety and efficacy of dapagliflozin therapy in combination with insulin in japanese subjects with t1dm

Conditions: Type 1 Diabetes Mellitus

Summary: this study will enroll eligible subjects into a long-term safety study (part b). japanese male and female patients with t1dm and age 18 to 75 years, with inadequate glycemic control on insulin defined as hba1c ≥ 7.5% and ≤ 10.5% at screening visit. as a condition of enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 u/kg/day for at least 3 months prior to the screening visit. the study design of part b is a randomized, open-label, 2 arm, parallel-group design. 140 japanese subjects in total will be randomized in a 1:1 ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.


Eligibility criteria:
inclusion criteria: * signed written informed consent * diagnosis of t1dm. in addition, the following criteria also needs to be met; central laboratory test of c-peptide \< 0.7 ng/ml * insulin use for at least 12 months prior to the enrolment per subject report or medical records and method of insulin administration (mdi or csii) must have been unchanged for at least 3 months prior to the enrolment per subject report or medical records. subjects must be taking a total daily insulin dose of ≥ 0.3 u/kg/day for at least 3 months prior to the enrolment. if on mdi insulin administration subject must be on ≥ 3x injections per day. * japanese men and women * screening visit: central laboratory hba1c ≥ 7.5% and ≤ 10.5% * bmi ≥ 20.0 kg/m² at visit 1 * age 18 to 75 years, inclusive exclusion criteria: - target disease exceptions history of t2dm maturity onset diabetes of young (mody) any anti-hyperglycemic agent use, other than α-gi or insulin, within 1 month prior to the enrolment. use of thiazolidinediones within 6 months prior to the enrolment history of dka requiring medical intervention within 1 month prior to the enrolment history of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to the enrolment * medical history and concurrent diseases malignancy within 5 years of the enrolment (with the exception of treated basal cell or treated squamous cell carcinoma) history of bladder cancer history of radiation therapy to the lower abdomen or pelvis at any time * physical and laboratory test findings aspartate aminotransferase (ast) \> 3x upper limit of normal (uln) alanine aminotransferase (alt) \> 3x uln serum total bilirubin (tb) \> 2.0 mg/dl (34.2 μmol/l) estimated gfr (egfr) by the japanese society of nephrology formula ≤ 45 ml/min/1.73m2 hemoglobin ≤ 11.0 g/dl (110 g/l) for men; hemoglobin ≤ 10.0 g/dl (100 g/l) for women. positive for hepatitis b surface antigen or anti-hepatitis c virus antibody abnormal free t4

Keywords: japanese patients with type 1 diabetes with inadequate glycemic control on insulin
comparison of outcome and effectiveness between micropulse diode laser cyclophotocoagulation and cyclocryoablation in treatment of refractory glaucoma

Conditions: Treatment of Refractory Glaucoma

Summary: laucoma having bad prognosis after maximally tolerated medication,glaucoma that fails after filtering operations, neovascular glaucoma, glaucoma following vitrectomy and glaucoma secondary to uveitis etc. is collectively termed as refractory glaucoma. for such glaucoma patients, cyclodestructive procedures are often used to reduce iop, as well as to relieve ocular and periocular pain. recently,diode laser transscleral cyclophotocoagulation has proved to be an effective method for the treatment of refractory glaucoma and it has become a standard treatment for refractory glaucoma.(yu, q., liang, y., ji, f. and yuan, z.,et al 2020. ) in previous articles, little is known about the long-term outcomes of micropulse diode laser cyclophotocoagulation and cyclocryotherapy. discrepancies in the results of several large observational analyses have introduced further ambiguity on the role of micropulse diode laser cyclophotocoagulation and cyclocryotherapy.the mechanism of transcleral cyclophotocoagulation iop lowering in refractory glaucoma is not well understood. in this study, we perform cyclocryoablation and micropulse diode laser cyclophotocoagulation in patients with refractory glaucoma and report the outcomes / mechanism of iop control using this new surgical paradigm. the objective of our project is to assess the end result and outcome of the role of micropulse diode laser cyclophotocoagulation and cyclocryotherapy.we aim to evaluate the comparison between micropulse diode laser cyclophotocoagulation and cyclocryotherapy. only those subjects will be recruited who provide written informed consent. patients are diagnosed on bases of tonometry, gonioscopy, ophthalmoscopy, perimetry. patients' age, gender, type of glaucoma, number of diode laser treatment sessions, postoperative complications, number of hypotensive medications required to control iop, and best corrected visual acuity (bcva) will be evaluated. the criteria for success will be defined as postoperative iop \ 20% decrease in iop with or without additional medical treatment.


Eligibility criteria:
inclusion criteria: positive diagnosis of refractory glaucoma * poor visual acuity: hand movements or less * age ≥ 18 years * intraocular pressure ≥ 21 mmhg * signed informed consent exclusion criteria: * eye surgery performed over the last 3 months * eye inflammation