Kornimate/medical-research-clean huggingface dataset:
mass-balance study of [14c]-apd421 in healthy volunteers

Conditions: Post-operative Nausea and Vomiting

Summary: open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14c-labelled apd421


Eligibility criteria:
inclusion criteria: * healthy males * age 18 to 65 years of age at time of signing informed consent * body mass index (bmi) of 18 to 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator * must be willing and able to communicate and participate in the whole study * must provide written informed consent * must agree to use an adequate method of contraception (as defined in section 8.4) * must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day) exclusion criteria: * prior participation in another study with a radiation burden of \> 0.1 msv and ≤ 1 msv in the period of 1 year prior to screening; a radiation burden of \> 1 msv and ≤ 2 msv in the period of 2 years prior to screening; a radiation burden of \> 2 msv and ≤ 3 msv in the period of 3 years prior to screening, etc (add 1 year per 1 msv)
her2-low unresectable and/or metastatic breast cancer in russia

Conditions: Breast Cancer

Summary: planned study population consists of approximately 3,150 adult patients with her2-negative (ihc 0, + or ihc2+/ish-) unresectable or metastatic bc enrolled to the study in order to obtain approximately 2,000 patients with confirmed her2 low status (ihc1+ or ihc2+/ish ).


Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of unresectable and/or metastatic bc established between the 1st july 2021 and the 1st july 2022. * patients have her2-negative status (ihc0, ihc1+, ihc2+/ish-) obtained in the local laboratory. -. patients have an adequate archival tumor sample and slides suitable for reassessment her2 status\* by the reference laboratory. * patients have documented hormonal status (er, pr) ihc score. * age ≥ 18 years at the time of inclusion. * patients provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use in accordance with ich gcp, gpp (good pharmacoepidemiology practices) and local law prior to inclusion in the study. if the patient is deceased, a waiver may be accepted exclusion criteria: * patients with previous her2 positive status in the anamnesis at the diagnosis or after the diagnosis of breast cancer. * presence of other malignancies within period since diagnosis until the timepoint of data collection. * patients receiving trastuzumab deruxtecan currently or received in anamnesis. * the participation in any randomised controlled trial within period since diagnosis until end of study.
investigation of regional interdependence of the hip and spine in baseball players with low back pain

Conditions: Low Back Pain; Thoracic

Summary: low back pain (lbp) is a common musculoskeletal symptom in athletes. more than 40% percent of high school baseball players reported incidents of lbp during the previous year. university baseball athletes were 3.23 times more likely to have lumbar intervertebral disk degeneration than the nonathletic university students. according to the regional interdependence model, a patient's chief complaints may be directly or indirectly related to or influenced by physical impairments from various body systems and regardless of proximity to the primary symptom(s). athletes with a chief complaint of lbp frequently demonstrate with mobility restrictions in the thoracic spine and hips, which may contribute to compensatory hypermobility in the lumbar spine and subsequently lead to lbp. few studies have examined the relationship between thoracic spine mobility and lbp, while many studies investigating the relationship between hip joint mobility and lbp in athletes showed inconsistent results. the inconsistent results may be due to different types of sports and measurement methods. therefore, the objectives of this research project are to: (1) examine if baseball players with a history of lbp have mobility restriction in the thoracic spine and hips and movement coordination within the spine and hip regions during baseball batting that are different from those without a history of lbp; (2) identify thoracic spine and hip joint mobility and coordination related predictors for batting velocity and lbp in baseball players. this 2-year research project plans to recruitment a total of 110 male baseball players aged between 18 and 30 years from university and community recreational league baseball teams (55 players with a history of lbp and 55 age-matched players without a history of lbp). participants will receive physical examination for the thoracic spine and hip joints (joint mobility and muscle stiffness) and 3d motion analysis for baseball batting. the results of this research project will guide the development of more specific and effective treatment and preventative training for baseball players with lbp and enhance their batting performance.


Eligibility criteria:
inclusion criteria: • baseball players who had experienced at least 2 episodes of lbp that limits their performance for a period of greater than 3 days in the previous year. exclusion criteria: * current lbp symptoms including weakness and numbness in the lower extremities * previous surgery to the back, upper or lower extremities * marked spinal deformity (e.g., scoliosis, or kyphosis) * any other orthopedic or medical problem that would have limited their ability to fully participate in baseball training and competition in the last year.

Keywords: baseball batting motion analysis regional interdependence, hip joint mobility muscle stiffness
reporting usual physiotherapy care in stroke survivors in catalonia

Conditions: Stroke

Summary: stroke is one of the major leading causes of death and disability globally and presents a high interest of research around all its branches, including rehabilitation. there are published recommendations and clinical guidelines to guide the care of stroke patients with regard to physical therapy. however, the status of current clinical practice is unknown. this study aims to identify and describe the therapeutic approaches most used by physiotherapists in catalonia in the care of stroke survivors in different phases of evolution. an observational study will be carried out through an anonymous survey of physiotherapists in catalonia. through the college of physiotherapists of catalonia, all members will be invited to answer a survey on current clinical practice in the care of stroke survivors. the survey will collect data related to the physiotherapist's training and experience, the most frequently used therapeutic approaches, user profiles and institutions. it is intended to collect the data between october 2022 and february 2023. the data will be analyzed by the team of researchers


Eligibility criteria:
inclusion criteria: * physiotherapists who are currently working in catalonia with patients who have suffered a stroke. exclusion criteria: * physiotherapists do not currently work with at least one stroke patient

Keywords: stroke physiotherapy rehabilitation catalonia usual care
pentoxifylline add-on therapy for schizophrenia

Conditions: Schizophrenia

Summary: the etiology and pathogenesis of schizophrenia remain unclear. the immune dysfunction hypothesis for schizophrenia has attracted increasing attention from researchers, and substantial evidence suggested that the levels of tnf-α and other cytokines are markedly elevated in patients with schizophrenia. the investigators aim to evaluate the adjuvant therapeutic effect of pentoxifylline, a tnf-α inhibitor that crosses the blood-brain barrier, in a randomized, double-blind, 6-week trial. individuals with schizophrenia will receive either pentoxifylline or a matching placebo as an add-on treatment to antipsychotic agents. subjects' positive and negative symptoms and plasma concentration of neuroinflammatory markers will be monitored at baseline and every two weeks until the end of the trial.

ninety schizophrenic patients will be randomized to a pentoxifylline (400 mg twice a day) or placebo treatment for six weeks. pentoxifylline and placebo will be added to the current antipsychotic drug treatment. participants will be asked to fill a socio-demographic questionnaire and to undergo a clinical differential diagnosis using the symptoms check list (scl)-90, clinical global impression (cgi), positive and negative symptoms scale (panss), and hamilton depression rating scale (ham-d). following baseline evaluation, participants will be monitored for symptoms every two weeks until the end of the trial (overall three visits) using cgi, panss, and ham-d. adverse effects will be documented every visit using the treatment emergent symptom scale. finally, yet importantly, a blood sample will be collected at baseline and every two weeks until the end of the trial to study the treatment effect on inflammatory markers.

Eligibility criteria:
inclusion criteria: 1. patients meeting the dsm-v criteria for schizophrenia spectrum disorders. 2. clinical global impression (cgi) score ≥ 4 and ≤ 6 at screening. 3. initiated treatment with a stable dosage of typical and/or atypical antipsychotic medication for at least four weeks. exclusion criteria: 1. previous sensitivity to pentoxifylline (ptf). 2. chronic immune and/or inflammatory diseases (such as rheumatoid arthritis, systemic lupus erythematosus, chronic inflammatory bowel disease). 3. consumption for \> 3 consecutive days of any immune-modulating or anti-inflammatory drug in the last month. 4. current active and persistent substance and/or alcohol abuse. 5. any severe, unstable medical condition (e.g., cardiovascular disorders, diabetes mellitus, respiratory diseases, cancer). 6. obesity (body mass index \> 30). 7. cognitive dysfunction such as retardation. 8. known or suspected pregnancy or breastfeeding women. 9. lactose intolerance or sensitivity.
conventional follow-up versus mobile app for post-operative acl reconstruction patients

Conditions: Anterior Cruciate Ligament (ACL) Tear

Summary: background: telemedicine is increasingly used to overcome distance between patients and physicians. preliminary studies suggest that mobile app follow-up care for acl reconstruction patients is feasible, can avert in-person follow-up care, and is cost-effective. objective: to avert in-person follow-up through the use of a mobile app in the first six weeks after surgery. methods: this will be a single-center, prospective randomized controlled trial results: data to be analyzed from 72 patients.


Eligibility criteria:
inclusion criteria: * patients undergoing acl reconstruction at women's college hospital (wch), between the ages of 18-70. * patients must be able to use a mobile device and communicate in english. exclusion criteria: * patients who are smokers, as they carry increased rates of complications. * patients must not: * suffer from chronic pain * be taking narcotic (morphine-like) medication for pain on a regular basis, and * have an allergy to local anesthetics or morphine-like medications * pain scores captured in the vas and qor-9 are important for judging post-operative recovery. pre-existing pain or inability to take narcotics post-operatively would compromise the reliability of these measures.
feasibility study of the hemolung respiratory assist system

Conditions: Hypercapnic Respiratory Failure, COPD

Summary: the purpose of this study is to evaluate the safety and efficacy of the hemolung respiratory assist system in patients with hypercapnic respiratory failure associated with acute exacerbation of chronic obstructive pulmonary disease (copd) and a 50% likelihood of failure of noninvasive positive pressure ventilation leading to intubation and mechanical ventilation.


Eligibility criteria:
inclusion criteria: * moderate or severe copd, as defined by the gold criteria * acute exacerbation of copd (sustained worsening of patient's condition necessitating a change in regular medication) * on non-invasive positive pressure mechanical ventilation \> 1hour with either: * paco2 \> 55 mmhg with ph \< 7.25 or * paco2 \> 55 mmhg with \< 5mmhg decrease from baseline and ph \< 7.30 * not severely hypoxemic (pao2/fio2 ≥ 200 mmhg on peep/cpap ≤ 5 cmh2o) * hemodynamically stable (mean arterial pressure \> 65 mmhg without vasopressor support) * chronic arrhythmias (e.g., atrial fibrillation) well controlled * minimum platelet count of 100,000/mm3 * minimum red blood cell count of 2.5 mill/μl exclusion criteria: * presence of acute, uncontrolled arrhythmia * acute ischemic heart disease * presence of bleeding diathesis * significant abnormality or weakness/paralysis of respiratory muscles due to a know muscular dystrophy or neurologic disorder * recent (\ 24 hrs) use of muscle paralyzing agents * cerebrovascular accident, intracranial bleed, head injury or other neurologic disorder likely to affect ventilation * coma from any cause, or decreased consciousness * hypersensitivity to heparin or previous heparin induced thrombocytopenia * recent (\< 6 months) major chest abdominal trauma or surgery * presence of septic shock * presence of a significant pneumothorax or bronchopleural fistula * history of uncontrolled major psychiatric disorder * pregnant women * known to have aids or to have symptomatic hiv * received chemotherapy or radiation within the previous 90 days * received an organ transplant other than corneal transplants * received or currently receiving immunosuppressive therapy, excluding corticosteroids within the last 3 months * presence of severe renal or liver failures * known vascular abnormality with could complicate or prevent successful insertion of the vascular access catheter in the right femoral vein * presence of another catheter in the right femoral vein that cannot be moved * presence of an inferior vena cava filter

Keywords: hypercapnic respiratory failure, copd
effect of group-task-oriented training on gmfm and adl in children with ds

Conditions: Downs Syndrome

Summary: down syndrome, a genetic condition resulting from an additional copy of chromosome 21, manifests with distinct facial features and intellectual challenges. individuals with down syndrome often face delays in motor skills, speech, and language development, alongside potential health issues. down syndrome commonly encounter difficulties in both gross and fine motor functions due to factors like low muscle tone. nonetheless, targeted interventions, including physical, significantly enhance motor skills. daily living activities for individuals with down syndrome cover personal care and household tasks, with structured routines and consistent support fostering independence. group task-oriented training, focusing on skill improvement and social interaction through collaborative activities, offers a meaningful approach to enhancing the overall quality of life for individuals with down syndrome.

group a receive group-task-oriented training. group b receive routine therapy. both the groups receive intervention for 40 minutes per session 4 times a week for six weeks.this study will be a randomized controlled trial and will be completed over a 10-month period in lahore. data will be collected from psrd hospital and rising sun institute for special children. the estimated sample size is 44 participants, will be divided into two groups using non-probability convenient sampling. inclusion criteria for down syndrome children aged 4-8 include willingness to engage in group-task-oriented training sessions and stable health conditions. exclusion criteria involve recent surgeries or severe medical conditions hindering participation. data collection tools comprise the jebsen hand function test, gross motor function measure, and pediatric evaluation of disability inventory.participants are randomly assigned to an experimental group undergoing group task-oriented training and a control group receiving routine physical therapy. the training sessions for both groups are detailed, focusing on motor skills, fine motor function, gait training, and activities of daily living.

Eligibility criteria:
inclusion criteria: * down syndrome children age ranged between 4-8 years (20). * both male and female genders are included (21). * children and their families willing to engage in group-task-oriented training sessions (20). * participants in stable health conditions suitable for engaging in the prescribed training program (20). exclusion criteria: * any recent surgical procedure (21). * children with severe medical conditions or comorbidities that may interfere with participation in the group-task-oriented training (21). * children with severe physical limitations that could hinder active participation in the training sessions (21)

Keywords: down syndrome, group-oriented task training, motor skills
low-flow co2 removal for mild to moderate ards with prismalung

Conditions: Acute Respiratory Distress Syndrome

Summary: this pilot observational study will assess changes in ph /pao2 /paco2, respiratory rate and device co2 clearance in the first 24 hours of extracorporeal co2 removal (ecco2r) following tidal volume (vt), and plateau pressure reduction in patients with mild to moderate ards.

extracorporeal co2 removal (ecco2r) with a low-flow co2 removal device (prismalung, gambro-baxter) integrated on the prismaflex platform (gambro-baxter) allows tidal volume (vt) and plateau pressure reduction in patients with mild to moderate ards. this pilot observational study will assess changes in ph /pao2 /paco2, respiratory rate and device co2 clearance in the first 24 hours of ecco2r following vt and plateau pressure reduction in patients with mild to moderate ards. safety variables during treatment will also be analyzed. a series of 20 consecutive patients will be included in this observational study.

Eligibility criteria:
inclusion criteria: * mechanical ventilation with expected duration of \>24 hours * mild to moderate acute respiratory distress syndrome (ards) according to the berlin definition: 100 mmhg \ 5 cmh2o exclusion criteria: * age \<18 years * pregnancy * severe hypoxemia with pao2/fio2 \<100 mmhg * body mass index \> 40 kg/m2 * decompensated heart insufficiency or acute coronary syndrome * severe chronic obstructive pulmonary disease (copd) * major respiratory acidosis with paco2 \>60 mmhg * acute brain injury * severe liver insufficiency (child-pugh scores \>7) or fulminant hepatic failure * heparin-induced thrombocytopenia * contraindication for systemic anticoagulation * patient moribund, decision to limit therapeutic interventions * catheter access to femoral vein or jugular vein impossible * pneumothorax * platelet \<50 g/l * lacking consent
stereotactic ablative radiosurgery of recurrent ventricular tachycardia in structural heart disease

Conditions: Ventricular Tachycardia

Summary: a multicentre trial on clinical effects of radiosurgical ablation of ventricular tachycardia (vt).

patients with previously failed conventional rf catheter ablation will be randomized to radiosurgery (active treatment group) or repeated catheter ablation (control treatment group). details on inclusion and exclusion criteria are provided below. randomization eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of structural heart disease (shd), left ventricular (lv) ejection fraction, and serum b-type natriuretic peptide (nt-probnp) level.

Eligibility criteria:
inclusion criteria: 1. patients with structural heart disease (shd) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected) 2. implanted implantable cardioverter-defibrillator (icd) or cardiac resynchronization therapy-defibrillator (crt-d) 3. prior ≥1 catheter ablation procedure for vt due to shd of them the last one performed in the expert center and employed: 3.1 all meaningful mapping/ablation approaches (endocardial/epicardial access to left / right ventricular substrate as possible or appropriate) 3.2 precise electroanatomical mapping of the arrhythmogenic substrate in anticipation of future radiosurgery 3.3 additional mapping of structures used for precise image integration (aortic arch, left main ostium, right ventricular endocardial surface) 4. vt recurrence after the last catheter ablation fulfilling all criteria as follows: 4.1 clinically relevant and requiring further intervention 4.2 compatible with the previously characterized arrhythmogenic substrate 4.3 occurred on stable antiarrhythmic medication (mostly amiodarone) unless contraindicated 4.4 reversible cause excluded 5. signed an institutional review board (irb)-approved written informed consent exclusion criteria: 1. age \< 20 years 2. acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (\< 3 months) 3. primary electrical disease (channelopathy) 4. pregnancy or breastfeeding 5. chronic heart failure with new york heart association (nyha) class iv 6. serious comorbidities with presumed life expectancy less than one year 7. significant peripheral artery disease precluding retrograde aortic mapping

Keywords: structural heart disease ventricular tachycardia substrate ablation stereotactic radiosurgery functional radiosurgery 4d navigation
dietary soy isoflavones in chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: dietary soy isoflavones in chronic pancreatitis: investigating the anti-inflammatory effects of food innovation science on gastrointestinal disease

management of pancreatic disorders imparts a major burden on healthcare costs, estimated at over 3 billion dollars annually. chronic pancreatitis is characterized by chronic inflammation and progressive scarring, leading to abdominal pain, irreversible damage to the pancreas and the loss of both exocrine and endocrine function. additionally, chronic pancreatic inflammation is a risk factor for pancreas cancer. there are no current treatments to modify the natural history of this disorder. thus, identifying novel therapeutic options for this disease represents a high priority, and could fill an unmet medical need to improve quality of life, reduce risk of malignant transformation, and limit exorbitant medical costs associated with patient care. the investigators have assembled a multi-disciplinary research team to pursue an alternative, non-pharmacologic approach to limiting inflammatory cascades in (chronic pancreatitis) cp patients. they will assess compliance, toxicity and measure the changes in pro-inflammatory cytokine expression from a soy based dietary bread product using a classic 3+3 dose escalation study design in subjects with chronic pancreatitis.

Eligibility criteria:
inclusion criteria: 1. diagnosis of chronic pancreatitis by fulfilling one of the following clinical scenarios: 1. presence of pancreatic calcifications 2. suggestive for chronic pancreatitis - consistent eus criteria or at least 3 abnormal side branches on pancreatic duct imaging 3. indeterminate eus findings for chronic pancreatitis with evidence of exocrine pancreatic insufficiency (epi) 2. age ≥18 years exclusion criteria: 1. inability to provide written consent 2. inability to comply with the study protocol 3. soy allergy 4. pancreatic cancer 5. history of prior pancreatic surgery (this does not include endoscopic therapies) 6. comorbid diseases characterized by a chronic inflammatory state, including, but not limited to rheumatologic diseases, chronic kidney disease, extra-pancreatic malignancy 7. pregnancy