Kornimate/medical-research-clean huggingface dataset:
assessing the efficacy and tolerability of azarga® (brinzolamide 1%/timolol 0.5% fixed combination) as replacement therapy in patients on brimonidine 0.2%/timolol 0.5% fixed combination therapy (combigan®) in latin america

Conditions: Glaucoma

Summary: the purpose of this study was to assess the efficacy and tolerability of changing to azarga® from prior combigan® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye). * on a stable iop (intra-ocular pressure) lowering regimen within 30 days of screening visit. * iop considered safe in both eyes in order to assure clinical stability of vision and optic nerve throughout the study period. * best corrected visual acuity of 6/60 (20/200 snellen; 1.0 logmar) or better in each eye. * iop between 19 and 35 mmhg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy. * other protocol-defined inclusion criteria may apply. exclusion criteria: * presence of other primary or secondary glaucoma. * history of ocular herpes simplex. * any abnormality preventing reliable applanation tonometry. * corneal dystrophies. * concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. blepharitis or non-clinically significant conjunctival injection is allowed. * intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to screening visit. * risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator. * progressive retinal or optic nerve disease from any cause. * use of systemic medications known to affect iop which have not been on a stable course for 7 days prior to screening visit or an anticipated change in the dosage during the course of the study. * pregnant or lactating. * other protocol-defined exclusion criteria may apply.

Keywords: primary open angle-glaucoma ocular hypertension pigment dispersion glaucoma
effects of intradialytic cognitive and physical exercise training on functional status of hemodialysis patients

Conditions: Cognitive Dysfunction; Physical Inactivity; Chronic Kidney Diseases

Summary: the aim of this study is to investigate the effect of cognitive training combined with physical exercise on cognitive function, physical performance and frailty indicators in the hemodialysis population.

the prevalence of cognitive impairment in hemodialysis (hd) patients is extremely high. despite the well-documented benefits of interventions on cognitive function, there is a widespread call for effective strategies that will show the long-term consequences in patients undergoing dialysis. a randomized controlled intervention trial to examine the effects of a combined non-pharmacological intervention in the form of intradialytic physical exercise and intradialytic cognitive training on cognitive function, indicators of frailty, and physical performance measures in hd patients will be conducted. the group of patients receiving the study intervention will be compared to the control group receiving standard hd care. the duration of the intervention will be 12 weeks (3 days a week). we will use sensitive instruments (cognitive domain tests) to assess cognitive functions. the primary outcome of the study at 12 weeks will be performance on the alertness subtest of the computerized test of attentional performance. secondary study outcomes will be: performance in other domains of cognitive function (executive function, psychomotor speed, information processing efficiency, working memory, attention), physical fitness (10 repetition sit-to-stand test, timed up and go test, handgrip strength test, spontaneous gait speed, stork balance test), and assessment of frailty (edmonton frail scale). study outcomes will be assessed at baseline and immediately after the 12-week intervention. this study will be among the first to test the synergistic effects of a uniquely designed physical exercise and cognitive training intervention on functional status in hd patients.

Eligibility criteria:
inclusion criteria: * dialysis patients on renal replacement therapy with chronic hemodialysis * duration of hemodialysis treatment for at least 3 months * capable of independent walking and independent feeding exclusion criteria: * the presence of chronic malignant or infectious disease * uncontrolled arterial hypertension with an average of the last five pre-dialysis blood pressure values above 180/100 mm hg, * unstable angina pectoris or canadian cardiovascular society class 2-4, * heart failure new york heart association class 3 and 4, * the presence of a psychotic illness or a mental disability, * a condition with an amputated limb (more than 2 fingers on the lower limb and / or more than 2 fingers on the upper limb) * any other condition that causes the clinical unstability of the patient (i.e. repetitive gastrointestinal hemorrhagies, liver cirrhosis with frequent exacerbations)

Keywords: cognitive functions hemodialysis physical activity intradialytic training non-pharmacological interventions
proof of concept study of a sucker hemostatic intra uterine in postpartum hemorrhage after abruptio placenta assisted

Conditions: No Placental Abruption; No Hemorrhage

Summary: the postpartum hemorrhage (pph) is the major complication of the delivery. in clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. escalating therapy after obstetric maneuvers (placenta, uterus, examination of the birth canal), begins with uterotonic treatments for invasive treatments lead to embolization, vessel ligation and hysterectomy. however, the morbidity of these techniques and the desire to preserve fertility required to devise new therapeutic solutions, which have recently led to the development of an innovative medical device intrauterine hemostasis. the postpartum haemorrhage are mainly the result of weak and bleeding from the surface corresponds to the placental insertion, which is no longer localized. with the innovative medical device, our main hypothesis is that the uterine walls will append to the walls of the cup after depressurization of the latter. the actuation of the suction cup will lead to aspiration of all sides of the uterus (it is mostly the anterior and posterior that are important). the suction cup is flexible to adapt to the size of the uterus in order to be placed and removed easily from the uterine cavity.

in this study, as a first pass in human, innovative medical device not ce marked, we did not aim to show control of the bleeding stops in the case of pph but to prove, in a clinical situation with no foreseeable risk to the volunteers included (volunteers who have given birth without placental abruption after 30 minutes despite the directed delivery), proof of concept of using this system in these women that creates a vacuum in the intra uterine haemostatic vacuum and thus a joining of the walls of the uterus. this first step seems essential in order to effectively implement this medical device with serenity in emergency situations of pph.

Eligibility criteria:
inclusion criteria: * woman between 18 and 45 years old, * affiliation to the french social security system or equivalent, * volunteers signed a consent to participate, * volunteer is under loco-regional anaesthesia, * volunteer whose the placenta has not taken off after 30 minutes despite the directed delivery. exclusion criteria: * volunteer carries uterine malformations, * volunteer with post-partum haemorrhage (blood loss\> 500 ml), * volunteer allergic to silicon, * volunteer under general anaesthesia, * pregnancy not unique, * volunteer with fever or suspected infection during labor, * person deprived of freedom by judicial or administrative decision * person hospitalized without their consent * person under legal protection * person hospitalized for psychiatric care

Keywords: medical device
immune effects in patients treated with whole breast irradiation

Conditions: Breast Cancer

Summary: the purpose of this study is to obtain data to determine whether whole breast irradiation (wbi) differentially influences the frequency of components of innate and adaptive immunity and their relative functional activity, to assess the patient's quality of life (qol) and to evaluate the cosmetic assessment of the breast on follow-up after wbi treatment.


Eligibility criteria:
inclusion criteria: * willingness and ability to provide written informed consent and to comply with the study protocol as judges by the investigator. * patient has new diagnosis of breast cancer and has elected bcs and wbi. these patients must be consented prior to the start of wbi. * for patients with invasive breast cancer sentinel node biopsy (slnb) must be performed and confirm pathologic negative disease. * tumor size must be less than or equal to 3 cm. * patient is 45 years of age or older. * women of childbearing potential must agree to use adequate contraception prior to study entry and through the wbi treatment. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. exclusion criteria: * male patients * patients who are pregnant or nursing. * patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the duration of the study or is not in the best interest of the patient to participate, in the opinion of the treating investigator. * breast cancer that involves the skin or the chest wall. * history of ipsilateral breast cancer treated with radiation therapy. * multicentric breast cancer in the ipsilateral breast as diagnosed by clinical exam, mammogram, ultrasound, or mri * patients known to have a brca gene mutation. genetic testing is not required. * patient with clinically positive nodal disease. * patient with proven nodal disease by either fna, core biopsy or sentinel node biopsy.
impact nerium oleander on immune function

Conditions: Covid19 Positive Patient; Covid19 Close Contact; Immune Function

Summary: assess the impact of a proprietary extract of nerium oleander on immune function as evidenced by covid-19 symptoms and mortality in covid-19 positive patients and their close contacts compared to controls that did not receive the extract.

this is an exploratory study based on positive in-vitro, and in-vivo (humans) that appear to support an immune function benefit. up to 100 patients that are covid-19 positive in the ambulatory setting will be invited to participate. after informed consent is obtained, patients will be in either the intervention group (receive extract) or comparison group (did not receive extract). a baseline assessment and record review will be conducted to assure eligibility criteria. patients in the intervention group will be given .5 ml (6.25 mg of extract) every 6 hours for 5 days, total of 25 mg per day / 125 mg for 5 days. patient vital signs (temperature, pulse oximetry, blood pressure) and cdc symptoms / side effects will also be tracked. a dedicated medical oversight team with 24 / 7 access to care will be provided to monitor safety and tolerance. patients will be followed for 10 days. baseline antibody, rt-pcr, and live virus will be collected on day 1, day 5, and day 10. a data monitoring committee at the schull institute will meet weekly to review data.

Eligibility criteria:
inclusion criteria: * age 18 * covid 19 positive or close contact of covid 19 positive * no use of cardiac glycosides or other antiarrhythmic medications exclusion criteria: * no use of cardiac glycosides or other antiarrhythmic medications * no allergy to coconut oil

Keywords: covid19 nerium oleander clinical symptoms mortality immune function
a study to evaluate the long term safety of otx-tp (sustained release travoprost) intracanalicular insert

Conditions: Open Angle Glaucoma and Ocular Hypertension

Summary: to evaluate the long term safety of repeat dose otx-tp, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * had prior bilateral treatment and completion, through a minimum of week 12, of the otx-16-002 trial * are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year * have provided written informed consent, approved by the appropriate institutional review board exclusion criteria: * had more than 1 replacement, per eye, during participation in the otx-16-002 trial * had punctal or canaliculi related adverse events during the otx-16-002 trial which required discontinuation (e.g., canaliculitis) * used prohibited medications during the otx-16-002 study, or the period between otx-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy) * missed more than 2 visits during participation in the otx-16-002 trial
ffs - far field sensing test study in cardiac dual chamber pacemakers

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers.

far-field r-wave sensing (ffs) in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate mode switch from the ddd mode to the ddi or vdi mode. inappropriate loss of atrioventricular synchrony due to false positive mode switch is hemodynamically disadvantageous, may induce atrial tachyarrhythmias, can lead to pacemaker syndrome, and impairs the reliability of pacemaker holter data. the aim of the study is to determine whether individual adjustment of the postventricular atrial blanking period (pvab) based on an additional test is effective in avoiding inappropriate mode switch due to ffs when compared to standard programming of the pvab

Eligibility criteria:
inclusion criteria: * indication for dual chamber pacing * implantation of an identity dr pacemaker (st. jude medical) * bipolar atrial pacing electrode exclusion criteria: * heart failure nyha iii and iv * unstable angina pectoris * indication for the implantation of an icd * cardiac surgery within previous 6 months * cardiac surgery planed for the next 3 months
syncing screening and services for suicide prevention across health and justice systems

Conditions: Suicide Prevention

Summary: this study aims to harmonize jail release record data with electronic health record data in order to connect patients to an evidence-based suicide prevention and clinical care pathway upon jail release.

this study is designed to test the effectiveness of a care pathway delivered at the time of jail release, to increase behavioral health services engagement and prevent suicide attempt. there are 3 primary aims of this study: (1) examine the effectiveness of the intervention on suicide attempt outcomes. (2) evaluate the impact of the intervention on behavioral health utilization mechanisms. (3) evaluate implementation outcomes and processes to guide future implementation and research, including: cost and cost-effectiveness; scalability; sustainability; feasibility, acceptability, and appropriateness to providers/systems; and implementation strategies.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * released from jail between february 2021 and july of 2028 * had a prior primary care visit or behavioral health visit at a participating health system in the past 3 years exclusion criteria: * does not currently reside in the same state as the study site (i.e.- michigan, minnesota) * would require a translator to participate in the research according to ehr data * previously requested to be excluded from research
comparative study between photodynamic therapy with urucum and led and probiotics in halitosis reduction

Conditions: Halitosis

Summary: introduction: halitosis is a term that defines any foul odor emanating from the oral cavity. the origin may be local or systemic. the aim of the proposed project is to determine whether treatment with antimicrobial photodynamic therapy (apdt) and treatment with probiotics are effective at eliminating halitosis. methods and analysis: fifty-two patients from 18 to 25 years old with a diagnosis of halitosis (h2s≥112 ppb determined by gas chromatography) will be randomly allocated to four groups (n=13) who will receive different treatments: group 1 - treatment with teeth brushing, dental floss and tongue scraper; group 2 - brushing, dental floss and apdt; group 3 - brushing, dental floss and probiotics; group 4 - brushing, flossing, apdt and probiotics. the results of the halimeter testing will be compared before, immediately after, seven days and thirty days after treatment. the microbiological analysis of the coated tongue will be performed at these same times. the quantitative analysis will be conducted using real-time pcrq. the normality of the data will be determined using the shapiro-wilk test. data with normal distribution will be analyzed using analysis of variance (anova). non-parametric data will be analyzed using the kruskal-wallis test. the wilcoxon test will be used to analyze the results of each treatment at the different evaluation periods. ethics and dissemination: this study has been approved by the ethics committee of uninove under process number 3.669.442. results will be published in peer-reviewed journals and will be presented at national and international conferences.


Eligibility criteria:
inclusion criteria: * age between 18 and 25 years; * sulphide (sh2) ≥ 112 ppb in the gas chromatography. exclusion criteria: * dentofacial anomalies (such as cleft lip and cleft palate); * undergoing orthodontic and/or orthopedic treatment; * undergoing oncological treatment; * systemic alterations (gastrointestinal, renal, hepatic); * treatment with antibiotics up to 1 month before the survey; * pregnant. * individuals with fissured tongue
a feasibility and acceptability pilot study evaluating a patient-specific targeted intervention using patient navigators or routine clinical care

Conditions: Breast Cancer

Summary: project lets start will provide individual support to breast cancer patients with the goal of reducing delay to chemotherapy initiation. in this study participants will identify areas of need and work with patient navigators who will provide weekly 1-1 support throughout patient's journey to beginning chemotherapy

objectives: among patients with early-stage breast cancer, delays with the administration of chemotherapy significantly reduce its benefit. interventions aimed at reducing ttc have the potential of improving outcomes and reducing health disparities. in this study we propose to develop an effective targeted intervention that is culturally sensitive and that addresses the roots of chemotherapy delay. our objective is to conduct a pilot study randomizing patients with breast cancer, in whom adjuvant or neoadjuvant chemotherapy has been recommended, to a culturally sensitive and patient-specific targeted intervention using patient navigators or routine clinical care primary aim: to establish feasibility and acceptability. we hypothesize that the intervention will be feasible and accepted by participants. secondary aim: explore ttc according to treatment arm. we hypothesize that the ttc will be shorter among participants randomized to the intervention exploratory aim: 1) to determine if social support, interpersonal trust in a physician, and general self-efficacy changed from baseline to the end of the intervention; and 2) to determine if that change was similar between participants randomized to the intervention compared to the control arm. we hypothesize that there will be favorable changes in scores among participants randomized to the intervention, while no change will occur among those randomized to the control arm.

Eligibility criteria:
inclusion criteria: i. at least 18 years of age. ii. diagnosis of primary invasive breast cancer. iii. chemotherapy (adjuvant or neo-adjuvant) recommended by treating physician (including pregnant women in 2nd or 3rd trimester). iv. patient of the university of texas md anderson cancer center or planning on receiving treatment at our institution. v. can speak, read, and understand english and/or spanish. vi. participant can provide consent for themself exclusion criteria: i. hospitalized for a critical condition or who are considered medically unstable by their medical team. ii. patients that have been previously treated with chemotherapy.
an open-label, uncontrolled study of ono-7913 and ono-4538 in combination with modified folfirinox therapy, the standard of care, as first-line treatment in patients with metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: to investigate the tolerability and safety of ono-7913 and ono-4538 used in combination with modified folfirinox (mffx therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.


Eligibility criteria:
inclusion criteria: * 1. untreated metastatic pancreatic cancer * 2. life expectancy of at least 3 months * 3. patients with ecog performance status 0 or 1 exclusion criteria: * 1. patients with severe complication * 2. patients with multiple primary cancers