Kornimate/medical-research-clean huggingface dataset:
healing effects of hp802-247 versus antibiotic ointment in mohs micrographic surgery patients

Conditions: Non-melanoma Skin Cancer

Summary: this study compares hp802-247 versus an antibiotic ointment for healing the wound after mohs surgery.


Eligibility criteria:
inclusion criteria: * provide informed consent. * age ≥ 18 years and of either sex. * type i, ii, or iii skin as assessed by the fitzpatrick scale. * willing to comply with protocol instructions, including allowing all study assessments. * scheduled to have head or neck non-melanoma skin cancers removed by mohs micrographic surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long axis if not circular. * acceptable state of health and nutrition, in the opinion of the investigator. exclusion criteria: * history of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin b. * therapy with blood-thinning agents including aspirin within 14 days of the baseline visit (these may be resumed post-surgery). * subjects with platelet or coagulation disorders. * therapy with another investigational agent within thirty (30) days of screening, or during the study. * current systemic therapy with cytotoxic drugs. * current therapy with chronic (\> 10 days) oral corticosteroids. * in the opinion of the investigator the subject has a current life expectancy of less than 1 year.

Keywords: wound non-melanoma skin cancer mohs micrographic surgery head or neck
active detection of the extension of atherothrombosis in high risk coronary patients

Conditions: Coronary Artery Disease

Summary: coronary artery disease is the first cause of death related to atherothrombosis.

coronary artery disease is the first cause of death related to atherothrombosis. there is a close correlation between the extension of coronary artery disease and the severity of atherosclerotic lesions in extra coronary arterial beds. in addition, these symptomatic extracoronary lesions dramatically decrease the survival of these patients. however, scant data are available regarding the prevalence of extracoronary asymptomatic lesions. conversely, the annual absolute risk of these lesions remains unknown. consequently, whether a systematic identification of these extracoronary asymptomatic lesions is relevant remains to be established. the primary objective and primary endpoint of the america study is to demonstrate the superiority of an active detection and management of the extension of atherothrombosis in high risk coronary patients (active strategy) in comparison with standard of care for coronary atherosclerosis (conservative strategy).

Eligibility criteria:
inclusion criteria: 1. three vessel disease recently identified recently (\<6 month) 2. accrue coronary syndromes in patients\>75 years old (\<1 month) exclusion criteria: 1. absence of significant coronary lesions 2. other causes of rise in the troponin level 3. patient\<18 years old 4. pregnant women 5. patient without affiliation to national social security

Keywords: coronary artery disease myocardial infarction atherothrombosis atherosclerosis
micropulse 810 nanomolar (nm), diode laser for diffuse diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: objective: to compare micropulse 810nm diode laser photocoagulation versus argon laser photocoagulation for treatment of diabetic macular edema. micropulse laser technique will be determined by an initial clinical trial comparing single versus double density laser photocoagulation techniques for treatment of diabetic macular edema.the single density is based on the early treatment diabetic retinopathy study (etdrs) grid photocoagulation technique and the double density increases the number of spots. methods: patients with diabetic macular edema will be assigned to receive either micropulse 810nm diode laser photocoagulation or argon laser photocoagulation therapy. first, in a smaller clinical trial, patients will be assigned to single or double density micropulse 810nm diode laser to determine best strategy for this therapy. visual acuity, fundus photographs and fluorescein angiography, and optical coherence tomography measurements , autofluorescence and mferg were obtained at baseline and at 1, 3 and 6 months and 12 months.


Eligibility criteria:
inclusion criteria: * diabetes mellitus (type 1 or 2) * diabetic macular edema in study eye associated to diabetic retinopathy * diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography. * best corrected visual acuity between 34 (20/200) and 68 letters (20/50). * macular thickness greater than 300 mcm on oct. exclusion criteria: * uncontrolled systemic disease * start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit. * hba1c levels greater than 10% * presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema. * presence of epiretinal membrane * presence of vitreomacular traction in the study eye. * neovascularization of disc or elsewhere in the study eye. * history or presence of choroidal neovascularization in the study eye. * presence of rubeosis irides in the study eye. * eye opacity that interfere with clinical documentation and photography. * intra-ocular surgery 90 days before initial visit. * scheduled surgery for study eye. * patients with known allergies to fluorescein.
effects of periodontal therapy on systemic inflammation

Conditions: Periodontal Disease; Cardiovascular Disease; Type 2 Diabetes; Obesity; Metabolic Syndrome

Summary: the purpose of this study is to determine if treating periodontal infections (gum disease) will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.

aims: to determine the effects of periodontal treatment on systemic markers of inflammation in subjects with risk of coronary heart disease. methods: the current study is a randomized, double blind clinical trial, with two treatment groups. eligible participants will be allocated by restricted randomization using the minimization method to the treatment group or to the control group. the treatment group will receive periodontal therapy consisting of instructions of plaque control, supra and subgingival scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid for 7 days. the control group will receive plaque control instructions, supragingival scaling and two placebos. the study plan to enroll 160 participants, 80 in ech arm, over a 6-month period. follow-up clinic visits will be scheduled to occur every 3 months after finishing treatment. baseline and follow-up clinic visits will include periodontal examination, blood collection and medical and dental histories. the following biochemical markers will be determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, ldl and hdl lipoprotein cholesterol and triglycerides, glycemia, high sensitivity c-reactive protein, fibrinogen, erythrocyte sedimentation rate and white blood cells count. in diabetic patients, glycosylated hemoglobin will be also assessed. the study will be conducted in a public health center in santiago, chile. to be eligible for the study, participants have to be older than 35 years and fulfill the medical and periodontal criteria. for the medical criteria participants have to have dyslipidemia, and at least one of the following coronary heart disease risk factors: obesity, smoking, diabetes, hypertension. the periodontal inclusion criteria are: no history of periodontal treatment, the presence of at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and \>30 % of sites with bleeding on probing. the outcomes measures will be levels of serum c-reactive protein, fibrinogen, erythrosedimentation rate, white blood cell count.the outcomes will be measured at 0, 3,6,9, and 6 months after periodontal therapy.

Eligibility criteria:
inclusion criteria: * clinically diagnosis of marginal periodontitis * no history of periodontal treatment * at least 14 natural teeth present * dyslipidemia * and at least one of the following factors: * obesity * diabetes * smoking, hypertension exclusion criteria: * rheumatoid arthritis * any type of cancer in the previous 2 years * pregnancy and lactation * indication of the use of antibiotic for invasive procedures * use of antibiotics in previous three months.

Keywords: periodontitis cardiovascular disease diabetes
integration of refugees into public mental health care

Conditions: Psychiatric Disorders From Chapters 3 and 4 of ICD10

Summary: there are specific barriers to utilise psychotherapeutic services for refugees with mental health problems in the german public health care system. this study aims to evaluate additional organisational components that are hypothesised to improve service utilisation. in a randomised controlled trial, refugees with mental health problems are identified by peers, subsequently assessed by professional staff and referred to public psychotherapeutic health services who offer standard care. participants are assigned to care as usual or to "coordinated and peer supported mental health care"; the latter includes several additional organisational assistance components, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and a interpreter pool. measures include service utilisation and symptom change after 6 months. furthermore the study evaluates whether trained peers can correctly identify participants with mental health problems.


Eligibility criteria:
inclusion criteria: * psychiatric diagnosis from chapters 3 and 4 of icd10 * participant applied for asylum in germany * entry to germany after 2012 * participants is motivated to utilise psychotherapeutic services * patient speaks one of the languages in which services are offered (i.e. german, english, french, arabic, kurdish, dari, farsi, urdu, pashto, tirginya, somali) exclusion criteria: * mental disorder that requires inpatient treatment
efficacy and safety of heparin-grafted membrane for crrt

Conditions: Acute Kidney Injury; Hemorrhage; Coagulopathy

Summary: the investigators hypothesize that the use of heparin-grafted membrane versus conventional membrane in critically-ill patients with bleeding-risk undergoing continuous renal replacement therapy, will effectively prolong the circuit lifespan, without worsening of the systemic aptt or underlying bleeding risk.

aims and objectives: we aim to compare the performance and safety of heparin-grafted an69 membrane (oxiris, gambro) with the conventional an69 membrane (m150, gambro) without systemic anticoagulation during continuous renal replacement therapy (crrt), in critically ill patients with acute kidney injury (aki) admitted to the intensive care unit (icu), who has moderate bleeding risk and in whom systemic anticoagulation is contraindicated.

Eligibility criteria:
inclusion criteria: adult patients (age 21 and above) who are admitted to icus or ccu and requiring crrt for acute kidney injury or esrd patients who has moderate bleeding risk (see below definitions) patients with no systemic or regional circuit anticoagulation informed consent taken from the patient, or proxy if the former is unable to sign due to medical reasons anticipated need for prolonged crrt \> 3 days (moderate bleeding risk criteria:) moderate bleeding risk is defined by any of the following: 1. platelet count \ 50) 2. inr \> 1.5 (but \< 2.5) 3. aptt \> 50 seconds (but \< 75) 4. post-surgery for \< 48 hours 5. post-invasive procedures (eg. pericardiocentasis) \< 24 hrs 6. post major artery puncture or catheter removal from major arteries (carotids, subclavian, or femoral) \< 24 hours 7. recent internal or gastrointestinal bleeding within 48 hours (should be secured bleeding with no relapse noted) exclusion criteria: patients with very high bleeding risk (for which they should also fall outside of the below inclusion criteria - see below) patients who are known to have heparin-induced thrombocytopenia or allergic to heparin patients with other medical conditions for which heparin is contraindicated. patients who require systemic anticoagulation for medical indications (we will accept patients who are on prophylactic doses of anticoagulation for dvt prophylaxis) patients who are pregnant patients/legally accepted surrogate who decline to consent

Keywords: heparin-grafted membrane circuit lifespan continuous renal replacement therapy anticoagulation free bleeding risk acute kidney injury critical illness
skin test study of bm32

Conditions: Hypersensitivity

Summary: the aim of the present skin test study cs-bm32-001 is to evaluate whether the bm32 proteins exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to grass pollen allergic patients

bm32 is a hypoallergenic grass pollen allergy vaccine which consists of an aluminum hydroxide-adsorbed equimolar mix of four active ingredients, bm321, bm322, bm325 and bm326. the four active ingredients are purified recombinant proteins containing non-allergenic peptides from the four major timothy grass pollen allergens, phl p 1 (bm321), phl p 2 (bm322), phl p 5 (bm325) and phl p 6 (bm326) which are fused to the pres domain of hepatitis b virus, a protein used in childhood vaccines. bm32 holds promise not to induce ige mediated immediate type (e.g. anaphylactic reactions) or t-cell mediated late phase side effects during immunotherapy. the aim of the present skin test study cs-bm32-001 is to evaluate whether the bm32 proteins due to their low/absent ige- and t cell-reactivity exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to grass pollen allergic patients (n=60). this study will therefore provide important information for immunotherapy studies based on bm32.

Eligibility criteria:
inclusion criteria: * positive history of grass pollen allergy and positive skin prick test reaction to grass pollen extract * age between 18 and 60 years * subjects must have a standard health care insurance * subject must appear capable to understand and comply with all relevant aspects of the study protocol exclusion criteria: * pregnancy or breast feeding * autoimmune diseases, immune defects including immuno- suppression, immune-complex-induced immunopathies * contra-indication for adrenaline * severe general maladies, malignant diseases * patients under long-term treatment with systemic corticosteroids, immunosuppressive drugs, tranquilizers or psychoactive drugs * contra-indications for skin prick testing such as: skin inflammation in the test area, urticaria facticia, unstable or uncontrolled bronchial asthma (30) * use of beta-blockers * participation in another clinical trial within one month prior to the study; however, participation during the previous month solely in the form of blood donation without other interventions will be acceptable * risk of non-compliance with the study procedure and restrictions * use of oral h1 antihistamines within the previous 3 days, oral ketotifen within the previous 5 days and topical corticosteroids in the test area within the previous 14 days. * systemic (short-term) corticosteroids within the previous 14 days

Keywords: specific immunotherapy grass pollen vaccine allergy grass pollen allergy
cbt enhanced with social cognitive training vs. cbt only with depressed youth

Conditions: Depression

Summary: depression in youth is a serious public health concern for which more personalized treatments are needed. this randomized controlled trial will test the effect of an intervention aimed at enhancing social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. participants in the r33 (n=82) will be youth between ages 13- through 17-years-old currently experiencing depression. youth will be randomized to either an enhanced cbt intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind (cbtsct) as compared to cbt only. the primary target is improvement in both social cognitive skills and depressive symptoms at post-treatment and at a 6-month follow-up.

depression in adolescents is a recurrent and impairing disorder. although some treatments have shown modest effects in children and adolescents (e.g., cognitive behavioral therapy - cbt), there remains a critical need to build upon these therapies to reach even more youths with depression. one variable hypothesized to affect children's interpersonal relationships is their level of social cognitive development on abilities particularly relevant to social functioning and cbt (e.g., social perspective taking; theory of mind). this rct will test the efficacy of an intervention aimed at increasing children's social cognitive (sc) abilities. adolescents (ages 13-17; n=82) with depression diagnoses or clinical levels of depressive symptoms (phq9 \>15) will be randomized to either the social cognitive training enhanced cbt (cbtsct) or cbt only. in the r33 rct, investigators will conduct a trial aimed at replicating the results of the r61 with a new sample of 82 youth (ages 13-17) randomized to cbtsct or cbt only. youth will be evaluated regarding their social cognitive abilities (i.e., theory of mind), level of depressive symptoms, and social functioning at baseline, post-treatment, and at a 6-month follow-up. finally, investigators will test if increases in social cognitive abilities partially accounted for the relation between treatment condition and decreases in depression. if the cbtsct intervention significantly improves participants' social cognitive abilities and decreases depressive symptoms, then this will provide therapists with a more efficient and personalized treatment of depression in youth.

Eligibility criteria:
inclusion criteria: 1. participants ages 13- through 17-years-old 2. youth must have a diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the patient health questionnaire (phq9) \> 15 exclusion criteria: * ever met criteria for a diagnosis of bipolar disorder, schizophrenia, autism, or conduct disorder * current alcohol or substance use disorder with significant impairment * imminent risk of suicide * reading level \< 4th grade

Keywords: depression adolescents cognitive behavior therapy
optimizing parameters for long-pulsed nd:yag laser for reducing hair shaft diameter

Conditions: Androgenetic Alopecia; Hair Loss/Baldness

Summary: this study evaluates the optimizing parameters of long pulse nd:yag laser for reducing the size of hair shaft diameter of the donor for hair transplantation. all participants will receive long-pulsed nd-yag laser treatments with three different parameters at the occipital area.

since the beginning of hair transplantation era, hair transplant technique has been greatly improved to achieve the best natural looking of hairline and hair density. most asians tend to have large size of hair shaft at the donor area, which often cause unnatural look of the hairline at the frontal area after hair transplantation due to the contrast between the transplanted hair and the original hair. the idea of reducing the size of the hair shaft in the certain part of donor area before being transplanted to the frontal hairline becomes appealing. this transection is being practiced extensively in the field of cosmetic medicine by using long-pulsed neodymium-doped:yttrium aluminum gamet (nd:yag), a laser treatment for permanent hair removal and vascular lesions.

Eligibility criteria:
inclusion criteria: * men and women, aged 25-60 years with aga or healthy * completed informed consent form exclusion criteria: * pregnancy or breastfeeding * acute infection on the scalp or any systemic infection * immunocompromised host * chronic wasting diseases * use of any medications which may affect hair loss such as anticoagulants, anti-hypertensive, hormones, anticonvulsants, retinoid, mood stabilizers and antidepressants * unstable medical problems which may affect hair loss such as thyroid diseases, autoimmune diseases, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, congestive heart failure, cerebrovascular accident and psychiatric problems * hair thinning at the occipital area

Keywords: hair transplant hairline laser hair removal
pk and safety evaluation of daptomycin in children ages 2-6 with proven or suspected gram-positive infections

Conditions: Gram Positive Infection; Concurrent Antibiotic Treatment

Summary: this is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called gram-positive bacteria).


Eligibility criteria:
inclusion criteria: * written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care; * male or female between the ages of 2 and 6 years old, inclusive; * able to comply with the protocol for the duration of the study; * clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise; * suspected or diagnosed gram-positive infection for which the subject is receiving standard antibiotic therapy; * a calculated creatinine clearance rate (clcr) ≥ 80 ml/min/1.73m2 as determined by the schwartz equation at baseline; * creatine phosphokinase (cpk) levels less than 2x uln (upper limit of normal) at baseline. * presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on study day 1. exclusion criteria: * investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry; * known allergy/ hypersensitivity to daptomycin; * history of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency; * pneumonia as sole gram-positive infection being treated with standard antibiotics; * subjects with clinically significant abnormal laboratory test results \[including electrocardiograms (ecgs)\], as determined by investigator; * administration of rifampin within 7 days of study drug administration; * body mass index (bmi) that is outside of the 5th to 95th percentile; * subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of investigator); * history of or current clinically significant (at the discretion of the investigator) muscular disease, nervous system or seizure disorder; * administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing; * expected surgical procedure(s) within 24 hours prior to and following dosing; * unexplained muscular weakness, history of peripheral neuropathy, guillian-barre or spinal cord injury; * history of or current rhabdomyolysis.