Kornimate/medical-research-clean huggingface dataset:
comparative study of edp-420 versus another antibiotic in the treatment of community acquired pneumonia

Conditions: Community Acquired Pneumonia

Summary: this study will compare the efficacy, safety and tolerability of edp-420 versus another oral antibiotic in the treatment of community acquired pneumonia


Eligibility criteria:
inclusion criteria: * recent respiratory illness with signs and symptoms and chest x-ray consistent with the diagnosis of community-acquired pneumonia. * suitable candidate for oral antibiotic therapy and able to swallow large capsules intact * if female, must be non-lactating and at no risk for pregnancy exclusion criteria: * other infections * other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy * history of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins * evidence of uncontrolled clinically significant disease, malignancy, or other abnormality * requirement of parenteral antimicrobial therapy for treatment of pneumonia * currently receiving or likely to receive any known inhibitors or inducers of cytochrome p450 mediated drug metabolism * immunocompromised subjects
diffrence in thromboprofilaksis in elderly ostoepenic hip fractures according to mobility status by genetic analysis

Conditions: Hip Fracture of Intertrochanteric Type; Thromboembolic Event; Osteopenia; Thrombosis Embolism

Summary: hip fracture is a common and severe disease in elderly patients. the question of the study is whether elderly patients with severe osteopenia have significantly lower levels of the collagen-binding protein hsp47 than relatively mobile patients due to advanced immobility before the fracture, and whether they participants have a similar risk of vte to the normal population despite having had a hip fracture and surgery.

in this study, the investigators aimed to prospectively measure the hsp 47 gene expression levels in patients scheduled for surgery due to intertrochanteric femur fracture and healthy volunteers in the same age group and compare the results with the literature. also the complications prior or after surgery will be compared.

Eligibility criteria:
inclusion criteria: * \>65 years of age * interthrocanteric femur fracture ao type 31a1, 31a2, 31a3 * patients treated proksimal femoral nail * minor trauma * fracture mobility score 1,2,3,4,5 * inial thrombocytes count 150.000-450.000 /µl exclusion criteria: * body mass index \>40 * fracture mobility score 6 (unknown type) * stage 4 chronic kidney disease * patients with rheumatological diseases * patients at serious risk of vte(venous thromboembolism) (according to the international society on thrombosis and hemostasis, categorization of venous thromboembolism) : * active hematologic cancer * antiphospholipid syndrome * history of recurrent thrombosis (dvt) * paroxysmal nocturnal hemoglobinuria

Keywords: hip fracture serpinh1 thromboembolism rock1
myeloma novel drug discovery ver 1.2

Conditions: Multiple Myeloma

Summary: myeloma is a bone marrow cancer with over 5000 patients diagnosed in the uk each year. researchers are committed to improving understanding of myeloma and developing more effective treatments with fewer side effects in order to improve patient outcomes. in order to do this, researchers are collecting samples of blood and bone marrow to test the activity of potential new treatments in the laboratory and to understand what may be the cause of some treatments not working.


Eligibility criteria:
inclusion criteria: 1. participants who have a diagnosis, or suspected diagnosis, of myeloma or related plasma cell disorder 2. participants who are undergoing a peripheral blood or bone marrow aspirate sampling for diagnostic, staging or follow-up purposes, before, whilst or after receiving anti-myeloma treatment 3. participants aged 18 years of age or above 4. participants willing to consent to an additional sample being taken at the time of their peripheral blood or bone marrow aspirate sampling exclusion criteria: 1. participants unable to provide consent 2. participants with known active infectious diseases (e.g. hiv, hepatitis b/c, covid) that pose a risk to the use of the sample in the laboratory
pelvic physiotherapy in the prevention of vaginal stenosis secondary to the radiotherapy

Conditions: Gynecologic Cancer; Pathological Constriction

Summary: vaginal stenosis is one of the most prevalent side effects of pelvic radiation, affecting about one third of women. in this randomized controlled trial, the effect of a pelvic physiotherapy protocol on an incidence rate of vaginal stenosis in women with gynecological cancer undergoing gynecological brachytherapy. in addition, the investigators will explore an improvement in quality of life, sexuality, and contractile function of the pelvic floor muscles.

tis study will be conducing in a reference hospital to oncology treatment were mane patients with gynecologic cancer are management on radiotherapy services. the aim of this work is evaluated the effects of the pelvic physiotherapy (pp) on the more prevalent constriction pathology (vaginal stenosis) secondary to the brachytherapy. the pp will be conduced by three months after the radiotherapy starts and the incidence of the vaginal stenosis will be compared with a control group throughout six months of fallow-up.

Eligibility criteria:
inclusion criteria: * women over 18 years old; * no vaginal stenosis at first evaluation; * women free of previous intracavitary radiation; * women diagnosed with gynecological cancer who are undergoing brachytherapy treatment during the period of research at the santa rita hospital of the santa casa de misericórdia in porto alegre; * women who agree to participate in the research through the informed consent form (tcle). exclusion criteria: * women who do not sign the icf; * women not being treated for gynecological cancer; * women who have a 30% lack of physical therapy sessions (4 sessions); * women who present complications that prevent the accomplishment of the protocol of pelvic physiotherapy or that do not perform all the treatment with brachytherapy.

Keywords: radiotherapy brachytherapy physiotherapy vaginal dilators pelvic floor exercises vaginal stenosis
follow-up of the pepites study to evaluate long-term efficacy and safety of viaskin peanut in children

Conditions: Peanut Allergy

Summary: this is an open-label, follow-up study for subjects who completed the pepites study. subjects will be offered enrollment in this follow-up study to receive viaskin peanut 250 μg for 2 additional years if previously on active treatment in the pepites study, or for 3 years if previously on placebo in the pepites study.


Eligibility criteria:
inclusion criteria: * subjects who completed the pepites study. exclusion criteria: * generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the viaskin patches. * diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.

Keywords: allergy food allergy viaskin peanut epicutaneous
the effects of iontophoresis in women with gynoid hidrolipodystrophy.

Conditions: Caffeine; Cellulitis

Summary: introduction: gynoid hydrolipodystrophy (hldg) or cellulitis is a subcutaneous tissue disorder, with several strategies for its treatment, such as caffeine and iontophoresis. objective: to evaluate the effects of caffeine-associated iontophoresis for the treatment of hldg. methods: in a longitudinal study, participants will be evaluated for: photographic documentation, ultrasound imaging, thermography and quality of life questionnaire. if included, they will be separated into 3 randomized groups (n = 30). g1: use of base gel (n = 10); g2: use of iontophoresis and gel with caffeine (n = 10) and g3: use of iontophoresis alone (n = 10). the groups will be treated with 10 sessions, 2 times per week. after that they will be reevaluated. statistical analysis: the software used will be the spss statisticalpackage (ibm spss statistics, chicago, il, usa). the data distribution will be analyzed by the shapiro-wilk test. in case of normal distribution, the data will be described as mean ± standard deviation; otherwise, as median \[interquartile range 25-75%\]. for comparison of the data, we will use anova and for comparison of means the tukey test and case not normal distribution, krulskal-wallis test and the dunns test. the level of statistical significance adopted will be p \<0.05. expected contributions: it is expected that investigators can contribute to the treatment of patients with hldg and analyze the effects of iontophoresis with caffeine, both in clinical and scientific practice, providing a method that is valid and reliable for this purpose; multidisciplinary training of highly qualified human resources and the strengthening and consolidation of a research team.


Eligibility criteria:
inclusion criteria: * patients with mild to moderate cellulite diagnosis will be included, according to the validated photonumeric scale of cellulite severity * body mass index less than 30 (kg / m2) exclusion criteria: * individuals who have a deregulated menstrual cycle who are pregnant; * breastfeeding or using some hormone; * antibiotic medication including steroids over 1 month of treatment of skin diseases; •sensitivity or hypersensitivity of the skin; * use of the same or similar cosmetics or remedies on the glutes within 1 month; * surgical procedure (liposuction and skin treatments) in the region to be treated or planning some procedure within the study period; * chronic debilitating diseases such as asthma, diabetes or hypertension; * atopic dermatitis
oral desensitization to peanut in peanut-allergic children and adults using characterized peanut allergen oit

Conditions: Peanut Allergy

Summary: this is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

this is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oit in peanut allergic individuals. all eligible subjects will receive an escalating dose of cpna or placebo. approximately 50 subjects will be randomized 1:1 to peanut oit or placebo.

Eligibility criteria:
key inclusion criteria: * ages 4 through 26 years, inclusive * clinical history of allergy to peanuts or peanut-containing foods * serum ige to peanut \>0.35 ku/l (determined by unicap within the past 12 months) and/or a spt to peanut \>3 mm compared to control * experience dose-limiting symptoms at or before the 100mg dose of peanut protein (measured as 200 mg of peanut flour) on abbreviated screening ofc conducted via practall guidelines * use of birth control by females of child-bearing potential key exclusion criteria: * history of cardiovascular disease * history of frequent or repeated, severe or life-threatening episodes of anaphylactic shock * history of other chronic disease * history of eosinophilic gastrointestinal disease * severe asthma * mild or moderate asthma if uncontrolled * use of omalizumab within the past 6 months or current use of other non-traditional forms of allergen immunotherapy * use of beta-blockers(oral), angiotensin-converting enzyme (ace) * pregnancy, lactation * having the same place of residence as another study subject * participation in an interventional clinical trial 30 days prior to randomization

Keywords: characterized peanut allergen peanut oit oral desensitization peanut allergen allergy peanut allergy peanut-allergic children children peanut-allergic adults
self-management and recovery technology psychosocial intervention trial

Conditions: Schizophrenia; Affective Disorders, Psychotic; Psychotic Disorders

Summary: this project is a component of a broader research program referred to as "self-management and recovery technology (smart): use of online technology to promote self-management and recovery in people with psychosis", which has been funded by the victorian department of health mental illness research fund (mirf33). the overall research program is examining the therapeutic potential of using online (internet-based) educational and multimedia resources in mental health services. it involves the development of a website which can be accessed via an internet browser on a desktop computer, tablet computer, or smartphone. it consists of a series of educational modules containing textual information, exercises, audio, and video clips designed to promote self-management and recovery in people with a history of persisting mental illness. this particular project (smart-therapy) involves a randomised controlled trial examining the use of a discrete 8-session psychosocial intervention delivered in addition to routine care which utilises these online materials. the intervention will involve a mental health worker meeting with the participant with a tablet computer (e.g. ipad) on which online materials can be viewed, and used to guide an interaction with the participant. the randomised controlled trial will include 148 participants, who will be randomised to receive one of two interventions: (a) meeting with a support worker using the smart website to guide interaction (health intervention), or (b) meeting with a support worker delivering a social interaction-based control condition (social intervention). in each condition, there will be 8 x 50min face-to-face sessions over 3 months. assessments will be completed pre-randomisation, and at 3, 6 and 9 months. the primary hypothesis is that participants randomised to the health intervention will show greater improvement in personal recovery than participants randomised to the social intervention, and that these improvements will be maintained at follow-up (6 and 9 months following intake).


Eligibility criteria:
inclusion criteria: 1. diagnosis of a functional psychotic disorder (schizophrenia-related disorder or bipolar disorder or major depressive disorder with the presence of a severe episode with psychotic features within the past 2 years); 2. sufficient fluency in english to make use of the resources; 3. overall intellectual functioning within normal limits (wtar estimated iq\>70); exclusion criteria (e) change in medication or in-patient admission in the previous 2 months;

Keywords: psychosis schizophrenia self-management recovery tablet computer digital health internet online peer support
biomarkers of neuropathic pain in women treated for breast cancer

Conditions: Neuropathic Pain; Breast Cancer

Summary: investigators aim to identify the key phenotypes (biological, psychological, genetic) involved in the transition from acute to chronic neuropathic pain (np) by comparison of the neuropathic pain phenotypes and genomics of patients developing np or not under similar nerve injury conditions. the cohort is part of a previous prospective study of 1000 patients operated for breast cancer of whom 350 have surgeon defined intercostobrachial nerve resection during operation with or without persistent pain and additional 50 patients with pain, but no nerve resection during operation. patients fill in questionnaires and a detailed sensory examination, cognitive tests, and a cold water test with autonomic nervous system monitoring are performed during the research visit. a selected group of patients undergo quantitative sensory testing (qst).

this cohort is part of a previous prospective study of 1000 breast cancer operated women. of these, there are 350 patients with surgeon defined intercostobrachial nerve resection during the operation. part of the patients have pain, part of them are pain free. in addition the investigators plan to enroll 50 patients with pain, but no nerve resection during operation. the patients come for a clinical research visit. beforehand they fill in questionnaires of medical history, pain, mood, temperament, quality of life, and sleeping. after informed consent the patients give a blood sample with prior 12 hour fasting. the investigators present a detailed sensory testing with body maps and patient pain drawings. the investigators perform a cold water test with autonomic nervous system monitoring and conduct a set of cognitive tests, part of them computer based. a selected group of patients undergo qst.

Eligibility criteria:
inclusion criteria: * belongs to the cohort of 1000 breast cancer operated women and has had nerve resection during the operation (with or without pain) or no nerve resection, but pain * sufficient finnish language skills exclusion criteria: * age over 75 years * living far away from study site

Keywords: neuropathic pain breast cancer post surgical
tightrope or screw fixation of acute tibiofibular syndesmotic injury

Conditions: Syndesmotic Injury of the Ankle

Summary: syndesmotic injuries are common and often associated with unstable ankle fractures. the most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. the tightrope syndesmosis repair kit (arthrex; naples, florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. it does not need removal and thus avoids subsequent surgery. this trial compares these two treatment methods for syndesmotic injuries of the ankle.

patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: one group receives a tightrope (r) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised ct scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.

Eligibility criteria:
inclusion criteria: * 18 to 70 years * acute syndesmotic injury with or without weber type c fracture exclusion criteria: * prior injury of the same ankle * severe injury of same leg affecting rehabilitation * symptomatic osteoarthritis of same ankle * open injury * decubital injury affecting surgical site * dementia or unable to sign informed consent * neuropathic conditions affecting same leg

Keywords: syndesmosis injury ankle fracture
evaluation of educational tools for pregnant women

Conditions: Preeclampsia

Summary: hypertensive disorders of pregnancy happen in 5% of pregnancies. being aware of symptoms and complications may help women to present early and preserve their own and their baby's health. the proposed research aims to evaluate the impact of educational tools in pregnant women from an ambulatory population. these tools include a detailed pamphlet (including a graphic-based summary), a magnet summarizing symptoms and appropriate action, and a video. level of knowledge will be evaluated after one month with a validated questionnaire. we will also evaluate if getting more information about preeclampsia increases patient anxiety as well as satisfaction about the tools.

background: preeclampsia is a leading cause of maternal/fetal morbidity/mortality. pregnant women are often poorly informed on preeclampsia and seeking care too late results in maternal/fetal complications. many healthcare providers believe that delivering information for low-risk women only make them more anxious. preliminary data: we published that an information pamphlet on preeclampsia increases knowledge, without increasing anxiety, and generates high satisfaction in women hospitalized for preeclampsia. objectives: demonstrate that (1) ambulatory low-risk pregnant women will benefit from the pamphlet/video with improved knowledge; (2) without any increase in anxiety, and with great satisfaction. design: prospective randomized controlled pilot study. inclusion criteria: consecutive pregnant women aged ≥18 y.o. between 200-326 weeks presenting at the clinic and who read/write french or english. exclusion criteria: anticipated delivery or termination within one month. intervention: pamphlet, magnet and video. control: no educational tool. at baseline, women in both groups will answer questionnaire #1 on demographics; one month later: self-administered questionnaire #2 on knowledge, anxiety, satisfaction. sample size: n=178 will provide 80% power to find a significant improvement of at least 20% in knowledge score and 96% power to find a difference of at least 1 on scale for anxiety (alpha of 5%). assuming a drop-out rate of 10%, missing answers \<20%, and rate of answered questionnaire #2 of 50%, 400 subjects will be recruited. anticipated results: the tools will improve knowledge by about 20% in intervention group compared to control group. they will not increase anxiety over one point and will be highly appreciated by women.

Eligibility criteria:
inclusion criteria: * women between 20+0 to 32+6 weeks pregnant * aged 18 years old or more * who present at the blood sampling in pregnancy clinic * with an adequate understanding of written and spoken french or english in order to read the pamphlet and fill out the self-administered questionnaire exclusion criteria: * consideration of an interruption of pregnancy for maternal or fetal reasons * anticipated delivery within the next month.

Keywords: preeclampsia hypertensive disorders of pregnancy patient education educationnal tools pamphlet video knowledge anxiety satisfaction
cardiometabolism and atherosclerotic plaque progression

Conditions: Coronary Artery Disease; Diabetes Mellitus, Type 2; Dyslipidemias; Obesity; Metabolic Syndrome

Summary: systematic metabolic diseases are closely related to prevalence and progression of atherosclerosis. this prospective cohort consecutively enrolls patients with coronary artery disease compliacted with metabolic abnormalities such as diabtetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.

cardiometabolism and atherosclerotic plaque progression (campus) study is a single center, prospective cohort study to investigate the impact of cardiometabolic factors on coronary diseases. this study consecutively enrolls patients with coronary artery diseases complicatied with metabolic abnormalities, including diabetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.

Eligibility criteria:
inclusion criteria: * age 18-80 years * established coronary artery disease or metabolic disorders, including: 1. type 2 diabetes diagnosed by one of the following criteria: hba1c \>/= 6.5% fasting plasma glucose \>/= 7.0 mmol/l (confirmed) 2h plasma glucose value during ogtt \>/= 11.1 mmol/l already receiving glucose-lowering agents 2. prediabetes 3. obesity 4. chronic kidney disease 5. hyperuricemia 6. dyslipidemia exclusion criteria: * severe liver failure (child-pugh grade b to c) * severe anemia (hemoglobin \< 60g/l) * familial hypercholesterolemia * active malignant tumor * active autoimmune diseases on corticosteroids * acute or chronic infection * life expectancy \< 1 year