Kornimate/medical-research-clean huggingface dataset:
open label study of ath-1017 for treatment of mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: the objective of this study is to determine the safety and tolerability of fosgonimeton (ath-1017) in subjects with mild to moderate alzheimer's disease who completed the 26-week randomized treatment in study ath-1017-ad-0201 or study ath-1017-ad-0202.

this is a multicenter, seamless, open-label extension (olex) study of ath-1017 treatment in subjects with a clinical diagnosis of mild to moderate alzheimer's disease who completed 26 weeks treatment in the randomized, placebo-controlled, double-blind studies, ath-1017-ad-0201 and ath-1017-ad-0202. this olex study will provide additional, longer-term safety and tolerability information on ath-1017 administration up to 48 months in subjects with mild to moderate alzheimer's disease.

Eligibility criteria:
inclusion criteria: * subject has completed the week 26 visit of either of the two blinded parent studies (ath-1017-ad-0201 or ath-1017-ad-0202). * reliable and capable support person/caregiver who is willing to accept responsibility for supervising the daily treatment or, if required, administering study drug. * subject capable of giving signed informed consent, or by a legally acceptable representative. * subjects must be in generally good health. * male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential. exclusion criteria: * subject has experienced a serious adverse event during the parent study, which could present an increased safety risk during the open label extension. * new diagnosis of severe major depressive disorder even without psychotic features. * any subject with formalized delusions or hallucinations. * significant suicide risk. * newly-diagnosed malignant tumor, except for the following conditions that are stable in the judgement of the investigator: * adequately treated squamous and basal cell carcinoma, or squamous and basal cell carcinoma in situ * prostate carcinoma in situ

Keywords: alzheimer's dementia ath-1017 open label
evaluate the predictive impact of the ehmrg

Conditions: Emergencies; Heart Diseases

Summary: external validation of the ehmrg score for hospitalized patients with acute heart failure in the emergency department

it is a prospective cohort study carried out in the ed of monastir which included patients admitted to the ed with a discharge diagnosis of ahf.

Eligibility criteria:
inclusion criteria: * patients consulted for acute dyspnea and were diagnosed with acute heart failure. * major patient. * subject who accept to participate in the research. exclusion criteria: * patient who refuse to participate in the study. * impossibility of giving the patient informed information

Keywords: ehmrgscore acute heart failure
maximizing analgesia to reduce pain in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this research is being done to evaluate whether combining medications that are fda approved, but have not yet been approved for combination treatment, can be effective in reducing pain.

this study will evaluate whether a combination of pharmacotherapies can effectively alleviate pain. subjects will complete two screening sessions before completing four study sessions that will occur once weekly. participants will receive double blind doses of study medications the morning of each experimental session day and will undergo standardized pain testing, physical functioning assessment, blood draws, ratings of drug effects and cognitive testing.

Eligibility criteria:
inclusion criteria: * diagnosis of knee osteoarthritis * urine sample tests negative for common illicit substances of abuse (e.g., cannabis) * medically cleared to take study medications * are not pregnant or breast feeding * willing to comply with the study protocol. exclusion criteria: * pain other than knee osteoarthritis * taking opioids for pain * prescribed and taking gabapentinoid, tricyclic antidepressants (tca), venlafaxine, duloxetine, stimulants or benzodiazepines * presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event * known allergy to the blinded study medications

Keywords: clinical trial phase ii
study of celecoxib or diclofenac for efficacy and safety in chinese patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac sr in the treatment of chinese patients with ankylosing spondylitis (as).


Eligibility criteria:
inclusion criteria: * meet the 1984 modified new york criteria for classification of ankylosing spondylitis * with axial involvement * without peripheral joint involvement (synovitis) at the time of study entry, (excluding involvement of the hips, knees and shoulders) * need for daily treatment with nsaids during the previous 30 days before study entry exclusion criteria: * known inflammatory enteropathy (eg, ulcerative colitis, crohn's disease, etc) * presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.) * known vertebral compression * need for a corset during the study
hydrochlorothiazide (+) losartan potassium vs. amlodipine comparative study (0954a-314)

Conditions: Essential Hypertension

Summary: an efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to amlodipine at week 12 in korean patients with essential hypertension


Eligibility criteria:
inclusion criteria: * patients of age 20 70 75 with essential hypertension * sidbp 90 \~ 114mmhg at v1 \& v2 exclusion criteria: * patient has known or suspected secondary hypertension * patient has a history of malignant hypertension (sisbp \> 210mmhg) * individuals has a known sensitivity or intolerance to hctz or any aiias, or any sulfonamide-derived drugs. * patient has shown significant abnormal laboratory evaluations
a research study looking at different oral formulations and the effect of food intake on how the medicine nnc0487-0111 behaves in the body of participants living with overweight or obesity

Conditions: Obesity; Overweight

Summary: this study consists of two phases: phase a and phase b. participants are being asked to participate in both phases. phase a of this study is comparing two formulations of a study medicine called nnc0487-0111 for weight control in people with overweight or obesity. phase b of this study is testing how taking nnc0487-0111 at the same time as a meal affects the way nnc0487-0111 works in participants body. the aim of this study is to compare how two different formulations of nnc0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. participants will either get nnc0487-0111 formulation c, or nnc0487-0111 formulation d. both formulations are given as tablets. which treatment participants get is decided by chance. oral nnc0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. the study will last for about 5 - 6 months (155-184 days).


Eligibility criteria:
inclusion criteria: * male or female * age 18-64 years (both inclusive) * body mass index (bmi) between 27.0 and 39.9 kilogram per meter square (kg/m\^2) (both inclusive) * considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: * vitamin d (25-hydroxycholecalciferol) less than (\<) 12 ng/ml (30 nanometer (nm)) at screening * parathyroid hormone (pth) outside normal range at screening * total calcium outside normal range at screening * calcitonin greater than or equal to (≥) 50 pg/ml at screening * amylase greater than or equal to (≥) 2 times upper limit of normal * lipase greater than or equal to (≥) 2 times upper limit of normal * glycated hemoglobin (hba1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening
small catheter drainage with chest tube versus chest tube alone after uniport video-assisted thoracoscopic procedures

Conditions: Lung Diseases

Summary: small catheter drainage with chest tube after uniport video-assisted thoracoscopic procedures

traditionally an intercostal tube is applied intraoperative following vats procedures to drain the remaining pneumothorax and residual effusion , some of the residual effusion can't drain by intercostal tube which lead to prolonged hospital stay hypothesis that putting an additional small catheter drainage at the most depended part of hemithoracic early removal of chest tube without add more pain or hospital stay to the patient.

Eligibility criteria:
inclusion criteria: * patients undergoing uniport video-assisted thoracoscopic surgery at assiut university hospital who need intercostal drainage postoperative exclusion criteria: * patients who do not need intercostal tube post operative
event related potentials in borderline personality disorder and major depression

Conditions: Borderline Personality Disorder; Major Depression

Summary: this study examines whether depression in people with borderline personality disorder is different than depression in people without borderline personality disorder. unlike people who have depression alone (i.e. without borderline personality disorder), people with borderline personality disorder have depressions that often do not improve with medications. this makes treating depression much more challenging in someone with borderline personality disorder than without borderline personality disorder. borderline personality disorderis associated with difficulty in understanding and communicating feelings. impaired emotion processing may reflect dysfunction of an area of the brain, the anterior cingulate. depression is associated with changes in anterior cingulate activity. the investigators believe that when borderline personality disorder is present with depression, brain activity changes in the anterior cingulate will not be the same as in depressed patients without borderline personality disorder. an electroencephalogram records brain electrical activity. in this study, the investigators will measure electroencephalogram indices reflecting anterior cingulate activity. hypothesis: in this study, the investigators predict that when borderline personality is present with depression, electroencephalogram indices of anterior cingulate activity will be different from when depression is present alone (without borderline personality). this could help to explain why people with borderline personality have depressions that are harder to treat than depressions in people without borderline personality. the investigators also predict that electroencephalogram indices of the anterior cingulate will reflect emotional processing ability, as measured by validated questionnaires.


Eligibility criteria:
inclusion criteria: * age between 18 and 45 * female * noncontrols diagnosis: major depression \&/or borderline personality disorder * control participants should have neither major depression or borderline pers. * meet structured controlled interview for dsm - ii cut off scores * meet beck depression inventory (bdi)cut off scores * meet borderline evaluation of severity over time(best) cut off scores. exclusion criteria: * based on having none of the below diagnoses from patient history, prior clinical records and based on mini plus international neuropsychiatry interview * schizophrenia * psychosis * attention deficit hyperactivity disorder * obsessive compulsive disorder * bipolar disorder * mental retardation * dementia * cns disease * post-traumatic stress disorder in non-borderline personality disorder groups * recreational drug or alcohol use in the past week.

Keywords: borderline personality disorder major depression electroencephalogram n2 error related negativity emotional processing levels of emotional awareness
telotristat etiprate - expanded treatment for patients with carcinoid syndrome symptoms

Conditions: Carcinoid Syndrome

Summary: the primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.


Eligibility criteria:
inclusion criteria: * ongoing participation in a phase 2 \[lx1606.1-202-cs (nct00853047), lx1606.1-203-cs (nct01104415)\] or phase 3 \[lx1606.1-301-cs (nct01677910), lx1606.1-303-cs (nct02063659)\] study * patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of \<1% per year) during the study and for 12 weeks after the follow-up visit. * ability and willingness to provide written informed consent exclusion criteria: * major protocol violations or tolerability concerns in a phase 2 (eg, lx1606.1-202-cs, lx1606.1-203-cs) or phase 3 (eg, lx1606.1-301-cs, lx1606.1-303-cs) study * positive pregnancy test * presence of any clinically significant findings at entry for medical history, laboratory values, or physical examination
seerlinq: non-invasive lvfp monitoring in hf

Conditions: Heart Failure; Photoplethysmography; Right Heart Catheterization

Summary: left ventricular filling pressure (lvfp) monitoring has been associated with improved quality of life, survival and reduced hospitalization rates. however, current lvfp monitoring methods are invasive, costly, and require long-term antithrombotic therapy. the purpose of this study is to validate seerlinq heartcore, a novel ce-certified, non-invasive system that enables remote lvfp monitoring using photoplethysmography (ppg) and machine learning-based signal analysis.

heart failure (hf) affects approximately 1-2% of the adult population in developed countries, with prevalence exceeding 10% among individuals older than 70 years. despite advancements in diagnostics and treatment guided by evidence-based medicine, hf remains associated with high morbidity and mortality; up to 17% of patients die and up to 44% require hospitalization within 12 months. monitoring of left ventricular filling pressure (lvfp) has been shown to improve survival, quality of life, and reduce hospitalization rates in patients with hf. however, existing methods for lvfp assessment are invasive, costly, and require long-term antithrombotic therapy, limiting their widespread application. the purpose of this study is to validate heartcore, a novel ce-certified, non-invasive system that enables remote lvfp monitoring using photoplethysmography (ppg) combined with machine learning-based signal analysis. this will be a prospective, multicenter study enrolling three patient cohorts: rhc cohort, echo cohort, and rpm cohort. participants will undergo 120-second ppg recordings in both upright and supine positions using a standard pulse oximeter connected to a smartphone. the ppg signals will be transmitted to a secure server and processed by the heartcore algorithm to estimate lvfp, expressed as the diastolic reserve index (dri), where a higher dri indicates lower lvfp. the primary outcomes of the study will be: * the discrimination performance of the ppg-based heartcore system for detecting elevated lvfp in the rhc and echo cohorts, measured by receiver operating characteristic area under the curve (roc auc), sensitivity, and specificity. * the change in dri following furosemide up-titration in the rpm cohort. the secondary outcome will be: • the correlation between dri and pulmonary capillary wedge pressure (pcwp) in the rhc cohort. this study aims to demonstrate that a non-invasive, widely available, and scalable ppg-based system can provide reliable assessment of lvfp in hf patients, potentially improving the management and outcomes of this population.

Eligibility criteria:
inclusion criteria: * males and females aged ≥ 18 years * able to understand, and willing to provide written icf * stated willingness to comply with all study procedures * healthy volunteer exclusion criteria: * pregnancy or female participant lactating * other possible unforeseen medical conditions that the investigator deems unsafe for study participation

Keywords: heart failure photoplethysmography right heart catheterization
protocol for women at increased risk of developing breast cancer

Conditions: Breast Cancer

Summary: a pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.

a pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. subjects will have hyperplasia with atypia (or borderline epithelial hyperplasia/atypical hyperplasia) and evidence of estrogen receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. the feasibility of performing rt-qpcr on breast specimens for aromatase expression will also be done at baseline.

Eligibility criteria:
inclusion criteria: * evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast * on hormone replacement therapy * postmenopausal * increased risk of developing breast cancer based on personal or family history * never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months * women who have a high risk of breast cancer * older than 18 years exclusion criteria: * anticoagulants * marked breast tenderness * pregnant or within twelve months of breast feeding/childbirth

Keywords: breast atypia open label pilot study letrozole fine needle aspiration high risk for breast cancer breast epithelial hyperplasia ki-67 hormones plus chemoprevention chemoprevention
hematological abnormalities in children

Conditions: Hematologic Diseases

Summary: the aim of the study is to determine hematological abnormalities in congenital cyanotic heart disease

congenital heart defects are the most common developmental anomaly and are the commonest noninfectious causes of mortality in newborns; they affect up 1000 infants and in most cases the cause is unknown . erythrocytosis, thrombocytopenia, platelets function defects, coagulation factors deficiencies are the main hematologic disorders in patients with cyanotic congenital heart disease .the hemorrhagic tendency was initially attributed to an increase in tissue vascularity, but co-existing hemostatic defects were subsequently identified and attributed to thrombocytopenia, shortened platelet survival, and deficient von willebrand multimers . in patients , platelets are shown to have both qualitative and quantitative abnormalities.however, there are conflicting data as regards the etiology of thrombocytopenia in congenital cyanotic heart disease . significant association has been reported between thrombocytopenia and a high hematocrit in cyanotic patients and multiple etiologies has been suggested including chronic compensated disseminated intravascular coagulation (dic), reduce synthesis of clot factors and/or deranged platelet aggregation. immature reticulated platelets represent the youngest platelets released into the circulation by regenerated marrow megakaryocyte and are the analogue of the red cell reticulocyte .the rate of platelet turnover can be evaluated by the relationship between the percent of reticulated platelets and the platelet count. erythrocytosis is an isolated increase in the number of red blood cells. primary erythrocytosis is an increased red cell mass which surfaces in the absence of a definable stimulus, whereas secondary erythrocytosis refers to an isolated increase in the red cell mass in response to such stimulus as low systemic arterial oxygen saturation in the context of cyanotic congenital heart disease. polycythemia could often be beneficial. yet, it poses certain risks to the microcirculation. this is mainly because the capillary diameter is significantly smaller than the red cell diameter and this mismatch could cause viscosity to increase at the capillary level. patients with cyanotic heart disease may have an acceptable quality of life. however, they are invariably prone to several complications. for instance, hyperviscosity, hyperuricemia (mainly due to age-related impairment of uric acid excretion in adults), thrombocytopenia (decreased level of platelet production), blood clotting abnormalities (reduced synthesis of clotting factors and/or deranged platelet aggregation), cerebral abscess, cerebral embolism and endocarditis .

Eligibility criteria:
inclusion criteria: * all children. * congenital cyanotic heart disease exclusion criteria: * other congenital heart disease. * other congenital anomalies. * other chronic disease. * post-operative patient.
anesthesia for retinopathy of prematurity

Conditions: Retinopathy

Summary: premature infants experience more respiratory problems after surgical procedures. the investigators aimed to compare general anesthesia with sedation on the need for post-operative mechanical ventilation in infants undergoing retinopathy of prematurity surgery.

60 patients who underwent laser surgery due to retinopathy of prematurity (rop) were included in the study. the sedation group (group s, n=30), received 1 mg/kg ketamine and 1 mg/kg propofol as a bolus for induction. the patients then received an infusion of 100-150 mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance. in the general anesthesia group (group g, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a neuromuscular blocker agent. anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen. our primary objective was to evaluate the need for post-operative mechanical ventilation.

Eligibility criteria:
inclusion criteria: * infants aged 32-40 weeks who were scheduled to undergo laser surgery for treatment of rop exclusion criteria: * the exclusion criteria were patients requiring inotropic support, * the need for mechanical ventilation or intubation in the 3 days prior to the operation, * known allergy or hypersensitivity reaction to ketamine and propofol, * age ˃40 weeks.

Keywords: prematurity, retinopathy, propofol, ketamine, sedation
early pregnancy antioxidant supplementation in the prevention of preeclampsia

Conditions: Preeclampsia; Pregnancy Loss

Summary: use of juice plus+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. this is a prospective randomized and blinded placebo controlled study sponsored by nsa, llc of memphis, tn.

not desired

Eligibility criteria:
inclusion criteria: * pregnant patients seen in first trimester with low or high risk pregnancy exclusion criteria: * pregnant patients first seen after the first trimester * unlikely to continue care in our system * unwilling to comply with rigor of taking food supplements throughout gestation

Keywords: preeclampsia prevention food supplement