Kornimate/medical-research-clean huggingface dataset:
trial of iloprost in pulmonary hypertension secondary to pulmonary fibrosis

Conditions: Pulmonary Fibrosis; Pulmonary Hypertension

Summary: idiopathic pulmonary fibrosis(ipf) is chronic progressive fibrosing lung disease of unknown cause. there is no effective therapy yet for this disease and the mean survival in most reports is about 3 years after the diagnosis. because of the stiff fibrosis of the lung, pulmonary hypertension is the late complication of ipf and its development heralds a very poor outcome of the patients. for the primary pulmonary hypertension, recently the effective drugs have been available. however, there is no study about the efficacy of these drugs in the patients with pulmonary hypertension secondary to pulmnary fibrosis, and the aim of this trial is to study the safty and efficacy of "iloprost," one of the safe and effective drugs in primary pulmonary hypertension.

* prospective open labeled observational study * subjects: about 15 patients with secondary pulmonary hypertension due to ipf or pulmonary fibrosis associated with collagen vascular diseases. * method: 3 month trial of inhaled iloprost. check the safty and measure the pulmonary arterial pressure by right heart catheterization, exercise capacity by 6 minute walking test, echocardiography, and quality of life questionnaires before and after the trial.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pulmonary fibrosis or fibrotic nsip according to american thoracic society and european respiratory society guidelines by biopsy and diagnosis of pulmonary fibrosis associated with connective tissue disease. * mean pulmonary artery pressure over 30mmhg. * nyha functional class ii to iv exclusion criteria: * suffering lung diseases other than pulmonary fibrosis (copd, pulmonary thromboendarterectomy ). * administration of prostanoids, bosentan, beta- blocker or phosphodiesterase5 inhibitor. * dosage adjustment of calcium channel blockers within 6 weeks. * resting pulmonary capillary wedge pressure over 15mmhg. * bleeding tendency. * bilirubin level above 3mg/dl or creatinine clearance level below 30ml/min. * unstable angina pectoris, myocardial infarction or severe arrhythmia within 6 months. * cerebrovascular accident within 6 months. * present lung infection.

Keywords: pulmonary fibrosis pulmonary hypertension iloprost efficacy
development of children with dcd before the age of six

Conditions: Developmental Coordination Disorder

Summary: the aim of this study is to map the early development of children with dcd and compare it to typically developing (td) children. at first we will investigate to what extent motor delay, reduced force, higher bmi, behavioral, adl and participation problems occur in toddlerhood in dcd children and how this relates to td children. we will also look into the evolution of these parameters in time (stability of development). secondly we will explore if the diagnosis of dcd can be predicted using a standardized test before the age of five.

a longitudinal study design enables us to assess children at three different ages (3y, 4y and 5y). assessment scores (aims or/and bsid) before the age of three will be retrieved retrospectively in the clinical group.

Eligibility criteria:
inclusion criteria dcd group: 1. the multidisciplinary team of the center of developmental disabilities reports that the child has dcd or is at-risk for developing dcd and this at the age of 2 and/or 3 years. 2. at least one parent speaks dutch to the child inclusion criteria controlgroup: 1. the child is three years of age at the moment of the first testing 2. little-dcd-q score ≥ 55 at 3y 3. m-abc-2 percentilescore ≥25 at 3y 4. no medical diagnoses possibly influencing the motor development (dcd, adhd, ass, cp,...) 5. no history of developmental motor stimulation (therapy) and/or support 6. gestational age ≥37w 7. birthweight ≥2500g 8. at least one parent speaks dutch to the child

Keywords: motor development toddler prediction
liverpal: a pilot study of inpatient palliative care for patients with advanced liver disease

Conditions: Cirrhosis, Liver

Summary: frequently patients with advanced liver disease experience physical and emotional symptoms during their hospitalization that can may cause a level of discomfort to both the patient and the family members that surround them. this study involves the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these discomforting symptoms. this team of clinicians is called the palliative care team and they focus on ways to improve pain and other symptom management and to assist patients and their families in coping with the physical, emotional and social issues associated with a diagnosis of advanced liver disease. the team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness and their caregivers. the investigators are studying the feasibility of delivering this program, the acceptability and satisfaction with the program, and changes in the quality of life, illness understanding, and symptoms of hospitalized patients who receive the program and their caregivers. the study will use a series of questionnaires to measure the study participants' quality of life, physical symptoms, illness and prognostic understanding, and mood. study questionnaires will be completed in the hospital, home or clinic. qualitative interviews will be conducted with hepatology and palliative care clinicians as well as patients and caregivers.


Eligibility criteria:
patient inclusion criteria: 1. adult (≥ 18 years old) with advanced liver disease defined as cirrhosis complicated by one of the following (new or ongoing) clinically-evidence decompensating events 1. ascites (requiring diuretics or large volume paracenteses) 2. hepatic encephalopathy (requiring medical therapy) 3. history of variceal bleed episode within 1 year of enrollment 2. admitted to the general medicine service 3. ability fo communicate in english and provide informed consent 4. have a score ≥ 7 on the short portable mental status questionnaire patient exclusion criteria: 1. patients with severe hepatic encephalopathy or any other comorbid condition which the primary medical team believes prohibits compliance with study procedures 2. patients with advanced malignancies being treated with palliative intent 3. patients already receiving specialty palliative care and/or hospice care caregiver eligibility criteria 1. a relative or friend of eligible patient, who lives with them and has in-person contact with them at least twice per week 2. verbally fluent in english or able to complete questionnaires with the help of an interpreter 3. age 18 or older clinician selection: all palliative care clinicians who deliver the liverpal intervention will participate in qualitative interviews. inpatient clinicians who provided direct care to enrolled patients in either the inpatient or outpatient setting will also be eligible to participate in the qualitative interviews.
safety and tolerability of a cell-derived influenza vaccine in healthy adults aged ≥18 years and ≤ 49 years

Conditions: Healthy

Summary: a controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.


Eligibility criteria:
inclusion criteria: * healthy female or male subjects aged ≧18 and ≦49 years * willing and able to give informed consent exclusion criteria: * influenza vaccination of laboratory confirmed influenza infection within six months of informed consent, * presence of any significant medical condition, * a serious adverse reaction after a previous (influenza) vaccination, * underlying medical conditions for which annual influenza vaccine is recommended by the advisory committee on immunization practices (acip), * chronic diseases requiring long-term immunosuppressive therapy

Keywords: cell-derived subunit influenza vaccine safety reactogenicity
risk assessment of indirect exposure to the environment in the gastrointestinal endoscopy center

Conditions: Infection Control

Summary: study objective: to clarify the risk of exposure to indirect contact and transmission of environmental objects during digestive endoscopy diagnosis and treatment for patients and medical staff, simulating by using vitamin b2 solution. study design: this is a case-only research.

in the study, the object surface of the digestive endoscopy room is preliminarily analyzed, and several key exposure units, such as potential high-frequency touch areas such as the surface of the bed unit, are screened and defined. a fluorescence photographing system is arranged in the digestive endoscopy room, and the exposure unit before treatment is photographed with the best excitation wavelength of the fluorescent marker as the light source, to get the experimental background reference. then, patients undergoing digestive endoscopy in the same endoscopy work unit (usually half a day) are selected. before entering the digestive center, the hands of patients are fluorescently marked with vitamin b2 mixed hand sanitizer 1ml (vitamin b2 0.12mg/ml). meanwhile, the process of the gastroscopy is recorded by camera for the recognition of touch behaviors. then, the doctors and nurses give routine care and procedure. based on the fluorescence tracing and detection methods, the indoor light source is turned off after each selected endoscopy work unit, and the fluorescence residue on the surface of key exposed units is photographed. the environmental surfaces touched by the patient are sampled by the wiping method. then the video of the gastroscopy process is analyzed for the recognition of touch behaviors. the dosage is detected by the fluoro max-4® fluorophotometer (horiba, japan), which is quantified as a cumulative mass (μg) over all the exposure time.

Eligibility criteria:
inclusion criteria: * during the study period, patients who were treated in the digestive endoscopy center of beijing union medical college hospital and planned to undergo gastroscopy. age and gender are not limited temporarily. exclusion criteria: * allergic to medical non-toxic fluorescent agent: vitamin b2 aqueous solution. * poor general condition, including severe cardiopulmonary disease, difficult to tolerate examination, and coagulation disorders. * patients with contraindications to endoscopy.

Keywords: infection control indirect contagion transmission digestive endoscopy center
a study to evaluate opevesostat (mk-5684) in male participants with moderate hepatic impairment (mk-5684-009)

Conditions: Hepatic Impairment; Healthy Participants

Summary: researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer. the purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic \[pk\] study). researchers will compare what happens to opevesostat in the body when it is given to healthy participants and participants with moderate hepatic (liver) impairment.


Eligibility criteria:
the main inclusion criteria include but are not limited to the following: * all participants: * is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing * has body mass index (bmi) ≥ 18.0 and ≤ 42.0 kg/m2 * participants with moderate hepatic impairment: * has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology the main exclusion criteria include but are not limited to the following: * all participants: * has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including brugada syndrome) * has a history of cancer (malignancy) * has positive results for human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) * participants with moderate hepatic impairment * has unstable electrolyte abnormalities or electrolyte abnormalities that are considered difficult to manage for participants with hepatic impairment * has a history of liver or other solid organ transplantation
assessment of a vaginal ring with meloxicam on ovarian cycle in fertile women

Conditions: Contraception; Bleeding Pattern

Summary: in this study, the investigators propose to assess if a non-hormonal agent is absorbed by a local route (vaginal) and to observe the effect on follicular development.

each volunteer will participate for 3 menstrual cycles, beginning with one menstrual control cycle without treatment, following by one menstrual cycle with meloxicam ring administration, and finishing with another control menstrual cycle. meloxicam will be administered in the second menstrual cycle via a vaginal ring in two doses of 2.4 g or 3.0 g/ring. the safety of the vaginal ring and the absorption of meloxicam will be assessed. also the effect on follicular development and if it maintains ovarian cyclicity, as shown in a recent study with oral administration, will be assessed.

Eligibility criteria:
inclusion criteria: * previous (or history of) proven fertility * regular menstrual cycle * surgically sterile * without breastfeeding * haemoglobin at least 11g/dl * willing to participate in the study exclusion criteria: * allergy to meloxicam or other nsaid * allergy to silicone polymer * vaginal discharge non diagnosticated * history of shock toxic syndrome * history of : gastrointestinal, bleeding, renal, liver, heart, brain,clot, endocrine or pulmonary disorders

Keywords: pharmacokinetic
autoantibodies on spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery.

most patients experience variable degrees of functional recovery after spinal cord injury (sci), predominantly in the first months after lesion. in sci animal models, autoantibodies are pathogenic and their titers rise up at the time when spontaneous recovery stops. the aim of this study is to determine the autoantibody profiles after sci and to infer their relation with functional recovery. to achieve this, autoantibody profiles, biochemical, hematological and immune-related parameters (cytokines, chemokines and growth factors) will be determined from a serum blood sample and functional recovery will be evaluated accordingly to standardized scales.

Eligibility criteria:
inclusion criteria: * traumatic or non-progressive vascular sci * less than 45 days after lesion * any neurological level * complete and incomplete lesions * if patient has been treated with glucocorticoids, it should have passed at least 7 days from the end of the treatment exclusion criteria: * cauda equina syndrome * autoimmune disorder * tumor (even if benign) * neurodegenerative disease

Keywords: autoantibodies
prospective clinical registry of subcutaneous implantable cardioverter defibrillator (s-icd) (s-icd korea registry)

Conditions: Heart Failure; Sudden Cardiac Death; Ventricular Tachycardia

Summary: s-icd avoids the use intravascular leads and their associated risks, has been increasingly used for primary and secondary prevention of sudden death. the long-term safety and feasible of s-icd system in asian population with a smaller body size remain unclear. the investigators propose to perform a prospective study in korean population to investigate the safety and feasibility of s-icd for primary or secondary prevention of sudden cardiac death.

the investigators propose to prospectively recruit 300 patients who are qualified to receive the emblem s-icd system by following the proposed bsc patient screening steps in 10 sites in korea. all patients will be follow-up as standard of care to collect acute procedural and device related complications as well as long-term, device related, clinical and patient reported outcomes. follow up data will be systematically collected over 24 months post-implant.

Eligibility criteria:
inclusion criteria: 1. \> 18 years of age 2. patients with conventional indications for icd and; 3. ability to provide informed consent and to complete the study and required follow-up exclusion criteria: 1. planned cardiac surgery within 3 months of enrollment; 2. pregnancy; 3. life expectancy \<3 months; 4. indication for crt-d or permanent ventricular pacing for new implant; 5. incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing; and 6. patients with unipolar pacemakers or implanted devices that revert to unipolar pacing

Keywords: s-icd safety feasibility
association of serum ferritin and bone mineral density with bone metabolism in chinese healthy postmenopausal women

Conditions: Postmenopausal Osteoporosis; Iron Metabolism Disorders

Summary: large amounts of experimental and animal evidence have confirmed that iron accumulation is associated with bone loss. however, it is still lack of the clinical studies relating iron accumulation to bone loss, especially in the pathological conditions during our chinese. in this study, the investigators aim to assess the association between the levels of serum ferritin and bone mineral density in chinese healthy postmenopausal women.

for the past few years, an increasing number of in vitro studies show the association of iron accumulation with bone loss, particularly in postmenopausal women. and body iron accumulation is accurately reflected by levels of serum ferritin in clinic. the levels of serum ferritin among healthy women are about 13-150μg/l, and we give a definition of iron accumulation when serum ferritin range from 500μg/l to 1000 μg/l. how will the bone mineral density change in iron accumulation? the investigators intend to perform this study to explore and establish the relational function and logical function between serum ferritin, bone mineral density and biochemical markers of bone metabolism in chinese healthy postmenopausal women.

Eligibility criteria:
inclusion criteria: 1. healthy postmenopausal women 2. subjects aged 55 years or older exclusion criteria: 1. subjects with acute or chronic inflammatory or infectious diseases 2. chronic liver or renal diseases 3. history of transfusion or iron therapy in the previous year 4. history of drug therapy such as bisphosphonates and glucocorticoids, which might have affected bone metabolism 5. subjects with hematonosis

Keywords: bone mineral density bone turnover markers ferritin
ice: intracardiac ultrasound within the left atrium during radiofrequency ablation of nonvalvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: imaging real time within the left atrial chamber enhances safety and efficacy of radiofrequency ablation of atrial fibrillation

atrial fibrillation is the most common rhythm disturbance affecting the human population. 1. its prevalence increases with age and can be found in \>8% of humans over the age of eighty; 2. radiofrequency ablation for drug refractory nonvalvular atrial fibrillation has become a common therapy available to patients. it has been shown to be both efficacious and cost effective; 3. the standard approach to atrial fibrillation involves electrical isolation of the pulmonary veins (pvi) from the rest of the atrium chamber. this involves moving a 3.5mm tip ablation catheter point to point around the pv structures until an encircling ablation line is formed. this can be made difficult by not knowing if the tip is in good contact with the atrial tissue. in addition the esophagus is a posterior lying structure and injury to the esophagus by ablating the overlying tissue has been reported, at times fatal; 4. currently, intracardiac imaging of the left atrium has fda approval in the right atrial chamber. this leads to difficulty in visualizing tip tissue interface, and important left sided structures such as carina, ligaments, and esophagus. by placing the tip of the ice catheter in the left atrium, enhanced visualization of the tip tissue interface may lead to more effective ablation points, fewer needed ablation points, and enhanced safety by avoiding placement over adjacent noncardiac structures.

Eligibility criteria:
inclusion criteria: * age 18 to 80 years * recommended for radiofrequency ablation of nonvalvular atrial fibrillation exclusion criteria: * none

Keywords: atrial fibrillation
clinical trial to evaluate the safety and efficacy of im21 car-t cells in patients with relapsed and refractory (r/r) multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a open-label to determine the efficacy and safety of im21 car-t cells in adult with r/r multiple myeloma.


Eligibility criteria:
inclusion criteria: * diagnosis of mm with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor . * evidence of cell membrane bcma expression. * subjects must have measurable disease,including 1) serum m-protein greater or equal to10 g/l. 2) urine m-protein greater or equal to 200 mg/24 h. 3)serum free light chain (flc) assay: involved flc level greater or equal to 100 mg/l provided serum flc ratio is abnormal. * ≥ 18 years of age at the time of signing informed consent. * estimated life expectancy \>3 months. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up. * adequate organ function. * voluntarily sign informed consent form(s). exclusion criteria: * subjects with graft versus host disease and need to use immunosuppressive agents. * subjects who had received chemotherapy or radiotherapy within 3 days prior to the blood collection period. * use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids) * subjects who had previously used any gene therapy product. * subjects with known central nervous system disease. * subjects with plasmacytic leukemia, wallenian macroglobulinemia, poems syndrome, or primary light-chain amyloidosis. * subjects had the following cardiac conditions, including but not limited to unstable angina pectoris, myocardial infarction or coronary artery bypass graft in the 6 months prior to enrollment, severe arrhythmias with poor drug control; * subjects infected with active hbv or hcv, hiv, syphilis or other untreated active infections; * pregnant or lactating women. * subjects who have other uncontrolled diseases and are considered by the researchers to be unsuitable to participate in the study. * any situation that the researcher believes may increase the risk of subjects or interfere with the results of clinical trials.

Keywords: multiple myeloma