Kornimate/medical-research-clean huggingface dataset:
evaluate efficacy and safety of lacudy for improving vaginal environment in breast cancer patient

Conditions: Hormone Receptor-positive Breast Cancer

Summary: adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. even though previous studies have reported that estrogen topical agent relives these symptoms, non-hormonal therapy should be considered first due to concerns about the role of estrogen in breast cancer development. therefore, this trial is planned to evaluate the efficacy and safety of lacud (hyaluronic acid, lactic acid and alginate) in the vaginal environment of breast cancer patients receiving hormone therapy.

* registered subjects are 1:1 randomized using a random sequencing generator (www.random.org). experimental group with 30 patients and control group with 30 patinets. * in the case of the experimental group, lacudy 2ml is inserted twice a week for a month before going to bed for 4 weeks. * unpack the product and take it out. * remove the cap by turning it. * fit the nozzle to the end of the syringe and turn it to combine. * hold the syringe with the nozzle facing the vulva, insert it about 5-6 cm into the vagina, and then slowly press the tip of the push rod with patient's thumb to inject all the liquid in the syringe into the vagina. * slowly remove the syringe as the nozzle opens. * it is recommended to wear a pad as the injected solution may flow out. * in the case of the control group, they go about their daily lives without any treatment. * both the experimental group and the control group are instructed not to administer intravaginal suppositories or other drugs related to vaginal atrophy and sexual function improvement. * a total of 2 questionnaires were conducted before and after treatment.

Eligibility criteria:
inclusion criteria: 1. female 2. aged 20 to 60 years diagnosed with breast cancer 3. receiving anti-hormonal therapy 4. patients who subjectively complain of vaginal dryness 5. patients without current psychiatric problems 6. patients who can understand and respond to the contents of the questionnaire 7. ability to provide informed consent exclusion criteria: 1. women under 19 and over 61 2. pregnant woman 3. in case of recurrence or disease progression 4. patients without sexual experience 5. unable to provide informed consent
five year study to track use of decisiondx-melanoma test in patients with cutaneous melanoma and associated patient outcomes

Conditions: Cutaneous Melanoma

Summary: the expand registry study follows patients with cutaneous melanoma who have had the decisiondx-melanoma gene expression assay performed as part of their clinical care. data will be collected through review of medical records from clinical visits with physician. the purpose is to document the clinical application of results obtained from the decisiondx- melanoma multi-gene assay and to track outcomes of patients for whom decisiondx-melanoma testing has been completed. additionally the study will assess the health economic impact of decisiondx-melanoma testing as it relates to the melanoma population.


Eligibility criteria:
inclusion criteria: * patients diagnosed with melanoma and determined, by their physician, to be appropriate for decisiondx-melanoma testing and who have successful results available to the investigator are eligible for registration * patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data. * 16 years and older exclusion criteria: * less than 16 years of age

Keywords: melanoma cutaneous melanoma decisiondx-melanoma
safety and immunogenicity of two adjuvanted and one non-adjuvanted h5n1 influenza vaccine in adults

Conditions: Influenza

Summary: the present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of h5n1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of h5n1 influenza antigen, in adults


Eligibility criteria:
inclusion criteria: * male and female volunteers 18-60 years of age exclusion criteria: * any auto-immune disease or other serious acute, chronic or progressive disease * hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine * within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy

Keywords: influenza pandemic influenza influenza vaccine adjuvanted influenza vaccine h5n1 influenza antigen mf59 pandemic influenza disease
prospective randomized double blind clinical trial of polyhexamethylene biguanide impregnated foam dressing

Conditions: Wounds

Summary: this is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. the purpose of this study is to compare the efficacy of copa amd phmb impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds.


Eligibility criteria:
inclusion criteria: * subject is 18 to 85 years of age inclusive * subject has a foot ulcer * subject has a leg ulcer * subject has an open wound of at 1.0 cm (2) * subject has one of the following: palpable pulse, abi \> 0.56 or toe pressure \> 50 mmhg * subject or legally authorized rep is able to understand and willing to give written informed consent exclusion criteria: * subject has an allergy to chlorhexidine gluconate (chg) * subject has open wounds that in the opinion of the principal investigator do not have the ability to heal * subject has current malignant disease or history of malignant disease in past 5 years * subject has inability to comply with the study protocol and procedures * subjects who require use of topical agents other than the impregnated or regular foam dressings dressings
incidence of paroxysmal atrial fibrillation (af) in patients with acute ischemic stroke or transient ischemic attacks (tias) by 48 hours holter monitoring

Conditions: Transient Ischemic Attack

Summary: 200 patients presenting with symptoms of acute ischemic stroke or transient ischemic attack were included. all patients free of af on presentation underwent 48 hours holter monitoring within one week.


Eligibility criteria:
inclusion criteria: * patient with acute ischemic stroke or tias (within one week of onset) exclusion criteria: * history of persistent af * initial ecg is af * primary hemorrhagic stroke * acute large vessel dissection * inability or refusal of consent

Keywords: atrial fibrillation transient ischemic attack
comparison of total and partial fundoplication during surgery of patients with gastroesophageal reflux disease

Conditions: Reflux, Gastroesophageal

Summary: 460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (gerd) participate in the study following the usual preoperative clinical routines (medical history, endoscopy with biopsies, esophageal manometry with 24 hour ph (acidity) registration ). patients are randomized to fundoplication according to nissen or modified toupet. postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.

patients aged 18-75 years planned for elective surgical treatment of gerd participate in the study. patients with recurrent reflux disease following prior surgery, asa (american society of anesthesiologists (asa) physical status") class\> 3, paraesophageal herniating and / or major herniation without reflux and those with other contraindications against laparoscopic surgery are excluded. in addition, patient completes a qol protocol. patients in the study are randomized to laparoscopic fundoplication performed either with a 360 degrees (nissen) alternatively 270 degree (modified toupét). both of these techniques are well established clinical routines. general intubation anesthesia is standardized to all study patients. discharge from the hospital is typically on the first postoperative day. at a visit, after 6-8 weeks for clinical control, is a qol protocol is completed as well. after 12 and 36 months, patients undergo upper endoscopy and manometry with 24 hour ph-registration and qol protocol completion. the latter also occurs after 24 months and 60 months.

Eligibility criteria:
inclusion criteria: * surgery treatment for gerd * laparoscopic surgery exclusion criteria: * previous surgery for gerd * asa classification \>3 * paraesophageal hernias or large hiatal
pilot cohort study of rb-82 myocardial pet imaging to evaluate coronary microvascular dysfunction in men with prostate cancer receiving androgen-deprivation therapy

Conditions: Prostate Cancer

Summary: to determine the feasibility of using myocardial pet imaging as a means to assess cardiovascular risk in men with prostate cancer planned for androgen- deprivation therapy with external beam radiation therapy.


Eligibility criteria:
inclusion criteria: * either clinically localized prostate cancer or biochemically-recurrent prostate cancer patients who are planned for at least 6 months adt with a gnrh agonist and curative-intent radiation therapy per their oncologic providers. * over 50 years of age. calculated 10-year framingham general cardiovascular risk score of ≥10% at the time of planned initiation of adt. * patients must be able to read and understand english. * participants must sign the informed consent form. exclusion criteria: * prior treatment with gnrh agonist therapy. * history of active asthma or other reactive airway disease. * ischemic cardiac event (myocardial infarction, unstable angina) within the preceding 6 months.
evaluation of the technical feasibility of testing ct dna for homologous recombination gene variants in metastatic prostate cancer.

Conditions: Circulating Tumor DNA; Metastatic Prostate Cancer

Summary: evaluation of technical feasibility for homologous recombination (hr) genes variants research on circulating tumor dna (ctdna) from plasma and urine of patients with a metastatic prostate cancer.

the benefit of parpi has been well established for ovarian (solo-1 study) and prostate cancer (profound study) with defects in the homologous recombination repair (hrr) system due to brca1 or brca2 variants. somatic variants in hrr genes are currently researched by next generation sequencing (ngs). however, in metastatic prostate cancer, using formalin-fixed and paraffin-embedded (ffpe) samples, failure rate is around 30 % according to our retrospective datas, in agreement with the data of the profound study, highlighting a real pre-analytical matter when ffpe samples are used for ngs testing. research of such alterations on circulating tumor dna (ctdna) extracted from plasma or urine could be a promising alternative test.

Eligibility criteria:
inclusion criteria * age \> 18 years * metastatic prostate cancer * archived tissue sample available for testing for somatic variants of hrr genes (including brca1/brca2) * free, informed and signed consent for research non inclusion criteria * refusal of blood and urine collection * patient cognitively incapable of signing consent to participate in this study * patient under guardianship or curatorship

Keywords: prostate cancer ctdna hr genes
eras (enhanced recovery after surgery) protocol implementation in piedmont region for colorectal cancer surgery

Conditions: Colorectal Cancer; Quality Improvement; Perioperative Care; Recovery of Function

Summary: the study assesses the impact on quality of care of implementing the eras (enhanced recovery after surgery) protocol for colorectal cancer surgery in the network of public hospitals in the regione piemonte (north-west italy). every hospital is a cluster entering the study treating patients according to its current clinical practice. on the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the eras protocol.

eras (enhanced recovery after surgery) protocol is a multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. even if efficacy and safety of eras protocol in colorectal surgery is well-established in the literature, its implementation is limited to few selected centres in piemonte. the aim of the study is to extend the implementation of the eras protocol to whole regional network of hospitals. specific objectives are to estimate its impact on different dimensions of quality of care, including length of stay, complications and patient satisfaction, and to identify possible barriers or facilitating factors.

Eligibility criteria:
inclusion criteria: * all the hospital wards within the piemonte region performing colorectal cancer surgery * all the patients receiving an elective surgery for colorectal cancer, with or without protective stoma. exclusion criteria: * hospital wards performing less than 30 expected cases per year * emergency surgery * high severity cases not allowing eras protocol implementation (i.e. american society of anesthesiologists score: asa v).
study of efficacy, safety and tolerability of levodopa-carbidopa intestinal gel in levodopa-responsive parkinson's subjects

Conditions: Advanced Parkinson's Disease

Summary: the primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.

study s187.3.001 (nct00357994) and study s187.3.002 (nct00660387) were 2 identically designed, phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. these studies evaluated the efficacy, safety, and tolerability of levodopa-carbidopa intestinal gel (lcig) in the treatment of levodopa-responsive subjects with advanced pd who had persistent severe motor fluctuations, despite optimized treatment with oral levodopa-carbidopa, concomitant with other available antiparkinsonian medications. participants were randomized to either lcig active gel + placebo capsules or levodopa-carbidopa immediate release (ir) active capsules + placebo gel. both treatment arms received the percutaneous endoscopic gastrostomy with jejunal extension (peg-j) procedure for gel administration, active lcig or placebo gel. data from these 2 studies were combined for analysis. the decision to combine the study data for analysis was made before enrollment was completed for both studies.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (pd) according to united kingdom parkinson's disease society (ukpds) brain bank criteria * levodopa-responsive participants who demonstrate some identifiable 'on response,' established by investigator observation * demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated exclusion criteria: * diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism * undergone surgery for the treatment of pd * contraindications to levodopa * subjects with any neurological deficit that may interfere with the study assessments

Keywords: levodopa-carbidopa carbidopa levodopa dyskinesia duodopa levodopa-carbidopa intestinal gel severe motor fluctuations levodopa/carbidopa suspension duopa
tas test: online motor-cognitive tests for early detection of alzheimer's disease

Conditions: Alzheimer Disease; Dementia; Age-related Cognitive Decline

Summary: global dementia prevalence is rising. alzheimer's disease (ad), the most common cause, has devastating effects on people's quality of life. ad has a preclinical (pre-ad) period of 10-20 years when brain pathology silently progresses before any cognitive symptoms appear. current tests for pre-ad are invasive, costly and unsuitable for screening at population level. similar to screening for pre-diabetes and carcinoma in situ, it is important to detect ad at the preclinical stage in order to offer early interventions before the pathology progresses to the irrerversible degenerative stage. in the study, research will develop a new scalable test (tas test) by combining two innovative ideas: hand-movement tests to detect pre-ad \>10 years before cognitive symptoms begin; and computer vision so people can "self-test" online using home computers. this unique approach builds on recent discoveries that hand-movement patterns change in pre-ad. the research team will use exquisitely precise computer vision methods to automatically analyse movement data from thousands of participants, and combine this with machine learning of overall motor-cognitive performance. the project team has access to 3 well-phenotyped cohorts, \>10,000 existing participants and a cutting-edge assay for a blood ad biomarker, ptau181. the research team will develop a tas test algorithm to classify hand-movement and cognitive test data for pre-ad risk (p-taua181 levels) and determine tas test's precision to prospectively predict 5-year risks of cognitive decline and ad.

sub-study 1: cross-sectional study design: from two established cohorts with pre-existing datasets of up to 10 years of longitudinal cognitive, genetic and demographic data, the team will recruit 500 participants over 50 years old who are confirmed to have normal cognition. at baseline and months 3 and 6, the participants will be invited to complete tas test online at home, or in the research centre if preferred. the participants will also have a baseline blood test for ptau181 levels (and apoe4 if required). the research team will integrate movement data to develop a multivariable model that discriminates between pre-ad (positive p-tau181) and normal cognitive ageing (negative p-tau181). sub-study 2: prospective 5-year cohort study design: the researchers will invite 10,000 adults from an established long-term (island project) cohort to complete online tests at home: (i) tas test every 6 months, and (ii) cambridge neuropsychological test automated battery (cantab) cognitive tests every 24 months. the prospective 'high risk' predictions of tas test at baseline will be validated against cantab scores, and also clinically (face to face gold standard consensus diagnosis of ad vs mci vs normal) in a subsample of 300.

Eligibility criteria:
inclusion criteria: \> 50years old exclusion criteria: established diagnosis of dementia

Keywords: pre-clinical early detection online tests artificial intelligence
oxidative stress markers in copd

Conditions: Role of Oxidative Stress in COPD

Summary: background:striking feature of chronic obstructive pulmonary disease (copd) is its inability to resolve after cigarette smoke exposure has ended, which has contributed to the possibility that the disease could also be driven by other endogenous causes, such as autoimmunity or chronic infection . many of the pathogenetic pathways involved in copd and its development tend to be driven by oxidative stress.


Eligibility criteria:
inclusion criteria: * 1-forty subjects of copd who are non-smokers or stopped smoking for more than 6 months based on the global initiative for chronic obstructive lung disease guidelines, copd was diagnosed.9 2- thirty subjects of non smokers healthy control exclusion criteria: * patients of: 1. acute exacerbation, at the time of the study, of copd. 2. any obvious abnormal lung parenchymal lesions. 3. lung cancer. 4. congestive heart failure. 5. current smokers 6. drugs e.g anti-inflammatory , steroids ,analgesics, insulin , antineoplastic, antipsychotic drugs in the previous 2 weeks before the study.

Keywords: copd , oxidative stress, superoxide dismutase
expression of ku70/xrcc6 in waldenström's macroglobulinemia

Conditions: Waldenström Macroglobulinemia

Summary: waldenström's macroglobulinemia is a rare disease whose pathophysiology remains at present poorly understood, although a recurrent mutation (l265p myd88) has recently been described. unlike other lymphoproliferative disorders, there is a defect in isotype switching, mechanism involving aid and nhej complex. using a two-dimensional electrophoresis technology, our group showed that mw had a specific proteomic profile, and one of the differentially expressed proteins is ku70 (encoded by xrcc6 belonging to nhej complex) . the investigators purpose to explore the mechanisms of underexpression of ku70/xrcc6 (genetic or epigenetic modification) in comparison with other lymphoid malignancies and normal b cells.


Eligibility criteria:
inclusion criteria: * patient over 18 years, affiliated to the social regimen * written consent collected mw group : * patient with a diagnosis of mw according to who criteria (based on the results of serum protein electrophoresis, bone marrow analysis with immunophenotyping, cytogenetic analysis and mutation l265p myd88) other slp : * patient with diagnosis of chronic lymphocytic leukemia, splenic marginal zone lymphoma or multiple myeloma healthy volunteers : * volunteers without blood disorders exclusion criteria: * women of childbearing age who do not have an effective means of contraception * pregnant or nursing * demonstration of a kappa or lambda monotype on b lymphocytes * healthy volunteer with b-cell malignancy
phase ii gm-csf plus mitoxantrone in hormone refractory prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (gm-csf) on progression-free survival (pfs) and overall survival (os), in patients with hormone-refractory prostate cancer.

this trial evaluates if the addition of gm-csf to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and therefore both drugs will be given at standard (approved) doses.

Eligibility criteria:
inclusion criteria: * signed written informed consent * age ≥ 18 years * histologically-confirmed adenocarcinoma of the prostate * hormone-refractory prostate cancer * failed 1st-line docetaxel-containing regimen * no prior immunotherapy including: * vaccines * gm-csf * minimum prostate-specific antigen (psa) \> 5 mg/dl and rising according to the psa consensus criteria * karnofsky performance status (kps) \> 60% * eastern cooperative oncology group (ecog) performance status \< 3 * life expectancy \> 6 months exclusion criteria: * concomitant hormonal therapy other than luteinizing hormone-releasing hormone (lhrh) agonist * use of herbal products known to decrease psa levels * use of supplements or complementary medicines, except for: * conventional multivitamin supplements * selenium * lycopene * soy supplements * vitamin e * initiation of bisphosphonates within one month prior to enrollment or throughout the study * any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment * major surgery or radiation therapy completed \< 4 weeks prior to enrollment * any concomitant second malignancy other than non-melanoma skin cancer * any concomitant serious infection * any nonmalignant medical illness * absolute neutrophil count (anc) \< 1,500/µl * platelet count \< 100,000 µl * hemoglobin \< 8 mg/dl * total bilirubin greater than 1.5 x upper limit of normal (uln) * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2.5 x uln if no demonstrable liver metastases, or greater than 5.0 x uln in presence of liver metastases * ejection fraction \< 50% as measured by echocardiogram (echo) or multigated acquisition (muga) scan * noncompliance with study procedures