Kornimate/medical-research-clean huggingface dataset:
incidence and prognostic implication of acute cv events in patients hospitalized for cap in internal medicine units.

Conditions: Cardiovascular Events

Summary: fadoi-icecap is a observational, prospective, multicenter study involving 20-25 nationwide units of internal medicine. the study foresees the participation of 26 internal medicine operative units, and for each of them a prospective registration of data relative to at least 50 patients admitted with cap (in total, at least 1300 evaluable subjects) is foreseen.

phase 1 - patients enrollment (october 2016 - february 2018) each investigator have recorded data concerning 50 patients. it will be collected general characteristics of patients, clinical parameters and conditions, diagnostic imaging and blood tests, phase 2 - database review and validation (april 2018 - october 2018) the data collected will be analysed to process the endpoints.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. diagnosis of pneumonia defined by the presence on chest x-ray or ct-scan of lung of new infiltration associated with at least two of the following clinical features: * fever \> 37.8°c * typical symptoms (dyspnea, productive cough, pain) * typical clinical signs on chest examination (crepitation, bronchial breathing, pleural effusion) * leukocytosis exclusion criteria: * patients with hospital-acquired pneumonia (hap) (i.e. those patients with pneumonia acquired in hospital more than 48 hours after admission) * patients with tuberculosis in active phase * patients with cystic fibrosis * patients who refuse to participate in the study and/or to give the written informed consent.

Keywords: community-acquired pneumonia (cap)
immunological and viral response to antiretrovirals in hiv patients with cd4 cell count below 100

Conditions: HIV Infections

Summary: the study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with cd4 \< 100/mm3, when they receive treatment with two nucleoside analogs (nrti) plus one protease inhibitor (pi) compared with 2 nrti plus one non-nucleoside (nnrti).


Eligibility criteria:
inclusion criteria: * diagnosed hiv-1 infection. * age 18 years or over. * no previous antiretroviral therapy. * cd4 lymphocyte count of \< 100 cells/ml. * patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study. exclusion criteria: * pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period. * currently undergoing treatment for an opportunistic infection (parenteral administration). * any formal contraindication to treatment with the study drugs

Keywords: treatment naive
methotrexate (rheumatrex) high dose special investigation (regulatory post marketing commitment plan)

Conditions: Arthritis; Rheumatoid; High Dose

Summary: this investigation is to be performed for the purpose of assessing the following information in the long-term post-marketing daily medical practice in the patients who receive reumatolex 2 mg capsule for the treatment of rheumatoid arthritis (ra) at the dose higher than 8 mg/week. 1. condition of occurrence of adrs 2. factors considered to affect safety 3. verification of efficacy

implemented as a special investigation by central registration system

Eligibility criteria:
inclusion criteria: * patients need to be administered rheumatrex in order to be enrolled in the survey * patients who receive the rheumatrex at the dose higher than 8 mg/week for the treatment of rheumatoid arthritis exclusion criteria: * patients who have been treated with rheumatrex at the dose higher than 8 mg/week since the days when the high dose therapy for ra was not approved * patients who have been treated mtx other than rheumatrex administered rheumatrex

Keywords: rheumatrex high dose
comparison of walking in water and on land in people with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate the metabolic load during a single session of moderate intensity walking in water compared to walking on land (over-ground) in people with chronic obstructive pulmonary disease (copd) who are normal weight and obese, compared with peak exercise metabolic response. the hypothesis is that the metabolic load of walking at a moderate intensity in water will be greater than walking on land.


Eligibility criteria:
inclusion criteria: * diagnosis of copd (fev1/fvc \<0.7) in a clinically stable state (no acute exacerbation of copd within the previous 4 weeks) * accepting of walking in water * bmi \>/= 21 kg/m2 exclusion criteria: * long-term oxygen therapy * contraindications to entering a hydrotherapy pool

Keywords: hydrotherapy walking
delivery of polyphenols in gum as an anti-caries agent

Conditions: Dental Caries

Summary: the short-term effects of chewing gum containing xylitol and/or blackberry extract on oral microbiota was studied. fifty healthy adults participated in a randomized, placebo-controlled, cross-over design study.

the short-term effects of chewing gum containing xylitol and/or blackberry extract on oral microbiota was studied. fifty healthy adults participated in a randomized, placebo-controlled, cross-over design study. one group chewed 1 piece of xylitol-containing chewing gum 4 times/day and the other chewed 1 piece of bbe+xylitol-containing gum 4 times/day. all wore a custom stent with a sterile enamel chip luted to the facial surface during the 1-day experiment. unstimulated saliva was collected at 8 am and 4 pm, and enamel chips were harvested at 4 pm. a week later participants chewed gum from the other group. the bacterial composition in saliva and on the enamel chips were assessed using real-time pcr.

Eligibility criteria:
inclusion criteria: * systemically healthy, had 20 or more natural erupted teeth, and had gingivitis (bleeding on probing \[bop\] in more than 15% of sites, less than 25% sites with \> 4 mm probing pocket depths (ppd), and less than 5% sites with 5 mm depth ppd, who were a non-smoker, willing to participate, and verbally understood and signed an informed consent prior to enrollment exclusion criteria: * unable or unwilling to provide informed consent or follow study protocol, current smoker, systemic condition including diabetes mellitus, liver disease, kidney disease, autoimmune disease, and any cardiovascular condition that would require premedication prior to dental treatment, use of systemic antibiotics within three months of study entry, use of over the counter or prescription medications known to have anti-inflammatory/immunosuppressant activities (e.g., nonsteroidal anti-inflammatory drugs (\>14 day use in past 3 months), steroids, vitamin supplements, statin drugs, topical chlorhexidine on a daily basis, pregnancy as diagnosed by administered of a pregnancy test, cancer or cancer therapy within the last year, immunosuppression (e.g., organ transplant), orthodontic therapy (current or within the last 6 months), inability to communicate verbally or in writing, clinically detectable oral mucosal inflammatory condition (e.g., aphthous, lichen planus, leukoplakia, oral cancer), or febrile illness, persistent cough or current infectious condition (e.g., influenza, hepatitis), or any ppd of 6 mm or greater at the time of the baseline periodontal examination.
safety and efficacy of radio-immunotherapy (rit) for patients with relapse or refractory acute lymphoblastic leukaemia (all) b cd22+

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to determine whether fractionated rit with epratuzumab and radiolabeled epratuzumab are effective in the treatment of relapsing or refractory all.


Eligibility criteria:
inclusion criteria: * age 18-70 years * b-all (oms) with \>=20% of blasts in bone marrow * cd22+ expression \>=70% of the blast population * all previously treated all patients who have experienced relapse or treatment failure * at least 15 days since previous treatment * performance status 0 - 2 * creatinine clearance \>= 50 ml/min (cockroft formula). * serum bilirubin \<= 30 mmol/l * written informed consent exclusion criteria: * t-all * meningeal involvement * cd22 expression on tumor cells or \< 70% * hiv positive * active hepatitis b or c * active infection within 7 days of starting treatment * left ventricular ejection fraction \< 50%. * contra-indication to 90y-dota-hll2 * previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * participation at the same time in another study in which investigational drugs are used * absence of written informed consent

Keywords: patient with relapsing or refractory cd22+b-acute lymphoblastic leukemia (all)
dual-plane breast augmentation: axillary approach with assistant of endoscope

Conditions: Mammoplasty

Summary: the purpose of this study is to evaluate the feasibility and outcome of performing dual plane breast augmentation with assistant of endoscope by axillary approach.

dual plane augmentation mammoplasty is a logical approach to realize the benefits of retromammary and partial retropectoral implant placement while minimizing the tradeoffs of other pocket locations. traditionally, dual plane augmentation has been performed using transareolar or inframammary fold approach. however, the approach is unacceptable to chinese patients because of the front scar formation. for aesthetic reasons, the axillary incision is more acceptable approach for augmentation mammoplasty. the endoscope assistant technique has been widely used in transaxillary breast augmentation. it provides the feasibility to perform dual plane breast augmentation by axillary approach. in this research, at least 40 patients with light degree of glandular ptotic and constricted lower pole breasts are selected to receive soft cohesive gel microtextured anatomic style silicone implants. portions of the pectoralis major muscle is split without its release from the costal margin with the help of a 10mm, 30°endoscope and endoscopic diathermy scissors through a 4-cm incision in the axilla each side. bleeding during surgery is kept to the minimum. the results of outcomes, operative time, bleeding volume, drainage volume, complications are observed.

Eligibility criteria:
inclusion criteria: * all women who want breast augmentation using the implants.especially for the patients with * glandular ptotic (\< i degree) breasts * thick soft tissues (\> 10 mm) in the low pole of the breast exclusion criteria: * with thin soft tissues (\< 9 mm) in the low pole of the breast

Keywords: augmentation mammoplasty dual plane endoscope transaxillary incision
investigations of reproductive cancers in women

Conditions: Uterine Cancer

Summary: the goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.


Eligibility criteria:
inclusion criteria: 1. evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study. 2. willing and able to comply with scheduled visits, study plan, and other procedures. 3. expected to be available for the duration of the study and can be contacted by telephone during study participation. 4. females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50). 5. presence of uterus. 6. aub or pmb being worked up to diagnose the cause of the bleeding exclusion criteria: 1. investigator site staff members directly involved in the conduct of the study and their family members or subjects who are pinkdx, inc. employees or their family members. 2. other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the investigator. 3. women who have had a hysterectomy. 4. women with a known history of endometrial cancer or uterine sarcoma. 5. women who have received prior treatment for endometrial cancer. 6. inability or unwillingness to sign informed consent. 7. clinical suspicion of pregnancy. 8. women who have used a tampon within 7 days of sample collection.
impact of 3d-planimetry on optimized therapeutic assessment in complex benign esophageal stenosis

Conditions: Benign Esophageal Stricture

Summary: esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health. for benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines. since the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult. therefore, the aim of this study is to compare the effect of 3d-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.


Eligibility criteria:
inclusion criteria: * symptomatic benign esophageal stenosis * medical indication for endoscopic therapy * written consent after detailed information exclusion criteria: * non-benign esophageal stenosis * missing written consent * trans-oral endoscopic access is not possible * medical contraindication for endoscopic dilatation therapy * age \<18 years
efficacy and safety study of meditoxin® to treat essential blepharospasm

Conditions: Essential Blepharospasm

Summary: the purpose of this study is to evaluate the efficacy and safety of meditoxin® in the treatment of essential blepharospasm.


Eligibility criteria:
inclusion criteria: * men and women aged above 18 * subjects who was diagnosed with essential blepharospasm * subjects who voluntarily signed written informed consent * subjects who can adhere to protocol and study requirements exclusion criteria: * subjects with known history of allergy considered due to botulinum toxin type a * subjects who have received botulinum toxin a type within 3 months * any disease that might affect neuromuscular function (e.g.. myasthenia gravis, lambert-eaton syndrome, amyotrophic lateral sclerosis ect.) * subjects who are participating in other clinical trials * pregnant or lactating female subjects * subjects who are not eligible for the study at the discretion of the investigator.
transoral robotic surgery (tors) for oral and laryngopharyngeal lesions using da vinci robotic surgical system

Conditions: Head and Neck Neoplasms

Summary: the purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (tors) for oral and laryngopharyngeal benign and malignant lesions using the da vinci robotic surgical system.

patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a quality of life survey (head and neck cancer inventory, hnci-qolq).

Eligibility criteria:
inclusion criteria: * patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx) * patients must have adequate transoral exposure of the oral cavity and laryngopharynx for tors instrumentation exclusion criteria: * unexplained fever and/or untreated, active infection * patient pregnancy * previous head and neck surgery precluding transoral/robotic procedures * the presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
short-term sugary beverage consumption on glucose control and cardiovascular disease risk factors

Conditions: Metabolic Syndrome

Summary: our goal is to determine how the addition of sugar-sweetened beverages to the diet affects glucose control, cardiovascular disease risk factors, and pulmonary function in healthy, young adults.

in a 3-arm randomized controlled trial, 36 participants consumed one of three beverages for three weeks: water (w), caffeine-free soda (s), or 100% fruit juice (fj). participants consumed two servings/day (\~710ml) of their randomized beverage for three weeks, along with their habitual diets. at baseline and following the 3-week intervention, participants completed glucose control, cardiovascular disease risk factor, and pulmonary function assessments.

Eligibility criteria:
inclusion criteria: * free from diagnosis of diabetes and pulmonary illness * have no intake of glucose or lipid lowering medication. exclusion criteria: * smoke * currently pregnant * have bronchitis * have more than 2 risk factors for cardiovascular disease, as defined by the american college of sports medicine (acsm).

Keywords: glucose control cardiovascular disease risk factors sugary beverages pulmonary function
measuring health related quality of life in veterans with stroke

Conditions: Stroke; Quality of Life; Rehabilitation

Summary: approximately 11,000 veterans annually are hospitalized with a newly acquired incident stroke. based on american heart association ratios of stroke incidence and prevalence, up to 80,000 veterans may be stroke survivors. the assessment of outcomes in stroke survivors is important for clinical practice and research, yet there is no consensus on the best measures of stroke outcome in either clinical practice or research. we have developed a new stroke-specific outcome measure, the stroke impact scale (sis), to capture physical function and other dimensions of health-related quality of life.

background: approximately 11,000 veterans annually are hospitalized with a newly acquired incident stroke. based on american heart association ratios of stroke incidence and prevalence, up to 80,000 veterans may be stroke survivors. the assessment of outcomes in stroke survivors is important for clinical practice and research, yet there is no consensus on the best measures of stroke outcome in either clinical practice or research. we have developed a new stroke-specific outcome measure, the stroke impact scale (sis), to capture physical function and other dimensions of health-related quality of life. objectives: the major research questions in this investigation are: 1) does the sis have concurrent and discriminate validity in a veteran stroke population when compared to the fim, rankin, and the sf-36v? 2) what effect does mode of administration have on response rates, bias, data quality, reliability and validity, sis domain scores, and cost of data collection? 3) what factors differentiate responders and non-responders? 4) will the sis scores predict health care costs and utilization? methods: using icd-9 discharge codes and electronic medical records, patients were screened for a valid diagnosis of stroke. at three months post-stroke, patients were randomly assigned to receive a mailed sis instrument or sis via telephone interview. at four months post-stroke, all respondents were evaluated using the functional independence measure and sf-36v by telephone. status: completed.

Eligibility criteria:
inclusion criteria: no exclusion criteria. exclusion criteria: no exclusion criteria.
study to evaluate the safety and initial effectiveness of the sinusway™ for endoscopy of sinuses in conjunction with bsd

Conditions: Sinusitis

Summary: 3nt flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures

the rationale behind this feasibility study is to show that access and visualization of the nasal anatomy and paranasal sinuses (maxillary, frontal and sphenoid sinuses) in conjunction with balloon sinus dilation in patients suffering from symptoms attributable to sinusitis is feasible in the office and operating room settings; this is an essential step in the development of a combined dilation and visualization system that will allow visualization, dilation and lavage of the sinuses via their natural ostia during an office visit, and minimize radiation exposure, antibiotic use, multiple office visits, and cost.

Eligibility criteria:
inclusion criteria: 1. male or female patient indicated for balloon sinus dilation procedure by the ent specialist 2. patient age: adult (\>18 years old) 3. patients in general good health in the opinion of the investigator as determined by medical history and physical examination 4. a patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent exclusion criteria: 1. known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation 2. patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic coumadin treatment)

Keywords: endoscopy, bsd
inhibitor: retrospective study of patients with renal cell carcinoma and mantle cell lymphoma treated with temsirolimus

Conditions: Carcinoma, Renal Cell; Lymphoma, Mantle-Cell

Summary: the principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with renal cell carcinoma and mantle cell lymphoma.

there is not sampling method

Eligibility criteria:
inclusion criteria: patients with renal cell carcinoma or mantle cell lymphoma that have been treated with temsirolimus as per clinical practice. exclusion criteria: patients that do not have a minimum (pre-specified) of data in their clinical record.