Kornimate/medical-research-clean huggingface dataset:
the influence of acute static stretching on the ankle joint-position sense of soccer players

Conditions: Healthy

Summary: the aim of this study isto investigate the influence of acute static stretching on the ankle joint position sense of soccer players.

this crossover randomized controlled trial will include semi-professional soccer players. all participants will perform 3 conditions: two experimental conditions, of static stretching of the gastrocnemius and tibialis anterior muscles, for 30 seconds or 90 seconds; and a control condition (rest). ankle joint position sense of the dominant limb will be assessed before and immediately after the conditions for the range of 20º of plantar flexion by active repositioning, and using a video camera. absolute, relative and variable angular errors will be calculated.

Eligibility criteria:
inclusion criteria: * male soccer players from the senior level * aged between 18 and 30 years old * with normal plantar flexion range of motion * without history of lower limb injuries in the last 6 months exclusion criteria: * those with cardiorespiratory, vestibular or neurological diseases * with bone or joint deformities in the lower limb * cerebral concussion in the last 3 months * history of lower limb surgery * those with positive ankle integrity tests (anterior drawer test, talus tilt test and external rotation stress test)

Keywords: static stretching joint position sense proprioception ankle soccer
d-dimer to establish duration of anticoagulation after venous thromboembolism

Conditions: Deep Vein Thrombosis; Pulmonary Embolism

Summary: the optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. the present study addresses the possible role of the d-dimer test in assessing the need for continuation of anticoagulation.the study aims at assessing whether d-dimer assay may have a role in guiding the duration of anticoagulation in these patients

this is a multicenter prospective follow-up study in patients with a first episode of symptomatic idiopathic venous thromboembolism (proximal deep vein thrombosis and/or pulmonary embolism) who are treated with vitamin k antagonists (either warfarin or acenocoumarol) for a minimum of 3 months. eligible patients who give informed consent are instructed to immediately stop oral anticoagulation and refrain from taking any other antithrombotic drugs until the next visit, scheduled after 30 days. at that visit, venous blood is sampled to perform d-dimer assay and thrombophilia tests. d-dimers are assessed using the clearview simplify d-dimer assay (agen biomedical limited, brisbane, australia). patients with normal d-dimer results do not continue anticoagulation, whereas those with elevated d-dimer results are randomized using a computer program to either stop or resume anticoagulation with vitamin k antagonists (inr 2.0-3.0). all patients are followed-up for 18 months. the study outcome are the composite of confirmed recurrent venous thromboembolism and major bleeding events. all suspected outcome events and all deaths are evaluated by a central adjudication committee whose members are unaware of the d-dimer and thrombophilia results and of the group assignments.

Eligibility criteria:
inclusion criteria: * age \> 18 years * after a first documented idiopathic proximal deep vein thrombosis and/or pulmonary embolism * after at least 3 months of oral anticoagulation * after written informed consent exclusion criteria: * if the venous thromboembolism occurred: * during pregnancy or puerperium * after recent (i.e. within three months) fracture or plaster casting of a leg, * after immobilization with confinement to bed for three consecutive days * after surgery with general anesthesia lasting longer than 30 minutes * patients with: * active cancer * antiphospholipid antibody syndrome * antithrombin deficiency * serious liver disease or renal insufficiency (creatininemia \> 2 mg/dl), * other indications for anticoagulation or contraindications for this treatment * limited life expectation * patients who live too far from the clinical center

Keywords: d-dimer recurrence venous thromboembolism anticoagulation duration
fitmi pd home therapy for parkinson's disease

Conditions: Parkinson Disease

Summary: the investigators will run an at-home usability study of a newly developed home exercise device (fitmi pd) for individuals with parkinson's disease. fitmi pd uses embedded sensors that can track and record the user's direction and degree of movement while performing exercises described on a computer.


Eligibility criteria:
inclusion criteria: * mild to moderate pd (hoehn and yahr stage i to iii) * mini-mental state examination greater than 28 exclusion criteria: * age less than 18 years old
corneal endothelial cell loss in diabetes type ii during cataract surgery

Conditions: Diabetes Mellitus

Summary: the aim of the present study is to evaluate changes in the morphology and function of the corneal endothelium before and after cataract surgery in patients with diabetes type ii. also to explain if determination of hgba1c in diabetics is a predictor for the changes in morphology and function.

thirty patients with diabetes type ii and thirty non-diabetes patients scheduled to cataract surgery (phacoemulsification with intraocular lens implantation) were invited to participate in the study. preoperatively, all patients had a full eye examination and 3 endothelial cell photos were taken. three months postoperatively the patients were called for a re-examination including 3 endothelial cell photos. the function of the cornea is dependent of the number and morphology of the endothelial cells, and even small traumas like cataract surgery may disrupt the cornea integrity leading to corneal haze and blur. diabetics may be more vulnerable to corneal stress.

Eligibility criteria:
inclusion criteria: * patients with cataract scheduled for surgery exclusion criteria: * patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.

Keywords: cataract surgery, endothelial cell, cell loss, diabetes mellitus type ii
evaluation of a lam flisa for the diagnosis of tuberculosis

Conditions: Tuberculosis

Summary: tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide. diagnosis of the disease is often time consuming or challenging. many cases of tuberculosis require advanced and expensive diagnostic methods that restrict their availability in resource limited countries where the burden of tuberculosis is highest. the development of rapid point of care diagnostics is required. lipoarabinomannan (lam) is part of the bacterial cell wall in m. tuberculosis. it is released when bacteria are multiplying or dying. lam can be detected in the urine since it is filtered from the blood in the kidneys. the detection of lam in the urine by conventional enzyme linked immuno-sorbent assay (elisa) techniques was hampered in the past by a low sensitivity and multiple processing steps. recently, fluorescence linked immuno-sorbent assay (flisa) has been shown to detect lam in concentrations that are several magnitudes lower that with elisa based methods. furthermore the procedure requires less separate steps for processing the sample. this study aims to validate the new diagnostic test by comparing patients with (a) confirmed tuberculosis (n=25), (b) infection with non-tuberculous mycobacteria (n=25), (c) bronchial carcinoma (n=25), (d) suspected tuberculosis but confirmed alternative diagnosis (estimated n=20). single blood and urine samples of these groups will be used to evaluate the sensitivity and specificity of the test. in patients with confirmed tuberculosis the lam flisa will also be assessed as a biomarker for the monitoring of tuberculosis treatment success. initially, 2-5 samples blood and urine are required during the first week, followed by twice weekly and weekly sampling intervals over a period of 12 weeks maximum. the study participation ends when the patient is discharged from hospital. as a substudy, the blood samples will be used to evaluate an enzyme linked immuno-sorbent assay (elisa) for the detection of lipid antigens that are specific for mycobacterium tuberculosis.


Eligibility criteria:
inclusion criteria: 1. suspected or confirmed infection with m. tuberculosis (mtb) or confirmed infection with non-tuberculous mycobacteria (ntm) or confirmed bronchial carcinoma 2. oral and written consent to study participation (children: parent's consent) exclusion criteria: 1. inability to follow the study requirements 2. patient in custodianship or guardianship

Keywords: tuberculosis
role of hyaluronic acid in the prevention of post-operative adhesions: a rct

Conditions: Post Operative Adhesions

Summary: the objective of study is to determine the effect of hyaluronic acid on the formation of post-operative adhesions. it will be a randomized control trial comparing the product against normal saline.


Eligibility criteria:
inclusion criteria: - all consenting patients between the ages of 12-80, who undergo exploratory laparotomy and stoma formation exclusion criteria: previous history of abdominal surgery history of peritoneal dialysis patients in whom permanent stoma is formed -
does the use of a moisture chamber decrease the incidence of corneal abrasions in critically ill pediatric patients?

Conditions: Eye Injuries; Critically Ill

Summary: the purpose of this study is to identify the incidence of scratches on the surface of the eye in children who cannot blink due to medication use and to identify how best to reduce the risk of a scratch on the surface of the eye when patients are using specific medicines.

critically ill children may require neuromuscular blockade as a treatment modality. these children require careful eye care to prevent corneal abrasions. however, current evidence does not exist to guide best practices on eye care. this research study will evaluate 2 types of eye care therapy. the eyes will be randomly assigned to the control or experimental eye care therapy group. the control eye will receive lubricating ointment every 6 hours. the experimental eye will receive lubricating ointment every 6 hours and have a plastic covering to create a moisture chamber. using daily fluorescein staining to detect corneal abrasions, each child will be studied for up to 9 days. children who develop corneal abrasions will be discharged from the study and the primary care team will be notified. the two groups will then be compared to determine the therapy associated with the lowest incidence of corneal abrasions.

Eligibility criteria:
inclusion criteria: * age greater than 42 weeks post-conceptual age and less than 18 years * anticipated need for neuromuscular blockade therapy for at least 24 hours exclusion criteria: * use of continuous neuromuscular blockade therapy for more than 36 hours (early intervention study) * past medical history of abnormal blink reflex or incomplete lid closure * history of daily eye drop use * facial trauma * alteration in periorbital skin integrity prohibiting eyelid closure or effective creation of a moisture chamber * known allergy to eye lubricant

Keywords: pediatric critical care neuromuscular blocking agents corneal abrasions
a reminder app to reduce radiation dermatitis rates in patients with head-and-neck cancer

Conditions: Radiation Dermatitis; Radiation-induced Oral Mucositis

Summary: the goal of this randomized trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (scchn). the primary endpoint is the rate of patients experiencing grade ≥2 radiation dermatitis at 60 gy of radiotherapy. 80 patients are required per arm within the full analysis set. taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. if the addition of a reminder app to standard care will result in a significant reduction of radiation toxicity, it could become a helpful tool for these patients.

the goal of this trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (scchn). this is a randomized, active-controlled, parallel-group trial, which will compare the following treatments of radiation dermatitis (primary endpoint) and oral mucositis in patients with scchn: standard care supported by a reminder app (arm a) vs. standard care alone (arm b). the primary endpoint is to investigate the rate of patients experiencing grade ≥2 radiation dermatitis at 60 gy of radiotherapy, the minimum planned total dose for all patients receiving definitive or adjuvant radiotherapy for locally advanced scchn with curative intention. in addition, the following endpoints will be evaluated: radiation dermatitis grade ≥2 at the end of radiation treatment (eot), radiation dermatitis grade ≥3 at 60 gy and eot, quality of life, pain, and radiation-induced oral mucositis grade ≥2 and grade ≥3 at 60 gy and at eot. according to sample size calculations, 80 patients are required per arm within the full analysis set. taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. the impact of the reminder app will be considered clinically relevant, if the rate of grade ≥2 radiation dermatitis can be reduced from 85% to 65%. if the addition of a reminder app to standard care will result in a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for patients during radiotherapy of for scchn.

Eligibility criteria:
inclusion criteria: * histologically proven squamous cell carcinoma of the head-and-neck (scchn) * indication for definitive or adjuvant radio(chemo)therapy * possession of and ability to use a smart phone * age ≥18 years * written informed consent * capacity of the patient to contract exclusion criteria: * nasopharynx cancer * pregnancy, lactation * treatment with epidermal growth factor receptor (egfr)-antibodies (either given or planned) * expected non-compliance

Keywords: head-and-neck cancer radiotherapy radiation dermatitis oral mucositis reminder app
chronic plaque psoriasis (ps) registry

Conditions: Chronic Plaque Psoriasis

Summary: the purpose of this study is to evaluate the long-term safety of humira® in adult patients with chronic plaque psoriasis (ps).

esprit is a 10 year registry of patients taking humira® for psoriasis. patients who volunteer to participate will be asked to provide information about their medical history and experiences with humira®. no registry specific testing will be performed. patients will be asked to provide data on their experiences with humira® approximately every 6 months, or as determined by the study doctor. no drug will be provided as a result of participation in the registry. all treatment decisions are independent of participation in the registry.

Eligibility criteria:
inclusion criteria: 1. an adult patient (18 years of age or older) with chronic plaque psoriasis who has been prescribed humira® therapy according to the local product labeling and meets one of the following criteria: * new initiated (within 4 weeks of registry entry) on humira® therapy; * initiated humira® therapy in the past and: * has received continuous (no more than 70 consecutive days off drug) humira® therapy and the physician can provide source documentation of saes, aes, of special interest, and dosing information since initiation of therapy. or * is entering after participation in an abbvie humira (adalimumab) sponsored study and has received continuous (no more than 70 consecutive days off drug) humira® therapy after the completion of abbvie sponsored study and physician can provide source documentation of saes, aes of special interest, and dosing information since initiation of commercial humira® (defined as a prescribed/non study drug). 2. patient is willing to consent to data being collected and provided to abbvie; 3. patient is capable of and willing to give written informed consent and to comply with the requirements of the registry. exclusion criteria: - patient should not be enrolled if he/she cannot be treated in accordance with the local product label.

Keywords: psoriasis moderate psoriasis severe psoriasis chronic plaque psoriasis severe chronic plaque psoriasis registry
music therapy experiences in patients with mild cognitive impairment (mci) and alzheimer's disease (ad)

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Summary: this study compares different music therapy (mt) experiences and their impact on memory and language in patients with alzheimer's disease and mild cognitive impairment. the 12-month study will assess the role of common experiences involving familiar music and other pleasant events (blinded control) to benefit cognition and measure the quality of life for people with alzheimer's disease and mild cognitive impairment. following screening, all participants will meet with a licensed music therapist at the first study visit. thereafter, each group will have an individualized schedule of follow-up telephone calls and visits. screening for the study and participation in the study intervention can be completed in-person or from your home, if you do not live in the area.

interested participants and their study partner will be enrolled after an evaluation to determine cognitive impairment or mild dementia. the evaluation, either in person or remote, will include cognitive testing, clinical and neurological evaluation, a review medical records and medical history and an examination as deemed necessary by a dementia physician. eligible participants will undergo baseline testing including linguistic analyses and will be randomly assigned to one of 3 intervention groups. participants and their study partners will be contacted at least once every three months for cognitive testing and medical review. contact with the music therapy team will occur up to twice per week but not less than once per month, for the first six months study enrollment.

Eligibility criteria:
inclusion criteria: * diagnosis of alzheimer's disease or mild cognitive impairment * must have study partner * english speaking * no verbal impairment * community-dwelling * must have webcam or smart phone exclusion criteria: * a diagnosis of dementia other than probable or possible ad * probable ad with down syndrome * history of a clinically significant stroke with residual deficit * current evidence or history in past two years of epilepsy, focal brain lesion, head injury * current diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse. * participation in another interventional study * comorbidity causing disability interfering with intervention such as pain or discomfort or life expectancy less than 1 year

Keywords: music music therapy memory executive function cognitive function caregiver burden
tesetaxel for previously treated patients with bladder cancer

Conditions: Carcinoma, Transitional Cell

Summary: the intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients. tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. this study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis * measurable disease (revised recist; version 1.1) * karnofsky performance status ≥ 60% * previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent * adequate bone marrow, hepatic, and renal function, as specified in the protocol * at least 4 weeks and recovery from effects of prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent * ability to swallow an oral solid-dosage form of medication exclusion criteria: * known metastasis or symptoms of metastasis to the central nervous system * significant medical disease other than cancer * presence of neuropathy \> grade 1 (nci ctc, version 4.0) * prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid * need to continue any regularly-taken medication that is a potent inhibitor or inducer of the cyp3a pathway or p-glycoprotein activity

Keywords: bladder cancer previously treated patients tesetaxel oral taxane
italian ncl registry: a registry for ncl as an integration tool for future therapeutic strategies

Conditions: Neuronal Ceroid Lipofuscinosis

Summary: the goal is to create a solid and harmonious disease registry of patient affected by neuronal ceroid lipofuscinosis (ncls) that facilitates the collection and management of patients' data over time encouraging the research and the development of future clinical trials. in-depth clinical phenotyping will develop significant clinical outcome measures that can be used in clinical trials and will allow the phenotypic complexity of the disease to be captured with the use of validated clinical scales, biomarkers and so-called patient reported outcomes (pros).

the registry will involve three recruiting clinical centres (irccs fondazione stella maris in pisa, ospedale pediatrico bambin gesù in roma e irccs istituto neurologico carlo besta in milano). participants will be assessed annually at one of the three participating clinical sites. for each patient, at least one follow-up visit will be scheduled at an interval of 12 months in order to monitor and compare the longitudinal progression of ncls in similar groups (for example based on phenotype, age at onset, or genotype). at each visit all enrolled subjects will carry out a clinical-instrumental evaluation as per clinical practice, including: anamnestic collection, general and neurological objective examination; administration of illness scales (e.g. the hamburg scale, ubdrs) and questionnaires about psychiatric symptoms, sleep disorders and quality of life. any biological samples will be collected as tissues, blood or urine and stored in the laboratories or bio-repositories of the individual centers and also reported in the electronic clinical report form (crf) of ncl registry. the results of further diagnostic tests carried out such as optical coherence tomography (oct), brain magnetic resonance imaging (mri) or neurophysiology performed during diagnostic practice or clinical follow up will also be collected. any further clinical scales/evaluation questionnaires to be administered will be selected according to clinical need based on the neurological characteristics and genotype of each participant. all data relating to further instrumental and/or neurophysiological investigations carried out by the patient for clinical needs will also be collected. the data collected during the aforementioned clinical-instrumental-laboratory evaluations will be entered into the italian ncl registry in pseudonymized form.

Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of neuronal ceroid lipofuscinosis * participants/parents/legal guardians will have to give informed consent for enrollment in the registry and privacy data management exclusion criteria: * subjects affected by other forms of neurodegenerative diseases. * lack of informed consent