Kornimate/medical-research-clean huggingface dataset:
scope: observational study of the consequences of the protease inhibitor era

Conditions: HIV Infections

Summary: scope is an observational, prospective study of hiv-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. scope specimens will be used to examine multiple questions involving virologic, immunologic, and host factors involved in hiv-1 infection, progression, non-progression, response to treatment, control of hiv-1 virus, and evolution of drug resistance.

scope is an observational, prospective study of hiv-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. samples from scope will be used to examine: 1. virologic, immunologic, and host factors involved in the natural control of hiv-1 infection (long term non-progression and/or virologic control of hiv-1 without antiretroviral therapy) 2. virologic and immune correlates associated with disease progression 3. evolution of antiretroviral drug resistance 4. factors associated with transmission or acquisition of hiv infection enrolled subjects are seen at san francisco general hospital every four months for a detailed interview, saliva collection, and blood draw. baseline visits take approximately one hour, follow up visits take approximately 20-40 minutes. no personal identifiers are used for specimen bank samples.

Eligibility criteria:
inclusion criteria: scope is currently recruiting hiv-1 infected subjects with any of the following criteria: 1. documented hiv viral load less than 2000 copies/ml without taking antiretroviral therapy 2. undetectable hiv viral load with cd4 t-cells consistently less than 350 for the last 12 months while taking a stable antiretroviral regimen. 3. antiretroviral naive and planning to start an antiretroviral regimen - any cd4 or hiv viral load acceptable. 4. long-term non progressors: hiv-positive at least 10 years, no antiretroviral therapy for the past 10 years or more, any viral load acceptable, cd4-t cell count always above 500. exclusion criteria: 1. active opportunistic infection or systemic treatment for opportunistic infection within the last 4 months (oral candidiasis acceptable) 2. active treatment for cancer 3. active treatment for hepatitis c requiring interferon based therapy 4. immunosuppressive therapy taken within the last 4 months

Keywords: hiv antiretroviral agents drug resistance, multiple long term non progression long term non progressor elite suppression elite suppressor natural history observational
scp vs husls for pelvic organ prolapse repair

Conditions: Pelvic Organ Prolapse; Cystocele; Rectocele; Enterocele

Summary: the purpose of this study is to compare the effectiveness of r-scp versus husls for treatment of pelvic organ prolapse.

to compare the effectiveness of robotic sacrocolpopexy versus vaginal high uterosacral ligament suspension for treatment of pelvic organ prolapse. both surgeries are standard of care and are equally and widely used throughout the country with well known safety and efficacy.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * signed informed consent * symptomatic pelvic organ prolapse, * willing and able to complete all study visit exclusion criteria: * non-high uterosacral ligament suspension (unable to do husls at time of surgery), * dementia or considered unable to complete questionnaires 1. hx of alzheimer disease 2. hx multiple strokes or other neurologic condition 3. caregiver states the subject is unable to complete 4. mds opinion * inability to complete follow up visits due to transportation issues 1. no access to transportation (ie. does not have vehicle) 2. live \> 2 hours from lluh 3. does not have financial means * congenital anomalies 1. bladder exstrophy 2. connective tissue disease 3. neovaginal prolapse 4. prolapse of sex change vagina * chronic pelvic pain 1. \> 6 months of pelvic pain of undetermined origin 2. not cyclic pain (eg. period pain or dysmenorrhea) 3. patient has comorbidities of cpp 4. fibromyalgia 5. interstitial cystitis 6. vulvodynia * contraindications to mesh, 1. opposition to the use mesh (ie. due to religious beliefs) 2. history of mesh complications in past * pregnant or planning to become pregnant during the study period.

Keywords: pelvic organ prolapse cystocele rectocele enterocele
impact of disney movies during chemotherapy on qol of gynecologic oncology patients

Conditions: Ovarian Cancer; Chemotherapy; Quality of Life

Summary: to evaluate the impact of disney movies on quality of life (qol) of gynecologic oncology patients. 25 patients are watching disney movies on portable dvd players during chemotherapy, 25 patients are not allowed to watch tv. eortc qlq-c30 and eortc qlq-fa12 surveys are given to the patients before and after the six chemotherapies. hypothesis: disney movies can elevate patients qol.


Eligibility criteria:
inclusion criteria: * planned 6 cycles of chemotherapy with carboplatin/paclitaxel or carboplatin/pegylated liposomal doxorubicin * age \>18 years exclusion criteria: * inadequate knowledge of the german language
study to assess the efficacy and safety of budesonide (pt008) in adult subjects with mild to moderate persistent asthma

Conditions: Asthma

Summary: study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (bd mdi, pt008) relative to placebo mdi in adult subjects with mild to moderate persistent asthma.

this is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (bd mdi, pt008) relative to placebo mdi in adult subjects with mild to moderate persistent asthma.

Eligibility criteria:
inclusion criteria: * ≥ 18 - 65 years of age * diagnosis of mild to moderate persistent asthma, diagnosed at least 6 months prior to screening * currently receiving treatment with a low to medium dose of an inhaled corticosteroid (ics) or a combination of controller medications for at least 4 weeks preceding screening * pre-albuterol fev1 of \> 60% and \< 85% of predicted normal value * reversibility: increase in fev1 of ≥ 12% and ≥ 200 ml over the pre-albuterol fev1 within 30 - 60 minutes after the inhalation of 4 puffs of ventolin hydrofluoroalkane (hfa) * asthma symptom criteria: have required albuterol use on at least two of the last seven days and have an asthma control questionnaire (acq) total score ≥ 1.5 prior to randomization exclusion criteria: * life-threatening asthma: a subject must not have life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening * worsening of asthma: a subject must not have experienced a worsening of asthma which involved an emergency department visit, hospitalization or use of oral/parenteral corticosteroids within 6 weeks of screening * intermittent, seasonal, or exercise-induced asthma alone: subjects with only intermittent, seasonal or exercise-induced asthma are excluded from participation in this study * concurrent respiratory disease * pregnant women or nursing mothers * a current diagnosis of chronic obstructive pulmonary disease (copd * current smokers or subjects with a \> 10 pack year history of cigarettes, cigars, or pipe smoking * respiratory tract infection within 6 weeks prior to visit 1 * subjects with documented myocardial infarction within a year from screening visit * clinically significant abnormal ecg * abnormal liver function tests defined as aspartate aminotransferase (ast), alanine aminotransferace (alt), alkaline phosphatase or total bilirubin ≥ 1.5 times upper limit of normal on repeat testing * subjects who have cancer that has not been in complete remission for at least 5 years * drug allergy: subjects who have a history of hypersensitivity to any component of the metered-dose inhaler (mdi)

Keywords: mild moderate persistent adult
intraoperative midazolam on delirium outcome of elderly patients

Conditions: Delirium; Anxiety

Summary: this study was a multicenter, randomized, double-blind, placebo-controlled trial to treat elderly surgical patients with low-dose midazolam or placebo for anesthesia induction. the incidence of postoperative 7-day delirium was assessed and compared between two groups, to provide valuable reference for clinical practitioners in the use of midazolam in elderly surgical patients.

this study is a multicenter, randomized, double-blind, placebo-controlled trial. a total elderly patients who underwent elective non cardiac surgery were included in the plan and randomly divided into an intervention group and a control group. the intervention group patients were given 2mg midazolam injection (jiangsu enhua pharmaceutical co., ltd.) during anesthesia induction; the control group patients were given equal volume physiological saline. follow up assessment of postoperative delirium and anxiety will be conducted 1-7 days after surgery, and cognitive function follow-up will be conducted 1 month after surgery.

Eligibility criteria:
inclusion criteria: 1. 65 ≤ age ≤ 85 years old; 2. elective surgery under general anesthesia, with an estimated surgery time of ≥ 2 hours; 3. non cardiac surgery, non neurosurgical surgery; 4. asa grades i-iii; 5. agree to participate and sign the informed consent form; exclusion criteria: 1. preoperative history of comorbidities such as depression and schizophrenia; 2. history of neurological disorders, moderate stroke; 3. long term use of benzodiazepines before surgery; 4. 18.5≤bmi≤30 kg/m2 5. there is cognitive impairment, which is determined based on mini mental state examination (mmse) scores below the standard threshold; 6. there are communication barriers, such as severe dementia, language barriers, and severe hearing or visual impairments; 7. there are any contraindications for the use of midazolam (contraindications for patients with severe respiratory dysfunction, patients with severe liver and kidney damage, patients with sleep apnea syndrome, and patients known to be allergic to benzodiazepines); 8. preoperative severe liver and kidney dysfunction; 9. patients expected to enter the icu after surgery;

Keywords: midazolam delirium anxiety
the arrhythmogenic potential of midwall septal fibrosis in dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: midwall septal fibrosis (msf) is a common structural abnormality in non-ischaemic dilated cardiomyopathy (dcm). its presence is believed to increase the risk of malignant ventricular arrhythmias (va), but the mechanism of arrhythmogenicity is not known. this is particularly relevant in dcm patients with msf and mid-range left ventricular ejection fraction (lvef) as they do not currently fulfil criteria for a primary prevention implantable cardioverter-defibrillator (icd) insertion. access to the epicardium for electrical measurements of the heart can enhance the understanding of arrhythmogenicity in dcm, however direct epicardial access is invasive. instead, the investigators will non-invasively combine high resolution 256-lead ecg imaging (ecgi) and latest generation cardiovascular magnetic resonance (cmr) to study the hearts of 60 dcm patients with and without msf regardless of lvef, and 60 matched healthy volunteers. the investigators recently invented the re-usable and cmr-safe smart-ecgi vest technology for this purpose. using supercomputers, the investigators will fuse the collected ecgi/cmr data and run electromechanical simulations of whole-heart activation to non-invasively measure each participant's personalised risk of malignant va induction. by panoramically mapping the dcm heart in a single beat, the investigators aim to elucidate how msf perturbs the cardiac activation front and how this could lead to life-threatening va. this has the potential to change the method by which cardiologists risk stratify patients with dcm.


Eligibility criteria:
inclusion criteria: * adults with dilated cardiomyopathy * with and without midwall septal fibrosis on previous cmr exclusion criteria: * needle-phobic patients that would preclude cannulation for contrast injection and blood taking * anyone unwilling to consent * anyone with a conventional contraindication for cmr * anyone with any condition precluding full participation in the study such as dcm patients with infarct-pattern lge, or subepicardial lge or non-septal midwall fibrosis (participants with small volume right ventricular insertion point lge will not be excluded).
concurrent chemoradiotherapy using intensity modulated radiotherapy (imrt) & docetaxel-cisplatin (or carboplatin) followed by adjuvant chemotherapy for inoperable stage iii non-small-cell lung cancer

Conditions: Lung Neoplasms

Summary: primary objective: * response rate (by contrast ct scan) secondary objectives: * progression-free survival (pfs) * overall survival (os)

the duration of the study for each patient will include an up to 6-week screening phase, 12 weeks treatment phase (including a resting period of 2 weeks) followed by a long-term follow-up.

Eligibility criteria:
inclusion criteria: * pathologically proven locally advanced, inoperable, confirmed by pet scan (thorax/ upper abdomen) to be international stage iii (2009) nsclc and without multifocal tumours in the lung * disease volume encompassible within a tolerable planning target volume treated to 66 gy * fev1 (force expiratory volume in 1 second) \>1000 ml * hemoglobin ≥ 9.0 g/dl * absolute neutrophil count (anc) ≥ 1,500/mm3 * platelet count ≥ 100,000/mm3 * total bilirubin ≥ 1.5 times the upper limit of normal * alt (alanine aminotransferase) and ast (aspartate transaminase) ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for patients with liver derangement) * ecog (eastern cooperative oncology group) ps 0-1 exclusion criteria: * previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents * inadequate lung function (exercise tolerance less than 1 fos/fight of stairs, fev1 \< 1 l/sec, or raised pco2) * history of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80 * pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry * participation in a clinical trial with any investigational drug used and within 30 days prior to study entry the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
macular involvement in diabetic retinopathy evaluated with swept-source oct

Conditions: Diabetes Mellitus; Diabetic Retinopathy

Summary: this study evaluates micro-vascular changes in patients with diabetes. results of diseased retinas will be compared to healthy controls.

the prevalence of diabetes mellitus (dm) is increasing worldwide. diabetic retinopathy is the most prevalent complication of dm and a leading cause of visual impairment due to closure of capillaries. high-resolution imaging techniques of the retina and its supplying vascular networks can allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. in this study capillary changes of patients with different severity levels of diabetic retinopathy will be investigated with non-invasive imaging technology to better understand the process of disease progression. imaging will be done with optical coherence tomography (oct) angiography as well as spectral domain oct and ultra wide-field imaging.

Eligibility criteria:
inclusion criteria: * age ≥18 participants can have 1 or 2 study eyes patient group: * diabetes mellitus type 1 or 2 * study eye with any dr severity level: no dr, mild npdr, mod npdr, sev npdr, pdr exclusion criteria: * substantial media opacities that would preclude successful imaging * active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye * structural damage to the center of macula in the study eye * history of prior panretinal photocoagulation * history of treatment with intravitreal agents over the prior 6 months * macular edema involving the central subfield * prior history of vitrectomy * atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (faz) or organized hard exudate plaques * substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies * intraocular surgery (including cataract surgery, yag laser capsulotomy) in the study eye within 3 months preceding day 0, or history of corneal transplantation in the study eye * uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmhg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery * inability to obtain fundus images of sufficient quality to be analyzed and graded
enhancing synaptic plasticity and cognition in schizophrenia

Conditions: Schizophrenia

Summary: to explore: (a) if physical exercise (sports) combined with cognitive training leads to (superior) improvement of cognition in schizophrenia compared to sports or cognitive training alone (b) if a sports program alone or in combination with cognitive training has influence on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo condition.


Eligibility criteria:
inclusion criteria: * male and female patients with the diagnosis of schizophrenia (based on icd-10 criteria) * age between 18 and 55 * verbal iq ≥ 85 * stable psychopathology on constant medication for 2 weeks * informed consent. exclusion criteria: patients, who are * not willing or able to participate in the sports program and cognitive training * reveal a significant worsening of psychopathology (based on an increase over 20% of the panss positive score) * have an organic mental disorder (such as intoxication or neurological disorders of the cns) * suffer from instable somatic diseases * have an active substance abuse

Keywords: schizophrenia negative symptoms cognitive deficits synaptic plasticity
stroke cincinnati prehospital stroke severity scale evaluation in prehospital

Conditions: Stroke

Summary: the effectiveness of acute ischemic stroke (ais) management has improved considerably in recent years with thrombolysis and more recently with mechanical thrombectomy (mt). currently, mechanical thrombectomy can only be performed in stroke unit with an interventional neuroradiology center by experienced/qualified interventional neuroradiologists. in the rhone area, only one hospital has the authorization to perform mechanical thrombectomy. therefore, transferring directly eligible acute ischemic stroke patients for mechanical thrombectomy to this center constitutes an important stake of the triage of suspected acute ischemic stroke patients. some validated scores for the identification of severe strokes and large vessel occlusion, including the cincinnati prehospital stroke severity scale (cpsss), appear to be relevant for pre-hospital use in order to identify patients potentially eligible for mechanical thrombectomy and address them to a stoke unit with interventional radiology center.


Eligibility criteria:
inclusion criteria: * consecutive patients calling emergency medical services for suspected acute ischemic stroke exclusion criteria: * symptom onset (or the last time the patient was seen without deficit ) of more than 6 hours
fermented milk on the appearance of common winter infectious diseases

Conditions: Acute Gastroenteritis; Upper Respiratory Tract Infections

Summary: respiratory and gastrointestinal infections are common in children under the age of 4 years, especially after the start of schooling. these conditions are facilitated by a still incomplete functional maturation of the immune system and the anatomical structure and function of the respiratory and gastrointestinal tract still developing. the frequency and duration of these conditions involves a high discomfort and significant costs, in relation to medical appointments, taking medication, the need for hospitalization, days of absence from school and work days lost by parents. functional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. several products have been investigated, with sometimes conflicting results. diversity in experimental designs, populations evaluated, and bacterial strains used in the preparation of fermented products are probably responsible for these discrepancies. recently we started a study approved by the ethics committee for biomedical activities "carlo romano" of the university of naples "federico ii" (protocol number 210/12) to evaluate the effectiveness of foods fermented with lactobacillus paracasei cba-l74 in the prevention of common winter infections in school children aged between 12 and 48 months. studies of pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain lactobacillus paracasei l74-cba in terms of stimulation of the production of the cytokine il-10 and decreased synthesis of il-12, also in response to stimulation with salmonella typhimurium. the data were obtained in in vitro studies on dendritic cells and ex vivo intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental colitis. a preliminary analysis of the data was found that subjects treated with fermented milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract infections or gastrointestinal, with a statistically significant difference between the study groups. it was also observed a significant increase in the levels of α- and β- defensins, ll-37 and secretory iga in the group of subjects treated with fermented milk compared to subjects treated with fermented rice or placebo. therefore, we decided to extend the period of study of five additional months, in order to perform an evaluation of the effectiveness of fermented milk (which was more effective)vs placebo.


Eligibility criteria:
inclusion criteria: * children aged 12-48 months attending educational program (either at nursery or primary school) exclusion criteria: * concomitant chronic/congenital diseases and disabilities * active tubercolosis * congenital cardiac defects * autoimmune diseases * immunodeficiency * cystic fibrosis * metabolic diseases * malignancy .chronic pulmonary diseases * malformation of he gi tract * food allergy * antibiotic use * pre/pro/symbiotic use * severe wasting (less than 3 standard deviations of weight-for-height z score)