Kornimate/medical-research-clean huggingface dataset:
intra-individual comparison of efficacy and safety of metvix® natural daylight photodynamic therapy versus conventional metvix® photodynamic therapy in subject with mild actinic keratoses

Conditions: Actinic Keratoses

Summary: the main objective of this study is to compare efficacy and safety of metvix® natural daylight photodynamic therapy with those of metvix® conventional photodynamic therapy with aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).


Eligibility criteria:
inclusion criteria: 1. male or female above 18 years; 2. subject with clinical diagnosis of mild ak on the face or the scalp with or without clinical diagnosis of moderate ak on the target areas (tas); exclusion criteria: 1. subject with clinical diagnosis of at least one severe ak on tas 2. subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the tas; 3. subject with pigmented ak on the tas
the "step4life" randomized control trial in hemodialysis

Conditions: Physical Activity; End Stage Kidney Disease; Hemodialysis

Summary: persons with end-stage kidney disease (eskd) have very low physical activity, and among eskd patients, the level of inactivity is strongly associated with morbidity and mortality. this study aimed to assess the feasibility and effectiveness of a 12-week intervention coupling use of wearable pedometers (fitbit ®) and feedback coaching to increase physical activity in hemodialysis patients.

physical activity is an important modifiable behavior that is known to impact morbidity and mortality. the patients with advance kidney disease especially those on chronic hemodialysis are deconditioned with decreased muscle mass, and have co-morbidities such as anemia, malnutrition, and depression. these factors may explain why hemodialysis patients are known to have very low physical activity relative to healthy populations. we have recently demonstrated that hemodialysis patients are frequently sedentary, walk less with lower levels of physical activity. thus, this provides an opportunity to design interventions to improve and sustain physical activity levels in hemodialysis patients. there is a growing experience of digital technology and intervention delivery modalities to promote physical activity in chronic comorbid conditions, but little is known in hemodialysis patients. we set forward to test a weekly coaching intervention guided by a wearable pedometer to determine whether it would be feasible, promote physical activity, and be sustained for 12 weeks in hemodialysis patients. equipped with pedometer data, informing subjects quantitatively about their levels of physical activity relative to other hemodialysis patients, might promote physical activity in this high-risk population. we conduct a 12-week, open label, randomized controlled trial to determine the feasibility and effectiveness of providing structured feedback instruction (e.g., behavioral feedback, goal setting) along with a wearable pedometer (fitbit ®) in sustaining or improving physical activity levels in chronic hemodialysis patients as compared to the wearable pedometer (automated self-managed) alone. i hypothesized that the structured feedback intervention coupled with the wearable pedometer would be feasible, would improve physical activity, and would be sustainable for 12 weeks in hemodialysis patients.

Eligibility criteria:
inclusion criteria: 1) hd for ≥3 months, 2) age ≥18 years, and 3) ability to walk with or without assistive devices, exclusion criteria: 1) wheelchair bound, 2) unstable severe health conditions (e.g., acute infections, heart failure (hf) nyha class 4 and/or unstable angina), 3) hospitalization within 3 months before enrollment for non-access related reasons, or 4) clinically recognized cognitive impairment including dementia or psychosis.
long-term effect of fingolimod on circulating immunocompetent mononuclear cells in patients with multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the purpose of this study is to explore immunomodulatory and immunosuppressive mechanisms of action of fingolimod in patients with relapsing remitting multiple sclerosis to collect data on biomarkers after initiation of fingolimod treatment.

after treatment with fingolimod the blood of the patients will be collected at different time points to examine the changes of t cells, b cells and biomarkers.

Eligibility criteria:
inclusion criteria: 1. written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed in this trial. 2. male or female subjects aged 18-65 years. 3. subjects with relapsing remitting forms of ms defined by 2010 revised mcdonald criteria (see appendix). 4. patients with high disease activity despite treatment with a disease modifying therapy (≥ 1 relapse in the previous year, ≥ 9 hyperintense t2 lesions or ≥1 gd-enhancing lesion or "non-responding" which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year) or patients with rapidly evolving severe rrms (e.g. ≥ 2 relapses with disease progression in one year and ≥ 1 gd-enhancing lesion or with a significant increase in t2 lesions compared to a recent mri). 5. patients with expanded disability status scale (edss) score of 0-6.5 (see appendix). 6. sufficient ability to read, write, communicate and understand exclusion criteria: 1. patients with a manifestation of ms other than relapsing remitting ms. 2. patients with a history of chronic disease of the immune system other than ms, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. 3. history or presence of malignancy (other than localized basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the last 5 years 4. diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with hba1c \> 7%. 5. diagnosis of macular edema during baseline visit (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic baseline visit). 6. patients with active systemic bacterial, viral or fungal infections, or known to have aids, hepatitis b, hepatitis c infection or to have positive hiv antibody, hepatitis b surface antigen or hepatitis c antibody tests. 7. negative for varicella-zoster virus igg antibodies at baseline. 8. have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 1 month prior to baseline. 9. patients who have received total lymphoid irradiation or bone marrow transplantation. 10. patients who expect to be treated with any disease modifying drugs (dmd) during the study (i.e. ifn-β, glatiramer acetate); however no washout is needed for dmds prior to baseline.
a long-term extension study of roactemra/actemra (tocilizumab) in patients with juvenile idiopathic arthritis who completed wa19977 core study

Conditions: Juvenile Idiopathic Arthritis

Summary: this long-term, open-label extension study will evaluate the safety of roactemra/actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the wa19977 core study. patients aged 9-18 years with at least jia acr30 clinical response to roactemra/actemra in the core study will be eligible to receive roactemra/actemra 8 mg/kg intravenously every 4 weeks. anticipated time on study treatment is 104 weeks.


Eligibility criteria:
inclusion criteria: * patients 9 to 18 years of age who completed visit 33 (week 104) of wa19977 study with at least jia acr30 clinical response to roactemra/actemra relative to baseline in wa19977, with no aes, saes or conditions that lead to unacceptable risk of continued treatment * scheduled to receive first roactemra/actemra infusion in this study between 4 and 6 weeks after the last iv infusion in the core study * females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol exclusion criteria: * patients with, according to investigator judgment, not satisfactory benefit from roactemra/actemra therapy within wa19977 * treatment with any investigational agent since the last administration of study drug in the core study wa19977 or current participation in another clinical trial except wa19977 * patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course jia subsets: rheumatoid factor positive or negative jia or extended oligoarticular jia * patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug * any significant concomitant disease or medical or surgical condition * history of significant allergic or infusion reactions to prior biologic therapy * known current active acute, subacute, chronic or history of recurrent infection; patients suffering from ongoing active infections with epstein barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided * positive for latent tuberculosis (tb) * currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for \>/= 2 weeks within 6 months prior to entering the study * inadequate hepatic, renal or bone marrow function
the utility of mobile based patient reported outcome measures in patients with acetabular fractures: a randomized controlled trial.

Conditions: Acetabular Fracture; PROMs; Mobile Phone Use

Summary: acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation.

the percentage of patients with lost follow up is significantly high. previously all other studies mainly focused on the radiographic outcome after acetabular fractures and rarely on patient reported functional outcomes and quality of life. the use of patient-reported outcome measures (proms) is increasing and may lead to modifications of treatment. recent technologic advances, namely smartphones, capable of measuring outcomes after acetabular fractures are now very important in quantifying value-based care. this was previously accomplished through office assessments and surveys with variable follow-up but this strategy lacks continuous and complete data. studies show that these remote modes of follow-up are safe and that patients are as equally satisfied with them as they are with in-person follow- up care

Eligibility criteria:
inclusion criteria: * all patients older than 18 years old who will have surgery for an acetabular fracture at assiut university hospitals from 1/10/2020 to 30/9/2022. exclusion criteria: * patients younger than 18 years.
music-instruction intervention for treatment of post-traumatic stress disorder

Conditions: Stress Disorders, Post-Traumatic; Depression

Summary: the purpose of this study was to examine the feasibility and potential effectiveness of an active, music-instruction intervention in improving psychological health and social functioning among veterans suffering from moderate to severe post-traumatic stress disorder (ptsd).

the study was designed as a prospective, delayed-entry randomized pilot trial. regression-adjusted difference in means were used to examine the intervention's effectiveness with respect to ptsd symptomatology (primary outcome) as well as depression, perceptions of cognitive failures, social functioning and isolation, and health-related quality of life (secondary outcomes).

Eligibility criteria:
inclusion criteria: * veterans who (i) had at least one visit for mental health treatment in the prior six months with a primary diagnosis of ptsd (icd9cm 309.81-83) and (ii) exhibited moderate to severe ptsd symptoms at the time of enrollment (posttraumatic stress disorder checklist \>=50) exclusion criteria: * veterans who were currently participating in an intense psychotherapy program (residential or outpatient) * veterans who were already receiving guitar lessons from a guitars for vets volunteer
a clinical trial assessing the impact of inhaled insulin on glucose control in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus Type 2

Summary: to assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * failing two or more oral anti-diabetic agents exclusion criteria: * asthma, copd * smoking

Keywords: type 2 diabetes melllitus
transgender post-reassignment urogynecologic measures and perceptions

Conditions: Gender Identity Disorder of Adult; Voiding Disorders; Sexual Dysfunction

Summary: the intent of this mixed methods study for transgender women after gender confirmation surgery is to characterize and subsequently create a validated screening questionnaire for postoperative urologic and pelvic floor symptoms. for individuals who seek gender-confirming treatment, about 13% undergo genital surgery for cosmetic purposes with or without gonadectomy, and this number is increasing. patient satisfaction following surgery is high, particularly regarding sexual and cosmetic outcomes; however, unexpected negative functional outcomes such as bowel and bladder dysfunction and pelvic organ prolapse impact overall patient satisfaction. the available information suggests that 16-33% of patients experience incontinence postoperatively, with stress predominance, 32-47% experience abnormal voiding, and 24-66% experience overactive bladder symptoms. outside of the typically assessed voiding symptoms, unique complaints of mtf postoperative patients include obstructive voiding symptoms due to urethral stenosis, persistent perimeatal erectile tissue, prostatic hypertrophy, and irritation from neovaginal tissue. additionally, may of these patients develop symptomatic neovaginal prolapse, requiring re-suspension. we suggest that further clarification regarding mtf postoperative urologic and pelvic floor complaints can be achieved via a mixed methods approach. by using focus group interviews to create specific evaluative questions for this unique population, we can then prospectively assess patients undergoing surgery via a national multicenter sampling strategy. the goal of the study is to better understand the unique symptoms these women experience and create a validated, reliable screening questionnaire to monitor patients after surgery.


Eligibility criteria:
inclusion criteria: * stage 1 -- male-to-female transgender women who are at least 4 weeks postoperative following genital surgery for gender confirmation * stage 2 -- male-to-female transgender women who are scheduled to undergo surgery or are within 4 weeks postoperative * both stages -- minimum age 18 years old * both stages -- english fluency * both stages -- reliable contact information and/or permanent residence exclusion criteria: * preexisting pelvic pathology, including abnormal anatomy or baseline voiding dysfunction * urinary or intestinal problems prior to surgery lasting greater than 6 weeks

Keywords: transgender women male-to-female gender confirmation surgery voiding disorder vaginal dysfunction
effects of the sodium-glucose cotransporter 2 inhibitors+sacubitril/valsartan therapy in patients with hfref.

Conditions: Heart Failure; Ventricular Remodeling; Ventricular Dysfunction

Summary: the goal of this observational study is to investigate the effects of combination therapy with arni and inhibitors of sglt2 in patients affected by hfref. the main questions it aims to answer are: * what is the medium-long term impact of the arni + glyphozine combination therapy in terms of ventricular remodeling studied by speckle tracking echocardiography (gls%) and by variation of volumetric indices and contractile function (lvedv, lvedd, fe%)? * what is the medium-long term impact of the arni + glyphozine combination therapy in terms of variation of laboratory data indicative of heart failure (nt-pro-bnp)? * what is the medium-long term impact of the arni + glyphozine combination therapy in terms of major cardiovascular events (macve)? * what are the echocardiographic and laboratory parameters predictors of medium-long term major cardiovascular events (macve) and ventricular remodeling? participants will undergo, at the time of enrollment and after approximately 3 and 12 months from the introduction of sglt-2 inhibitor therapy, at clinical, echocardiographic and biohumoral investigations.

according to the 2021 esc guidelines for heart failure, isglt2 has become the cornerstone of the treatment of heart failure with reduced ejection (hfref) fraction, with a class of recommendation ia (1). however, the mechanisms of action of isglt2 remain still little known. in particular, if the combined therapy with arni and isglt2 may have an effect in terms of left ventricular remodeling evaluated by speckle tracking echocardiography (gls%) in patients with hfref at a medium-long term (3-12 months) is still to be defined (primary objective). furthermore, our study will aim to evaluate the clinical and echocardiographic impact of the combined therapy with arni + isglt2 in terms of left ventricular remodeling evaluated through volumetric and contractile function indices (lvedv, lvedd, fe%) and in terms of variation of laboratory data suggestive of decompensated heart failure (nt-pro-bnp) in patients with hfref at a medium-long term follow-up (3-12 months) (secondary outcomes).

Eligibility criteria:
inclusion criteria: * hfref on arni * ability to express written informed consent to participate in the study exclusion criteria: * contraindication to glyphozine therapy (i.e., severe renal insufficiency with filtration estimated glomerular \<30ml/min/m2 or history of recurrent urinary tract infections); * comorbidities with expected survival of less than 1 year; * limited or legal inability to give written informed consent
adrecizumab (ham8101) to improve prognosis and outcomes in covid-19 trial

Conditions: COVID-19

Summary: the clinical trial is designed as a prospective, multi-center, double-blind, randomised, placebo-controlled, interventional trial to assess safety, tolerability and efficacy of adrecizumab (on top of soc) in patients with covid-19, and to evaluate if improvement of vascular integrity with adrecizumab on top of soc is superior to placebo/ control substance (nacl 0.9%) on top of soc in reduction of morbidity and mortality endpoints in patients with covid-19. the main reason for admission to icu and need for mechanical ventilation of these patients is acute lung injury within a broad pneumonic spectrum, increased ventricular filling pressures and resulting congestion. it is hypothesized, that adrenomedullin (adm) is a key player in the (dys)-regulation of vascular integrity (figure 2). adrecizumab is the first-in-class humanized monoclonal anti-adrenomedullin antibody, and acts as a long-lasting plasma adrenomedullin enhancer stabilizing barrier function at a reasonable safety profile. the mode of action for the anti-adrenomedullin antibody adrecizumab has been developed on the basis of published data, own experimental data and theoretical considerations.


Eligibility criteria:
inclusion criteria: * hospitalization with moderate to severe covid-19, defined as fulfilling at a minimum the following clinical status category on the who 8-point ordinal scale: (i) "score 4" \[oxygen via mask or nasal\] * laboratory-confirmed sars-cov-2 infection at index hospitalisation as determined by pcr or other validated commercial or public health assay * bio-adm ≥50 pg/ml or ≥30% increase until the end of the next day (with a minimum of 35 pg/ml at all) * dpp3 ≤30 ng/ml * age ≥18 years at time of screening * body weight ≤ 150 kg at time of screening exclusion criteria: * life expectancy less than 3 months before covid-19 at the discretion of the investigator * invasive mechanical ventilation ≥ 72 hours at time-point of randomization * resuscitation \> 45 minutes * hypersensitivity to the active substance, to adrecizumab or any of its excipients, or known serious hypersensitivity to other monoclonal antibodies * uncontrolled haematological/ oncological malignancies * pre-existing severe chronic liver disease (i.e. child-pugh c) before covid-19 hospitalization * absolute neutropenia \<500 per μl

Keywords: vascular integrity adrecizumab enibarcimab acute lung injury
clinical study of diazoxide choline controlled-release tablet (dccr) in patients with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: • this is a single-center, open-label, single-arm study with a double-blind, placebo-controlled, randomized withdrawal extension. patients are initiated on a dccr dose of about 1.5 mg/kg (maximum starting dose of 145 mg) and are titrated every 14 days to about 2.4 mg/kg, 3.3 mg/kg, 4.2 mg/kg, and 5.1 mg/kg (maximum dose of 507.5 mg). these dccr doses are equivalent to diazoxide doses of 1.03, 1.66, 2.28, 2.9, and 3.52 mg/kg. the administered dose will be as close to the mg/kg dosing as can be achieved by the available dose strengths of dccr. patients will be up-titrated at each visit at the discretion of the investigator. all patients will be continued in the double-blind, placebo-controlled, randomized withdrawal extension. any patient who showed an increase in resting energy expenditure and/or a reduction in hyperphagia from baseline through day 55 or day 69 will be designated a responder, whereas all others will be designated non-responders. responders will be randomized in a 1:1 ratio either to continue on active treatment at the dose they were treated with on day 69 or to the placebo equivalent of that dose for an additional 4 weeks. non-responders will continue open label treatment during the extension.


Eligibility criteria:
inclusion criteria: * children. adolescents and young adults with genetically confirmed prader-willi syndrome * ages at ≥ 10 years and ≤ 22 years * generally healthy as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ecg), and clinical laboratory assessments * bmi exceeds the 95th percentile of the age specific bmi value on the cdc bmi charts * fasting glucose ≤ 126 mg/dl * hba1c ≤ 6.5 % exclusion criteria: * administration of investigational drugs within 1 month prior to screening visit * anticipated requirement for use of prohibited medications * history of allergic reaction or significant intolerance to: diazoxide, thiazides or sulfonamides * anticipate transitions in their care from family home to group home or other similar potentially disruptive changes * congestive heart failure or known compromised cardiac reserve * any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the investigator

Keywords: prader-willi syndrome