Kornimate/medical-research-clean huggingface dataset:
pilot study of open-label placebo to treat major depressive disorder

Conditions: Major Depressive Disorder

Summary: placebo pills (pills with no active ingredients) have been shown in research studies to somehow produce self-healing processes. the purpose of this study is to determine whether people will be willing to enter an open-label non-deceptive placebo treatment for major depressive disorder (mdd) and whether open-label placebo can be effective for treating mdd in the context of a supportive physician-patient relationship.


Eligibility criteria:
inclusion criteria: * men or women aged 18-60 years old. * current major depressive disorder (mdd) exclusion criteria: * pregnant women or women of child bearing potential not using a medically accepted means of contraception. * patients who are a serious suicide or homicide risk. * unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease. * the following diagnostic and statistical manual of mental disorders-iv diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol, active within the last year; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) bipolar disorder; 7) acute bereavement; 9) severe borderline or antisocial personality disorder; 10) current primary diagnoses of panic disorder, social phobia, generalized anxiety disorder (gad), or obsessive compulsive disorder (ocd) (disorders that present as chief complaint and/or have their onset preceding the onset of major depressive disorder). * uncontrolled seizure disorder. * patients with mood congruent or mood incongruent psychotic features. * current use of other psychotropic drugs. exception: patients who have been on a stable dose for 30 days of classes of medications such as non-benzodiazepine sedatives, anxiolytic benzodiazepines, non-narcotic analgesics may be included. flexibility will be allowed based on physician discretion. * clinical or laboratory evidence of hypothyroidism. * patients who have taken an investigational psychotropic drug within the last year. * patients who have not responded to two or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g.,for six weeks or more) over the past five years. * any concomitant form of psychotherapy (depression focused)

Keywords: depression placebo effect complementary therapies alternative therapies
harapan kita ecp (external counter pulsation) study hartec study

Conditions: Cardiac Rehabilitation; Angiogenesis; Refractory Angina

Summary: external counterpulsation therapy (ecp) is a therapeutic procedure that performed on patients with angina or heart failure to relieve the ischaemic symptoms, improve functional capacity, and quality of life. in recent studies, ecp has already proved to reduce angina symptoms, decrease degree of ischemic in heart train test. external counterpulsation therapy (ecp) therapy is a non-invasive technique for sequentially pressuring calf, lower thighs, and upper thighs through developed cuffs at pressure above systolic blood pressure when diastole, then deflated at systole.

this study aims to evaluate the effect of ecp therapy on cardiovascular hemodynamic, coronary perfusion, endothelial function, angiogenesis and artery genesis of the coronary blood vessel to refractory angina pectoris patients refractory angina pectoris patients in harapan kita hospitals who do not respond to drugs adequately will be divided by 2 groups, control \& treatment. inclusion criteria include age 21 - 80 years, refractory angina ccs iii-iv whom are not candidate for re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medications). exclusion criteria include aorta aneurysm, abdominal aneurysm, acute coronary syndrome, acute heart failure, heavy aortic regurgitation, malignant arrhythmia, blood pressure above 180/100mmhg, acute limb ischemia, dvt, active thrombophlebitis, and pregnancy. the investigator conducts a double-blind randomized control trial. the participants will get 35 hours ecp treatment, initial treatment pressure is 300 mmhg. whilst control groups will get 75mmhg. at the end of treatment, the investigator compare the hemodynamic effect on coronary perfusion, endothelial function, angiogenesis, and coronary blood vessel arteriogenesis. quality of life improvement based on who-5 between groups

Eligibility criteria:
inclusion criteria: * age 21 - 80 years * refractory angina ccs iii-iv whom are not candidate for re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medica mentosa). exclusion criteria: * aorta aneurysm, * abdominalis aneurysm, * acute coronary syndrome, * acute heart failure, * heavy aortic regurgitation, * malignant arrhythmia, * blood pressure above 180/100mmhg, * acute limb ischaemia, * dvt, * active thrombophlebitis, * pregnancy

Keywords: refractory angina angiogenesis external counterpulsation angiopoietin
trial of nrx 194204 in castration- and taxane-resistant prostate cancer

Conditions: Castration Resistant Prostate Cancer

Summary: this study is to evaluate the benefits of investigational drug, nrx 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer.

numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. nrx 194204, a second generation rexinoid, is a highly potent and specific activator of rxrs (retinoid x receptors). because nrx 194204 is significantly more selective for the rxrs relative to the rars (retinoic acid receptors) than a first generation approved drug, it is associated with fewer adverse events in clinical use. this study seeks to investigate nrx 194204 monotherapy in patients with castration- and taxane- resistant prostate cancer.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed prostate cancer * documented progression on at least one prior hormone treatment, and at least one taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment * male, age \> 18 years * ecog (eastern cooperative oncology group) performance score of 0-2 * adequate bone marrow, renal and hepatic function * men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter exclusion criteria: * prior treatment with nrx 194204 or bexarotene (targretin) * presence of parenchymal brain metastases * history of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage i or stage ii cancer in complete remission for at least 12 months * patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or myocardial infarction within 6 months of enrollment * known hiv or hepatitis b or c infection * life expectancy \< 3 months * patients with any history of thyroid disease, pituitary disease or treatment with thyroid replacement hormone * patients with a history of pancreatitis or at significant risk of developing pancreatitis

Keywords: hrpc (hormone refractory prostate cancer) androgen independent prostate cancer crpc (castration and taxane resistant prostate cancer)
online training for healthcare professionals: a possible strategy for prevention of burnout

Conditions: Burnout

Summary: this study aims to evaluate the effects of online training on self-esteem and occupational stress of healthcare professionals, in order to evaluate the potential of this intervention as a preventive measure to burnout syndrome. the study will be developed in three phases,the first being the period of one week before the intervention(t0), when instruments will be first applied.the second phase corresponds to intervention period, when the instruments will be reapplied after the second (t1), third (t2) and fourth (t3) training intervention. the third phase corresponds to the follow up (t4-t8), when all instruments used in the second phase will be reapplied in 2 months (t4), 4 months (t5), 6 months (t6), 8 months (t7) and 12 months (t8) after the end of the intervention. the sample will consist of 100 health professionals randomized into two groups (50 in each group): intervention group (i), formed by those who will participate in the online training and control group (c), formed by those who will receive the intervention after research is finished. the hypotheses are: the online training will have greater effect on the increase of self-esteem, and will be identified in health professionals: low levels of global self-esteem, high levels of occupational stress and average levels of burnout.


Eligibility criteria:
inclusion criteria: * health professionals who work at university of sao paulo general hospital * agree and sign the inform consent form. exclusion criteria: * those who, one week before training, presents anxiety and depressive symptoms (gad ≥ 14 e/ou phq ≥ 14) * in psychotherapy during data collection; * diagnosed with burnout syndrome.

Keywords: burnout syndrome self esteem occupational stress online training health professionals
brain structure and development in pre-term and full-term infants

Conditions: Healthy

Summary: the purpose of this study is to see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life. all infants who participate in this study will have a magnetic resonance image (mri) of the brain prior to discharge from the hospital. infants will then have follow-up appointments every 3-6 months at home or at the infant motor behavior laboratory at the university of delaware. the follow-up sessions will test how infants change their movements to respond to interesting objects or sounds in their environment. it is hoped that the results of this study will assist clinicians in developing better testing and treatment methods for those infants at risk for developmental problems.


Eligibility criteria:
inclusion criteria: * pre-term infants (\< 1 kg birthweight) * full-term infants (well)

Keywords: pre-term infants full-term infants mri brain structure development pre term full term
a phase ii study of ssgj-707 combination therapy in advanced nsclc patients

Conditions: First-line Advanced NSCLC Patients

Summary: this study includes two parts, part a is for non-squamous nsclc and part b is for squamous nsclc.

this study is a study of ssgj-707 combination therapy in first-line advanced nsclc patients. this study includes two parts, part a is for non-squamous nsclc and part b is for squamous nsclc. each part will assess the efficacy and safety of the preset several dose levels of ssgj-707 in advanced nsclc patients.

Eligibility criteria:
inclusion criteria: 1. males and/or females over age 18 2. histologically and/or cytologically documented local advanced or metastatic nsclc . 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. expected survival \>=3 months. 5. signed informed consent form. exclusion criteria: 1. known uncontrolled or symptomatic central nervous system metastatic disease. 2. adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (national cancer institute common terminology criteria \[nci ctcae\] v.5.0). 3. inadequate organ or bone marrow function. 4. pregnant or breast-feeding woman. 5. known allergies, hypersensitivity, or intolerance to ssgj-707 the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
canadians achieve cholesterol targets fast with atorvastatin stratified titration

Conditions: Hypercholesterolemia

Summary: the objective of this study is to assess the effectiveness of an atorvastatin treatment regimen involving starting doses between 10 and 80 mg, followed by a single-step titration (except for subjects started at 80mg), if required


Eligibility criteria:
inclusion criteria: * age 30 to 79 years old * triglyceride level 6.8 mmol/l at screening * ldl-c of 5.7 mmol/l at screening exclusion criteria: * pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception. the latter are defined as: abstinence, surgical sterilization, oral contraceptives for at least 3 cycles, intrauterine device, implant, depot injection, or barrier method in conjunction with contraceptive foam or jelly. * subjects whose blood cholesterol levels are controlled (ldl-c targets) with statins other than atorvastatin * subjects receiving statin doses higher than the following: 10-40mg for simvastatin , 20-40mg for fluvastatin, pravastatin and lovastatin and 10-20 mg for rosuvastatin. subjects already treated with atorvastatin at the time of screening are not eligible unless atorvastatin has been discontinued at least 2 months prior to screening * subjects receiving 2 or more lipid lowering agents are excluded (statins + resins or fibrates or niacin or fish oils)

Keywords: (d006937)
spectroscopic evaluation of middle ear infection (withdrawn)

Conditions: Middle Ear Infection

Summary: otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. researcher can use diffuse optical spectroscopy and diffuse optical imaging for the analysis of ear drum and the middle ear.

the research can use low energy laser signal light from diffuse optical spectroscopy that is harmless to the tissues and sends them into the ear canal to measure the tissue optical properties including the absorption of the laser signal and the amount of signal that will be backscattered by the ear drum. these measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum. diffuse optical spectroscopy an imaging method use near- infrared light to measure absolute tissue concentrations of oxyhemoglobin, deoxyhemoglobin, water, and lipids, as well as subtle changes in water and protein binding states

Eligibility criteria:
inclusion criteria: 1. male/ female at all age- newborn to adult. 2. non- pregnant woman. 3. diagnose of middle ear infection and plan for surgery procedure. exclusion criteria: 1. pregnant woman 2. incompetent adults (i.e. individuals with cognitive impairment) 3. no diagnose of middle ear infection and no plan for surgery procedure. 4. adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.

Keywords: middle ear infection
efficacy and safety of lisdexamfetamine dimesylate (ldx) in adolescents with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: the study will evaluate the efficacy of ldx treatment group compared to placebo on the change from baseline adhd-rs-iv score at endpoint.


Eligibility criteria:
inclusion criteria: * meet dsm-iv-tr criteria for a primary diagnosis of adhd * baseline adhd-rs-iv score \>=28 * bp w/in 95th percentile for age, gender, and height exclusion criteria: * subject has controlled or uncontrolled comorbid psychiatric diagnosis * subject has conduct disorder * suicidal * under or overweight * concurrent chronic or acute illness that might confound results.
blue light for treating eczema

Conditions: Eczema

Summary: monocenter, randomized, intraindividual, open label, exploratory study comparing 4 weeks of treatment with 453nm blue light with no treatment in patients with eczema. patients will be screened up to 28 days before start of treatment. during the screening visit, the purpose and procedures of the study will be explained to potential patients and informed consent will be obtained. in addition, fungal superinfection of the target area will be examined using direct preparations and mycology cultures. at the baseline visit, patients with eczema will be determined and all inclusion and exclusion criteria will be assessed. for eligible patients, two comparable treatment areas will be randomized to treatment with blue light (target area) or to serve as untreated control area. after randomization, patients will receive treatment of the target area with 3 applications per week at the investigational site for a total treatment period of 4 weeks. during those 4 weeks, safety and effectiveness assessments will be performed at weekly intervals. after end of treatment, the patients will be followed-up for another 2 weeks. in case no full resolution of adverse events occurred at the 2 week follow-up visit, a follow-up call will be performed after another 2 weeks. treatment responses will be photo documented


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent prior to any study-mandated procedure 2. good health as determined by the investigator according to physical examination 3. willing and able to comply with study requirements 4. skin type i-iv according to fitzpatrick 5. eczema, severity defined by an eczema area severity index (easi)smaller/equal 20 6. comparable clinical symptomatology of both intended treatment areas 8. reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year; e.g. oral contraceptives, intrauterine device \[iud\] or transdermal contraceptive patch) 9. willing to abstain from excessive sun / uv exposure (e.g. sunbathe, solarium) during the course of the study exclusion criteria: 1. inmates of psychiatric wards, prisons, or other state institutions 2. investigator or any other team member involved in the conduct of the clinical study 3. participation in another clinical trial within the last 30 days 4. pregnant and lactating women 5. photodermatosis and/or photosensitivity 6. porphyria and/or hypersensitivity to porphyrins 7. congenital or acquired immunodeficiency 8. patients with any of the following conditions present on the study areas; malignoma of the skin or severe actinic damage of the skin, atypical naevi or signs of hyperpigmentation, precancerosis viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin 9. patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. xeroderma pigmentosum, cockayne syndrome, bloom- syndrome) 10. current diagnosis of exfoliative or toxic dermatitis. 11. evidence of superinfection of the intended treatment areas
pivotal study to evaluate the effectiveness of a micro-coring device treating moderate to severe facial wrinkles

Conditions: Laxity; Skin

Summary: study evaluating the effectiveness of a micro-coring device for the treatment of moderate to severe cheek wrinkles.

up to 60 subjects who meet the inclusion/exclusion criteria will be treated. all subjects will be monitored for a period of 90 days after treatments. evaluation results will be based in the following: * wrinkle severity score assessed using the lemperle wrinkle scale * subject satisfaction scale * pi global aesthetic improvement scale

Eligibility criteria:
inclusion criteria: * males and females 40-70 years of age * fitzpatrick skin type i to iv as judged by the investigator. * cheek areas are at least a score of 3 using the lemperle wrinkle assessment scale as judged by the investigator * able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits exclusion criteria: * lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated * history of keloid formation or hypertrophic scarring * history of trauma or surgery to the treatment areas in the past 6 months * scar present in the areas to be treated * silicone injections in the areas to be treated * injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, rf devices) * active smokers (0.5 pack/day) or having quit within 3 months prior to treatment * active, chronic, or recurrent infection * history of compromised immune system or currently being treated with immunosuppressive agents * history of sensitivity to analgesic agents, aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine * excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment * treatment with aspirin or other blood thinning agents within 14 days prior to treatment * history or presence of any clinically significant bleeding disorder * any issue that, at the discretion of the investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study * treatment with an investigational device or agent within 30 days before treatment or during the study period * female and pregnant or plan on becoming pregnant during the study

Keywords: facial wrinkles skin laxity sagging skin
proof-of-concept for the aldosterone synthase inhibitor lci699 in patients with primary hyperaldosteronism

Conditions: Primary Hyperaldosteronism

Summary: the purpose of this study is to determine if lci699, thorough reductions in aldosterone, can lower bp in patients with primary hyperaldosteronism.


Eligibility criteria:
inclusion criteria: * diagnosis of primary hyperaldosteronism (ph) within the last 3 years, either with or without an aldosterone producing adenoma (apa). * hypertension at screening exclusion criteria: * persistent hypokalemia * renal impairment * significant hepatic disease * any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance other protocol-defined inclusion/exclusion criteria may apply

Keywords: primary hyperaldosteronism hypokalemia hypertension aldosterone synthase inhibitor
uterine artery embolization for symptomatic fibroids

Conditions: Uterine Fibroids; Menorrhagia; Adenomyosis

Summary: this study will evaluate the safety, efficacy , quality of life and patient satisfaction of uterine artery embolization for the treatment of symptomatic uterine fibroids. it will provide useful information in the development od guidelines in patient selection, procedural management and subsequent follow up.


Eligibility criteria:
inclusion criteria: * symptoms related to the pressence of uterine fibroids serious enough to consider surgical options * confirmation of fibroids by endovaginal and transabdominal ultrasound exclusion criteria: * pedunculated fibroids * desire for fertility * carcinoma of pelvic organs * previous pelvic irradiation * bleeding diathesis and vasculitis * history of allergiy to contrst medium