Kornimate/medical-research-clean huggingface dataset:
incorporating patient capacity into the clinical landscape

Conditions: Chronic Disease

Summary: this study is designed to answer why "patient capacity" (i.e. patient available abilities and resources to enact self-care and access healthcare) is not regularly documented in the electronic medical record (emr) in a way that is useful for clinicians. through the implementation of communication tools designed for patient capacity assessment and engagement of stakeholders in a process of user-centered design, the study team hypothesizes that the study can help clinicians elicit this information in conversation and regularly document it in the medical record for future healthcare discussions.


Eligibility criteria:
inclusion criteria: * patients who have one or more chronic condition and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment.

Keywords: patient capacity
a follow up study designed to obtain long term data on participants who either achieved a sustained virologic response or did not achieve a sustained virologic response in an abbvie sponsored hepatitis c study

Conditions: Hepatitis C

Summary: a follow-up study to assess resistance and durability of response to 3 experimental drugs abt-450/r, abt-267, and abt-333 in participants who have participated in abbvie phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis c virus (hcv). studies include: m11-646 (nct01716585), m11-652 (nct01464827), m12-746 (nct01306617), m12-998 (nct01458535), m13-098 (nct01715415), m13-099 (nct01704755), m13-386 (nct01563536), m13-389 (nct01674725)' m13-393 (nct01685203), m13-961 (nct01767116), m14-002 (nct01833533), and m14-103 (nct01911845).


Eligibility criteria:
inclusion criteria: * subject has received at least one dose of abt-450, abt-333 or abt-267 in a prior abbvie hcv phase 2 or 3 study which is being submitted as a us ind. * the interval between the last dose of the abbvie daa therapy from the previous clinical study and enrollment in study m13-102 must be no longer than 2 years. * the subject must voluntarily sign and date the informed consent form. * subject completed the post-treatment period of an eligible prior study. exclusion criteria: * the investigator considers the subject unsuitable for the study for any reasons. * receipt of any investigational product from day 1 and while enrolled in this study.

Keywords: chronic hepatitis c hepatitis c virus direct acting antiviral sustained virologic response hepatitis c persistence of treatment-emergent substitutions
reproducibility study of oabss and its response to treatment

Conditions: Overactive Bladder

Summary: the objective of this study is to evaluate change of overactive bladder (oab) symptom score (oabss) scores between before and after solifenacin treatment to oab patients and to evaluate correlation between change of oabss scores and other measures for oab symptoms.


Eligibility criteria:
inclusion criteria: * at screening visit (week -2): * symptoms of oab ≥ 3 months * number of urgency episodes in last 3 days ≥ 3 * based on the 3-day micturition diary prior to visit 1 (week 0): * number of micturition per day ≥ 8 * number of urgency episodes in 3 days ≥ 3 exclusion criteria: * at screening visit (week -2): * stress is the predominant factor as determined by the investigator * indwelling catheters or practicing intermittent self-catheterization * symptomatic urinary tract infection, chronic inflammation * treatment for oab was started, quitted or changed in 4 weeks * diabetic neuropathy * at visit 1 (week 0): * patient who did not complete the 3-day micturition diary according to the instruction

Keywords: solifenacin overactive bladder
the effects of high dose fish oil supplementation on delayed onset muscle soreness and inflammatory markers

Conditions: Muscle Damage; Muscle Inflammation

Summary: the purpose of this study is to determine the effects of fish oil supplementation (lovaza, glaxosmithkline) on muscle strength, muscle soreness and inflammation following exercise.

when a person exercises at a high intensity or starts a new exercise program, muscle soreness will develop. muscle soreness that peaks between 24-72 hours after exercise and diminishes in 5-7 days is characterized as delayed onset muscle soreness (doms). doms is associated with the eccentric phase of exercise, where the muscle is actively creating force while lengthening. the onset of muscle soreness is part of an inflammatory response due to the muscular damage caused by the exercise. research has shown that fish oils have anti-inflammatory properties. direct intake of various polyunsaturated fatty acids (pufa) alters the cell membrane fatty acid composition, which, in turn modulates cell/tissue response to infection, injury and inflammatory events. these properties may be beneficial to relieve muscle soreness. therefore, the purpose of this study is to determine the effects of fish oil supplementation (lovaza, glaxosmithkline, 3 grams per day for 65 days) on muscle strength, muscle soreness and inflammation following exercise. participants will be randomly assigned to one of two groups: lovaza (3 grams/day) or placebo. participants will consume either the lovaza or the placebo for 65 consecutive days. on day 60, participants will have baseline measurements of muscle strength, muscle soreness, creatine kinase activity, and muscle inflammatory marker assessed. participants will then perform eccentric exercise on an isokinetic dynamometer using the quadriceps muscles in order to induce muscle soreness. on each of days 61-65, muscle strength, muscle soreness, creatine kinase activity, and muscle inflammatory markers will again be assessed.

Eligibility criteria:
inclusion criteria: * healthy, free of disease * must be able to swallow capsules * free of orthopedic or muscular injuries * recreationally active * prior consumption of fish and corn with no adverse reactions exclusion criteria: * use of non-steroidal anti-inflammatory drugs (nsaids) or topical analgesics during study enrollment * pregnant or nursing * food allergy to fish or any components of the pills which includes alpha tocopherol, partially hydrogenated vegetable oils including soybean oils and gelatin and glycerol or wheat germ oil * competitive athlete or physically active more than 10 hours per week
metformin and prevention of cardiovascular events in patients with acute myocardial infarction and prediabetes (mimet)

Conditions: PreDiabetes; Acute Myocardial Infarction; Non ST Elevation Myocardial Infarction; ST Elevation Myocardial Infarction

Summary: prediabetes is associated to an increased risk of cardiovascular disease and mortality. although metformin can delay progression to diabetes there is a lack of rcts evaluating the effect of metformin on cardiovascular outcomes. mimet aims to investigate if addition of metformin to standard care has effects on the occurrence of cardiovascular events after acute myocardial infarction in patients with newly detected prediabetes (identified by oral glucose tolerance test, hba1c or fasting glucose levels).

the study is a national multicenter r-rct associated to the the swedish web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (swedeheart registry) where participants, after informed consent, will be randomly assigned to either open treatment with standard care + metformin or standard care alone in a 1:1 ratio. standard care consists of diet and life-style advice according to national guidelines but does not include metformin. baseline data for individual patients will be collected from the swedeheart registry. patients will be followed per routine care at 2 and 12 months post index ami and in addition at a final study visit at 24 months. laboratory measurements and collection of sae will be performed yearly. in total n=5150 patients is expected to be followed for major cv event (all-cause mortality, myocardial infarction, heart failure and stroke) by linkage with swedeheart and national health registries.

Eligibility criteria:
inclusion criteria: i. ami ii. swedish citizens with a personal id number ≥18 years and ≤80 years iii. newly diagnosed prediabetes: 1. hba1c 42-47 mmol/mol or 2. capillary or venous fasting plasma glucose concentration 6.1-6.9 mmol/l or 3. 2-hour post-load capillary glucose concentration 8.9-12.1 mmol/l or 4. 2-h post-load venous plasma glucose concentration 7.8-11.0 mmol/l 5. hba1c \ 12.1 mmol/l or 2-h post-load venous plasma glucose concentration \>11.0 mmol/l (thus elevated 2-hour glucose levels in the diabetes range but without hba1c levels diagnostic for diabetes) iv. naïve to metformin and other glucose lowering therapy v. signed informed consent exclusion criteria: i. type 1 diabetes ii. known type 2 diabetes iii. indication for glucose lowering treatment iv. acute condition with high risk for volume depletion, circulatory shock, hypoxia v. serious illness, other than cardiovascular, with short life expectancy vi. renal failure (egfr \<60ml/min) vii. hepatic failure viii. malignancy within the last year ix. contraindication or hypersensitivity to the study drug x. alcohol or drug abuse xi. pregnancy or breastfeeding xii. women of childbearing potential without adequate anticonception during any part of the study period xiii. previous hospitalisation for lactic acidosis xiv. predicted inability to comply with the study protocol
vegf signaling promotes cell growth and metastasis in intrahepatic cholangiocarcinoma in a vegf receptor mediated pathway

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the investigators study the vegf signaling in icc cell lines／human tissues and its mechanism in hcc growth, proliferation and apoptosis.

several studies have documented the elevated expression of vegf and its receptors in icc cell lines and tumor tissues. another study observed that the elevation of vegf promotes the growth. clinical analyses have discovered the high expression of vegf is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. however, few studies have been conducted to investigate the vegf signaling in icc cells and its possible mechanism in regulating icc growth.therefore,we try to clarify the mechanism of vegf signal in icc growth,proliferation and apoptosis.

Eligibility criteria:
inclusion criteria: 1. hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma and ca199\>100u/l；or two or more dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma 2. child-pugh a or b 3. well preserved renal and hematopoietic function 4. receive complete surgical therapy 5. achieve complete section accessed by contrast-enhanced ct exclusion criteria: 1. incomplete section 2. child-pugh c 3. combination with other hepatobiliary disease 4. suffer from other tumors concurrently or in last five years

Keywords: intrahepatic cholangiocarcinoma icc vegf signal pathway
rota-biotic: measuring the impact of rotavirus vaccines on paediatric antibiotic usage

Conditions: Rotavirus Gastroenteritis; Rotavirus Vaccines; Antimicrobial Resistance (AMR); Antibiotic; Microbiome; Infant Diarrhea

Summary: rotavirus is the most common aetiology of serious diarrhoea in young children. despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribing in low-income settings. we hypothesized that effective rotavirus vaccination could reduce diarrhoeal episodes and thereby unnecessary antibiotic usage in young children in low-income settings. the study aimed to evaluate the impact of rotavirus vaccination on antibiotic usage. specifically, the study quantified how differences in rotavirus vaccine efficacy would impact days of prescription and nonprescription antibiotic usage in the first 2 years of life among two large cohorts of children in zambia and ghana. the key goal was to understand the effect of rotavirus vaccine efficacy on antibiotic usage and household antibiotic costs. the goal was to generate evidence needed to inform policymakers seeking to introduce new rotavirus vaccines into national vaccination programs, of potential, and often under-appreciated, secondary effects of rotavirus vaccine implementation on antibiotic usage. the study was conducted within a phase iii randomised controlled trial comparing the efficacy of a new parenteral trivalent p2-vp8 subunit rotavirus vaccine to the oral live attenuated vaccine, rotarix®, against severe rotavirus gastroenteritis in the first 2 years of life in zambia and ghana.


Eligibility criteria:
inclusion criteria: healthy infants as established by medical history and clinical examination before randomisation into the study age: ≥6 and \<8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old) parental ability and willingness to provide written informed consent. intention of the participants' parents to remain in the area with the child during the study period exclusion criteria: acute disease at the time of enrollment/first study vaccination - temporary exclusion presence of fever on the day of enrollment/first study vaccination (axillary temperature \>37.6oc) concurrent participation in another clinical trial (other than the parent study) throughout the entire timeframe for this study. presence of severe malnutrition (weight-for-height z-score ≤-3sd median (per who published child growth standards) history of premature birth (\<37 weeks gestation) and/or birth weight of \<2.5 kg history of congenital abdominal disorders, intussusception, or abdominal surgery prior receipt of rotavirus vaccine
the impact of germanium-embedded knee brace on patient recovery after knee arthroscopy

Conditions: Knee Arthroscopy; Knee Arthropathy Associated With Other Conditions

Summary: anti-inflammatory brace technology has demonstrated superior clinical outcomes in the management of knee osteoarthritis and accelerate recovery time for major league soccer players. authors have postulated that embedding germanium into cotton garments increases circulation and augments the inflammatory process through a transdermal micro-electromagnetic field. in addition to immunomodulatory effects, knee braces immobilize and stabilize the joint through tactile feedback from the skin. thus, a germanium-embedded knee brace may provide inflammatory control to augment pain and edema while concomitantly enhancing proprioception. knee arthroscopy rehabilitation goals during the acute post-operative phase include diminishment of pain and edema as well as restoration of knee range-of-motion. the presented study intends to assess the impact of a germanium-embedded knee brace on patient recovery after knee arthroscopy. single-center blinded randomized controlled clinical trial to study effectiveness of germanium-infused knee brace on rehabilitation in patient population undergoing knee arthroscopy. patients will be randomized into germanium-infused knee brace group and compared to a replica knee brace group. inclusion criteria will include skeletally mature individuals undergoing primary knee arthroscopy. exclusion criteria will include autoimmune disorders and history of surgery on ipsilateral joint. the presented protocol intends to assess the impact of a germanium-embedded knee brace on patient recovery after knee arthroscopy. the primary outcome measure was chosen for its implications for the design and conduct of the study,1 including well-validated outcome instrument for comparison, facilitation of a priori power analysis, randomization, and blinding. secondary outcomes were chosen for their pertinence to surgeon decision-making during patient rehabilitation.


Eligibility criteria:
inclusion criteria: * 18-100 years old * male or female * compliant patient * bmi less than 35 * undergoing knee arthroscopy within 30 days exclusion criteria: * rheumatoid arthritis * poorly controlled diabetes (hga1c \> 7.5) * previous blood clots * bmi greater than 35 * varicosities on operative leg
in-home technology for caregivers of people with dementia and mild cognitive impairment

Conditions: Dementia; Mild Cognitive Impairment; Alzheimer Disease

Summary: this study aims to develop and evaluate new in-home supportive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with alzheimer's disease, other dementias, or mild cognitive impairment.

this study aims to develop, refine, and evaluate a new hardware/software system designed to integrate in-home sensors and devices, internet-of-things technologies (i.e., devices that can be controlled and communicated with via the internet), and social networking to create a more safe and supportive home environment for caregivers and people who have alzheimer's disease, other dementias, or mild cognitive impairment. the system monitors troublesome behaviors in people with dementia or mild cognitive impairment (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia or mild cognitive impairment with adverse caregiver outcomes (declines in health and well-being). the system is designed to minimize demands on caregivers' limited time and energy and to provide a platform for data collection that can be used by researchers and care professionals. hypotheses: 1. caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, better mental and physical health, higher well-being) than those in the control condition. 2. greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms. 3. greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.

Eligibility criteria:
inclusion criteria: * caregivers are fluent/literate in english * caregivers currently reside with spouse/family member who has received a diagnosis of alzheimer's disease, other dementias, or mild cognitive impairment * caregivers primarily use a smartphone (e.g., iphone, android) * caregiver has wireless internet in home exclusion criteria: * caregivers providing care for individuals with known non-neurodegenerative conditions affecting behavior and cognition * caregivers providing care for individuals with longstanding axis i psychiatric disorder * caregivers providing care for individuals with metabolic disorder or major organ dysfunction * caregivers providing care for individuals with alcohol abuse or dependence (within 5 years of dementia onset) * caregivers providing care for individuals with head trauma with loss of consciousness greater than 30 minutes * caregivers providing care for individuals with contraindications to mri imaging * caregivers providing care for individuals with large confluent white matter lesions * caregivers providing care for individuals with significant systemic medical illness * caregivers providing care for individuals who use a medication likely to affect central nervous system functions adversely

Keywords: caregivers dementia mild cognitive impairment in-home technology alzheimer disease
rehabilitation of dynamic muscle, back pain and postural balance

Conditions: Low Back Pain

Summary: workers in the various branches of the investigators industrial society can be considered as a group susceptible to risks due to the nature of its activities related to the intense demands of their work units with varying degrees of physical overload. among the risk factors involved in postural genesis of occupational low back pain is work in uncomfortable positions, such as maintenance of static postures for long periods of time and frequent implementation of flexion, extension and trunk rotation.the association between body instability (lack of postural balance) and back pain is seen with some frequency, especially in working groups.

the aim of this study was to investigate the effect of rehabilitation of the dynamic muscle (rdm®) in back pain and postural balance of industrial operators. the sample consisted of industrial operators, individuals with low back pain, referred to the industry of physical therapy. after the screening criteria of inclusion and exclusion, 82 individuals were randomly selected and divided at random in: experimental group (ge, n = 41, age = 41 ± 4 years, body mass index (imc) = 26.46 ± 3 , 25) and control group (cg, n = 42, age = 42 ± 5 years, imc = 26.47 ± 3.34). the ge was part of treatment with rdm. the cg was composed of individuals who did not participate in any physical therapy treatment during the search. the procedures used for evaluation were: back pain (borg scale) and postural balance (pedana stabilometric and posturométrica). the process of intervention by the rdm had a duration of 20 minutes, frequency of twice a week and was extended for 12 weeks, and the systematic treatment performed on 4 occasions.

Eligibility criteria:
inclusion criteria: * fcc officials with medical indication of low back pain to perform physical therapy or medical exclusion criteria: * the investigators excluded patients who were doing treatment with medication and who reported worsening of the crisis period.

Keywords: back pain postural balance rdm industrial operators
a sequential allocation study to determine the ed50 of dexmetedomidine as an adjuvant to lidocaine intravenous regional anesthesia

Conditions: Bier Block; Dexmedetomidine; Tourniquet Pain; Carpal Tunnel; Tendon Release; Tendn Transfer

Summary: intravenous regional anesthesia (ivra) is an easy and reliable anesthetic technique for hand and forearm surgery. its use is however limited by the presence of tourniquet pain during the surgery and the absence of postoperative analgesia. many adjuvants to local anesthetics have been studied in order to overcome these shortcomings, including α2 adrenergic agonists. clonidine has been shown to be efficacious when used with ivra at a dose of 1µg/kg. dexmetedomidine (dex) is a recent more selective α2 adrenergic agonist that has been used successfully during ivra at a dose of 0.5µg/kg. however when comparing potency ratios of clonidine and dex (8 to 1), the investigators hypothesize that a lower dex dose would provide patients with adequate anesthesia. we will determine the population average dose of dex (ed50) that provides 50 minutes of tolerance to the tourniquet during a lidocaine ivra by a sequential dixon up-down allocation study. eligible patients will be enrolled after obtaining informed consent. patients will receive a standardized ivra with lidocaine and dex adjuvant following a sequential allocation scheme. the first patient will receive a dose of 0.5 µg/kg of dex. the dose will be then adjusted in 0.1 µg/kg increments for the following patients dependent on the success of the previous patients block. if a patient experiences tourniquet pain prior to 50 minutes after inflation of the distal tourniquet the next patient will receive a higher dose, if he does not experience pain prior to 50 minutes after inflation of the distal tourniquet the dose for the following patient will be decreased. recruitment will continue until 6 independent crossovers are observed with a minimum of 20 patients. the mean and the standard deviation of the ed50 of dex will be calculated using the modified up-down method. this study will help determine the ed50 of dex used as an adjuvant in ivra. based on the potency ratios of clonidine vs. dex, the investigators hypothesize that the dose of dex needed to achieve 50 minutes of pain free tourniquet time will be closer to 0.125 µg/kg rather than 0.5 µg/kg, a 75% reduction in the dose studied.


Eligibility criteria:
inclusion criteria: • patients 18 to 70 years of age, asa physical status i-ii, undergoing unilateral hand or forearm surgery (that require 30 minutes or more) under ivra. exclusion criteria: •patients with raynaud's disease, sickle cell anemia, heart block, allergy to any of the anesthetic drugs used, patients on α-adrenergic agonists, asa iii or iv, emergency surgery and pregnant patients., weight greater than 100kg.