Kornimate/medical-research-clean huggingface dataset:
inspiratory muscle training during pulmonary rehabilitation in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: demonstrate that imt associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe copd than a conventional pulmonary rehabilitation program alone.


Eligibility criteria:
inclusion criteria: * patients with copd stage 3 or 4 * hospitalized in the pulmonary rehabilitation unit in the hospital of morlaix, with a 3 weeks pulmonary rehabilitation course; exclusion criteria: * fev ≥ 50% * pneumonectomy, lobectomy less than 6 months * patient with risk of spontaneous pneumothorax or rib fracture

Keywords: inspiratory muscle training copd dyspnea multidimensional dyspnea profile questionnaire (mdp). pulmonary rehabilitation
primary hyperparathyroidism: does a systematic treatment improve the calcium and bone metabolism after surgery?

Conditions: Primary Hyperparathyroidism; Bone Metabolism

Summary: primary hyperparathyroidism (phpt) increases bone turnover and resorption and thus calcium efflux out of bone. after successful surgical treatment of phpt, bone takes up calcium again which may result in secondary hyperparathyroidism or even "hungry bone syndrome". until today there are no studies about this problem helping to develop recommendations or guidelines how to prevent these symptoms. study hypothesis: calcium and vitamin d intake after surgery for phpt protects the bone by keeping pth in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).


Eligibility criteria:
inclusion criteria: * postmenopausal women * male patients * biochemically proven phpt, ptx planned * no evidence for osteoporosis exclusion criteria: * postoperative hypocalcemia needing substitution with calcium and vitamin d/ 1-25-oh-vitamin d * cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma \>1cm) * persisting or recurrent phpt (postoperative hypercalcemia) * four-gland hyperplasia * multiple endocrine neoplasia (men) or hereditary phpt * familial hypercalciuric hypercalcaemia (ca/creatinine ratio \< 0.01) * phenylketonuria * renal impairment (creatinine clearance \<30ml/h) * severe hepatic disorder * severe systemic disorder * thyroid dysfunction * immobilisation * intake of drugs with potential effects on bmd like glucocorticoids, lithium, estrogen-replacement therapy, selective estrogen-receptor modulators (serms), bisphosphonates in the last three months * intake of drugs containing digoxin or digitoxin * known allergy against any component of the study medication

Keywords: postoperative follow-up
an observational study to investigate the role of b cells in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) typically afflict young people in their twenties, when they start a career and establish a family. the disease thus imposes a severe impact on quality of life and heavy economic burdens on society. critical barriers to progress in the field are the lack of knowledge of relevant immune cell subsets driving the pathology and the targets of the immune response within the central nervous system. in this project, we will test the hypothesis that a subgroup of ms patients is defined by a genetically determined b cell response against specific antigenic epitopes. the hypothesis is based on our recent, pioneering results showing that approximately half of ms patients have a restricted population of b cells in the cerebrospinal fluid defined by polymorphisms in the constant heavy-chain of the immunoglobulin b cell receptor, the g1m1 allotype. here, we aim to characterize the g1m1 b cells, to disentangle the genetic basis of the b cell response, and to identify the molecular targets.


Eligibility criteria:
inclusion criteria: * symptoms and brain mri scans strongly suggestive of multiple sclerosis according to the 2017 mcdonald revisions * intrathecal immunoglobulin g synthesis * age \> 18 years exclusion criteria: * treatment with immunomodulatory drugs
a study of ortd-1 in patients hospitalized with covid-19 related pneumonia

Conditions: COVID-19

Summary: evaluate the safety and effect of ortd-1 on covid-19 related pneumonia.

this is a randomized, blinded, vehicle-controlled dose-escalation study. initial enrollment and treatment will be conducted as an inpatient study. patients will be randomized 2:1, ortd-1 treatment versus vehicle control. patients will be allocated into 1 of 3 sequential escalating dose cohorts. blinded study drug will be infused intravenously once daily for 5 consecutive days.

Eligibility criteria:
inclusion criteria: * positive rt-pcr assay for sars cov-2 in a respiratory tract sample * hospitalized for covid-19 * radiographic diagnosis of pneumonia * respiratory insufficiency * receiving pharmacologic thromboprophylaxis exclusion criteria: * premorbid abnormal pulmonary function or disease * concurrent or prior intubation or ventilated support for covid-19 * receiving systemic corticosteroids or other immunomodulators or immunosuppressant drugs * previous hospitalization for covid-19

Keywords: covid-19 pneumonia sars-cov-2 covid-19 drug treatment theta-defensins
adherence to treatment in hemophilia

Conditions: Haemophilia

Summary: psychosocial factors and adherence to treatment in patients with hemophilia. a multicenter study. multicenter cross sectional study of patients with hemophilia and their families

research project whose main objective is to assess adherence and major psychosocial issues affecting patients with hemophilia and their families treated at the hematology and hemotherapy services clinical hospital universitario virgen de la arrixaca of murcia and the university hospital carlos haya, malaga. the data obtained in this project will identify those psychosocial aspects affecting patients and their families about the disease, its evolution and treatment of it. they will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for hemophilia patients. the main characteristics of the study are: * descriptive study of adherence to treatment of pediatric patients, adolescents and adults with hemophilia. * descriptive study of family functioning, perceived stress, anxiety and quality of life in parents of children with hemophilia under 14 years and adolescents with hemophilia, depending on the administered medical treatment, clinical and musculoskeletal patient situation. * descriptive study of illness behavior or perception of illness, perceived stress, anxiety, quality of life and coping strategies of young adults with hemophilia, depending on the medical treatment administered, and skeletal muscle clinical situation of the patient. * validation of psychosocial assessment tools in patients with hemophilia and their families.

Eligibility criteria:
inclusion criteria: * patients with hemophilia a or b * patients followed at the hematology department of the hospitals included in the study * patients without cognitive disorders exclusion criteria: * patients with other congenital coaguopatías * patients with more than 2 years without going to review your hospital * patients from other provinces of spain

Keywords: haemophilia adherence family functioning quality of life anxiety illness behavior coping strategies
plasma concentration of lidocaine and bupivacaine axillary bpb mixture solutions [pclbaxmix]

Conditions: Arm Injury

Summary: the doses of local anesthetics can be decreased with the use of ultrasound guidance. in case of using mixture solutions the benefits and drawbacks are controversial. the plasma concentrations were not studied up to this time in this kind of settings, so investigators believe that this is the first work that shows how lidocaine change the plasma concentration of bupivacaine after axillary approach to brachial plexus employed with different dilute and mixed solutions for upper limb surgery in trauma patients.

total of 30 american society of anesthesiologist (asa) i-iii adult patients scheduled to elective or emergency trauma surgery of hand and forearm under ultrasound-guided (ug) brachial plexus block (bpb) are planned to be assigned into this randomized-prospective observational study after approval by the university research ethics board, pécs university medical school, hungary. all of the patients will receive detailed information about the planned bpb techniques and surgeries, then written informed consents will be obtained. study participants are planned to be assigned randomly by the research coordinator into 3 groups (lidocaine, bupivacaine and mixture solution) according to the concentration of lidocaine and bupivacaine in the mixture solution. standardized ug axillary-supraclavicular (ax-sc) approach to the bp is planned to be performed under sterile conditions by the same anesthesiologist. the standardized dose is 0.4 ml/kg with the targeted maximized the single-shot volume of 30 ml. blood samples will be taken at 0-time point (straight after the administration of bp injection) and 30, 60, 240 and 480 minutes after. plasma concentrations are determined, the results are collected and analyzed. under standard monitorization, vital parameters, data are collected on the onset time and duration of actions of local anesthetics (las).

Eligibility criteria:
inclusion criteria: * unpremedicated patient scheduled for elective or emergency trauma surgery of hand and forearm under ultrasound-guided bpb exclusion criteria: * continuous peripheral nerve catheter technique or bilateral block was planned, or the patient refused to participate. exclusion criteria included psycho-mental conditions interfering with consent or assessment; pre-existing chronic pain condition or daily analgesic or sedative consumption; sedative or analgesic premedication; pre-existing neurological disorders aﬀecting the brachial plexus.
comparison of misoprostol ripening efficacy with dilapan

Conditions: Labor Onset and Length Abnormalities; Induced; Birth

Summary: the purpose of this study is to find out if dilapan works as well as misoprostol for preparing the mouth of the uterus (cervix) for inducing labor in women who need to undergo this procedure. the primary objective is to assess the efficacy of dilapan for cervical ripening compared to misoprostol in women undergoing induction of labor (iol) at or more than 37 weeks gestation.

in developed nations 25 % of pregnant women undergo labor induction for various indications. likelihood of vaginal delivery depends on the degree of ripeness of cervix. majority of women undergoing induction of labor are candidates for cervical ripening. dilapan is an osmotic hygroscopic dilator of cervix commonly used for cervical preparation for mid trimester abortions. it has been proven safe for use for induction of labor (iol) at term. misoprostol is a synthetic prostaglandin e1 analogue, widely used for cervical ripening and iol in united states and is considered as standard of care. this is a non-inferiority, unblinded randomized, controlled trial where 322 eligible participants undergoing iol at \>37 weeks gestation and admitted to labor and delivery unit will be enrolled and randomly assigned in a ratio 1:1 to either receive dilapan or misoprostol for cervical ripening. after randomization all participants will undergo assessment as per standard of care. participants will have either 1-5 dilapan rods inserted into their cervix by the providers or receive 25 mcg of misoprostol orally every 2 hours to a maximum of 6 doses over 12 hours. participants will be evaluated for artificial rupture of membranes and initiation of oxytocin for inducing uterine contraction. a diagnosis of failed iol will be made if patient does not go into active labor within 24 hours after initiation of oxytocin and artificial rupture of membranes (arom). intrapartum management will be according to institutional guidelines. all participants will be followed up and contacted by phone 2 weeks after discharge regarding their experience with the method of induction.

Eligibility criteria:
inclusion criteria: 1. women undergoing labor induction with a gestation of ≥37 weeks (based on a sure last menstrual period and an ultrasound done before 22 0/7 weeks) 2. live fetus with in cephalic presentation 3. singleton pregnancy 4. able to provide informed consent for participation in the study exclusion criteria: 1. contraindication for vaginal delivery 2. age less than 18 years 3. prior uterine scar from a cesarean section or myomectomy 4. patients who have hellp syndrome or eclampsia 5. active genital herpes at the time of labor induction 6. complex medical problems that may require assistance with second stage of labor 7. bishop score ≥ 6 8. major fetal congenital anomalies (as assessed by investigator) 9. premature rupture of membranes

Keywords: misoprostol dilapan induction of labor aquacryl hydrogel
a study of yervoy and opdivo combination therapy in participants with unresectable advanced/recurrent malignant pleural mesothelioma (mpm)

Conditions: Mesothelioma, Malignant

Summary: the purpose of this study is to observe the safety of the combination therapy with yervoy and opdivo in japanese participants for the treatment of unresectable advanced/recurrent malignant pleural mesothelioma (mpm).


Eligibility criteria:
inclusion criteria: * initiated treatment with yervoy and opdivo in combination for the first time in accordance with the japanese package insert exclusion criteria: * received combination therapy with yervoy and opdivo for indications other than malignant pleural mesothelioma (mpm). * received the yervoy and opdivo combination for mpm, but for an indication that is outside of the japanese package insert.

Keywords: malignant pleural mesothelioma (mpm) opdivo yervoy unrectable advanced/recurrent
assessment of vmcore biopsy versus standard of care biopsy

Conditions: Prostate Cancer

Summary: prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. the standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. the vmcore biopsy system has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. this study is to compare the characteristics of tissue captured by either standard of care needles and the vmcore needle.

this post-market study is being conducted in order to assess the capability of the vmcore biopsy needle to capture prostate tissue in subjects consenting to the use of both the vmcore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. the primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.

Eligibility criteria:
inclusion criteria: * male * scheduled for a prostate biopsy * able and willing to provide verbal assessment of his condition 5 days post-procedure exclusion criteria: * unable or unwilling to provide consent
a 12-week, multicentric study to evaluate the safety and efficacy of bisoprolol in filipino hypertensive subjects with diabetes

Conditions: Hypertension

Summary: the aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day bisoprolol in filipino hypertensive subjects with diabetes as monotherapy or as an add-on therapy.


Eligibility criteria:
inclusion criteria: * adult subjects with hypertension, either newly diagnosed or treated but currently uncontrolled as defined by joint national committee (jnc) 7 for subjects with type 2 diabetes mellitus (t2dm) (that is, greater than or equal to \[\>=\] 130/80 mmhg) * aged at least 18 years old * diagnosed with t2dm and already on anti-diabetic therapy, and with glycosylated hemoglobin of less than 7 percent exclusion criteria: * subjects who were already on beta-blocker therapy at the time of recruitment * subjects with heart rate of at most 60 beats per minute (bpm) at rest * subjects with secondary hypertension, congenital heart disease, coronary artery disease, peripheral arterial disease or congestive heart failure in any stage * subjects with coronary conduction disorders (bundle branch block) * subjects with signs of definitive target organ damage consistent with world health organization (who) stage iii or with severe renal or hepatic disease * subjects who are pregnant or expect to be pregnant within the 24-week study period * subjects on oral contraceptives * subjects with asthma or a history of asthma * subjects with documented severe renal disease * subjects on anti-neoplastic drugs

Keywords: hypertension diabetes mellitus bisoprolol
digital versus hybrid interventions in promoting nutrition knowledge among saudi adolescent girls

Conditions: Nutrition Knowledge; Generalized Anxiety Disorder (GAD); Food Habits; Body Mass Index

Summary: this study primarily aims to compare the efficacy of different approaches to nutrition education intervention delivery in improving nutrition knowledge (nk) among saudi adolescent girls. a secondary aim is to compare the effectiveness of these interventions in enhancing dietary habits and reducing generalized anxiety disorder (gad) scores.a randomized sample of 104 saudi adolescent girls aged 16-18 years from a single high school in makkah city enrolled in a 4-week lifestyle educational intervention for health promotion. participants were randomly assigned to either a hybrid or a fully digital nutritional education program. outcome measures included knowledge (nk), dietary and lifestyle habits assessed by the healthy plate variety score (hpvs), and mental health evaluated using the generalized anxiety disorder (gad) scores.


Eligibility criteria:
inclusion criteria: * healthy * adolescents (15-19 years old) * reliable internet access * willing to participate exclusion criteria: * has chronic disease/s * \ 19 years * no internet access * not willing to participate

Keywords: diet anxiety nutritional knowledge educational intervention saudi arabia adolescents digital hybrid intervention
zipline incision approximation verses suture:zips3 physician preference study

Conditions: Wounds and Injuries

Summary: zipline incision approximation vs. suture -- zips 3 study. a prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.

the objective of this study is to evaluate user preferences associated with the zipline 3 system versus conventional suture placement.

Eligibility criteria:
inclusion criteria: 1. patients between 18 and 75 years of age * in generally good health * willing to be evaluated in 5-14 days and 3-months post op 2. patient requiring a non-emergent skin incision or biopsy * maximum excision size 1.5x3.0 cm * requiring 4-0 or smaller suture for closure * in area of body trunk or extremities with low mobility and tension exclusion criteria: 1. facial incisions or incisions in high stress or tension areas 2. previously diagnosed peripheral vascular disease 3. insulin-dependent diabetes mellitus 4. known bleeding diathesis 5. known personal or family history of keloid formation or scar hypertrophy 6. known allergy or hypersensitivity to adhesives 7. presently taking steroids, immune stimulants, beta blockers, or anticoagulants 8. atrophic skin deemed clinically prone to blistering 9. any skin disorder affecting wound healing 10. incisions requiring dermal sutures 11. any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Keywords: zipline3 device vs. conventional sutures
fixed-dose activated versus variable-dose inactivated prothrombin complex concentrate for warfarin-associated major bleed

Conditions: Hemorrhage

Summary: this study aims to assess a fixed-dose regimen of activated prothrombin complex concentrate (feiba vh, baxter) versus the variable, manufacturer recommended, dose regimen of inactivated prothrombin complex concentrate (kcentra, csl behring) for reversal of warfarin-associated major hemorrhage.

warfarin, a vitamin k antagonist (vka), is the most frequently prescribed oral anticoagulant. warfarin-associated major hemorrhage occurs at a rate of 1.7% to 3.4% in routine clinical practice and warrants rapid reversal of anticoagulation by correcting supratherapeutic international normalized ratio (inr) values. warfarin inhibits synthesis of vitamin k dependent coagulation factors ii, vii, ix, and x, and strategies for reversal of warfarin-associated coagulopathy are aimed at restoring deficient factors. four-factor prothrombin complex concentrates (pccs) contain the coagulation factors which warfarin inhibits and are an attractive option for rapid reversal due to ease of reconstitution and no requirement for blood-type matching. manufacturer dosing recommendations exist for pccs based on patient weight, baseline inr, and target inr, but studies have suggested fixed dosing strategies in an effort to determine the most efficacious dose for vka-reversal while sparing adverse events. these studies have also utilized different pcc formulations, with some studies utilizing 4-factor activated pcc (apcc), which denotes product containment of factor vii in an activated state. in the united states, product availability is limited to a single 4-factor apcc (feiba vh, baxter) indicated for hemophilia patients with inhibitors and a single 4-factor inactivated pcc (kcentra, csl behring) approved for vka-reversal. various institutions choose to utilize off-label fixed dosing strategies of 4-factor apcc in an effort to administer the lowest possible dose to reverse vkas, while others utilize manufacturer recommended dosing of 4-factor inactivated pcc.

Eligibility criteria:
inclusion criteria: * pre-treatment inr lab value greater than 1.5 * receipt of treatment with a 4-factor pcc for inr normalization due to warfarin-associated major hemorrhage exclusion criteria: * patients treated with a pcc for an urgent invasive procedure without active hemorrhage * patients treated with pcc not taking a vka * unavailable pre- or post-treatment inr lab values * pregnant patients

Keywords: vitamin k 1 prothrombin complex concentrates warfarin