Kornimate/medical-research-clean huggingface dataset:
rct comparing upper body vs. combined exercise protocols during active diabetic foot ulcer treatment

Conditions: Diabetic Foot Ulcer

Summary: this randomized controlled trial (rct) aims to evaluate the effectiveness of two different structured exercise interventions compared to standard care during active diabetic foot ulcer (dfu) treatment. participants will be allocated to one of three groups: upper body exercise (ube), combined exercise (ce), or standard care control (sc). the interventions are designed to improve cardiorespiratory fitness-as measured by changes in vo₂peak-and other secondary clinical, metabolic, vascular, inflammatory, muscular, and quality-of-life outcomes while ensuring proper offloading and wound management.


Eligibility criteria:
inclusion criteria: age: adults aged 18 years or older. diagnosis: confirmed diagnosis of type 1 or type 2 diabetes. active dfu: presence of a diabetic foot ulcer under active treatment, as documented by the wound care team. wound stability: ulcer size that meets protocol criteria (e.g., \<2 cm² or ≥2 cm²) and without critical limb ischemia. ability to exercise: medical clearance from a physician to safely participate in unsupervised upper body and non-weight bearing exercises. compliance: capacity and willingness to adhere to the study protocol, including scheduled exercise sessions and offloading procedures. glycemic control: stable glycemic control medications regimen for at least 4 weeks prior to enrollment. informed consent: ability to provide written informed consent. exclusion criteria: critical dfu complications: ulcers with signs of critical limb ischemia, severe infection (e.g., osteomyelitis), or wound deterioration that contraindicates participation. cardiovascular limitations: unstable cardiac conditions (e.g., uncontrolled arrhythmias, recent myocardial infarction within 6 months), severe heart failure, or any other condition contraindicating exercise. neurological or musculoskeletal limitations: conditions that significantly impair upper body or core exercise performance (e.g., severe arthritis, recent upper body injury). cognitive impairment: significant cognitive or psychiatric disorders that would limit the ability to provide informed consent or adhere to the intervention protocol. concurrent participation: enrollment in another clinical trial or exercise program that conflicts with the study protocol. other medical risks: any other condition, as determined by the study physician, that places the participant at increased risk of adverse events during exercise (e.g., severe peripheral vascular disease not amenable to offloading).
immune signature of chronic hand eczema unveiled by spatial transcriptomics and single-cell proteomics

Conditions: Hand Eczema

Summary: the study explores the immune landscape of chronic hand eczema using spatial transcriptomics and single-cell proteomics, offering new insights into disease mechanisms and potential therapeutic targets.

patients aged 18 to 65 affected with chronic hand eczema will be included in the study. as clinical practice, severity of chronic hand eczema will be evaluated by validated scores as hecsi, dlqi, and nrs itch. moreover patch tests will be performed. skin biopsies will also be performed to confirm the diagnosis. this study utilizes spatial transcriptomics and single-cell spatial proteomics to analyze biopsies of chronic hand eczema. it aims to identify distinct inflammatory cell subgroups and molecular markers that define the immune landscape of chronic hand eczema. by comparing endogenous (atopic dermatitis, dyshidrotic eczema, idiopathic forms) and exogenous (allergic/irritant) chronic hand eczema, the research wants to describe specific immune endotypes and potential therapeutic targets. the study also includes idiopathic chronic hand eczema subtypes, such as pompholyx and hyperkeratotic eczema, to clarify immune profiling and improve treatment strategies. by identifying molecular signatures unique to each chronic hand eczema subtype, this research could lead to more personalized and effective therapies.

Eligibility criteria:
inclusion criteria: * patients affected with chronic hand eczema of endogenous and/or exogenous origin, age from 18 to 65 years * patients affected with eczema located on the hands for at least 3 months or with ≥ 2 disease flare-ups in the last year. * patients affected with atopic dermatitis affecting the hands and other areas of the body, provided the eczema lesions involve less than 30% of the body surface area. exclusion criteria: * concurrent or previous treatment with immunosuppressants, except for short courses of systemic corticosteroids (less than one month of continuous treatment), or biologic agents that may affect the clinical aspects or progression of chronic hand eczema. * patients who have received systemic corticosteroids within one month prior to enrollment in the study. * patients using topical corticosteroids or calcineurin inhibitors within one week of study enrollment (this time frame is considered to provide a good balance between potential residual pharmacological effects and ethical considerations). * patients with chronic hand eczema of mixed etiology (e.g., allergic and atopic) or those considered "etiologically unclassifiable" will not be included in the data analysis.

Keywords: atopic biopsy itch
assessment of efficacy and safety of monalizumab plus cetuximab compared to placebo plus cetuximab in recurrent or metastatic head and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: this is a randomized, double-blind, multicenter, global phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in participants with recurrent or metastatic head and neck cancer.

participants with recurrent or metastatic squamous cell carcinoma of the head and neck (scchn) who had prior immune checkpoint inhibitor and platinum-based chemotherapy treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. participants in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. all participants will be followed for survival after progression is confirmed.

Eligibility criteria:
inclusion criteria: * are aged 18 years and over * recurrent or metastatic squamous cell carcinoma of the scchn, oral cavity, oropharynx, hypopharynx, or larynx which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy * received prior treatment using a programmed cell death ligand-1 (pd-l1) inhibitor * prior platinum failure * received 1 or 2 prior systemic regimens for recurrent or metastatic scchn * has measurable disease per recist 1.1 * a fresh or recently acquired tumor tissue for the purpose of biomarker testing * world health organization (who)/ eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with scchn of unknown primary or non-squamous histologies * had prior cetuximab therapy (unless it was administered in curative locally advanced setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose) * active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or crohn's disease\], diverticulitis * any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)

Keywords: head and neck cancer squamous cell carcinoma of the head and neck monalizumab cetuximab erbitux oral cavity larynx pharynx natural killer oropharynx hypopharynx
efficacy and safety of the pediatric formulation of artemether- lumefantrine in children with uncomplicated p. falciparum malaria.

Conditions: Malaria; Falciparum

Summary: this study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused p. falciparum in children of 5-35 kg bodyweight.


Eligibility criteria:
inclusion criteria: * male or female infants and children ≤12 years of age * body weight of ≥5 kg and \<35 kg, * with a confirmed diagnosis of uncomplicated malaria caused by the p. falciparum parasite exclusion criteria: * complicated malaria * persistent vomiting * malaria due to parasites other than p. falciparum * antimalarial treatment received in the past 2 weeks * known chronic disease e.g. positive hiv status, severe cardiac, renal, or hepatic disease

Keywords: marsh fever plasmodium infections remittent fever paludism artemether artemisinins malaria benflumetol lumefantrine
phase ib trial of hs-20117 in combination with other drugs in advanced solid tumors

Conditions: Solid Tumors; Non-Small Cell Lung Cancer; Colorectal Cancer

Summary: hs-20117 is a fully-human egfr-met immunoglobulin g1(igg1)-like bispecific antibody. the purpose of study is to evaluate the safety, tolerability, efficacy, pk profile and immunogenicity of hs-20117 in combination with other drugs in advanced solid tumors.

this is a multicenter, open-label, phase ib clinical trial of hs-20117 combination therapies to evaluate the safety, tolerability, efficacy, pk profile and immunogenicity in participants with advanced solid tumors. the study includes a dose escalation part and a dose expansion part. the dose-escalation study will be performed to evaluate the safety, tolerability, pk profile, immunogenicity, and efficacy of hs-20117 combination therapies in participants with advanced solid tumor. the subsequent dose-expansion study will be performed to evaluate the efficacy of hs-20117 combination therapies in participants with locally advanced or metastatic nsclc harboring egfr exon 20 insertion mutations or egfr classical mutations, and ras/braf v600e wild type crc.

Eligibility criteria:
inclusion criteria: * males or females aged 18 - 75 years (inclusive). * histologically confirmed unresectable, recurrent or metastatic solid tumors. * at least one target lesion per the recist v1.1. * ecog performance status of 0-1. * minimum life expectancy \&amp;gt; 12 weeks. * males or females should be using adequate contraceptive measures throughout the study. * females must not be pregnant at screening or have evidence of non-childbearing potential. * signed informed consent form. exclusion criteria: * received or are receiving the following treatments: 1. any anticancer therapy targeting met, including tkis, antibodies or antibody-drug conjugates. 2. monoclonalor bispecific antibodies targeting egfr. 3. systemic anti-cancer treatment (cytotoxicities and anti-cancer traditional chinese medicine or tkis) within 2 weeks prior to the first dose of hs-20117. 4. investigational anti-cancer drugs or antibodies or adcs within 4 weeks prior to the first dose of hs-20117. 5. local radiotherapy within 2 weeks prior to the first dose of hs-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of hs-20117. 6. presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion. 7. major surgery within 4 weeks prior to the first dose of hs-20117. * presence of grade ≥ 2 toxicities due to prior anti-tumor therapy. * presence of uncured secondary primary malignancies. * untreated, or active central nervous system metastases. * severe, uncontrolled or active cardiovascular disorders. * serious infection within 4 weeks prior to the first dose of hs-20117.

Keywords: solid tumor egfr/c-met bispecific antibody b7h3 adc chemotherapy
minocycline and celecoxib as adjunctive treatments of bipolar depression

Conditions: Depression; Bipolar Disorder; Bipolar Depression; Mood Disorders

Summary: bipolar disorder is a leading cause of disability worldwide. a high proportion of patients with bipolar disorder experience persistent depressive symptoms that do not respond to standard drug treatments. recent evidence has suggested that anti-inflammatory treatment may reduce depressive symptoms. minocycline is a tetracycline antibiotic with good central nervous system (cns) penetration that has been suggested to be effective as an adjunct drug in improving depressive symptoms. celecoxib, a selective cyclooxygenase 2 (cox-2) inhibitor, has also shown promising results in the treatment of depressive symptoms. in this factorial design, double blind, randomised controlled trial the investigators will determine the efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (tau) in patients experiencing a depressive phase of bipolar i or ii disorder. the investigators hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement in depressive symptoms in participants in comparison with placebo.


Eligibility criteria:
inclusion criteria: * patients aged 18-65 years; * diagnostic and statistical manual-5 (dsm 5) diagnosis of bipolar i or ii disorder and current major depressive disorder; * experiencing current depressive symptoms for at least 4 weeks (hamd-17 score ≥18); * competent and willing to give informed consent; * taking the current medication for a minimum of 4 week prior to baseline; * able to take oral medication; * if female, willing to use adequate contraceptive precautions and to have monthly pregnancy tests. exclusion criteria: * relevant medical illness (hiv, renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis); * prior history of intolerance to any of the tetracyclines or nsaids; * concomitant penicillin therapy; * concomitant anticoagulant therapy; * presence of a seizure disorder; * currently taking other antibiotics, other nsaids, acetazolamide, or methotrexate; * any change of psychotropic medications within the previous 4 weeks; * diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to dsm-5 criteria; * pregnant or breast-feeding; * presence of primary psychotic disorder; * serious risk of suicide; * current three or more manic/hypomanic symptoms.
developing a digital handover application for paramedics to provide a personalized approach to pre-hospital stratification for out of hospital cardiac arrest

Conditions: Out of Hospital Cardiac Arrest

Summary: a prospective study validating the role of the miracle2 score in patients with resuscitated out of hospital cardiac arrest in a pre-hospital setting.

design: prospective observational cohort study enrolling oohca patients across london in a pre-hospital setting study protocol: patients with oohca and rosc will be recruited from the community into the study by london ambulance service nhs trust (las). las has -40 advanced paramedic practitioners in critical care (app-cc) who have a range of specialist skills including airway management and focused ultrasound and attend to over 1500 oohcas/year. point of care ph test: the recruited participants will have point of care ph testing performed using the cg4+ istat system (abbott vascular, illinois, u.s.a.). the test requires 2ml of venous blood and can provide blood results within minutes. the device and blood taking system have received ce marking and are already in routine use across the nhs. once the blood results are received, the blood sample and testing system are discarded in a routine manner. standard care: participants will then be conveyed to either the local emergency department or to a hac based on current routine protocols. patients will be treated in a routine manner after reaching secondary care in accordance with local and national guidance with no change in care based on this study. power calculation: in 2019, app-ccs from las attended to -700 oohca patients with rosc. assuming 60% recruitment, we could comfortably envisage -500 patients to be recruited in a 15 month period. from previous data, we can expect approximately 60% of the patients (n=300) to have a cpc score of 3-5 on hospital discharge. this would be of a similar size to the dataset used to derive the original score, which gave good levels of accuracy in model performance measures.

Eligibility criteria:
inclusion criteria: * patients with out of hospital cardiac arrest with sustained rosc (defined as \>20 minutes or sufficient stability to consider conveyance) exclusion criteria: * any clear non-cardiac cause of arrest (trauma, drowning overdose, asphyxia, asthma, anaphylaxis). * suspected or confirmed intra-cerebral bleeding * known cpc score 3 or 4 pre-cardiac arrest * known disease limiting survival to 6 months * suspected or known pregnancy
use of sildenafil (viagra) in diabetic men with erectile dysfunction: the impact on blood vessels

Conditions: Impotence

Summary: * to evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and without proven endothelial dysfunction and coexisting erectile concerns. * to determine if chronic sildenafil use compared to placebo positively impacts endothelial function among a cohort of diabetic mend with erectile dysfunction * to assess the salvage rate of sildenafil - failures who demonstrate improved response rates over time with chronic use * to assess if microalbuminuria predicts flow-mediated dilation (fmd) response * to measure and identify if other patient specific characteristics predict for sildenafil erectile response and flow-mediated dilatation (fmd) response over time (patient specifics; blood pressure, hba1c, weight, bmi, age iief score at baseline)

60 type ii diabetic men with erectile dysfunction will be enrolled in this trial, evaluated over a 12 week period. randomization into one of two arms (placebo, daily sildenafil 50mg) will be a doubly blinded. subjects will be followed by iief, diaries and brachial forearm medial dilatation duplex scans, urinary microalbuminuria and serum chemistry. study time-points are at baseline, 6 and 12 weeks. study participants will be instructed to use the study medication at the specified frequency but will be allowed flexibility to suit their erectile needs.

Eligibility criteria:
inclusion criteria: * age \> 18 years of age * type 2 diabetes \> 6 months in duration. men using oral hypoglycemic agents and /or insulin will be permitted into the trial. * stable hetero- sexual relationship for \> 6 months * iief score at baseline \<21· * agrees to sign informed consent exclusion criteria: * known hypersensitivity to sildenafil * use of nitrates * use of anti-coagulants * history of significant heart disease, +/or myocardial infarction within last 6 months * unable to understand or unwilling to sign informed consent * concomitant use of erectogenic agent during study

Keywords: viagra sildenafil
coping and attachment in pediatric oncohematology

Conditions: Pediatric Cancer; Coping Behavior; Relationship, Parent Child

Summary: cancer can be a traumatic and particularly salient experience in a person's history. the ways in which the pediatric patient copes with it depend on the interaction of several factors present in his or her life context, primarily the relationship that is established between parent and child. despite the paucity of studies in the literature in this regard, it would seem that parental coping is predictive of child coping. coping strategies represent the ways in which people try to manage traumatic events or stressful everyday situations. currently, the literature identifies two main categories of coping strategies: emotion-oriented and problem-oriented strategies. the former are aimed on reducing stress-induced unpleasant emotions (e.g., problem avoidance, positive reappraisal, etc.); the latter, on the other hand, focus on stress dissolution/alteration (e.g., problem identification and resolution, stress cause research). some studies, previously conducted in oncology, show that emotion-focused coping strategies are associated with better adaptation immediately after diagnosis, but their positive influence tends to weaken over time; problem-focused coping strategies are more correlated with poor adaptation immediately after diagnosis, but in the later stages of treatment. the clinical experience with patients in the pediatric oncohematology department brings out the need to develop and structure a psychological assessment model, in order to ensure a more effective care of the family units followed. the research aims, through a single administration of psychological tests, to investigate the role of attachment and some variables (age, gender, stage of treatment, stage of the disease, social support, resilience, ability to adapt to environmental stimuli, emotional state of of caregivers) on the coping strategies implemented by the parents of patients and the patients themselves, in order to differentiate the types of psychological intervention, to try to reduce psychological distress and increase levels of mental well-being.


Eligibility criteria:
parents inclusion criteria: * parents of both sexes * age of son/daughter between 8 and 17 years old (included) * son/daughter being treated at the pediatric oncohematology departments involved in the research (day hospital and hospitalization) * good understanding of the italian language parents exclusion criteria: ● son/daughter in off-therapy patients inclusion criteria: * age between 8 and 17 years old (included), undergoing treatment at the pediatric oncohematology departments (day hospital and hospitalization) * parents enrolled in the study * good understanding of the italian language patients exclusion criteria: ● patients in off-therapy