Kornimate/medical-research-clean huggingface dataset:
phase 2 study of belimumab administered subcutaneously to subjects with systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to test the safety and tolerability of repeated subcutaneous (sc) doses of belimumab in subjects with sle.

this clinical trial will evaluate the safety, pharmacokinetics (pk), and effect on biomarkers of repeated subcutaneous (sc) administration of belimumab in subjects with sle. as data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, pga, selena seldai, and biomarker effects.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sle by american college of rheumatology (acr) criteria * active sle disease * on stable sle treatment regimen exclusion criteria: * pregnant or nursing * have received treatment with an b cell targeted therapy * have received treatment with a biologic investigational agent in the past year * have received intravenous (iv) cyclophosphamide within 180 days of day 0 * have severe lupus kidney disease * have active central nervous system (cns) lupus * have required management of acute or chronic infections with the past 60 days * have current drug or alcohol abuse or dependence or within the past year * have a historically positive test or test positive at screening for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c * have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention

Keywords: sle lupus systemic lupus erythematosus antibodies autoimmune diseases belimumab
pembrolizumab plus epacadostat vs pembrolizumab plus placebo in metastatic non-small cell lung cancer (keynote-654-05/echo-305-05)

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (nsclc) expressing high levels of programmed cell death ligand 1 (pd-l1).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of stage iv nsclc without epidermal growth factor receptor (egfr)-sensitizing mutation, ros1 and/or anaplastic lymphoma kinase (alk) translocation. * measurable disease based on recist 1.1. * tumor tissue that demonstrates programmed cell death ligand 1 (pd-l1) expression in ≥ 50% of tumor cells (tumor proportion score \[tps\] ≥ 50%) as assessed by immunohistochemistry at a central laboratory. * life expectancy of at least 3 months. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate organ function per protocol-defined criteria. exclusion criteria: * known untreated central nervous system metastases and/or carcinomatous meningitis. * history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease. * symptomatic ascites or pleural effusion. * known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. * active autoimmune disease that has required systemic treatment in past 2 years. * has had an allogeneic tissue/solid organ transplant. * has a known history of human immunodeficiency virus (hiv) infection. hiv testing is not required unless mandated by the local health authority. * has known history of or is positive for active hepatitis b (hbsag reactive) or has active hepatitis c (hcv rna). note: testing must be performed to determine eligibility. * history or presence of an abnormal electrocardiogram (ecg) that, in the investigator's opinion, is clinically meaningful. * use of protocol-defined prior/concomitant therapy.

Keywords: non-small cell lung cancer programmed cell death 1 (pd-1) inhibitor indoleamine 2 3-dioxygenase 1 (ido1) inhibitor
ocp vs metformin on ovarian stromal blood flow in pcos

Conditions: PCOS

Summary: this study is undertaken to compare the effects of treatment with commonly used ocp containing ethinylestradiol-cyproterone acetate and metformin in women with pcos. special attention will be paid to changes in ovarian stromal blood flow by using color doppler and they will be correlated with changes in hormonal parameters post-treatment.


Eligibility criteria:
inclusion criteria: * women diagnosed with pcos according to the rotterdam criteria exclusion criteria: * current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs. * medical or surgical treatment of pcos during the previous 3 months * presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone * pregnancy, breastfeeding or desire for pregnancy during study interval (6 months) * inability to understand the proposal of the study precluding effective informed consent
a prospective comparison of methadone, fentanyl, and morphine for post-laparotomy epidural analgesia

Conditions: Post Laparotomy Pain Treatment

Summary: the current study aim is to compare between the opioids morphine, fentanyl and methadone in terms of efficacy and side effects profile when administered epidurally for pain management after laparotomies. intravenous morphine will also be used. the outcomes of that method will be compared to those obtained using epidurally administered opioids, as this is another commonly used postoperative pain relief method.


Eligibility criteria:
inclusion criteria: \* elective laparotomy exclusion criteria: * subjects with diabetes mellitus, other neurological or systemic disease associated with altered sensory perception * illicit drug abusers * chronic use of pain medication * inability to understand consent form * age \< 18 * renal failure (clcr\<50 ml/min) * chronic use of drugs that can alter plasma levels and\\or effect of the study drugs * corrected q-t interval(qtc)=450msc and above * contra-indication for epidural catheter insertion * pregnancy

Keywords: morphine fentanyl methadone epidural intravenous pain analgesia
a skeletal muscle recovery intervention with dietary protein in heart failure

Conditions: Heart Failure; Muscle Atrophy

Summary: severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (hfref). this prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with hfref randomized between 3 groups of no, low- or high-dose protein supplementation. the dietary protein supplementation will be ensure(r) products manufactured by abbott nutrition. the investigators hypothesize that skeletal muscle wasting in hfref is promoted by neurohumoral activation of catabolic metabolism (such as gdf-15 and actrii pathways) and can be at least partially reversed by increased dietary protein intake. it is anticipated that this study will determine whether dietary protein supplementation helps to prevent muscle wasting and will advance understanding of the gdf-15 and actrii muscle wasting pathways.


Eligibility criteria:
inclusion criteria: 1. left ventricular ejection fraction (lvef) ≤40%, new york heart association (nhya) class ii to iv symptoms or n-terminal pro b-natriuretic peptide (nt-probnp) \>300 pg/ml 2. age 18 years to 100 years, inclusive 3. receiving guideline-directed medical therapy (gdmt), unless contraindicated or not tolerated 4. any of the following markers of severe hf within prior 12 months: i) inotropic therapy; ii) 1 or more hf hospitalizations; iii) lvef ≤25%; iv) peak oxygen consumption (vo2) \ 5% of bodyweight over the past year; vii) moderate or severe muscle wasting on physical examination; viii) nt-probnp ≥900 pg/ml exclusion criteria: 1. pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pre-dxa urine pregnancy test before first dxa or randomization 2. history of left ventricular assist device (lvad), heart transplantation, or estimated glomerular filtration rate (egfr) \<20 ml/min/1.73 m2 3. an identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified rankin score greater or equal to 4 post-stroke) 4. milk allergy, protein allergy, lactose intolerance, and galactosemia 5. weight ≥350 pounds and/or bmi ≥40 kg/m2
insecticidal school uniforms for dengue prevention in thailand

Conditions: Dengue

Summary: this is a randomised controlled trial that will be conducted in eastern thailand in a group of schools with approximately 2,000 students aged 7-15 years. pre-fabricated school uniforms will be commercially treated to ensure consistent high quality of insecticide impregnation with permethrin. a double-blind randomised cross-over trial at the school level will cover two dengue transmission seasons.


Eligibility criteria:
inclusion criteria: * pupils in participating schools exclusion criteria: * skin sensitivity, exema

Keywords: dengue
glucose oxidase as treatment against common cold

Conditions: Common Cold

Summary: glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey. human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in laboratory studies. in the present study we aim to investigate if a nasal spray with glucose oxidase could treat a common cold, when the treatment is started even after the onset of the symptoms. the study is randomized and placebo controlled.

persons that are convinced of that they have caught an episode of common cold can be included into the study within 24 hours after the onset of symptoms. before they start the treatment with the nasal spray they perform a viral sample from the nose and also fill in the wurss-21 protocol. after this the persons spray with glucose oxidase+glucose/only saline+glucose 5 times the first day and thereafter 3 times daily for a total treatment of one week. every day the included persons fill in the wurss-21 protocol.

Eligibility criteria:
inclusion criteria: * symptoms of a common cold within the last 24 hours exclusion criteria: * use of a nasal steroid due to allergy

Keywords: duration
effects of gonadotropin replacement therapy on metabolic parameters in patients with hypogonadism

Conditions: Idiopathic Hypogonadotropic Hypogonadism

Summary: effects of gonadotrophin replacement therapy lipid profile and oxidative stress parameters of patients with idiopathic hypogonadotropic hypogonadism

30 male patients diagnosed with ihh and a control group of 20 healthy cases with similar age and bmi were included in the study. the levels of advanced oxidation protein products (aopp), thiol, malondialdehyde (mda), nitric oxide (no) and 8-hydroxydeoxyguanosine (8-ohdg) and the levels of triglyceride (tg), total cholesterol (tc), high density lipoprotein (hdl-k), low density lipoprotein (ldl-k), apolipoprotein a1 (apoa1) and apolipoprotein b100 (apob100) were measured before and after gonadotrophin therapy.

Eligibility criteria:
inclusion criteria: serum testosterone concentration \< 300ng/dl absence of a pituitary or hypothalamic mass lesions, presence of gonadotropin response to gnrh, - exclusion criteria: diabetes mellitus, arterial hypertension other hormone deficiencies -
intraprocedural assessment of ablation margins using computed tomography co-registration in primary liver tumor treatment with percutaneous ablation

Conditions: HCC

Summary: a pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software


Eligibility criteria:
inclusion criteria: * age 18 yrs or above * hcc very early (0) or early stage (a) according to the bclc staging system * either de novo or recurrent hcc (prior locoregional therapy is allowed in the study) * candidate for percutaneous thermal ablation as discussed in a multidisciplinary tumor board. ablation as 'bridge-to-transplant' is allowed in the study exclusion criteria: * estimated gfr \<30 ml/min * morbid obesitas or any pulmonary condition that is a contraindication to prolonged apnea and high jet-ventilation * child pugh c * portal vein tumor invasion * extrahepatic metastasis * uncorrectable coagulopathy * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * inability or unwillingness to give informed consent
use of electroanalgesia in pain and pulmonary function.

Conditions: Bariatric Surgery; Obesity, Morbid

Summary: it is a consensus in the literature that changes in lifestyle and carbohydrate-rich diet are part of a context that has led to an obesity pandemic. its treatment is multidisciplinary, however, in many cases, conventional therapy has no effect, requiring surgical intervention. the latter, in turn, is not free of risks and causes important changes in lung function. therefore, this study aims to evaluate the effect of electroanalgesia through conventional transcutaneous nerve stimulation (tens) on pulmonary function in the postoperative period of bariatric surgery.

this is an uncontrolled cross-sectional clinical trial with a sample of 66 individuals between 18 and 50 years of age in a hospital in the west of paraná. pain assessment will be performed through analogue pain scale, pulmonary function through spirometry and respiratory muscle strength through manovacuometry. four tens applications will be performed for a period of 30 minutes. through this research, it is expected that the patients who perform tens present a reduction in postoperative pain and, consequently, a lower impact on lung function.

Eligibility criteria:
inclusion criteria: * this research will include patients who are in the postoperative period of bariatric surgery and who are aged 18 years or over exclusion criteria: * patients over the age of 50; * individuals who present hemodynamic instability in the postoperative period; * use of mechanical ventilation for more than 24 hours; * contraindications regarding the use of tens (presence of a cardiac pacemaker, hypersensitivity regarding the use of tens); * previous history of epilepsy; * pregnant women during the first trimester; * patients with a score, on the glasgow coma scale (appendix i), less than 15; * patients who choose to withdraw during the study.

Keywords: spirometry electroanalgesia bariatric surgery
dose finding study of oral eltrombopag in patients with sarcoma receiving adriamycin and ifosfamide

Conditions: Thrombocytopaenia

Summary: the study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving adriamycin and ifosfamide (ai) chemotherapy.


Eligibility criteria:
inclusion criteria: * adult subjects, 18 years or older * adequate liver and kidney function * prior history of ≥grade 2 thrombocytopenia (platelet nadir ≤ 75,000/microliters) * ability to ingest and retain oral medication * practice acceptable birth control * ability to understand and follow study requirements * life expectancy of at least 3 months exclusion criteria: * history of platelet disorders, dysfunction, or a bleeding disorder * anti-coagulant used within 2 weeks prior to study start * females who are lactating or expecting * history of thromboembolic events or drug induced thrombocytopenia * history of central nervous system, brain and/or leptomeningeal metastases * prior surgery within 2 weeks or radiotherapy within 4 weeks of study start * pre-existing cardiac disease

Keywords: sarcoma eltrombopag thrombopoiesis thrombocytopenia
to investigate the safety and efficacy of de-104 ophthalmic solution to treat open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: to investigate the intraocular pressure (iop)-lowering effect and safety of de-104 ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * diagnosed with primary open-angle glaucoma or ocular hypertension. * provided signed, written informed consent. * if a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. exclusion criteria: * females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. * presence of any abnormality or significant illness that could be expected to interfere with the study.
enhancing protection against vector-borne diseases in forcibly displaced communities: evaluating the efficacy of spatial repellents for cutaneous leishmaniasis control in north-east syria

Conditions: Leishmaniasis, Cutaneous; Vector Borne Diseases

Summary: the aim of this study is to determine the efficacy of mosquito shield (spatial repellent) in reducing cutaneous leishmaniasis case incidence among internally displaced persons and sandfly density in temporary shelters and camp settings in ar-raqqa governorate, north-east syria.


Eligibility criteria:
inclusion criteria: known history of cutaneous leishmaniasis in camp sleeping under same shelter type (all unhcr tents / plastic sheets) camp easily accessible by road camps a minimum of 5km apart adequate security levels exclusion criteria: camps closer than 5km from a camp included in the study camps with no previously recorded cases of cutaneous leishmaniasis displaced communities living outside of defined camp settings

Keywords: conflict internally displaced people temporary shelter spatial repellants
mhealth physical activity trial for older hiv-infected adults (mfit)

Conditions: HIV

Summary: this pilot study will examine the effect of a mobile health text messaging platform linked to a digital physical activity tracker on physical activity among persons living with hiv and frailty.

hiv is associated with frailty, an important aging-related phenotype associated with adverse clinical outcomes. the investigators propose that personalized health coaching using a digital activity tracker with mobile health text messaging can increase physical activity in this population. the total duration of the intervention will be 12 weeks.

Eligibility criteria:
inclusion criteria: * hiv-1 positive adults of any gender * age 50 years and older * frailty score of 2 or greater (at least 1 criteria is slow gait speed or decreased grip strength) * ability to provide informed consent exclusion criteria: * any physical condition that would prevent or prohibit moderate physical activity * \>3 days per week of moderate or vigorous leisure time activity lasting \>30 min/day

Keywords: frailty physical activity hiv aging exercise mhealth smartphone activity tracker pedometer text messaging short message service (sms)
metformin for pulmonary hypertension hfpef

Conditions: Pulmonary Hypertension; Heart Failure

Summary: the main objective of this study is to determine the clinical efficacy of metformin versus placebo and the therapeutic response with regards to functional capacity and hemodynamics in ph-hfpef.

this is a 12-week blinded cross over trial of metformin in ph-hfpef to improve exercise hemodynamics, functional capacity, and glucose metabolism. this phase ii clinical trial will provide detailed phenotyping, physiological and mechanistic data on ph-hfpef.

Eligibility criteria:
inclusion criteria: 2. ph-hfpef confirmed diagnosis by rhc within the past 6 months: mean pulmonary arterial pressure (mpap) ≥ 25 mm hg and pulmonary artery wedge pressure (pawp) ≥ 15 mm hg and transpulmonary gradient (tpg) ≥ 12 mm hg or exercise measurements mean pulmonary arterial pressure (mpap) ≥ 30 mm hg and pulmonary artery wedge pressure (pawp) ≥ 20 mm hg and pa calculation (change in mpap/change in cardiac output) = ≥3 mmhg/l/min 3. three or more features of metabolic syndrome defined as: body mass index (bmi) ≥ 30 kg/m² systolic blood pressure (bp) ≥ 130 mm hg and/or diastolic bp ≥ 85 mm hg elevated waist circumference \> 102 cm in men and \> 88 cm in women fasting triglyceride (tg) level over 150 mg/dl high-density lipoprotein \<40 mg/dl in men or \< 50 mg/dl in women exclusion criteria: 1. age less than 18 years; 2. uncontrolled systemic hypertension based on repeated measurement of sitting systolic blood pressure \>170 mm hg or sitting diastolic blood pressure \>95 mm hg at screening; 3. systemic sitting blood pressure \< 110 mmhg systolic or \< 60 mm hg diastolic at screening; 4. hemoglobin a1c \> 10; 5. currently taking metformin or history of intolerance to metformin or contraindication to taking metformin; 6. known type 1 diabetes 7. positive urine pregnancy test or breastfeeding 8. ejection fraction \< 50% 9. dementia; 11. end-stage malignancy; 12. major cardiovascular event or procedure within 6 weeks prior to enrollment; 13. severe valvular disease; 14. other severe acute or chronic medical, psychiatric or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study or would prevent completion of the study; 15. current smoker; 16. hemoglobin \<9 g/dl; 17. estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2; 18. receipt of an investigational product or device, or participation in a drug research study within a period of 15 days 19. \<3 months of stable dose of pde5i
natural history of gastroesophageal reflux (ger) in children < 12 years of age

Conditions: Gastroesophageal Reflux

Summary: the goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (ger). we are inviting subjects that were previously followed in the pediatric gi programs at massachusetts general and children's hospital, boston. we have compiled a database of more than 200 subjects that completed diagnostic testing for ger in the 1970's and 1980's. subjects are being contacted initially by mail using a previously approved recruitment letter. subjects that fail to respond to this recruitment letter are called by phone. in each case, contact information has been abstracted from the children's hospital database. subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy. subjects receive no compensation for their participation in this study. subjects will be compared to controls. controls will complete the same questionnaire as the subjects. inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study. controls will receive $25 to participate in the study.


Eligibility criteria:
inclusion criteria for subjects: * patients who were evaluated for gerd at the age of 12-17 years, inclusive at children's hospital, boston or massachusetts general hospital * positive for gerd per biopsies or ph probe results inclusion criteria for controls: * no gi diseases prior to age 21 including, but not limited to reflux, inflammatory bowel disease,hirschsprung's disease * date of birth is within 1 year of a subject's date of birth

Keywords: gastroesophageal reflux