Kornimate/medical-research-clean huggingface dataset:
efficacy of topical tolasure on acute induced wounds in healthy participants

Conditions: Wound Healing

Summary: tolasure is a topical gel for the promotion of accelerated wound healing. this phase ii study will primarily assess the efficacy of tolasure when applied to skin wounds created by punch biopsy in healthy participants. safety, cutaneous tolerability, wound pain control, and quality of healing will also be assessed. a total of 80 healthy volunteers, males and females ages 18 years or older, will be enrolled. subjects will be monitored for safety and efficacy until wound closure (estimation about 8 weeks) following topical administration of tolasure.


Eligibility criteria:
inclusion criteria: * healthy males and females \> 18 years of age * health history review * physical exam * blood and urine clinical chemistries * negative pregnancy test exclusion criteria: * acute or chronic skin disorders (e.g. psoriasis); * acne or dermatitis at the test site; * prone to keloids or hypertrophic scarring; * topical or systemic antibiotics within 4 weeks of study enrollment; * subjects with known severe mental illness which, in the investigator's opinion, may prevent informed consent or interfere with the subject's ability to comply with study protocol procedures; * diagnosed with diabetes type i/ii or glucose results indicative of prediabetic condition; * morbidly obese with a body mass index (bmi) ≥ 40; * surgery within the previous 3 months (except for minor cosmetic or dental procedures) * history of severe vitamin or mineral deficiency; * history of drug or alcohol abuse (as defined by the investigator); * smoking/vaping; * hiv/aids; * consistently taking steroids and/or non-steroidal anti-inflammatory drugs. subjects may use nsaids on an as needed basis with no more than 7 days of consecutive use; * cancer diagnosis in the last 5 years; * currently receiving chemotherapy or radiation; * women who are pregnant, nursing, or planning a pregnancy; * hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields; * symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study; * treatment with any investigational agent within one month before treatment application for this trial; * unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule; * other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.

Keywords: healthy participants skin dermal biopsy
effect of memoptic on visual field of patients followed for a chronic open-angle glaucoma

Conditions: Open-angle Glaucoma; Visual Field

Summary: open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric alterations, and wose only current therapeutic target is the lowering of the intra-ocular pressure (using eye drops, surgery or laser). memoptic is a tablet combining citicoline, magnesium and gingko biloba, which have a neuroprotective effect already used in neurodegenerative diseases such as alzheimer's disease for example. citicoline has also shown several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently in ischemic optic neuropathies). the citicoline used in eye drops (neurodrop) has already shown results on the preservation of the vision of glaucomatous patients. the purpose of this project is to determine if memoptic can have an effect, in addition to the conventional treatments, in the preservation of vision of patients treated for an open-angle glaucoma.


Eligibility criteria:
inclusion criteria: * diagnosis of gcao defined by oct rnfl alterations and visual fields defects * age between 20 and 80 years old * well controled intra-ocular pressure under treatment (pio\<21mmhg or decreased by 20% compared to initial the pio) exclusion criteria: * retinal or macular disease * diagnosis of cataract or surgery of cataract during the follow-up * allergy to citicolin * ocular hypertonia due to a secondary cause (like corticosteroids) * history of anterior, intermediate or posterior uveitis * general treatment affecting pio (beta blockers, corticosteroids) * pregnancy or breastfeeding

Keywords: citicoline gingko biloba magnesium open-angle glaucoma visual field memoptic
the effects of a concor smartphone application

Conditions: Congenital Heart Disease; Smartphone Application; Arrhythmia; Heart Failure; mHealth; Mobile Health

Summary: life expectancy of children with congenital heart disease (chd) has increased dramatically during the past years, due to the successes of cardiac surgery. nearly all of these children with chd can be operated at young age and more than 90% reach adulthood. however, many adults with chd are life-long affected by cardiac events, particularly arrhythmias and heart failure, putting them at risk of premature death. these events have a large impact on quality of life of patients and their families and merit life-long hospital visits in a medical center specialized in adult chd. especially for adults with chd patient care with a smartphone is suited because of their young age and chronic condition. so far, data are lacking on smartphone interventions in patients with chd.

the investigators aim to determine feasibility of concor smartphone application management in adults with chd. moreover, during a twelve months follow up period the investigators aim to evaluate whether management with a concor smartphone application results in a lower rate of heart failure events and arrhythmia as well as a better quality of life than usual care, because of increased patient awareness, behavioral stimuli, healthy life style reminders and more precise medical treatment.

Eligibility criteria:
inclusion criteria: * adults with chd being an academic medical center (amc) patient and/ or patients registered in the dutch concor registry * owning a smartphone exclusion criteria: * mental retardation and/ or down syndrome
atorvastatin pre-treatment influences the risk of percutaneous coronary intervention (pci) study 2

Conditions: Coronary Artery Disease; Coronary Angioplasty

Summary: this study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (pci) on chronic statin therapy. patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before pci) and control group (pci without atorvastatin pretreatment, chronic statin treatment). endpoint is myocardial infarction measured by troponin i and creatine kinase myocardial band.

this randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (pci) and chronic statin therapy. two arms: 1. atorvastatin pre-treatment group (80mg atorvastatin for seven days) 2. control group (without atorvastatin pre-treatment, chronic statin treatment) primary endpoint: periprocedural myocardial infarction measured by troponin i level (time frame 24 hours) secondary endpoint: periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)

Eligibility criteria:
inclusion criteria: * indication for percutaneous coronary intervention * informed consent * chronic statin therapy exclusion criteria: * acute coronary syndrome in last 14 days * renal insufficiency (creatinine more 150 umol/l) * diseases severely limiting prognosis * previous participation in this study * chronic occlusion of the coronary artery, bypass intervention, left main intervention * chronic statin treatment with atorvastatin 80mg daily and rosuvastatin

Keywords: atorvastatin percutaneous coronary intervention periprocedural myocardial infarction hydroxymethylglutaryl-coa reductase inhibitors
glecaprevir/pibrentasvir for the treatment of ptsd

Conditions: PTSD

Summary: an open-label pilot study to further investigate glecaprevir/pibrentasvir (gle/pib), a direct acting antiviral (daa) that has been associated with posttraumatic stress disorder (ptsd) symptom improvement when prescribed for the treatment of chronic hepatitis c viral infection (hcv).

to perform an open-label pilot study (n=10) to further investigate glecaprevir/pibrentasvir (gle/pib), a direct acting antiviral (daa) that has been associated with posttraumatic stress disorder (ptsd) symptom improvement when prescribed for the treatment of chronic hepatitis c viral infection (hcv). the specific research described in this proposal is intended to pilot gle/pib for n=10 patients with ptsd in the absence of hcv. primary aims: aim 1: determine the feasibility of testing gle/pib for ptsd symptoms. aim 2: determine the feasibility of testing gle/pib for functioning among patients with ptsd. aim 3: assess the safety and tolerability of gle/pib treatment for patients with ptsd in the absence of hcv. exploratory aim: investigate the possible biological mechanism of gle/pib for ptsd via blood bio-marker analyses.

Eligibility criteria:
inclusion criteria summary 1. age 19-70 years 2. weight ≥ 45 kg 3. ptsd as determined by the caps within seven days of enrollment. 4. eligible for veterans affairs healthcare. 5. if of childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required. 6. able to read, understand, and sign the informed consent document. exclusion criteria: 1. pregnant or lactating person 2. moderate or severe hepatic impairment (child-pugh b or c) 3. history of prior hepatic decompensation 4. current use of drugs listed as having significant drug interactions on prescribing label 5. advanced liver disease 6. current or prior hepatitis b infection 7. prior clinical use of gle/pib or hcv ns5a inhibitor and ns3/4a protease inhibitor 8. current hcv infection 9. current psychosis or mania 10. significant suicidal ideation 11. unstable medical conditions 12. current severe alcohol or substance use disorder (excluding nicotine) 13. evidence-based ptsd psychotherapy changes in the past two months 14. evidence-based ptsd medication changes in the past two months

Keywords: ptsd antiviral hepatitis c
improving neurological outcome for acute basilar artery occlusion with sufficient recanalization after thrombectomy by intraarterial tenecteplase (insist-it)

Conditions: Stroke, Ischemic

Summary: the potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (bao) patients with successful reperfusion following endovascular treatment (evt) has not been studied. the current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute bao patients with successful reperfusion after evt.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per basics trial definition; * national institute of health stroke scale (nihss) ≥ 6 before endovascular treatment; * successful recanalization (mtici 2b-3) after endovascular treatment; * pc-aspects ≥ 6 on ct; * absence of parenchymal hematoma on ct images done in the angio suite immediately after the procedure; * modified rankin scale score before stroke onset ≤ 3; * signed informed consent by patient or their legally authorized representative. exclusion criteria: * baseline pc aspects \< 5 on ct; * more than six retrieval attempts in the same vessel; * hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage; * coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (\ 1.7; * severe hepatic or renal dysfunction, increase in alt or ast (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; * after recanalization, severe and sustained (i.e., \> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmhg or diastolic blood pressure over 105 mmhg) refractory to antihypertensive medication; * patients with contraindication or allergic to any ingredient of drugs in our study * pregnancy, plan to get pregnant or during lactation * the estimated life expectancy is less than 6 months due to other serious diseases; * other conditions unsuitable for this clinical study assessed by researcher.
the potentially addictive properties of soda: a feasibility study

Conditions: Withdrawal Symptoms

Summary: the purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (sbbs) in teenagers aged 13-18 years. it is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the ssb withdrawal period.


Eligibility criteria:
inclusion criteria: * drinks more than 36 ounces of sugar-sweetened beverages per day * speaks fluent english * parent speaks english or spanish * lives in san francisco bay area exclusion criteria: * pregnant or nursing * taking medication to address mental health issues

Keywords: caffeine addiction withdrawal symptoms pediatric adolescent overweight
a study of zn-c5 in participants with breast cancer

Conditions: Breast Cancer

Summary: this is a phase 1 open-label, multicenter study to evaluate biomarkers for zn-c5 in subjects with breast cancer


Eligibility criteria:
inclusion criteria: 1. signed and dated icf 2. age ≥ 18 years of age, either gender 3. females must be postmenopausal as defined by at least one of the following: 1. age ≥ 60 years; 2. age \< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle stimulating hormone levels within the local laboratory's normal reference range for postmenopausal females; 3. documented bilateral oophorectomy 4. histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 6. adequate organ function defined as follows: 1. hematologic: platelets ≥ 100 × 109/l; hemoglobin ≥ 9.0 g/dl; absolute neutrophil count ≥ 1.5 × 109/l (without platelet transfusion or any hematopoietic growth factors within previous 7 days of the hematologic laboratory values obtained at the screening visit) 2. hepatic: aspartate aminotransferase (ast) / alanine aminotransferase (alt) ≤ 2.5 × upper limit of normal (uln); total or conjugated bilirubin ≤ 1.5 × uln 3. renal: serum creatinine ≤ 1.5 × uln or creatinine clearance (crcl) ≥ 60 ml/min exclusion criteria: 1. major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first administration of study drug 2. treatment with another investigational drug or other intervention within 28 days before the first administration of study drug 3. impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral medication, including any unresolved nausea, vomiting, or diarrhea that is ctcae v.5.0 grade \> 1 4. myocardial infarction, symptomatic congestive heart failure (new york heart association classification \> class ii), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study day 1 5. uncontrolled inter-current illness 6. history or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion
observational study of heart valve disease in patients with parkinson's disease treated with pergolide

Conditions: Parkinson's Disease; Pergolide

Summary: the purpose of this study is to determine whether patients with parkinson's disease and treated with pergolide have a higher risk of heart valve disease compared to patients with parkinson's disease not treated with pergolide.

pergolide is an ergot dopamine receptor agonist with demonstrated efficacy in parkinson's disease. last year, two studies showed that pergolide can induce unexpected heart valve disease potentially severe and frequent. the late discovery of this unknown side effect had dramatic consequences in parkinson's disease management and the french drug agency (affsaps) has recently published guidelines for its prescription. little is known about the prevalence and the molecular mechanisms leading to this adverse event. to determine the prevalence, evolution, and potential risk factors of pergolide-induced heart valve disease, we propose an echocardiographic observational study in parkinsonian patients taking pergolide compared to matched controls. this clinical study will be performed in the clinical investigation centre in collaboration with the institute of cardiology of the salpétrière hospital

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease * hoehn and yahr score inferior or equal to 4 * treated with pergolide since more than 3 months (pergolide group) * never treated by pergolide (control group) exclusion criteria: * parkinson + syndrome, multiple system atrophy, supranuclear palsy * hoehn and yahr score equal to 5

Keywords: parkinson's disease pergolide heart valve disease
pharmacokinetics of lcq908 in patients with hepatic impairment

Conditions: Hepatic Impairment

Summary: this study will compare the pharmacokinetics of lcq908 in subjects with varying degrees of hepatic impairment to healthy subjects.


Eligibility criteria:
inclusion criteria: individuals with hepatic impairment only • hepatic impairment evidenced by a child-pugh score * mild hepatic impairment defined child-pugh class a (5-6 points) * moderate hepatic impairment defined child-pugh class b (7-9 points) * severe hepatic impairment defined child-pugh class c (10-15 points). healthy subjects only • good health determined. exclusion criteria: all individuals * a past medical history of clinically significant ecg abnormalities or a family history of a prolonged qt-interval syndrome. * female subjects must be of non child bearing potential or use an effective method of contraception. individuals with hepatic impairment * history of drug or alcohol abuse within 3 months prior to dosing. * history or presence of significant uncontrolled disease of any major organ class. * any surgical or medical condition other than hepatic impairment which might alter the drug metabolism. healthy subjects * history or presence of significant uncontrolled disease of any major organ class. * any surgical or medical condition other than hepatic impairment which might alter the drug metabolism. * history or presence of hepatitis b or c and/or positive hepatitis b surface antigen (hbsag) or hepatitis c test result at screening. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: lcq908, hepatic impairment, pharmacokinetics
the impact of altered arterioventricular coupling on central cardiovascular energy delivery

Conditions: Cardiovascular Diseases

Summary: this study will assess the amount of energy that the heart will deliver to the central circulation and the efficiency of that energy transfer, in patients undergoing a coronary artery bypass graft operation. measurements will be taken just after induction of anaesthesia and repeated just after the end of the operation. the total energy delivered by the heart will be calculated by multiplying a pressure curve from the artery in the hand with the instantaneous ultrasound recorded cardiac output flow curve. the energy responsible for the acceleration of the blood volume, known as oscillatory power will also be calculated. the energy transfer will be calculated using a mathematical model based upon other ultrasound and blood pressure recorded variables. we would like to see if any alteration in energy delivered is in part due to impairment in energy transfer or alteration of fraction of oscillatory power rather than a change in total energy production. we would also like to study if there are changes in the oscillatory power after cardiac bypass surgery. the patients will be sampled sequentially into the study. we are not aware of any such studies undertaken in humans previously.


Eligibility criteria:
inclusion criteria: * elective coronary artery bypass graft patients * no contraindications to transoesophageal echo * ejection fraction 40% or over exclusion criteria: * lack of consent * emergency operation * prosthetic aortic valve

Keywords: cardiac power oscillatory power coronary artery bypass graft arterioventricular coupling
intervention effects of optimized carbohydrate diet in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: this study is a multi-center, randomized, crossover investigator-initiated trial conducted at shanghai sixth people's hospital and other centers. each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. the optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. the study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with type 2 diabetes according to the ada diagnostic criteria 2. hba1c ≥ 7% and \< 9% 3. antidiabetic medication has been stable for at least 3 months before recruitment 4. aged 35-70 years 5. signed the informed consent form exclusion criteria: 1. treatment with insulin 2. treatment with glp-1 receptor agonists or dpp-4 inhibitors 3. occurrence of diabetic ketoacidosis, lactic acidosis, hyperosmolar coma, or recurrent severe hypoglycemia within the past year 4. having one or more severe chronic diabetic complications, including advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or impaired renal function (egfr ≤60 ml/min/1.73 m²) 5. presence of cardiovascular events (e.g., myocardial infarction, stent placement, unstable angina, heart failure, cardiac dysfunction) or cerebrovascular diseases (e.g., intracerebral hemorrhage, ischemic stroke) within the past 6 months 6. diagnosis of acute or chronic gastrointestinal diseases (e.g., ulcers), hyperthyroidism or hypothyroidism, uncontrolled hypertension, active malignancy not in remission, or other life-threatening diseases 7. recent use of antibiotics, probiotics, or prebiotics within the past 3 weeks or need for long-term use 8. unstable medication regimen or use of prescription medications affecting metabolism (e.g., thyroid hormones, glucocorticoids) 9. pregnancy, breastfeeding, or planning pregnancy 10. presence of a pacemaker or metal implants, claustrophobia, or other contraindications to fmri 11. psychiatric disorders impairing cooperation 12. expected poor compliance 13. current or recent (within 4 weeks prior to study initiation) participation in other clinical trials