Kornimate/medical-research-clean huggingface dataset:
flexor hallucis longus tendon transfer vs gastrocnemius augmented flexor hallucis longus tendon transfer in management of achilles tendon defect

Conditions: Achilles Tendon Repairs/reconstructions; Achilles Tendon Rupture

Summary: this study aims to compare the functional outcome of isolated flexor hallucis longus tendon transfer and gastrocnemius augmented flexor hallucis longus tendon transfer in repair of achilles tendon defects. also, compare the two procedures regarding complication rate, time to restore the function, and the need for secondary procedures.

the achilles tendon (at) is the largest and strongest tendon in the human body, yet it is also one of the most commonly ruptured tendons, with an annual incidence of about 18 cases per 100,000 people. around 75% of achilles tendon ruptures (atr) occur in middle-aged patients during sports activity or following trauma. these injuries typically happen in a region 2 to 6 cm above the tendon's attachment to the heel, an area that has a relatively poor blood supply, that reducing the probability of the healing of the tendon by conservative management. because of the absence of significant pain and the ability to partially maintain plantar flexion, it has been reported that around 10-25% of achilles tendon rupture (atr) cases are overlooked or misdiagnosed during the initial medical assessment. the delaying of the diagnosis and by the way the treatment results in a greater separation between the tendon ends, with scar tissue filling the gap leading to lengthening to the gastrocnemius muscle decreasing its tensile forces. this makes the surgical intervention for repair of chronic tendo achillis rupture necessary to restore normal leg function. various surgical procedures such as reconstruction with v-y advanced flap, gastrocnemius turn-down flap, local tendon transfer augments (flexor hallucis longus (fhl) or peroneus brevis), semitendinosus autograft, free tissue transfer including synthetic grafts and allografts to bridge the gap have been described. some techniques have been combined, such as tissue advancement and tendon transfer. multiple studies have been done comparing two or more of the mentioned techniques, but to our knowledge there is no randomized controlled study comparing the isolated fhl tendon transfer to gastrocnemius augmented flexor hallucis longus (gafhl) tendon transfer.

Eligibility criteria:
inclusion criteria: * age range: adolescents and adults with skeletally mature feet (above 12 y in females and 14 years in males). * achilles tendon defects more than 4 cm resulted from acute or chronic rupture, post-debridement defects in case of neglected insertional tendinopathy, spontaneous ruptures due to tendinosis or after tumor resection. exclusion criteria: * general medical contraindications to surgical interventions * calcaneal fracture, subtalar fusion * infection or previous surgery in the ipsilateral hindfoot or ankle * systemic disease including seronegative inflammatory diseases, spondyloarthropathies or sarcoidosis.

Keywords: achilles tendon rupture flexor hallucis longus gastrocnemius augmentation achilles tendon repairs/reconstructions
biofeedback rehabilitation in parkinson's disease

Conditions: Parkinson Disease

Summary: background: in this study, a new biofeedback system for balance and gait rehabilitation (gamepad) was developed. the system, based on wearable inertial sensors, provides users with real-time visual and acoustic feedback about their movement during functional tasks. gamepad was applied on subjects with parkinson's disease (pd) in a pilot randomized controlled trial to investigate its feasibility and efficacy versus conventional physiotherapy. the investigators hypothesized that gamepad system can be easily applied in clinical settings and that biofeedback training with gamepad provides larger improvements of balance and gait in pd subjects, respect to conventional physiotherapy. methods: forty-two pd patients underwent a 20-session training for balance and gait (45 minutes per session, 3 sessions per week). participants were randomized into gamepad group (biofeedback rehabilitation with gamepad system), and control group (conventional physiotherapy). clinical and instrumental assessments were performed by a blind examiner pre-, post-intervention and at 1-month follow-up.


Eligibility criteria:
inclusion criteria: * hoehn-yahr stage 2 to 4. * ability to stand up more than 10 s and inability to stand on one foot more than 10 s. * ability to walk for at least 6 m even with an assistive device. * stable drug usage. exclusion criteria: * mini-mental state examination \< 24. * implanted deep brain stimulator.

Keywords: rehabilitation balance gait biofeedback
effects of joint integrity exercises verses mirror therapy in hemineglect stroke survivors

Conditions: Stroke

Summary: the aim of this study is to compare the effects of joint integrity exercises and mirror therapy to evaluate that which intervention is more effective to improve proprioception and motor function of upper limb in hemineglect stroke survivors. this will be randomized clinical triall study. data will be collected from lahore general hospital by using non-probability convenient sampling technique. patients will be divided into two groups, (group a and group b). group a will include patients that will be treated with joint integrity exercises of upper limb by applying tactile stimulation, kinaesthetic stimulation and stereognosis. and group b will include those patients which will be treated with mirror therapy of upper limb. session will be 3 days per week. data will be collected pre (baseline=0 week) and post intervention (after 6 weeks) from two groups using nottingham sensory assessment, fugl mayer assessment and motor assessment scale. spss for windows software, version 25 will be used to analyze the data.


Eligibility criteria:
inclusion criteria: * hemi neglect stroke patients after performing line bisection test * patients having mini mental state examination score above 24 * patients having catherine bergego scale score above 27 * patients having minimum miq-3 score 6 or above * sub-acute phase (2 months) following stroke exclusion criteria: * patients with neurological conditions other than stroke including parkinson's, alzheimer and multiple sclerosis

Keywords: joint integrity ,proprioception, mirror therapy, hemineglect
phase iii clinical trial of npb-01 in patients with guillain-barré syndrome

Conditions: Guillain-Barré Syndrome

Summary: patients diagnosed with guillain-barré syndrome were confirmed based on the diagnostic criteria for guillain-barré syndrome. patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive npb-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. patients evaluate the functional grade（fg） and arm grade（ag） et al. as a safety endpoint, the safety of npb-01 will be investigated the occurrence of adverse events by the start of the study treatment.


Eligibility criteria:
inclusion criteria: 1. in principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms. 2. patients with predominant motor neuropathy and hughes's functional grade(fg) is grade4 or grade5(in this regard, if symptoms is progressive, patients with fg is grade3 involve in this study). 3. patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset. 4. patients with greater than or equal to 18 years old at informed consent. exclusion criteria: 1. patients with history of shock for npb-01. 2. patients with history of hypersensitivity for npb-01. 3. patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to hiv,impaired peripheral neuropathy except guillain-barré syndrome. 4. patients with malignancy at informed consent. 5. patients treated with immune globulin at 8 weeks before informed consent. 6. patients with iga deficiency. 7. patients with impaired liver function. 8. patients with impaired renal function. 9. patients with cerebro- or cardiovascular disorders. 10. patients with high risk of thromboembolism. 11. patients with hemolytic/hemorrhagic anemia. 12. patients with decreased cardiac function. 13. patients with decreased platelet.
registry study for talimogene laherparepvec

Conditions: Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial

Summary: a registry study to evaluate the survival and long-term safety of subjects who previously received talimogene laherparepvec in amgen or biovex-sponsored clinical trials

a registry study is to evaluate the overall survival, use of subsequent anti-cancer therapy, and the long-term safety of subjects who have received at least one dose of talimogene laherparepvec on an amgen or biovex-sponsored clinical trial for any tumor type. follow-up will occur every 3 months.

Eligibility criteria:
inclusion criteria: all subjects must provide informed consent prior to initiation of any study activities. all subjects must have received at least one dose of talimogene laherparepvec on an amgen or biovex-sponsored clinical trial for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial. exclusion criteria: subjects currently receiving talimogene laherparepvec in amgen or biovex-sponsored clinical trial. subject currently participating, including for long-term follow-up (if applicable), in other amgen-sponsored talimogene laherparepvec clinical trial.

Keywords: melanoma talimogene laherparepvec
azd0585 phase iii long-term study in japan

Conditions: Hypertriglyceridemia

Summary: this study is a randomised, double-blind phase iii long-term study to evaluate efficacy and safety of 12 weeks and 52 weeks of azd0585 administration compared to placebo in patients with hyperlipidemia accompanied by hypertriglyceridemia .


Eligibility criteria:
key inclusion criteria: * japanese men or women, ≥20 years of age. * subjects must meet all of the following criteria; 1. fasting triglyceride level: average of visit 2 and visit 3 must be in the range 150 - 499 mg/dl 2. %tg change between visit 2 and visit 3 must be within 30% 3. %ldl-c change between visit 2 and visit 3 must be within 25% key exclusion criteria: * allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters. * known lipoprotein lipase impairment or deficiency, or apolipoprotein c-ii deficiency or familial dysbetalipoproteinemia. * current or history of pancreatitis. * type i diabetes mellitus, use of insulin, or haemoglobin a1c \>10% at visit 1.
pilot study on the effectiveness of a tap-block for inguinal hernia repair

Conditions: Hernia Inguinal

Summary: an prospective double blinded randomised trial,whether the use of an perioperative echoguided unilateral tap block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic.

hernia inguinal repair is the most common operation performed by general surgeons in the netherlands. on of the most common complications after hernia repair is postoperative and chronic pain. postoperative pain is an expected but undesirable effect after an operation, which can result in an prolonged hospital stay or longer time to return to full normal daily activities. there are indications that an insufficient treatment of postoperative pain is a risk factor for persistent or chronic pain after open inguinal hernia repair. chronic pain is not uncommon after hernia repair, with an incidence of 11%. the objective of this study is to determine, whether the use of an perioperative echo guided unilateral tap block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic. there will be no further analysis in this study regarding the incidence of open hernia inguinal repair and chronic pain.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 year, competent, elective surgical treatment, body mass index (bmi) between 20-35. exclusion criteria: * fever, a coagulation disorder, patients with kidney and liverfaillure, an infection at the place where the puncture place, preoperative use of narcotic and nonsteroidal antiinflammatory drugs.

Keywords: abdominal muscles/ultrasonography adult ambulatory surgical procedures anesthetics, local/administration & dosage levobupivacaine/administration & dosage levobupivacaine/analogs & derivatives hernia, inguinal/surgery humans nerve block/methods pain measurement/methods pain, postoperative/prevention & control ultrasonography, interventional
prehabilitation of elderly patients with frailty syndrome before elective surgery (praep-go)

Conditions: Frailty; Frail Elderly

Summary: the aim of the study is to evaluate the effect of a shared decision-making conference and three-week prehabilitation program on the outcome "care dependency" one year after surgery. the cost-effectiveness of the intervention will also be evaluated in this n = 1400 patient, national multicenter, assessor-blinded, randomized, pragmatic, controlled, parallel-group, clinical trial. the objective of präp-go is to establish and employ a suitable preoperative case-care management system to improve the short and long-term outcome of elderly surgical patients with signs of a frailty syndrome, improving postoperative quality of life and reducing care dependency by a three-week individualized prehabilitation program.


Eligibility criteria:
study patients: inclusion criteria: * age ≥ 70 years * consent by patient or legal representative * elective surgery planned * expected anesthesia duration≥ 60 min * statutory health insurance * frailty syndrome (≥1 positive out of 5 standardized parameters according to the physical frailty phenotype according to fried et. al.) exclusion criteria: * severe cardiac or pulmonary disease (nyha iv, gold iv) * intracranial interventions * moribund patients (palliative situation) * not enough language skills * participation in another interventional rehabilitation study or other interventional clinical trial that has not been approved by the study management committee (exception: participation in adjuvant intervention study)

Keywords: prehabilitation, physiotherapy, exercise therapy, rehabilitation, nutritional intervention, multidisciplinary intervention, frailty, surgery
mannitol versus supportive care in ciguatera fish poisoning

Conditions: Ciguatoxin

Summary: ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global public health concern. in the us, the vast majority of ciguatera poisonings occur in florida, followed by hawaii and california. equipoise exists in the medical literature regarding the effectiveness of mannitol therapy in treatment of ciguatera poisoning. while there are many case reports attesting to its utility, the only randomized control trial (rct) comparing mannitol therapy with supportive care failed to show any significant benefit from mannitol treatment for a variety of clinical outcomes. investigators therefore propose a second, larger rct to test this question.


Eligibility criteria:
inclusion criteria: * history consistent with ciguatera poisoning exclusion criteria: * minors * pregnant patients * those unable to give consent * severe congestive heart failure or renal failure

Keywords: mannitol treatment
a study of xeloda (capecitabine) as adjuvant monotherapy in patients with colon cancer.

Conditions: Colorectal Cancer

Summary: this single arm study will evaluate the safety profile of xeloda as monotherapy for adjuvant treatment of colon cancer. all patients will receive xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * colon cancer (dukes stage c); * surgery, with no evidence of remaining tumor; * ecog performance status of \<=1. exclusion criteria: * previous therapy for currently treated colon cancer; * any evidence of metastatic disease; * history of other malignancy within last 5 years; * clinically significant cardiac disease.
circulating mirnas as biomarkers of hormone sensitivity in breast cancer

Conditions: Breast Cancer

Summary: this is a biomedical and prospective study of interventional type. the trial will include 29 patients over a period of 15 months + 24 months of follow up maximum. the study will be conduct in womens with metastatic invasive breast cancer or locally advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line hormone therapy for metastatic breast cancer) is indicated. the main objective of this pilot study is to evaluate the feasibility to detect in the circulating blood of patients, before treatment (t0), the presence of the fifteen tissular micrornas described in preclinical studies as possibly involved in hormone resistance/sensitivity. in parallel of the detection of these specific mirnas, we will conduct a larger scale analysis of circulating mirnas in these patients before (t = 0) and after one month of treatment (t28).


Eligibility criteria:
inclusion criteria: 1. women of more than 18 years old (menopausal or not) 2. women with metastatic invasive breast cancer or locally advanced (without surgical project), for which treatment with tamoxifen or anti aromatase +/- lh-rh agonist, is indicated (anti-aromatase prescribed for menopausal womens; tamoxifen prescribed for both menopausal, pre menopausal or not menopausal womens). 3. cancer hormone-expressing estrogen receptor (er) and / or progesterone receptor (pr) (\>= 10% of tumor cells by ihc technique). cancer her2 negative. 4. evaluable disease (measurable according recist criteria or not) 5. any previous adjuvant hormone therapy should be discontinued for at least 21 days. 6. one or two prior metastatic lines of chemotherapy are allowed 7. general status who 0-2 8. the women of childbearing age must use an effective contraception for the duration of the study 9. informed consent obtained and signed before any specific study procedure 10. patient member in a national insurance scheme exclusion criteria: 1. patient already treated with hormone therapy or not having stopped the previous adjuvant hormone therapy for at least 21 days. 2. prescription of chemotherapy and / or other targeted therapy (other than hormone therapy) for the treatment of the breast cancer 3. any previous hormone therapy for metastatic or locally advanced (without surgical project) breast cancer 4. known hypercalcaemia before mirna dosage at t=0 requiring immediate biphosphonate therapy 5. any other medical or psychiatric condition or severe or chronic laboratory abnormality making the the inclusion of the patient in the study inappropriate in the opinion of the investigator. 6. patient unable to follow procedures, visits, examinations described in the study. 7. pregnant women or nursing mothers will not participate in the study. 8. patients under legal guardianship

Keywords: breast cancer, hormonotherapy, mirnas, biomarkers hormone therapy
effectiveness of individual physical activity programs to prevent sarcopenia and frailty among older adults

Conditions: Sarcopenia; Frailty

Summary: sarcopenia and frailty could be prevented and rehabilitated through individual physical activities in the form of combined exercise that could be practiced at home in daily life.

the volunteers were randomly assigned to either the intervention or control group using sealed envelopes containing documents marked with either ig (intervention group) or cg (control group). the intervention group received training, after which they demonstrated and practiced the physical activities. they were provided with an exercise leaflet for self-practice at home and were followed up by phone, line application, and leaders of social club for older adults at least once a week to ensure regular practice. the older adults' relatives and caregivers were also trained and encouraged to practice with them in a 1:1 match. support techniques and warning signs for stopping or taking a break during exercise were added to each posture, along with suggestions for suitable environmental management, such as flat plains, sufficient light, and no barriers within 2 meters, to reduce the risks of accidents. however, the control group did not receive any intervention apart from general suggestions and continued with their usual daily activities.

Eligibility criteria:
inclusion criteria: * individuals aged between 60 and 80 years. * those who are able to walk independently or with the aid of walking devices. exclusion criteria: * participants with leg or foot amputations. * participants who had been admitted to hospitals in the past 6 months. * those with underlying medical conditions such as heart disease, bone and muscle injuries, and infectious diseases. * individuals who did not pass the physical activity readiness questionnaire (par-q).
therapeutic effects of monochromatic infrared energy therapy on patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: to investigate the effects of short-term and medium-term monochromatic infrared energy therapy on patients with chronic low back pain (lbp) according to the international classification of functioning, disability and health.

methods：70 participants with chronic lbp will be included. participants received six 40-min sessions of hot pack therapy combined active or placebo monochromatic infrared energy therapy over the low back (wavelength = 890 nm, radiant power output = 6.24 w, power density = 34.7 milliwatt/cm2 for 40 min, total energy 83.2 j/cm2) followed by 20-min supervised therapeutic exercise, for 3 times per week for a 4-week duration. patients will be assessed at before treatment and follow-up assessments, including after 2 week of treatment; after 4 weeks of treatment; and 1 and 3 months, respectively, after treatment is terminated. main outcome measures: patients will be assessed periodically with pain, multidimensional fatigue inventory, postural stability (using the postural stability evaluation system: biodex stability system), and fear-avoidance behavior questionnaire.

Eligibility criteria:
inclusion criteria: participants with chronic low back pain exclusion criteria: 1. low back pain accompanied by specific pathological conditions, such as an infection,inflammation, rheumatoid arthritis, fracture, or tumor; 2. a self-reported history of malignancy, vertigo, stroke, or other condition that may impair postural stability; 3. a history of low back surgery with an implant; 4. pregnancy or plans to become pregnant during the course of the study; 5. having received concurrent treatment for low back pain by another health care professional

Keywords: chronic low back pain infrared energy effects