Kornimate/medical-research-clean huggingface dataset:
tri-split face study of skin resurfacing modalities for the treatment of melasma

Conditions: Melasma

Summary: tri-split face study of skin resurfacing modalities for the treatment of melasma, comparing the medium depth trichloroacetic acid peel, co2 laser and qs-ndyag laser.

melasma is an acquired chronic and relapsing hyperpigmentation disorder, with a significant negative impact on the quality of life of patients. melasma is more common in patients with skin of color and has also been linked to chronic ultraviolet (uv) and heat exposure, family history and hormonal factors. there are several studies in the literature using various therapies for melasma, including sun protection, topical therapies, lasers and chemical peels. however, many of these studies vary greatly in their efficacies and side effect profiles, due to varying and undelineated pre and post-op procedure regimens. side effects of post-inflammatory hyper and hypopigmentation and rebound are reported in these studies. the investigators would like to conduct a tri-split face study that compares a 22% trichloroacetic acid (tca) deep medium peel with an ablative fractionated co2 laser and more pigment selective q-switched (qs) nd:yag laser. to minimize possible post-procedure side effects and melasma rebound, the investigators will perform above treatments in conjunction with an optimal skincare regimen, starting 6 weeks before and continuing after the treatments. the investigators will perform the 22% tca chemical peel, co2 laser and qs-nd:yag at 6 weeks after the start of the skincare regimen, and repeat treatments with qs-nd:yag at weeks 8, 10, and 12. the investigators will assess participants using standardized photos in conjunction with uv imaging (visia cr) at weeks 0, 6, 16, 20 and 24 (6 months), by measuring the modified melasma area and severity index (mmasi) scores and visual analog scale (vas) scores as graded by participants as well as by blinded physicians based on photos and uv imaging.

Eligibility criteria:
inclusion criteria: * male or female participants * 20 to 60 years old * participants with melasma on forehead and both cheeks * participants who failed topical therapy for melasma * participants who have never tried other therapies for melasma exclusion criteria: * pregnancy * lactation * use of oral contraceptive (ocp) within 3 months of starting the study * hormonal therapy within 3 months of starting the study * hormonal intrauterine device (iud) within 3 months of starting the study * history of poor wound healing or abnormal scarring * history of lip or face herpes simplex virus infections * active facial skin infection * history of connective tissue disorders (such as lupus or scleroderma) * history of isotretinoin therapy within 6 months of starting the study * history of chemical peels, dermabrasion, laser therapy or intense pulse light (ipl) within 6 months before enrollment into the study
exercise and acarbose in type 2 diabetes

Conditions: Diabetes Mellitus Type 2

Summary: the purpose of this study is to investigate the impact of exercise training, acarbose, and the combination of exercise and acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. further, muscle biopsies will be obtain to study gene expression. our hypothesis is that the combination therapy will be superior to monotherapy with exercise or acarbose.


Eligibility criteria:
inclusion criteria: men and women, diagnosis of type 2 diabetes established since at least three months, treatment with diet or maximum one oral anti-diabetic drug, ghb \< 8.5 %, age 45 - 60 years, bmi 25 - 30 kg/m2, no participation in any regular exercise program. - exclusion criteria: unable to perform exercise, significant gi-disease, severe heart-disease, renal failure -
study of retinal function using electroretinogram in regular alcohol users

Conditions: Alcohol Use Disorder

Summary: alcohol is a major public health problem and its neurotoxic effects are, among other things, responsible for altering the functioning of cerebral neurotransmission pathways. the retina is an anatomical and developmental extension of the central nervous system. it is composed of several layers of retinal neurons that share similar anatomical and functional properties with brain neurons. retinal neurons are notably equipped with a complex system of neurotransmission constituted by the main neurotransmitters that are involved in the central effects of alcohol: glutamate, dopamine, serotonin ... the retina is used here as a site of indirect investigation for abnormal central neurotransmission pathways following regular alcohol use. it is recognized to date as a good site for investigating central abnormalities in neuropsychiatric and addictive disorders. the objective of this project is to study the retinal function using electroretinogram (erg) in regular alcohol users to isolate potential markers of cerebral neurotransmission abnormalities.


Eligibility criteria:
for alcohol consumer with alcohol use disorder : inclusion criteria: * aged between 18 and 35 years * alcohol use disorder according to the dsm 5 * affiliation to a social security scheme exclusion criteria: * psychoactive substance consumption (other than alcohol) * psychiatric disease in progress according to the dsm 5 * neurologic disease in progress * mental impairment making it difficult or impossible to participate to the study * major under guardianship or curatorship or under safeguarding of justice * pregnant women or feeding * people in emergency situation * participation to another interventional study * retinal disease in progress * chronic glaucoma * ophtalmic disease affecting the visual acuity * ocular infection in progress * urinary positive drug check the day of the inclusion * postive breathalyser the day of the inclusion

Keywords: retina and electroretinogram
the effect of mobile health-based exercise on hepatocellular carcinoma patients with insulin resistance

Conditions: Hepatocellular Carcinoma; Insulin Resistance

Summary: exercise is predicted to have positive effect among patients with hepatocellular carcinoma (hcc). however, little attention has been paid to the role of physical activity with wearable device in the management of hcc patients in the aspect of improvement in insulin resistance. we designed this study to investigate whether personalized exercise with mobile health program improves insulin resistance without decompensation in hcc patients with insulin resistance.


Eligibility criteria:
inclusion criteria: * patients aged 20 to 70 years * patients who were diagnosed with early-stage hcc, defined by modified uicc stage 1 or 2 * patients with treatment-naive and recurrent hcc who have received treatment and achieved complete response at the time of screening * eastern cooperative oncology group (ecog) performance status of 0-2 * patients with insulin resistance (homa-ir \>=2.2) exclusion criteria: * child pugh class b or c * alcohol intake \>20g/day * history of decompensation * severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \> 200/120 mmhg) or psychiatric illnesses which limit ability to exercise safely * who takes insulin sensitizer (sulfonylurea, biguanide, thiazolidinedione, glucagon-like peptide-1 agonist, dipeptidyl peptidase-4 inhibitor) or uses insulin * uncontrolled diabetes mellitus (hemoglobin a1c \>10%)
precision nutrition counseling in type 2 diabetes patients

Conditions: Type 2 Diabetes

Summary: the aim of this study is to evaluate the effect of precision nutrition education using continuous glucose monitoring system (cgms) in longterm glycemic control in patients with type 2 diabetes mellitus. glucose levels in subjects who received diet education using cgms will be compared to those in subjects who received conventional diet education.

fifty subjects with type 2 diabetes will be recruited. every subject will be randomized in two groups, which are cgms education group and conventional education group. the study will be conducted for 12 weeks for each participants. intervention group will receive diet education based on cgms data, using post prandial glucose response, calculated by incremental area under curve of glucose level. control group will receive conventional diabetes diet education without cgms data. primary outcome is change of hba1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, homeostatic model assessment of insulin resistance (homa-ir) , c-peptide, microbiome, 7-point self monitoring of blood glucose (smbg), and compliance/satisfaction questionnaire from baseline for 12 weeks.

Eligibility criteria:
inclusion criteria: * type 2 diabetes patients (fasting blood glucose ≥ 126 mg/dl or hba1c ≥ 6.5% or subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin) * hba1c 6.5%\~10% * body weight change less than 5% in 3 month * subjects who agreed to the study protocol exclusion criteria: * type 1 diabetes patients * subjects using insulin other than basal insulin * subjects who have newly started or have changed anti diabetic drugs within 3 months * subjects who have been received diabetes diet education within 6 months * females who are pregnant or doing breast feeding * subjects with alcohol addiction or drug abuse * subjects who are using drugs that can influence blood glucose levels (e.g. steroid) * subjects who are currently using acetaminophen or who should use acetaminophen during cgms attach period * subjects who have skin problems on cgms sensor insertion site (e.g. burn, excessive body hair, inflammation, rash, tattoo) * subjects who have newly started, changed, or stoped probiotics or prebiotics within 2 weeks * subjects who have used antibiotics (oral or intravenous) within 2 weeks * in addition, if it falls under the exclusion criteria according to researchers discretion

Keywords: continuous glucose monitor diet education precision nutrition
hypnotherapeutic olfactory conditioning for posttraumatic stress disorder (ptsd)

Conditions: Posttraumatic Stress Disorder

Summary: chronic combat-related posttraumatic stress disorder can be difficult to treat. the investigators believe that hypnosis, with a stress on the sensation of scent which often plays a role in the traumatic memories, can offer help for victims of this disorder who continue to suffer after receiving other treatments.

our study examines the effect of hypnosis upon 36 individuals who suffer from posttraumatic stress disorder incurred in battles or training. the hypnotherapy stresses elements of odor, both in conditioning the subject to relate certain pleasant odors with security and calm, and in gradually reexposing the patient to the olfactory aspects of the traumatic memories. all subjects are taken form the israel defense forces mental health clinic, treated with 6 one-and-a-half-hour hypnotherapy sessions, and evaluated at baseline, end of treatment, after 6 months, and after 12 months, on a battery of clinical scales.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of chronic combat-related ptsd according to dsm-iv criteria (apa, 1994), as determined by semi-structured psychiatric interview conducted by a psychiatrist with over ten years of experience treating ptsd 2. flashbacks and/or panic attacks with olfactory components 3. prior attempt at treatment with unsatisfactory results 4. competence and agreement to sign an informed consent. exclusion criteria: 1. evidence of psychosis 2. severe traumatic brain injury 3. post-concussion syndrome 4. uncontrolled substance abuse.

Keywords: hypnotherapy hypnosis ptsd
the effects of a single intravenous administration of secukinumab (ain457) or canakinumab (acz885) in dry eye patients

Conditions: Dry Eye

Summary: this study assessed the effects of a single intravenous dose of secukinumab (ain457) 10 mg/kg or canakinumab (acz885) 10 mg/kg on the signs and symptoms of dry eye. in addition, the pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were assessed. blood samples were collected for the analysis of the effect of secukinumab and canakinumab on select biomarkers.


Eligibility criteria:
inclusion criteria: * male and female patients age 18-85 with a diagnosis of moderate to severe dry eye. * schirmer test without anesthesia ≥ 1 and \< 10 mm wetting over 5 minutes in at least 1 eye. * tear break up time \< 7 seconds in at least 1 eye. * corneal staining score ≥ 3 (national eye institute \[nei\] grading scale). * conjunctival redness of ≥ 1. * ocular surface disease index of modest to severe. * ability to provide informed consent. exclusion criteria: * pregnant or breastfeeding women. * hemoglobin \< 10 g/dl. * total white blood count (wbc) outside the range of 3000-14,000/µl. * platelets \< 100,000/µl. * use of ocular, periocular, or systemic steroids within 60 days prior to screening. * use of contact lenses or prior corneal refractive surgery in either eye. * requirement of eye drop use during the study. * anesthetic or neurotrophic corneas. * temporary punctal plugs. * recent or planned exposure to live vaccinations. * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: dry eye il17/ il-1β biologic
nucleoside analogue prevent vertical transmission of hepatitis b virus

Conditions: Hepatitis B Infection; Chronic Infection; Viremia

Summary: to explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.to establish the best therapy strategy to pregnant women with high level of hbv dna.

telbivudine and lamivudine,a preganancy category b medication,reduces hbv dna and normalizes serum alt in chronic hepatitis b patients with few adverse effects.two aspects on the drug use in pregnancy will be evaluated prospectively in this study.

Eligibility criteria:
inclusion criteria: hbeag+chb pregnant woman gestational age 28 weeks hbv-dna\>log10 copies/ml exclusion criteria: co-infection with hepatitis a,c,d,e or hiv evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had chb
implementation of nasal non-invasive ventilation with a ram cannula in the inpatient /outpatient setting

Conditions: Chronic Respiratory Failure

Summary: the purpose of this study is to implement a standardized protocol to initiate nasal non-invasive ventilation with ram nasal cannula (niv/ram-nc) with trilogy mechanical ventilator at children memorial hospital inpatient and outpatient sites, as well as to explore the side effects and complications associated with the use of niv/ram-nc in children.


Eligibility criteria:
inclusion criteria: * children admitted to the children memorial hermann hospital and consulted to pediatric pulmonary service for initiation of niv/ram-nc both at the inpatient and outpatient sites. * children who fail to wean from chronic respiratory support (cpap, bipap, hfnc) in whom long-term ventilation is considered between 10/2016 - 10/2017 will be included. exclusion criteria: * children with minimal setting (cpap \< 5cmh2o, hfnc \< 3lpm) able to be weaned to regular nasal cannula. * patients with upper airway obstruction that may be candidates for surgical procedure will be excluded.

Keywords: nasal non-invasive ventilation ram cannula pediatric complex care tracheostomy avoidance
a dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease

Conditions: Dry Eye Syndrome

Summary: a dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.


Eligibility criteria:
inclusion criteria: * be of either gender and any race 18 years or older exclusion criteria: * have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

Keywords: sign and symptoms of dry eye disease
effects of a supportive mobile health for life style modification on blood pressure and insulin resistance improvement in people with metabolic abnormalities

Conditions: Metabolic Syndrome

Summary: the purpose of this randomized study is to assess the efficacy of a mobile application for the improvement of blood pressure and insulin resistance in people with metabolic abnormalities.

the purpose of this randomized study is to assess the efficacy of a mobile application for the improvement of blood pressure and insulin resistance in people with metabolic syndrome. this study is a 24 week follow up randomized prevention trial. participants visit for a screening test, then eligible participants are randomly assigned for one of the following arms; 1 intervention group using a mobile application to monitor their life style behaviors, 1 intervention group using a mobile application for personal coaching on purpose of improving their life style behavior, and 1 control group providing education about managing life style behaviors.

Eligibility criteria:
inclusion criteria: * "etiologic study on cardiovascular and metabolic diseases: prospective cohort study (severance hospital irb no. 4-2013-0661)" participants * smartphone user * metabolic abnormality. having 2 or more components of metabolic syndrome described below: 1. central obesity : waist circumference ≥ 90cm in male, ≥ 80cm in female 2. systolic/diastolic blood pressure ≥ 130/85 mmhg 3. serum triglyceride ≥ 150 mg/dl 4. serum high density lipoprotein cholesterol \< 40 mg/dl in male, 50 mg/dl in female 5. fasting glucose ≥ 100mg/dl exclusion criteria: * presently or planning for pregnant/breastfeeding during the study. or confirmed pregnancy by a urine test. * currently taking medication (including insulin injection) for hypertension, dyslipidemia, or diabetes. * presently using a mobile application for lifestyle modification
cognitive and affective processes online

Conditions: Depression

Summary: this study will provide data for evaluating the psychometric characteristics of the tests assessing cognitive flexibility, including their (1) internal consistency, (2) feasibility and tolerability, their (3) convergent and discriminant validity of cognitive and affective constructs such as those introduced to understand mental disorders, and (4) sensitivity (and correspondence) to individual differences. for these tests to be useful in studying clinical conditions, they must show adequate reliability, validity, and sensitivity in large samples of convenience.


Eligibility criteria:
inclusion criteria: * adults 18 years or older * english-speaking * live in the u.s. * have access to an internet connected computer * users of the mturk and prolific survey website exclusion criteria: * na

Keywords: cognitive rigidity foraging exploration-exploitation
the light sword lens for presbyopia compensation

Conditions: Presbyopia

Summary: clinical assessment of a new optical element for presbyopia compensation - the light sword lens.

healthy dominant eyes of presbyopes were examined for visual performance. the examination was performed in the ophthalmic trial frame, which included assessment of 3 trials: reference (with lens for distance correction); stenopeic (distance correction with a pinhole ϕ=1,25 mm) and light sword lens (distance correction with a light sword lens). in each trial, visual acuity was assessed in 7 tasks for defocus from 0.2d to 3.0d while contrast sensitivity in 2 tasks for defocus 0.3d and 2.5d.

Eligibility criteria:
inclusion criteria: * emmetropic or hyperopic eyes with a spherical error of maximum +1.75d and astigmatism of ≤ 0.5d. * corrected distance visual acuity (cdva) had to be better than 0.1 logmar (20/25) and at the same time contrast sensitivity (cs) could not be less than 1.9 logcs. -uncorrected near visual acuity was required to be worse than 0.4 logmar (20/50), as a proof of presbyopia. exclusion criteria: * any history of ophthalmic surgeries * evidence of serious ocular or brain pathologies affecting visual acuity (va) * clinically active inflammation.

Keywords: presbyopia compensation edf light sword lens
visual assessment of dailies® aquacomfort plus® for astigmatism as compared to 1-day acuvue® moist® for astigmatism

Conditions: Astigmatism

Summary: the purpose of this study is to evaluate functional vision associated with rotational stability at blink of dailies® aquacomfort plus® toric (dacp t) compared to 1-day acuvue® moist® for astigmatism (1dam a).


Eligibility criteria:
inclusion criteria: * must sign an informed consent document; * wear toric soft contact lenses within the protocol-specified range; * cylinder equal or higher than -0.75 diopters (d) in both eyes; * have an acceptable fit with both study contact lenses; * willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible; * best corrected visual acuity (bcva) of 20/30 snellen; * other protocol-specified inclusion criteria may apply. exclusion criteria: * any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear; * use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator; * monocular (only 1 eye with functional vision) or fit with only 1 lens; * require presbyopic correction; * any ocular condition observed during examination at the enrollment visit; * history of herpetic keratitis, ocular surgery or irregular cornea; * pregnant or lactating; * participation in any clinical trial within 30 days of the enrollment visit; * currently wearing focus® dailies® toric or 1-day acuvue® moist® for astigmatism; * other protocol-specified exclusion criteria may apply.

Keywords: dacp toric dailies® aquacomfort plus® astigmatism toric
ds2330b alone and with sevelamer in patients on chronic hemodialysis

Conditions: Hyperphosphatemia

Summary: this three-part study will be performed with participants on chronic hemodialysis. * part a will assess plasma pharmacokinetics of ds2330a (free form of ds2330b) after a single dose of powder in bottle (pib) or tablet formulations of ds2330b * part b will test the safety, tolerability, and effects on serum phosphate (pi) of 14-day repeated oral doses of ds-2330b pib when given alone and when given along with sevelamer carbonate three times a day * part c is optional, and will test the effects on serum phosphate (pi) of 14-day repeated oral doses of ds-2330b tablets when given with sevelamer carbonate after screening, participants should expect the study to last about 21 days for part a, and 46 days for parts b and c.


Eligibility criteria:
inclusion criteria: * has a body mass index (bmi) of 18 kg/m\^2 to 40 kg/m\^2 (inclusive) * is on prescribed maintenance hemodialysis (three times a week) for at least 3 months before screening with adequacy demonstrated by a dialysis clearance within 3 months before the first dose of the investigational medicinal product * has permanent vascular access \[arteriovenous (a-v) fistula or graft\] * is willing to comply with protocol-specified methods for family planning * for parts b and c only: 1. has protocol-specified acceptable serum pi levels at screening and in serum pi after up to 3 weeks of washout from all pi binders 2. has protocol-specified acceptable serum ca\^2+ level and intact parathyroid hormone (ipth) level at screening exclusion criteria: * is employed by the clinic or the sponsor * has family relationship with another study participant * has any history, current condition, or drug use that per protocol or in the opinion of the investigator might compromise: 1. safety of the participant or their children 2. safety of study staff 3. analysis of study results * for parts b and c only: 1. is not able to take sevelamer carbonate 2. has had partial or total parathyroidectomy within the last six months

Keywords: chronic hemodialysis investigational drug