Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of painless 5-aminolevulinic acid photodynamic therapy for moderate and severe acne vulgaris

Conditions: Acne

Summary: this study is being done to compare a new, continuous illumination and short incubation time regimen of 5-aminolevulinic acid photodynamic therapy (painless ala- pdt) to low-dose and conventional dose of oral isotretinoin for treatment of moderate or severe acne vulgaris. the hypothesis is that the painless ala- pdt will be equally or more efficacious as oral isotretinoin, and taking effect more quickly with less adverse effect.


Eligibility criteria:
inclusion criteria: * clinical diagnosed with moderate to severe acne * male and female patients of age between 18-40 years old * all patients read the instructions of the subject, willing to follow the program requirements * no other topical treatment received within 2 weeks prior to enrollment * no systemic treatment was given within 4 weeks prior to enrollment * patients were unsuitable for other treatments for various reasons and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion exclusion criteria: * those who did not complete the informed consent * the lesions belongs to any of the following conditions: there is damage and inflammation, which may lead to the drug entering the open wound * patients with skin photoallergic diseases, porphyria * known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs * patients with other obvious diseases that may affect the evaluation of efficacy * scars or patients with a tendency to form scars * known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants * severe heart, liver, kidney disease; with hereditary or acquired coagulopathy * those with severe neurological, psychiatric or endocrine diseases * women who are pregnant, breast-feeding or using inappropriate contraceptives -those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment

Keywords: acne low-dose isotretinoin photodynamic therapy painless
dilated perivascular spaces in the dentate nucleus on mri in patients with hypertensive angiopathy or cerebral amyloid angiopathy

Conditions: Hypertensive Arteriopathy; Cerebral Amyloid Angiopathy

Summary: hypertensive arteriopathy (ha) and cerebral amyloid angiopathy (caa) are the two most common forms of cerebral small vessel disease. on mri, chronic small vessel disease-related abnormalities include white matter hyperintensities, dilated perivascular spaces (dpvs), lacunar infarction, and hemorrhagic features (e.g. cerebral microbleeds, cmb). in the cerebellum, deep cmb involving the dentate nucleus (dn) is associated with ha, whereas the presence of superficial cerebellar cmb are associated with caa. dpvs are observed in both diseases, predominant in the subcortical white matter (especially in the centrum semiovale) in caa whereas ha-related dpvs are predominant deep in the brain inside or nearby the basal ganglia. to the best of our knowledge, dn-dpvs have never been studies systematically in small vessel disease. the researchers want to study dn-dpvs on t2-weighted 3t mri in patients with ha or caa and to compare both groups.


Eligibility criteria:
inclusion criteria: * patient registered in the chu de nîmes (france) stroke database with lobar intracerebral hemorrhage \[ich\], subarachnoid hemorrhage or cortical superficial siderosis for caa or basal ganglion ich for ha * patient managed at the chu de nîmes (france) between 01/1/2015 and 31/12/2024 * patient with t2-weighted mri performed with a 3t magnet exclusion criteria: * refusal to participate
an evaluation of the safety and performance of the cathvision cube® system

Conditions: Cardiac Arrhythmia

Summary: the primary objective is to evaluate the safety and technical performance of the cathvision cube® system. the secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.

a prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the cathvision cube® system. patients undergoing assessment and ablation of cardiac arrhythmias, by electro physiology (ep) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the ep procedure. intracardiac signals will be passively recorded using the cathvision cube® system in parallel with a commercial (ce marked) ep recording system and later compared and evaluated. the investigational device will not be used for direct clinical care decisions or therapy. the ep procedure will be guided by the study site standards of care.

Eligibility criteria:
inclusion criteria: * patient indicated by investigator for catheter ablation or diagnostic electrophysiology procedure. * male or non-pregnant female aged ≥18 years. female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure. * able and willing to directly provide informed consent. exclusion criteria: * patient inability to understand or refusal to sign informed consent. * pregnant or nursing patients and those who plan pregnancy in the period up to 1 month following the index procedure. * current participation in another investigational drug or device study that interferes with this study. * patient is a prisoner. * patients who in the opinion of the physician are not candidates for this study. prior atrial septal defect (asd) or patent foramen ovale (pfo) closure with a device using a transcatheter percutaneous approach.

Keywords: atrial fibrillation pulmonary vein isolation radiofrequency cryo balloon ablation software
monitoring anticoagulation in patients on ecmo for severe lung failure

Conditions: ARDS; COVID-19

Summary: a monocentric observational study evaluates the accuracy of anticoagulation monitoring in critically ill patients on ecls (extracorporeal life support) using new markers of the effect of direct thrombin inhibitors and also the accuracy of anticoagulation monitoring in patients on unfractionated heparin using anti-xa. a more accurate setting of anticoagulation may lead to a reduction in the number of serious bleeding and thrombotic complications in these patients.

anticoagulation using a direct thrombin inhibitor, argatroban, is one of the modern options for anticoagulation in patients on vv (veno-venous) ecmo (extracorporeal membrane oxygenation) support, and in 2021 the ecmo center of the university hospital ostrava changed the standard anticoagulation using uhf (unfractionated heparin) to anticoagulation using argatroban as a new standard of routine care. argatroban shows more stable levels and has a short half-life, and a number of foreign ecmo centers have been using argatroban for a long time also as basic anticoagulation in all ecmo patients. to monitor the effect of direct thrombin inhibitors, it is possible to use monitoring of anti-fiia activity, which directly assesses the effect of the anticoagulant on thrombin activity. anticoagulation with argatroban may reduce the risk of serious bleeding complications. target values of aptt (activated partial thromboplastin time) and anti-fiia can be determined according to elso (extracorporeal life support organization) guidelines.

Eligibility criteria:
inclusion criteria: * patients with covid-19 * ards according to the berlin definition * veno-venous (vv) ecmo * full coagulation with argatroban or heparin to an anti-fiia value of 0.4-1.5 or aptt 50-60 exclusion criteria: - age under 18 years

Keywords: ecmo ards (acute respiratory distress syndrome) anticoagulation thrombotic complications lmwh (low-molecular-weight heparin) argatroban
sentinel lymph node identification in the axilla of women with breast cancer using ultrasound and iron injection

Conditions: Breast Neoplasm; Carcinoma, Ductal, Breast; Carcinoma, Intraductal, Noninfiltrating

Summary: this study evaluates a new method of testing the lymph nodes in the armpit of patients with breast cancer for tumor involvement. all participants involved in this study will undergo an injection of a small amount of iron dissolved in liquid followed by an ultrasound of the axilla that will make previously invisible lymph nodes visible, allowing them to be sampled in an outpatient setting.

lymph nodes are small collections of tissue all over the body that drain bodily fluid. these axillary lymph nodes are important in evaluating breast cancer since, if they are positive, it suggests that the cancer cells have spread outside of the breast. the current standard of care is for most breast cancer patients undergoing surgery to have a sentinel lymph node biopsy which is a procedure to take a sample of the lymph nodes in the armpit (also called the axilla) during their breast surgery. however this intraoperative biopsy comes with certain risks such as arm swelling or lymphedema, arm pain, arm numbness/tingling, and/or psychological distress from waiting for the results or the possibility of further interventions. in order to avoid this and have a result before surgery, this study will explore a nonsurgical method of sampling these lymph nodes. normally suspicious lymph nodes are hard to find accurately by exam and ultrasound. a new method has been developed that involves injecting a small amount of iron dissolved in liquid into the breast that gets absorbed by the lymph nodes making them bright on ultrasound and possible to biopsy. this method has been shown to have results as accurate as standard sentinel lymph node biopsy by comparing them in the operating room. this study will now investigate performing these ultrasounds and biopsies in the office as well as compare these results to the results of the standard sentinel lymph node biopsy in the operating room. the results of this study could help future breast cancer patients to avoid invasive sampling and all of the accompanying risk as well as give patients and the care team an idea of the extent of disease sooner in order to guide management.

Eligibility criteria:
inclusion criteria: * female patients at least 21 years old * patients with invasive ductal carcinoma staged t1 or t2 with estrogen receptor and progesterone receptor positive (er+/pr+) who are scheduled for sentinel lymph node biopsy * patients with ductal carcinoma in situ (dcis) (high or low grade) who are scheduled for sentinel lymph node biopsy including: * patients having a mastectomy * patients with palpable dcis * patients undergoing breast conservation with large (\>5cm) area of dcis * patients with signed consent to participate exclusion criteria: * preoperative palpable axillary lymphadenopathy * preoperative ultrasound demonstrating suspicious adenopathy * previous axillary dissection or previous lymph node biopsy * patients with invasive lobular carcinoma * patients who are pregnant
finasteride (mk-0906) and male breast cancer - a register-based nested case-control study (mk-0906-162/2003.021).

Conditions: Male Breast Cancer

Summary: the objective of this study is to investigate the potential association between finasteride (mk-0906) exposure and the development of breast cancer in men residing in denmark, sweden, finland, and norway from data in national registries. the primary hypothesis of this study is that the previously reported increased incidence of male breast cancer among finasteride users is explained by confounding factors.


Eligibility criteria:
inclusion criteria: * participant's study medical information available in population-based health and medical registries, prescription registries, and mortality registries in denmark, finland, norway, or sweden within the observation period of 1995 to 2013 * male with breast cancer with medical information in one of the 4 country-specific registries in this study or country- and age-matched control men without breast cancer and with medical information in one of the 4 country-specific registries * study participant's exposure to finasteride is available exclusion criteria: for country- and age-matched control men without breast cancer * previous cancer diagnosis or treatment for cancer except non-melanoma skin cancer * previous prostatectomy * finasteride or dutasteride use (dutasteride is a drug in the same class as finasteride) within first 6 months of registration in the prescription registers (new user design).

Keywords: males breast cancer finasteride proscar® propecia®
effect of acetazolamide on visuo-motor learning in lowlanders older than 40 years at altitude

Conditions: Altitude Hypoxia

Summary: randomized, placebo controlled trial evaluating the effect of acetazolamide on visuo-motor learning performance in lowlanders older than 40 years travelling from 760 m to 3'100 m.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide intake on visuo-motor learning performance in lowlanders older than 40 years travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3'100 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3'100 m. an interim analysis will be carried out when 80 participants will have completed the study or after the first year. the peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility criteria:
inclusion criteria: * healthy men and women, age 40-75 yrs, without any disease and need of medication. * born, raised and currently living at low altitude (\<800m). * written informed consent. * kyrgyz ethnicity exclusion criteria: * any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure. * any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol. * allergy to acetazolamide and other sulfonamides.

Keywords: healthy participants older than 40 years cognition visuo-motor learning performance prevention acetazolamide
visual processing speed and objective analysis of ocular movements in multiple sclerosis

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing Remitting Multiple Sclerosis; Progressive Multiple Sclerosis

Summary: this project aims to analyze ocular motility problems, visual processing speed and microperimetry, and their relationship with consolidated retinal structural biomarkers (optical coherence tomography, oct) in patients with multiple sclerosis w/w reading complaints comparing with healthy subjects.

anamnesis, ophthalmological medical history including difficulties in reading with appropriate glasses. the following protocol will be applied: * comprehensive eye examination * stereopsis * primary gaze position * cover test: far and near * vergence and version eye movements * presence of nystagmus * far and near best corrected visual acuity, with updated refraction -.pupillary light reflex * biomicroscopy of the anterior pole * intraocular pressure * recording of eye movements during two standardized tests: international reading speed texts test (irest®) and developmental eye movement test (dem™) with tobii™ pro nano hardware package eye-tracking system and tobii™ pro lab - full edition software. * visual processing speed * microperimetry * optical coherence tomography * eye fundus * patients with a history of clinical optic neuritis will additionally undergo contrast sensitivity tests, the farnsworth® test (farnsworth test 28 hue x 100) and normal monocular perimetry using the standard swedish interactive thresholding algorithm (sita-central 24-2) perimeter test. humphrey® (humphrey visual field analyser) and other tests at the discretion of the investigator.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * best distant corrected visual acuity equal or greater than 0.7 (decimal scale). glasses or soft contact lenses users. * best close corrected visual acuity equal to or greater than 20/30 (snellen scale).glasses or soft contact lenses users. exclusion criteria: * patients with a history of acute optic neuritis (on) and/or who experienced an episode of on \<6 months prior to the study, to avoid potential interference of papilledema with accurate peripapillary rnfl thickness measurements. * patients with other retinal and optic nerve diseases, advanced cataracts according to the international lens opacities classification system iii (locs iii) (opacities greater than c2n2) * patients with other ophthalmological diseases that could affect central visual acuity * subjects with high refractive error (+ - 6 diopters). * subjects with other demyelinating disorders (neuromyelitis optica or acute disseminated encephalomyelitis).

Keywords: ocular motility disorders eye movement eye tracking microperimetry fixational eye movements visual processing speed optical coherence tomography
ecare for moods: an internet-based management program

Conditions: Major Depressive Disorder; Bipolar Disorder

Summary: the study aim is to explore the effect of a comprehensive internet-based disease management program for bipolar disorder and recurrent or chronic major depression on clinical outcomes and satisfaction with care.

this study is a randomized controlled trial that includes 404 subjects, 300 subjects with bipolar disorder and 104 subjects with recurrent or chronic major depressive disorder. the study subject diagnostic groups (bipolar and depressive) are separately randomized to either usual care or to ecare and the data collected from the two diagnostic groups are analyzed separately. all subjects randomized to the ecare intervention are assigned an ecare nurse care manager in addition to one year of access to an internet-delivered care management and patient self-management program. while both diagnostic groups receive similar internet-delivered services for depression, the subjects with bipolar disorder receive special services for bipolar disorder. all subjects randomized to usual care will receive their normal psychiatric care and do not have access to the website. study subjects are followed for 24 months and outcome measurements are taken every six months by telephone interviewers blinded to treatment assignment. specific measures include depression and mania symptoms, severity, adherence with medication, general health, functioning at work and at home, satisfaction with care, and confidence in coping with their disorder. the primary outcomes for patients with bipolar disorder are the severity of depression and the severity of mania over time. the primary outcome for patients with recurrent or chronic depression is the severity of depression over time. the hypothesis is that internet-based care management will have a favorable effect on the burden of bipolar disorder and/or on recurrent/chronic depression over time.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar or recurrent major depressive disorder and access to a computer exclusion criteria: * no diagnosis of bipolar or recurrent major depressive disorder, no computer access

Keywords: internet based disease management program
efficacy safety, and tolerability of topical terbinafine in patients with mild to moderate toenail fungus of the big toenail

Conditions: Onychomycosis

Summary: this study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. this trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.


Eligibility criteria:
inclusion criteria: * male and females 12 - 75 years of age * fungal toenail infection of one or both of the large (great) toenails * the nail infection must be due to a dermatophyte, (mixed infections dermatophyte and non-dermatophyte\] are not allowed) exclusion criteria: * target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinafine prior to baseline or at any time during the trial. other topical treatments for athlete's foot may be recommended at the discretion of the investigator. * subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved * no administration of systemic antifungal medications within 6 months prior to screening visit * no application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit * no professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit * known pregnancy or lactation at time of enrollment other protocol-defined inclusion/exclusion criteria may apply

Keywords: toenail fungus onychomycosis nail fungus toenail fungal infection tinea unguium dermatophytes foot dermatoses
circulating oxidative stress and gestational hypertension. study of the evolution of free-radical markers of oxidative stress from before to after childbirth in two groups of women: normal pregnancy and pre-eclampsia.

Conditions: Pregnancy Complicated by Pre-eclampsia.; Normal Pregnancy

Summary: the aim of this study is to explore a mechanism that could potentially explain why women with a pregnancy complicated by pre-eclampsia are described as having an increased risk of cardiovascular disease later in life. if the hypothesis of this study turns out to be true, that is to say that women with pre-eclampsia have a higher level of oxidative stress than women with a normal pregnancy and that this difference persists after the delivery (6 months), a controlled randomized interventional study aiming to evaluate either therapeutic supplementation with antioxidant vitamins (vit c and e) or modifications in diet could be envisaged.


Eligibility criteria:
inclusion criteria: * patients who have provided written informed consent * patients covered by a health insurance scheme * age \> 18 years * normal pregnancy * or pre-eclampsia defined according to the following classical criteria: (i) de novo hypertension defined by arterial blood pressure of at least 140 mm hg (systolic) or at least 90 mm hg (diastolic) confirmed by at least two measurements separated by at least 4-6 h, occurring after the 20th week of gestation in a women known beforehand to have a normal blood pressure, (ii) proteinuria defined by urinary excretion of at least 300 mg of protein per 24 h. if 24-hour urine is not available, proteinuria is defined as a concentration of urinary protein of 300 mg/l or more (or \>1 + on the urinary dip) in at least two samples of urine taken randomly, but at an interval of at least 4-6 h \[7\]. pre-eclampsia is defined as severe if: persistent systolic bp \> 170 mm hg and/or diastolic bp \> 110 mm hg, and/or diuresis \ 70 ui/l and or hemolysis manifesting as haptoglobin \< 0.06 g/l, or a fall in ldh or the presence of schistocytes, the latter three signs define the hellp syndrome) and/or seizures. * term\> 26 sa. exclusion criteria: * refusal to provide consent * context of patent infection. * premature rupture of the fetal membranes. * preexisting or gestational diabetes. * vasculoplacental diseases other than pre-eclampsia: placental abruption or infarction, intrauterine growth retardation of in utero fetal death not occurring in a context of pre-eclampsia. * chronic or gestational aht not meeting the criteria for pre-eclampsia. * twin/multiple pregnancies