Kornimate/medical-research-clean huggingface dataset:
responsiveness of quantitative musculoskeletal ultrasound measures on the healing of achilles tendon

Conditions: Achilles Tendinopathy

Summary: to this day, the most accepted treatment for the achilles tendinopathy (at) remains the exercise program to strengthen the plantar flexor muscles. the eccentric exercises protocol proposed by alfredson is the most popular and recommended one by the rehabilitation professionals. currently, the response to interventions is measured almost exclusively by clinical data, especially using questionnaires, since the quantitative ultrasound (qus) is rarely used. in fact, the thickness of the achilles tendon, which is generally the only measure noted when using musculoskeletal ultrasound on at, does not allow the clinician to confirm an improvement following an eccentric exercise program if the tendon is thinner, especially in adults with chronic at. no scientific evidence indicates whether there is an improvement in the biological integrity of the achilles tendon following the completion of alfredson's eccentric strengthening protocol. this is why it seems relevant to use the pre-established minimal biomarker data set obtained with the qus in order to study the variation of these data in response to a rehabilitation intervention and to verify how these variations influence clinical data.

a comprehensive clinical evaluation (questionnaires, clinical examination and ultrasound imaging) will be completed immediately before the intervention (pre), immediately after the intervention (post), and three months after the intervention (follow-up).

Eligibility criteria:
inclusion criteria: * symptoms consistent with at in the middle third of the achilles tendon for at least six weeks * at signs objectified by the physical exam and the ultrasound imaging at the initial evaluation * at least 18 years old * victorian institute of sport assessment-achilles questionnaire (visa-a) score below 90 * have pain of at least 3 out of 10 according to the analog visual scale during athletic activities exclusion criteria: * pain at the achilles tendon enthesis * a complete rupture of the achilles tendon history of achilles tendon rupture inflammatory arthropathy * sign of neurological lesion on physical examination of the lower limb * neurological disease (e.g. multiple sclerosis, stroke) * history of intervention of the achilles tendon or ankle (e.g. surgery, cortisone infiltration, extracorporeal shock waves therapy, platelet-rich plasma injection).
treatment recommendations for patients with adhd tdapp2

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to compare the recommendations made by tdapp2 with those by relevant clinical practice guidelines in children/adolescents with adhd.

clinical practice guidelines (cpg) allow optimizing medical decisions and health care based on the best evidence available. nevertheless, cpgs have several limitations. first, many gpc are outdated shortly after their publication. second, cpg recommendations are often not applicable to many patients treated in clinical practice. most cpgs do not make recommendations for complex patients with comorbidities. another limitation is that patients involvement in cpgs development is still poor. to overcome these limitations, study investigators developed tdapp, an ehealth tool to formulate decentralized, participatory, individualized and automated pharmacologic treatment recommendations for patients with attention deficit hyperactivity disorder. tdapp was initially tested in a clinical sample of adhd patients (https://clinicaltrials.gov/ct2/show/nct04228094), but, as it was the first human use, treatment recommendations were kept hidden to the clinicians until the last patient enrolled completed study participation. this safeguard was implemented to avoid potential misguidance. after completing this study, the investigators developed a new iteration of tdapp (tdapp2) that can also recommend non-pharmacological interventions. in this study, the investigators aim to assess tdapp2: an ehealth tool that formulates participatory, participatory, explainatory and automated therapeutic recommendations for patients with attention deficit hyperactivity disorder. the recommendations made by tdapp2 will be compared with those made by relevant clinical practice guidelines in children/adolescents with adhd. a 6-week, one group, open label study will be conducted. tirty-two children/adolescents aged \< 18 yo with adhd and their parents will use tdapp. the treatment recommendations made by the tdapp2 will be compared to those made by relevant cpg (american academy of pediatrics cpg, canadian adhd resource alliance (caddra) gpc, national institute for health and care excellence (nice) gpc, the australian adhd professionals association guideline, and the spanish gpc). as the study will be carried out in catalonia (spain), the primary comparison will be performed vs. the spanish cpg. also, tdapp2 recommendations will be compared with the actual treatment prescribed by the clinicians.

Eligibility criteria:
inclusion criteria: * patients aged 6-17 yo * meeting dsm 5 criteria for adhd * requiring treatment initiation for adhd or requiring a treatment change exclusion criteria: * patients who are receiving treatment for adhd and who are well controlled with it * patients who do not have a suitable electronic device for tdapp2

Keywords: ehealth evidence based medicine clinical decission support systems
safety and dose-finding study of dtx401 (aav8g6pc) in adults with glycogen storage disease type ia (gsdia)

Conditions: GSD1

Summary: the primary objective of the study is to determine the safety of single doses of dtx401, including the incidence of dose-limiting toxicities (dlts) at each dose level.

participants enrolled in the 401gsdia01 study will be monitored for 52 weeks following dtx401 administration. participants in cohorts 1, 2, and 3 will receive reactive oral steroid treatment for possible vector-induced hepatitis following treatment with dtx401. participants in cohort 4 will receive prophylactic oral steroid treatment to prevent possible vector-induced hepatitis. after completion of the week 52 visit or early withdrawal, participants will be offered enrollment into a 4-year extension study.

Eligibility criteria:
key inclusion criteria: * males and females ≥18 years of age * documented gsdia with confirmation by molecular testing * documented history of ≥1 hypoglycemic event with blood glucose \<60 mg/dl (\<3.33 mmol/l) * patient's gsdia disease is stable as evidenced by no hospitalization for severe hypoglycemia during the 4-week period preceding the screening visit key exclusion criteria: * anti-aav8 neutralizing antibody titer ≥1:5 * screening or baseline (day 0) blood glucose level \<60 mg/dl (\<3.33 mmol/l) * liver transplant, including hepatocyte cell therapy/transplant * presence of liver adenoma \>5 cm in size * presence of liver adenoma \>3 cm and ≤5 cm in size that has a documented annual growth rate of ≥0.5 cm per year * significant hepatic inflammation or cirrhosis as evidenced by imaging or any of the following laboratory abnormalities: alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> upper limit of normal (uln), total bilirubin \> 1.5 x uln, or alkaline phosphatase \> 2.5 x uln note additional inclusion/exclusion criteria may apply, per protocol.

Keywords: glycogen storage disorder ia aav gene therapy von gierke disease glucose metabolism disorder
a study to evaluate the utilization of 3d printed models in pre-operative planning

Conditions: Sarcoma, Ewing; Chondrosarcoma; Osteosarcoma; Fibrous Histiocytoma; Fibrosarcoma

Summary: this prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3d printed models in preoperative planning for the excision of tumors involving bony structures within the body. the study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites. subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3d printed models and imaging, or the active comparator arm, using only imaging. primary endpoint: operative time of surgical procedure. secondary endpoints: reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins. exploratory endpoints: surgical planning ease, changes in surgical plan, and surgeon satisfaction.


Eligibility criteria:
inclusion criteria: 1. subjects must be at least 22 years of age. 2. subjects must have the ability to provide written informed consent. 3. subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis. 4. subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3d printed model. exclusion criteria: 1. pregnant or nursing women. 2. subjects that have a serious systemic pathology. 3. subjects that have clotting disorders. 4. subjects that have uncontrolled hypertension. 5. subjects that are hiv-positive. 6. subjects that are unable to be randomized; i.e surgical team prefers to use either 3d model or standard cross-sectional imaging for surgical pre-planning. 7. subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable). 8. subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.

Keywords: bony tumor
a study to investigate ale.p02 as monotherapy in adult patients with selected cldn1+ solid tumors

Conditions: Squamous Non-small-cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Cervical Squamous Cell Carcinoma; Esophageal Squamous Cell Carcinoma

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended phase ii dose (rp2d) of the ale.p02 monotherapy in adult patients with selected squamous solid tumors.

this study has a phase i ale.p02 monotherapy dose escalation and recommended dose for expansion (rde) study and a phase ii study of ale.p02 as monotherapy at rp2d in adult patients with selected advanced or metastatic claudin-1 positive (cldn1+) cancers.

Eligibility criteria:
inclusion criteria: * have disease and treatment history as: have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic sqnsclc, hnscc (nasopharyngeal cancer included), escc or cscc. * phase i dose escalation: have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment. * phase i rde and phase ii: have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment. * have provided tissue for cldn1 analysis in a central laboratory. * have a performance status of 0 or 1 on the eastern cooperative oncology group performance scale. * demonstrate adequate bone marrow and organ function. * patients must have recovered from all toxicities led by prior treatment. * have measurable disease based on recist 1.1 as determined by the site. exclusion criteria: * diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma. * has received antineoplastic therapies prior to study intervention within specified time frame. * has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain). * patients with uncontrolled diabetes. * has known active central nervous system (cns) metastases and/or carcinomatous meningitis. * has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate. * concomitant use of drugs that are known to prolong or shorten qt and/or have known risk of torsades de pointes.

Keywords: claudin-1 targeted antibody-drug conjugate monotherapy first-in-human recommended phase 2 dose recommended dose for expansion
evaluation of the predictive value of 18f-fluorodeoxyglucose positron emission tomography and brain perfusion computed tomography for the efficacy of anti-angiogenic therapy (bevacizumab) in recurrent glioblastoma

Conditions: Glioblastoma

Summary: in this pilot study, the study evaluators will evaluate the ability of positron emission tomography (pet) with 18f-fluorodeoxyglucose (fdg pet) and the computed tomography (ct) perfusion scanner, individually and combined, to predict the effectiveness of anti-angiogenic treatment.


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * the patient has an who score ≤ 3 * the patient's estimated life expectancy is more than 3 months. * patient with histologically proven diagnosis of glioblastoma. * patient presenting with tumor progression on morphological mri confirmed by a multidisciplinary committee. * patient with a unilateral supratentorial target lesion upon inclusion to establish a tumor region of interest (roi) zone and an equivalent roi zone in contralateral healthy tissue. * patient progressing after radiotherapy and at least one line of chemotherapy with temodal * patient in whom treatment with bevacizumab monotherapy has been validated by a multidisciplinary committee. exclusion criteria: * the subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * pregnant or breast feeding patients * hypersensitivity to iodinated contrast media and creatinine clearance less than 60 ml / minute.
effects of peripheral somatosensory stimulation through mechanical pressure on lower limb muscle strength in stroke survivors

Conditions: Stroke

Summary: somatosensory information is essential for the motor system because when the central nervous system stops receiving afferent signals, it cannot use information about the state of the affected body part to plan or adjust movement. this phenomenon is known as sensory deafferentation, and it significantly affects motor function. this principle offers an opportunity to observe changes in strength through a peripheral proprioceptive stimulus that activates the muscular system with the aim of increasing recruitment. this would justify the implementation of proprioceptive input in approaches focused on motor learning in movement disorders resulting from cortical lesions such as stroke.

objective: o determine whether the application of a peripheral proprioceptive stimulus to the neuromuscular motor points of the quadriceps increases strength and muscle activation during the squat movement in the affected limb of stroke survivors. methods:the design of this study is a randomized crossover clinical trial. all participants (n=36) will randomly receive both the active and sham proprioceptive stimulation.the proprioceptive stimulus will consist of intermittent mechanical pressure on the skin, localized at the neuromuscular motor points of the rectus femoris, vastus lateralis, and vastus medialis of the quadriceps. the tissue subjected to precise pressure in these highly innervated neuromuscular zones promotes the stimulation of kinesthetic cortical sensitivity. the outcome variable will be the assessment of maximum strength (ms) generated by the participant during the squat movement, from a 90º knee flexion position to full extension. at the moment of peak force, the mean velocity (mv) of the concentric phase of the movement and the maximum load the participant can move will be evaluated. the intervention, assessment, and recruitment will take place at avan private foundation sabadell and ricard i fortuny socio-healthcare center (cssv rif), vilafranca.

Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of unilateral hemispheric stroke (ischemic or hemorrhagic) confirmed by mri or ct scan. * at least 3 months must have passed since stroke onset. * ability to stand independently in a static position or to walk, regardless of whether assistance is needed. exclusion criteria: * diagnosis of cognitive, visual, or cardiorespiratory disorder (including the presence of a cardiac pacemaker, heart failure, arrhythmia, or severe copd) * orthopedic intervention in the lower limb * balance disorders of vestibular origin * skin diseases * botulinum toxin treatment within the past year
effect of an antioxidant on cancer-cachectic patients undergoing exercise training

Conditions: Gastrointestinal Neoplasms; Bronchial Carcinoma; Hodgkin Disease; Non-Hodgkin Lymphoma; Weight Loss

Summary: the purpose of the study is to tests the hypothesis, that n-acetylcysteine (a thiol-antioxidant)improves the exercise training effect on cancer patients that experience weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology.


Eligibility criteria:
inclusion criteria: * gastrointestinal or bronchial cancer * weight loss of 10% within 6 months * sufficient mobility exclusion criteria: * severe pain, steroid therapy, severe internal, muscular, neurological, psychiatric disease, n-acetylcysteine allergy

Keywords: cancer cachexia muscle wasting weight loss proteolysis
effect of ssp-004184 (spd602) on the pharmacokinetics of simvastatin in healthy adult subjects

Conditions: Healthy

Summary: this is a randomized, open-label study to evaluate the effect of a single dose of ssp-004184 on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * normal healthy male and female volunteers * serum ferritin, hemoglobin and erythrocyte indices within normal range exclusion criteria: * evidence of any active or chronic disease
goal-directed cpr using cerebral oximetry

Conditions: Ischemia; Reperfusion Injury

Summary: the proposed study is a single-center, randomized controlled pilot trial of adults who suffer in-hospital cardiac arrests. using cerebral oxygenation and end-tidal carbon dioxide physiological targets to predict survival and neurological outcome, the impact of physiological-feedback cpr will be assessed. 150 adult patients who have a cardiac arrest event at nyu tisch hospital will be randomized to one of two treatment groups: (1) physiological-feedback cpr or (2) non-physiological (audiovisual) feedback cpr.


Eligibility criteria:
inclusion criteria: 1. in-hospital cardiac arrest patient 2. age ≥18 years 3. age \<80 years 4. cpr lasting ≥5 minutes exclusion criteria: 1. patients \ 80 years of age 2. out of hospital cardiac arrest patients 3. ≥3 acute organ failures (defined as acute renal failure requiring dialysis, fulminant liver failure i.e. liver failure with inr≥1.5, respiratory failure requiring mechanical ventilation) 4. repeat in-hospital cardiac arrest event within 14 days of a prior cardiac arrest 5. presence of known raised intracranial pressure 6. presence of known traumatic brain injury or subarachnoid hemorrhage \<14 days old, frontal lobe brain tumors or subdural hemorrhage 7. hyperbilirubinemia \>1.0 mg/dl (based on the absorption of near-infrared light by bilirubin) 8. resuscitation using extra-corporeal membrane oxygenation (ecmo)

Keywords: cpr
monotherapy with eribulin in her2 negative metastatic breast cancer as a first line treatment

Conditions: Breast Neoplasm; Metastasis

Summary: multicentre, prospective, non-controlled phase ii clinical trial to evaluate the efficacy and tolerability of first line single agent eribulin in patients with her2-negative metastatic breast carcinoma (mbc) previously exposed to taxanes for early stage. the primary objective of the study is to determine the median time to progression achieved with eribulin. other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic breast cancer her2 negative, stage iiib/iv * previous history of early disease (stage i-iiib), surgically resected and treated with standard chemotherapy for at least 12 weeks at which included a taxane or ixabepilone * patients must have progressed in the 36 months after treatment with taxanes or ixabepilone. * age ≥ 18 years * given written informed consent * index of eastern cooperative oncology group (ecog) of 0 or 1 * patients must have recovered from toxicities related with previous treatment (ctc ≥ 1) * measurable or evaluable disease (recist 1.1) * adequate bone marrow function * adequate hepatic function * adequate renal function * life expectancy ≥ 3 months exclusion criteria: * breast cancer patients initially diagnosed with local disease advanced or metastatic disease. * patients who have previously received cytotoxic therapy hormone therapy permitted if the patients have interrupted it at least two weeks before the start of the study treatment. * major surgery or significant traumatic injury during the 4 weeks prior to study treatment or patients who may require major surgery during the assay. * brain metastases or leptomeningeal uncontrolled. * serious medical condition and / or not properly controlled (unstable angina, lung function severe impaired, uncontrolled diabetes, active serious infection,liver disease, hiv seropositivity, active bleeding diathesis) * other malignancies in the last three years, except: cervical carcinoma in situ, basal cell carcinoma or squamous cell skin carcinoma,that have been properly treated * patients who are pregnant or breastfeeding, or adults with reproductive capacity wich are not using effective contraception. * patients receiving chronic treatment with systemic corticosteroids or other immunosuppressive drugs (except corticosteroids with a daily dose equivalent to prednisone ≤ 20mg on a stable dose regimen one minimum of 4 weeks prior to study entry. topical and inhaled corticosteroids are allowed * active alcoholism or drugs addiction documented. * prior history of noncompliance with medical regimens * patients who do not want or can not comply with the study protocol

Keywords: breast neoplasm metastasis receptor,her-2 eribulin furans, ketones antimitotic agent
telerehabilitation in individuals with rheumatic disease

Conditions: Rheumatic Diseases

Summary: increasing the prevalence of exercise models designed in accordance with the biopsychosocial model is very important in terms of ensuring the sustainability of these models with telerehabilitation in periods such as epidemics and pandemics. the aim of this study was to investigate the effects of a biopsychosocial exercise model provided via telerehabilitation in individuals with rheumatic diseases during the covid-19 pandemic.

telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. the intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therapy. this exercise content was based on a biopsychosocial model, named the cognitive exercise therapy approach (bety) which was used in the study, and it was a method that patients already practiced before the pandemic. at the beginning, at the 12th week and 24th week, the health assessment questionnaire (haq), the hospital anxiety and depression scale (hads), the bety biopsychosocial questionnaire (bety-bq) were applied.

Eligibility criteria:
inclusion criteria: members of an exercise group before the pandemic at the physiotherapy and rehabilitation department of a university. exclusion criteria: * individuals who had difficulty in cooperation

Keywords: biopsychosocial, rheumatology, remote care, holistic