Kornimate/medical-research-clean huggingface dataset:
msc - onebiome ux pilot study

Conditions: Microbial Colonization

Summary: evaluating the user (pregnant women and parents of young children) experience of the onebiome consumers value journey service offered to the 1000 days and young children consumers market

the onebiome service aims to empower consumers with microbiome science in a friendly/consumer centric manner. the investigators wants to show that microbiome data can be used as an estimate of consumer's health and can be translated into actionable insights. the investigators aim to pilot a consumers' insight study to measure the perception/sentiments of this service in the singapore market by recruiting study subjects from local public/private hospitals.

Eligibility criteria:
inclusion criteria: 1. pregnant women who are in the third trimester, or children from birth to 5 years of age 2. pregnant women or parents of children should have access to the internet and a smartphone or tablet to access the onebiome mobile friendly website. 3. pregnant women or parents of children should be able to comprehend the content in the onebiome mobile friendly website and complete the questionnaires in english. 4. pregnant women and parents of children should stay in singapore and remain contactable should they decide to do two microbiome assessments within 8 weeks exclusion criteria: 1. children born prematurely 2. incapability of the pregnant women or parents of children to access onebiome mobile friendly website and complete the questionnaires in english. 3. any other family member is enrolled in the study 4. incapability of the pregnant women or parents of children to comply with study protocol or investigator's uncertainty about the willingness or ability of the pregnant women or parents of children to comply with the protocol requirements

Keywords: onebiome consumer insights user experience
preoperative levosimendán and hip fracture

Conditions: Ventricular Dysfunction, Left; Hip Fracture

Summary: the purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters.

hip fracture is a very predominant entity in elderly patients and it is one of the most frequent cause of admission in a hospital. elderly patients undergoing surgery for hip fracture have a high risk of morbidity and mortality in the postoperative. several studies have shown that there is a high risk of cardiovascular complications in this group of patients and 3-months mortality is 15-20%. one of the causes of this high morbidity and mortality is the high incidence of chronic cardiac failure in this patients. the goal of the present study is to evaluate if the optimization of preoperative cardiac function with levosimendan in patients with left ventricular ejection fraction \< 45% can improve haemodynamic and the tissue perfusion values, and reduce cardiac morbidity and mortality 3 months postoperatively. following written consent, the patients with left ventricular ejection fraction \< 45% will be admitted in the resuscitation and anaesthesia room where they will receive a levosimendan intravenous injection undergoing a strict haemodynamic vigilance. before the levosimendan intravenous injection the patients firs have an echocardiography to evaluate myocardial function, nt-probnp. subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a proaqt sensor system ( pulsion , edwards). the system uses pulse wave analysis to assess several parameters including: stroke volume index (svi), cardiac index (ci), systemic vascular resistance index (svri), cardiac power index (cpi).the levosimendan will be administered like a continues injection during 24 hours (0,1 mcg/kg/min) without initial dose. following the optimization the patients will be transferred to the operating room in the next 3 days and will come back to the resuscitation and anaesthesia room where they will stay 24 hours more if there is no any complication. all the cardiac complications will be documented and follw-up will be done by after 30 days and 3 months postoperative. the patients will be selected for more than 24 months.

Eligibility criteria:
inclusion criteria: 1. patients due to undergo urgent of hip fracture. 2. patients with cardiac failure (ef \< 45 %). 3. decompensated heart failure. 4. informed consent provided by the patient. exclusion criteria: 1. \<18 years old 2. emergency surgery 3. serious aortic stenosis (\< 1 cm2) 4. sustained ventricular tachycardia or atrial fibrillation \>140 5. earlier episodes of "torsades depointes" 6. systolic blood pressure \< 85 mmhg 7. serious kidney failure (gfr \< 30 ml/min) 8. serious liver failure (known class c child-pugh score) 9. allergy levosimendan
csl312 (garadacimab) in the prevention of hereditary angioedema attacks

Conditions: Hereditary Angioedema

Summary: this is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of csl312 (garadacimab) in the prophylactic treatment of hereditary angioedema.


Eligibility criteria:
inclusion criteria: * male or female ≥ 12 years of age; diagnosed with clinically confirmed c1-inh hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening. note: for subjects taking any prophylactic hae therapy during the 3 months before screening, ≥ 3 hae attacks may be documented over 3 consecutive months before commencing the prophylactic therapy. exclusion criteria: * concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3
user-friendly spirometer and mobile app for self-management and home monitoring of asthma patients

Conditions: Asthma Acute; Asthma in Children; Asthma Chronic; Asthma Attack

Summary: the primary goal of this proposal is to use an in-home, smartphone-enabled, hand-held spirometer to determine the fev1% predicted ranges that predict the yellow zone threshold.

the study hypothesizes that objective lung function tracking at-home, using a portable spirometer in addition to conventional symptom monitoring (in which asthmatic patients self-report and track their own symptoms), will result in more reliable detection of exacerbation in children 6-15 years old with asthma. this is a 44-week, single arm, blinded nonrandomized trial to determine clinically relevant ranges in fev1% predicted that correlate with the yellow zone of the asthma action plan. a total of 100 pediatric subjects (between the ages of 6 and 15 years old) with physician-diagnosed mild or moderate persistent asthma treated on controller therapy will be enrolled from the ed, inpatient units, pulmonary medicine clinic, and allergy/immunology clinic at ucsf benioff children's hospital san francisco. primary specific aim to determine the fev1% predicted changes that correspond with a change from the green to yellow zone. the primary outcome will be yellow zone episodes, as identified by the occurence of any of the following: symptom diary score \> 4 ataq score \> 1 secondary specific aim to determine the fev1% predicted changes that correspond with a change from the yellow to red zone. the secondary outcome will red zone episodes, as identified by the occurence of any of the following: ed or urgent care visit administration of systemic (oral, im, or iv) corticosteroids hospitalization

Eligibility criteria:
inclusion criteria: 1. physician-diagnosed mild or moderate persistent asthma 2. on controller therapy \[inhaled corticosteroid (ics), ics + leukotriene receptor antagonist (ltra), or ics + long-acting beta agonist (laba)\] for at least the previous six months 3. at least one severe exacerbation requiring systemic corticosteroids in the previous year 4. baseline fev1 \>/= 70% predicted for age, gender, and height according to published reference standards 5. parental consent and the child's assent exclusion criteria: 1. chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis, primary ciliary dyskinesia) 2. severe persistent asthma, as evidenced by any of the following: * 3 hospitalizations * 6 severe exacerbations in the previous year on chronic oral corticosteroid therapy daily symptoms 3. inability to perform acceptable spirometry 4. history of collapsed lung 5. history of syncope with forced exhalation 6. not owning an ios™ device (e.g., iphone®, ipod®, or ipad®) 7. lacking access to wireless local area networking (wi-fi™)

Keywords: asthma, children, spirometry, lung function, asthma action plan, asthma exacerbation, self management
effects of the buddy-up dyadic physical activity program on health outcomes of care dyads of dementia: a pilot study

Conditions: Mild Dementia; Moderate Dementia

Summary: this project seeks to develop a novel dyadic intervention (titled as buddy-up dyadic physical activity; budpa), using exercise as the common treatment component to improve the cognitive outcomes of persons with dementia and manage the stress-related symptoms of their family caregivers.

this project is a pilot study that seeks to develop a novel dyadic budpa intervention, using exercise as the common treatment component to improve the cognitive outcomes of persons with dementia and manage the stress-related symptoms of their family caregivers. budpa has integrated the concept of developing social capital for dementia management. by applying partner exercise, the longer-term provider for this therapeutic care will be shifted from service providers to the family caregivers and the persons with dementia. helping them to translate the practice to a home-care setting further strengthens the notions of family responsibility and ability in dementia management. budpa fully engages the care dyads in a mutual helping relationship during the exercise training. the partner exercise also creates a platform to enable more meaningful encounter within the care dyad. the family caregivers are facilitated to find meaning in the caregiving process, which eventually can benefit their role commitment and mental wellness. also, the use of mixed-method study design can provide high quality findings to inform both the feasibility and preliminary effects of the budpa program.

Eligibility criteria:
inclusion criteria: for pwd, * confirmed diagnosed of mild to moderate-intensity dementia * cognitive impairment as indicated by a hk-montreal cognitive assessment (hong kong version; hk-moca) score of 8-19 to indicate mild to early moderate dementia will be recruited for family caregivers * live together with the pwd * identify as the primary family caregivers of the pwd exclusion criteria: * engaging in \> 60 minutes per week of moderate or more vigorous exercise in the previous six months * acute muscular-skeletal problem, stroke or cardio-respiratory disease.

Keywords: mild to early moderate dementia
vitamin d replacement after kidney transplant

Conditions: Kidney Transplantation; Vitamin D Deficiency

Summary: vitamin d deficiency accelerates vascular risk progression after kidney transplant.

this trial will assess the following aims: 1. time to plateau vitamin d concentrations after initiating vitamin d supplements 2. safety of vitamin d replacement based on serum and urine calcium 3. effect of vitamin d on pth concentration in individuals with elevated parathyroid hormone 4. effect of vitamin d on markers of insulin resistance and inflammation

Eligibility criteria:
inclusion criteria: * kidney transplant more than 6 months ago * 19 years or older * 25-hydroxy vitamin d ≤35 ng/ml exclusion criteria: * estimated glomerular filtration rate (gfr) \<30 ml/min/1.73m² * previous small bowel or lung transplant * pancreas transplant less than 6 months ago * cancer or any condition that would change their weight dramatically in the near future such as malabsorption * willing to return for testing every two months * women who are pregnant or \< 6 weeks postpartum * calcium \> 10.5 mg/dl * phosphate \> 4.8 mg/dl * drinking more than 2 alcohol drinks a day or 14 drinks per week * history of parathyroid surgery * known granulomatous disease * taking any seizure medication that affects vitamin d * taking zemplar ® and/or rocaltrol ® * history of kidney stones in the past 20 years * not on a stable dose of bisphosphonate for the past three months * planning on a pancreas transplant within the next year * in any other research study

Keywords: kidney transplantation (ktx) vitamin d deficiency cardiovascular disease (cvd) vascular risk parathyroid hormone (pth) carotid intima media thickness (cimt) insulin resistance (ir)
clofarabine in chronic lymphocytic leukemia

Conditions: Hematologic Neoplasms; Lymphoproliferative Disorders; Leukemia; Leukemia, Lymphocytic, Chronic

Summary: this is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. thus, it is hoped that this drug will be more active and less toxic than similar drugs.

the first group of patients will be treated at the starting dose level of 2 mg/m2 over 1 hour daily for 5 days. dosage escalation will be permitted in individual patients if no toxicity occurred during the preceding course. subsequent dose escalations will be by 50% until grade 2 toxicity, then by 35% until the maximum tolerated dose. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
inclusion criteria: * diagnosis of chronic lymphocytic leukemia * diagnosis of other acute leukemia * at least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy * recovered from toxic effects of prior therapy * bilirubin no greater than 2 mg/dl * creatinine no greater than 1.5 mg/dl exclusion criteria: * candidate for treatment of higher efficacy or priority * pregnant or nursing

Keywords: acute leukemia chronic lymphocytic leukemia antineoplastic agents nucleosides dose-response relationship, drug cladribine fludarabine
adaptation of perioperative satisfaction scale in regional anesthesia and investigation of its psychometric properties

Conditions: Scales, Repression-Sensitization; Anesthesia Awareness

Summary: the aim of the study is to determine the psychometric properties of perioperative satisfaction scale in regional anesthesia. in the turkish version of the scale, a blind reverse translation method will use. and validity and reliability analyses will conduct.

the aim of the present research is to contribute to the international literature determining and describing the factor structure and psychometric qualities of the perioperative satisfaction scale in regional anesthesia. an additional aim is to contribute to the national literature regarding the performance of the instrument in cross-cultural adaptation. the following steps will be taken: (a) translation of the scale from english into turkish, (b) data collection, and (c) checking validity and reliability evidence for the adapted perioperative satisfaction scale in regional anesthesia.

Eligibility criteria:
inclusion criteria: * volunteer to participate in the research * participants are over 18 years of age * provided regional anesthesia * postoperative second day * no cognitive problems in self-expression exclusion criteria: * lack of turkish literacy * use of anesthesia technique other than regional anesthesia

Keywords: scale validity reliability
dual-antiplatelet therapy strategies for elective pci in a real-world setting

Conditions: Coronary Artery Disease

Summary: to assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc pci versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc pci.


Eligibility criteria:
inclusion criteria: * adult men and women aged at least 18 years * scheduled for diagnostic cag due to suspected obstructive coronary artery disease exclusion criteria: * presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding, patients known to be poor cyp2c19 metabolizers, patients using pharmacological cyp2c19 inhibitors and inducers) * patients using clopidogrel for other reasons than the scheduled diagnostic cag (e.g. due to previous stroke) * patients using p2y12 inhibitors other than clopidogrel (e.g. prasugrel, ticagrelor, cangrelor) * patients using vka (e.g. acenocoumarol, fenprocoumon) * patients using doac/noac (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) * inability to give informed consent (e.g., language barrier) * patients who have a documented mentioning of previous denial to any trial participation in the electronic patient dossier

Keywords: pretreatment diagnostic angiography ad-hoc pci
cobiprostone prevention of nsaid-induced gastroduodenal injury

Conditions: NSAID-induced Gastroduodenal Injury; Ulcers; Rheumatoid Arthritis; Osteoarthritis

Summary: the primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in oa/ra patients treated with an nsaid for 20 months.


Eligibility criteria:
inclusion criteria: * patient is more than 40 and less than 70 years of age. * patient has confirmed osteoarthritis (oa) and/or rheumatoid arthritis (ra) and could benefit from nsaid therapy. * no current gastrointestinal h. pylori infection. exclusion criteria: * known allergy or hypersensitivity to nsaids, or has any other contraindicated condition(s) to nsaid therapy. * patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the screening visit, or has had a bowel resection at any time. * medical history includes prior or active gi complications and/or disorders, including but not limited to barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (ibs), or inflammatory bowel disease (ibd). * active symptomatic peptic ulcer disease or gi bleeding. * patient has received cobiprostone (spi-8811; ru-8811) or amitiza (other names: lubiprostone, spi-0211, or ru-0211) at any time prior to participation in this study.
comparison of two tooth-borne expanders in rapid maxillary expansion

Conditions: Malocclusion; Posterior Crossbite

Summary: this study will assess the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in orthodontic patients with permanent dentition, from 12 to 16 years old. half of participants will be treated using the hyrax expander, while the other half will use the mini hyrax expander. the null hypothesis is that there is no difference between dentoalveolar effects and impact on quality of life of the two protocols.

transverse maxilla deficiency is characterized by narrowing of the maxillary arch with important functional and esthetic impact. in individuals which have not reached bone maturity, a rapid expansion of the maxilla by using tooth-borne expanders as haas and hyrax appliance are efficient and safe. a presentation of favorable results for the "mini-hyrax inverted" expander with a small screw in the transversal correction of the maxilla in patients with cleft lip and palate, besides improving the comfort and the teeth cleaning, provoked an idea of application of this small screw to correct posterior crossbite in individuals without cleft lip and palate. the objective of this study is to compare the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in adolescent patients with permanent dentition and active bone growth. the sample size calculation indicated a total sample of 28 individuals. taking into account the loss of sample during the study, 34 subjects that have posterior crossbite and age from 12 to 16 years, will be recruited at the dental school, pontifical university catholic of minas gerais, belo horizonte, minas gerais, brazil. these patients will be randomly divided into two groups, hyrax and mini hyrax, with 17 patients each. digital models of both dental arches will be obtained by intraoral scanning precede the procedure (t0) and at the end of the retention period, after appliance removal (t2). ohip-14 oral health impact profile questionnaires, validated in portuguese, will be applied before expansion (t0), after an expansion (t1) and at the end of the retention period (t2). in digital dental models, maxillary first and second bicuspids and first molar width, and rotation and inclination of maxillary first bicuspids and first molars will be assessed. after the normality test, the appropriate statistical test will be used in the intergroup comparison. a significance level of 5% will be regarded for all tests.

Eligibility criteria:
inclusion criteria: * maxillary permanent dentition, except canines * ages ranging from 12 to 16 years old; * maxillary constriction associated to posterior crossbite uni or bilateral. exclusion criteria: * cleft lip and palate; * craniofacial syndromes; * carious lesions; * history of previous orthodontic treatment.

Keywords: palatal expansion technique adolescent quality of life
natalizumab and chronic inflammation

Conditions: Multiple Sclerosis

Summary: in this study the investigators will assess the ability of natalizumab, a medication given to treat multiple sclerosis (ms), to restore blood brain barrier integrity and repair subtle leakages of the blood brain barrier (bbb).

the investigators will image a cohort of persons with relapsing remitting multiple sclerosis (pwrrms) using dynamic contrast-enhanced magnetic resonance imaging (dce-mri) and selective inversion recovery quantitative magnetization transfer imaging (sir-qmt). pwrrms will be imaged at baseline and at month-3 and month-12, after starting treatment with natalizumab. changes in ktrans, a measure of bbb permeability derived from dce-mri, and in pool saturation ratio (psr) a measure of myelin integrity derived from sir-qmt will be computed to assess the ability of natalizumab to fully restore bbb integrity. as a corollary aim, the investigators will assess changes in quality of life (qol) measurements and the relation between those measurements and those derived from the above detailed quantitative mri methods. qol will be measured using the visual analogue scale. this questionnaire entails 13 questions regarding the perceived effect of tysabri, but also level of pain, fatigue, anxiety, depression before and during treatment with natalizumab. the answer to each question is rated on a color-coded bar the range of which is between 0 to 100.

Eligibility criteria:
inclusion criteria: 1. multiple sclerosis 2. clinical eligibility to treatment with natalizumab 3. no previous exposure to natalizumab treatment exclusion criteria: 1. inability to perform an mri with contrast 2. inability to undergo a paper-pencil questionnaires and blood work

Keywords: multiple sclerosis, mri, blood brain barrier, myelin