Kornimate/medical-research-clean huggingface dataset:
effects of liposomal encapsulation on calcium powder absorption and metabolism

Conditions: Osteoporosis

Summary: compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. this allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. liposomal calcium can be taken orally directly. it does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. according to the recommendations of the world health organization, the daily calcium intake for adults should be 1000-1300 mg. in taiwan, the seventh edition of the revised reference intake of dietary nutrients for chinese people recommends that the daily intake for adults should be 1,000 mg. the calcium dose used in this study was 500 mg. the purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. it is expected that microlipids made by lecithin can lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements.


Eligibility criteria:
inclusion criteria: * adults aged 20-60 years old, without heart, liver, kidney, endocrine or major organic diseases (patient report), and able to fully cooperate with the experiment. exclusion criteria: 1. patients with renal insufficiency and dialysis 2. cancer patients 3. underweight (bmi#17) or obese (bmi#27) 4. those taking medications for chronic diseases 5. blood pressure systolic blood pressure # 130 mmhg or diastolic blood pressure # 85 mmhg 6. fasting blood glucose # 100 mg/dl 7. fasting triglycerides # 150 mg/dl, total cholesterol # 200 mg/dl 8. have a history of vitamin c allergy 9. people suffering from mental illness 10. pregnant and breastfeeding women 11. patients with hemosiderosis 12. kidney stone patients 13. supplements for those who take calcium for a long time
aeriseal system for lung volume reduction

Conditions: Emphysema; Chronic Obstructive Pulmonary Disease (COPD); Pulmonary Emphysema; Lung Diseases

Summary: the purpose of this study is to evaluate the safety and efficacy of aeriseal treatment in patients with advanced emphysema.

the purpose of this study is to evaluate the safety and efficacy of aeriseal treatment in patients with advanced homogeneous and heterogeneous emphysema.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of advanced emphysema as defined by fev1/fvc\ 100% predicted, and rv \> 135% predicted. * patients must have persistent symptoms despite medical therapy and either not be candidates for lung volume reduction surgery (lvrs) or have elected not to undergo lvrs. * patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Keywords: polymeric lung volume reduction (plvr) biologic lung volume reduction (blvr) aeriseal treatment device breathing copd emphysema heterogeneous homogeneous pathologic processes respiratory tract diseases lung diseases pulmonary disease, chronic obstructive
mifepristone 2.5, 5, 10 mg versus placebo in the treatment of endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to evaluate the effectiveness and safety of 2.5, 5 and 10 mg doses of mifepristone against a placebo in women with laparoscopic diagnostic of endometriosis. the hypothesis of the study is that the 5 mg mifepristone dose is safe and effective and should be used in future studies on medical treatment of endometriosis.

this is double-blind randomized clinical trial. examinations undertaken thorough gynecological examination, pelvic ultrasound examination, diagnostic laparoscopy before starting treatment in order to determine the localization, extent and degree of severity of the endometrial lesions and a score was assigned in accordance with the revised american fertility society (afs) classification.19 blood samples were taken for hematological tests and hepatic function. endometrial biopsy was performed if endometrial thickness as calibrated by ultrasound was \>8 mm or if there had been abnormal bleeding in the past 3 months. after 90 and 180 days of treatment an ultrasound examination of the pelvis was carried out and then followed by diagnostic-therapeutic laparoscopy and endometrial biopsy. subjects women with laparoscopic confirmed diagnosis of endometriosis who volunteered to take part in the study. inclusion criteria: a) age between 18 and 45, b) certain diagnosis of endometriosis of any degree corresponding to the american fertility society (afs); c) patients with symptoms of endometriosis: dysmenorrhea or pelvic pain not attributable to other gynecological illness and d) acceptance of the use of barrier contraceptive methods during the study. exclusion criteria: a) breastfeeding, b) hormonal or surgical treatment for the endometriosis less than 4 months previous to study, c) diabetes, d) severe arterial hypertension, e) hepatopathy, f) renal malfunction, g) endocrinopathy, and f) any other contraindication regarding the use of antiprogestins.

Eligibility criteria:
inclusion criteria: * women with laparoscopic confirmed diagnosis of endometriosis * age between 18 and 45 * certain diagnosis of endometriosis of any degree corresponding to the american fertility society (afs) * patients with symptoms of endometriosis: dysmenorrhea or pelvic pain not attributable to other gynecological illness and * acceptance of the use of barrier contraceptive methods during the study exclusion criteria: * breastfeeding * hormonal or surgical treatment for the endometriosis less than 4 months previous to study * diabetes * severe arterial hypertension * hepatopathy * renal malfunction * endocrinopathy * any other contraindication regarding the use of antiprogestins.

Keywords: mifepristone endometriosis
exercise training in individuals with coronary artery disease

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: in this controlled trial, patients referred to post-myocardial infarction cardiac rehabilitation will be randomized to either interval or continuous training.

the trial would i) compare the acute effects of each exercise type on selected cardiovascular indicators; ii) compare the chronic effects of each exercise type on selected cardiovascular indicators; iii) provide information on the association between acute and chronic effects of each exercise type; iv) provide insight into possible mechanisms of effectiveness of each exercise type; v) identify the most safe and effective exercise type for patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: * myocardium infarction 120 days prior to cardiac rehabilitation exclusion criteria: * contraindications for exercise training, * uncontrolled dysrhythmias, * uncontrolled heart failure (new york heart association (nyha) stage iv), * intellectual development disorder, * pregnancy.

Keywords: exercise interval training continuous training endothelial dysfunction
self-assessment of flare in osteoarthritis of lower limbs

Conditions: Osteoarthritis

Summary: the need for a tool to measure flare in lower limb osteoarthritis (oa of the hip and knee) is justified by the opportunities for development of clinical trials targeting hip and knee oa long-term treatment (slow acting drug, disease modifying drug) and short-term treatment of symptoms. such treatments are currently under development and will likely bring important changes in the treatment of patients. the development of a flare-oa tool would be essential to capture the occurrence of flare, and to implement and adapt treatment strategies. this project was elaborated with the aims to: 1. define the construct through development of a conceptual framework 2. use the conceptual framework to inform the development of a patient-reported outcome measure, flare-oa tool, for people with oa 3. evaluate the psychometric properties of the new measure using the omeract (outcome measures in rheumatology) filter 2.0 and rasch measurement methods.

chronologically, the development of a flare-oa (osteoarthritis) tool will be addressed in the first part of the project (part 1) and its psychometric validity was evaluated in the second part (part 2). part 1 of the project: the development of the flare-oa tool will be conducted in several steps, and needs multiple proficiencies in qualitative research (health psychologist), in quantitative research (epidemiologist, psychometrician), in experience of the disease (patients), and in experience of care of the disease (health care professionals). two approaches will be taken to define the construct of a flare in lower limb oa: a review of the literature, and the development of a conceptual framework informed by the results of the literature. to help define/conceptualize the construct "flare in oa" a procedure will be implemented to identify (what are the key variables, or symptoms, that get worse) and clarify (how exactly these variables are described in the literature, by patients, and by clinicians. participants : 1. - patients should be representative of the disease spectrum, i.e. of prevalent cases. they will be recruited in clinical settings and epidemiological sources. 2. - health care professionals (hcp) will include general practitioners, rheumatologists, rehabilitation specialists, orthopaedic surgeons, nurse in general practice or orthopedic wards, physiotherapists.

Eligibility criteria:
inclusion criteria: * with clinical and radiological hip or knee oa confirmed by a physician, * whatever their status regarding flare of oa. the intention of the flare-oa tool is not to detect current flare only, but also a flare that may have occurred before the encounter with the health care professional. therefore patient will not be selected on flare, and patients with flare will not be excluded. exclusion criteria: * patients who never experienced nor currently report having a flare of oa * patients with both hip and knee oa
study for evaluation of probiotics in the re-equilibration of the intestinal microbiota, in paediatric age

Conditions: Diarrhea

Summary: to evaluate the efficacy, safety and hydration index about the oral administration of probiotics food supplement in the re-equilibration of the intestinal microbiota, in presence of acute diarrhea

multicenter, observational prospective study evaluating the efficacy, safety and index of hydration resulting from oral administration of probiotics food supplement in paediatric age.

Eligibility criteria:
inclusion criteria: * • male and female patients aged between 3 and 14 years; * patients with one of the following conditions: * population with acute diarrhea; * occurrence of at list three liquid or loose stools per day; * consistency of stools (≥ type 5) according to bristol stool scale form (bfs). * informed consent signed by parents or the patient's legal guardian(s) for study enrollment. exclusion criteria: * • presence of chronic diarrhea characterized by the emission of poorly formed stools, for more than 4 weeks, accompanied by increased frequency of evacuation or urgency to defecation; * known or potential hypersensitivity and/or history of allergic reactions to one of the components of probiotics food supplement; * coexisting severe infection (e.g. sepsis, pneumonia, meningitis); * patients affected by chronic intestinal disease, immune deficiency, neurological disease and tumors; * contemporary consumption of other probiotics compounds; * patients whose parents or the patient's legal guardian(s)refuse to provide written informed consent; * patient who has not expressed his consent according to his age and level of understanding; * participation in another clinical trial within the previous 30 days; * evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the investigator does not allow the participation in the study or could compromise the results
environmental contaminants and infant development

Conditions: Mercury Poisoning; Lead Poisoning

Summary: this study is designed to examine the effects of prenatal exposure to environmental contaminants on cognitive and behavioral development and physical growth in two groups of inuit infants-one in northern quebec; the other in greenland.

due to prevailing weather patterns and ocean currents, certain environmental contaminants are transported to the arctic region. the inuit are among the most heavily exposed populations on earth due to the prevalence of these contaminants in traditional foods that comprise a large portion of their diet. the contaminants assessed in this study include polychlorinated biphenyls (pcbs), methylmercury, selenium, organochlorine pesticides, and lead. these contaminants are measured in umbilical cord blood samples obtained at birth, milk samples obtained from breast-feeding mothers and, in the case of mercury, hair samples obtained from the mothers. omega-3 and omega-6 fatty acids are also assessed in these samples to examine the degree to which these nutrients may protect against adverse effects attributable to these contaminants.

Eligibility criteria:
infant born during recruitment period to a mother who is a resident of povungnituk, inukjuak, and kuujjuarapik, quebec or nuuk, greenland

Keywords: methylmercury pcbs lead fish consumption breast-feeding
a two week dosing study to determine the safety and antiviral activity of lcq908 in hepatitis c patients

Conditions: Hepatitis C

Summary: this is a proof of concept study, designed to look at the safety and antiviral activity of lcq908 in hepatitis c infected patients.


Eligibility criteria:
inclusion criteria: * written informed consent. * male and female subjects 18 to 65 years of age with hepatitis c infections (genotypes 1, 2 or 3). * no prior therapy or inadequate response to therapy for hepatitis c. * weight at least 50 kg and body mass index (bmi) within 18 - 35 kg/m2. exclusion criteria: * use of other investigational drugs within at least 30 days of enrollment * women of child-bearing potential. other protocol-defined inclusion/exclusion criteria apply

Keywords: hepatitis c virus chronically infected treatment naive non responders to prior therapy
the effect of breathing-based pelvic floor muscle training on menstrual symptoms, pain and quality of life

Conditions: Dysmenorrhea Primary; Pain Management; Diaphragmatic Breathing; Pelvic Floor Muscle Exercise

Summary: primary dysmenorrheic (pd) pain usually begins during adolescence, at menarche or shortly after (6-24 months), and has a clear and predictable temporal pattern. the pain typically radiates to the back and thighs and lasts for 8-72 hours. the pain is most severe on the first and/or second day of menstrual bleeding. additionally, systemic symptoms such as nausea, vomiting, diarrhea, fatigue, and insomnia often accompany the pain. in secondary dysmenorrhea, it can result from a range of identifiable pathological conditions, including endometriosis, adenomyosis, fibroids, and pelvic inflammatory disease. other gynecological symptoms such as intermenstrual bleeding and menorrhagia may also accompany it, depending on the underlying condition. empirical treatment approaches have been reported as appropriate for patients with primary dysmenorrhea based on symptoms and physical examination results. recent studies have indicated that during diaphragmatic breathing, all the muscles that make up the thoracic and abdominal walls should expand in a cylindrical manner in all directions through synchronized eccentric activity. thus, a more effective result will occur with the concentric contraction and 360-degree expansion of the diaphragm during inspiration, which raises intra-abdominal pressure . within the framework of this information, the aim of this study is to examine the effects of respiration-based physiotherapy approaches on menstrual symptoms, pain, and quality of life in women with pd.


Eligibility criteria:
inclusion criteria: * aged between 18-35, * voluntary participation, * having a regular menstrual cycle (every 24-35 days) , * menstrual pain intensity of 3/10 or higher on the visual analog scale during the initial assessment, * pain radiating to the back, legs, lower abdominal, or suprapubic region during menstruation, * restriction of daily living activities due to pain, * requirement for medical intervention or self-medication to control the pain. exclusion criteria: * history of pelvic pathology and/or surgery that could cause pain, * neurological or psychological disorders, * anovulation, * other diseases that could affect chest expansion or the respiratory system (copd, asthma, pneumonia, bronchiectasis, etc.), * being pregnant, having a positive birth control status, or being less than 6 months postpartum, * use of an intrauterine device, * history of childbirth or miscarriage. individuals who miss two consecutive exercise sessions will be excluded from the study.
comparison of 2 strategies of adjustment of mechanical ventilation in patients with acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury

Summary: the aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.

most patients suffering from acute lung injury or acute respiratory distress syndrome require mechanical ventilation. in this setting, positive end-expiratory pressure is used to improve arterial oxygenation. while the beneficial effect on clinical outcome of using low tidal volume is clearly proven, the best way to titrate peep is not known. higher peep levels may better improve oxygenation and reduce ventilator-induced lung injury by reducing end-expiratory alveolar collapse but may also cause circulatory depression and aggravate lung injury from end-inspiratory overdistension. this trial compares the impact on outcome of two strategies for setting peep. in the "minimal alveolar distension" arm, peep is set for a total peep (peep + intrinsic peep) between 5 and 9 cm h20). in the "maximal alveolar recruitment" arm, peep is set for a plateau pressure between 28 and 30 cm h20. a tidal volume of 6 ml/kg predicted body weight is used in the two arms. the goals for arterial oxygenation and paco2 are the same in the two arms.

Eligibility criteria:
inclusion criteria: * mechanical ventilation through an endotracheal tube * bilateral infiltrates consistent with pulmonary edema * pao2/fio2 \< 300 mmhg * no clinical evidence of left atrial hypertension. if measured, pulmonary artery occlusion pressure \< 18 mmhg * criteria 1, 2 et 3 jointly present for less than 48 hours * written informed consent obtained from the patient or surrogate exclusion criteria: * age \< 18 years * pregnancy * expected duration of mechanical ventilation through an endotracheal tube \< 48 hours * participation in other trials within the previous 30 days * increased intracranial pressure * severe chronic respiratory disease * morbid obesity (weight \> 1kg/cm) * sickle cell disease * bone marrow transplant or chemotherapy-induced neutropenia * extended burns (\> 30 % total body surface area) * severe chronic liver disease (child-pugh score c) * pneumothorax

Keywords: acute respiratory distress syndrome positive end-expiratory pressure acute lung injury mechanical ventilation randomized controlled trial
a multi-center study of lapatinib in patients with trastuzumab-refractory metastatic breast cancer

Conditions: HER2 Positive Breast Cancer

Summary: evaluating the efficacy of lapatinib in combination with chemotherapy in patients with trastuzumab-refractory metastatic her2-positive breast cancer.

some studies has demonstrated that even in trastuzumab pretreated patients with her-2 positive breast cancer, might benefit from the treatment of trastuzumab. however, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. in clinical practice, the investigators also found it is fact. and the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic her2-positive breast cancer.

Eligibility criteria:
inclusion criteria: * metastatic breast cancer * eastern cooperative oncology group (ecog) 0 or 1 * her2-expressing primary or metastatic tumor * recurrence within 1 year completing adjuvant trastuzumab or rapid progress following first-line trastuzumab-based care. * measurable disease with response evaluation criteria in solid tumors (recist) 1.1 * normal organ function, including bone marrow function, renal function, liver function, and cardiac function * signed and dated an informed consent form * life expectancy of at least 12 weeks exclusion criteria: * pregnant or breast feeding * left ventricular ejection fraction (lvef) \< 45% by echocardiogram * disease-free interval (dfi) less than 12 months * uncontrolled medical problems * any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin * patients were unable or unwilling to comply with program requirements
post-market clinical follow-up data collection from procedures with biotronik ep products

Conditions: Cardiac Arrhythmia

Summary: this data collection is designed to provide evidence for the safety, performance, and clinical benefit of biotronik's ep products. additionally, residual risks will be monitored and newly emerging risks identified.

in this study, data from routine care will be collected and evaluated to support regulatory post-market clinical follow-up demands under mdr as well as maintenance of the regulatory approval of the biotronik's ep product portfolio in the ce region. this is a prospective, observational, multi-center, international, open-label, non-randomized study that aims to provide evidence for the clinical safety, performance, and clinical benefit of biotronik's ep products. the patients participating in the study either receive a diagnostic or therapeutic catheter intervention, which are indicated for temporary transvenous application in patients with cardiac arrhythmias. they will be used in combination with external devices like rf generators, external pacemakers cardiac stimulators and / or irrigation pumps.

Eligibility criteria:
inclusion criteria: * indication for diagnostic or therapeutic ep intervention * ep intervention is planned to involve the use of biotronik ep products from at least 2 of the 3 following categories: * biotronik catheter (alcath, viacath, multicath, khelix) * biotronik external device (qubic stim, qubic rf, qiona) * biotronik transseptal sheath (senovo bi-flex) * biotronik ep product is planned to be used within its intended purpose * ability to understand the nature of the study * willingness to provide written informed consent * ability and willingness to perform all follow-up visits at the study site exclusion criteria: * age less than 18 years * pregnant or breastfeeding * prior participation in this study with performed ep procedure * participation in an interventional clinical investigation in parallel to the bio\|collect.ep study