Kornimate/medical-research-clean huggingface dataset:
feasibility, efficacy and safety of ibs ® for implantaiton in the pda in duct-dependent cyanotic chd

Conditions: Patent Ductus Arteriosus; Duct-dependent Cyanotic Congenital Heart Disease

Summary: this is a pilot study on feasibility, efficacy and safety of ibs ® for implantation in the pda in duct-dependent cyanotic chd, and its objective is to investigate the feasibility, safety and efficacy of iron resorbable stent implantation in the pda as initial palliation of cyanotic chd with duct-dependent pbf.

study type: interventional, prospective, single arm, investigator initiated study population: 10 patients primary purpose: treatment follow up: review at 1 month and thereafter 3 monthly (clinical examination and echocardiography for stent patency, sao2 measurement. serum iron and ferritin levels will be measured before procedure and at follow ups. from 6 months onwards the patients will be assessed for the need of repeat catheterization with a view of surgery or for continued observation. study endpoints: 9 months post implant or the following: 1)patients are subjected for surgical repair of chd; 2)death before surgical repair; 3)unplanned re-intervention with additional stenting procedure.

Eligibility criteria:
inclusion criteria: * weight \>3.0 kg * age \<3 months * patients with uncomplicated pda morphology (the pda is not tortuous i.e. relatively straight exclusion criteria: * weight \ 3 months * angiographic criteria-tortuous pda * family history of diseases related to iron overload or iron disorder e.g. hereditary hemochromatosis * other severe congenital anomalies with life expectancy \<12 months
role of ceus as a secondary diagnostic modality

Conditions: Hepatocellular Carcinoma

Summary: to determine the role of contrast-enhanced ultrasound (ceus) as a second-line imaging modality after gadoxetate-enhanced mri (gd-eob-mri) for identifying hepatocellular carcinoma (hcc) among at-risks observations.

the purpose of our study was to evaluate the diagnostic ability of ceus with perflubutane to identify hcc on the indeterminate observation in gd-eob-mri and to establish the role of ceus as a second-line (post-gd-eob-mri) modality for hcc diagnosis.

Eligibility criteria:
inclusion criteria: * at risk of hcc by liver imaging reporting and data system (li-rads) * at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance using us, ct or mri * signed informed consent exclusion criteria: * congestive hepatopathies * severe cardiovascular dysfunction * no recent cross-sectional images within 4 weeks * suboptimal cross-sectional images quality
adaptive therapy for post-second-line advanced breast cancer

Conditions: HER2-negative Metastatic Breast Cancer

Summary: the primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of post-second-line metastatic breast cancer.

this is a phase ii, prospective, single arm clinical trial. the objective of the study is to evaluate the efficacy and safety of adaptive therapy in the treatment of post-second-line advanced breast cancer. the therapy regimen primarily including gemcitabine, vinorelbine, or eribulin, will be selected by the investigator based on current guidelines, available treatments, and an assessment of the patient's clinical status, preferences, and financial situation. this study plans to recruit 10 subjects.

Eligibility criteria:
inclusion criteria: * understands and voluntarily signs the informed consent form. * minimum life expectancy 16 weeks. * histologically or cytologically confirmed advanced invasive breast cancer. * histological type: human epidermal growth factor receptor 2 (her2) negative. * prior failure of at least first-line treatment for metastatic disease. * at least 1 measurable lesion as defined by response evaluation criteria in solid tumors (recist) criteria. * adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve. * premenopausal women must use medically acceptable contraception during the study. * compliance with the study protocol. exclusion criteria: * pregnant or breast feeding. * uncontrolled medical problems. * evidence of active acute or chronic infection. * hepatic, renal, cardiac, or bone marrow dysfunction. * concurrent malignancy or history of other malignancy within the last five years. * patients were unable or unwilling to comply with program requirements. * concurrent use of any other anti-cancer therapy.
impact of blood-flow-restriction prehabilitation on pre- and postoperative rehabilitation after total knee arthroplasty

Conditions: Osteoarthritis (OA) of the Knee

Summary: degenerative and traumatic diseases of the musculoskeletal system lead to increased immobility of a patient, which in turn results in muscle atrophy. bfr training is a training method in which a blood pressure cuff partially blocks the arterial blood flow to the exercising limb and completely blocks the venous blood flow. during exercise, an externally induced venous occlusion occurs. this stimulus increases the metabolic stimulus in the occluded extremity - this means that strength can be increased even with low weights, which is why this training is also suitable for people who should not use high training loads due to injuries or operations.


Eligibility criteria:
inclusion criteria: * indication for tka surgery * ability to perform prehabilitation exercise exclusion criteria: * sickle cell anemia * iatrogenic changes in the vessels of the lower extremities (e.g. stents) * open wounds/infection of the lower extremities
impact of blueberries on uric acid and quality of life

Conditions: Hyperuricemia

Summary: the purpose of this study is to determine the impact of blueberries on uric acid in patients with hyperuricemia that are not receiving uric acid pharmacotherapy. the central hypothesis the investigators propose is that daily blueberries added to a pre-existing diet will promote uric acid lowering and improve quality of life without detriment to vital signs.


Eligibility criteria:
inclusion criteria: * 18 years or older * uric acid \> 6.0 mg/dl exclusion criteria: * current moderate-to-severe symptomatic gout * currently receiving gout pharmacotherapy * current participation in another clinical trial * documented non-compliance or consistent missed appointments * women who are pregnant or nursing

Keywords: blueberry
whole blood metal ion concentrations in metal-on-metal total hip arthroplasty and hip resurfacing

Conditions: Osteoarthritis, Hip

Summary: the investigators aimed to investigate the possible differences in metal ion concentrations in patients following one of two types of metal-on-metal articulating hip prosthesis regarding chromium and cobalt concentration, radiological findings, patient reported outcome measures and rate of revision at 5-years follow up.

the metal-on-metal large-diameter-head (mom-ldh) hip replacements increased in popularity during the start of the 21st century. subsequently reports raised concerns regarding adverse reactions due to elevated chromium (cr) and cobalt (co) concentrations as well as high rates of other complications and revisions. this was a single center parallel-group randomized controlled trial. the primary outcome was to compare cr and co concentrations at 5-years follow up following mom-ldh total hip arthroplasty (mom-ldh-tha) or mom-ldh hip resurfacing (mom-ldh-hr). secondary outcomes were radiological findings, patient reported outcome measures and revision rate at 5-years follow up. the study was prematurely terminated in 2012 due to alerts and safety communications from the danish national regulatory agency regarding early failure rates and high incidence of armd in patients with mom hip implants \[13\]. at that time the study population consisted of 75 patients out of 200 planned for inclusion.

Eligibility criteria:
inclusion criteria: * primary or secondary hip osteoarthritis eligible for hip replacement surgery * able to give informed consent * able to complete follow up consultations exclusion criteria: * earlier or present infection of the hip * severe systemic or metabolic disease leading to weakening of the bone * severe congenital hip dysplasia * osteoporosis and/or renal disease

Keywords: metal ion concentration total hip arthroplasty hip resurfacing
establish quantitative measurements of laryngeal sensorimotor functions and evaluating the grade of phonation and swallowing impairment

Conditions: Unilateral Vocal Cord Paralysis

Summary: laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance, which often happens after the treatment for laryngopharyngeal and esophageal cancer and may induce fatal complications such as aspiration pneumonia. by the conventional examinations, the tiny sensory or motor changes are hard to be detected before complete vocal paralysis. it is utmost important to establish a comprehensive quantitative method which is sensitive enough to evaluate the neuromuscular functions. the present project will evaluate the laryngeal nerve function by quantitative laryngeal electromyography, which was developed by the research team, and another novel examination technique, mucosal membrane sensation test. the comprehensive method is expected to grade the laryngeal nerve injuries quantitatively before the significant symptoms or complications and can also help to evaluate the treatment effect from medicine, rehabilitation or surgery.


Eligibility criteria:
inclusion criteria: * patients with laryngopharyngeal or esophageal cancer who have taken active therapy and are not neck tissue damage. * patients with clear conscious and stable mental status exclusion criteria: * patients who cannot sit for longer than 30 minutes or received other vocal cord treatments before the selection * pregnant and breastfeeding women * patients with communication disorder

Keywords: laryngeal electromyography intrinsic laryngeal muscles recurrent laryngeal nerve superior laryngeal nerve laryngeal sensation tone language
implication of new high resolution ultrasonographic modalities for diagnosis of fetal nervous system anomalies

Conditions: Ultrasound Therapy; Complications Anomaly Central Nervous System Diseases

Summary: the fetal cns screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.these planes are commonly referred to as the transventricular and transcerebellar planes. a third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (csp). head shape and brain texture should also be noted on these views.

the neural system malformation is one of the more common congenital anomalies encountered in pregnancy. they represent about 0.3-1 percent of all live births. during a prenatal anomaly scan, detection of cns malformations is important, especially since these anomalies have a poor prognosis and are also associated with genetic syndromes or chromosomal anomalies. such malformations have clinical importance because they are associated with high rates of morbidity and mortality, influencing the neurocognitive and motor development of the survivors, who may have lifelong sequelae. thus, it's extremely important to assess the fetal cns during the prenatal period in order to identify any changes in its development and give appropriate advice to parents regarding pregnancy follow-up. also, it is vital to explore options for fetal therapy and the timing/type of delivery, as well as postnatal treatment and prognosis. the fetal cns screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.these planes are commonly referred to as the transventricular and transcerebellar planes. a third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (csp). head shape and brain texture should also be noted on these views.

Eligibility criteria:
inclusion criteria: suspicion of cns or spinal malformation at routine screening ultrasound suspicion of cns or spinal malformation at nuchal translucency scan family history of inheritable cns spinal malformations previous pregnancy complicated by fetal brain or spinal malformation fetus with congenital heart disease monochorionic twins suspected congenital intrauterine infection exposure to teratogens known to affect neurogenesis exclusion criteria: low risk pregnancy
aprepitant injectable emulsion in patients with covid-19 (guards-1)

Conditions: COVID-19

Summary: the study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with covid-19.


Eligibility criteria:
inclusion criteria: * is hospitalized for ≤48 hours with sars-cov-2 infection. confirmed by polymerase chain reaction (pcr), antigen or immunoglobulin m (igm) antibody test. * has at least 1 of the following: radiographic infiltrates by imaging, or oxygen saturation of \<94% by pulse oximetry on room air or requiring supplemental oxygen. * not anticipated to require mechanical ventilation within 48 hours. exclusion criteria: * is taking high-dose hydroxychloroquine or chloroquine. * is taking pimozide or strong or moderate cyp3a4 inhibitors. * is currently receiving treatment with products intended to modify immune response to covid-19 (exception: dexamethasone, methylprednisolone, or equivalent are allowed), chemotherapy or on hemodialysis or peritoneal dialysis. * has known hypersensitivity to any components of aprepitant injectable emulsion. * has evidence of ards. * is being treated with oxygen delivered by high-flow nasal cannula nonrebreather mask, noninvasive positive pressure ventilation, or ecmo. * has multiple organ failure. * has current confirmed influenza a or b infection, or a a history of organ or hematologic transplant, hiv, or active hepatitis b or hepatitis c infection.

Keywords: covid-19 coronavirus
long-term safety evaluation of treatment of constipation due to opioids being taken for persistent non-cancer pain

Conditions: Bowel Dysfunction; Constipation

Summary: adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (obd) will be randomized (1:1) to alvimopan or placebo. the primary objective of this phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of obd. participants will be required to attend 8 clinic visits over approximately 1 year.


Eligibility criteria:
inclusion criteria: * consented to participate in this study. * taking opioid therapy for persistent non-cancer pain. * has bowel dysfunction mainly due to opioids. * has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms. * willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed). exclusion criteria: * pregnant, lactating, or planning to become pregnant. * not ambulatory. * participated in another trial with an investigational drug in the past 30 days. * taking opioids for the management of drug addiction or cancer-related pain. * severe constipation whereby the subject is at immediate risk of developing serious complications of constipation. * gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (gi) obstruction, or contribute to bowel dysfunction. * human immunodeficiency virus (hiv)-infected, has active hepatitis, or has ever been infected with hepatitis c.

Keywords: bowel dysfunction constipation gastrointestinal opioids pain non-cancer pain opioid-induced
aims to explore the safety, tolerability, and preliminary efficacy of sctb41 in adult patients with advanced malignant solid tumours.

Conditions: Advanced Malignant Solid Tumours

Summary: this study aims to explore the safety, tolerability, pk characteristics, immunogenicity, and preliminary anti-tumor efficacy of sctb41 as a monotherapy in adult patients with advanced malignant solid tumours. this study is an open label, multicentre, dose-escalation and dose-expansion phase i/ii clinical trial.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent form (icf); 2. male or female, ≥18 years old; 3. survival duration more than 3 months; 4. ecog score ≤ 1 point; 5. participants in phase ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour; 6. participants in phase ib (dose-expansion phase) and phase ii are required to meet the following criteria: histologically or cytologically confirmed specific type advanced malignant solid tumours; 7. adequate organ and bone marrow function. exclusion criteria: 1. participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases; 2. other malignancies diagnosed; 3. history of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. history of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment; 4. presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence; 5. received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment; 6. need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study; 7. significant coagulopathy or other evident risk of bleeding; 8. uncontrolled effusions in the serous cavities within 4 weeks before enrollment； 9. major surgery or significant trauma within 4 weeks prior to enrollment;presence of unhealed skin wounds, surgical sites, trauma sites, severe- page 3 of 4 \[draft\] -mucosal ulcers, or fractures, or if the investigator deems the participantunsuitable for the study; 10. history of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ grade 3 iraes; 11. known severe allergy to similar antibody drugs; 12. presence of active infection； 13. history of organ transplantation or stem cell transplantation; 14. pregnant or breastfeeding female; women of childbearing potential withpositive pregnancy test within 7 days before the enrollment; participants(including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.
study of xpf-001 in the treatment of pain from primary/inherited erythromelalgia (iem)

Conditions: Primary Erythromelalgia; Inherited Erythromelalgia

Summary: the purpose of this study is to determine whether xpf-001 is safe and effective in the treatment of pain caused by inherited erythromelalgia (iem).


Eligibility criteria:
inclusion criteria: the study requires you to: * be18-75 years old * have inherited erythromelalgia * be experiencing pain caused by erythromelalgia (moderate pain score 4/10) * be generally healthy (apart from your pain) * stop taking your usual pain medications for 9 days * not be pregnant or breast-feeding your role in the study includes: * an out-patient screening visit * 9-days/8 nights-in-patient treatment visit at nijmegen medical center (where you will be closely monitored) * a follow up phone call (after your return home) * taking the investigational medication daily * recording your pain levels daily during stay at the medical center. exclusion criteria: * coexistent source of pain from other conditions * receiving professional psychological support for dealing with iem * treatment for significant depression within 6 months of screening * active hiv, hepatitis b or c * use of prescription or otc medication between check-in and discharge * women who are pregnant, or lactating * not currently using adequate contraception * alcoholism or alcohol or substance abuse * presence or history of major psychiatric disturbance * unwilling or unable to comply with all dietary and activity restrictions * any other condition or finding that may pose undue risk for participation * use of any other investigational drug in the 60 days prior to dosing
the effects of tdcs combined with balance training on postural control in chronic stroke patients

Conditions: Ischemic Stroke

Summary: purpose: the incidence of stroke in low-to-middle income countries is increasing .balance impairment and falling negatively impact function of stroke patients. mobility is based on successful postural control and about 30% of individuals with stroke are unable to ambulate without assistance.transcranial direct current stimulation (tdcs) is a new promising tool for motor recovery in neurological disease.this can be addressed through a tdcs intervention. objective:the objectives of this study is to examine the efficacy of anodal tdcs combined with biodex balance training on postural control in chronic stroke patients using laboratory and clinical assessments. the following essential treatment components; a) active tdcs stimulation paired with biodex balance training, b)sham tdcs paired with biodex balance training program. to identify combinations effects of tdcs stimulation plus balance training . hypothesis: anodal tdcs targeting leg motor area (cz) for 5-days plus biodex balance training, will significantly improve stroke clients' balance and functional mobility. double blinded sham -controlled randomized tdcs stimulation arms assigned interventions experimental: arm 1 tdcs brain stimulation and simultaneous balance training participants underwent active tdcs brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days. no intervention: arm 2 sham tdcs brain stimulation (20 minutes) and simultaneous balance training

participants underwent tdcs(2ma) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days, all outcome measures will be measured in 4 time points: pre-test, post-test after 10 sessions of intervention, and after 1 week and 1 months post intervention as follow ups.

Eligibility criteria:
inclusion criteria: age ≥18 years; first-ever ischemic stroke; chronic phase of recovery (\>6 months); ability to walk 6- meter supported or unsupported; ability to stand at least unsupported for 40-seconds with eyes closed; only ischemic stroke involving middle cerebral artery (mca) territory confirmed by ct or mri. exclusion criteria: use of any neuro- or psycho-active medications that alters balance; any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases; ongoing/recent (within 3 months) balance rehabilitation.

Keywords: tdcs, stroke, postural control