Kornimate/medical-research-clean huggingface dataset:
mechanistic inflammatory sub-study embedded within the albumin vs balanced crystalloid trial

Conditions: Sepsis

Summary: mis-abc sepsis is a sub-study looking to understand how the immune response in patients with infection changes during the early stages of the illness, as well as after intravenous fluid treatment. participants in the main trial will be given one of two types of fluid (human albumin solution (has) and balanced crystalloid) via a drip when they present to the hospital with severe infection (sepsis). the main trial is assessing which fluid is better, and we are going to take three blood samples around the time people come to hospital to see what happens to their immune system as a result of the infection and fluid treatment. we hope our findings will explain why one fluid might be better than another. it may also give us an important information about whether we can predict which people might get sicker despite treatment.

mis-abc sepsis is linked to the abc-sepsis trial, a pilot feasibility trial recruiting patients with community acquired infection/sepsis with a news2 score of five or more and randomising the participants to receiving either balanced crystalloid or 5% has as the intravenous resuscitation fluid up to six hours after randomisation. mis-abc sepsis will take serial blood samples from a small number of these participants, at hospital presentation and at two further points early during the patient's admission, to allow analysis of how inflammation changes during their course of illness. investigating temporal change and differences between treatment arms of the main study will allow a nuanced analysis of the interplay between severity of illness, physiological changes over time and any potential differences between fluid treatment arm. this is a prospective observational study enrolling patients randomised to the abc sepsis study. centres for this trial will be selected from uk nhs hospitals who are recruiting to the main abc sepsis study. participants will be recruited as soon as possible, and up to 12 hours after presentation to the emergency department, surgical assessment unit or medical admissions unit. the treatment phase of the main study spans 6 hours following randomisation, with the follow up period extending to 90 days. this sub-study requires three blood samples: immediately after enrolment, at approximately 12 and 24 hours thereafter. the follow up period similarly extends to 90 days, using routine data from the medical records for follow up.

Eligibility criteria:
inclusion criteria: * able to obtain informed consent * eligible for and randomised into the abc sepsis trial exclusion criteria: * excluded from the abc sepsis trial

Keywords: sepsis infection inflammation cytokine interleukin intravenous fluids resuscitation albumin crystalloid
a study of ak106-001616 in patients with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this will be a phase ii, multi-centre study consisting of 2 parts. part 1: clinical pharmacology study (drug-drug interaction between ak106-001616 and methotrexate) part 2: proof of concept study


Eligibility criteria:
inclusion criteria: * diagnosis of ra (class i to iii) * stable dose of methotrexate (at least 12 weeks) exclusion criteria: * pregnant or breastfeeding * abnormal screening laboratory test values considered to be clinically significant

Keywords: ak106-001616
efficacy and safety of fractional carbon dioxide laser for treatment of facial freckles.

Conditions: Freckles

Summary: freckles are clusters of melanin in the superficial epidermis. they affect mostly face and sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a fair complexion patient, but may be present in other skin types. the gold standard in the industry for non-surgical facial rejuvenation, removal of wrinkles, pigmentation, and general sun damage has been the carbon dioxide (co2) laser since the mid 1990s. the traditional co2 laser was very effective, however it fell out of favor because it required general anesthesia. it also had a prolonged recovery time. over the last several years, advances in technology known as fractional resurfacing has made the co2 laser popular again: fractional co2 laser treatment is one of the newest laser rejuvenation technology. it proved successful in treatment of melasma, one of the pigmented dermatoses. to the best of our knowledge, based on a thorough search of literature, no clinical studies assessing fractional co2 laser in treatment of freckles could be retrieved.


Eligibility criteria:
inclusion criteria: * -patients affected with facial freckles. * age: 10 years or more exclusion criteria: * patients younger than 10 years old. * patients aged 10-21 years who can not provide a written consent of parents or legal guardian. * patients with known tendency to keloid or hypertrophic scar formation. * patients receiving treatment with systemic retinoids or having stopped their course since less than six months duration.

Keywords: carbon dioxide laser fractional resurfacing freckles melanosis
heart failure and sleep apnea: exercise training and continuous positive airway pressure

Conditions: Heart Failure; Sleep Apnea Syndromes

Summary: introduction. heart failure is the result of primary ventricular dysfunction followed by neurohormorais changes, distribution of cardiac output, peripheral circulation, the skeletal and respiratory muscles, which determine their clinical and prognosis. despite the advancement in treatment, morbidity and mortality remain high. physical training appears as a therapeutic strategy, because most of its beneficial effects is by inducing changes in peripheral physiological changes resulting from heart failure. associated factors that may contribute to its progression and worse prognosis, now beginning to be studied, such as sleep apnea, the diagnosis provides important prognostic information and a potential therapeutic option for these patients. objectives. demonstrate the benefits of physical training for patients with heart failure and sleep apnea, and compare treatment with cpap alone and associated with the exercise program. will also be assessed risk and adherence to physical training. material and methods. the design will be prospective, longitudinal, randomized consecutive patients. after screening and baseline evaluations the patients will be randomized into group 1 (cpap, n = 20), group 2 (cpap + physical training, n = 20), group 3 (physical training, n = 20) and group 4 (control without intervention, n = 20). outcomes (baseline and 3 months): quality of sleep (polysomnography), quality of life (minnesota and sf-36), sexual function (qs-m and qs-f) and functional capacity (cardiopulmonary exercise testing and isokinetic testing). physical training: aerobic and resistance exercises three times a week for three months. cpap therapy:after polysomnography for titration with ventilator servo-assisted, and outpatient follow monthly, for three months.


Eligibility criteria:
inclusion criteria: * age range 20-70 years * new york heart association class ii-iii * clinically stable for one month * ejection fraction \<40% * peak vo2 \<20 ml/kg/min * stable and optimized medical therapy at least one month before the study * b-blocker therapy * clinical and polysomnographic diagnosis of sleep apnea (iah\>10) exclusion criteria: * patients with previous treatment of sleep apnea * new york heart association class iv * clinical instability * poor adherence to drug treatment * myocardial infarction or revascularization within the past two months * unstable angina * symptomatic arrhythmias (pacemaker and defibrillator) * obstructive aortic or mitral valvular disease * hypertrophic cardiomyopathy * abnormal exercise testing * pulmonary arterial pressure \>50mmhg * chronic obstructive pulmonary disease * intermittent leg claudication * musculoskeletal disorders or psychiatric disease that prevents the patient from understanding and following the exercise prescription safely

Keywords: heart failure sleep apnea syndromes exercise continuous positive airway pressure
the efficacy and safety of task-state-based temporal interference stimulation (ti) in the treatment of patients with depression

Conditions: Major Depressive Disorder

Summary: this study intends to investigate the intervention efficacy of temporal interference stimulation (ti) on mood symptoms in depressed patients, as well as to explore the neuroimaging mechanisms of ti improvement in depressed patients using pre- and post-treatment magnetic resonance.


Eligibility criteria:
inclusion criteria: 1. aged 18-50 years old, right-handed, and completed nine years of compulsory education; 2. met diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) diagnostic criteria for depression; 3. hamd-17≥18; 4. subject was a first-time medication-naïve patient or had previously used antidepressant medication and was currently off medication for ≥2 weeks; 5. the subject/ legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after fully understanding the temporal interference stimulus (ti). exclusion criteria: 1. co-morbid other psychiatric disorders, including bipolar disorder, affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.; 2. severe suicidal ideation or behavior; 3. history of a serious physical illness or a disease that may affect the central nervous system; 4. neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy; 5. contraindications to magnetic resonance scanning or time-interference stimulation (ti), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies); 6. those who have received or are receiving electroconvulsive therapy (ect ), modified electroconvulsive therapy (mect ), transcranial magnetic stimulation (tms), transcranial direct current stimulation (tdcs), transcranial alternating current stimulation (tacs), or other neurostimulation treatments; 7. pregnant and lactating women, and women of childbearing age with positive urine pregnancy.
a comparison of two anti-hiv triple-drug combinations in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to compare the safety and effectiveness of two anti-hiv drug combinations when given to hiv-infected patients who have never been treated with anti-hiv drugs. one drug combination is stavudine (d4t) plus didanosine (ddi) plus crixivan. the other combination is retrovir (azt) plus epivir (3tc) plus crixivan.

100 patients will be randomized to receive zerit (stavudine) + videx (didanosine) + crixivan (indinavir) and 100 patients will be randomized to receive retrovir (zidovudine) + epivir (lamivudine) + crixivan (indinavir). patients will be treated for 48 weeks.

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection. * cd4 cell count of 200 - 700 cells/mm3. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: aids defining condition within 1 month of study entry. prior medication: excluded: patients with any history of antiretroviral therapy treatment.

Keywords: didanosine drug therapy, combination zidovudine stavudine hiv protease inhibitors cd4 lymphocyte count lamivudine indinavir reverse transcriptase inhibitors anti-hiv agents viral load
prevalence and characteristics of intimate partner violence against individuals seeking hematological consultations

Conditions: Intimate Partner Violence; Deep Vein Thrombosis (DVT)/Thrombophlebitis; Pulmonary Embolism and Thrombosis

Summary: intimate violence against individuals, which is particularly marked among women, is one of the most widespread human rights violations in the world. the women abuse screening tool (wast) self-questionnaire is a screening tool validated in french. our preliminary data describing the association between intimate violence against women and the first attack of unexplained venous thromboembolic disease, show a significant frequency of positive responses to the wast among women attending a biological hematology consultation at the chu de nîmes, for reasons of hemostasis disorders (8% out of the first 200 cases). the study authors wish to establish the prevalence of this situation among patients presenting to the chu de nîmes for hematological exploration and management. they hypothesize that the prevalence of violence against individuals seen in hematology consultations is higher among individuals with hemostasis pathologies (hemorrhagic and thrombotic pathologies) than those with cellular pathologies, and higher among women than men.


Eligibility criteria:
inclusion criteria: * currently in a relationship or has been in one in the last 12 months, regardless of the length of the relationship * willing to complete the anonymous wast self-questionnaire * able to read and understand french * outpatient consultant at nîmes university hospital in one of the following departments: * biological hematology consultation * clinical hematology consultation * vascular medicine consultation exclusion criteria: * individuals under court protection, guardianship or curatorship * individuals unable to read and understand french * individuals who have already completed the wast questionnaire during the study period * individuals unable to get away from their partner during the consultation to complete the questionnaire in isolation
prevalence of metabolic syndrome in patients with intermittent claudication

Conditions: Intermittent Claudication; Metabolic Syndrome X

Summary: metabolic syndrome, a group of cardiovascular risk factors related to insulin resistance, is a major determinant of cardiovascular mortality. intermittent claudication is a symptom of an early stage of atherosclerosis. the aim of this study is to determine the prevalence of the metabolic syndrome in patients with intermittent claudication and its correlation with age, gender, localization of arterial obstruction and association with coronary artery disease.

studies correlating metabolic syndrome and several illnesses are being published, especially affections associated with atherosclerosis, like coronary artery disease, cerebrovascular disease and peripheral arterial disease. the term peripheral arterial disease, however, refers to several stages of the development of atherosclerosis in the extremities, comprising since asymptomatic patients as far as individuals with critical ischemia. intermittent claudication is a symptom of an early stage of atherosclerosis, when medical interventions may still prevent the progression of the disease. despite the importance of a precocious diagnosis of metabolic syndrome to initiate adequate treatment, its prevalence among these patients is not well determined in the literature. this is the biggest casuistic in the literature as far as we know.

Eligibility criteria:
inclusion criteria: * adult patients with complaints compatible with intermittent claudication of the lower limbs, absence or weakness of arterial pulses on the limb or limbs that are limiting deambulation, ankle-brachial index simila or lower than 0.9 exclusion criteria: * patients with critical limb ischaemia

Keywords: intermittent claudication metabolic syndrome
optimized antiretroviral therapy during allogeneic hematopoietic stem cell transplantation in hiv-1 individuals

Conditions: HIV

Summary: to find out if it is possible for hiv-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant

determine the feasibility of maintaining optimal art in hiv-1 infected patients during allogeneic hematopoietic stem cell transplant (hsct). the primary outcome is the fraction of patients who maintain any form of anti-retroviral therapy, including enfuvirtide monotherapy, through day 60 post-transplant. if patients are unable to take oral anti-retroviral medications, but are able to tolerate subcutaneous enfuvirtide monotherapy this will be considered maintenance of art. failure to maintain art will be defined as ≥ 24 hours without any anti-retroviral therapy.

Eligibility criteria:
inclusion criteria: * hiv-1 infection, as documented by a rapid hiv-1 test or any fda-approved hiv-1 enzyme or chemiluminescence immunoassay (e/cia) test kit and confirmed by western blot at any time prior to study entry. alternatively, two hiv-1 rna values \> 200 copies/ml at least 24 hours apart performed by any laboratory that has clia certification, or its equivalent may be used to document infection. * patients must be ≥ 18 years of age. * plan to undergo a myeloablative, hla matched or partially hla-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation cy using bone marrow from a related donor: * plan to undergo a nonmyeloablative, hla matched or partially hla-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation cy using bone marrow from a related donor: exclusion criteria: * patients with a known history of enfuvirtide resistance will not be eligible for this trial.

Keywords: hiv positive hiv-1 bone marrow transplant allogeneic bmt bmt
parkinson's disease, diagnostic observations (paddo)

Conditions: Parkinson's Disease; Atypical Parkinsonism

Summary: background: parkinson's disease and the atypical parkinsonian disorder (like multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, lewy body dementia) are disease entities with partly common symptomatology. especially very early in the course of disease, the differentiation between both disease entities can be challenging, even for specialists in the field of movement disorder. however, the establishment of a correct diagnosis is very important for adequate patientcounseling, treatment and the correct inclusion of patients in research trials. ancillary diagnostic investigations are looked upon to aid in this diagnostic dilemma. objective: to investigate the value of ancillary diagnostic investigations, more specific mri, analysis of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to differentiate parkinson's disease and the atypical parkisonisonian disorder.


Eligibility criteria:
inclusion criteria: * hypokinetic rigid syndrome * disease duration of maximum 36 months exclusion criteria: * probable diagnosis of pd without any red flags * probable diagnosis msa * probable diagnosis psp * diagnosis cbd * diagnosis dlb * probable diagnosis vascular parkinsonism * other neurodegenerative disease than parkinsonism * a prior history of brain surgery * instable comorbidity

Keywords: prospective study diagnostic accuracy csf mri
systemic therapies in the treatment of cutaneous t-cell lymphoma

Conditions: Cutaneous T Cell Lymphoma; Cutaneous T-Cell Lymphoma/Mycosis Fungoides; Cutaneous T-Cell Lymphoma/Sezary Syndrome

Summary: the study is designed to describe the different approaches of systemic therapies for the treatment of cutaneous t-cell lymphoma in real world setting.

the treatment of mycosis fungoides (mf)/sézary syndrome (ss) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. the approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies). although there are several well recognized therapies for the treatment of mf/ss, curative therapies are still needed. in this scenario, effective treatments that provide long term responses and disease control are still lacking. also, international guidelines (eortc 2017, esmo 2018, bad2018, nccn) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials. this study is designed to analyze the different approaches of systemic therapies for the treatment of cutaneous t-cell lymphoma in real world setting.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ctcl according to the eortc 2017 update criteria1. * age ≥18 years. * have received first dose of a systemic therapy, lasted at least 3 months, between 1 january 2016 and 31 december 2021. * availability of complete medical records in order to provide protocol required variables * signed written informed consent. exclusion criteria: * patients not meeting the above-mentioned inclusion criteria. * refuse to sign a written informed consent.

Keywords: cutaneous t cell lymphoma mycosis fungoides sézary syndrome retrospective systemic therapy real world
a study to evaluate the efficacy and safety of tarcocimab tedromer and tabirafusp tedromer compared to aflibercept in participants with neovascular (wet) age-related macular degeneration (wamd) - daybreak

Conditions: Wet Age-related Macular Degeneration

Summary: a study to evaluate the efficacy and safety of tarcocimab tedromer and tabirafusp tedromer compared to aflibercept in participants with neovascular (wet) age-related macular degeneration (wamd)


Eligibility criteria:
inclusion criteria: * active, treatment-naïve choroidal neovascularization (cnv) secondary to amd, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (rap) lesions with a cnv component that affects the central subfield, as evidenced by fa or oct in the study eye at screening * bcva etdrs score between 78 and 25 letters (snellen equivalent \~20/32 and 20/320) inclusive, in the study eye at screening and reconfirmed at day 1. * capable of giving signed informed consent. exclusion criteria: * bcva of hand motion or worse in the non-study eye or non-physical presence of a non-study eye (i.e., monocular) * fibrosis or atrophy of \>50% of the lesion size and/or involving the foveal center of the study eye at screening

Keywords: wet amd ksi-301 ksi-501 tarcocimab tabirafusp aflibercept antibody biopolymer conjugate amd anti-vegf vascular endothelial growth factor kodiak sciences
tranexamic acid for the latarjet procedure.

Conditions: Anterior Shoulder Instability

Summary: the investigators propose a double-blinded randomized study evaluating the effectiveness of tranexamic acid in reducing postoperative swelling and haematoma formation after the latarjet procedure. the purpose of this study is to assess the efficacy of tranexamic acid (txa), given via intra-articular injection at the time of surgery in patients undergoing the latarjet procedure for shoulder instability.


Eligibility criteria:
inclusion criteria: • anterior shoulder instability, warranting the latarjet procedure exclusion criteria: * patients with known risk factors for hyper-coagulable state * patients under 16 * patients unable to give consent to partake in the trial

Keywords: tranexamic acid anterior shoulder instability latarjet hematoma