Kornimate/medical-research-clean huggingface dataset:
additive effect of twice-daily brinzolamide 1%/brimonidine 0.2%combination as an adjunctive therapy to travoprost in patients with normal tension glaucoma

Conditions: Glaucoma

Summary: the purpose of this study was to determine the incremental intraocular pressure (iop) lowering that is achieved when simbrinza is used adjunctively to travatan in patients with normal tension glaucoma that may benefit from further iop lowering.

this study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * sign written informed consent * diagnosed with normal tension glaucoma * intraocular pressure measurements in at least 1 eye as specified in the protocol * willing and able to attend all study visits exclusion criteria: * history of hypersensitivity to any of the study drugs * use of medications prohibited by the protocol * pregnant or nursing * of child-bearing potential unless using contraception, as specified in the protocol * any form of glaucoma other than open angle glaucoma in either eye * chronic, recurrent or severe inflammatory eye disease * ocular trauma or surgery within the past 6 months in either eye; ocular infection or laser surgery within the past 3 months in either eye (all from screening) * conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.

Keywords: travoprost brinzolamide 1%/brimonidine 0.2% normal tension glaucoma intraocular pressure efficacy safety
a study to evaluate incb161734 in participants with advanced or metastatic solid tumors with kras g12d mutation

Conditions: Solid Tumors

Summary: this study is conducted to determine the safety and tolerability of incb161734 as a single agent or in combination with other anticancer therapies.


Eligibility criteria:
inclusion criteria: * ≥18 years old * locally-advanced or metastatic solid tumor with kras g12d mutation * for part 1 and part 2 combination groups 1 and 2: disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome * for part 2 combination groups 3 and 4: no more than 1 prior standard treatment * cohort specific requirements as follows: * parts 1a and 1d: histologically or cytologically confirmed malignant solid tumor of any tissue origin * part 1b * disease group 1: diagnosis of pdac and ≤ 2 prior standard systemic regimens for pancreatic cancer * disease group 2: diagnosis of crc * disease group 3: diagnosis of nsclc * disease group 4: diagnosis of other advanced solid tumor and not part of disease groups 1, 2 or 3 * part 1c: confirmed diagnosis of pdac, crc, or nsclc * parts 2a and 2b * combination 1: diagnosis of pdac or diagnosis of crc and * prior treatment in the advanced setting with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan and * in part 2a: ≤ 3 prior standard regimens * in part 2b: ≤ 2 prior standard regimens * combination 2: diagnoses of pdac, crc or nsclc * combination group 3 (incb161734 in combination with gemnabp) and combination group 4 (incb161734 in combination with mfolfirinox): * diagnosis of pdac * ≤ 1 prior standard systemic regimen for pancreatic cancer * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * prior treatment with any kras g12d inhibitor * known additional invasive malignancy within 1 year of the first dose of study drug * history of organ transplant, including allogeneic stem cell transplantation * significant, uncontrolled medical condition * history or presence of an ecg abnormality * inadequate organ function other protocol-defined inclusion/exclusion criteria may apply

Keywords: incb161734 krasg12d mutation pancreatic ductal adenocarcinoma (pdac) colorectal cancer (crc) non-small cell lung cancer (nsclc)
coping strategies and responsiveness to a brief online intervention during covid-19 pandemic

Conditions: Behavior, Social; Autonomic Imbalance

Summary: the present study investigates the efficacy of a brief and cost-effective video-intervention that combines bottom-up elements of deep breathing and third-wave cognitive behavioral therapy techniques (i.e., mindfulness and compassion) on coping strategies during the covid-19 pandemic.


Eligibility criteria:
inclusion criteria: * being healthy * previous participation (maximum elapsed time: 2.0 years) in a study conducted by the same research group and incorporating cardiac autonomic assessment at rest exclusion criteria: * self-reported development of cardiovascular disease since previous assessment * use of psychotropic medications or medications affecting the autonomic nervous system
appropriate care of uri (acuri): early head start

Conditions: Upper Respiratory Infection

Summary: the purpose of this study is to comparatively assess the effectiveness of a tailored educational intervention to improve health literacy levels regarding upper respiratory infections (uris) and to decrease pediatric emergency department (ped) visits, among latino households in early head start.


Eligibility criteria:
inclusion criteria: * attending an infant or toddler ehs group at participating site exclusion criteria: * participant in pilot study * participant in community intervention regarding uri
bioequivalence study of carbidopa/levodopa/entacapone combination vs. carbidopa/levodopa combination plus entacapone in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fed conditions in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects age 18 to 55 years of age included, and in good health * at screening, and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least five (5) minutes, and again when required after three (3) minutes in the standing position. vital signs should be within the normal ranges * body mass index (bmi) within the range of 18 to 27 and weigh at least 50 kg * female subjects must have undergone hysterectomy, or must be postmenopausal. exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease * history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin * receiving monoamine oxidase (mao) inhibitors within 28 days prior to the first dose * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result * history of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). a known hypersensitivity to the study drug or drugs similar to the study drug. * significant illness within two weeks prior to dosing * subjects who, through completion of the study, would have donated in excess of: 500 ml of blood in 14 days; 1500 ml of blood in 180 days; 2500 ml of blood in 1 year. * history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result. * history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations. * women of child bearing potential ( wocbp) * history or presence of glaucoma or any suspicious undiagnosed skin lesions other protocol-defined inclusion/exclusion criteria may apply

Keywords: bioequivalence bioavailability carbidopa levodopa entacapone fed condition healthy volunteers study
durability of combination of insulin and glp-1 receptor agonist or sglt-2 inhibitors versus basal bolus insulin regimen in type 2 diabetes (beyond)

Conditions: Type 2 Diabetes

Summary: beyond represents an open-label, parallel, three-arm randomized controlled trial, aimed at evaluating the effects of combination therapy of fixed ratio basal insulin/glp-1 receptor agonist (glp-1ra) or basal insulin/sglt-2 inhibitors (sglt-2i) on the durability of the glycemic control, as compared with the basal bolus insulin regimen, in people with type 2 diabetes failing to achieve glycemic targets with injective therapy. the potential benefits for participants in the study include the possibility of improving the glyco-metabolic control with drugs that have been evaluated as safe and protective for the heart and the kidneys. the primary outcome of the study is the mean hba1c change between groups at six months. participants in the study will be followed for subsequent 18 months in order to evaluate the durability of glycemic control and the chenge of other secondary outcomes.


Eligibility criteria:
inclusion criteria: * poor glycemic control (hba1c ≥7.5%) * stable basal bolus insulin regimen for almost a year, eventually associated with metformin. exclusion criteria: * type 1 diabetes or secondary diabetes; * previous treatment for the last three months with glp-1ra or dpp-4 inhibitors; * hypersensitivity towards active substances or other ingredients of the drugs used in the study * participation in other trial with experimental drugs within 30 days * diseases that represent contraindication to glp-1ra use (pancreatitis, gallstones) * pregnancy or planned pregnancy within the time of the study * serum creatinine \> 1,3 mg/dl in women and \>1,4 mg/dl in men * egfr \< 30 ml/min * previous cancer or antineoplastic therapy for five years before randomization * current therapy with glucocorticoid (oral, topic or sistemic administration) or with antypsichotic drugs * previous ketoacidosis * any clinical, psychologic or psychiatric condition that is incompatible with the study according to the investigator

Keywords: type 2 diabetes glp-1ra sglt-2i basal insulin basal bolus glycemic control
treatment of intrapartum depression using non-invasive photobiomodulation

Conditions: Depression; Pregnancy Related; Intrapartum Depression

Summary: depression during pregnancy can cause fetal and maternal problems such as growth restriction, preterm labor, low birthweight, poor compliance and suicide. since antidepressant medications have the potential to harm the baby, but since treatment of intrapartum depression is essential to maternal and fetal wellbeing, a non-pharmacological approach would be ideal. this project seeks to apply infrared light noninvasively to depressed patients during pregnancy in order to treat depressive symptoms through alteration of mitochondrial function and modulation of neural cell receptors.

depression is common in pregnancy and affects about 70% of women and, for many women, pregnancy can lead to the first episode of major depression. complications of intrapartum depression include intrauterine growth restriction, preterm labor, low birthweight, gestational diabetes, preeclampsia, decreased prenatal follow-up and suicide. for this reason, the standard of care has been to screen for depression during pregnancy and treat this illness, reducing maternal and fetal morbidity. unfortunately, many first-line pharmacological approaches, such as serotonin reuptake inhibitors, may cause fetal malformations, persistent pulmonary hypertension and withdrawal syndrome. thus, a non-pharmacological approach, without risk of fetal complications, would be ideal. the investigators propose a photobiomodulation based approach that uses non-ionizing near-infrared light (irl) to upregulate mitochondrial function (through modulation of cytochrome c oxidase activity), which in-turn increase neurosteroid production and modulates gabaa receptor activity, thus alleviating depression. the investigators will perform a pilot study using irl for the treatment of intrapartum depression. while other trials have shown success using irl for depression in non-pregnant patients, this will confirm that photobiomodulation can modulate mitochondrial function and mitigate depressive symptoms compared to untreated controls in pregnancy by using real-time app-based depression scoring system and neuroimaging.

Eligibility criteria:
inclusion criteria: * viable intrauterine pregnancy \ 10. exclusion criteria: * pregnancy \> 20 weeks * history of seizures * history of migraines * history of multiple sclerosis * prior traumatic brain injury * prior history of preeclampsia/toxemia * elevated blood pressure greater than 140/90 * proteinuria (as defined by urine proteins \>300 mg/24 h) * headaches * visual changes * right upper quadrant pain * history of bipolar disease * currently taking psychotropic medications (including antidepressants) and * prior history of attempted suicide

Keywords: photobiomodulation intrapartum depression phototherapy
safety and immunogenicity of exg-5003

Conditions: COVID-19

Summary: this is a first in human, randomized, placebo-controlled phase i/ii trial to evaluate the safety and immunogenicity of the intradermal covid-19 vaccine, exg-5003 in healthy adults.


Eligibility criteria:
inclusion criteria: * has provided written consent for participation * age between 20 and 55 * has a negative nucleic acid-based test result for sars-cov-2 * has a negative antibody test result for sars-cov-2 exclusion criteria: * signs and symptoms consistent with covid-19 upon screening * history of covid-19 * presence of uncontrolled cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease * presence of diabetes mellitus * presence of active autoimmune disease * positive for hbc, hcv or hiv antibody * history of anaphylactic shock * history of epilepsy * presence of active malignancy * presence of lung disease (e.g., copd, asthma) * positive urine pregnancy test within 24 hours * pregnant, lactating, planned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug * if female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug * if male, not agreeable to contraception for 90 days after second administration of the trial drug * presence of clinically relevant electrocardiogram or vital sign abnormality at screening * participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days * received any sars-cov-2 vaccine * received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product * received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties * received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid * deemed ineligible for the study as determined by the principal investigator or a co-investigator
tap water intake and perceptions in us latinx adults

Conditions: Dehydration

Summary: the purpose of this exploratory cross-sectional investigation is to evaluate associations between tap water perceptions, water consumption behaviors, and hydration status in latinx adults (18 - 65 y). the objective is to identify perceptual determinants that explain the associations between tap water avoidance and plain water intake and hydration status in latinx adults. aim 1: characterize the degree to which individual- and community-level factors uniquely predict the perception that tap water is not safe in latinx adults. aim 2: evaluate household income, education level, and us nativity as potential moderators of the associations between predictors and perceptions of tap water safety. aim 3: evaluate the influence of tap water safety perceptions on plain water intake and 24-h hydration status, after adjustment for predictors of tap water safety perceptions, in a sub-sample of latinx adults.


Eligibility criteria:
inclusion criteria: * self-identify as hispanic or latinx * english- and/or spanish-speaking * interested in participating in both study phases * live in phoenix, arizona exclusion criteria: * currently pregnant or breastfeeding * currently use diuretics * do not have access to a desktop, laptop, tablet, or smartphone * do not have internet access
the effect of milnacipran in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: use of the drug milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.

patients with fibromyalgia will show elevated ventricular lactate levels as measured via magnetic resonance spectroscopy (mrs). patients treated with milnacipran will show normalization of ventricular lactate levels compared to those treated with placebo, and will also show normalization of the increased latency to respond to complex reaction time probes compared to those treated with placebo.

Eligibility criteria:
inclusion criteria: * female or male subjects who fulfill the american college of rheumatology's case definition for fibromyalgia. * 18 through 68 years of age exclusion criteria: * pregnant or trying to become pregnant * taking any other serotonin norepinephrine reuptake inhibitor (snri) or already taking milnacipran * patients who do not indicate their pain levels as less than substantial despite their best care * history of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview * presence of current depression as determined by psychiatric diagnostic interview * presence of brain lesion on mri anatomical study
rct of cbt combined with d-cycloserine for treating ptsd

Conditions: Post-Traumatic Stress Disorder

Summary: the purpose of this study is to investigate if the effectiveness of cognitive-behavioral therapy for post-traumatic stress disorder can be increased by combining it with d-cycloserine (tcc/d-cycloserine) by comparing with a placebo (tcc/placebo).

post-traumatic stress disorder (ptsd) is one of the most frequent anxiety disorder in the general population (kessler and al., 2005). currently, the treatment of choice for ptsd is cognitive-behavioral therapy (cbt; foa, davidson and frances, 1999). based on remission rates after treatment, successful outcomes of cbt for ptsd vary between 46 and 54 % when dropouts are considered, and between 56 and 70% among those who completed their therapy (bradley and al., 2005). thus, there is room for improvement. recently, the results of two published studies on the treatment of phobia of heights (ressler and al., 2004) and social phobia (hofman, 2006) indicated that the efficacy of cbt was increased by adding d-cycloserine. the superior efficacy of cbt/d-cycloserine over cbt/placebo in the treatment of anxiety disorders can result from a greater release of glutamate, a substance facilitating the extinction of fear (davis, myers, ressler and rothbaum, 2005; richardson, ledgerwood an cranney, 2004). however, to our knowledge, no study has yet compared cbt/d-cycloserine to cbt/placebo in the treatment of ptsd. the main hypothesis of the current study is that the efficacy of cbt for ptsd will be increased when combined with d-cycloserine compared to a placebo.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ptsd * no other axix i disorder of higher intensity than ptsd * accept not to start a psychopharmacological treatment before and during the participation to the project exclusion criteria: * substance abuse * psychotic episodes (past or current) * bipolar disorder * organic caused mental disorder * intellectual deficiency * pregnant or breast-feeding woman * épilepsy

Keywords: post-traumatic stress disorder cognitive-behavioral therapy
role of mesh in laparoscopic sacropexy surgical techniques for the treatment of female genital prolapse

Conditions: Female Genital Prolapse

Summary: this study aims to determine the rate of recurrence of central pelvic organ prolapse in patients who have undergone surgery (sacropexy with and without mesh) for the same pathology.

there is a lack of data in the literature comparing sacroplexing with the use of mesh with sacroplexing performed without the use of mesh in terms of recurrence, improvement in symptoms, and restoration of normal pelvic organ prolapse relationships. the objective of this study is to determine the rate of recurrence of central pelvic organ prolapse in patients with a clinical diagnosis of genital prolapse stage ≥ 2 according to the pop-q classification who underwent laparoscopic sacroplasty with mesh (group 1) and without mesh (group 2). the study may provide information on the impact of mesh in laparoscopic surgery for the correction of central pelvic organ prolapse.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * clinical diagnosis of genital prolapse stage ≥ 2 according to pop-q classification * surgical treatment of laparoscopic sacropexy by mesh (group 1) and without (group 2) in female patients * acquisition of informed consent * at least one follow-up evaluation at 24 months exclusion criteria: * age \> 80 years * previous genital prolapse surgery

Keywords: prolapse female genital gynaecology sacropexy mesh
[kj-int-002] be study

Conditions: Gastritis

Summary: assess the safety and the pharmacokinetic characteristics of int-2150 after oral administration to healthy adult male subjects


Eligibility criteria:
inclusion criteria: 1. male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent. 2. body weight \>= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m\^2 (inclusive). 3. healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. 4. capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form exclusion criteria: 1. patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system. 2. history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation. 3. systolic blood pressure ≥ 150 or ≤ 100 mmhg, diasolic blood pressure ≥ 95 or ≤ 55 mmhg. 4. gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product. 5. alanine aminotransferase, alkaline phosphatase \ 2.0mg/dl and egrf \<60ml/min/1.73m2 6. history of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \>21 units for males. one unit is equivalent to 10 gram of alcohol. 7. the subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).