Kornimate/medical-research-clean huggingface dataset:
effect of simbrinza® suspension as an added therapy to a prostaglandin analogue

Conditions: Ocular Hypertension; Open Angle Glaucoma

Summary: the purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (simbrinza® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (pga) monotherapy.

this study was divided into 2 sequential phases. the screening/eligibility phase included one screening visit and two eligibility visits, during which subjects washed out of all other intraocular pressure (iop)-lowering medications and dosed with travatan z®, xalatan®, or lumigan®, 1 drop instilled in each eye once daily for 28 days. subjects who met all inclusion/exclusion criteria were randomized at the second eligibility visit. the treatment phase consisted of two on-therapy visits (week 2 and week 6).

Eligibility criteria:
inclusion criteria: * diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension; * mean intraocular pressure (iop) measurements in at least 1 eye (study eye) of ≥ 21 mmhg and \<32 mmhg at 2 consecutive visits (eligibility 1 and eligibility 2); * previously prescribed travatan z® 0.004%, xalatan® 0.005%, or lumigan® 0.01% monotherapy for at least 28 days prior to the screening visit; * able to understand and sign informed consent document; * other protocol-defined inclusion criteria may apply. exclusion criteria: * women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study; * any form of glaucoma other than open angle glaucoma or ocular hypertension; * severe central visual field loss; * chronic, recurrent, or severe inflammatory eye disease; * ocular trauma within the past 6 months; * ocular infection or ocular inflammation within the past 3 months; * best-corrected visual acuity score worse than approximately 20/80 snellen; * eye surgery within the past 6 months; * any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the investigator; * use of any additional topical or systemic ocular hypertensive medication during the study; * patients who, in the opinion of the investigator, cannot discontinue all iop-lowering ocular medication(s) per the appropriate washout schedule prior to eligibility 1 visit; * other protocol-defined exclusion criteria may apply.

Keywords: glaucoma prostaglandin analogue brinzolamide brimonidine
the effect of dark chocolate consumption on blood parameters in healthy adult individuals

Conditions: Cardiovascular Diseases

Summary: in healthy individuals, the effect of regular dark chocolate consumption for 4 weeks on blood lipid parameters such as; total cholesterol, ldl cholesterol, hdl cholesterol and triglyceride levels, in addition to fasting blood glucose, hba1c, crp levels and blood pressure was investigated.

recent studies have shown that dark chocolate consumption may have a positive effect on cardiovascular risk markers.the aim of this study is to investigate the effect of regular consumption of dark chocolate (36 g/day) on biochemical blood parameters in healthy individuals. a total of 37 healthy individuals completed the study conducted in this direction. participants were randomly divided into two groups as dark chocolate group (n=17) and control group (n=20). while the dark chocolate group consumed 36 g/day (400 mg/day flavanol) dark chocolate for 4 weeks, the control group did not receive any intervention. at the end of the study, the anthropometric measurements of the individuals were evaluated. blood lipid profile, fasting blood glucose, hba1c, crp levels, systolic blood pressure and diastolic blood pressure measurements were investigated.

Eligibility criteria:
inclusion criteria: * bmi \< 30 kg/m2 * systolic blood pressure \<140 mmhg and/or diastolic blood pressure \<90 mmhg exclusion criteria: * individuals with any diagnosed chronic or acute illness * individuals diagnosed or in contact with covid-19 * individuals with allergies to cocoa/chocolate products * individuals in the process of losing weight * individuals with smoking and alcohol consumption * individuals taking medication or vitamin/mineral supplements * individuals doing heavy physical activity * individuals who regularly consume cocoa/chocolate products for the last 1 month (\> 3 days a week) * pregnant or lactating women were excluded from the study.

Keywords: chocolate cacao cholesterol blood glucose blood pressure
melatonin and osteogenic loading on osteopenia

Conditions: Osteopenia

Summary: this study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.


Eligibility criteria:
inclusion criteria: to be included in the study, the participant must be a male or female with osteopenia (t-score between -1.0 and -2.5) who is at least 18 years of age. the participant must be willing to undergo an osteogenic loading protocol once per week and/or take a pill (placebo or melatonin) for one year. the participant must also be willing to come to the study location to receive their monthly capsules and to provide urine, have their blood pressure taken and complete questionnaires on 3 occasions (baseline/month 0, month 3 and month 12). the study participants must also be willing to get a dxa scan at months 0 and 12 at one of the three weinstein imaging locations. exclusion criteria: women or men with osteoporosis; women or men with osteopenia due to hyperparathyroidism, multiple myeloma, metastatic bone disease, chronic steroid use including corticosteroids; women or men who are on any bone therapies (i.e. bisphosphonates, selective estrogen receptor modulators (serms), hormone therapy, teriparatide, and denosumab); men and women with chronic obstructive pulmonary disease (copd); women or men who smoke; pregnant women; and men or women with muscular dystrophy, unmedicated hypertension, or unrepaired hernia, restrictions to movement and exercise, and parathyroid dysfunctions.
controlled investigation to evaluate impact of dcbt on psychological symptom burden in adult subjects with pf

Conditions: Pulmonary Fibrosis; Anxiety

Summary: the purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.

patients will be randomised 1:1 to either receive treatment with the digital therapy, or to act as control group. patients will be treated for 9 weeks, followed by a 3 week follow-up period. efficacy will be assessed after 9 weeks.

Eligibility criteria:
inclusion criteria: 1. age ≥22 years at the time of signing the informed consent 2. self-reported pulmonary fibrosis diagnosis 3. a gad-7 score of ≥5 at pre-screening and baseline 4. if currently on prescribed medication for depression/anxiety, a stable dose for at least 4 weeks prior to baseline 5. ct scan report within 5 years prior to baseline with signs of pf (interstitial changes) 6. capable of using a mobile device and common applications, and has an appropriate mobile or tablet device exclusion criteria: 1. self-reported manic disorders, psychotic disorders, schizophrenia, or alcohol/drug abuse during the past 6 months prior to baseline (visit 1), as judged by the investigator or designee. 2. self-reported history of hospital admissions due to suicidal behavior or attempts, as judged by the investigator or designee 3. self-reported previous or current diagnosis of major depressive disorder, as judged by the investigator or designee 4. verbal and/or written communication problems limiting ability to engage with dcbt-ipf 5. inability to comply with investigation procedures, due to e.g. cognitive impairment or severe medical conditions as judged by the investigator or designee 6. currently receiving cognitive behavioral therapy
prevention of renal complications of diabetes with thiamine

Conditions: Diabetic Nephropathy

Summary: thiamine is a key component in the creation of physiologic anti-inflammatory mediators. serum thiamine stores have been found to be deficient in diabetic patients. thiamine deficiency may be a key pathological mechanism of inflammation that results in diabetic kidney and retinal injury. the investigators hypothesize that the repletion of a patient's thiamine by oral supplementation may result in reduced inflammation, and therefore reduced kidney injury.

thiamine (vitamin b1) is a water-soluble vitamin. it is absorbed from the gastrointestinal tract and taken up into tissues by transport proteins and converted to thiamine pyrophosphate (tpp) by thiamine pyrophosphokinase (tppk). tpp is a co-factor of pyruvate dehydrogenase (pdh), α-ketoglutarate dehydrogenase and transketolase (tkt)-enzymes involved in the metabolism of glucose. various transport proteins are involved in the transport of thiamine monophosphate (tmp) and tpp across membranes. these include thiamine transported isoform-1 (thtr1) and thiamine transporter isoform-2 (thtr2), reduced folate carrier-1 (rfc-1), which transports tmp and tpp across cell plasma membranes and the mitochondrial tpp transporter (mthtr). thiamine and tmp/tpp transporters may have abnormal expression in diabetes. increased thtr1 levels are found in red blood cells (rbcs) and mononuclear leucocytes of patients with diabetes compared to those of healthy subjects. rbc precursors and leucocytes appeared to up-regulate thtr1 expression in response to decreased thiamine availability. in the presence of hyperglycemia, renal tubular epithelial cells, by contrast, have decreased expression. in both experimental models of diabetes and in human diabetics increased clearance of thiamine has been demonstrated. this precedes the development of microalbuminuria. patients with microalbuminuria and early decline in glomerular filtration rate had higher fractional excretion of thiamine compared to patients with stable renal function. thiamine supplementation in stz- diabetic mice prevented the development of microalbuminuria, decreasing urinary albumin excretion (uae) by approximately 80%. in addition thiamine supplementation prevented diuresis and glycosuria. human studies are limited but in one placebo controlled study the thiamine group showed a significant decrease in microalbuminuria in diabetic patients on thiamine.

Eligibility criteria:
inclusion criteria: * with a diagnosis of type ii diabetes which has been present for at least 5 years, * persistent microalbuminuria (30-299 mg/24 h), * hba1c ≤ 8%, and * bmi 19-40 kg/m2. exclusion criteria: * significant comorbidities, * "deficient renal function" known allergy or intolerance to thiamine, * use of thiamine supplements, * participation in an interventional study within 30 days, * recipients of renal and/or pancreatic transplant and * women who were pregnant or breast feeding.
pre and post-gastrostomy evaluation of ger in children using 24-hour ph monitoring

Conditions: Gastroesophageal Reflux

Summary: the aim of this study was to evaluate 24-hour ph monitoring results before and after gastrostomy in neurological impaired (ni) children who underwent gastrostomy or nissen fundoplication (nf) concurrently with gastrostomy.

gastrointestinal (gi) problems causing malnutrition may develop quite frequently in patients with neuromotor developmental delay. diagnosis of gerd in patients with neurological impairment (ni) might be more difficult due to the absence of characteristic features in many cases. one of the best methods for the diagnosis of ger is the 24-hour esophageal ph monitoring.even though there are some statements in the literature advocating that gastroesophageal reflux may develop in the late period in patients undergoing only gastrostomy, there are also reports supporting that gastrostomy does not contribute to the development of reflux.regardless of whether the patient received anti-reflux surgery or not, the long-term follow-up is necessary in patients feeding with gastrostomy.the aim of this study is to compare the results of pre- and postoperative 24-hour ph monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ lnf+ gastrostomy on ger.

Eligibility criteria:
inclusion criteria: clinical diagnosis of neurological damage must be able to apply gastrostomy or nissen fundoplication concurrently with gastrostomy. exclusion criteria: to use anti-reflux medications long period of time gastroesophageal reflux disease
mindfulness-based cognitive therapy (mbct) and cognitive behavioral therapy (cbt) for depression in diabetes patients

Conditions: Depressive Symptoms

Summary: the purpose of this study is to determine whether mindfulness-based cognitive therapy (mbct)and cognitive behavioral therapy (cbt)are effective in reducing depressive symptoms in patients with diabetes.

depression is a common co-morbidity of diabetes, negatively affecting physical performance, glycemic control, adherence to medication, and dietary, and exercise recommendations. modalities of psychotherapy like cognitive behavioral therapy (cbt) and mindfulness-based cognitive therapy (mbct) can reduce depressive symptoms in patients with medical conditions. however, proper designed randomized trials assessing and comparing effectiveness of these psychological interventions are rare. this longitudinal study aims to investigate the effectiveness of cbt and mbct in reducing depressive symptoms in diabetes patients. furthermore, potential moderators and mediators of treatment effect will be explored, as well as the role of common factors and treatment integrity.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 1 or 2 for at least three months prior to inclusion * written informed consent * age ≥ 18 and ≤ 70 * depressive symptoms as assessed by bdi-ii score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression) exclusion criteria: * not being able to read and write dutch * severe (psychiatric) co-morbidity * acute suicidal ideations or behavior * pregnancy * receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study using an antidepressant drug during participation in the present study is allowed, on condition that a patient has been on stable medication regimen for at least two months prior to inclusion in the study, and that no new treatment with an antidepressant is initiated during the course of the study
randomized controlled trial of the effectiveness of perineal pain and security of the suture led by the result of hemostasis versus manual compression routine suture perineal tears of first degree during childbirth

Conditions: Parturition; Delivery, Obstetric

Summary: during childbirth, the recommendations have evolved to a restriction of episiotomy. this reduction results in an increase of superficial vaginal and perineal tears. these lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. these studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis. our objective is to evaluate the possibility of not suture the perineum of the first degree. the use of suture only result of bleeding not yielding to manual compression. our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.


Eligibility criteria:
inclusion criteria: * single pregnancy * primiparae * delivery by spontaneous vaginal delivery * forward delivery (≥ 37 weeks) * cephalic presentation * children living * perineal tear or isolated first-degree vaginal tear exclusion criteria: * known haemostatic anomaly * premature birth (before 37) * caesarean * instrumental delivery * placenta and / or uterine revision * episiotomy * perineal tear ≥ 2nd degree

Keywords: perineal tear of first degree suture
a single-center, exploratory study to analyze the dynamics of skin microflora following exposure to surfactants

Conditions: Dermatitis

Summary: the purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. the results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.


Eligibility criteria:
inclusion criteria: * healthy subjects with fitzpatrick skin types i, ii or iii exclusion criteria: * subjects with visible skin disease, tattoos, skin condition, or abnormal skin color
gastric volume in paralyzed obese patients after high-flow nasal oxygen therapy

Conditions: Undefined

Summary: preoperative preoxygenation is performed using high-flow nasal oxygen therapy, and the gastric volume before and after high-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.

preoperative preoxygenation is performed using high-flow nasal oxygen therapy, and the gastric volume before and after high-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.

Eligibility criteria:
inclusion criteria: * adult patients with a bmi of 30 kg/m2 or more, undergoing surgery under general anesthesia exclusion criteria: * nasotracheal intubation * history of a surgery or anatomical anomaly in the head and neck * history of inability to breathe through nose * history of difficult airway * severe cardiac or respiratory disease * gastric reflux disease, diabetes, pregnancy * previous gastric surgery
a study to assess the safety and effectiveness of sjp-0035 for the treatment of patients with dry eye disease

Conditions: Dry Eye Syndromes

Summary: a double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with dry eye disease (ded). patients will be randomly assigned to receive either sjp-0035 0.001% or placebo

there are currently no approved products available anywhere worldwide for the treatment of dry eye disease (ded) that directly affect the corneal epithelium. this study will evaluate the safety and efficacy of sjp-0035 0.001%, compared with a placebo, on corneal healing. patients meeting the requirements of the inclusion/exclusion criteria will administer 1 drop of the study drug/placebo 4 times per day for 4 weeks.

Eligibility criteria:
inclusion criteria: * signed informed consent form (icf). * has dry eye disease (ded) with moderate to severe corneal fluorescein staining in both eyes. * has blurred vision caused by ded in both eyes. * women of childbearing potential must have negative serum pregnancy test results at screening and randomization and agree to use effective contraception throughout the study; post-menopausal women must have negative serum pregnancy test results at screening and randomization. * male participants must agree to use an acceptable form of contraception (i.e. a condom plus spermicide) and to refrain from sperm donation throughout the study. exclusion criteria: * has any corneal stromal or endothelial abnormalities in either eye. * has any active or chronic allergic, bacterial or viral infection of ocular adnexa and eye structures in either eye. * has had eye surgery (including cataract, vitreous or eyelid surgery) in either eye within the last 28 days prior to first dose of study drug. * has had refractive surgery (including eye surface laser surgery) in either eye within the last 180 days prior to first dose of study drug. * has used any eye medication in either eye within 14 days prior to first dose of study drug, or is anticipated to require such medications during the study. preservative-free artificial tears may be used up to 72 hours prior to the first dose in either eye. * is a contact lens wearer and cannot discontinue use in both eyes from screening through the duration of the study. * has previously received sjp-0035 (study drug) in either eye. * currently has punctal occlusions, of any type, inserted into both superior and inferior puncta in either eye at screening through the duration of the study. other protocol-defined inclusion/exclusion criteria could apply.

Keywords: dry eye disease corneal epithelial disorders re-epithelialization
primary care management of community-acquired, methicillin-resistant staphylococcus aureus (ca-mrsa) infections

Conditions: Methicillin-Resistant Staphylococcus Aureus

Summary: the goal of this study is to further the investigators' understanding of community acquired methicillin-resistant staph aureus (ca-mrsa) and treatment of it by developing real-world sustainable strategies consistent with existing guidelines on treatment of ca-mrsa from the centers for disease control and prevention (cdc) and test these strategies in busy primary care settings.


Eligibility criteria:
inclusion criteria: * all patients presenting at a primary care clinic who have a skin or soft tissue infection. exclusion criteria: * none

Keywords: primary health care
diagnosis and management of arterial hypertension for algerian patients in current medical practice

Conditions: Arterial Hypertension

Summary: blood pressure reduction and control are associated with reduced risk of stroke and cardiovascular disease. there is evidence that ambulatory blood pressure monitoring (abpm) results more accurately reflect the risk of cardiovascular events than do office measurements of blood pressure. new international guidelines recognize the importance of abpm which has an important and growing role in the diagnosis and in guiding antihypertensive therapy. in 2011 in the united kingdom, the national institute for health and care excellence (nice) recommended that abpm be performed on all patients with suspected hypertension to confirm the diagnosis and reduce unnecessary treatment in people who do not have true hypertension. the aim of this observational study is to describe the utility of abpm generally and specifically in the management of hypertension by cardiologists in the algerian context.

the primary objective of this study is to assess the benefit of the abpm in the diagnosis and management of arterial hypertension in by cardiologists. the secondary objectives are: * to identify the conditions of usage of abpm for the diagnosis of arterial hypertension, * to evaluate the blood pressure during the abpm assessment and at 6 weeks of follow up * to describe the study population (socio-demography), * to describe the therapeutic stratégies and the compliance to treatment.

Eligibility criteria:
inclusion criteria: * patients who are either hypertensive (defined as those with a clinic sbp ≥ 140 mmhg or dbp ≥ 90 mmhg \[7\]) or referred for the assessment of hypertension * informed consent obtained before any study-related activity exclusion criteria: * abpm contraindication * patient with psychiatric disorder * patient not able to comply with study-related procedures based on clinical judgement of the investigator

Keywords: hypertension abpm