Kornimate/medical-research-clean huggingface dataset:
comparison of two tri-luma® maintenance regimens in the treatment of melasma

Conditions: Melasma

Summary: melasma is an acquired, symmetric, irregular hypermelanosis on sun-exposed areas of the face, commonly seen in latin american women. it is a very frequent disease, although its true incidence is unknown. melasma has historically been difficult to treat and therapy remains a challenge for this chronic condition. melasma being a relapsing disease, there is a real need to address how to maintain efficacy achieved after acute treatment. a previous 12-month trial has shown that tri-luma® applied once daily over a long-term period is safe and tolerable. however, there are no robust data available either on the efficacy of tri-luma® in long-term treatment or guidance for a maintenance dosage regimen with this product. investigations have been made through a feasibility work among dermatologists from usa and latin america to assess their current practice in terms of maintenance therapy. two regimens appear to be prescribed frequently and will be compared in this study. the expectation is that tri-luma® will be effective, in one of the two regimens explored, in maintaining the melasma improvement achieved with a previous treatment of tri-luma®.

this study will last 32 weeks (8 months) as a maximum. 11 visits will take place (last visit of initial treatment phase = baseline of maintenance phase) initial treatment phase : visit 1 (baseline), 2 (week 2), 3 (week 4), 4 (week 6), 5 (week 8), maintenance phase : visit 1 (baseline), 2 (week 4), 3 (week 8), 4 (week 12), 5 (week 16), 6 (week 20) , 7 (week 24)

Eligibility criteria:
inclusion criteria: * subjects with a clinical diagnosis of moderate to severe melasma * subjects with a fitzpatrick skin type between i and v exclusion criteria: * female subjects who are pregnant or planning a pregnancy during the study; * subjects with a wash-out period for topical treatments on the treated areas less than 2 weeks for corticosteroids, glycolic acid (in daily care cream, bleaching products, uv light therapy and sunbathing, topical retinoids including retinol, and less than 3 months for lasers, ipl, dermabrasion, peeling * subjects with a wash-out period for systemic treatments less than 1 month for corticosteroids and hormone-replacement therapies (unless subjects have been on treatment for at least 3 months) * subjects who foresee intensive uv exposure during the study (mountain sports, uv radiation, sunbathing, etc...);
clinical evaluation of rapid antibody test for covid-19

Conditions: COVID-19

Summary: rapid, accurate diagnosis of covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible covid-19. currently results of the standard test for the virus take 2-3 days to be reported. watford general hospital has imported rapid antibody tests manufactured by zuhai livzon diagnostics inc in china and our team would like to evaluate their accuracy and clinical usefulness. the test involves taking a drop of blood from the patient (either from a venous blood sample taken for other blood tests, or from a fingerprick). this is applied to a test strip (similar to a pregnancy test) and two drops of diluent are added. if the patient has antibodies to covid-19, two lines appear on the test strip (like a positive pregnancy test) whereas if the patient has no antibodies, only one line appears (like a negative pregnancy test). there are two different types of antibody: igm is produced early in the course of the illness (day 7-14) and then igg is produced later and continues to be present, probably for months or years. there are two test strips, one for each of these types of antibody. in this study we aim to evaluate the accuracy of this new test, in three groups of patients. firstly those with proven covid-19 and at least 7 days after the onset of their illness. we aim to recruit 200 patients in total: at least 138 patients with 10 or more days of symptoms, plus a subgroup of up to 62 patients with 7-9 days of symptoms (to explore the usefulness of the test earlier in the course of illness). the second group of 250 patients will be those hospital staff who report symptoms possibly caused by covid-19 and are receiving a standard antibody test. the third group of patients will be those followed up in a "virtual hospital" for clinically suspected covid-19 who had never been tested with a standard pcr test. as we are not sure of the accuracy of the new test, its results will not be used to make decisions about treatment for the patient. this study will enable us to discover rapidly whether the new test is accurate, and if so we will conduct further studies to assess how it can help to improve management of patients with suspected covid-19.


Eligibility criteria:
inclusion criteria: 1. inpatient or patient in the "virtual hospital" with confirmed covid-19 infection on pcr or with history of clinically suspected covid-19 but no pcr test or hospital staff with clinical suspicion of past covid-19 infection. 2. age 18 or over 3. at least 7 days since onset of symptoms 4. willing and able to give written informed consent exclusion criteria: 1. symptom duration \<7 days. 2. lack of written consent 3. age under 18
a causal relationship study between anxiety, depression, and rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Anxiety; Depression

Summary: rheumatoid arthritis (ra) is a systemic chronic inflammatory disease, and depression and anxiety are among the most common comorbidities in ra patients, with a high prevalence rate. epidemiological studies have found that joint deformities, severe pain, positive serum rf titers, as well as comorbidities such as hypertension, insomnia, pain, and fatigue are significantly associated with depression and anxiety in ra patients. currently, clinical studies have found that the relief of depression or anxiety is one of the expected treatment goals for ra patients. due to the unclear pathogenic factors of depression or anxiety in ra patients, there is a lack of effective clinical treatment options. therefore, this study will use a "causal inference model" to identify possible "mediating variables" that may lead to the comorbidity of ra and emotional disorders through clinical investigation, aiming to improve the precision of treatment for physicians.


Eligibility criteria:
inclusion criteria: * patients diagnosed with ra. exclusion criteria: * patients diagnosed as non-ra.
sevoflurane in covid-19 ards (sevcov)

Conditions: ARDS, Human; Coronavirus

Summary: the purpose of this trial is to study the effect of initial temporary sevoflurane sedation on mortality and persistent organ dysfunction (pod) in survivors at day 28 after icu admission in the population of patients suffering from covid-19 ards.

the corona virus disease 19 (covid-19) pandemic, caused by the severe acute respiratory syndrome corona virus 2 (sars-cov-2), is spreading rapidly across europe. while data from european centers are still missing, several publications from chinese centers are available. respiratory failure from acute respiratory distress syndrome (ards) is the leading cause of mortality, and may be caused or exacerbated by a 'cytokine storm syndrome'. recent trials from our group demonstrated that the volatile anesthetic sevoflurane administered during ventilation of patients has anti-inflammatory properties. moreover, in in vivo studies volatile anesthetics reduce the severity of ards compared to intravenous sedation, which has been confirmed in a clinical pilot trial. attenuating ards and thereby improving oxygenation strongly decreases morbidity and mortality of patients.

Eligibility criteria:
inclusion criteria: * sars-cov-2 infection (positive testing) or computed tomography (ct) scan-suspected covid-19 ards * male and female patients, age 18 to 85 years * icu patients with ards defined as pao2/fio2 \< 200mmhg (=26.6kpa) * time of intubation not longer than 24 hours * qtc time (ecg) not longer than 470 ms ♂ (male)/ 480 ms ♀ (female) * sedation and mechanical ventilation in icu * informed consent, signed by a representative or by an independent physician exclusion criteria: * high dose systemic corticosteroids in the phase before hospitalization (\> 10mg/d prednisone or equivalent dose) * significant concomitant disease (acute cerebral vascular event, acute coronary syndrome, seizure, burn, neuromuscular disease) * organ transplant * aids * pregnancy and/or breastfeeding * use of cytokine absorber

Keywords: covid-19 ards
arch support effects on balance and gait in older adults with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this study aims to explore the effects of arch support insoles on balance and gait performance in older adults with mild cognitive impairment (mci). we will recruit 40 female older adults with mci. a randomized crossover trial will be used to determine the immediate effect of arch support insoles. all participants received one assessment session wearing and one session not wearing insole in a random order within 1-day. then participants will be randomly allocated to experimental group (arch support insoles, n=20) or control group (no insoles, n=20) for at least 4-h every day for 1-month. our primary outcomes include static standing balance, timed-up-and-go test, 10-m obstacle crossing, functional reach test, short physical performance battery (sppb), and gait assessment during single- and dual-task walking for 20 m at self-selected comfortable pace while performing serial subtractions (cognitive interference) or carrying a tray (motor interference). assessments will be conducted at baseline and after 2-wk and 4-wk of insole wear. statistical analyses will be performed using spss 21.0 software. two-way mixed anova will be used to determine the immediate and short- and long-term effect of arch support insoles. the results of the current study are expected to provide evidences in supporting the use of arch support insoles for improving gait performance and postural stability for older adults with mci which will contribute to balance and gait training as well as fall prevention.


Eligibility criteria:
inclusion criteria: * (1) female aged 65 years and over; (2) able to walk more than 20 m without walking aids; (3) had a montreal cognitive assessment (moca) score lower than 26 ; (4) had self-reported memory complaints; and (5) had the ability to perform adls. exclusion criteria: * (1) dementia; (2) a history of malignant tumors ; (3) the presence of an unstable neurological or orthopedic disease, or visual problems interfering with participation in the study; and (4) an education level less than 6 years (elementary school).
impact of acupuncture on vasomotor rhinitis

Conditions: Vasomotor Rhinitis; Acupuncture

Summary: chronic rhinitis without an allergic or infectious aetiology (vasomotor rhinitis) is a common disease for which there are only poor therapeutic treatment options. the current placebo controlled partially double blinded pilot study evaluated the effects of acupuncture on the symptoms of vasomotor rhinitis.


Eligibility criteria:
inclusion criteria: * term of sickness \> 3 month * negative allergic testing exclusion criteria: * term of sickness \< 3 month * previous nasal surgeries * polyposis nasi * contraindications regarding acupuncture (such as: risk of bleeding, pregnancy) * psychologic disorders * drug addiction * autoimmune disease * other severe disease

Keywords: acupuncture randomised controlled trial placebo sham laser vasomotor rhinitis
assess the effect of metaxalone 640 mg (m640) compared to tizanidine 8 mg on truck driving ability and cognition

Conditions: Cognitive Impairment

Summary: every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. each drug will be taken one (1) time after a high fat meal. vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. there will be ( four (4) visits.

every participant will receive active study drug and one (1) comparator in two (2) stages, one after the other. each drug will be taken one (1) time after a high fat meal. vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. the screening visit will be followed by the baseline (visit 1) 1-14 days later. at the baseline visit participants will be given written tests to measure thinking process. you will also be asked to take a computer driving simulation test. visits 2 and 3 approximately one (1) week apart will be the dosing days after eating a high fat meal within 30 minutes. the testing from the baseline visit will be repeated at four (4) hours and 1.5 hours after dosing with comparator drug. the end of study safety visit will take place two (2) weeks later. participants will be given discharge instructions.

Eligibility criteria:
inclusion criteria: * equal to or greater than 20 years old * weight at least 120 pounds * medically healthy * able to eat a high fat meal exclusion criteria: * medications known to affect sleep-wake cycle * current use of cimetidine * current use of certain anti-depressants * current us of certain antibiotics * positive urine drug test for mind altering medications

Keywords: impaired driving
enamel matrix derivatives & periodontal therapy in diabetic patients

Conditions: Periodontal Diseases

Summary: the aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of periodontal healing in diabetic patients.

patients with periodontitis will be randomly allocated to two groups. in both groups, periodontal root instrumentation will be performed. in the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm. metabolic glucose control as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.

Eligibility criteria:
inclusion criteria: * patients diagnosed with diabetes mellitus type ii and currently under treatment; * no previous periodontal treatment in the last 6 months; * presence of periodontitis (clinical attachment loss of at least 3 mm in 2 or more non- adjacent teeth); * ability to understand the study procedures and comply with them through the length of the study. exclusion criteria: * pregnancy and breast feeding; * need for antibiotic treatment during periodontal therapy; * chronic infections; * systemic diseases; * patients who report current smoking over 20 cigarettes per day.
biomarkers in samples from adult patients with acute myeloid leukemia who failed existing standard-of-care treatment

Conditions: Leukemia

Summary: rationale: studying samples of bone marrow and blood from patients with cancer who failed treatment may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer resistance. it may also help doctors find better ways to treat cancer. purpose: this research trial studies biomarkers in samples from adult patients with acute myeloid leukemia who failed standard-of-care treatment.

objectives: * define a "non-response" signature that will help up-front identification of cases of intermediate-risk acute myeloid leukemia (aml) destined to fail existing standard-of-care therapy. * identify biological pathways in the "non-response" group that can provide targets for novel therapeutics. outline: dna and rna extracted from cryopreserved bone marrow cells and/or blood cells are analyzed for mutations and gene expression signatures (genome-wide methylation, mrna and mirna expression, and single nucleotide polymorphism (snp) analysis) by microarray assays.

Eligibility criteria:
disease characteristics: * samples from previously untreated non-m3 acute myeloid leukemia (aml) * normal karyotype (nk) intermediate-risk disease * two or more vials of cryopreserved pretreatment bone marrow cells and/or two or more vials of cryopreserved pretreatment blood cells available from the intergroup aml repository * blast count ≥ 60% * eligible and evaluable for the patient's clinical trial, and did not have fatal induction toxicity * response to protocol induction chemotherapy: * non-response: aml with failure to achieve a complete remission (cr) after induction chemotherapy ("7 \& 3"-based therapy using cytatabine and/or daunorobicin hydrochloride (dnr) or idarubicin and/or dnr * responders: continued complete remission (ccr) \> 2 years patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: adult acute basophilic leukemia adult acute eosinophilic leukemia adult erythroleukemia (m6a) adult pure erythroid leukemia (m6b) adult acute minimally differentiated myeloid leukemia (m0) adult acute monoblastic leukemia (m5a) adult acute monocytic leukemia (m5b) adult acute myeloblastic leukemia with maturation (m2) adult acute myelomonocytic leukemia (m4) adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with del(5q) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) untreated adult acute myeloid leukemia adult acute myeloblastic leukemia without maturation (m1) adult acute megakaryoblastic leukemia (m7)
overall survival and disease-free survival in breast cancer patients under cos

Conditions: Breast Cancer

Summary: the main objective of the study is to evaluate the overall survival and disease-free survival in breast cancer patients under 40 years old. they underwent controlled ovarian stimulation (cos) for fertility preservation versus women of the same age, type and stage of breast cancer, who have not been subjected to cos.

breast cancer is a disease where the tumor size, lymph node involvement and histological grade provide rich information about prognosis and enable to stage the disease. as in any other oncological pathology, stage of disease at diagnosis is the major determining factor for estimating survival. ovarian stimulation for fertility preservation is performed in this study, in patients with stage i-ii (tnm) after the neoplasia is treated (surgical removal of the tumor) prior to systemic therapy, when indicated. among young women there is a greater incidence of basal type tumors and her2 (human epidermal growth factor receptor 2), which do not always express hormone receptors. in early stages of the disease, the controlled ovarian stimulation procedure, after removal of the tumor, has not revealed any worsening in the prognosis of the disease, in terms of overall survival and disease-free survival (absence of local or distant recurrence). it is a study that aims to collect data retrospectively from 2008 to 31 december 2015. to this end, we will collect the follow-up data, up to 5 years for patients from 2008, 2009 and 2010. four years for patients in 2011, 3 years for 2012, 2 years for 2013, one year for those included until 31 december 2014 and patients followed until 31 december 2015. each patient is called in order to request data authorization, to complete and track information.

Eligibility criteria:
inclusion criteria: * age under 40 years ( at the time of diagnosis) * tnm stage i- ii * authorization of the fertility preservation multidisciplinary committee exclusion criteria: * contraindications for pregnancy * previous history of infertility * previous history of ovarian surgery * prior chemotherapy * history of pelvic radiation * diabetes mellitus * hypertension * renal failure * liver failure * autoimmune disease.
development and feasibility of an internet intervention for adults with spinal cord injury to prevent pressure ulcers

Conditions: Spinal Cord Injury; Pressure Ulcers

Summary: the investigators propose to test the feasibility of ishiftup (internet skin health intervention for targeted ulcer prevention) for adults with spinal cord injury (sci) to prevent serious pressure ulcers (prus) and promote protective health behaviors. this protocol is phase 2 of a three phase project. in phase 1, the investigators developed ishiftup. in phase 2, the investigators will test the intervention by partnering with woodrow wilson rehabilitation center (wwrc) to conduct a randomized controlled trial (rct) of 18 participants. in phase 3, the investigators will focus on optimizing the intervention based on our outcome findings and feedback, sustaining the program at wwrc, and seeking future funding for a larger rct. the investigators will conduct an rct of up to 18 participants (9 participants in treatment as usual (tau) group, 9 participants in tau + ishiftup intervention group) (18 participants are needed to obtain statistically significant results). the investigators will meet with potential participants in-person to complete the informed consent process and confirm eligibility. participants in the tau+ishiftup group will use the program during the study period. participants randomized to tau will have usual treatment during the study period and an opportunity to use the program following trial participation. the investigators will collect information from participants at two times during the study, at enrollment and post-intervention at 6-weeks (42 days). the investigators will also collect qualitative information from participants in the tau+ishiftup group, during an optional focus-group setting, to learn users' experiences with the program. the investigators expect participants in the tau+ishiftup group as compared to the tau group, to display greater awareness of personal risk for pressure ulcers; increased preventive behaviors; and increased skin care self-efficacy and knowledge.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * history of traumatic spinal cord injury resulting in paraplegia or tetraplegia. * regular internet access * physical ability to use computer * able to understand, read and speak english * have identified healthcare provider exclusion criteria: * sci of non-traumatic etiology such as: * tumor, * ischemia, * developmental disorders, * neurodegenerative diseases, * demyelinative diseases, * transverse myelitis, * vascular malformations. * severe pressure ulcer (stage 3 or stage 4). * currently pregnant or plan to become pregnant during the study period.

Keywords: pressure ulcer prevention spinal cord injury internet delivered pressure ulcer intervention
comparison of short implant assisted mandibular overdenture designs

Conditions: Mandibular Bone Resorption

Summary: the aim of the study was to clinically and radiographically evaluate and compare the use of unsplinted and splinted short implants with ball abutments to support mandibular overdentures in cases with severe mandibular ridge resorption.

twelve patients from the prosthodontics department in the faculty of dentistry, alexandria university participated in the study. patients were divided into 2 groups. the test group received 4 short implants with ball abutments for the construction of a mandibular assisted overdenture, while the control group received 4 short implants splinted using a bar with a ball attachment for retaining a mandibular overdenture.

Eligibility criteria:
inclusion criteria: * completely edentulous patients. * mandibular ridge should be a maximum of 10mm height and with a minimum width of 8 mm to insert implants without grafting procedures. * patients free from systemic diseases that contradict the use of dental implants. * patients with class i ridge relation. * patients with adequate zone of keratinized mucosa. * patients with u-shaped or square shaped arches exclusion criteria: * non-compliant patients based on history. * heavy smokers. * senile patients (over 75 years) with impaired neuromuscular control.

Keywords: short implants