Kornimate/medical-research-clean huggingface dataset:
experimental evaluation of the virtual eggs test on stroke participants

Conditions: Stroke

Summary: the study protocol focuses on evaluating the virtual eggs test (vet) as a tool for assessing hand dexterity and grip strength control in post-stroke patients. the study aims to validate the reliability and concurrent validity of the vet, comparing its outcomes with established tests like the nine hole peg test (nhpt), the motricity index, the semmes-weinstein monofilament test (swmt), and the abilhand-ula questionnaire


Eligibility criteria:
inclusion criteria: * age: participants of both sexes and any ethnicity, aged 18 to 85 years. * post-stroke patients: * participants who have experienced a first ischemic or hemorrhagic stroke. * participants must be in the sub-acute phase (between 2 weeks and 6 months after the stroke) or the chronic phase (more than 6 months after the stroke). * sufficient motor capabilities to perform motor tasks. * cognitive and language capabilities: participants must have sufficient cognitive and language abilities to understand the experiment and follow instructions. * informed consent: participants must provide signed informed consent after being fully informed about the study. exclusion criteria: * visual or oculomotor impairments: participants with significant visual or eye movement disorders. * comorbidities/disabilities: * participants with conditions such as multiple sclerosis, parkinson's disease, muscle tone disorders, or malignant neoplasms, which may interfere with the ability to understand or perform the protocol. * cardiopulmonary or circulatory pathologies. * pregnancy or breastfeeding. * psychiatric comorbidities. * language barriers: participants unable to adequately understand the italian language. * lack of collaboration: participants who cannot cooperate sufficiently with the study requirements. * substance use: consumption of alcohol or diuretics before the tests. * motor function criteria: * participants with a motricity index score of \&lt;19 for the pinch grip item. * a total upper limb motricity index score of \&lt;57. * participants with a fixed contracture of the affected limb (modified ashworth scale = 4).
a study of the safety and pharmacokinetics of escalating doses of dstp3086s in patients with metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: this is a phase i, multicenter, open-label, dose-escalation study of dstp3086s administered as a single agent by intravenous (iv) infusion to patients with metastatic castration-resistant prostate cancer (crpc).


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * life expectancy of at least 12 weeks * histologic documentation of adenocarcinoma of the prostate * surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone * metastatic progressive crpc defined as progressive disease despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone * for patients in the dose-expansion cohort of the study, not more than two prior lines of cytotoxic chemotherapy in the metastatic setting * evaluable or measurable disease * documented willingness to use an effective means of contraception exclusion criteria: * anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, or radiotherapy within 4 weeks prior to day 1, with the following exceptions: maintenance hormonal therapy for metastatic prostate cancer and palliative radiation to bone metastases within 2 weeks prior to day 1 * major surgical procedure within 4 weeks prior to day 1 * known active bacterial, viral, fungal, mycobacterial, or other infection (including hiv and atypical mycobacterial disease, but excluding fungal infections of the nail beds) * ongoing corticosteroid use with \> 10 mg of daily prednisone or equivalent * symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible. * history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * untreated or active central nervous system (cns) metastases. patients with a history of treated cns metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the cns, radiographic demonstration of improvement upon the completion of cns-directed therapy and no evidence of interim progression between the completion of cns-directed therapy and the screening radiographic study, and screening cns radiographic study is \>/= 8 weeks since completion of radiotherapy and \>/= 4 weeks since the discontinuation of corticosteroids and anticonvulsants * dose expansion cohort (b): no prior chemotherapy is allowed
investigation into the infectivity levels of human papilloma virus (hpv) in tonsillar tissue

Conditions: Human Papillomavirus, Palatine Tonsil

Summary: human papilloma virus (hpv) has been shown to be a cause of head \& neck squamous cell carcinoma (hnscc) and the majority of current studies focus on what is happening in patients with a hpv hnscc. but there is limited investigation into hpv infection in the oropharynx of patients who do not have hnscc. the current incidence of oral hpv infection is not known in the general population locally and there is also limited information on what particular localities within the mouth that patients' harbour hpv infection what strains are present and if there are any differences in viral load. therefore the aim of this project is to investigate within patients that undergo tonsillectomies the rate of hpv infection in tonsils to determine the amount of hpv present within the community.

patients are having no additional invasive testing than is all ready being carried out for their care pertaining to their tonsillar tissue. patients are routinely swabbed pre-operative for evidence of mrsa, this trial would add an extra swabbing procedure for the mouth. the ethical implications are related to the tissue which is being tested for a virus that can be implicated in head and neck squamous cancer. these patients would not normally be aware of hpv infection and this would raise an new health burden in these patient who are likely to be fit and well. the research team would be suitable to counsel patients from any worries related to hpv infection.

Eligibility criteria:
inclusion criteria: * all patients undergoing routine tonsillectomies who can provide consent to participate over the age of 18 years old would eligible to enter the study. they would all ready be listed for a tonsillectomy after being seen by an ent surgeon. exclusion criteria: * patients unable to give informed consent * if the tonsillectomy is carried out to diagnose cancer * patient chooses to decline recruitment into the study
influenza vaccination for flu prevention in patients with plasma cell disorders

Conditions: Plasma Cell Neoplasm

Summary: this phase iv trial studies how well influenza vaccination works in preventing infections such as influenza in patients with plasma cell disorders. influenza infections may theoretically support the growth of tumor cells and improving protection against influenza may improve the status of patients' plasma cell disorder. giving influenza vaccination may reduce influenza-related complications including infections, hospitalizations, and deaths, and improve the status of plasma cell disorders.

primary objectives: i. demonstrate an absolute 25% increase in seroprotection, defined as hemagglutination antibody inhibition (hai) \> 40 against all strains, at week 21 in the experimental arm compared to the control arm. ii. determine correlation between hai, predefined risk of influenza-like illness (low, moderate, high), and progression-free survival (pfs). exploratory objectives: i. measurement of b \& t-cell subsets and flu-specific responses as a way of understanding immunosuppression in this patient population, correlating with influenza-like illness. outline: patients are randomized to 1 of 2 arms. arm i: patients receive trivalent influenza vaccine intramuscularly (im) at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine im at week 5 in the absence of disease progression or unacceptable toxicity. arm ii: patients receive trivalent influenza vaccine im at week 1 and pneumococcal 13-valent conjugate vaccine im at week 5 in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed for 4 weeks and then periodically for 2 years.

Eligibility criteria:
inclusion criteria: * patient must have a plasma cell dyscrasia that fits in the international myeloma working group (imwg) diagnostic criteria. * both men and women of all races and ethnic groups are eligible for this study. * eastern cooperative oncology group (ecog) performance status ≤ 3 (karnofsky ≥ 30%) is required for eligibility. * patient must be eligible to receive standard of care influenza vaccination. if the patient has a history of egg allergy with symptoms more severe than urticaria, e.g. angioedema, respiratory distress, lightheadedness, or recurrent emesis, they remain eligible to receive influenza vaccination but must receive the vaccine in a facility able to recognize and manage severe allergic reactions. persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic, although egg-allergic persons might tolerate egg in baked products. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients who have already received the seasonal influenza vaccine in the current season. * history of guillain-barré syndrome. * patients with a previous severe allergic reaction to influenza vaccination or pneumococcal 13-valent conjugate vaccine (pcv13). * expected survival \< 9 months. * prisoners.
dailies® aquacomfort plus® multifocal (mf) - comparative assessment of visual performance

Conditions: Presbyopia; Refractive Error

Summary: the purpose of this study is to evaluate the visual performance of dailies® aqua comfort plus® (dacp) mf contact lens using new objective measurements.

in this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.

Eligibility criteria:
inclusion criteria: * history of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week * spectacle add between +1.50 and +2.50 diopters (d) (inclusive) * requiring lenses within the power range of both study contact lenses to be fitted * cylinder, if present, less or equal to 0.50d in both eyes at visit 1 * vision correctable to 20/30 (0.2 logmar) or better in each eye at distance * acceptable fit with both study contact lenses * willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible * other protocol-defined inclusion criteria may apply exclusion criteria: * current multifocal contact lens wearer * current monovision wearer or failed attempt with monovision * ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear * use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator * eye injury or surgery within 12 weeks immediately prior to enrollment in this trial * any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit * history of herpetic keratitis, ocular surgery or irregular cornea * prior refractive surgery (e.g. lasik, prk, etc) * monocular (only 1 eye with functional vision) or fit with only 1 lens * habitually uncorrected anisometropia \>2.00d * clinically significant anisocoria * participation in any clinical trial within 30 days of the enrollment visit * other protocol-defined exclusion criteria may apply

Keywords: dacp mf dailies aquacomfort plus® multifocal presbyopia visual performance
oral glucocorticosteroid in the treatment of severe asthma exacerbation in hospitalized patients

Conditions: Asthma

Summary: a comparison of oral prednisolone administration with intravenous methylprednisolone infusion in the treatment of acute asthma exacerbation in hospitalized patients. oral glucocorticosteroids administration may be effective as intravenous high-dose methylprednisolone infusion.


Eligibility criteria:
inclusion criteria: * asthma patients, who need hospitalized treatment, who do not respond with initial treatment including bronchodilator and iv methylprednisolone therapy exclusion criteria: * need for incubation * with severe complications * received systemic glucocorticosteroid therapy in the previous 4 weeks

Keywords: asthma patients
immunophenotyping in metastatic kidney cancer patients receiving ablative therapy

Conditions: Metastatic Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8

Summary: this early phase i trial evaluates blood samples to see if patients undergoing standard of care treatment with either stereotactic body radiation therapy or percutaneous ablation (using radio waves to create heat to destroy the tumor), have an increase in serum immune markers in kidney cancer. information gained from this study may help doctors make treatment decisions for patients with kidney cancer.

primary objectives: i. compare pre- and post-treatment immune markers and peripheral blood mononuclear cell (pbmc) characteristics in metastatic renal cell carcinoma (rcc) patients overall. ii. compare pre- and post-treatment immune markers and pbmc characteristics between patients being treated with stereotactic body radiation therapy (sbrt) versus percutaneous cryoablation (pca) and are also undergoing immunotherapy. iii. compare pre- and post-treatment immune markers and pbmc characteristics in patients being treated with either sbrt or pca and not undergoing immunotherapy. iv. assess the impact of post-treatment immune markers and pbmc characteristics on distant disease progression in metastatic rcc patients overall. outline: patients undergo blood sample collection at baseline prior to sbrt or pca, then at 14 days, 3 and 6 months after sbrt or pca.

Eligibility criteria:
inclusion criteria: * histological diagnosis of primary rcc * histological or radiographic diagnosis of metastatic rcc * age \>= 18 years * eastern cooperative oncology group (ecog) performance status 0-3 * feasible vascular access as determined by study staff * undergoing standard of care sbrt or pca to rcc metastatic lesion(s) * provide written informed consent * willing to consent to research blood draws * willing to return to enrolling institution for follow-up exclusion criteria: * prior local treatment of the index metastatic lesion * pregnant or nursing women * co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry * patients receiving prophylactic steroids, defined as initiation of steroids within 1 week prior to local ablative therapy start, including the first day of local ablative therapy. * note: patients initiating steroids after the first day of local ablative therapy and within 14 days after local ablative therapy completion, will be allowed into the study and the use of steroids will be recorded.
immunogenicity and safety of a monovalent glycoprotein-conjugated (diptheria toxin -crm197) hib vaccine in 13-59 months old healthy children

Conditions: Haemophilus Influenzae Type b (Hib) Infection

Summary: this study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent haemophilus influenzae type b infections in children 13-59 months of age.


Eligibility criteria:
inclusion criteria: * infants 13-59 months of age. exclusion criteria: * prior hib vaccine administration. * history of serious reaction(s) following vaccination. * any vaccination within 7 days of study vaccination. * known or suspected immune impairment. * premature (before 37th week of gestation) or birth weight less than 2500g * for additional entry criteria please refer to the protocol.

Keywords: haemophilus influenzae type b (hib) vaccine anti prp antibody
monocentric prospective pilot study evaluating the value of indocyanine green (icg, indocyanine green) during a surgical resection of cancerous lesions peritoneal colorectal origin.

Conditions: Colorectal Cancer Metastatic

Summary: between 30% and 40% of patients with colorectal cancer develop metastatic disease intraperitoneally. the optimal treatment of this disease combines surgery and chemotherapy but requires resection of all lesions larger than 2mm. indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries. the ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated. this study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.


Eligibility criteria:
inclusion criteria: * patient with progressive colorectal cancer in intra-abdominal surgery requiring resection + / - chemotherapy hyperthermic intraperitoneal * aged 18 to 70 inclusive * signature information form and consent by the patient exclusion criteria: * pregnant women, a urine pregnancy test or blood will be realized within 72 hours before surgery * contraindication to surgery * diagnosis not confirmed colorectal adenocarcinoma * persons major subject of legal protection or unable to consent

Keywords: colorectal cancer metastatic indocyanine green
prevention of contrast-induced nephropathy in patients with acute myocardial infarction

Conditions: Contrast Induced Nephropathy

Summary: objective: to evaluate the efficacy of prevention of contrast induced nephropathy in patients with st segment elevation myocardial infarction treated with primary percutaneous coronary intervention. design: prospective study. setting: three-center study acute kidney injury was defined as a rise in creatinine \>25% from baseline serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days. patients will be randomised to: 1. standard treatment 2. standard treatment + acetylcystein for 2 days 3. standard treatment + sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours 4. standard treatment + acetylcystein for 2 days + sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours


Eligibility criteria:
inclusion criteria: * stemi patients treated with primary pci exclusion criteria: * cardiogenic shock

Keywords: cin stemi
autoimmune protocol diet and inflammatory bowel disease

Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Summary: there is limited data to guide the use of dietary change in the management of ibd, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. therefore there is an important need to study diet as a therapy for ibd. here, the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune protocol (aip) diet in patients with active crohn's disease (cd) and ulcerative colitis (uc).

the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune paleo (aip) diet in patients with crohn's disease (cd) and ulcerative colitis (uc). specific aims: 1. to evaluate the effect of the aip diet on clinical and endoscopic disease activity for cd and uc, 2. to examine changes in inflammatory biomarkers during aip diet 3. to characterize changes in rna expression from intestinal mucosal biopsy specimens from prior to diet initiation to end of the study. 4. to characterize changes in fecal microbiome during diet intervention

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. able to provide written informed consent prior to screening and to comply with the requirements of the study protocol. 3. established diagnosis of small bowel cd or colonic cd or ulcerative colitis 4. confirmation of active cd or uc with recent (within 6 months of consent or prior to study start) objective evidence of endoscopically active disease on colonoscopy or computed tomography/magnetic resonance enterography or video capsule endoscopy 5. any medications being currently used for ibd must remain stable during the study period with the exception of tapering of corticosteroids. 6. current disease activity defined as a harvey bradshaw index ≥ 5 at baseline for cd or partial mayo score ≥ 3 for uc 7. established facebook account 8. comfortable with internet-based surveys and email exclusion criteria: 1. if female, is pregnant or is breast feeding 2. known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies) 3. inability to provide informed consent or unwilling to participate 4. evidence of untreated infection (e.g. clostridium difficile) 5. presence of stoma or j pouch 6. bowel surgery within 12 weeks prior to enrollment and/or has surgery planned or deemed likely for inflammatory bowel disease during the study period 7. use of tube or enteral feeding, elemental diet, or parenteral alimentation within 4 weeks prior to study initiation