Kornimate/medical-research-clean huggingface dataset:
different vitamin d preparations & fgf23 in humans

Conditions: Vitamin D Deficiency

Summary: fibroblast growth factor 23 (fgf23) is a new hormone which controls phosphate and vitamin d levels in humans. excess fgf23 is associated with an increased risk of death in patients with chronic kidney disease. in this study the investigators are investigating the effects of different forms of vitamin d on fgf23 levels in the blood in order to increase our understanding of how this important hormone works.

fibroblast growth factor 23 (fgf23) is a novel hormone involved in phosphate and vitamin d physiology. x-linked hypophosphatemia (xlh), autosomal dominant hypophosphatemic rickets (adhr), and tumor induced osteomalacia (tio) are 3 rare diseases characterized by rickets/osteomalacia, fractures, and hypophosphatemia secondary to renal phosphate wasting and inappropriately low levels of activated vitamin d (calcitriol), which are caused by excess amounts of or mutated fgf23. fgf23 excess also occurs in renal failure, where elevated fgf23 levels predict increased mortality. thus, abnormal fgf23 appears to be central to both rare and common diseases. while fgf23 appears to be regulated by vitamin d, dietary and serum phosphate, much is still unknown. the effects of different forms of vitamin d on fgf23 stimulation are not well characterized. similarly, any racial differences in the regulation of fgf23 by vitamin d have not been investigated. to address these knowledge deficits, we will randomize 52 vitamin d deficient (25ohd \< or = 24 ng/ml by lc/ms) caucasian and african-american men and women to treatment with either dietary vitamin d or activated vitamin d for 12 weeks. our primary endpoint will be the change in fgf23 with dietary versus activated vitamin d.

Eligibility criteria:
inclusion criteria: * age 18 to 45 yrs * serum 25ohd \< 24 ng/ml by liquid chromatography/mass spectroscopy * at least 1 menses in the last 3 months (females) and normal serum testosterone (males) * african-american or caucasian race exclusion criteria: * significant cardiac, hepatic, oncologic, or psychiatric disease * history of malabsorption, kidney stones, or recent alcohol excess/abuse * use of medications known to affect serum phosphate levels including phosphate-binding antacids, sodium etidronate, calcitonin, excessive doses of vitamin d (\> 1000 units per day), excessive doses of vitamin a (\> 20,000 units/day), calcitriol, growth hormone, or anti-convulsants * use of thiazide diuretics or cholestyramine * serum calcium \ 11 mg/dl, creatinine \> 1.5 mg/dl, or hgb \< 11 gm/dl * serum glucose \>140mg/dl * liver function tests \> 2 times the upper limit of normal * tsh \ 7 uu/ml * wbc \ 15,000/cmm * platelet count \ 500,000/cum * hormone replacement therapy (however, oral contraceptives are allowed) or testosterone use * urine beta-hcg positive (females) * serum phosphate \> 4.6 mg/dl * allergy to vitamin d

Keywords: vitamin d fgf23 fgf-23 phosphate
safety and efficacy of dapagliflozin as monotherapy in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this clinical research study is to learn if bms-512148 (dapagliflozin) can help reduce the blood sugar levels in subjects with type 2 diabetes who are not well controlled on diet and exercise alone. the safety of this treatment will also be studied


Eligibility criteria:
inclusion criteria: * male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus * subjects must have central laboratory pre-randomization a1c ≥7.0 and ≤ 10.0% * c-peptide ≥ 1.0 ng/ml (0.34 nmol/l) * body mass index ≤ 45 kg/m² * must be able to perform self monitoring of blood glucose exclusion criteria: * aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \>3\* upper limit of normal (uln) * serum total bilirubin \>2 mg/dl (34.2 µmol/l) * creatinine kinase \>3\* uln * serum creatinine ≥1.50 mg/dl (133 µmol/l) for male subjects, ≥1.40 mg/dl (124 µmol/l) for female subjects * currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Keywords: diabetes mellitus, type 2 diabetes mellitus endocrine system diseases glucose metabolism disorders metabolic diseases
feasibility of aerobic exercise for recovery from work-related concussion

Conditions: Concussion, Brain

Summary: there is a lot of research on how to treat people with sport-related concussion. there has not been a lot of research on the treatment of injured workers with concussion. an exercise program has been developed for people with sport-related concussion. it is suspected that this program may be helpful for injured workers with concussion too. this study will test the effect of this exercise in injured workers with concussion.

participants who are diagnosed with a concussion and agree to participant in the study will complete a demographics form and other relevant questionnaires. they will then perform a graded exertion test (the buffalo concussion treadmill test \[bctt\]) at the clinic, this takes approximately 15 minutes. participants will then be prescribed the individualized thrae based on the results from the bctt and will be sent home with a commercial heart rate monitor. participants will perform exercises at home on their free time 4-5 days per week. participants will return to the clinic weekly to be re-examined by the study physician and obtain a new heart rate prescription for the first six weeks until clinical recovery or the intervention period ends (6-weeks).

Eligibility criteria:
inclusion criteria: * aged 18-40 * received a concussion at work and are engaged with the workers compensation program * within 3 weeks of concussive injury exclusion criteria: * 3-point or less difference between current and pre-injury symptoms as measured by the post-concussion symptom inventory (pcsi) * moderate or severe tbi * injury involving loss of consciousness for \>30 minutes or post-traumatic amnesia \> 24 hours * pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation * history of more than 3 diagnosed concussions * active substance abuse/dependence * report of injury mechanism occurring due to physical assault * unwillingness to perform intervention * limited english proficiency.
adherence and quality of life of cpap for obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: a multicentre, randomized controlled trial (rct) design.the control group followed the usual treatment, while the intervention group (pima) followed the treatment with an adapted and flexible care plan depending on socio-demographic, clinical and psychological variables. the treatment plan includes different channels (home, telephone, care center), a continuous evaluation, and the use of the motivational interview in each of the interventions with the patient. the main outcome was adherence. secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.

the aim of this trial was to determine adherence to cpap and health- related outcomes in patients with osa via a comprehensive and multidisciplinary program based on stratification and individualized care plans, including the motivational interview. a multicentre, randomized controlled trial (rct) design was used. the control group followed the usual treatment, while the intervention group (pima) followed the treatment with an adapted and flexible care plan depending on socio-demographic, clinical and psychological variables. the treatment plan includes different channels (home, telephone, care center), a continuous evaluation, and the use of the motivational interview in each of the interventions with the patient. the main outcome was adherence. secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.

Eligibility criteria:
inclusion criteria: * older than 18 years * diagnosis of osa confirmed by sleep studies with polygraphy (ps) and / or polysomnography (psg) exclusion criteria: * subjects with obesity-related hypoventilation * severe copd (chronic obstructive pulmonary disease) * cognitive disorders and those unable to understand the consent to participate

Keywords: cpap sleep apnea adherence quality of life
how does mindful mood balance for moms work?

Conditions: Depression; Pregnancy Related; Antenatal Depression; Depression, Postpartum

Summary: the purpose of this investigation is to conduct a randomized trial comparing a web-based mindful mood balance for moms course without coaching support to waitlist control among pregnant or early parenting women with depression histories.

mindfulness-based cognitive therapy (mbct) prevents depressive relapse and reduces residual depression symptoms among adults with recurrent depression not currently in episode. women in perinatal or early parenting years constitute a significant portion of this at-risk population with a history of depression for whom mbct was designed. novel delivery formats that provide access to core knowledge and skills of mbct could increase public health impact-particularly for perinatal or early parenting women-but it is unclear whether such formats have comparable mental health outcomes and changes in putative targets as in-person mbct. in the present study, we planned to randomize 60 pregnant or early parenting women with a history of major depression and current residual depressive symptoms to mmb for moms, a web-based course that teaches skills from mbct customized specifically for pregnant and postpartum women, or waitlist control. we planned to address the following specific aims: aim 1. we evaluated the extent to mmb for moms was associated with significant reduction in residual depression symptoms as compared to wlc. we predicted the rate of change in depression symptoms across the study would be greater on average for participants randomized to mmb for moms relative to those randomized to wlc. aim 2. we evaluated the extent to mmb for moms significantly engaged the putative target of decentering as compared to wlc. we predicted the rate of change in decentering across the study would be greater on average for participants randomized to mmb for moms relative to participants randomized to wlc. aim 3. we evaluated the extent to mmb for moms significantly engaged the putative target of self-compassion as compared to wlc. we predicted the rate of change in self-compassion across the study would be greater on average for participants randomized to mmb for moms relative to participants randomized to wlc.

Eligibility criteria:
inclusion criteria: 1. female, 2. pregnant or having had a child within the past 36 months, \* 3. 18 years of age or older, 4. having a history of one or more prior major depressive episode (as assessed by a single question, "have you had a history of mood concerns or major depression?") 5. a current phq-9 score of \<= 14, and 6. endorses ability to read and write fluently in english. exclusion criteria: 1. meeting criteria for current moderately severe depression symptoms (as assessed by the phq-9 \>= 15), 2. current imminent suicidality (as assessed by the phq-9), and 3. indication of other disorders or symptoms that necessitate priority treatment.
heart at work study

Conditions: Occupational Diseases; Cardiovascular Diseases; Cardiovascular Risk Factor; Occupational Exposure

Summary: this is an observational study to examine the cardiovascular mechanisms of increased cardiovascular mortality in those with high activity occupations.

the current proposal uses a repeated-measures, within-subject design to address our aims. twenty male participants will report to the laboratory to provide informed consent, complete baseline assessments, and receive ambulatory monitors. following this session, each participant will wear physical activity and ambulatory cardiovascular monitors for 7 days, including at least one non-work day and one work day. characterization of work activity will use physical activity data from self-reported time at work (specific aim i). the 24-hour cardiovascular load (hr and bp) and nocturnal hrv will be compared across work and non-work days (specific aim ii). lastly, whether fitness level or job strain modify the difference in cardiovascular strain between work vs. non-work days will be evaluated (specific aim iii).

Eligibility criteria:
inclusion criteria: * middle age (35-59 years) * male * self-report working full-time in the food service industry (≥30 hours/week) * self-report predominantly completing light intensity activity job responsibilities (≥75% work time walking, light movement, or standing) exclusion criteria: * resting blood pressure of ≥150 mmhg systolic and/or ≥95 mmhg diastolic * currently taking medications that are known to affect blood pressure or heart rate (e.g. beta-blockers, ace inhibitors, etc.) * greater than low risk to participate in physical activity as determined by par-q (answer of yes to any of the 7 physical activity readiness questionnaire questions) * report working a second job in addition to their primary full-time job * report working overnight shifts (10pm-6am) * reported physical dysfunction (inability to walk 2 city blocks or climb 2 flights of stairs) * inability to complete the sub-maximal exercise test to completion (80% age-predicted heart rate maximum) * currently being treated for a serious medical condition such as kidney disease, liver disease, cancer, or heart disease.
optimal transfusion in anaemic cancer patients treated with chemotherapy (haemoptimal)

Conditions: Cancer; Anaemia

Summary: this an open two-arm interventional randomised feasibility study in anaemic patients treated with chemotherapy. randomisation is performed between two transfusion thresholds: haemoglobin \< 6.0 mmol/l (9.9 g/dl) versus haemoglobin \< 7.1 mmol/l (11.7 g/dl) for female and 8.1 mmol/l (13.4 g/dl) for males.primary end-point is quality of life

title: randomised feasibility study of optimal transfusion thresholds in anaemic cancer patients treated with chemotherapy (haemoptimal) background: cancer patients treated with chemotherapy very often become anaemic, which have profound negative impact of their quality of life. blood transfusions can ameliorate symptoms caused by anaemia. data are lagging with regard to what threshold should be used when offering blood transfusion. aim: the primary aim is to determine which end-points reflect symptoms caused by anaemia in cancer patients treated with chemotherapy. the secondary aims are to collect data to estimate sample size in a future definitive study and to compare symptom relief using to different transfusion thresholds. end-points: * numeric rating scale measuring fatigue, dizziness, palpitations, headache, and dyspnea. * fact-g, * fact-an (total anemia scale) including a fatigue subscale * patient-assessed who performance status design: open two-arm interventional randomised feasibility study intervention: * blood transfusion. * randomisation between two transfusion thresholds: haemoglobin \< 6.0 mmol/l (9.9 g/dl) versus haemoglobin \< 7.1 mmol/l (11.7 g/dl) for female and 8.1 mmol/l (13.4 g/dl) for males. population: cancer patients treated with chemotherapy inclusion criteria: * documented cancer * planned treatment with chemotherapy * age 18 years or older * informed consent exclusion criteria: * heart failure (nyha 3 and 4) * prior serious complications to blood transfusion * medical conditions that require special considerations for blood transfusion * treatment with erythropoiesis-stimulating agents. number of patients: transfusion of at least 30 patients in each intervention arm. an estimated number of 90 patients will be randomised in each arm (180 in total) as a third of included patients are expected to require transfusion.

Eligibility criteria:
inclusion criteria: * documented cancer * planned treatment with chemotherapy * age older than 18 years * informed consent exclusion criteria: * heart failure (nyha 3 and 4) * prior serious complications to blood transfusion * medical conditions that require special considerations for blood transfusion * treatment with erythropoiesis-stimulating agents

Keywords: anaemia, transfusion, cancer, chemotherapy, quality of life
supportive care for cognitively impaired patients and families

Conditions: Dementia; Primary Palliative Care; Mild Cognitive Impairment

Summary: currently almost 5 million americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. the overall goals of the proposed project are to evaluate, in community dwelling alzheimer's disease research center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. the relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. this study will contribute substantially to that effort.

200 adrc participants will be recruited and randomized 100 each to usual care (uc) or {usual care plus an early palliative care intervention} (epc) to be delivered by a nurse over a twelve-month period. the epc will include one nurse-led palliative consult for a two-hour virtual session followed by 11 monthly 30-minute phone/video sessions plus usual care. the study aims are to determine whether epc will lead to (a) eliciting and alleviating the supportive care needs of patients, (b) help them complete and sign (with witnesses) their advance directives and the polst (signed by the patient/proxy and their doctor) upload these into the electronic health records. exploratory outcomes will include health resource use (e.g. hospital admissions and days, emergency visits) for the participants and caregiver burden for their caregivers. mixed-methods framework will be utilized to analyze the audiotapes of the encounters between the research nurse and the patient during the twelve intervention sessions and to assess whether the information that is provided to participants differs by patient ethnicity and cognitive levels.

Eligibility criteria:
inclusion criteria: * all patients enrolled in the stanford alzheimers disease research center (sadrc). * all caregivers enrolled in the stanford alzheimers disease research center (sadrc). exclusion criteria: 1. institutionalized (not a community dweller) at the time of entry into the study; 2. have severe dementia and are incapable of responding to the outcome measures at baseline. 3. participants who live alone and don't have a proxy will be excluded only if they are deemed as lacking the capacity to provide informed consent at the time of entry into the study.

Keywords: palliative supportive mci palliative care supportive care serious illness rct randomized clinical trial mild cognitive impairment primary palliative care
a study of shr-1210 plus apatinib in patients with soft tissue sarcoma

Conditions: Sarcoma

Summary: the main purpose of this study is to evaluate the efficacy of shr-1210 plus apatinib versus amd plus ifo in participants with soft tissue sarcoma.


Eligibility criteria:
inclusion criteria: * male or female subjects with the age from 16 years to 70 years. * eastern cooperative oncology group (ecog) performance status of 0 or 1;the ecog performance status of 2 can be accepted after the amputation. * life expectancy of at least 3 months. * histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.the histopathologic types as specified in the protocol. * without prior systemic chemotherapy or relapse more than 6 months after the completion of last systemic chemotherapy. * presence of measurable disease as defined by the response evaluation criteria in solid tumors (recist 1.1). * acceptable liver function, renal function, hematologic status and coagulation function as specified in the protocol. * females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug. * willingness to comply with the study protocol for any reason. exclusion criteria: * receiving any previous anticancer treatment, other investigational drugs or any attenuated live vaccine with 4 weeks of the first does of study drug. * prior treatment with pd-1/pd-l1/ctla-4 targeted drugs or vegfr targeted drugs. * plan to receive surgery or radiotherapy to treat the sarcoma during the trail. * radiological evidence of brain metastases or primary tumors. * diagnosed other malignancies within the last 3 years from the first dose of drug. * known allergy to any of the treatment components. * active infection including human immunodeficiency virus (hiv) ,hbv or hcv. * concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Keywords: sarcoma shr-1210 apatinib
assessment of esophageal pressure reliability to estimate pleural pressure in critically ill children

Conditions: Mechanical Ventilation

Summary: background during ventilatory assistance, optimization of settings is critical to allow a personalized support and avoid over- or under-assistance. but little data are available in clinical practice to guide the adjustment of the support. in adults, esophageal pressure (pes) has been shown to be a reliable surrogate of pleural pressure (ppl) and clinical studies suggest that pes may be useful to guide the management of mechanical ventilation. in children, the pes measurement could have similar potential benefits, but beforehand the reliability of pes to estimate ppl needs to be assessed. objective the primary objective of this study is to validate the reliability of pes directly monitored using a miniature catheter tip pressure transducer (gaeltec® system) to estimate ppl, when compared to a gold standard, i.e the direct ppl measurement in situ. method this is a prospective single center study. children \<18 years old, hospitalized in the pediatric intensive care unit, requiring invasive ventilation and with at least one chest tube will be included. protocol a pressure transducer will be connected to the existing chest-tube and pes (measured by gaeltec® and feeding tube), ppl, paw, respiratory volume and flow will be simultaneously recorded. expected results we expect that the pes-based methods will provide an accurate estimation of ppl. once this tool validated, pes could be helpful to optimize mechanical ventilation in children, and further interventional trials would be warranted to evaluate if its use could allow a reduction of the ventilation support duration.


Eligibility criteria:
inclusion criteria: * children \<18 years old, hospitalized in the pediatric intensive care unit; * requiring invasive ventilation for more than 4 hours according to the prescription of the attending physician; * with at least one chest tube. exclusion criteria: * contraindications to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical or nasopharyngeal regions, severe coagulation disorder); * hemodynamic instability, as defined by the treating team, and the absence of recent (\<4 hours) increase in the flow of dopamine, epinephrine, norepinephrine, or dobutamine; * respiratory instability defined as a severe respiratory failure requiring fio2 \> 60%, or paco2 \> 80 mmhg on blood gas in the last hour; * persistent pleural effusion or pneumothorax despite the chest-tube; * bronchopleural fistula; * recent (\<12 hours) thoracic hemorrhage; * delayed sternal closure at the time of study; * significant pericardial effusion; * absence of parental or tutor consent; * patient for whom a limitation of life support treatments is discussed or decided.

Keywords: mechanical ventilation children esophageal pressure pleural pressure