Kornimate/medical-research-clean huggingface dataset:
5% sodium l-ascorbyl-2-phosphate lotion for the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: 12-week study to compare the efficacy and safety of a course of a twice daily treatment with aps in the form of a lotion to its vehicle for the treatment of acne.


Eligibility criteria:
inclusion criteria: * subject has read, understood, and signed appropriate informed consent, photo consent, and hipaa consent in their own language. * subject has visible mild to severe acne, as assessed by the investigator. * subject will be available and willing to return for follow-up visits. * subject agrees not to use any other acne treatment products during the study. * subject is otherwise healthy, non-febrile, and is not suffering from an infection likely to require antibiotic therapy during the study period. * subject or guardian must be able to understand the new hipaa regulations and sign the hipaa form. * subject is between the ages of 18 and 39. * subject agrees and understands that aps or its vehicle is to be applied to the subject twice daily for 12 weeks; no other topical or systemic medication affecting the course of acne and/or evaluability is to be used during the study. * subject agrees to use only the cleanser, moisturizer with sunscreen, and treatment provided by the study site for the duration of the study. * subject understands and agrees that he/she can not be treated with a systemic antibiotic for acne during the study. * subject agrees he/she will not use an acne topical treatment for two weeks prior to day 0. exclusion criteria: * subject or guardian has not signed informed consent, photo consent or hipaa form. * subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment which in the opinion of the investigator could influence the results of the study. * subject is pregnant or lactating. * subject is suffering from an abnormal skin condition not usually associated with acne. * subject will not be available for follow-up visits. * subject has been previously enrolled in any clinical study in which treatment was received within the past 30 days. * subjects without comedones, papules, pustules, or nodules. * subject has a history of hypersensitivity to any other ingredients of the study lotion. * subject has a history of anaphylaxis. * subject is not able to avoid excessive sun exposure.
evaluation of cfdna as a marker of response in rectal cancer

Conditions: Cancer of Rectum

Summary: a pathological complete response (pcr) after surgery occurs in approximately 20% of rectal cancer patients submitted to neoadjuvant chemotherapy, with apparent survival benefit. this group could, potentially, be spared the morbidity of surgery. the diversified response to neoadjuvant chemotherapy (ncrt) amongst tumors suggests a complex relationship between tumor biology and response possibly due to a number of genetic or molecular pathways that might regulate chemoradiosensitivity. accumulating evidence indicated that circulating cell-free nucleic acids can be a promising biomarker of response, in liquid biopsy, for rectal cancer. the concentration of baseline plasma cell-free dna (cfdna) appears significantly higher in responders compared to non-responders. the objective of this study is to investigate the potential role of cfdna as a marker of pcr (or partial response) to ncrt as well as a marker of outcomes (overall survival and disease-free survival). the investigators are conducting a prospective, observational, cohort, non-randomized study of consecutive patients with locally advanced rectal cancer submitted to ncrt, followed by surgical excision 6-12 weeks later. patients are assigned to groups according to their pathological response to ncrt. a total of 20 patients with complete pathological response, 50 partial response and 50 non-responders will be selected over a year and followed for another year. participants will be observed and examined during the entire course of treatment and the follow-up period. serial analysis of cfdna through liquid biopsies will be performed in consecutive patients at specific time points (pre-ncrt, post-ncrt and postoperative week 1), incorporating analysis of concentration, dimension of dna fragments, % of mutation frequency (cin, apc, p53, msi, kras, braf, egfr, ckit) and next-generation sequencing of tumour biopsy and surgical specimens. this study will serve as the feasibility of a larger, comparative study.


Eligibility criteria:
inclusion criteria: 1. patients aged over 18 years old, ecog 0-2 2. high-risk patients with biopsy proven rectal adenocarcinoma who will undergo long-course chemoradiotherapy and who are potentially eligible for curative surgery 3. patients who can fully understand the content of the informed consent form and sign it upon their own opinion 4. patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-up exclusion criteria: 1. patient has any underlying or current medical condition, which would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosus etc.). 2. patient has severe mental illness. 3. patient has any other conditions, which would interfere with the evaluation of the subject.

Keywords: rectal cancer neoadjuvant therapy cfdna
study of dasatinib vs imatinib in patients with chronic myeloid leukemia (cml) who did not have favorable response to imatinib

Conditions: Chronic Phase Chronic Myeloid Leukemia

Summary: the purpose of this study is to test the hypothesis that patients with cml who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.


Eligibility criteria:
inclusion criteria: * chronic phase (cp)-cml ph+ patients with complete hematologic response (chr) but without one log bcr-abl reduction (bcr-abl level \>10% is) 3 months of imatinib 400mg treatment. (imatinib transient dose adjustments due to adverse event (aes) are allowed with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within the 3 month period before randomization). imatinib monotherapy must have been started within 6 months of cp-cml diagnosis (ph + /bcr-abl detection) * currently tolerating imatinib 400mg qd. patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with 400 mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib * eastern co-operative group (ecog) performance status = 0 - 2 * adequate renal function defined as serum creatinine ≤3 times the institutional upper limit of normal (uln) * adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional uln; alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤2.5 times the institutional uln exclusion criteria: * previous diagnosis of accelerated phase or blast crisis * subjects with clonal evolution in ph+ cells observed in ≥2 metaphases at baseline bone marrow cytogenetic test, unless the same abnormalities were present at diagnosis. patients with no evidence of clonal evolution, including those patients whose cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are eligible for the study * subjects with less than chr after 3 months of imatinib treatment or lost chr after initial achievement * documented t315i/a, f317l, or v299l mutations (if already available - not required for screening) * a serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
the hop-step intervention: improving maternal health in women with lupus sirb

Conditions: Systemic Lupus Erythematosus; Contraception

Summary: while the hop-step (healthy outcomes in pregnancy with sle through education of providers) program has been demonstrated to be effective in improving provider confidence, increasing contraception documentation, and facilitating equitable pregnancy planning care in a single sub-specialty clinic here at duke, the delivery of hop-step may need to be changed to increase its fit with the local context at the university of chicago medical center (ucmc) and subsequent locations. thus, the investigators will now fit the intervention into a high-minority, high-poverty academic rheumatology center, and later pilot it through a randomized trial to identify and overcome existing barriers to equitable pregnancy prevention and planning at another institution (the university of chicago medical center). the objective of this study is to prepare for a multi-center trial of the hop-step intervention by fitting and then piloting its implementation and measuring its potential impact on maternal outcomes.

the study creates opportunities for sle (systemic lupus erythematosus) patients seeking reproductive care by restructuring the rheumatology clinic environment. specifically through: aim 1: fit the implementation of the hop-step intervention to the local rheumatology specialty clinic context with key stakeholder input. aim 2: evaluation of a pilot trial of the hop-step intervention. at the completion of this study, the investigators will know how to equitably implement and study the hop-step intervention within an academic rheumatology setting that cares for a high-minority, high-poverty population of women with sle.

Eligibility criteria:
provider inclusion criteria: rheumatology providers who have seen at least 6 females 18-44 years old within the last year (at least 3 if provider has been at ucmc clinics for less than a year). exclusion criteria: rheumatology fellows\*. does not consent to join the study.

Keywords: family planning sle contraception
photobiomodulation to alter cerebral blood flow and to affect the emotional status of patients with major depression

Conditions: Major Depression; Anxiety Disorder; Post-Traumatic Stress Disorder; Substance Abuse Disorder

Summary: a pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in the frontal poles and to affect the emotional status of patients with major depression.

we wish to study whether photobiomodulation (pbm) with near infrared (nir) light emitting diodes (led), a non-ionizing phototherapy, in patients with major depression, can acutely alter frontal brain blood flow measured by near infrared spectroscopy (nirs). secondarily, we will examine whether pbm can improve emotional state immediately and over the following month. we see this as a pilot study to gather preliminary data that will guide future studies.

Eligibility criteria:
inclusion criteria: * all patients must be right handed, between the ages of 18 and 60, and meet criterion for depression on a structured clinical diagnostic interview * enrollment will be made without regard to gender or ethnicity * patients who are receiving treatment for depression, either psychological or pharmacological, may continue their treatment during the time of the study, but will be asked to try not to alter their treatment from one month prior to the onset of the experiment until its conclusion. if they must alter their treatment, the patient will continue in the study for observation, but will be excluded from any follow-up statistical comparisons exclusion criteria: * past history of psychotic disorder (including schizophrenia or schizoaffective disorder * bipolar disorder * obsessive compulsive disorder) * substance abuse disorder that has been active with the past 6 months, * a history of violent behavior * a history of a past suicide gesture or attempt * a history of current suicidal ideation * a history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke) * pregnancy * current acute or chronic medical condition requiring a medications that has psychological side-effects * any person whom we judge to have an impaired decision-making capacity

Keywords: major depressive disorder, anxiety disorders, treatments, photobiomodulation, near infra-red phototherapy, cerebral blood flow
fibroblasts and thoracic aortic aneurysms: in vitro characterization in with marfan syndrome and genetic aortic diseases

Conditions: Rare Diseases; Thoracic Aortic Aneurysm (TAA); Marfan Syndrome

Summary: the aim of the present study is to characterise the phenotype of fibroblasts and to classify different mechanisms involved in the onset and progression of taad in syndromic and non-syndromic subjects in order to evaluate potential markers related to taad.

the aim of the study is to analyse cutaneous fibroblast properties in patients with thoracic aortic aneurysms (both syndromic and non-syndromic) to identify differences in molecular mechanisms in collagen turnover pathways compared to healthy controls in the general population.

Eligibility criteria:
inclusion criteria (general for the study): signed informed consent; subjects aged 18 years and above. inclusion criteria (case): subjects with marfan syndrome and thoracic aortic aneurysms (in clinical follow-up or with cardiac surgery program); subjects with non-syndromic thoracic aortic aneurysms (in clinical follow-up or with cardiac surgery program); inclusion criteria (healthy controls): absence of any aortic/thoracic disease; exclusion criteria (all groups): * presence of any confounding cardiovascular risk factor (hypertension, dyslipidaemia, diabetes, smoking habits) or previous cardiovascular disease * corticosteroid or steroids or fluorochinolones treatment within six months before enrollment subjects on chronic immunosuppressive therapies such as oral steroids, but also on chronic topical steroids in the area of investigation; * a history of keloid formation (data found in anamnesis and medical records); * anaesthetic drug allergy (data found in anamnesis and medical records).

Keywords: fibroblasts collagen turnover thoracic aortic aneuryms
mri-based approaches for multi-parametric model to early predict pathological complete response to neoadjuvant therapy in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this clinical research is to evaluate the accuracy of a multi-parametric model based on magnetic resonance imaging (mri) in predicting pathological complete response (pcr) after the first cycle of neoadjuvant therapy (nat) given to patients with locally advanced breast cancer, thus allowing early chemotherapy regimen modification to increase number of patients achieving pcr or save patients from toxic effects of ineffective chemotherapy.

breast cancer is the most prevalent cancer among women worldwide. nat has been well established in managing breast cancer for patients with locally advanced cancer and early-stage operable breast cancers of specific molecular subtypes. though pcr has been demonstrated to be associated with better survival, it can only be judged by pathological testing of surgically resected specimens. thus, predicting pcr earlier during nat is imperative and can timely switch to a new personalized treatment strategy and exempt from unnecessary chemotherapy toxicity for patients. this is a multicenter, prospective cohort study of 301 patients undergoing mri after the first cycle of neoadjuvant chemotherapy. this project plans to establish and validate a model for determining pcr during nat in breast cancer based on clinical information, imaging and pathological information of patients in multiple centers, in order to provide important references for further early diagnosis and personalized treatment. 1. collecting mri images data, clinical and pathological information, treatment regimens, and curative effect information to build an mri-based, multi-parametric model. 2. evaluating the performance of model through internal and external validation cohort by using the receiver operating characteristic (roc) curve, the area under the curve (auc), discrimination and calibration measures.

Eligibility criteria:
1. for training cohort: inclusion criteria: * age ≥18 years; * histologically confirmed invasive breast carcinoma; * clinical stage ii-iii at presentation; * complete basic information and image data; * have mri imaging data at baseline and after the first cycle of nac; * finish the standard nac treatment and undergo surgery; exclusion criteria: * with chemotherapy contraindications; * multifocal of multicentric lesions; * poor quality of mri images; 2. for validation cohort: inclusion criteria: * age ≥18 years; * complete basic information and image data; * clinical stage ii-iii at presentation; * scheduled for neoadjuvant chemotherapy; * eastern cooperative oncology group (ecog) performance status of 0-1. * signed informed consent; exclusion criteria: * with chemotherapy contraindications; * metastatic breast cancer; * multifocal of multicentric lesions;

Keywords: magnetic resonance imaging (mri) neoadjuvant therapy (nat) therapeutic response breast cancer early prediction
clinical evaluation of myocare in europe (ceme)

Conditions: Myopia, Progressive

Summary: a 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. the study group will be composed of 150 children wearing myocare while the control group will be composed of 150 children wearing clearview. the inclusion criteria will be myopia with a spherical equivalent between -0.75d and -5.00d, astigmatism \< 1.50d, and anisometropia \< 1.00d, as well as having a historical evolution of at least -0.50 the primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. the secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.


Eligibility criteria:
inclusion criteria: * age 6-13 years * caucasian ethnicity * monocular/binocular decimal visual acuity with correction ≥ 1.00 * spherical equivalent between -0.75d and -5.00d * astigmatism \< 1.50d * anisometropia \< 1.00d * evolution of at least -0.50d in one year exclusion criteria: * presence of ocular pathology or a history of ocular and systemic abnormalities * strabismus or binocular vision problems * history of eye surgery * having previously used some method to control myopia. * having contraindications for the application of drugs for cycloplegia/corneal anesthesia

Keywords: myopia
iris suture fixation vs iris claw for correction of aphakia

Conditions: Aphakic Eye

Summary: evaluate and compare the advantages and disadvantages of iris suture fixation versus iris claw of posterior chamber iols

the eyes were randomly divided into two groups, a and b. group a included 25 eyes in which an iris claw lens was used; specifically, the artisan aphakia intraocular lens (ophtec bv, groningen, the netherlands), a pmma iol with an 8.5 mm length, 1.04 mm maximum height, and a 5.4 mm optical zone width. group b also included 25 eyes, in which iris fixation of posterior chamber foldable iols was performed using a single-piece pmma iol. this iol had a 6 mm optic, a total diameter of 12.75 mm, and featured one eyelet for suture fixation in each haptic. the a-constant used was 118.2.

Eligibility criteria:
inclusion criteria: * surgical aphakia with no capsular support, with cdva 4/60 or better on snellen chart including: aphakic eyes after complicated cataract surgery, crystalline lens subluxation (marfan syndrome, pseudoexofoliation syndrome or trauma), 2nd intervention in traumatized eyes, cases with sublaxated or dislocated iols. exclusion criteria: * surgical aphakia with decompensated corneas, aphakic patients with posterior segment pathologies like cystoid macular edema, choroidal neovascular membrane, aphakic patients with insufficient iris tissue, and rubeosis iridis, aphakic patients with intractable glaucoma.

Keywords: iris suture fixation , iris claw, aphakia
prevalence of pathologic gambling in the workforce: a cross-sectional study in brittany, france

Conditions: Behavior and Behavior Mechanisms

Summary: introduction: to date, very few studies about links between work and addictive disorders concern behavioral addictive disorders such as gambling. such behaviours may be adaptative strategy for unsatisfied workers. the common physiopathology of addictive disorders allows us to hypothesize that it is possible that such troubles at work could promote gambling. our aim was to evaluate the prevalence of gambling among workers and its links with work. patients and methods: we performed a descriptive cross-sectional monocentric study among all workers who consulted one physician between november 2016 and april 2017, from an occupational health service in brittany, france. the first step was to ask whether they have gambled during the last year and if it was related to their occupation. the second step was a screening for risky gamblers (using the "lie or bet" questionnaire) among these and then to assess more precisely the severity (using the indice canadien du jeu excessif, icje questionnaire).


Eligibility criteria:
inclusion criteria: * all employees coming in consultation in occupational medicine, between the 2016-11-01 and the 2017-04-30, with the investigator, having given their consent and replied to the questionnaires were included. exclusion criteria: * employees who did not speak the french language and those who refused to participate in the study were excluded. the number of refusals to participate and their reason were identified by the investigator. in addition, for employees who came to consult several times during the collection period, we only included the data from the first visit, in order to avoid overrepresentation.

Keywords: gambing occupational health services psychosocial risks
the impact of sexual health and amputation focused education on regulation of glucose and amputation prevention

Conditions: Diabetic Ulcers on Both Feet; Amputation; Traumatic, Limb; Sexual Dysfunction; Diabetic Foot Ulcer Ischemic

Summary: the purpose of this study is to investigate the effect of two types of education on hba1c level and future amputations in inpatient diabetics after initial minor foot amputation

this is a single center prospective randomized study evaluating inpatient diabetics after initial minor foot amputations. b) when a potential enrollee has been identified, while still inpatient, one research associate from a group of trained residents and medical students will spend 15-30 minutes with the patient to enroll and give one of the two education video presentations. the video presentations are the narrated versions of the slides attached to the irb application. we will have both english and spanish videos available. because we are using video education, the education provided will be standardized across all patients, and there will be minimal variation in education provided despite using different research associates. the patients will be randomized to one of the two presentations. both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes. each enrollee will also be asked if they are receiving structured diabetes education at the montefiore diabetic center and will be encouraged to follow up to receive structured education there. the education presentation will occur after post-operative day 1 after minor foot amputations. primary outcome: hba1c level secondary outcomes: ldl level, mortality, re-amputation (higher level or contralateral leg)

Eligibility criteria:
inclusion criteria: * hba1c 6.5 and above * had minor foot amputation this hospitalization * age 18 years old and older * all ethnicities * both genders exclusion criteria: none

Keywords: diabetic foot sexual dysfunction amputation