Kornimate/medical-research-clean huggingface dataset:
l-carnitine administration in early sepsis

Conditions: Septic Shock

Summary: sepsis is a severe and overwhelming response to an infection in the body. over 750,000 patients in the united states develop sepsis every year. as sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, which is necessary for normal cell function. this is called septic shock. when someone develops septic shock, it is very common for the smallest blood vessels in the body called the microcirculation to clog, like a highway during rush hour. even with the best medical care, more than one in three patients with septic shock will die. the major goal of this study is to test if intravenous replacement of a naturally occurring nutrient that is lost by the body during sepsis called l-carnitine can reduce how sick a patient with sepsis becomes. in our study, some patients will receive l-carnitine and others will receive saline. we will measure markers determining severity of illness in both groups and compare them to see if l-carnitine helps patients get better faster. based on research already conducted, we believe l-carnitine will improve blood flow in the microcirculation, delivering more oxygen to cells, and help the body get better. to test if this is true, we will directly look at the microcirculation under the tongue with a special magnifying camera that looks at red blood cells, and compare both groups.


Eligibility criteria:
inclusion criteria: * suspected or confirmed infection * any two of four criteria of systemic inflammatory response * requirement for vasopressors to treat shock * enrollment within 12 hours of vasopressor initiation * sofa score of greater than or equal to 5 at the time of enrollment exclusion criteria: * age \<18 years * pregnancy or breastfeeding * any primary diagnosis other than sepsis * established do not resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable * any history of seizures or a known seizure disorder * any known inborn error of metabolism * anticipated requirement for surgery that would interfere with the 12 hour infusion time * active participation in another interventional study * inability to obtain informed consent * cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment * known systemic allergy to carnitine

Keywords: carnitine shock sepsis
patterns of ptsd in adult patients after intensive care

Conditions: Intensive Care Unit Syndrome

Summary: this study aims to describe adult patients' patterns of post-traumatic stress disorder (ptsd) at discharge, 3, and 12 months after intensive care.

the present study is a secondary analysis of the rapit-trial study treating data from patients on post-traumatic stress disorder (ptds) (jensen et al., 2016). design observational study based on data from the rapit trial that is a non-blinded, multicentre, parallel-group rct conducted between december 2012-2015, at 10 intensive care units (icus) in four out of five regions in denmark. participants patients were consecutively recruited during the first 18 months of the study. we included danish-speaking adults (≥18 years) who received mechanically ventilated ≥48 hours and did not meet the baseline criteria of dementia. we excluded delirious patients unable to give informed consent at randomization, or patients, who were enrolled in other studies. a total of 386 adult patients were randomized to standard care (sc) plus a nurse-led intensive care recovery program or standard care alone after icu discharge (190 intervention, 196 sc). outcomes in this study, we will describe variations in patients, who experience symptoms of ptsd at icu-discharge, 3 and 12 months after intensive care based on the data collection in the rapit-trial (jensen et al., 2016). we will report trial participants' symptoms of ptsd at baseline, three months and twelve months after intensive care using the harvard trauma questionnaire (htq) supplemented with descriptions of patients' experiences of ptsd. symptoms of anxiety and depression were collected at 3 and 12 months, and utilization of healthcare services including mortality were obtained from hospital charts combined with self-reported data from patients. we will use descriptive statistical methods to analyze data. symptoms of ptsd by htq-iv consisted of 17 items covering three core symptoms corresponding to dsm-iv criteria for ptsd: re-experience (5 items), avoidance (7 items), and arousal (5 items). this was supplemented by four additional items: one functional and three related to stress. we used a total score, and a cut-off of ≥40 is categorized as "positive ptsd". symptoms of anxiety and depression were assessed using the hospital anxiety and depression scale (hads) covering two dimensions: anxiety (7 items) and depression (7 items); subscale scores were 0-21 with higher scores reflecting greater psychological distress.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * non-invasive or invasive ventilation ≥ 48 hours ( non-ivasive ventilation (niv) from current guidelines) * undiagnosed dementia exclusion criteria: * delirium at randomization (positive cam-icu score) * participations in scientific projects which include patient interviews * not speaking or understanding danish.
mixed methods study protocol_chronic pain and marginalized populations

Conditions: Chronic Pain; Marginalization, Social

Summary: a mixed-methods sequential explanatory design study. the first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. latent class analysis (lca) will be used to generate experience-based subgroups in cmp. the second qualitative phase will use focus group will elucidate, confirm, and more richly describe the findings from the first phase.

background: the global epidemic of chronic musculoskeletal pain (cmp) is an intractable issue adversely impacting gross domestic products and costing billions in lost productivity. the expansion of cmp occurs concurrently with historical global mass population movements. geopolitical negative and racist rhetoric have arisen in response to increased immigration rates. cmp is an invisible disease decoupled from normal tissue healing and results from the complex interplay of biological and psychological processing. different theoretical models of cmp development now include potential demographic and socio-cultural factors. cmp occurs disproportionately in populations at risk for marginalization, including women, non-caucasians, immigrants, and people experiencing increased socioeconomic deprivation. the same marginalized populations also are at greater risk for limited access to healthcare and demonstrate worse functional limitations, outcomes, and quality of life. aims: the primary aims are 1) to characterize self-reported features in people who have cmp and experience marginalization and 2) to interpret the pain experience for marginalised populations of people who have cmp. methods: a mixed-methods sequential explanatory design study will be used. the first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. latent class analysis (lca) will be used to generate experience-based subgroups in cmp. focus group will elucidate, confirm, and more richly describe the findings from the first phase. discussion: results from this study will be used to inform clinical conversations with patients who have cmp and experience marginalization. by increasing awareness of the potential influences on the clinical conversation, we hope to build opportunities to address inequities in cmp management.

Eligibility criteria:
inclusion criteria: * english, spanish, and arabic-speaking adults living in the piedmont triad, nc exclusion criteria: * declined to participate
magnetic resonance imaging in cerebral small vessel disease

Conditions: Cerebral Small Vessel Diseases; MRI

Summary: cerebral small vessel disease (csvd) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. early identification of csvd is critical for early intervention and improve clinical outcomes. magnetic resonance imaging (mri) may represent as a sensitive and robust tool to detect early changes in brain subtle structures and functions. the study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced mri technologies in early diagnosis and management of csvd.

cerebral small vessel disease (csvd) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. early identification of csvd is critical for early intervention and improve clinical outcomes. magnetic resonance imaging (mri) is sensitive to change in white matter structure and subtle vascular function alternation which correlates with cognition impairments in csvd. mri manifestation may also represent as useful surrogate marker. development of advanced mri technologies promotes their invaluable application in brain and vascular qualitative and quantitative assessment. the study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced mri technologies in early diagnosis and management of csvd.

Eligibility criteria:
inclusion criteria: * clinical evidence of cerebral small vessel disease or mri evidence of lacunar infarcts and white matter hyperintensity * no disability (modified rankin's scale \< 2) * no dementia (mmse \> 24 and absence of dependence in daily activities) * able and willing to consent exclusion criteria: * contraindications to mri * standard mri of bad quality due to movement artefacts * pregnant * unable to tolerate mri

Keywords: cerebral small vessel diseases cognitive impairments lesion burden mri
evaluation of the hypolipidemic effect of bergavit by a human trial.

Conditions: Hyperlipidemia

Summary: bergavit is a product contains bergamot. bergamot is an endemic plant of the calabrian region in southern italy with a unique profile of flavonoids and flavonoid glycosides present in its juice and albedo, its flavonoids was able to reduce serum levels of lipids and ameliorate the thickening of the arteries through modulating enzymatic activities, anti-oxidation, anti-inflammatory mechanisms and inhibition of monocyte activation and proliferation.the primary outcome of the study the assessment of the the hypolipidemic effect of bergavit. the secondary outcomes are the assessment of: a) the hypoglycemic effect of bergavit, b) the activity of bergavit on weight loss, and c) the hepatoprotective activity of bergavit.

the study duration is 4 months. subjects will attend clinic visits as follows: * t0: first visit: assessment of all baseline parameters, beginning of treatment * t2: second visit: assessment only of ldl level, total cholesterol, ox-ldl, triglycerides level, fasting glucose. * t3: third visit: assessment of all parameters. * t4: fourth visit: assessment of all parameters, end of the treatment.

Eligibility criteria:
inclusion criteria: * 1 healthy men and women (40-70 years old); * 2 asian subjects with ldl-cholesterol (ranging from 100 to 159; see here below) * 3 subjects naïve to statins or other treatment and food supplement that can interfere with the study treatment for the previous 1 month * 4 reading, understanding and signed approval of the informative consent * 5 no vegetarian. subjects who will continue, expect reserve, their normal lifestyle * 6 healthy volunteers without clinical illness diagnosed with relevant effect on the gastrointestinal system or the motility visceral exclusion criteria: * 1 subjects \ 70 years old * 2 clinical history with relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study * 3 lack of compliance defined as not using the correct bergavit dose or placebo for\>1 week), and inability to give informed consent * 4 subjects who have changed their diet significantly or have been placed on weight reduction products * 5 smokers, obesity subjects, during breast feeding * 6 changing the eating habits within the 2 weeks previous the screening * 7 during the pregnancy of the subjects or of the subjective planning of the study * 8 subjects with a history of drug, alcohol and other substance abuse * 9 known food intolerance or food allergy * 10 subjects involved in a clinical or food study within the previous month * 11 subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure) * 12 subjects with a history of paralysis or cerebral vascular accident * 13 subjects with active cancers or on chemotherapy
adaptations to breast cancer and exercise using telehealth (abrace: telehealth)

Conditions: Breast Cancer Female

Summary: the aim of the present study is to determine the effects of 12 weeks of multicomponent training associated with a health education program carried out remotely, compared to a health education-only program, on psychological and physical outcomes of women in primary treatment for breast cancer. for that, 36 women will be randomized to a multicomponent training group carried out remotely associated with health education or health education group. the psychological and physical outcomes will be measured pre (week 0) and post-intervention (week 13) in both groups, always by the same investigator blinded in relation to the groups. the multicomponent training group will carry out an exercise program twice a week, and health education will also be carried out on one of the two days. in this group, the conversation on the topic of the week will take place during stretching. the sessions (on pre-established and non-consecutive days) will be held by video call (approximately 60 min) in small groups (maximum three participants) and will be given by students of the physical education course, previously trained to perform the intervention. the order of the multicomponent training will be joint mobilization, aerobic stimulus, balance exercise, strength exercises and stretching of the main muscles used during the training session. for the participants of the health education group, also, once a week, a material with several topics related to the management of breast cancer diagnosis and physical activity will be sent by message. in addition, two days after this material is sent, a conversation will be held with the participants of this group, at a google meet of approximately 30 minutes, about the theme sent by message. the themes will be depression, pain, fatigue, body image, symptoms in the arm and breast, vasomotor symptoms, neuropathy, arthralgia, sexual dysfunction, quality of life, physical activity and eating habits. to analyze the outcomes collected, it will be used generalized estimating equations (gee) and the bonferroni post-hoc test.


Eligibility criteria:
inclusion criteria: * women from the city of porto alegre and pelotas in southern brazil * women diagnosed with breast cancer in stages i-iii * women undergoing primary treatment (adjuvant or neoadjuvant chemotherapy or only radiotherapy) of breast cancer * women can not be practicing periodized and systematic physical exercise programs exclusion criteria: * women can not have reached more than 50% of the completion of chemotherapy or only radiotherapy treatment * women can not have the following comorbidities: * autonomic neuropathy or severe peripheral neuropathy, proliferative diabetic retinopathy, non-proliferative diabetic retinopathy, uncompensated heart failure, unstable angina, peripheral amputations, uncontrolled arterial hypertension, chronic renal failure, severe psychiatric disorders and musculoskeletal impairment that limits physical exercise.
hospital discharge oral nutrition support trial

Conditions: Malnutrition

Summary: to investigate the effect of different strategies for managing malnutrition in the community


Eligibility criteria:
inclusion criteria: * male or female * age 50 years and over * able to eat and drink without the need for altered texture fluids * identified at risk of disease related malnutrition * competent to provide written informed consent * willingness to take part in the study and to follow the study protocol exclusion criteria: * individuals unable to eat or drink * chronic renal disease requiring dialysis * galactosaemia * dysphagia * normally or going to be residing in an institution e.g. care home upon discharge from hospital * palliative care * cancer (active treatment) * liver failure * poorly controlled diabetes * diagnosed lactose intolerance * participation in other clinical trials currently or in the previous 4 weeks * due to be discharged to an area out of the hospital region * requiring tube or parenteral nutrition * due to be discharged from hospital on oral nutrition support recommended by a dietitian
the effect of mindfulness training on premenstrual syndrome symptoms and quality of life

Conditions: Mindfulness; Premenstrual Syndrome-PMS; Quality of Life

Summary: premenstrual syndrome (pms) is an important health problem that negatively affects women's quality of life by reducing their daily activities, sleep quality, cognitive functioning, interpersonal relationships, academic performance, work and school attendance. studies show that pms is associated with unhealthy life behaviors and that pms can be reduced through the development of healthy life behaviors. midwives can benefit from mindfulness-based programs while providing quality health care services to develop a healthy lifestyle in the prevention and treatment of pms in women. in the literature, there is no study examining the effectiveness of mindfulness-based healthy life behaviors training on pms. to the best of our knowledge, our study is the first study to examine the effect of a mindfulness-based healthy life behaviors training program on premenstrual syndrome symptoms and quality of life.


Eligibility criteria:
inclusion criteria: being a student at gülhane faculty of health sciences, university of health sciences regular menstruation experiencing moderate pms agreeing to participate in the study exclusion criteria: being a student in the department of midwifery having a psychiatric diagnosis or gynecological disease kontraseptif medication use having a health problem receiving treatment for pms

Keywords: mindfulness-based education healthy living behaviours premenstrual syndrome symptoms quality of life midwifery
a non-blinded study demonstrating the effectiveness and safety of azilect alone or in combination therapy in parkinson's disease

Conditions: Parkinson's Disease

Summary: patients with parkinson's disease (pd) will be divided into 2 groups at each study center at their first visit based on the drugs they are taking for their pd: * group 1 patients using azilect and no other therapy. * group 2 azilect in combination with other medications like levodopa, mirapex, or requip.


Eligibility criteria:
inclusion criteria: 1. idiopathic parkinson's disease. diagnosis previously confirmed by the presence of bradykinesia and by at least one additional cardinal sign (i.e., resting tremor, rigidity), without other known or suspected cause of parkinsonism. 2. requiring therapy for pd symptom control * azilect monotherapy. * azilect as adjunct therapy.. exclusion criteria: 1. patients previously exposed to azilect 2. patients with pheochromocytoma 3. concomitant mao inhibitors or medications contraindicated for use with mao inhibitors are not allowed.
efficacy and safety of the combination of ketoprofen and cyclobenzaprine and caffeine in osteomuscular treatment

Conditions: Musculoskeletal Pain

Summary: the purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory plus caffeine in the treatment of osteomuscular pain in adults.

* double-blind,randomized, multicenter * maximal experiment duration: 9 days * 02 or 03 visits and a phone contact * evaluate the efficacy of an association with one anti-inflammatory and one muscle relaxant agent with caffeine compared to the one muscle relaxant agent plus caffeine in the treatment of osteomuscular pain in adults. * adverse events evaluation

Eligibility criteria:
inclusion criteria: * signed consent of the patient; * participants presenting musculoskeletal pain, moderate or moderately severe, with vas (visual analog scale) greater than 40 mm for a period of less than seven (7) days. exclusion criteria: * patients with any clinically significant disease that in the investigator is opinion can´t participate in the study; * patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; * patients with history of hypersensitivity to any of the formula compounds; * participation in clinical trial in the year prior to this study; * pregnancy or risk of pregnancy and lactating patients; * patients who were in use of drugs that can interfere with evaluation; * history of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia, dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or gastritis; * renal or hepatic impairment.
multiple dose safety tolerability, pharmacokinetics and midazolam interaction in healthy overweight and obese subjects

Conditions: Diabetes Mellitus Type 2

Summary: this study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of pf-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.


Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests). * women must be of non childbearing potential. * body mass index (bmi) of 25 to 35 kg/m2 inclusive; and a total body weight \>50 kg (110 lbs). * an informed consent document signed and dated by the subject. * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * evidence or history of any chronic ongoing or current pulmonary disease. * history of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.