Kornimate/medical-research-clean huggingface dataset:
evaluation of heart status in patients of beta thalassemia using echocardiogram

Conditions: Beta Thalassemia

Summary: heart failure from myocardial iron deposition is a severe complication for patients with transfusion-dependent beta thalassemia . increased cardiac iron content impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis, and arrhythmias. the severity of cardiac dysfunction depends on the amount of iron deposited in the myocardium.echocardiogram is used as noninvasive method to observe heart status. the objective of this study is to evaluate the heart status in patients of beta thalassemia from southern china.


Eligibility criteria:
inclusion criteria: * diagnosed with beta-thalassemia exclusion criteria: * iron deficiency anemia
opioid use disorder in pregnancy in long-term maternal/infant outcomes

Conditions: Opioid-use Disorder; Opioid Use, Unspecified; Buprenorphine Dependence

Summary: the objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (nas).

one of the greatest impacts on maternal/infant health in the united states today is mother's who have opioid use disorder also known as oud. this study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with mri's, blood draws, and a series of assessments. after the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal mri, blood draws and infant/child assessments. planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.

Eligibility criteria:
inclusion criteria: * age greater 18 years * currently taking buprenorphine for opioid use disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at iu health university hospital. * pregnant with single baby * planned delivery at methodist, university or riley hospital exclusion criteria: * serious maternal medical illness as deemed by study physician or investigator. * known or suspected major fetal/neonatal congenital abnormalities.

Keywords: pregnant with opioid use disorder opioid use disorder ( oud) subutex buprenorphine pregnant taking buprenorphine/subutex
docetaxel in treating patients with relapsed prostate cancer

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.

objectives: primary * determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel. secondary * determine the time to psa recurrence in patients receiving this treatment. * determine the time to metastatic disease in patients receiving this treatment. * determine the time to androgen independent state in patients receiving this treatment. * determine the time to death from any cause in patients receiving this treatment. outline: this is an open label study. patients receive docetaxel iv over 60 minutes on day 1. treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression. after completion of study therapy, patients are followed periodically for up to 5 years. projected accrual: a total of 36 patients will be accrued for this study.

Eligibility criteria:
criteria for patient eligibility inclusion criteria 1. histologically confirmed adenocarcinoma of the prostate. 2. prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy. 3. serum psa \> 0.2 ng/dl following 8 months of androgen deprivation therapy or a nadir psa \>0.2 ng/dl and at least 1 subsequent psa values at the same or higher level, if prior to 8 months. 4. serum testosterone \< 50 ng/ml. 5. no evidence of metastases on bone scan. 6. no evidence of metastases on ct scan of the abdomen and pelvis. 7. ecog performance status \< 2. 8. laboratory criteria for entry: absolute neutrophil count ≥ 1.2 k/cu mm, platelets ≥ 100 k/cu mm, serum bilirubin ≤ upper limit of normal (uln), sgot and sgpt ≤ 1.5 times institutional uln if alkaline phosphatase ≤ uln, alkaline phosphatase ≤ 5 times uln if sgot and sgpt are ≤ uln, a serum creatinine ≤ 2 times institutional uln. 9. signed informed consent. exclusion criteria 1. a second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer. 2. life expectancy \< 3 months. 3. grade 2 or higher peripheral neuropathy. 4. prior investigational agent within the past 28 days. 5. less than a 10% decrease (or continued rise) in psa in response to initial androgen-deprivation therapy. 6. more than 12 months since initiation of androgen-deprivation therapy. 7. prior docetaxel chemotherapy. 8. patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. patients on stable doses of systemic corticosteroids will be eligible.

Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage i prostate cancer stage ii prostate cancer stage iii prostate cancer stage iv prostate cancer
autonomic regulation trial (art)

Conditions: Infarction, Myocardial

Summary: the purpose of this study was to develope and evaluate a new method for risk stratification which predicts high mortality risk in patients with cardiac disease based on simultateous examination of high resolution ecg, continuous arterial pressure and a breathing signal.


Eligibility criteria:
inclusion criteria: acute myocardial infarction, presence of sinus rhythm exclusion criteria: diseases (other than acute myocardial infarction) with impact on prognosis

Keywords: autonomic nervous system assessment, risk
use and acceptability study of swallis dsa™ device for distanced swallowing assessment for older adults in nursing home chez les personnes agees en ehpad

Conditions: Dysphagia

Summary: swall ehpad is a multicenter, prospective study on the use and acceptability study of swallis dsa™ medical device for distanced swallowing assessment for older adults in nursing home

swallowing disorders are frequent in nursing homes and under-assessed, under-diagnosed, and under-managed. the swallis dsa™ investigative device is intended to capture and display pharyngolaryngeal activity in subjects with or at risk for swallowing disorders. this device will thus open the way to telecare in the field of swallowing, the expected benefit of which is to improve access to care in the population of subjects living in nursing home this study aims to verify three hypotheses: 1. the recording of the clinical swallowing assessment performed by the speech therapist at a distance allows observation and an interpretation equivalent to the clinical assessment performed in the presence. 2. this device is accepted by all the beneficiaries (residents) and users (nursing staff) in the usual context of a meal situation in a nursing home. 3. this device allows the identification of the events marked by the speech therapist and the analysis of the corresponding vibro-acoustic signals.

Eligibility criteria:
inclusion criteria: * subject over 60 years old residing in nursing homes * subject with a medical prescription for a swallowing assessment * subject affiliated or benefiting from the social security system * consent to participate obtained in writing and signed by the subject if he/she is able to give his/her consent, or if necessary by the family or, in case of guardianship, by the legally designated representative exclusion criteria: * presence of skin lesion(s) on the neck * any serious pathology (severe medical condition or behavioral disorder) where, in the opinion of the investigator, it may place participants at additional risk * tracheostomized subject * subjects with a nasogastric feeding tube * subjects under court protection
t-cell-immunity during standard radiotherapy in localised prostate cancer

Conditions: Prostate Cancer

Summary: immunological effects of radiotherapy have been described before, but not evaluated in a time-dependant manner. in order to identify a possible time frame for combination therapies, white blood cells are isolated of samples taken at different time points before during and after standard radiotherapy in patients with localised prostate cancer. the overall activity of the t-cell-system as well as tumor-specific t-cell-response are evaluated.


Eligibility criteria:
inclusion criteria: * localised prostate cancer (node negative) * definitive radiotherapy * informed consent exclusion criteria: * medication including steroids or immunosuppressants

Keywords: localised prostate cancer radiotherapy immunology
ga68-fapi-46 pet/ct for preoperative assessment of peritoneal carcinomatosis

Conditions: Cancer; Peritoneal Carcinomatosis

Summary: this is a prospective, phase ii, non-randomized clinical imaging trial. ga68-fapi-46 is a novel radiotracer used in pet/ct imaging, targeting a protein of the tumor microenvironment called fap (fibroblast activation protein). the aim of the study is to assess the accuracy of ga68-fapi-46 pet/ct for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.

fibroblast activation protein (fap) is a type ii transmembrane glycoprotein expressed on the surface of cancer-associated fibroblasts (cafs) in the stroma of various tumor entities. recently, radiolabeled molecules targeting the fap, called fap inhibitors (fapi) labelled with gallium-68, have been developed for molecular imaging with pet/ct (positron emission tomography/computed tomography). this radiotracer often presents a higher cancer lesion detectability than f18-fdg (fluorodeoxyglucose), partly thanks to its higher tumour-to-background ratio achieved by a low background activity, particularly in the brain, abdominal cavity and liver. these advantages have resulted in a superior sensitivity of ga68-fapi pet/ct over f18-fdg and higher suv (standardized uptake value) in evaluating various types of cancer. in this context, ga68-fapi pet/ct seems promising to further study as a clinical imaging modality for preoperative assessment of peritoneal carcinomatosis. in this study, the investigators correlate ga68-fapi pet/ct findings in terms of peritoneal involvement with intraoperative findings based on histopathology and try to find out how accurate ga68-fapi pet/ct is for the preoperative assessment of peritoneal carcinomatosis.

Eligibility criteria:
inclusion criteria: * histologically proven colorectal and ovarian cancer. * known or suspected peritoneal metastases from the tumour of origin. * scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy. * ecog (eastern cooperative oncology group) performance status ≤2. * signed written informed consent obtained before any study-specific screening procedures. exclusion criteria: * non-resectable extra-abdominal metastasis and/or \>3 hepatic metastases on standard work-up * known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, crohn's disease) * pregnant and lactating women * previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer. * subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.

Keywords: colorectal cancer ovarian cancer peritoneal carcinomatosis fibroblast activation protein inhibitor positron emission tomography fapi-46 pet fapi pet/ct fibroblast activation protein
return to work in patients with chronic pain

Conditions: Chronic Pain; Endometriosis

Summary: this study aims to evaluate whether a vocational behaviour change ability programme has any additional effect on return to work compared with return to work coordination only in persons with chronic pain.

new vocational rehabilitation models including the workplace are urgently needed for persons with chronic pain. return to work coordination means external and internal coordination regarding sick leave by help of a rehabilitation coordinator from health care. the goal is to establish a common return to work plan between employer and employee as dictated by swedish law. the hypothesis is that return to work coordination is not sufficient. additional effects on return to work and work ability from a behaviour change ability programme aiming to enhance work ability by targeting context at the workplace, physical and psychological functioning, and behavioral skills at work are expected. the hypothesis is tested in a randomised controlled trial. before the start of the trial a series of 3-6 experimental single case studies will be performed to study the implementation of the interventions more thoroughly.

Eligibility criteria:
inclusion criteria: * chronic pain with a duration for more than 3 months * on sick-leave 25%-100% from salaried employment or studies, for at least 30 days * identified employer or director of studies * ability to understand, speak, and write swedish exclusion criteria: * severe substance use disorder * severe psychiatric illness * recruited participants with employers who does not consent to participate

Keywords: chronic pain endometriosis opioid therapy return to work vocational rehabilitation behavioural medicine
incb047986 in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to explore the safety, tolerability and efficacy of incb047986, in subjects with moderate to severe rheumatoid arthritis.

this will be a double-blind, placebo-controlled study with 4 parallel treatment groups. subjects will be screened for up to 28 days before study drug administration to ensure that all eligibility criteria are met. on day 1, subjects will be randomized to 1 of 4 dose groups of 15 subjects each (incb047986 4 mg, 8 mg, 12 mg, or placebo qd). study drug will be self administered on days 1 through 28. a follow-up telephone call to the subject to assess safety will occur at day 42. a final safety and efficacy evaluation will be performed at the day 58 visit.

Eligibility criteria:
inclusion criteria: * men or women aged 18 to 75 years, inclusive. * body mass index between 18 and 40 kg/m\^2, inclusive. * subjects must have a diagnosis of rheumatoid arthritis (ra) of at least 6 months' duration at the time of screening and must satisfy the acr/european league against rheumatism (eular) 2010 classification criteria (appendix b). * subjects must have active moderate to severe ra as determined by the following: * ≥ 6 tender joints (28 joint count), * ≥ 4 swollen joints (28 joint count), and * crp level ≥ 6 mg/l. * subjects must have a negative tuberculosis (tb) test (quantiferon®-tb gold test or purified protein derivative (ppd)) at screening. exclusion criteria: * current or recent history of severe and/or progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease. * current or recent history (\< 30 days before screening and/or \< 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection. * onset of ra before the age of 16 years. * history of known or currently suspected inflammatory disease other than ra * current regimen of prednisone or equivalent with an average daily dose of \> 10 mg or having been treated with a stable daily dose ≤ 10 mg for \< 6 weeks. * previous treatment with at janus kinase (jak) inhibitor. * significant impairment of bone marrow function present at screening * receipt of any live vaccine within 2 months before screening or anticipated need for a live vaccine within the 2 months after last dose of study drug.
natural history study of leukoencephalopathy with brainstem and spinal cord involvement and lactate elevation (lbsl)

Conditions: Leukoencephalopathies; LBSL; Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation; White Matter Disease; Ataxia, Cerebellar; Genetic Disease

Summary: in this study, we will conduct retrospective chart and imaging reviews and prospective longitudinal virtual assessments of individuals with lbsl.

lbsl (leukoencephalopathy with brainstem and spinal cord involvement and lactate elevation) is a rare genetic disorder characterized by slowly progressive cerebellar ataxia and spasticity with dorsal column dysfunction (decreased position and vibration sense) in most patients. manual dexterity becomes impaired to a variable degree. associated problems include dysarthria, mild cognitive decline and learning problems, and epilepsy. lbsl is diagnosed by identification of biallelic pathogenic variants in dars2, encoding mitochondrial aspartyl trna synthetase and characteristic abnormalities observed on the brain and spinal cord mri. most of the literature consists of case reports and case series and there are only limited data that provide details on genotype-phenotype correlations. there is very little quantitative or semi-quantitative information about neurocognitive and neuromotor impairment in lbsl. there are currently no targeted therapies or guidelines about supportive therapies for lbsl. in this study, we will conduct retrospective chart and imaging reviews and prospective longitudinal virtual assessments of individuals with lbsl. we hypothesize that 1) there will be a broad phenotypic spectrum of neuromotor and neurocognitive deficits in lbsl patients; 2) most impairment will likely be related to gait; 3) there will be a threshold of impairment in gait that is associated with poorer quality of life for these patients; 4) and that even in patients with apparently mild disease there will be neurocognitive deficits related to cortical and cerebellar white matter abnormalities. answering these hypotheses will form the basis of a better understanding of the natural history of lbsl. it will help further characterize the expected level of impairment based on a patient's genotype. this will be particularly helpful for providing anticipatory guidance for newly diagnosed infants and children with lbsl. the information will also help identify priorities for existing supportive therapies and help clarify the common or clinically meaningful symptoms that should be targeted for new treatments.

Eligibility criteria:
inclusion criteria: 1. confirmed dars2 mutation through genetic analysis 2. ability of the caregiver or participant to speak and understand english at an 8th-grade level exclusion criteria: * the vulnerable populations of prisoners, non-viable neonates, pregnant women, adults lacking the capacity to consent, non-english speakers or children who are in foster care or wards of the state.

Keywords: natural history study kennedy krieger institute virtual assessment dars2 johns hopkins hospital
intraoperative lung protective ventilation needs periodic lung recruitment maneuvers

Conditions: Postoperative Complications; Abdominal Surgery; Intraoperative Mechanical Ventilation

Summary: postoperative pulmonary complications (ppc) are common. it severely affects postoperative recovery, particularly in abdominal surgery. several studies showed that intraoperative lung-protective ventilation with periodic lung recruitment maneuvers could reduce postoperative pulmonary complications. other studies showed that intraoperative lung protective ventilation without periodic lung recruitment maneuvers could also reduce postoperative pulmonary complications. the purpose of this study was to compare the effects of the above two regimens on postoperative pulmonary complications.


Eligibility criteria:
inclusion criteria: 1. undergoing elective major abdominal surgery (expected duration of mechanical ventilation ≥2 h) 2. had an intermediate to high risk of developing postoperative pulmonary complications as indicated by an assess respiratory risk in surgical patients in catalonia score (≥26) 3. pulse oxygen saturation in room air ≥ 94% exclusion criteria: 1. younger than 18 years 2. had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery 3. had a history of pneumonia within 1 month prior to surgery 4. had severe chronic obstructive pulmonary disease or pulmonary bullae 5. had a progressive neuromuscular illness 6. severe heart dysfunction (new york heart association classification ≥4) 7. with an american society of anesthesiologists (asa) physical status of iv or higher 8. intracranial hypertension 9. were pregnant (excluded by laboratory analysis) 10. were involved in other interventional studies
real-world study of foslevodopa/foscarbidopa to assess quality of life outcomes in adult participants with advanced parkinson disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is a neurological condition, which affects the brain. pd gets worse over time, but how quickly it progresses varies a lot from person to person. some symptoms of pd are tremors, stiffness, and slowness of movement. this study will assess how effective foslevodopa/foscarbidopa is in treating italian adult participants with advanced parkinson disease under routine clinical practice. this study will also assess the caregiver quality of life (qol) (if caregiver is present). foslevodopa/foscarbidopa is an approved drug for the treatment of parkinson's disease. approximately 270 adult participants who are prescribed foslevodopa/foscarbidopa by their doctors will be enrolled across approximately 19 sites in italy. participants will receive foslevodopa/foscarbidopa subcutaneous infusion as prescribed by their physician. participants will be followed for up to 12 months. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * participants with a diagnosis of levodopa-responsive advance parkinson's disease (pd) * investigator decision on participant treatment with subcutaneous foslevodopa/foscarbidopa (ldp/cdp) made prior to, and independently, the decision to approach the participant to participate in the study * 24-h subcutaneous ldp/cdp treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies exclusion criteria: * any condition included in the contraindications section of the approved local subcutaneous ldp/cdp label * participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. participation in another post-marketing observational study (pmos) or registry is acceptable * history of relevant skin conditions or disorders (e.g., psoriasis, atopic dermatitis) per investigator´s judgment. in case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the subject should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments

Keywords: parkinson disease foslevodopa/foscarbidopa