Kornimate/medical-research-clean huggingface dataset:
effectivity and safety of metronidazole 1% cream in rosacea therapy

Conditions: Rosacea

Summary: rosacea is a chronic inflammatory disease of the central facial region, which can also occur in the neck and chest regions. microbes that play a role in rosacea are demodex folliculorum and helicobactor pylori. on the skin with rosacea have decreased skin barrier function. this clinical study will compare the effectiveness and safety of metronidazole 1% cream as the main therapy in rosacea patients. participants who will become research subjects are women and men aged 18-60 years who meet the inclusion criteria. research subjects were divided into 2 groups. the control group will use placebo cream (without the drug substance) and the comparison group will use metronidazole 1% cream.

this study is an experimental study with a double-blind randomized controlled trial (rct) design for researchers and subjects in male and female patients aged 18-60 years who meet the inclusion criteria. this study used 1% metronidazole cream and placebo cream as a comparison. the creams will then be coded as cream a and cream b. this research will be conducted in two places, namely the dermatology and venereology polyclinic, division of cosmetic dermatology, cipto mangunkusumo hospital (rscm) and the dermatology and venereology polyclinic, university of indonesia hospital (rsui). the control group will use placebo cream (without the drug substance) and the comparison group will use metronidazole 1% cream. all participants will be evaluated twice on days 28 and days 56. evaluation of response to therapy that will be assessed includes the degree of erythema with a clinician erythema assessment scale (cea) score, examination of skin scrapings for demodex examination, dermoscopy examination, and tewl (transepidermal water loss) examination.

Eligibility criteria:
inclusion criteria: * male and female, aged 18-60 years * diagnosed with rosacea * the patient agreed to participate in the study and signed a inform consent exclusion criteria: * taking corticosteroid therapy (oral or topical) * patients with a history of using topical therapy on the face within one month before the study * taking metronidazole, clarithromycin, or azithromycin within one month before the study * patients who are frequently exposed to ultraviolet (uv) light * pregnant or breastfeeding * patient and/or family do not agree to participate drop out criteria: * pass away during the clinical trial * research subjects were not present when scheduling the action or did not comply with the research protocol. * research subjects were not present when scheduling the action or did not comply with the research protocol. * suffer from coronavirus disease 2019 (covid-19) at any time during the trial * experience major adverse event(s) caused by topical products or treatments given in the clinical trial (e.g. allergic drug eruption or contact dermatitis). the participants will receive appropriate management if such event occurs

Keywords: rosacea erythema
prepare for your diabetes care

Conditions: Type 2 Diabetes Mellitus With Hypoglycemia; Aging; Patient Activation

Summary: as adults with type 2 diabetes age, they are increasingly vulnerable to treatment-related hypoglycemia and its related complications (including hospitalization and death). this study proposes to evaluate, in a randomized clinical trial, a strategy of expanded advance care planning to support older adults in value-aligned re-assessment of diabetes treatment regimens with their primary care team. if the aims of this project are achieved and incidence of clinically-significant hypoglycemia is reduced, this prepare for your diabetes web-based patient educational care strategy could be scaled and applied in a wide variety of healthcare settings and chronic conditions in which evolving risks, benefits, and consequences of treatment require re-assessment with age.

in this pragmatic, clinical efficacy, parallel group randomized clinical trial, the study will enroll eligible kaiser permanente northern california members (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas \[sus\], and last measured hba1c \<=8%). participants randomly allocated to the intervention arm will view the prepare for your diabetes care web-based educational module that is designed to help them prepare to discuss their diabetes medication regimens with their primary care providers and receive an action plan handout. participants randomly allocated to the control arm will continue with usual care. all participants will complete baseline, 6-month, and 12-month surveys. the hypothesis is that empowering high-risk patients to engage in values-based discussions about diabetes treatment intensity will result - when clinically appropriate - in decreases in diabetes regimen intensity leading to decreased incidence of hypoglycemia over the 12-month study period. if successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.

Eligibility criteria:
inclusion criteria: * age ≥ 75 years * type 2 diabetes with last measured hba1c ≤ 8.0% * currently prescribed insulin and/or sus * kaiser permanente northern california member exclusion criteria: * unable to communicate in english * unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits * excluded by their primary care provider
phase 1/2 study of avutometinib (vs-6766) + sotorasib with or without defactinib in kras g12c nsclc patients

Conditions: Non Small Cell Lung Cancer; KRAS Activating Mutation

Summary: this study will assess the safety and efficacy of avutometinib (vs-6766) in combination with sotorasib with or without defactinib in patients with kras g12c non-small cell lung cancer (nsclc) in patients who have been exposed to prior g12c inhibitor and those who have not been exposed to prior g12c inhibitor.

this is a multicenter, non-randomized, open-label phase 1/2 study designed to evaluate safety and tolerability and efficacy of avutometinib (vs-6766) in combination with sotorasib with or without defactinib in patients with kras g12c mutant nsclc.

Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years of age * histologic or cytologic evidence of nsclc * known kras g12c mutation * either exposed or not exposed to a kras inhibitor to be included in part a (avutometinib + sotorasib + defactinib) and not exposed to kras inhibitor to be included in part b (avutometinib + sotorasib + defactinib), cohort 1 * received at least 1 dose of a g12c inhibitor to be included in part b, cohort 2 (avutometinib + sotorasib + defactinib) * must have received appropriate treatment with at least one prior systemic regimen, but no more than 2 prior regimens, for stage 3b-c or 4 nsclc * measurable disease according to recist 1.1 * an eastern cooperative group (ecog) performance status ≤ 1 * adequate organ function * adequate recovery from toxicities related to prior treatments * agreement to use highly effective method of contraceptive exclusion criteria: * systemic anti-cancer therapy within 4 weeks of the first dose of study therapy * history of prior malignancy, with the exception of curatively treated malignancies * major surgery within 4 weeks, minor surgery within 2 weeks (excluding placement of vascular access) * history of treatment with a direct and specific inhibitor of mek * exposure to strong cyp3a4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy * symptomatic brain metastases requiring steroids or other local interventions. * known sars-cov2 infection ≤28 days prior to first dose of study therapy * known hepatitis b, hepatitis c, or human immunodeficiency virus infection that is active * active skin disorder that has required systemic therapy within the past year * history of rhabdomyolysis * concurrent ocular disorders * concurrent heart disease or severe obstructive pulmonary disease * inability to swallow oral medications * female patients that are pregnant or breastfeeding * previously treated with sotorasib and were dose reduced due to toxicity

Keywords: nsclc kras g12c
a surveillance study of susceptibility to baloxavir marboxil in participants with influenza

Conditions: Influenza

Summary: the purpose of this study is to evaluate the pre-treatment and single-dose post treatment susceptibility of baloxavir marboxil in participants aged 1 to \<12 years with influenza.


Eligibility criteria:
inclusion criteria: * participants with symptoms suggestive of influenza with diagnosis confirmed by a positive local influenza test within 24 hours before full study screening. * participants with a negative severe acute respiratory syndrome coronavirus 2 (sars-cov-2) test within 48 hours before full study screening. * time interval between onset of influenza symptoms and the pre-dose examinations at screening is 48 hours or less exclusion criteria: * participants with severe influenza virus infection requiring inpatient treatment. * severely immunocompromised participants \[including participants receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus (hiv) infection\] as defined by the investigator. * participants with concurrent (non-influenza) infections requiring systemic anti-microbial and/or anti-viral therapy at the pre-dose examinations. * treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to screening. * treatment with an investigational influenza-specific monoclonal antibody within 6 months or 5 half-lives, whichever is longer, prior to screening. * treatment with an investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening. * known hypersensitivity to baloxavir marboxil or the drug product excipients. * females who have commenced menarche (i.e., child-bearing potential).
implementing tobacco treatment in low dose ct lung cancer screening sites

Conditions: Smoking Cessation

Summary: this study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. the investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.


Eligibility criteria:
inclusion criteria: site eligibility (as per sc self-report) \& must be designated as an american college of radiology (acr) designated lung cancer screening site * reports at least one year of lung cancer screening experience * reports conducting at least 20 new initial screenings per month site coordinator (sc) eligibility (as per sc self-report) * employed as a full-time site coordinator at participating lung cancer screening site patient eligibility (as per self-report) * between the ages of 50-80 years old * seeking baseline or annual follow-up ldct lung cancer screening * have at least a 20 pack-year history of smoking * currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days. * must be reachable by telephone * must be english or spanish speaking due to the study materials being available in only these languages and limited available resources for translation. exclusion criteria: patient (as per self-report) * nrt is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina). * smokers who are receiving other tobacco treatment services or have used cessation medications (nrt, bupropion, varenicline) within the past month.

Keywords: tobacco treatment lung ct cancer screening 17-500
study of a management strategy of functional bowel disordes related to irritable bowel syndrome (ibs) with a mixture of 8 microbiotic strains

Conditions: Irritable Bowel Syndrome

Summary: the aim of this study is to determine the impact of a 10-day treatment with lactichoc® on irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * having ibs symptomatology meeting the rome iv criteria; * having a ibs-sss score ≥150 ; * in a state of general and mental health compatible with participation in the study ; * agreeing to maintain their lifestyle during the study (same dietary and physical activity habits) ; * willing to take stool samples; * able and willing to participate in the research by complying with the protocol procedures, especially regarding the consumption of the study product; * having electronic tools (computer, tablet...) and an internet connection, allowing him/her to fill out the self-questionnaires of the study online; * affiliated to a social security system. exclusion criteria: * have a history of hypersensitivity to any of the ingredients of the study product; * under antibiotic treatment, or having stopped it for less than 14 days; * under dietary supplementation (prebiotics or probiotics) or having stopped it for less than one month; * having initiated or modified a background treatment for a comorbidity for less than one month, or planning to initiate it during the study, or planning to interrupt it during the study; * having a lifestyle incompatible with the study as determined by the investigator; * women who are pregnant or breastfeeding or who intend to become pregnant within the next 2 months; * planning to travel extensively during the study period or unable to be contacted in case of emergency; * psychologically or linguistically unable to understand and sign the informed consent; * participating in another clinical trial or on an exclusion period from a previous clinical trial; * under legal protection (guardianship, curatorship) or deprived of their rights following an administrative or judicial decision.
a study investigating the movement of lu ag09222 into, through, and out of the body of healthy caucasian, chinese, and japanese participants

Conditions: Migraine

Summary: the main goal of the study is to learn more about how the body absorbs and eliminates lu ag09222 after a single dose is injected under the skin. researchers will also investigate safety and tolerability effects of lu ag09222 after administration.


Eligibility criteria:
inclusion criteria: * the participant is japanese, defined as having 4 japanese grandparents, or the participant is caucasian, or the participant is chinese, defined as having 4 chinese grandparents. * the participant has a body mass index (bmi) ≥18 and ≤28 kilograms (kg)/square meter (m\^2) at the screening visit and at the baseline visit. exclusion criteria: * the participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. * the participant has a history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for \>5 years prior to the first dose of investigational medicinal product (imp). * the participant has had major surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) \<6 months prior to the first dose of imp. * the participant has previously been dosed with lu ag09222. * the participant has a history of severe drug allergy or hypersensitivity. other inclusion and exclusion criteria may apply.
reimbursement effects on enrollment in obesity treatment

Conditions: Obesity

Summary: the purpose of this study is to simulate what would occur if insurance reimbursement became available for obesity treatment but required that the individual meet defined performance milestones.

this is a prospective study to determine whether a reimbursement incentive (the prospect of reimbursement of half of the out-of-pocket fee for participation in the uab eatright weight management program, when it is contingent upon consistent program participation and loss of 6% of initial body weight) is associated with (1) a higher rate of program enrollment and (2) greater percent weight loss, greater reductions in medication dosages and costs, and fewer visits to health care providers after 12 weeks and 9 months.

Eligibility criteria:
inclusion criteria: * adults with obesity (bmi at least 30 kg/m2) * commitment of the full eatright weight management program fee exclusion criteria: * none

Keywords: obesity treatment insurance reimbursement health care utilization health care costs
radicle calm 2: a study of health and wellness products on feelings of anxiety, stress, and health outcomes

Conditions: Anxiety; Stress

Summary: a randomized, double-blinded, placebo-controlled study assessing the impact of health and wellness products on feeling of anxiety, stress, and other health outcomes

this is a randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the united states. eligible participants will (1) endorse a desire for less anxiety or stress, (2) indicate an interest in taking a health and wellness product to potentially help their feelings of anxiety or stress, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. those taking certain medications will be excluded. self-reported data are collected electronically from eligible participants over 7 weeks. participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. all study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility criteria:
inclusion criteria: * adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities * resides in the united states * endorses fewer feelings of anxiety or stress as a primary desire * selects feelings of anxiety or stress, looking to improve their feelings of anxiety or stress, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product * expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study exclusion criteria: * reports being pregnant, trying to become pregnant, or breastfeeding * unable to provide a valid us shipping address * the calculated validated health survey (pro) measurement result is less than mild severity/impairment * reports a diagnosis of liver or kidney disease * reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * unable to read and understand english * reports current enrollment in a clinical trial * lack of reliable daily access to the internet * reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection * reports taking medications with a known moderate or severe interaction with any of the active ingredients studied: anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or maois (monoamine oxidase inhibitors) * reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: nyha (new york heart association) class iii or iv congestive heart failure, atrial fibrillation, uncontrolled arrhythmias
kinematic real time feedback used to learn manual therapy on peripherical joints

Conditions: Musculoskeletal Diseases; Complication of Manipulation Procedure; Defective; Learning (Specific)

Summary: this study will try to analyze the effect of the real-time kinematic feedback (krtf) to learn manual therapy on peripherical joints comparing the results with the traditional teaching method.


Eligibility criteria:
inclusion criteria: * undergraduate students with no experience in manual therapy exclusion criteria: * to have some experience in manual therapy

Keywords: musculoskeletal manipulations learning feedback kinematics inertial sensor
smartphone-based self-care education program for women with interstitial cystitis: educational remote ic aide

Conditions: Cystitis, Interstitial

Summary: to implement and assess clinical efficacy of a text message and multimedia-based program that (i) remotely delivers first- and second-line american urological association (aua) treatments of ic/bps; (ii) integrates treatment of biological (neuropathic pain, pelvic floor dysfunction), psychological (symptom-related fear and anxiety) and social (barriers in access to care, limited patient-provider communication) domains of ic/bps; (iii) uses clinically validated messages to provide guidance and support.


Eligibility criteria:
inclusion criteria: * women over 18 * aua (american urological association) criteria for ic/bps of "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes" * interested in first- or second-line aua treatment * negative urinalysis and culture within two months of enrollment * english-speaking * own a smartphone with text message and video viewing capability exclusion criteria: * women currently on third line or higher treatments * currently being treated for uti * history of voiding dysfunction such as urinary retention or neurogenic bladder * recent (\<6 months) pelvic surgery/pregnancy * prior pelvic malignancy or radiation

Keywords: self-management technology text message multimedia pelvic floor physical therapy mindfulness cognitive behavioral therapy
jak inhibition in ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the treatment for ulcerative colitis (uc) aims to achieve and maintain remission and is usually lifelong and expensive. current available medications are unable to break the cycle of chronic inflammation, and still a significant proportion of patients will fail to respond (primary non-response) or lose response over time (secondary non-response). there is now growing evidence that there is substantial interpatient variation in the composition of the inflammation associated network of immune cells. a deeper knowledge of the patient's alterations in the mucosal immune response would help identify key drivers of inflammation and select the appropriate therapy. by analyzing the changes in the composition of immune cells induced by janus kinase (jak) inhibition, we aim to obtain a better insight into the mechanistic effects of jak inhibition and the downstream effects. these mechanistic insights are needed to identifying potential responders and non-responders in the future.


Eligibility criteria:
age ulcerative colitis active disease

Keywords: janus kinase inhibitors