Kornimate/medical-research-clean huggingface dataset:
an open label extension study to evaluate inhaled treprostinil in adult ph with ild including cpfe

Conditions: Pulmonary Hypertension; Interstitial Lung Disease; Combined Pulmonary Fibrosis and Emphysema

Summary: this is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (ph) associated with interstitial lung disease (ild) including combined pulmonary fibrosis and emphysema (cpfe). the study will include about 266 patients who completed all required assessments in the rin-ph-201 study at approximately 100 clinical trial centers. the study will continue your participation in this study is voluntary and will last until you discontinue from the study or the study ends. the study will continue until each subject reaches the week 108 visit or until inhaled treprostinil become commercially available for patients with ph associated with ild including cpfe (whichever is sooner).


Eligibility criteria:
inclusion criteria: 1. subject voluntarily gives informed consent to participate in the study. 2. the subject participated in study rin-ph-201, remained on study drug, was compliant with rin-ph-201 study procedures or was enrolled in study rin-ph-201 at the time that the study was discontinued by the sponsor. 3. females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at baseline) and non-lactating, and will: * either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or * use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug. 4. males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug. exclusion criteria: 1. the subject is pregnant or lactating. 2. the subject was prematurely discontinued from study rin-ph-201. 3. the subject developed a concurrent illness or condition during the conduct of rin-ph-201 which, in the opinion of the investigator, would represent a risk to overall health if they enrolled in this study.

Keywords: treprostinil ph ild cpfe 6 minute walk test
effects and mechanisms of n-3 pufas and irisin on abnormal glucose metabolism after gdm.

Conditions: Gestational Diabetes Mellitus

Summary: the purpose of this study is to clarify the relationship between n-3 pufa and irisin in regulating the glucose metabolism in gdm patients.

gestational diabetes mellitus (gdm) is an important risk factor for type 2 diabetes in women. studies have shown that n-3 polyunsaturated fatty acids (n-3 pufa) are associated with improving insulin resistance and prevent type 2 diabetes in the general population; a newly discovered myokine, irisin, is associated with reduced insulin resistance and plays an important role in human glucose metabolism; and results from cell studies suggested that n-3 pufa might increase the expression of irisin. therefore, the investigators hypothesize that n-3 pufa could improve glucose metabolism via the irs-1/pi3k/akt insulin signaling pathway by increasing expression of irisin and thus improving postpartum glucose metabolism in women with gdm. in order to test this hypothesis, the investigators plan to establish a prospective gdm cohort and collect related information at 24-28 weeks' gestation, 42 days postpartum, 1 year postpartum and 2 years postpartum, respectively. then the following would be tested: the changes of n-3 pufa and irisin during pregnancy and after delivery, and their association with postpartum abnormal glucose metabolism; and the correlation of n-3 pufa and irisin. furthermore, using a cell model of insulin resistance the investigators would examine the dose-response and time-response relationships between n-3 pufa and irisin, and next explore the role of irisin in n-3 pufa regulation of irs-1/pi3k/akt insulin signaling pathway. this study would help to clarify the relationship between n-3 pufa and irisin in regulating the glucose metabolism, and might provide scientific evidence for the prevention of type 2 diabetes after gdm.

Eligibility criteria:
inclusion criteria: * pregnant women with gestational diabetes mellitus were screened by the guidelines for diagnosis and treatment of gestational diabetes mellitus in china in 2014. exclusion criteria: * age \< 20 years or ≥ 45 years; * women with diabetes, cardiovascular disease, thyroid disease, blood disease and polycystic ovary syndrome before pregnancy; * multiple pregnancy and assisted reproductive technology pregnancy; * women with severe postpartum endocrine disorders and diseases, such as pancreatitis, hyperthyroidism, nephritis; * infection during pregnancy.

Keywords: n-3 polyunsaturated fatty acids irisin
red clover isoflavones in postmenopausal women with urge urinary incontinence and overactive bladder

Conditions: Urge Incontinence; Overactive Bladder

Summary: the purpose of this study is to investigate the effect of red clover isoflavones in postmenopausal women with and without urge urinary incontinence and overactive bladder


Eligibility criteria:
inclusion criteria: * postmenopausal (more than 5 years since last menstruation) * read and understand danish exclusion criteria: * participants receive treatment with estrogen both oral, transdermal, and topical within three months prior to inclusion in the study * participants take estrogen-like compounds (isoflavones) three months prior to inclusion in the study * participants take prebiotic and/or probiotic supplements within three months prior to study inclusion * receive antibiotics (any) within three months prior to inclusion in the study * recurrent urinary tract infections (defined as ≥ 2 infections in the last six months or ≥ 3 infections during the last year) * acute urinary tract infection defined as positive urine culture and symptoms of acute cystitis * previous or current diseases of the digestive and/or urinary systems evaluated by pi (including, but not limited to inflammatory bowel disease (ibd) and cancer) * current or prior suffering from breast, ovary, and/or endometrial cancer * use hormone spiral within the last 5 years if they are under 60 years * hysterectomy before cessation of menstrual periods if the women are below the age of 60

Keywords: microbiota microbiome
effect of inhalational anesthesia versus total intravenous anesthesia on blood glucose in type 2 diabetes patients

Conditions: Type 2 Diabetes Mellitus (T2DM); Thoracic Surgery

Summary: the aim of this study is to compare the effect of total intravenous anesthesia (tiva) and inhalational anesthesia (iha) as maintenance anesthesia on blood glucose level and complications in type 2 diabetic patients undergoing thoracic surgery . all participants had to understand and give written informed consent , and ethical committee approval (of faculty of medicine, ain shams university) will be obtained before participants allocation.

* type of study: prospective , randomized . * study settings: ain shams university hospitals, cairo, egypt. * study period: 12 months starting from janurary 2024 . * study population: all adult type 2 diabetic patients (30-70 year old) with class ii,iii based on the american society of anesthesiologists (asa) physical status undergoing elective thoracic surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes: 1. group a will receive total inravenous anesthesia (tiva). 2. group b will receive inhalational anesthesia (iha)

Eligibility criteria:
inclusion criteria: * age 30 - 70 years * sex: both sexes * patients with type 2 diabetes mellitus controlled with oral hypoglycemic drugs * patients with asa classification ii,iii * duration of surgery (≥2 h) exclusion criteria: * declining to give written informed consent * asa classification ⅳ to v * severe systemic diseases * metabolic disorders, diabetic ketoacidosis or hyperglycemia (fasting blood glucose more than 140 mg/dl) * hepatic and/or renal dysfunction * neuromuscular disease * pancreatic cancer * history of malignant hyperthermia * emergency surgery * ischemic heart disease and valvular heart disease * body mass index more than 40 * diabetic patients on insulin therapy
study of the safety of bms-986259 in participants with post-acute decompensated heart failure

Conditions: Acute Decompensated Heart Failure

Summary: the purpose of the study is to assess the safety of bms-986259 in stable participants hospitalized for acute decompensated heart failure.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * participants currently hospitalized for acute decompensated heart failure (adhf) * participants must be hemodynamically stable, as assessed by the investigator * men must agree to follow specific methods of contraception, if applicable, while participating in the trial * women participants must have documented proof that they are not of childbearing potential exclusion criteria: * acute cardiovascular condition other than heart failure (hf) decompensation * cardiogenic shock at presentation to emergency room (er) or at any time before randomization * recipient of ventricular assist devices or use of any cardiac extracorporeal devices, within 12 weeks of study randomization * participants with contraindications to vasodilator therapy such as restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis other protocol-defined inclusion/exclusion criteria apply

Keywords: heart failure
does capsulectomy, performed in total hip arthroplasty with a direct anterior approach cause knee extension strength loss?

Conditions: Coxarthrosis; Muscle Weakness

Summary: total hip arthroplasty (tha) has been successful in relieving pain and restoring function in patients with advanced arthritis of the hip joint. increased focus on earlier recovery and decreased postoperative pain has improved overall satisfaction. however, there is still a gap between the clinical scores in objective surveys and patient satisfaction. direct anterior approach total hip arthroplasty has a low dislocation rate, abductor strength restoration, acceleration, and cosmetic advantages. in this method, capsulotomy with repair or capsulectomy is applied as the preferences of surgeons. therefore, this can cause both a decrease in hip flexion strength and a loss in knee extension strength. our aim in this study is to reveal how much muscle loss was caused by comparing both methods with the intact side.

published data assessing biomechanical performance after thr are sparse. the majority of studies assessing post-thr hip function using robotic dynamometry have focused on evaluating surgical outcomes and prosthetic selection. these studies provide insight regarding the strength deficits of older adults after thr. however, the data are not consistent, making it difficult to assess the nature of the deficit.

Eligibility criteria:
inclusion criteria: * all primary tha exclusion criteria: * secondary tha

Keywords: hip arthroplasty quadriceps strenght muscle weakness knee flexion extension
safety, tolerability and immunogenicity of pneumovax 23 in healthy adults in india (v110-011)

Conditions: Pneumococcal Infection

Summary: to describe the safety, tolerability and immunogenicity of pneumovax 23 (v110) in healthy adults in india.

this was an open-label non-randomized study to assess the safety and immunogenicity of pneumovaxtm 23 in healthy adults in india. the participants enrolled in this study were healthy indian adults, 50 years of age or older, with no prior history of having received a pneumococcal vaccination (14-valent or 23-valent) and no prior history of pneumococcal disease. all participants enrolled in the study received one 0.5 ml dose of pneumovaxtm 23 by intramuscular (deltoid) injection on day 1. serum samples were obtained prior to vaccination on day 1 and on day 28 (+/-7 days) postvaccination. the duration of participation for each participant was approximately one month, with the study completion at the day 28 postvaccination bleed and return of the vaccination report card (vrc). enrollment was completed within approximately 2 months. the last postvaccination blood sample was collected within 3 months of study initiation.

Eligibility criteria:
inclusion criteria: * healthy indian adults of 50 years of age * in good health; any underlying chronic illness must be documented to be in stable condition * signed and dated informed consent prior to receipt of the study vaccine exclusion criteria: * functional or anatomic asplenia * history of auto immune disease * hypersensitivity to any of the components of the study vaccine,including phenol * known or suspected immune dysfunction, including persons with congenital immunodeficiency * prior vaccination with any pneumococcal vaccine
caremap: a digital personal health record for complex care coordination

Conditions: Children/Youth With Special Healthcare Needs; Adults With Multiple Chronic Conditions

Summary: this study will implement a new mobile application ('app') called caremap to improve care coordination for patients with complex health needs. the goal is to pilot test the mobile app with patients/families and clinic doctors to gather input on how well the app works and how to make it better. investigators plan to enroll up to 40 participants from duke university for this study. the study is sponsored by duke's institute for health innovation.


Eligibility criteria:
inclusion criteria for parents/caregivers of children/youth with special health care needs (cyshcn): * adult parent/legal guardian (age 18 or older) of a cyshcn * established care for their child/youth at duke pediatrics primary care or duke children's cystic fibrosis clinic (established = one or more completed visits in the past 12 months at the clinic) * high level of complex medical needs that could benefit from additional care coordination support (determined by clinical provider at the pilot site) * primary provider enrolled in the study as a provider participant/clinical provider site champion * active duke mychart (online ehr patient portal) account * full proxy access activated/enabled for parent to the child/youth's medical record in epic * apple ios device compatible with caremap app requirements at time of consent inclusion criteria for adult patients with multiple chronic conditions (mcc): * adult patient (age 18 or older) with mcc * established care for the patient at duke geriatrics clinic or duke pulmonary transplant clinic (established = one or more completed visits in the past 12 months at the clinic) * high level of complex medical needs that could benefit from additional care coordination support (determined by clinical provider at the participating clinic site) * primary provider enrolled in the study as a provider participant/clinical provider site champion * active duke mychart (online ehr patient portal) account * apple ios device compatible with caremap app requirements at time of consent inclusion criteria for clinical provider site champions (to participate in interviews and quantitative provider-reported surveys): * currently practicing at duke health * primary site of work is participating clinic site exclusion criteria: * non-english speaking * living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities * lacks requisite technology to access and use mobile app (e.g., device/tablet/smartphone, home internet, active epic mychart account) * lack of decision-making capacity (clinician-determined; e.g., patients with advanced dementia)

Keywords: complex care mobile health care coordination
cd19 car-t cells with crs suppression technology for r/r cd19+ acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia; CD19 Positive; Relapse; Refractory

Summary: this is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of t cells expressing cd19 chimeric antigen receptors treatment for relapsed/refractory cd19+ acute lymphoblastic leukemia patients.

relapsed/refractory cd19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. cd19 car-t cells； 2. cd19 car-t cells with crs suppression technology.

Eligibility criteria:
inclusion criteria: 1. age 6 to 65 2. voluntary informed consent is given 3. expected survival ≥12 weeks 4. relapsed or refractory cd19+ acute leukemia, ineligible for allo-hsct,or relapse after auto-hsct 5. organ function: (1)left ventricular ejection fractions≥ 0.6 by echocardiography (2)alt ≤3 times of uln, or bilirubin \ 92% 6. karnofsky score ≥ 60 ; 7. no history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months; exclusion criteria: 1. uncontrolled active infections 2. active hepatitis b or hepatitis c infection 3. hiv infection 4. history of myocardio infarction in the past 6 months, or history of severe arrhythmia 5. congenital immunodeficiency 6. pregnant or lactating women 7. history or presence of clinically relevant cns pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis 8. previous treatment with any gene therapy products

Keywords: cd19+ ,car-t, crs
umbilical vein needle catheterization for endotracheal intubation.

Conditions: Infant Respiratory Distress Syndrome

Summary: the investigators describe a simple and efficient method to give a premedication in the delivery room, using the umbilical vein, directly punctured through wharton's jelly.

the umbilical vein is punctured to inject drugs efficiently. the access is simple, the umbilical vein is clearly visible, and a blood reflux can be found easily. the investigators used the same equipment required for a peripheral venous injection: 24 gauge cannula, antisepsis, compress, and a syringe with the prepared anesthetic drugs. the investigators report 5 cases of intubations in the delivery room using this method to administer the premedication.

Eligibility criteria:
inclusion criteria: * all the patients were preterm neonates intubated in the delivery room for infant respiratory distress syndrome (irds). exclusion criteria: * refusal of legal owners

Keywords: endotracheal intubation neonatal premedication delivery room
post-market study of low-flow ecco2r using prismalung+

Conditions: Mild to Moderate Acute Respiratory Distress Syndrome

Summary: prismalung+ is indicated to provide extracorporeal carbon dioxide removal (ecco2r) as a stand-alone therapy or in combination with continuous renal replacement therapy (crrt). this study is intended for patients with increased levels of carbon dioxide (co2) in their blood and ≥ 18 years old, and will treat patients with mild or moderate acute respiratory distress syndrome (ards) using prismalung+. the study will assess tidal volume reduction and confirm the safety of prismalung+.


Eligibility criteria:
inclusion criteria: 1. patient age is ≥ 18 years old 2. patient is expected to receive ecco2r for a minimum of 24 hours 3. patient has mild or moderate ards according to the berlin definition: * 100 mm hg \< pao2/fio2 ≤ 300 mm hg, with peep ≥ 5 cm h2o, and * bilateral lung opacities not fully explained by effusions, lobar/lung collapse, or nodules, and * respiratory failure not fully explained by cardiac failure or fluid overload 4. written informed consent to participate in the study from the patient, if possible, or from the identified authorized representative if the patient is unable to provide consent. exclusion criteria: 1. patients body weight \< 30 kg 2. patients with a contraindication for systemic anticoagulation with heparin 3. patients with a platelet count \< 50,000/µl 4. patients on mv \> 7 days 5. patients with very severe, or stage 4 (as per gold staging system) chronic obstructive pulmonary disease (copd) 6. current or history of heparin-induced thrombocytopenia 7. patients who are pregnant and/or breastfeeding 8. patients not expected to survive the duration of the planned study treatment period (24 hours) 9. patients currently participating in another interventional clinical study, except if the patient is in an investigational medicinal product study, already in follow-up without further administration of study drug, and has not received any investigational medicinal product within 5 half-lives
interest of using the sevoflurane in the prevention of newborns pain

Conditions: Pain Measurement; Newborn

Summary: the objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care. main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.


Eligibility criteria:
inclusion criteria: * infants born between the 28th and 41th weeks of gestation admitted in intensive care unit * patient requiring a mechanical ventilation or cpap * patient requiring a ktec * given consent exclusion criteria: * contraindication to sévoflurane * patient already sedated with morphin and/or hypnotics * patient presenting neurologic troubles * patient enrolled in other study\* * infant without legacy representant
using interventional informatics to address social determinants of health during clinical care visits to promote behavior change and prevent cardiovascular disease

Conditions: Cardiovascular Diseases; Obesity

Summary: healthcare providers recognize the need for behavior change and the influence of social determinants on youth at risk for poor cardiovascular health (cvh), especially among those of low-socioeconomic status (ses). yet, providers lack the time and community data necessary to provide tailored, evidence-based care within routine practice. this project will use an interventional informatics approach to help providers prescribe patient-centered, evidence-based physical activity and nutrition prescriptions and link patients to community resources to account for social determinants at the point-of-care. this project will integrate our existing, novel, patient-centered real-time intervention (prevent) tool into the bjc electronic health record (ehr) and test it with providers and adolescent patients at-risk for poor cvh. ehr integration of prevent will enable a cyclical, synergistic and data-centric approach to impact modifiable risk factors (physical activity and food intake) and prevent cardiovascular disease. this approach uses health informatics technology (hit) to deliver data-driven, patient-centered care and generate evidence to support the use of hit as a way to prevent cardiovascular disease across diverse patients and communities.


Eligibility criteria:
inclusion criteria: * aged 12-17 years at baseline * at risk for poor cvh (body mass index \>= 85th percentile) * receiving care from the healthy start clinic at barnes jewish hospital.