Kornimate/medical-research-clean huggingface dataset:
educational intervention in heart failure patients

Conditions: Heart Failure

Summary: the main aim of this randomized study was to evaluate the effect of educational intervention on patients with heart failure and their care-giver with regard to patients' prognosis.

part i: this is a multicenter study on the effect of educational intervention on heart failure patients and their caregivers with respect to patients' prognosis, social support and quality of life. subsequent patients with heart failure (based on the inclusion criteria) coming to selected, ambulatory physician, were randomized to either a control or intervention group. both groups underwent questionnaire evaluation regarding clinical assessment and evaluation of familiarity with aspects of heart failure along with social support and quality of life. clinical assessment included information on demography, social status, medical history, pharmacotherapy, diagnostic procedures, and utilization of health system resources. after recruitment, patients from intervention group and their caregivers underwent one educational training, during which they received materials on the management of heart failure. before the meeting, data on familiarity with heart failure were acquired from patients' relatives. during further follow up all participants stayed under regular care from their ambulatory physicians. after 6 months patients underwent short term evaluation based on designated questionnaires, with special attention paid to hospitalization and ambulatory visits due to heart failure. also data on heart failure knowledge, social support and quality of life was collected. without any further intervention, follow up was continued. next long term assessment was undertaken after approximately 3 years from the recruitment. as previously patients fulfilled questionnaires regarding information on their familiarity with heart failure management and social support as well as quality of life. primary end points of the study were: death, hospitalization (including cardiovascular hospitalizations) and ambulatory visits. secondary end points included social support and quality of life. sub-study: genetic polymorphism - blood specimens collected during one of the visits and stored for further evaluation in future. study population - all main study participants who gave their informed consent to this part of protocol. aims: to describe the potential of selected genes candidates polymorphism on the heart failure prognosis and survival in patients nyha class ii-iv.

Eligibility criteria:
inclusion criteria * symptoms of heart failure * ef \< 45% (during past 2 years) or abnormal ecg and chest x-ray when echo unavailable * age \> 18 years * signed informed consent exclusion criteria: * severe copd * serious comorbidities, influencing life expectancy or quality of life * alcohol and drug addict * post mi less than 6 months * dementia * living in home nursing facilities

Keywords: heart failure education non-pharmacological management prognosis
bronchospasm associated with high nitric oxide

Conditions: Asthma; Airway Hyperresponsiveness

Summary: intraoperative bronchospasm challenges anesthesia's safety. this study aims to investigate high concentration of exhaled nitric oxide as a marker of intraoperative bronchospasm.

previous studies in asthmatic patients suggested that exhaled nitric oxide may represent a noninvasive measure for airway inflammation. anesthesia information forms from 1999 throughout 2004 were revised (n=146.358). bronchospasm occurrence appeared registered on 863 forms. from those, nine were identified as non-asthmatics patients (bronchospasm group). also, 12 asthmatics constituted one additional group (asthma group) and 10 subjects with no previous airway disease or symptoms (control group). all subjects were submitted to exhaled nitric oxide measurements (parts/billion), spirometry and induced sputum.

Eligibility criteria:
inclusion criteria: * patients with no systemic disease and registered bronchospasm during anesthesia induction exclusion criteria: * hypertension, copd, diabetes, pregnancy

Keywords: nitric oxide bronchospasm anesthesia induced sputum asthma
bartonella in liver transplant patients

Conditions: Cryptogenic Cirrhosis; Cryptogenic Chronic Hepatitis

Summary: approximately 20 volunteers who have received a liver transplant and have been diagnosed with cryptogenic cirrhosis will be included in this study. blood, skin and urine samples will be analyzed for bartonella spp..

approximately 20 volunteers who have received a liver transplant and have been diagnosed with cryptogenic cirrhosis will be included in this study. blood samples will be analyzed for bartonella using the state-of-the art bartonella alpha proteobacterium growth medium (bapgm) multi-platform testing, including liquid culture, enriched agar plating and molecular techniques. blood smears will be analyzed for intra-erythrocytic bartonella spp. four-millimeter skin biopsies from non-lesional skin will be acquired from the same patients, processed using our published techniques, and imaged using confocal microscopy and compared to bapgm test results. additionally, urine samples will be collected and analyzed for micrornas.

Eligibility criteria:
inclusion criteria: * o male and female subjects, ages 18 years and older * liver transplant recipient * diagnosis of cryptogenic cirrhosis * signed consent form exclusion criteria: * none

Keywords: cryptogenic chronic hepatitis bartonellosis
cervical motor control in long-term breast cancer survivors

Conditions: Breast Neoplasms

Summary: the aim of this study will be to determine the effectiveness of a physical therapy program which is based on cervical motor control exercises in long-term breast cancer survivors in order to improve their motor control and its possible impact on pain, mood state and quality of life.

background: breast cancer is becoming a common disease; however survival rates have improved throughout the last years. as a result, this also means that breast cancer survivors suffer side effects concerning the disease itself and treatments, as it is the case of certain kinds of pain. it is known that 80% of breast cancer survivors suffer this even 5 years after the completion of treatment and this impairment can be associated with a high tendency towards depression, cardiorespiratory deconditioning and even altered cervical control motor. aim: to determine the effectiveness of a physical therapy program based on cervical motor control training in order to improve motor control, mood state and quality of life. methods: fifty-two long-term breast cancer survivors will be allocated to experimental group (n=26) or control group (n=26). the experimental group will receive a nine-week tailored exercise training focused on cervical motor control. discussion: there is a lack of knowledge about effective interventions when it comes to deal with altered motor control pattern of cervical area in long-term breast cancer survivors. therefore, it is necessary to study the impact of this novel approach to improve quality of life in this population.

Eligibility criteria:
inclusion criteria: * to be over 18 years old * have passed a period equal o more 5 years since breast cancer diagnosis * have diagnosis of stage i, ii or iiia breast cancer * have signed informed consent * have medical clearance for participation * inability to get level 2 in the craniocervical flexion test exclusion criteria: * have diagnosis of arthritis or fibromyalgia * have cancer recurrence * have been operated through previous surgery of cervical column * to be taking any treatment for pain or altered motor control during last 12 months

Keywords: breast cancer long-term survival motor control cervical pain
exploration of the functional effect of different hearing aid noise reduction algorithms in an ecologically valid conversational situation

Conditions: Hearing Loss

Summary: a methodical evaluation of sound changing principles in ce-labelled sonova brand hearing instruments (e.g. phonak hearing instruments) is intended to be conducted on hearing impaired participants. these sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. the aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (phase of development). objective laboratory measurements as well as subjective ratings will be carried out. this will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at sonova ag headquarter based in stäfa.


Eligibility criteria:
inclusion criteria: * good written and spoken german language skills * no suffering from any speech disorders * experienced hearing aid user (min. 6 months) * ability to stand and walk during the experiment * ability to fill in a questionnaire conscientiously * ability to produce a reliable hearing test result * ability to describe listening experiences/impressions * the audiogram is in the fitting range of the hearing aid * the audiogram is in the range of mild to moderate hearing losses (n2 - n4) * hearing loss in both ears * informed consent form exclusion criteria: * contraindications to the medical device * unaidable hearing loss in one or both ears * acute tinnitus (in either one ear and occurrence for less than 3 months) * anatomical deformity of one or both ears * single-sided deafness * unwillingness to wear the investigational device during the investigational visits * active pacemaker implant * ear canals are too narrow to take ear impressions * ear canals are too narrow for the use of customized earpieces * uncomfortable loudness threshold less than 80 db for at least one measured frequency * known hypersensitivity or allergy against synthetic materials * acute symptoms of vertigo or dizziness * reported parkinson's disease
the healthy life choices project in hiv-positive patients

Conditions: Diarrhea; HIV Infections

Summary: this randomized clinical trial is designed to determine the efficacy of a dietary intervention to reduce the frequency of bowel movements and improve stool consistency as compared with subjects assigned to a control group. the study enrolled hiv patients with a history of three or more episodes of diarrhea for 3 weeks or more. the purpose of this study was to compare the efficacy of a combined behavioral dietary intervention using normal foods (condition 1: treatment) with hiv self-care (condition 2: control) to reduce the frequency and improve the consistency of bowel movements after 3 weeks and 24 weeks of study intervention.

thirty to fifty percent of individuals with hiv can be expected to have diarrhea at some point during their illness. diarrhea can be a chronic condition in hiv disease wherein three or more daily episodes of loose, watery stools are experienced for 4 weeks or more. chronic diarrhea has been associated with significant morbidity, weight loss, and severe malnutrition. researchers have reported that patients with chronic diarrhea experience a marked decrease in quality of life in comparison with hiv patients without diarrhea. the goal of nutrition management for patients with chronic diarrhea is to ensure that adequate caloric consumption meets the metabolic needs of such individuals and to provide symptomatic relief. hiv infection, regardless of stage, causes an increase in resting energy expenditure because of the response of the body to the viral infection. proper nutrition management can therefore assist in preventing further nutritional imbalances.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosed with hiv or aids based on the centers for disease control and prevention criteria * experienced a minimum of three episodes of loose, watery, or liquid stools in a 24-hour period for at least 3 weeks * provide verification from their primary care provider of hiv status, chronic diarrhea history, documentation of medical evaluations completed * laboratory confirmation that stool samples were negative for pathogens * patients who were taking antidiarrheal agents were required to be on a stable regimen (same drug, dosage, and frequency) for at least 7 days before entry into the study and still meet diarrhea frequency and consistency criteria * antiretroviral agents taken to manage hiv required a stable regimen (same drugs, dosage, and frequency) for at least 8 weeks before study entry * patients were required to complete a mini-mental state examination, obtaining a score of 24 or higher exclusion criteria: * not meeting any of the above criteria

Keywords: complementary therapies behavior therapy diarrhea diet therapy food hiv seropositivity
individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy. a prospective multicenter randomized controlled trial.

Conditions: Ventilator Lung

Summary: prospective multicenter randomized controlled trial. individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy.


Eligibility criteria:
inclusion criteria: * adult men and women ≥18 years of age who underwent emergency laparotomy with the presence of post-induction positive air-test (spo2 \<97% after a maximum of 15 minutes at fio2 of 0.21). a spo2 \<97% at any fio2 would also be considered a positive air-test. exclusion criteria: * 1) pregnancy or breast feeding, 2) moderate or severe ards defined, 3) refractory shock, 4) diagnosis or suspected intracranial hypertension (\>15mmhg), 5) mechanical ventilation in the last 15 days (including cpap), 6) presence of pneumothorax or giant bullae in a chest radiograph or computed tomography (ct), 7) patients participating in another intervention study with the same or similar primary outcome variable.
evaluation of the automated integration of a robotics and ecochg system for use with cochlear implant surgery

Conditions: Hearing Loss, Sensorineural; Cochlear Implantation

Summary: evaluation of the automated integration of a robotics and ecochg system for use with cochlear implant surgery

the purpose of this study is to evaluate the feasibility and proof of concept of the integration of the aim system and iotasoft insertion system during cochlear implantation. study results will help inform the need for future clinical investigations and data collection in the area of ecochg and robotic-assisted cochlear implantation.

Eligibility criteria:
inclusion criteria: 1. cochlear implant candidate in one or two ears per current fda indications 2. sufficient residual hearing to support use of electrocochleography, as determined by the investigator 3. cochlear implantation using the advanced bionics slimj electrode array 4. 18 years of age or older at the time of enrollment 5. willingness to participate in and comply with all requirements of the protocol exclusion criteria: contraindications for a ci. 2. prior cochlear implantation in the ear to be implanted. 3. cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion. 4. history of temporal bone fracture that involves the cochlea/internal auditory canal. 5. retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway). 6. active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease. 7. planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation. 8. additional medical concerns that would prevent participation in evaluations as determined by the investigator. 9. unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device. 10. vulnerable subject, as per fda regulations 21 cfr parts 50 and 56

Keywords: cochlear implantation sensorineural hearing loss robotics
a study of the effect of zinc-hyaluronate on ocular surface sensations in patients with dry eye

Conditions: Dry Eye

Summary: hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can already be found in several artificial tears recommended to alleviate symptoms of dry eye. a recent hyaluronate modification involves zinc-hyaluronate complex formation by adding zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular structure, which functions as both a mechanical barrier and a biocompatible film on the ocular surface. apart from its beneficial elastoviscous characteristics, previous results indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor endings underlying pain. although hyaluronate is widely used in artificial tears to improve tear film stability, its effect on ocular surface sensitivity was not evaluated in patients with dry eye. the aim of this study is to investigate the characteristics of ocular surface sensations and corneal sensitivity in dry eye patients before and after long-term tear supplementation with zinc-hyaluronate.


Eligibility criteria:
inclusion criteria: * patients who had been diagnosed as having dry eye symptoms for at least 3 months, with an osdi score of ≥13 evaluated by the questionnaire of ocular surface disease index (osdi) exclusion criteria: * subjects with ophthalmic conditions other than dry eye or systemic disease including blepharitis, meibomitis, lid abnormalities as well as contact lens wearers
assessment of patient-ventilator asynchrony by electric impedance tomography

Conditions: Acute Lung Injury

Summary: patient-ventilator asynchrony (pva) has deleterious effects on the lungs. pva can lead to acute lung injury and worsening hypoxemia through biotrauma. little is known about how pva affects lung aeration estimated by electric impedance tomography (eit). artificial intelligence can promote the detection of pva and with its help, eit measurements can be correlated to asynchrony.

patient-ventilator asynchrony (pva) is a common phenomenon with invasively- and non-invasively ventilated patients. pva has deleterious effects on the lungs. it causes not just patient discomfort and distress but also leads to acute lung injury and worsening hypoxemia through biotrauma. the latter significantly impacts outcomes and increases the duration of mechanical ventilation and intensive care unit stay. however, pva is a widely investigated incident related to mechanical ventilation, though little is known about how it affects lung aeration estimated by electric impedance tomography (eit). eit is a non-invasive, real-time monitoring technique suitable for detecting changes in lung volumes during ventilation. artificial intelligence can promote the detection of pva by flow versus time assessment. if continuous eit recording is correlated with the latter, impedance tomography changes evoked by asynchrony can be estimated

Eligibility criteria:
inclusion criteria: * any patient ventilated invasively * any patient ventilated non-invasively exclusion criteria: * age under 18

Keywords: artificial intelligence biotrauma electric impedance tomography patient-ventilator asynchrony
clinical study to investigate the safety and pharmacokinetics of sk3530 tablet in renal impaired male patients

Conditions: Renal Insufficiency; Kidney Diseases; Urologic Diseases

Summary: this study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of sk3530 in subjects with renal impairment compared to healthy subjects.


Eligibility criteria:
inclusion criteria: * adult males aged 19 to 64 years at screening. * subjects with body weight ≥ 50 kg and within ±30% of the ideal body weight : ideal body weight = (height \[cm\] - 100)x0.9. * subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol. exclusion criteria: * subjects with the test results of qtc \> 430 ms or non-sinus cardiac rhythm by ecg analysis. * subjects with hypotension or hypertension. * subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Keywords: sk-3530 renal impairment healthy volunteers
neoadjuvant nab-ptx and trastuzumab for er negative and her2 positive breast cancer

Conditions: Breast Cancer; Estrogen Receptor Negative Neoplasm; HER-2 Positive Breast Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of nab-ptx and trastuzumab for er negative and her2 positive operable (tumor size of 3cm or less and n0) breast cancer.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed invasive breast cancer 2. tumor size of 3cm or less and n0 3. hormone receptors have been identified as negative 4. her2 positive confirmed by ihc 3+ or fish+ 5. lvef \> 50% by echocardiogram or muga 6. adequate ekg 7. no prior treatment for breast cancer 8. ps 0-1 9. required baseline laboratory data wbc \> 4,000/mm3 and neut \> 2,000/mm3 plt \> 100,000/mm3 hb \> 9.0g/dl ast and alt \< ulnx2.5 t-bil \< 1.5mg/dl serum creatinin \< 1.5mg/dl 10. written informed consent exclusion criteria: 1. with history of hypersensitivity reaction for important drug in this study 2. with history of invasive breast cancer 3. bilateral invasive breast cancer 4. patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe diabetes mellitus 5. positive for hbs antigen or hcv antibody 6. with history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension 7. with severe edema 8. with severe peripheral neuropathy 9. with severe psychiatric disorder 10. pregnant or nursing women 11. the case that is judged to be unsuitable for this study by physician
pain reducing effect of transcutaneous electrical nerve stimulation in patients with chronic low back pain or lumbo-radiculalgia

Conditions: Chronic Low Back Pain; Chronic Lumbo-radiculalgia

Summary: prior studies showed contradictory results about the best type of tens in chronic pain pathology. therefore we want to evaluate the efficacy assessment of tens on patients with chronic low back pain or chronic lumbo-radiculalgia. the functional ability score is evaluated by the roland scale at 6 weeks.


Eligibility criteria:
inclusion criteria: * stable chronic low back pain or stable chronic lumbo-radiculalgia * patients with a pain score at least superior or equal to 4 * patients followed in pain clinics * written informed consent exclusion criteria: * prior ambulatory tens practice * lumbo-radiculalgia pathology surgery within 3 months before inclusion * acute low back pain or bilateral lumbo-radiculalgia * acute radiculalgia * surgery planned within 6 months * pacemaker * symptomatic low back pain

Keywords: tens chronic low back pain chronic lumbo-radiculalgia placebo roland scale