Kornimate/medical-research-clean huggingface dataset:
neoadjuvant study of navelbine in patients with her2 positive breast cancer

Conditions: Breast Cancer

Summary: this is a randomized, double-blind multicenter phase iii study for evaluating the efficacy of neoadjuvant navelbine plus trastuzumab and pertuzumab versus docetaxel plus trastuzumab and pertuzumab given as neoadjuvant treatment in her2 positive early-stage or locally advanced breast cancer.


Eligibility criteria:
inclusion criteria: female patients, 18 years ≤ age ≤ 80 years； performance status- eastern cooperative oncology group (ecog) 0-1 histologically confirmed invasive breast cancer（early stage or locally advanced） her2 positive (her2+++ by ihc or fish+) known hormone receptor status. cardiovascular: baseline left ventricular ejection fraction (lvef)≥55% measured by echo signed informed consent form (icf) exclusion criteria: metastatic disease (stage iv) or inflammatory breast cancer previous or current history of malignant neoplasms, except for curatively treated: basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix. clinically relevant cardiovascular disease: known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); unable or unwilling to swallow tablets.
impact of supra-renal fixation of evar on hemodynamics of renal arteries

Conditions: Aortic Aneurysm, Abdominal; Endovascular Procedures; Renal Artery Stenosis

Summary: the investigators conducted a bicentric prospective study to quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation evar with suprarenal fixation immediately postoperatively.


Eligibility criteria:
inclusion criteria: * elective evar with supra renal fixation * women who have been postmenopausal for at least 24 months or are surgically sterilized, or for women of childbearing potential, use of an effective method of contraception * consent to participate * affiliation to a french social security exclusion criteria: * stenosis of at least one renal artery * dialysis * rupture of abdominal aortic aneurysm * renal stenting during the procedure * fenestrated evar * legal incapacity or limited legal capacity * subject being in the exclusion period of another study * pregnant woman
efficacy of self-titration of ventilation in overlap syndrome (chronic obstructive pulmonar disease + sleep apnea syndrome ) with dynamic hyperinflation. edin-idin.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the combination of copd and obstructive sleep apnea (osa) can lead to undesirable interactions with the treatment approach. the investigators know that continuous positive airway pressure (cpap) can increase dynamic hyperinflation in copd patients, and in mechanical ventilation, the increase in peep can worsen dynamic hyperinflation. on the other hand, the team know that the severity of copd obstruction and hyperinflation alter sleep efficiency, with periods of wakefulness during sleep, and during these periods, the patient would not have upper airway obstruction, which could affect the therapy they are receiving in cpap mode for osa. moreover, it was observed that with greater hyperinflation, the rate of obstructive events decreases, dynamically affecting the ventilatory situation with upper airway resistance. recent studies have determined the safety and efficacy of auto-adjusting systems in the treatment of overlap syndrome, which could be more adaptable to the changing pulmonary mechanics of these patients. aerobic capacity is a good predictor to the health status in these patients and the investigators know it is reduced in patients with aos, where cpap treatment according to studies improves the peak vo2. therefore, the objective is to compare a ventilation system with fixed pressures established through polysomnography in patients with overlap syndrome and dynamic hyperinflation to a dynamic ventilation system using the fixed pressure limits typically established, based on their impact on the aerobic capacity (peak vo2) of these patients after 1 month of treatment.


Eligibility criteria:
inclusion criteria: * stability of at least 4 weeks without hospital admission. * previously presented pco2 \> 52. * age between 50 and 80 years. * agree to participate in the study and sign the informed consent. * both sexes. exclusion criteria: * refusal to participate in the study. * uncontrolled structural or coronary heart disease (no changes in medication in the last 15 days). * lvef \< 45%. * central sleep apnea syndrome (≥ 50% central events). * uncontrolled pulmonary hypertension. * inability to perform the tests. * having had an exacerbation 4 weeks prior. * severe psychiatric illness. * cognitive impairment. * not speaking spanish. * illiteracy. * active smoker (or \< 6 months since quitting smoking).
outcomes data of adipose stem cells to treat rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (svf), has on pain and functionality in people with rheumatoid arthritis (ra). svf contains multiple cellular components, including stem cells, with both regenerative and anti-inflammatory properties. this therapy has shown promise for ameliorating the symptoms of ra. this study is designed to evaluate changes in pain and functionality in individuals with ra for up to 12 months following svf treatment.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with rheumatoid arthritis * subjects scheduled for a stem cell/svf treatment * subjects willing and able to sign informed consent * subjects willing and able to perform follow-up interviews and surveys exclusion criteria: * subjects with addition major health condition/disease diagnoses * subjects that are pregnant or breastfeeding
a phase 2 trial of foscenvivint in liver cirrhosis patients caused by hiv/hcv co-infection with hemophilia (op-724-h201)

Conditions: Liver Cirrhosis

Summary: this is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by hiv/hcv co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.

this is designed a multi-center, single-arm, open-label trial of foscenvivint administered intravenously twice a week for 24 weeks. a follow up visit will be conducted 4 weeks after the last administration. liver cirrhosis patients due to co-infection of hiv and hcv with hemophilia who have a child-pugh classification of a or b are included.

Eligibility criteria:
key inclusion criteria * hemophilia patients with liver cirrhosis caused by hiv/hcv co-infection that fall under the following 1) and 2): 1. serum hiv-rna positive or hiv antibody positive patients (maintaining hiv-rna \ = 200 cells/µl at screening). 2. regarding hcv, patients who had passed \>= 12 months after achieving svr at registration. * patients with child-pugh classification a or b (child-pugh score 5-9). * patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis: 1. liver stiffness measurement by fibroscan is \>= 12.5 kpa (fibrosis stage f4) at screening. 2. abdominal ct scan shows changes in liver shape and/or portal hypertension. * patients with performance status 0-2. key exclusion criteria * patients with liver cirrhosis of which cause is not hcv or unknown. * patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening. * patients with complication or history of malignant tumor (within 3 years before registration). * patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation). * patients with active aids-indicator disease that require treatment.

Keywords: liver cirrhosis hemophilia hiv/hcv co-infection
effect of indinavir plus two other anti-hiv drugs on blood clotting in hiv-positive males with hemophilia

Conditions: HIV Infections; Hemophilia A

Summary: the purpose of this study is to see if indinavir plus two other anti-hiv drugs affect blood clotting in hiv-positive patients with hemophilia.

patients are enrolled in one of two study groups. the treatment group consists of hiv-1 seropositive patients with hemophilia a or b who are protease-inhibitor naive. the laboratory control group consists of hiv-1 seropositive patients with hemophilia a who are on a stable, triple-combination antiretroviral regimen. patients in the treatment group receive indinavir sulfate plus two of the following nrtis: zidovudine (zdv), didanosine (ddi), zalcitabine (ddc), stavudine (d4t), or lamivudine (3tc). patients in the treatment group preferably are naive to one or both of the nrtis. patients in the laboratory control group continue on their stable triple antiretroviral regimen consisting of a protease inhibitor plus two nrtis. patients in the control group are not provided antiretroviral medications as part of this study. patients in the treatment group are evaluated by physical examination, safety laboratory tests, cd4 cell counts, and viral load on day 1 and at weeks 2, 4, 8, and 12 and then every 8 weeks through week 52. patients in the control group are evaluated by physical examination, safety laboratory tests, cd4 cell counts, and viral load on day -1 and at week 12. all patients receive their usual factor concentrate infusion over a 10-minute period on day -1 and at week 12 to estimate factor viii (or ix) recovery and half-life. blood samples are taken prior to infusion and 30 minutes and 1, 3, 6, 9, 12, and 24 hours after infusion. all patients are required to keep a daily log documenting bleeding episodes and use of factor viii (or ix) throughout the study.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are an hiv-positive male. * have been diagnosed with hemophilia. * have been taking clotting factors for hemophilia for at least 6 months. * have been taking a combination of one protease inhibitor plus two other anti-hiv drugs for at least 6 months, or have never taken a protease inhibitor. * are at least 16 years old (consent of parent or guardian required if under 18).

Keywords: drug therapy, combination hiv protease inhibitors indinavir factor viii factor ix half-life reverse transcriptase inhibitors anti-hiv agents platelet aggregation hemophilia a hemophilia b
a prediction model of postoperative anxiety symptom in elderly patients undergoing major noncardiac surgery

Conditions: Predictive Model

Summary: a multicentre, prospective observational study to develop and validate a predictive model for postoperative anxiety symptoms in elderly chinese patients undergoing non-cardiac major surgery.

in 2015, the who introduced the concept of "healthy ageing" for global ageing, with a focus on the mental health of older people at its core. more than 20 million elderly patients undergo surgery each year in china, accounting for a quarter of the population who undergo surgery. previous studies have found high risk of anxiety in older perioperative patients, especially for non-cardiac major surgery patients. therefore, it is necessary to construct a predictive model of anxiety in elderly patients undergoing non-cardiac major surgery.

Eligibility criteria:
inclusion criteria: 1. elderly patients (age ≥ 65 years). 2. undergoing elective surgery with a planned overnight hospital stay following surgery. 3. major non-cardiac surgery, non-neurosurgical surgery. exclusion criteria: 1. history of previous severe mental illness or long-term use of psychotropic medications. 2. immediately admitted to icu after surgery. 3. death within 7 days after surgery. 4. grade of surgery ≤ 2. 5. failure to complete the postoperative anxiety assessment.

Keywords: predicted model major non-cardiac surgery elderly patients anxiety
vaccine therapy in treating patients with stage iib, stage iii, or stage iv colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: vaccines made from peptides may make the body build an immune response to kill tumor cells. purpose: this clinical trial is studying how well vaccine therapy works in treating patients with stage iib, stage iii, or stage iv colorectal cancer.

objectives: * determine whether vaccination comprising her-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (gm-csf), and montanide isa-51 causes an immune response in patients with stage iib, iii, or iv colorectal cancer. * determine the safety of this regimen in these patients. outline: patients receive vaccination comprising her-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (gm-csf), and montanide isa-51 on days 1, 8, and 15. on day 22, patients undergo removal of the lymph node into which the vaccination site drains to determine whether the immune system is responding to the vaccine. projected accrual: a maximum of 15 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of colorectal cancer * stage iib, iii, or iv disease * hla-a2- or -a3-positive patient characteristics: age * 18 and over performance status * ecog 0-1 life expectancy * not specified hematopoietic * absolute neutrophil count \> 1,000/mm\^3 * hemoglobin \> 9 g/dl * platelet count \> 100,000/mm\^3 hepatic * liver function tests ≤ 2.5 times upper limit of normal (uln) renal * creatinine ≤ 1.5 times uln cardiovascular * no new york heart association class iii or iv heart disease other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no known or suspected allergies to any component of the study drug * no active connective tissue disease requiring medications * no systemic autoimmune disease with visceral involvement * no uncontrolled diabetes * no other severe autoimmune disease * no medical contraindication or potential problem that would preclude study compliance prior concurrent therapy: biologic therapy * more than 30 days since prior immunotherapy * more than 30 days since prior growth factors * more than 30 days since prior allergy shots * no prior vaccination with any study peptides for malignancy chemotherapy * more than 30 days since prior chemotherapy endocrine therapy * more than 30 days since prior steroids radiotherapy * more than 30 days since prior radiotherapy surgery * more than 30 days since prior surgery other * at least 30 days, but ≤ 24 months, since prior therapy for colorectal cancer * no concurrent illegal drug use

Keywords: recurrent colon cancer stage iib colon cancer stage iiia colon cancer stage iiib colon cancer stage iiic colon cancer stage iva colon cancer stage ivb colon cancer recurrent rectal cancer stage iib rectal cancer stage iiia rectal cancer stage iiib rectal cancer stage iiic rectal cancer stage iva rectal cancer stage ivb rectal cancer
a phase 2 study of cellular and immunologic changes in the skin of subjects receiving ph-10

Conditions: Psoriasis

Summary: this is a multicenter study of subjects with mild to moderate psoriasis. subjects will apply ph-10 vehicle daily for 28 consecutive days followed by active ph-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites). biopsies of one target plaque will be collected at baseline (at least 7 days prior to first study treatment on day 1) and at days 29 and 64, with a 7-day interval between biopsy at day 29 and commencement of application of application of active ph-10 on day 36. study data from each subject will serve as an internal control (i.e., assessment at baseline and at the end of application of ph-10 vehicle) for assessment of clinical and cellular response to active investigational agent.


Eligibility criteria:
inclusion criteria: * men or women, age 18 or older. * presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas). * at least one target plaque having a minimum diameter of 5 cm (2 inches) with uniform mild to moderate plaque psoriasis. * fitzpatrick skin type i-vi. * written informed consent by the subject or legal guardian. exclusion criteria: * female subjects of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant. * subjects who have received ph-10. * subjects who have received puva or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (14 days for methotrexate). * subjects who have received uvb light therapy within 14 days of study initiation. * subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or vitamin d analogs) to the study plaque areas within 14 days of study initiation. * subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation. * subjects who have participated in a clinical research study within 28 days of study initiation. * subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum. * subjects with clinical conditions that, in the opinion of the investigator, may pose a health risk to the subject because of involvement in the study or detrimentally affect regular follow-up of the subject.
alterations in intestinal mucosal barrier visualized by confocal laser endomicroscopy in liver cirrhosis: a pilot trial (ambic)

Conditions: Liver Cirrhoses

Summary: clinical trial with medical devices. a diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(sbp), which is a complication of liver cirrhosis with ascites.the current recommendation for primary prophylaxis of sbp include a low protein content of the ascitic fluid or a gastrointestinal bleeding. this trial will use the cle (confocal laser endomicroscopy) technic in order to quantify the intestinal permeability in patients with liver cirrhosis and correlate this to the onset of spontaneous bacterial peritonitis.we aim to evaluate a new diagnostic tool (the confocal laser endoscopy(cle) technique -cellvizio- in the setting of endoscopy and defining parameters that are altered in cirrhotic patients of different severity and being at risk of developing a sbp (spontaneous bacterial peritonitis).the parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for time to occurrence of spontaneous bacterial peritonitis. defining a correlation between the quantified loss of intestinal integrity and i) total protein concentration in the ascitic fluid and ii) stadium of liver disease (child class a, b or c)


Eligibility criteria:
inclusion criteria: adult individual (\>18yo) with liver cirrhosis of any cause and healthy controls undergoing elective endoscopy exclusion criteria: * patients younger than \< 18, older than 80 years * pregnant or breastfeeding women * known allergy to fluorescein. * cardiac disease * asthma bronchiale * patients with inability or unwillingness to provide blood samples or samples of ascitic fluid. * patients unable to give informed consent * non-resident patients * contraindication for an endoscopic examination

Keywords: intestinal barrier dysfunction
the applanation tonometry in gca pilot

Conditions: Giant Cell Arteritis

Summary: the applanation tonometry in giant cell arteritis (atom-gca) study will answer the following questions: 1. how does pwv, measured by applanation tonometry of temporal arteries, differ between patients with and without a final diagnosis of gca (based on pre-defined criteria 6 months after inclusion)? 2. what is the diagnostic accuracy and positivity cutoff of the pwv, measured by applanation tonometry, in detecting: 1. a clinical diagnosis of gca (based on pre-defined criteria 6 months after inclusion)? 2. inflammation of temporal arteries on high-resolution ultrasound? 3. what is the acceptability and adherence of repeat applanation tonometry during the follow-up period in patients with gca?

atom-gca is a single-center, cross-sectional vanguard study.

Eligibility criteria:
inclusion criteria: 1. adult patient aged \> 50 years; 2. referred for suspected, new-onset or relapsing cranial gca; 3. ability to understand and willingness to sign a written informed consent form. exclusion criteria: 1. they had a temporal artery biopsy prior to the study visit; 2. they used systemic glucocorticoids for ≥ 14 consecutive days in the previous 30 days.

Keywords: diagnosis
outpatient clinic in obesity care during covid-19 outbreak: physically far, virtually near

Conditions: Bariatric Surgery Candidate; Patient Underwent Bariatric Surgery

Summary: bariatric patients represent a peculiar and frail subset of subjects, constantly increasing. during the novel coronavirus disease outbreak, for the lockdown of any non-urgent and non-oncological activity, the access to healthcare services was severely limited, according to the international federation for the surgery of obesity and metabolic disorders.

the constant and strict follow-up is mandatory in this special subset of patients. therefore, starting from the telemedicine experience in different medical fields, in our bariatric surgery division we designed and started a dedicated project to follow-up obese patients using remote counselling.

Eligibility criteria:
inclusion criteria: * obese adults (\> 18 years of age, bmi\> 40 or \> 35 with comorbidities) older than 18 years * patients undergoing bariatric surgery within 6 months * patients who required clinical and instrumental control * presence of a caregiver in case of subject with cognitive impairment; patients with a history of bariatric surgery who requested a first outpatients access or established patients who requested an outpatients' visit for an emerging problem. exclusion criteria: * virtual visit decline * the internet or smart devices unavailability * need for physical examination or radiological investigations established during a preliminary contact by phone.
evaluation of psa blood levels prior to and after digital rectal examination

Conditions: Prostate Cancer

Summary: patients with know prostate cancer (pca) under active surveillance and aged matched controls without evidence of pca will have a psa blood test prior to and following standardized digital rectal examination

patients with know prostate cancer (pca) under active surveillance (gleason 6, psa \< 10 ng/ml) and aged matched controls without evidence of pca will have a psa blood test prior to and following standardized digital rectal examination. the change of psa will be evaluated.

Eligibility criteria:
inclusion criteria: * males * intact rectum * prostate cancer eligible for active surveillance exclusion criteria: * pror radiation therapy * under androgen deprivation therapy * prior prostate surgery

Keywords: prostate cancer psa digital rectal examination