Kornimate/medical-research-clean huggingface dataset:
effect of nocturnal parenteral nutrition on bone turnover and energy metabolism

Conditions: Intestinal Failure; Osteoporosis; Insulin Sensitivity

Summary: this clinical trial will study the effect of daytime versus nighttime parenteral nutrition on bone turnover, glucose variability, nitrogen balance, sleep and wake rhythm and peripheral clock gene expression in patients with chronic intestinal failure.

objective: this randomized crossover pilot study aims to determine the effect of nocturnal versus daytime cyclic infusion of parenteral nutrition in adult patients with chronic intestinal failure on bone turnover, glucose metabolism, nitrogen balance, sleep and wake rhythm and clock genes expression. this study will include 20 adult patients with chronic intestinal failure. patients will receive nocturnal parenteral nutrition for 2 weeks (period a) and will switch to daytime parenteral nutrition (period b) for 2 weeks (random assignment). during both study periods glucose variability and sleep / wake rhythm will be measured. after both study periods, patients will be admitted to the metabolic unit for 24 hours to measure bone turnover markers, nitrogen balance, glucoregulatory hormones, energy expenditure and substrate oxidation rates and clock gene expression in leukocytes.

Eligibility criteria:
inclusion criteria: * home parenteral nutrition for at least 5 nights a week * on home parenteral nutrition for more than 1 year * no major changes in parenteral nutrition for 3 months prior to inclusion exclusion criteria: * parenteral infusion for more than 16 h a day * use of bone modifying drugs in the last 2 years * bone fractures in the past year * renal insufficiency (egfr \< 60 ml/min) * hba1c ≥48 mmol/ml * use of corticosteroids * shift work * performing intensive exercise (\> 2 hours a day and \> 3 times a week)

Keywords: parenteral nutrition intestinal failure circadian misalignment
pocus-peac to reduce femoral arterial blood flow

Conditions: Hemorrhage

Summary: the aim of this study is to evaluate the efficacy on healthy subjects of point of care ultrasonographically guided external aortic compression compared to the manual technique already described.

manual proximal external aortic compression (m-peac) has been described for temporizing non-compressible hemorrhage. point of care ultrasonographically guided external aortic compression (pocus-peac), a new technique, has been used for management of junctional hemorrhage. the aim of this study is to compare the efficacy of us-peac to m-peac in reducing the distal arterial flow. this study also evaluates whether a small weight operator would benefit most of the us-peac compared to a standard weight operator. other objectives are to evaluate pain and secondary effects. we will conduct an experimental crossover trial on healthy volunteers. subjects will be recruited using a convenient sample. m-eac and us-eac will be performed on each subject. femoral arterial flows will be measured by doppler before and after each compression. femoral flow reduction will be calculated for each technique and compared. the compression will be first accomplished by an 80 kg operator followed by a 57 kg operator. after each compression, pain will be evaluated using a visual analog scale (vas). fifteen minutes after the intervention, pain will be recorded using the same vas. a follow-up will be ensured at 24 hours and at one week to evaluate for secondary effects.

Eligibility criteria:
inclusion criteria: * age 18 to 40 years old exclusion criteria: * \ 40 years old, bmi \ 25, history of abdominal surgery, history of vascular surgery, known aortic disease, known peripheral vascular disease, coronary disease, smoking, history of smoking, diabetes, dislipidemia, arterial hypertension, abdominal or inguinal hernia, eating in the last 4 hours before intervention, abdominal pain on the day of intervention, abdominal bloating on the day of intervention, pregnancy, impossibility to visualize the aorta with the ultrasound
bomedemstat (img-7289/mk-3543) in participants with myelofibrosis (img-7289-ctp-102/mk-3543-002)

Conditions: Myelofibrosis; Post-polycythemia Vera Myelofibrosis (PPV-MF); Post-essential Thrombocythemia Myelofibrosis (PET-MF); Primary Myelofibrosis (PMF)

Summary: this is a phase 1/2 open-label study to evaluate the safety, tolerability, steady-state pharmacokinetic (pk) and pharmacodynamics (pd) of a lysine-specific demethylase 1 (lsd1) inhibitor, bomedemstat (img-7289/mk-3543), administered orally once daily in participants with myelofibrosis. the primary hypothesis is that bomedemstat is a safe and tolerable orally available agent when administered to participants with myelofibrosis including primary myelofibrosis (pmf), post-polycythaemia vera-myelofibrosis (ppvmf), and post-essential thrombocythaemia-myelofibrosis (pet-mf) (collectively referred to as 'mf'); inhibition of lsd1 by bomedemstat will reduce spleen size in those with splenomegaly, improve haematopoiesis and reduce constitutional symptoms associated with these disorders.

this study initiated as a phase 1/2a study assessing the safety of the starting dose, an 85-day duration of treatment, and the pk and pd effects of bomedemstat, with transition to a phase 2b study incorporating changes supported by the phase 1/2a data.

Eligibility criteria:
inclusion criteria: * \>18 years of age * diagnosis of either pmf per world health organization (who) diagnostic criteria for myeloproliferative neoplasms, or ppv-mf or pet-mf per the international working group for myelofibrosis research and treatment * high or intermediate-2 risk disease exclusion criteria: * receiving other treatments for the condition (with exceptions and time limits) * major surgery in last 4 weeks, any surgery in the last 2 weeks * history of, or scheduled, hematopoietic stem cell transplant within 24 weeks of screening * history of splenectomy * current use of prohibited medications * a concurrent second active and nonstable malignancy * known human immunodeficiency virus infection or active hepatitis b or hepatitis c virus infection * other hematologic/biochemistry requirements, as per protocol * use of an investigational agent within last 14 days * pregnant or lactating females

Keywords: lsd1
jab-bx102 monotherapy and combination with pembrolizumab in adult patients with advanced solid tumors

Conditions: Solid Tumor

Summary: this study is to evaluate the safety and tolerability of jab-bx102 monotherapy and combination therapy with pembrolizumab in adult participants with advanced solid tumors.

the primary objective of this study is to evaluate the safety and tolerability of jab-bx102 monotherapy to determine the mtd(maximum tolerated dose) and rp2d(recommended phase 2 dose) during dose escalation phase; then to evaluate preliminary antitumor activity when jab-bx102 is administered in combination with pembrolizumab during dose expansion phase in patients with advanced solid tumors.

Eligibility criteria:
inclusion criteria: * must be able to provide an archived tumor sample * must have histologically or cytologically confirmed metastatic or locally advanced solid tumor * must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition, or patient has no access to soc treatment. * must have at least 1 measurable lesion per recist v1.1 * must have adequate organ functions exclusion criteria: * has central nervous system(cns) metastases or carcinomatous meningitis, except if cns metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days * active infection requiring systemic treatment within 7 days * active hepatitis c virus(hbv), hepatitis c virus(hcv), or hiv * any severe and/or uncontrolled medical conditions * left ventricular ejection fraction(lvef) ≤50% assessed by echocardiogram (echo) or multigated acquisition scan (muga) * qtcf(corrected qt interval - fredericia formula) interval \>470 msec * experiencing unresolved ctcae 5.0 grade \>1 toxicities

Keywords: solid tumor
study to evaluate the ability of subjects with rheumatoid arthritis or psoriatic arthritis to effectively use a reusable autoinjector to self-inject etanercept

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

Summary: the purpose of this study is to assess the ability of people with rheumatoid arthritis (ra) or psoriatic arthritis (psa) to use an experimental autoinjector to self inject etanercept (enbrel®).

study participants need to have been self-administering etanercept for greater than or equal to 6 months prior to screening. you will be in this study for about 9 weeks. this includes a 4-week screening period and a 5-week treatment period.

Eligibility criteria:
inclusion criteria: * subject has diagnosis of ra or psa and indicated for treatment with etanercept per the current label, based on history. * subject is willing to self-inject per investigator judgement at screening. * subject has no known history of tuberculosis. exclusion criteria: * latex allergy. * subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first study dose of etanercept. * subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening. * other criteria may apply.
the assessment of the use of anti-adhesion agents to prevent pelvic postoperative adhesions

Conditions: Tissue Adhesion; Gynecologic Surgery

Summary: the aim of this study is to assess the safety and effectiveness of protahere absorbable adhesion barrier to prevent pelvic postoperative adhesions.

the study is a random, evaluator-blinded, controlled, single center clinical trial. recruiting patients who are premenopausal and scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy. patients recruited are randomly divided into five groups, protahere, hyalobarrier, seprafilm, interceed or no treatment when the inclusion criteria are met and the inform consents are obtained. they are followed for 24 months including visits at 14 days, 3, 6, 12, 18, 24 months post-operation for the safety and effectiveness evaluation. the primary endpoints are the incidence of adhesions at 3-month as well as the incidence of any adverse events during the study.

Eligibility criteria:
inclusion criteria: * patients who are premenopausal. * patients who are scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy. * patients who are 20 years old or older. * patients who are able to understand the objectives, sign the informed consent form, and willing to comply with study procedures. exclusion criteria: * patients who are 65 years old or older. * presence of uncontrolled diabetes, coagulative disorders, severe urinary system infection, or other severe diseases. * presence of malignant tumor or diagnosed with cancer. * any physical or psychological illness or symptom which is considered unsuitable to enroll by physicians. * patients who are unwilling to comply with study procedures. * patients who are known to have hypersensitivity to hyaluronic acid implants.

Keywords: hyaluronan gel adhesion agent
comparing use of a prehospital ultrasound system and standard prehospital care in thoracoabdominal trauma

Conditions: Thoracoabdominal Trauma; Focused Assessment With Sonography for Trauma (FAST); NanoMaxx Ultrasound System (SonoSite); RP-Xpress (InTouch Technologies)

Summary: the nanomaxx ultrasound system (sonosite) in connection with the rp-xpress (intouch technologies) provides a means of transmitting ultrasound images, video, and audio to a remote location in real-time. it has been envisioned that this system be used to diagnose trauma patients with suspected pleural effusion, hemothorax, pneumothorax, or abdominal blockage during prehospital care; under the guidance of in-hospital physicians, paramedics would perform an focused assessment with sonography for trauma (fast) examination while trauma patients are transported to hospital via ambulance. the investigators hypothesize that in-hospital physicians interpreting ultrasound images obtained by paramedics during trauma patients' transportation to hospital will reduce time to diagnosis; thus, preparations by emergency physicians, surgeons, and operating room teams to receive critically injured patients may begin earlier, reducing time to intervention during a critical period in patient care. data will also be collected regarding quality of images obtained in-ambulance and the interaction between paramedics and physicians using the remote-presence system.


Eligibility criteria:
inclusion criteria for fast cohort: * patient is 18 years of age or older * patient presenting with blunt or penetrating trauma to the thorax or abdomen * patient transported by md ambulance to royal university hospital * patient being transported by a paramedic who has received training in the above ultrasound system and who has with them a nanomaxx ultrasound system (sonosite) to be used in connection with the rp-xpress (intouch technologies) * patient will take longer than 10 minutes to transport to hospital * patient's care will not be compromised in completing a fast exam - opinion of paramedic * patient's care will not be compromised in completing a fast exam - opinion of er physician inclusion criteria for controls: * patient is 18 years of age or older * patient presenting with blunt or penetrating trauma to the thorax or abdomen * patient transported by md ambulance to royal university hospital * patient will take longer than 10 minutes to transport to hospital exclusion criteria: * patients under the age of 18 * patients whose care would be compromised if other procedures of higher priority (as determined by paramedics and/or remotely-present physicians) were not be able to be executed due to time involved in completing a fast exam * patients who are not being transported to royal university hospital * patients whose expected transport time from scene to hospital is less than 10 minutes

Keywords: fast thoracoabdominal trauma prehospital care ultrasound nanomaxx ultrasound rp-xpress
post-market clinical investigation of the clareon® iol

Conditions: Cataract; Aphakia

Summary: the primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the clareon® intraocular lens (iol). a comparison to historical safety and performance endpoint (spe) rates as reported in the european standard international organization for standardization (en iso) 11979-7:2014 will be conducted at one year. the secondary purpose of this study is to evaluate the visual acuity outcomes with the clareon iol at years 2 and 3.

subjects will attend a total of 12 study visits over a period of approximately 36 months: one preoperative screening visit, two operative visits, and nine post-implantation visits. both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. primary endpoint data will be collected at the year 1 visit (day 330-420 post-implantation from second eye surgery).

Eligibility criteria:
key inclusion criteria: * diagnosed with bilateral cataracts * planned small incision cataract removal surgery * able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits key exclusion criteria: * subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study * certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration * pregnant or lactating, current or planned during the course of the study other protocol-defined inclusion/exclusion criteria may apply.
diabetes education and a1c study

Conditions: Diabetes Mellitus, Type 2; Sleep

Summary: sleep problems are associated with poor blood glucose control, but current diabetes self-management programs do not include sleep education. this study will randomize participants into two groups: one that receives sleep education and one that does not. the researchers expect both groups to experience reductions in blood glucose. the researchers hypothesize that individuals who receive sleep education as part of their diabetes self-management training will experience greater improvements in blood glucose control, as measured by hemoglobin a1c, compared to the control group.


Eligibility criteria:
inclusion criteria: * individuals with a diagnosis of type 2 diabetes who are patients at the michigan state university (msu) endocrinology clinic, * a diagnosis of overweight or obesity (body mass index greater than or equal to 25.0 kg/m2), * the most recent hemoglobin a1c value greater than or equal to 7.5%, and * the ability to attend online program sessions. exclusion criteria: * significant psychiatric disorders, * advanced medical conditions that require alterations to the mnt for dm2, e.g., advanced chronic kidney disease, and * an inability to follow recommendations due to cognitive deficits.
full dose tenecteplase (tnk-tpa) together with heparin sodium, full dose tenecteplase with enoxaparin, half dose tenecteplase together with abciximab and heparin sodium in patients with acute myocardial infarction (ami)

Conditions: Myocardial Infarction

Summary: the objective of assent 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group a), full dose tenecteplase combined with enoxaparin (group b) and half dose tenecteplase combined with abciximab and heparin sodium (group c).


Eligibility criteria:
inclusion criteria: * onset of symptoms of ami within six hours prior to randomisation * a twelve-lead electrocardiogram with one of the following: st-segment elevation ≥ 0.1 millivolt (mv) in two or more limb leads, or ≥ 0.2 mv in two or more contiguous precordial leads indicative of ami, or left bundle-branch block * age ≥ 18 * informed consent received exclusion criteria: * hypertension defined as blood pressure \> 180/110 mm hg (systolic bp \>180 mm hg and/or diastolic bp \>110 mm hg) on repeated measurements during current admission prior to randomization * use of abciximab (reopro ®) or other glycoprotein-iib/iiia antagonists within the preceding 7 days * major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months * any minor head trauma and any other trauma occurring after onset of the current myocardial infarction * any known history of stroke or transient ischemic attack or dementia * any known structural damage of the central nervous system * prolonged cardiopulmonary resuscitation (\>10 minutes) in the previous two weeks * current oral anticoagulation * standard unfractionated heparin (heparin sodium) \>5000 iu or a subcutaneous dose within 6 hours of randomization of a therapeutic dose of any low molecular weight heparin * known thrombocytopenia (prior platelet count below 100000 cells/μl (100 x10\*\*9/l)) * known renal insufficiency (prior s-creatinine \>2.5 mg% (\>220 μmol/l) for men and \>2.0 mg% (\>175 μmol/l)) for women * pregnancy or lactation, parturition within the previous 30 days. women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control * treatment with an investigational drug under another study protocol in the past 7 days * previous enrollment in this study * known sensitivity to tnk-tpa, tpa, abciximab, heparin or low molecular weight heparin * any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated * inability to follow protocol and comply with follow-up requirements
can interval walking influence on fatigue in the danish cohort of myasthenia gravis patients

Conditions: Myasthenia Gravis

Summary: the study is a controlled, randomized intervention trial. patients are randomized into either an intervention group or a control group. the duration of the study is 10 weeks. patients in the intervention group participate in a 10 weeks exercise program consisting of 150 minutes interval walking per week administered by an app on the patient's telephone. patients in the control group live as usually, with a maximum of 30 minutes aerobic exercise per week. before and after the 10 weeks study period, patients (from both the intervention and the control group) participate in a 2 hours session of functional testing (e.g. walk tests, test of muscle strength ect.) at rigshospitalet.


Eligibility criteria:
inclusion criteria: * able to provide signed informed consent. * able to read and understand danish or english. * diagnosed with mild to moderate myasthenia gravis (i-iv on the myasthenia gravis foundation of american clinical classification, mgfa). * documented history of acetylcholine receptor (achr) or muscle specific kinase (musk) antibody positive, or abnormal repetitive nerve stimulation testing (decrement \> 10%) on emg or abnormal single fiber emg (conduction block or jitter) or based on their clinical history and symptom improvement with acethylcholinesterase inhibitors. * if the patient is on oral corticosteroids, the dose must be stable for at least 1 month prior to inclusion. * if the patient is on cholinesterase inhibitors the dose must be stable 2 weeks prior to inclusion. exclusion criteria: * mgfa grade v disease * other disorders that are not related to mg, or drugs, that interfere with muscle strength, balance and fatigue. * serious medical illness (e.g. uncontrolled insulin dependent diabetes mellitus, symptomatic coronary artery disease, and cancer). * dementia or pregnancy. * unspecified reasons judged by the investigator.
the glycaemic effect of isomaltulose consumption in healthy participants

Conditions: Diabetes Mellitus

Summary: the objective of this study is to determine the glycaemic effect of isomaltulose and sucrose in chinese, indian, malay, and caucasian individuals. the current study will provide important information on the potential health benefits of isomaltulose consumption in asian population. it will also reveal how the three main ethnicities in singapore respond to isomaltulose and whether the response differs from the caucasians.

the objective of the present study is to investigate the glycaemic effect of isomaltulose in chinese, indians, malays and caucasians. this will be a single intervention. up to fifty participants, consisting of at least ten chinese, ten malays, ten indians, and ten caucasians completed data sets, aged between 21 and 40 years will be recruited from the general public in singapore. participants will be asked to attend two test sessions for this study. participants will consume either a sucrose drink or an isomaltulose drink (each containing 50 g of available carbohydrate).

Eligibility criteria:
inclusion criteria: * chinese, indian, malay or caucasian ethnic origin exclusion criteria: * people with major chronic disease such as heart disease, cancer or diabetes mellitus * individuals with food intolerances or allergies to isomaltulose or sucrose * individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution * people with a major medical or surgical event requiring hospitalization within the preceding 3 months * individuals with the presence of disease or drugs which influence digestion and absorption of nutrients * pregnant women