Kornimate/medical-research-clean huggingface dataset:
comparison of non-invasive oxygenation strategies in patients admitted for covid-19 acute respiratory distress syndrome

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Summary: acute respiratory distress syndrome (ards) is the main clinical presentation of sars-cov-2 (covid-19) infected patients admitted in intensive care unit (icu). during the first phase of the outbreak (between february and may 2020), the use of invasive mechanical ventilation (mv) was largely required with 63% of icu patients intubated in the first 24 hours after admission and up to 80% of patients during the overall icu stay. mortality was especially higher when using mv in the first 24 hours. in contrast, the use of non-invasive oxygenation strategies in the first 24 hours was only 19% for high flow nasal cannula oxygen therapy (hfnc) and 6% for non-invasive ventilation (niv). several non-invasive oxygenation strategies were proposed in order to delay or avoid mv in icu patients suffering from covid-19 ards. the use of hfnc became the recommended oxygenation strategy, based in particular on publications prior to the outbreak. the use of niv or continuous positive airway pressure (cpap) combined with hfnc have also been proposed. although these non-invasive oxygenation strategies seem widely used in the second phase of the outbreak, they have not yet confirmed their clinical impact on mv requirement and patient's outcome. moreover, no comparison has been made between these different non-invasive oxygenation strategies. the aim of this study is to compare different non-invasive oxygenation strategies (hfnc, niv, cpap) on mv requirement and outcome in icu patients treated for ards related to covid-19.

retrospective multicenter observational registry in french intensive care unit including all consecutive patients admitted for acute respiratory distress syndrome related to sars-cov-2 pneumonia between1st july and 31th december 2020. patients characteristics, icu treatments and outcome will be recorded.

Eligibility criteria:
inclusion criteria: * patients admitted in intensive care unit because of a sars-cov-2 infection confirmed by pcr wherever was collected the analyzed sample * acute respiratory distress syndrome according to berlin criteria * age superior or equal to 18 years old exclusion criteria: * patient opposition to participate in the study * patients under judicial protection measures

Keywords: novel coronavirus disease 2019 (covid-19) severe acute respiratory syndrome coronavirus 2 (sars-cov-2) acute respiratory distress syndrome high flow nasal canula oxygen non-invasive ventilation continuous positive airway pressure
experience of non-melanoma skin cancer (nmsc) mohs surgery project

Conditions: Non-Melanoma Skin Cancer

Summary: mohs surgery excises non-melanoma skin cancer tumors of the head and neck while preserving maximum healthy tissue, an advantageous characteristic when dealing with the cosmetic and functional cervifacial region. yet, treatment can result in changes to function and appearance with effects on quality of life. this project uses grounded theory to explore the mohs surgery experience of nmsc patients who have head and neck lesions through interview and observation of the surgical appointment.

mohs surgery offers significant benefits in excising nmsc tumors of the head and neck by precisely removing cancerous tissue while preserving the maximum amount of healthy tissue, a characteristic of particular advantage when dealing with nmsc in the highly cosmetic and functional cericofacial region. despite this, few studies have explored the patient perspective on their experience with mohs surgery. futhermore, treatment for nmsc can result in scarring, disfigurement, and changes to function and appearance. ramifications on identity and self, embodiment and aesthetics, interaction and relationships appear likely and consequences on function and quality of life might then follow. using grounded theory, this project aims to explore the question "what is the experience of mohs surgery for non-melanoma skin cancer patients who have lesions of the head and neck?" potential patient participants are those diagnosed with non-melanoma skin cancer, who have undergone mohs surgery or are scheduled to undergo mohs surgery on skin located in any area above the shoulders, and are referred to the project by their surgeons. they will represent a range of disease, from those who have had a single mohs surgery to those with recurrent nmsc and repeated mohs. patients will also read and speak english and be at least 18 years of age. transcribed interviews and field notes will be analyzed using constant comparative technique to develop descriptive and theoretical understandings of how experience mohs surgery for non-melanoma skin cancer of the head and nexk.

Eligibility criteria:
inclusion criteria: * patient participants must have an upcoming mohs surgery scheduled or have already undergone mohs surgery within the university of pennsylvania health system. * all participants must read and speak english. * for those patient participants with communication impairments due to surgery and treatment, accomodations for alternate methods of communication, including typing responses to the interview guide into a laptop computer or writing responses with a pen on paper, will be provided. * both male and female * must read and speak english * be over the age 18 and able to give consent. exclusion criteria: * this study excludes patients and their partners who are incapacitated or not old enough to give consent, more specifically those under the age of 18.

Keywords: non-melanoma skin cancer patients who have undergone or about to undergo mohs surgery who are treated within the university of pennsylvania health system
long-term safety follow-up study of scm-agh in subjects who participated and administered scm-agh in to severe atopic dermatitis clinical trials

Conditions: Dermatitis, Atopic

Summary: this is a long-term safety follow-up study of the phase i/ii multicenter study of scm-agh in subjects with moderate to severe atopic dermatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. only subjects previously enrolled in protocol adt2002 (clinicaltrials.gov id: nct04179760) will be eligible for this long-term follow-up protocol.

subjects who meet all eligibility criteria for long term follow up(ltfu) study participation at the adt2002 end of treatment(eot) visit may continue ltfu for a maximum period of up to 240 weeks post first dose of investigational product. no additional dosing will be administered on this ltfu protocol.

Eligibility criteria:
inclusion criteria: 1. subjects who provide written informed consent 2. subjects who have received at least 1 dose of scm-agh in the adt2002 study 3. subjects who are willing to comply with the visit schedule and study requirements for reporting relevant information to the site. exclusion criteria: 1. subjects who are unable to comply with the visit schedule prior to week 240 after first dose of scm agh

Keywords: scm-agh atopic dermatitis stem cell therapy
acute effect of phototherapy with light emitting diode (led) on muscle and pulmonary oxygen consumption on diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine the phototherapy may be adjuvant to exercise to improve muscular efficiency and increase aerobic capacity. we hypothesized that phototherapy adjuvant with physical exercise may be benefit to populations with diabetes mellitus that have impairment in cardiopulmonary fitness and low oxygen uptake peak values (vo2peak) in exercise tests. two doses will be tested 150j and 300j. additionally, this study aims to evaluate the effect of phototherapy previously applied to the exercise on the cardiovascular coupling. we hypothesize that phototherapy previously applied to the exercise will result in the increase baroreflex sensitivity (increased coherence and gain and decreased phase), promoting the improvement of the cardiovascular autonomic control and cardiovascular coupling in diabetic subjects. two doses will be tested 150j and 300j.


Eligibility criteria:
inclusion criteria: * overt coronary disease * sedentary * clinical diagnosis of diabetes mellitus * free of diabetes mellitus to participate of control group exclusion criteria: * autonomic neuropathy * smoking * anemia * alcoholism * disability conditions precluding exercise

Keywords: diabetes mellitus, type 2 phototherapy physical exercise oxygen consumption arterial blood pressure heart rate baroreflex sensitivity cardiovascular autonomic control
food order intervention for gestational diabetes

Conditions: Gestational Diabetes

Summary: this is a randomized controlled feasibility trial for women diagnosed with gestational diabetes mellitus (gdm). the current front-line treatment for gdm is medical nutrition therapy (mnt), i.e. personalized diets which may or may not include mild carbohydrate restriction. use of carbohydrate restriction increases the risk of the mother developing ketosis, a harmful condition for both the mother and fetus. if mnt is not enough to stabilize blood sugar levels, then pharmaceuticals are prescribed. in patients with type-2 diabetes and prediabetes, the carbohydrate-last food order behavior has been shown to improve post-meal blood sugar control without the need of reduced carbohydrate intake. given this data, the addition of this intervention to mnt in patients with gdm may be helpful in achieving controlled blood sugar levels without increasing the risk of ketosis. this study will include two randomized groups diagnosed with gdm. patients in the control group will be prescribed standard mnt. patients in the intervention group will have identical mnt but with additional food order instruction/therapy. all patients will be followed up with at 1-2 week intervals. at each follow-up the physician and dietician will analyze the patient's blood sugar measurements and, among additional factors, determine if pharmaceuticals should be added. treatment will continue through delivery. the primary aim of this study is to assess the feasibility of the carbohydrate last food order in gdm and generate preliminary data on its effects on glucose control.


Eligibility criteria:
inclusion criteria: * pregnant subjects ≥18 years old * newly diagnosed with gdm between 24-32 weeks of gestation with at least 2 days of self-monitored glucose logs or diagnosed via a 50g glucose challenge test (gct) greater than 200mg/dl exclusion criteria: * pre-existing diabetes prior to conception * patients whom do not plan on consuming at least 3 meals daily throughout gestation (e.g. during ramadan) * requirement of special medical diet (e.g. from phenylketonuria, celiac disease, etc.) * history of bariatric surgery
high dose of activated recombinant human factor vii for treatment of mild/moderate joint bleeds in haemophilia patients with inhibitors

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this trial is conducted in europe. the aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor vii in treatment of joint bleeds in haemophilia patients with inhibitors.


Eligibility criteria:
inclusion criteria: * diagnosed of congenital haemophilia a or b with inhibitors to factor viii or ix, respectively * a history of 3 or more joint bleeds during the last 12 months exclusion criteria: * joint bleeding within 7 days prior to trial start * treatment for bleeds within the last 5 days prior to trial start * clinically relevant coagulation disorders other than congenital haemophilia a or b
ezetimibe/simvastatin (10 mg/40 mg) vs. the doubling of atorvastatin in high risk participants (mk-0653a-134 am1)(completed)

Conditions: Hypercholesterolemia

Summary: participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). after 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (ldl-c) will be assessed and compared between the two treatment groups.


Eligibility criteria:
inclusion criteria: * participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation * participant meets adult treatment panel (atp) iii high risk criteria exclusion criteria: * females who are pregnant or breastfeeding * participant consumes more than 14 alcoholic beverages per week * participant has been treated with an investigational drug within the last 30 days * participant has congestive heart failure (new york heart association \[nyha\] type iii or iv) * participant has had gastric bypass * participant is newly diagnosed with type 1 or 2 diabetes * participant is human immunodeficiency virus (hiv) positive * participant has a history of drug or alcohol abuse within the last 5 years
first-in-human single and multiple dose of hl-400

Conditions: Parkinson Disease

Summary: this is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of hl-400 (a nlrp3 inhibitor) following oral single and multiple ascending dose administration.

this is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of hl-400 following oral single and multiple ascending dose administration.this study will consist of 3 parts, which are part 1 (single ascending dose), part 2 (multiple ascending dose) and part3 (cerebrospinal fluid (csf) exposure). safety, pharmacokinetic parameters and relevant biomarkers will be assessed in the study.

Eligibility criteria:
inclusion criteria: * are capable of giving written informed consent and complying with study procedures, schedule, requirements, and restrictions. * are between the ages of 18 and 65 years, inclusive, at screening. * female subjects have a negative serum hcg pregnancy test result at screening andday （-1）, agree to refrain from ova donation for at least 3 months after the last dose, and willingness to comply with protocol-specified contraceptive methods. * male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional barrier method (female partner) of contraception for the duration of the study and for at least 3 months after last dosing; must also agree to refrain from sperm donation for at least 3 months after the last dose. * considered healthy by the investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ecg, and vital signs. * non-smoker for at least 6 months prior to screening. * body mass index (bmi) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg. exclusion criteria: * clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the investigator. * pregnant (as determined by pregnancy test result) or breastfeeding women. * history of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance. * positive blood screen for human immunodeficiency virus (hiv 1/2), hepatitis b surface antigen (hbsag), or hepatitis c antibody. * a positive screen for alcohol or drugs of abuse at screening or day -1. * an unwillingness or inability to comply with food and beverage restrictions during study participation. * volunteers who have participated in any investigational drug or device study within past 3 months prior to dosing. * any condition or finding that in the investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.
the utility of urinalysis prior to in-office procedures

Conditions: Urinary Tract Infections

Summary: the primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures.

overview: current urology practice requires every patient to have a urinalysis lab done prior to any in-office procedures. if the patient's urinalysis is positive, they are then required to have a urine culture done, which takes 1-3 days to show results, and they may also be prescribed antibiotics. this practice may cause diagnostic delays, unnecessary cancellations of procedures, and the overuse of antibiotics. the aim of this study is to assess the usefulness of urinalysis labs and urine cultures in patients prior to in-office cystoscopies, intravesical bcg treatments, and prostate biopsies. the investigators predict there is no difference in the number of cases of urinary tract infections in patients that undergo in-office procedures with or without a prior urinalysis. the investigators propose a change in protocol could allow for improved clinical efficiency, antibiotic stewardship, and be economically advantageous. outline: participants will be randomly assigned to either receive standard of care before their procedure or have their procedure conducted by their provider without consulting the urinalysis results beforehand. participants will have follow up questionnaires seven days and thirty days after their procedure. a total of 664 participants will be enrolled between the two study sites.

Eligibility criteria:
inclusion criteria: • patients receiving an in office cystoscopy, intravesical bcg treatment, or prostate biopsy exclusion criteria: * patients under 18 * patients with symptomatic uti infections at the time of recruitment * patients on antibiotics at the time of recruitment, not including prophylaxis * patients with a history of uti within 1 year * patients with indwelling catheters * patients with clean intermittent catheterization * patients undergoing stent removals or with ureteral stents

Keywords: uti urinalysis urine culture cystoscopy bcg treatment prostate biopsy
carbofix pedicle screw system: evaluation of the clinical and radiographic outcomes of the use of a carbon fiber device compared to titanium devices in patients undergoing spinal arthrodesis for degenerative spinal diseases

Conditions: Degenerative Disc Disease

Summary: previous clinical study carried out on cancer patients at ior spine surgery (approved in october 2014). the carbon device is indicated in patients suffering from vertebral tumors who need stabilization and will then carry out radiotherapy, because carbon has a practically zero level of interference with ionizing radiation. carbon also allows for better visualization of the implants on mri/ct and x-ray. there are no studies in the literature analyzing the use of carbon fiber devices in lumbar degenerative pathologies. 118 patients suffering from degenerative spinal pathology requiring 1 or 2 levels of lumbar or lumbosacral fusion will be valutated.


Eligibility criteria:
inclusion criteria: * patients suffering from degenerative spinal pathology or spondylolisthesis who require instrumented stabilization on 1-2 levels; * age greater than or equal to 18 years; * ability to understand and sign the informed consent to the study and to follow the required follow-ups. exclusion criteria: * metabolic bone disease. * history of paget's disease or other osteodystrophies, whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism, ehlers-danlos syndrome, osteogenesis imperfecta, achondroplasia. * neoplastic disease. * history of mental disorder or current psychiatric treatment. * pregnancy. * immunodeficiency diseases. * infectious bone disease (discitis, osteomyelitis) * treatment with drugs that can interfere with bone metabolism * inability to understand and sign the informed consent to the study and to follow the required follow-up visits. * alcohol and/or drug abuse * obesity * metal allergy * participation in other studies on drugs or devices (within 30 days)

Keywords: degenerative spine disease
saphir : assessment of predictive factors for persistence of treatment after initiation of adalimumab with a biosimilar (adalimumab fresenius kabi or substitution of reference adalimumab with the fresenius kabi adalimumab biosimilar in patients with chronic inflammatory diseases

Conditions: Crohn Disease; Ulcerative Colitis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Summary: a prospective, longitudinal, multicentre, observational cohort follow-up study conducted in france.

in a population of adult patients who are targeted to initiate adalimumab or previously treated with humira® to get switched to a biosimilar (fk adalimumab) and followed up for a period of 12 months under routine medical practice conditions. * primary objective: to define predictive factors for the persistence of treatment * secondary objectives: * to assess the therapeutic benefit and the tolerability of the treatment * to describe the reasons for treatment discontinuations occurring during follow-up

Eligibility criteria:
inclusion criteria: * patient aged 18 years or over * patient who have been informed of the objectives and the conditions of the study and who did not object to its participation * patient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (crohn's disease, ulcerative colitis) diseases * patient for whom the investigator has decided, with patient's agreement and prior to inclusion: * or to initiate adalimumab by prescribing a biosimilar (adalimumab fk) * either to replace humira® with a biosimilar (adalimumabfk) exclusion criteria: * patient enrolled in an interventional therapeutic trial at the time of inclusion * patient refusing or unable to comply with the study follow-up procedures (patient not contactable by telephone, unable to complete the self-administered questionnaire, or having poor french language skills, etc.)
a study of laquinimod in participants with systemic lupus erythematosus (sle) active lupus arthritis

Conditions: Lupus Arthritis

Summary: the study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams \[mg\] and 1 mg) in participants with active lupus arthritis. laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by teva pharmaceuticals ltd. for multiple sclerosis.


Eligibility criteria:
inclusion criteria: * participants diagnosed with sle. * participants with active lupus arthritis as evident by at least 4 tender and 4 swollen joints at screening and baseline visits, and moderate or severe arthritis with active synovitis in at least 1 joint, with some loss of functional range of movement present at screening and baseline visits. exclusion criteria: * the participant's estimated glomerular filtration rate (egfr) was less than or equal to 30 milliliters (ml)/minute/1.73 square meter (m\^2), as calculated by the modification of diet in renal disease (mdrd) formula at the screening visit. * participants with severe, unstable and/or progressive central nervous system (cns) lupus and/or associated with significant cognitive impairment (upon the investigators' judgement). * participants with a clinically significant or unstable medical or surgical condition that, in the investigator's opinion, would preclude safe and complete study participation. * women who are pregnant or nursing or who intend to be during the study period. * women of child-bearing potential who do not practice an acceptable method of birth control.

Keywords: systemic lupus erythematosus (sle) lupus arthritis laquinimod