Kornimate/medical-research-clean huggingface dataset:
clinical trial of safety and efficacy of daily application of topical dutasteride in men with androgenic alopecia.

Conditions: Male Androgenetic Alopecia

Summary: alopecia is a disorder that involves the loss of hair from the body. the causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population.this study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit.

alopecia is a disorder that involves the loss of hair from the body. the causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population. this disorder, although more visible in men, is suffered by both men and women. recent studies show that the stress experienced by patients with alopecia can be similar or greater than that suffered by a more serious or chronic disease. for all these reasons, alopecia can prefer a social problem without a definitive therapeutic solution.this study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit. the lipid nature of the formulation and the droplet size of between 150-300 nm means that the emulsion drops easily penetrate the hair follicle and accumulate in the sebaceous glands of said follicles.

Eligibility criteria:
inclusion criteria: * • - males over 18 years of age, diagnosed with sinclair grades i-iv androgenic alopecia, who are not currently undergoing any hair treatment and have not undergone any in the last 3 months. * - understand the purpose of the study and be available for frequent visits to the hospital. sign the informed consent form. * - males with a partner of childbearing age must agree to use a contraceptive method with the partner for the duration of the study. exclusion criteria: * • - patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors. * - patients with severe hepatic insufficiency. * - patients who are currently undergoing capillary treatment or have undergone capillary treatment in the last 3 months. * - patients unable to understand the objective of the study or to give informed consent. * - patients who, in the opinion of the investigator, present any difficulty or situation that would hinder or contraindicate their participation in this study. * - patients with a history of drug addiction and drug addictions. * - patients who are participating in another clinical trial. * - patients whose partner is pregnant
efficacy optimizing research of chronic hepatitis b patients with inadequate response to nuc therapy

Conditions: Hepatitis B

Summary: the purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis b patients with inadequate response to nuc therapy


Eligibility criteria:
inclusion criteria: * male or female aged 18-65 years; * capable of understanding and signing the informed consent. willing to comply with the study requirements; * serum hbsag positive and alt\<10uln at study screening; * patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment; exclusion criteria: * history of viral breakthrough or genotypic resistance on previous therapy; * history of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis; * patient has a history of hepatocellular carcinoma(hcc) or findings suggestive of possible hcc; * other protocol defined exclusion criteria.

Keywords: chronic hepatitis b inadequate response nuc therapy
an interactive web platform to teach children hunting, shooting and firearms safety

Conditions: Safety Issues; Injuries; Firearm Injury

Summary: firearms injuries present a major pediatric public health challenge, killing \>800 children ages 0-15 annually and leading to lifelong disability among \>1000 survivors. about ⅓ of firearms injuries to children under age 15 are due to unintentional causes rather than suicide or homicide. the investigators propose development and evaluation of shootsafe, an innovative, engaging, and educational website accessible by smartphone, tablet or computer that engages children to learn firearms safety. shootsafe extends existing programs to achieve 3 primary goals: a) teach children knowledge and skills they need to hunt, shoot, and use firearms safely; b) help children learn and hone critical cognitive skills of impulse control and hypothetical thinking needed to use firearms safely; and c) alter children's perceptions about their own vulnerability and susceptibility to firearms-related injuries, the severity of those injuries, and their perceived norms about peer behavior surrounding firearms use. shootsafe will accomplish these goals through a combination of interactive games plus podcast videos delivered by peer actors (impactful testimonials about firearms injuries/deaths they experienced) and experts (wisdom \& experience from trusted role models). the website will also incorporate brief messaging to parents, who will absorb key lessons and reinforce them with their children. the website will be evaluated through a randomized controlled trial with 162 children ages 10-12, randomly assigning children to engage in the shootsafe website or an active control website on child nutrition. the investigators will incorporate sub-aims to evaluate changes in children's (a) knowledge, (b) cognitive skills in impulse control and hypothetical thinking, (c) perceptions about firearms safety, and (d) simulated behavior when handling, storing and transporting firearms. all outcome measures will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up assessment to evaluate retention. training will comprise two 30-minute sessions.


Eligibility criteria:
inclusion criteria: * children ages 10-12 years * english-speaking child and parent * experience or exposure to firearms in their homes or through engagement in hunting or shooting exclusion criteria: * disabilities that prohibit participants from valid understanding of or participation in the experimental protocol * siblings of enrolled child
flxfit post market outcome study protocol

Conditions: Degenerative Disc Disease Lumbar

Summary: this investigation will provide safety and effectiveness information on the use of the flxfit™ cage. data will be used for post market follow-up of the flxfit™ system by evaluating: * safety as measured by the rate of serious operative and post-operative complications. * patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure, as compared to patient's baseline.

interbody fusion in patients with degenerative disc disease (ddd) at one or two contiguous levels from l2 to s1. patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level(s). patients should be skeletally mature and have completed six months of non-operative treatment

Eligibility criteria:
inclusion criteria: * adult (age 18 - 70 years) patient (male or female) with the following conditions of the lumbar spine as confirmed by advanced imaging (ct or mri), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions: * degenerative disc disease * with up to grade i spondylolisthesis * failure of at least 6 month conservative treatment bmi \< 40. * patient to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one. exclusion criteria: * this device is not intended for cervical spine use. pi may exclude patient from study contraindications include, but are not limited to: * infection, local to the operative site * signs of local inflammation, * fever or leukocytosis, * morbid obesity, * pregnancy, * mental illness, * any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (wbc), or a marked left shift in the wbc differential count, * suspected or documented allergy or intolerance to implant's materials, * any case not described in the indications, * any patient unwilling to cooperate with postoperative instructions. * these devices must not be used for pediatric cases, nor where the patient still has general skeletal growth. * any case where the implant components selected for use would be too large or too small to achieve a successful result. * any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. * any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. * prior fusion at the level to be treated.
clinical trial protocol for safety and efficacy of soft contact lens

Conditions: Myopia

Summary: this project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.

the test product is the soft contact lens (model: spherical lens), and the control product is a commercially available soft contact lens (model: sihy daily). the number of enrolled subjects is 148, and clinical observation is performed for 3 months.

Eligibility criteria:
inclusion criteria: * male or female with age of 18 to 45 * spherical power: -0.25 to -10.00d * cylinder power ≤0.75d and sph.p:cyl.p≥3:1, or 1.00d≤ cylinder power ≤1.50d and sph.p:cyl.p ≥4:1; * both eyes are ametropia, and there is no case where the investigator believes that the soft contact lens cannot be worn; : the case of wearing a soft contact lens as referred to in this trial is: i) no eyelid abnormalities or infections; ii) no clinically significant slit lamp findings iii) no other active eye diseases. * bcva of the left and right eye subjective refraction is greater than or equal to 5.0. exclusion criteria: * need to use therapeutic ophthalmic drugs, including antibiotics, hormones and compound ophthalmic drugs containing hormones * dry eye syndrome * any systemic disease contraindications to contact lenses or disease medications can affect the wearing of contact lenses * wearing a hard contact lens in the past 6 weeks * tear film break-up time is less than or equal to 5s * allergic to contact lenses and/or contact lenses * keratoconus or other irregular corneal patients * soft hydrophilic contact lens wearers are affected by long-term special conditions such as dryness, severe dust or volatile chemicals * pregnant, lactating or plan to be pregnant * only one eye meets the requirements for enrollment * participating in other clinical trials or less than ten days after the end of a soft contact lens clinical trial * less than three months after the end of a drug clinical trial * determined by the investigator that could not be enrolled
clinical-epidemiological characterization of covid-19 disease in hospitalized older adults

Conditions: COVID-19

Summary: retrospective clinical-epidemiological study aimed at characterizing covid-19 disease in adults older than 70 years, hospitalized in the "perpetuo socorro" hospital of albacete (spain) from 09/03/2020 until 20/04/2020. secondary objectives will be to analyze clinical-epidemiological characteristics of covid-19 patients treated with baricitinib or anakinra, and to describe the efficacy and secondary effects of those drugs.

design: retrospective postauthorization study. registry study. setting: covid unit, "perpetuo socorro" hospital of albacete (spain). participants: adults older than 70 years hospitalized for covid-19 disease between 09/03/2020 and 20/04/2020. all patients will be included without exclussion criteria. measurements: * age, sex, residency. * functional assessment: barthel index, katz index, functional ambulation classification. * cognitive assessment: reisberg´s global deteriorating scale. * comorbidity: charlson index, disease count. * chronic medicines consumed. * disease related symptoms. * lab determinations: white cells, neutrophyl count, lymphocyte count, platelets, haemoglobin, inr, fibrinogen, d-dimer, ferritin, crp, il-6, urea, creatinin, ast, alt, ck. * thorax x-ray findings: covid affectation, severity, pleural effusion, heart failure signs, pneumothorax. * drugs used during hospitalization, number of days of treatment and total doses: anakinra, baricitinib, glucocorticoids, antivirals (lopinavir/ritonavir, emtricitabina/tenofovir), azitromycin, ceftriaxone, hidroxychloroquin. * geriatric syndroms: delirium, immobility, dysphagia, pressure ulcers. * outcomes: mortality at discharge, institucionalización at discharge, length of stay, change in lab results, change in x-ray results, change in function at discharge. registry procedures: medical chart review by trained geriatricians, pharmachological chart review by expert pharmacists, x-ray review by trained radiologists. all data will be included in an anonimyzed database for further analysis by investigators, and supervised by principal investigator. regulatory status: the protocol was approved by the ethics review committee of albacete (number 2020-21 from 20/04/2020) and by the spanish medicines agency (aemps) who gave a "postauthorization study" classification (number pas-bar-2020-04. 20/04/2020). analysis: two stage analysis will be conducted. in first one, efficacy and security analysis of the 99 patients that have received either baricitinib or anakinra will be conducted, and in the second one, clinical-epidemiological analysis of the complete sample, n=576, will be realized.

Eligibility criteria:
inclusion criteria: * adults older than 70 years hospitalized for covid-19 disease between 09/03/2020 and 20/04/2020, in the "perpetuo socorro" hospital of albacete (spain). exclusion criteria: * none

Keywords: covid-19 older adults hospitalization baricitinib anakinra effectiveness security mortality
study with phage for cf subjects with pseudomonas lung infection

Conditions: Chronic Pseudomonas Aeruginosa Infection; Cystic Fibrosis (CF)

Summary: the goal of this phase 2b clinical trial is to see if nebulized phage (bx004) can treat chronic pseudomonas aeruginosa (psa) lung infection in cf subjects. the primary goal is to see if 8 weeks of twice daily bx004 can reduce the amount of psa in the sputum compared to placebo (on top of background cf therapy).

this is a randomized, double-blind, placebo-controlled, multicenter study to evaluate bx004 in cf subjects with chronic psa pulmonary infection. the main purpose of the study is to evaluate whether bx004 reduces the psa burden in the sputum of cf subjects with chronic psa pulmonary infection. secondary endpoints are to see how well bx004 works in improving lung function and quality of life, reducing the amount of psa in the sputum, getting negative sputum cultures for psa, and safety and tolerability. clinically stable cf subjects with a confirmed diagnosis of cf and chronic psa pulmonary infection will be enrolled. subjects will be included in a 6-month post-dose safety follow-up. a data safety monitoring board of the cf foundation will monitor safety.

Eligibility criteria:
key inclusion criteria: * cystic fibrosis patients with chronic pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics * age ≥ 18 years * fev1 40%-80% predicted * clinically stable lung disease * willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits. key exclusion criteria: * known hypersensitivity to bacteriophages or excipients in the formulation. * receipt of prior bacteriophage therapy within the 6 months prior to screening or day 1 * detection of burkholderia cenocepacia from respiratory tract within 1 year prior to screening or from screening culture * currently receiving systemic treatment for allergic bronchopulmonary aspergillosis * currently receiving treatment for active infection with non-tuberculous mycobacteria or prior detection of mycobacterium abscessus in 12 months prior to screening * history of severe neutropenia * history of lung transplant * history of solid organ transplant * acquired or primary immunodeficiency syndrome * initiation or change in type of cftr modulator less than 3 months prior to screening * pregnant or breastfeeding female
computer-based therapy for mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the purpose of this study is to determine the neuropsychological and neurophysiological impacts of a computer-based training program designed to improve the cognitive performance of patients with mild cognitive impairment (mci).

the study is a randomized, double-blind, controlled trial of a computerized, cognitive intervention with three main goals: 1) to assess the magnitude of improvements in memory, language function, and cognitive function following computer training, 2) to investigate the neurophysiological mechanisms underlying such neuropsychological improvements, and 3) to demonstrate the feasibility of using this kind of computer-based therapy in older populations.

Eligibility criteria:
inclusion criteria: 1)65 - 90 years of age 2)meet definition for mci including complaints of cognitive decline as indicated by patient report and/or informant report, and corroborated by clinician judgment and, the absence of dementia, defined as impairment of memory and at least one other domain of cognitive function. 3)fluency in english 4)willing to meet the time commitment of the study - exclusion criteria: 1. clinically significant cerebrovascular disease 2. individuals scheduled to begin acetylcholinesterase inhibitor (achei) therapy -

Keywords: cognitive remediation cognitive impairment computer training
study of management and prognosis of patients with acute myeloblastic leukemia in saint-antoine hospital

Conditions: Acute Myeloid Leukemia

Summary: aml in adults represents a group of heterogeneous diseases; the prognosis remains poor despite significant therapeutic advances in recent years. in order to optimize patient care, it is necessary to have "real life" data that exhaustively reports on the patients treated in our department. the objective of this study is: * to describe the aml treated within the hematology department * to optimize the management of patients with aml.

current state of knowledge: acute myeloblastic leukemia are the most common leukemias in adults. this pathology is very heterogeneous. it has a poor prognosis despite numerous therapeutic advances. the lack of randomized clinical trials can make certain treatment decisions difficult. in addition, patients with comorbidities or the elderly are most often excluded from these trials even though they represent a significant proportion of new diagnoses. objectives: primary objective evaluate the overall survival of adult patients treated for aml in our hematology department at saint-antoine hospital. secondary objectives * evaluate early mortality at 30 days and 60 days post-induction * evaluate the cr/cri rate after induction * evaluate the toxicity of the treatments * evaluate the relapse-free survival time * assess the prognostic value of jc-1 at diagnosis * evaluate the proportion of patients eligible for intensive treatment and/or allograft * evaluate the side effects of the treatments undertaken * describe the molecular and cytogenetic characteristics of hemopathies at diagnosis and at relapse duration of study: retrospective cohort (cohort a): patients diagnosed between junuary1,2010 and may 30,2022 prospective cohort (cohort b): patients diagnosed between june 1, 2022 and december 31, 2023. a follow-up of 2 years will be necessary after the end of treatment. the end of follow-up is estimated at december 2025 for the entire cohort. data collection: collection of clinical and biological data in the patient's medical file via the orbis software population: adult patients treated for aml at saint-antoine hospital

Eligibility criteria:
inclusion criteria: * age :18 years and older * patients with aml * non objection to research exclusion criteria: * minor patients * acute promyelocytic leukemia (aml3)

Keywords: prognosis of acute myeloblastic leukemia
a efficacy against otitis media in children with 11 valent pneumococcal vaccine

Conditions: Hepatitis A

Summary: the purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable hemophilus influenza, following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with booster dose in the second year of life. prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo (hepatitis a vaccine).


Eligibility criteria:
inclusion criteria: * male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Keywords: prophylaxis pneumococcal vaccine
rapid emergency department heart failure outpatient trial (redhot ii)

Conditions: Heart Failure

Summary: the purpose of this study is to test whether physicians can make more informed treatment, admission, and discharge decisions related to patient care by having serial triage® bnp test results available to assess disease severity, while patients are being treated for hf in the emergency department and/or during their admission. this is believed to lead to a better outcome as well as more efficient and cost-effective treatment.

this is a patient-randomized clinical study consisting of patients who present to the ed requiring treatment and/or admission for hf. at each site, patients will be randomized into either a control arm or an experimental arm. serial blood samples will be collected from all patients throughout their stay in the ed and the hospital. in the experimental arm, the triage® bnp test will be performed on all blood samples collected and each bnp result will be made available to the attending physicians immediately. in the control arm, blood samples will not be analyzed on-site for bnp but instead sent directly to biosite inc. for testing.a comparison will be made between the control and experimental arms of the study to determine if there are any significant differences in length of stay, re-hospitalizations, all cause mortality, bnp levels, quality of life, and costs to treat patients.

Eligibility criteria:
inclusion criteria: age 18 and older patient needs treatment for hf exclusion criteria: current mi or acs with st deviation of 1 mm or greater renal failure requiring dialysis undergone hemodialysis within the last month enrollment (baseline) triage® bnp concentration = 100 pg/ml or less enrolled in any other drug trial or receiving an experimental treatment for hf.