Kornimate/medical-research-clean huggingface dataset:
a phase ii, randomized study of aczone™ (dapsone) gel, 5% for papulopustular rosacea.

Conditions: Rosacea

Summary: the purpose of this study is to evaluate the safety and effectiveness of aczone™ gel compared to placebo (inactive substance), metrogel® and a combination of aczone™ gel and metrogel® for the treatment of rosacea. aczone™ gel, 5% is a topical (applied to the skin) medication that is approved by the united states food and drug administration (fda) for the treatment of acne vulgaris in people 12 years and older. the use of aczone™ for the treatment of rosacea is investigational. an investigational use is one that is not approved by the fda. subjects will apply the study treatment for 12 weeks. efficacy assessments will be performed at baseline and weeks 2, 4, 8, and 12. laboratory assessments will be conducted at baseline and week, 2, 4 and 12.

study objective: •to evaluate the safety and preliminary efficacy of aczone in subjects with papulopustular rosacea study population: approximately 400 male and female subjects will be enrolled at 27 study centers in the united states. study treatment: subjects will be randomized to 1 of 5 treatment regimens. subjects will receive study medication for 12 weeks. study participation is 13 weeks (5 clinic visits and 1 telephone follow-up).

Eligibility criteria:
inclusion criteria: to be eligible for the study, subjects must fulfill all of the following criteria: 1. men or women ≥18 years of age. 2. a diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline. 3. an investigator global assessment (iga) score ≥2 4. in good physical and mental health. 5. signature of an approved informed consent form for the study and hipaa authorization (if applicable). 6. willingness to comply with the protocol. exclusion criteria: subjects meeting any of the following criteria will be excluded from the study: 1. a skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that would confound the evaluation of the rosacea condition. 2. current or past ocular rosacea, such as conjunctivitis, iritis, and keratitis, of sufficient severity to require topical or systemic antibiotics. 3. treatment with topical antibiotics, topical steroids and other topical rosacea treatments on the face within 14 days of baseline and throughout the study. 4. treatment with systemic steroids within 30 days of baseline and throughout the study. 5. treatment with any systemic antibiotics within 30 days of baseline and throughout the study. 6. treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to baseline or throughout the study. 7. treatment with topical retinoids within 30 days or systemic retinoids within 180 days of baseline and throughout the study. 8. treatment with physical modalities that could benefit rosacea are prohibited within 30 days of baseline and throughout the study.

Keywords: rosacea, papulopustular rosacea,erythema, dapsone
the effect of bispectral index monitoring on recovery from deep sedation

Conditions: Cerebral Palsy

Summary: the purpose of this study was to compare bis (bispectral index) monitoring and clinical sedation scale assessment on the recovery time and propofol usage from deep propofol sedation in children with cerebral palsy who received botulinum toxin injection.

after arrival in the preoperative holding area, children were randomly allocated into two groups using a computer-generated random assignment scheme. five minutes before propofol sedation, remifentanil is administered intravenously at 0.025 μg / kg / min for analgesic effect and continued throughout the sedation process until just before the end of the procedure. five minutes after remifentanil administration, 2 mg / kg of propofol mixed with 1 mg / kg of lidocaine was administered over 30 seconds, followed by continuous infusion at 100 μg / kg / min. group c is monitored using umss(university of michigan sedation scale) scores every three minutes, and group b is monitored using bis score until deep sedation. deep sedation is defined based on umss score of 3-4 and bis score of 65 ± 5. if the sedation score is determined to have reached a deep sedation, a botulinum toxin injection is given by a practitioner blind to how to assess the depth of sedation. independent investigator who is blind to group assignement assesses the oxygen saturation, respiration, and blood pressure, recovery time from sedation, and adverse events during and after sedation.

Eligibility criteria:
inclusion criteria: * 3-12 years old children with spastic cerebral palsy receiving botulinum toxin injection with deep sedation * american society of anesthesiologists physical status 1-2 exclusion criteria: * body mass index \> 30 kg/m2 * unstable heart disease * anticipated difficult airway including congenital facial or airway anomaly * recent upper respiratory tract infection ( \< 2 weeks) * gastroesophageal reflux * allergy history to propofol, remifentanil or any drug used during procedure

Keywords: cerebral palsy botulinum toxin bispectral index monitor deep sedation recovery
very low calorie liquid diet for pre op patients

Conditions: Morbid Obesity; Steatosis

Summary: despite the relative consensus on the benefits of pre-surgical weight loss, i.e., the reduction of comorbidities associated with surgical act, such as decreased visceral fat, liver volume, hemorrhage perioperative and surgical time, the characteristics of the diet to be employed in this period need to be defined more clearly. as there is no description of comparative studies on diet of normal consistency, using solids and liquids, there are doubts as to the real need for consistency liquid diet in preoperative bariatric surgery. the lack of robust evidence has made nutrition professionals adopt different procedures. there is still a belief that these patients are unable to lose weight in the preoperative period, the ongoing history of previous attempts without success.


Eligibility criteria:
inclusion criteria: * to be clinically severe obese; to be in preoperative phase of bariatric surgery. exclusion criteria: * pregnancy and minors under 18 and adults over 60 years of age.

Keywords: very low calorie diet liquid diet visceral fat liver fat.
physician assessment of the clinical utility of a patient-specific 3d electro-anatomical heart model in vt ablation

Conditions: Ischemic Monomorphic Ventricular Tachycardia

Summary: ace-vt is a clinical pilot study designed to evaluate the ability of the cardiosolv software system to generate an output for the physician to review in a timely fashion, consistent with the standard of care vt ablation workflow. this study will assess the acute effectiveness of using the cardiosolv software system output as additional supporting information during ablation.


Eligibility criteria:
inclusion criteria: 1. participant meets standard criteria for vt ablation and is scheduled for vt ablation by their cardiologist or electrophysiologist 2. 18 to 85 years of age 3. vt and ischemic cardiomyopathy 4. a pre-procedure mri with lge is available (performed within 1 year of procedure, unless an mi has occurred since mri) with adequate image for analysis 5. participant is able and willing to provide written informed consent exclusion criteria: 1. contradiction to mri (except those with mri compatible pacemaker/icd/crt devices implanted or site has approved procedure for mri of non-compatible devices). 2. participant implanted with an lvad. 3. enrolled in another non-imaging intervention assignment study that could confound the results of this study.
early fixation for diaphyseal humeral shaft fractures in the elderly patients

Conditions: Humerus Shaft Fracture; Elderly (People Aged 65 or More)

Summary: the study purpose is to evaluate whether early surgical fixation of upper arm fractures in elderly patients' age 65 years and older improves patient functional and psychological outcome scores compared to the standard of care with non-operative management.

a prospective cohort study following patients that are 65 years or older after they have suffered a humeral shaft fracture. follow up will continue until 1 year post treatment to see functional and psychological outcomes.

Eligibility criteria:
inclusion criteria: 1. diaphyseal humeral shaft fracture (as defined as superior border of insertion of pectoralis major proximally, to the distal diaphysis) 2. ambulatory (with or without the use of walking aides) exclusion criteria: 1. fractures with intra-articular extension 2. ipsilateral upper extremity injury 3. patients with vascular injury 4. brachial plexus injury 5. compartment syndrome 6. pathological fractures 7. open fractures 8. periprosthetic fracture 9. bmi \&gt;40 10. dementia or cognitive impairment that inhibits the collection of outcome measures 11. likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.) 12. inability to provide informed consent

Keywords: patient outcomes
stepped care for mandated college students

Conditions: Alcohol Use

Summary: this project provides stepped care to college students mandated for alcohol-related offenses. students are first provided with a minimal intervention, a 15-minute discussion of their alcohol use. students who continue to drink in a risky manner are provided with a more intensive, hour-long brief motivational interview. by providing more intensive treatment to the students who exhibit risky drinking, we hope to maximize the efficiency of campus alcohol programs.

colleges and universities have seen a large increase in the number of students referred to the administration for the violation of alcohol policies. however, research indicates that the majority of mandated students may not require extensive treatment. stepped care assigns individuals to different levels of care according to their response to treatment. encouraging research indicates that minimal interventions and bmis may reduce heavy drinking in mandated college students. thus, implementing stepped care using these interventions could maximize treatment efficiency and reduce the demands on campus alcohol programs. participants will be students mandated to attend an alcohol program at a northeastern private university. all participants will receive step 1, a 15-minute minimal intervention including a discussion of the referral incident and the provision of a booklet containing advice to reduce drinking. participants will be assessed six weeks later, and those continuing to exhibit risky alcohol use will receive step 2, randomization to: (a) a 60-90 minute brief motivational intervention (bmi) or (b) an assessment-only control. all students will complete 3, 6, and 9 month follow-up assessments. the three groups will be compared on two outcome measures: frequency of binge drinking episodes and alcohol-related problems in the past 30 days. predictors of treatment response (readiness to change, alcohol expectancies, age of first drink, sensation seeking, descriptive norms, and reaction to the referral) will also be evaluated for both steps of the intervention. research findings will assist college alcohol programs in determining the most effective and efficient allocation of their limited resources in treating mandated students. the long-term objectives of this research are to inform preventive intervention research about the utility and cost-effectiveness of stepped-care approaches and to identify individual and situational factors that qualify these effects.

Eligibility criteria:
inclusion criteria: * male and female students 18 years of age or older. * participants will have signed a witnessed informed consent. * participants will have been referred for an alcohol-related offense exclusion criteria: * participants who meet current dsm-iv criteria for substance use disorder * participants who are currently in treatment for substance use.

Keywords: stepped care brief motivational intervention minimal intervention treatment response college students
cognitive outcome after two-stage liver-operation

Conditions: Delirium and Post-operative Cognitive Dysfunction (POCD)

Summary: cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.


Eligibility criteria:
study group: inclusion criteria: * patients undergoing a planned elective in situ split liver operation with following resection after approximately ten days with or without additional elective surgery in the same session at the university hospital, campus virchow-klinikum of the charité - university medicine berlin * patients aged greater than or equal to 18 years * patients of both genders * offered patient information and written informed consent * no participation in another clinical trial according to the german drug law (amg) during the trial and one month before inclusion exclusion criteria: * lacking willingness to save and hand out pseudonymised data within the clinical study * accommodation in an institution due to an official or judicial order * staff of charite university hospital berlin, virchow klinikum * illiteracy * unability of german language use * visual and acoustical impairment * core on the mini mental state examination (mmse) at screening of 23 or less * american society of anaesthesiologists (asa) classification greater than iv * ascertained psychiatric disease * intake of psychotropic drugs (including sleeping pills and benzodiazepine) * symptomatic bradycardia * symptomatic heart rhythm disorder (arrhythmia) * coronary heart disease canadian society of anaesthesiologists criteria (csc) stadium iv or the presentation of a coronary heart disease that needs intervention control group: inclusion criteria: •male and female asa ii/iii patients, aged ≥ 18 years exclusion criteria: * mini-mental-state-examination ≤ 23 points * neuropsychiatric morbidity, which limits the conduction of the neurocognitive testing * taking psychothropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis
ultrasound elastography of breast lesions

Conditions: Breast Neoplasms

Summary: our hypothesis is that the addition of shearwave elastography (swe) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.


Eligibility criteria:
inclusion criteria: * patients who have been referred to a breast ultrasound because of a positive physical palpation and/or positive mammograms and/or positive ultrasound and/or positive mri. * female * age 21 or older * provide informed consent exclusion criteria: * women who are unwilling or unable to provide informed consent * women with breast implants * women with superficial lesions or lesions on skin (with the most superficial surface of the lesion within 5 mm of the skin surface) * women who are pregnant or breastfeeding * women who are undergoing chemotherapy or radiotherapy for any cancer * women with previous breast conserving surgery on the breast of interest note: previous excision of a benign lesion 4 cm or more away from the suspected lesion does not constitute an exclusion criterion.

Keywords: breast lesion ultrasound bi-rads malignancy women
genetics of recurrent early onset major depression

Conditions: Depression

Summary: this study will identify specific genes that may cause a predisposition to depression in some families.

depression is a serious medical illness that is often difficult to diagnose and treat. studies on patterns of depression within families suggest that inherited genes may cause a predisposition to the disorder. people with early onset depression often have more relatives with depression than people whose depression does not begin until later in life. it is likely that several interacting genes cause this tendency towards the disorder, rather than one specific gene. this study will serve to identify particular genes that may cause a susceptibility to depression in order to better understand the brain mechanisms involved with severe depression. in turn, this may aid in the development of new treatments for depression. participation in this observational study will entail one interview and one blood test. participants will be interviewed, either in person or by telephone, about their personal and family psychiatric history. the blood sample will be collected at a time and location that is convenient for the participant. participants may also be asked to invite other family members to participate in the study. for information on a related study please follow this link: http://clinicaltrials.gov/show/nct00005914

Eligibility criteria:
inclusion criteria: * history of recurrent major depression * has a parent or sibling with a history of recurrent major depression * depression began before the age of 31 exclusion criteria: * bipolar i (manic-depressive) disorder * schizophrenia

Keywords: depressive disorder family genetics
a phase i safety, pk and pd study of kw-2478 in patients with multiple myeloma, chronic lymphocytic leukaemia or b-cell non-hodgkin's lymphoma

Conditions: Multiple Myeloma; Chronic Lymphocytic Leukaemia; B-cell Non-Hodgkin's Lymphoma

Summary: the aim of this study is to determine the safety, tolerability and dose-limiting toxicities of kw-2478 and to determine the maximum tolerated dose and recommended phase ii dose for patients with relapsed/refractory mm, cll or b-cell nhl.

this is a phase i, open-label, dose-escalation study of kw-2478 in patients with relapsed/refractory multiple myeloma, chronic lymphocytic leukaemia or b-cell non-hodgkin's lymphoma who have no established therapeutic alternatives. up to 42 patients will be enrolled at up to six investigational sites over a period of approximately 12 months until an mtd is reached. an additional 12 patients may be enrolled at the mtd in an expanded cohort of one or more of the eligible conditions.

Eligibility criteria:
inclusion criteria: 1. patients with a confirmed diagnosis of multiple myeloma, chronic lymphocytic leukaemia, or b-cell non-hodgkin's lymphoma, who have had at least two prior standard treatment regimens and are without established therapeutic alternatives. 2. signed iec-approved informed consent 3. ecog performance status of 0, 1 or 2; 4. life expectancy of at least 3 months; 5. adequate haematologic status, liver function and renal function 6. patients of reproductive potential must agree to follow accepted birth control methods during the study exclusion criteria: 1. no anti-cancer treatment for ≥ 3 weeks prior to receiving study drug 2. any other severe, acute or chronic illness 3. no other prior or concurrent malignancy 4. immunosuppressant therapy

Keywords: cancer blood disorders leukaemia, adult chronic lymphoma multiple myeloma
safety, tolerability and pharmacokinetics of oral doses of rp3128 of rhizen pharmaceuticals

Conditions: Healthy Volunteers; Asthma

Summary: rp3128 is a calcium release activated calcium (crac) channel modulator. the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending dose(s) of rp3128 in healthy volunteers and to evaluate the effect on late phase asthmatic response to allergen challenge in patients with mild asthma.

the study consists of three parts; part 1: single ascending dose (sad), part 2: multiple ascending dose (mad) in healthy volunteers and part 3: proof of concept (poc) study in mild asthmatics. there will be 5 cohorts in sad and 3 cohorts in mad, the doses used in the mad will be based on emerging safety, tolerability and pharmacokinetics (pk) from part 1 (sad). poc is a randomized, placebo- controlled, double blind, two period cross-over, proof of concept study in male and female of non child bearing potential with history of mild asthma. the highest identified dose of rp3128 in part 2 (mad) will be considered for poc

Eligibility criteria:
inclusion criteria: * male and non-childbearing female subjects (sad/mad) and male and non-childbearing female patients with mild asthma; * healthy subjects as determined by past medical history, vitals, physical examination and 12-lead ecg, clinical laboratory tests. * body mass index (bmi) between 18.0 and 30.0 kg/m2 inclusive, weight ≥50 kg; * non-smokers or ex-smokers * willingness to adhere to the protocol requirements as evidenced by the informed consent form (icf) duly read, signed and dated by the subject; able to comply with protocol requirements and or study procedure; * negative screen for drugs of abuse and alcohol at screening and on admission. * male subjects should agree not to donate sperm for 3 months post dose; and * female partners (of child bearing potential) of male subjects should use 2 methods of highly effective contraception for 3 months post last additionally for poc * pre- bronchodilator forced expiratory volume in 1 sec( fev1) of \> 70% (adjusted for age, sex and race) * steroid naïve subjects with history of mild asthma that satisfy the global initiative for asthma (gina) definition of asthma, but otherwise healthy. exclusion criteria: * subjects with evidence or history of clinically significant medical history. * history of tuberculosis (tb) and/or a positive tuberculin skin test and/or quantiferon- tb®-gold test. * use of any immunotherapy within 3 months prior to screening. * history of serious adverse reaction, severe hypersensitivity or allergy to any drug/drug substance (except house dust mite, pollen allergens or cat dander allergy in asthmatics) or in any other circumstance (e.g. anaphylaxis); * abnormal liver function * positive screen on hepatitis-b surface antigen (hbsag), antibodies to the hepatitis c (hcv) or antibodies to the human immunodeficiency virus (hiv) 1,2;

Keywords: rp3128 phase 1 healthy volunteers
alefacept mechanism of action in psoriasis

Conditions: Psoriasis

Summary: to determine the mechanism of action of alefacept in patients with psoriasis.

the purpose of the study is to better understand the mechanism of action of an fda approved drug (alefacept). subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 weeks. response is assessed by improvement in the pasi score. the responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. skin biopsies will be obtained throughout the study and t-cell apoptosis will be correlated to clinical response. there is no placebo group. the duration of the study is approximately 1 year.

Eligibility criteria:
inclusion criteria * alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. patients must have at least one plaque of least 2.5 cm in diameter (for biopsies). exclusion criteria * cd4 \< 400/ml * wbc less than lower level of normal for the reporting laboratory * \< 5% body surface area involved with psoriasis * serious infection e.g., latent or active tuberculosis * history of aids or hepatitis b,c, all internal cancers, lymphoma, untreated cutaneous basal or squamous cell carcinoma * systemic anti-psoriasis medications and phototherapy within 28 days of the first dose of alefacept * topical anti-psoriasis medications within 14 days of the first dose of alefacept, except for moisturizers, tar shampoos (exception, elidel is permitted to be applied on the face, groin and axillae areas. these areas are not biopsied.) * inability to understand consent form or comply with study requirements * pregnancy or lactation * concurrent medical illness that would make participation in this clinical trial ill-advised * any contraindications to using alefacept

Keywords: psoriasis alefacept