Kornimate/medical-research-clean huggingface dataset:
a clinical comparison of an experimental power brush compared to a manual toothbrush

Conditions: Gingivitis; Dental Plaque

Summary: the objective of the study is to evaluate and compare the efficacy of an experimental power brush to a regular manual brush in the reduction of gingivitis and dental plaque over an 8 week period by using the modified gingival index, the gingival bleeding index and the rustogi modification of the navy plaque index.


Eligibility criteria:
inclusion criteria: * give written informed consent prior to study participation and be given a signed copy of their informed consent form * be at least 18 years of age and typically use a manual toothbrush; * be in good general health as determined by the investigator/designee based on a review/update of their medical history; * possess a minimum of 16 natural teeth with facial and lingual scorable surfaces; * have a baseline pre-brushing mgi score of at least 1.75; * have a baseline pre-brushing rmnpi score of greater than 0.5; * have at least 20 bleeding sites (sites with a score of 1 or 2 on the gbi index) for baseline pre-brushing; * agree not to participate in any other oral care study for the duration of this study; * agree to not to have any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received at any time during the course of this study; * agree to refrain from using any non-study oral hygiene products for the study duration; * agree to return for all their scheduled visits and to follow all study procedures; * refrained from brushing their teeth or from performing any other oral hygiene procedures anytime within the 12 hours prior to their morning brushing and agree to follow these same restrictions prior to all visits except (the week 1 p.m. visit); * refrained from any oral hygiene, eating, drinking\* (except small sips of water), chewing gum, and tobacco use for at least 3 hours but not more than 6 hours prior to this visit and agree to follow these same restrictions prior to all p.m. visits. exclusion criteria: * a condition requiring the need for antibiotic premedication prior to dental procedures; * severe periodontal disease, including but not limited to, purulent exudates, generalized mobility, and/or severe recession; * teeth that are grossly carious, fully crowned, or extensively restored; * active treatment for the following conditions: periodontitis, cancer, or a seizure disorder; * report to be nursing or pregnant, or intend to become pregnant any time during the course of this study; * taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks; * have any of the following: orthodontic appliances, removable partial dentures, peri/oral piercings, a pacemaker or other implanted device; * oral/gum surgery within the previous two months; * a disease or condition that could possibly interfere with examination/procedures or with the subject's safe completion of this study.
screening for occult malignancy in idiopathic venous thromboembolism

Conditions: Venous Thromboembolism

Summary: prospective controlled randomized study. aim of this study is to assess the feasibility and sensitivity of ct scanning of the thorax, abdomen and pelvis for the detection of occult cancer in patients with idiopathic venous thromboembolism. patients presenting with acute idiopathic venous thromboembolism, free from already known cancer and in whom a routine battery screening has excluded the presence of cancer, are randomized to receive either a ct scanning of the thorax, abdomen and pelvis (completed by mammography if not already performed in the past year, and by gastroscopy and/or colonoscopy in patients with positive hemoccult) or a diagnostic programme freely decided by attending physicians. patients of either group in whom the search for cancer is negative are followed-up for two years to register the development of clinically symptomatic malignant disease. the rate of cancer detection and that of cancer development are compared between the two study groups.


Eligibility criteria:
inclusion criteria: * idiopathic venous thromboembolism exclusion criteria: * cancer already known or shown by routine battery tests * previous venous thromboembolism * geographic inaccessibility for long-term follow-up * allergy to contrast medium * refusal of informed consensus
phase 2b/3 trial of nusepin® in covid-19 pneumonia patients

Conditions: COVID-19 Pneumonia

Summary: a randomized, double-blinded, placebo-controlled, parallel-treatment group, adaptive design, multi-center, phase 2b/3 trial to evaluate efficacy and safety of nusepin® intravenous infusion in covid-19 pneumonia patients


Eligibility criteria:
inclusion criteria: 1. an individual who or whose legally authorized representative has fully informed of all pertinent aspect of the trial and imp, voluntarily decided to participate in the trial and adherence to the trial-related requirements, and provided a written informed consent 2. an adult man or woman aged between 19 years (or age of majority in his/her country) and 80 years. 3. a hospitalized patient with laboratory-confirmed sars-cov-2 infection by pcr test within 10 days (240 hours) prior to randomization. 4. at the time of randomization; whose clinical status is stage 4 (oxygenation by facial mask or nasal cannula) or 5 (non-invasive ventilation or high flow oxygen) on who 8-point ordinal scale 5. pneumonia that satisfies all the following criteria at the time of randomization 6. planned first dosing of the imp not later than 2 days after the initiation of standard of care (soc), when given in combination with soc for severe illness (according to nih clinical spectrum of sars-cov-2 infection) 7. a score of 5 points or more ("think sepsis") on the news 2 scale at the time of randomization exclusion criteria: 1. a patient whose clinical status is stage 3 or lower on the who 8-point ordinal scale (who 8-os) at the time of randomization 2. an individual who requires endotracheal intubation, mechanical ventilation (who 8-os stage 6), or extracorporeal membrane oxygen therapy (stage 7) at the time of randomization 3. a patient with multiorgan failure, shock, acute respiratory syndrome (ards) 4. a patient with renal dysfunction defined by egfr less than 30ml/min/1.73m², or the use of hemodialysis or hemofiltration 5. cholestatic liver disease (example: biliary obstruction, cholangitis, etc.) or hepatic dysfunction 6. any of the following laboratory test results at the time of screening: 7. an individual with hiv-positive results or who requires antiviral treatments against active hepatitis (hbv, hcv) and etc.
galactooligosaccharide (gos) supplementation and calcium absorption in girls

Conditions: Osteoporosis

Summary: the purpose of this study is to determine the effects of galactooligosaccharide (gos) supplementation on calcium absorption and and gut microbe profiles.

galactooligosaccharides (gos) have been shown to have positive effects on calcium absorption in animals and postmenopausal women. this study aims to see whether the addition of fiber in the form of gos to a calcium-containing yogurt drink will increase calcium absorption compared to placebo in a group of girls near menarche. secondary outcomes are to assess physical fitness and determine the relationship between physical fitness and calcium absorption in adolescent girls as well as assess changes in gut microbiota. during this three phase, randomized, controlled crossover study, participants will consume yogurt drinks supplemented with 0, 2.5 or 5 grams of gos twice daily for three weeks. following each three week period, participants will complete a weekend clinical visit to measure calcium absorption. height, weight, bone density and geometry, calcium absorption, gut microbiota and physical fitness will be measured. effects of this gos fiber intervention may help elucidate a mechanism of action for improving bone health with fiber supplementation.

Eligibility criteria:
inclusion criteria: * female between ages of 10 and 12 * calcium intake of 900-1300 mg/d exclusion criteria: * take medication that influences calcium metabolism * any disorder of calcium or bone homeostasis * bmi\>90th percentile for age * smoking, illegal drug consumption * any gastrointestinal disease (crohn's disease, celiac disease, inflammatory bowel disease) * any disease affecting kidney function * broken bone within last 6 months * dislike of yogurt or yogurt drinks * regular use of foods containing probiotics or prebiotics

Keywords: dietary supplement: galactooligosaccharide
neurodevelopmental assessment of children in uganda and malawi using a software package

Conditions: BPG Intervention; Control

Summary: the investigators will use brain power games as a neurocognitive "stress test" or medical "challenge" test, in order to evaluate or improve brain/behavior functional integrity in hiv-affected children. this dual use of bpg is a key innovative feature. each of the 5 core bpg games lasts 10 minutes and trains fine motor, monitoring/attention, visual/auditory working memory, spatial navigational learning. the investigator's central hypothesis is that the bpg performance gains will be improved compared to waitlist control for children in uganda and malawi.

we randomize equal numbers of each of three exposure groups of children (perinatally hiv infected, perinatally hiv-exposed but not infected, and unexposed/uninfected children) to one of two intervention arms. they are randomized to either the brain powered games (bpg) intervention arm of 12 sessions of hour-long training (twice a day for several days weekly at the study clinic), or to the "wait-listed" arm of no bpg training sessions. separate analyses by country (uganda and malawi) are planned. hiv exposure status is used for balancing of randomization.

Eligibility criteria:
inclusion criteria: * heu and huu children at least 5 yrs of age and older from the promise nd study (uganda and malawi) * hiv+ children from p1104s (uganda and malawi) * huu children age-matched from promise nd and p1104s study cohorts (uganda and malawi) exclusion criteria: * medical history of serious birth complications * severe malnutrition * bacterial meningitis * encephalitis * cerebral malaria * other known brain injury or disorder requiring hospitalization * seizures or other neurological disabilities

Keywords: cognitive games, attention, memory, learning, reasoning, planning, hiv, african, children
a prospective interventional cohort study to evaluate the efficacy and safety of the aqualumen, a novel filtration procedure for the treatment of open angle glaucoma

Conditions: Glaucoma Open-Angle

Summary: the study will follow a group of patients with glaucoma disease that undergo a surgical procedure intended to reduce the intra-ocular pressure (iop) for a period of one year.


Eligibility criteria:
inclusion criteria: * moderate to severe open angle glaucoma * central corneal thickness between 480 and 610 microns exclusion criteria: * surgical history of corneal graft * presence of corneal opacities * failed prior trabeculectomy
comparing surgical and economical parameters of total knee replacement.

Conditions: Osteo Arthritis Knee; Total Knee Arthroplasty

Summary: randomized study comparing surgical and economic parameter of total knee arthroplasty performed using two different specific surgical techniques.

randomized 1: ratio study comparing medacta myknee surgical technique using efficiency single use instruments versus stryker navigation surgical techniques performed with conventional instruments. myknee surgical technique patients will receive a ct scan of the surgical knee which enables custom manufacturing of the myknee cutting blocks. stryker navigational surgical technique patients will not require a ct scan. both groups of patients will undergo total knee arthroplasty.

Eligibility criteria:
inclusion criteria: * age 18 to 75 years 2) bmi ≤35 3) undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic oa) with the medacta gmk sphere 4) able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks exclusion criteria: * is participating in another clinical study 2) has inflammatory arthritis 3) has knee avascular necrosis 4) has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) has retained hardware in the knee that requires removal and interferes with tka procedure 6) has prior high tibial osteotomy (hto)
setting benchmarks for microsurgical clipping of unruptured intracranial aneurysms

Conditions: Aneurysm; Aneurysm, Brain; Aneurysm Cerebral; Aneurysm of Cerebral Artery; Aneurysm, Intracranial

Summary: to conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following microsurgical clipping of unruptured intracranial aneurysms (uia).

surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. therefore, monitoring and quality improvement is increasingly important in surgery. for this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. the concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. in the past years, the concept of benchmarking attaches greater importance in the field of healthcare, especially in surgery. benchmark values are established within a patients' cohort for which the best possible outcome can be expected. the aim of our study is the establishment of robust and standardized outcome references after microsurgical clipping of unruptured intracranial aneurysms. after successful implementation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials.

Eligibility criteria:
inclusion criteria: * patients who went through elective microsurgical clipping of unruptured intracranial aneurysm * high-volume centers with ≥40 cases per year during the study period exclusion criteria: * treatment following subarachnoid haemorrhage * clipping following an incomplete occlusion after previous treatment
efficacy of bis monitoring in deep hypnotic state

Conditions: Hypnotic; Withdrawal State With Delirium; Neurological Disorder; Postoperative Delirium; Postoperative Confusion; Anesthesia; Anesthesia Emergence Delirium; Gas; Inhalation

Summary: determining the efficacy of the bis monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients

this study will be conducted with a two-group, double-blind, randomized clinical trial design in elective patients who will undergo neurosurgical procedures under general anesthesia. patients scheduled for elective neurosurgery who meet the inclusion criteria will be randomized into one of the intervention groups, with or without bis. demographic data will be taken from medical records. in both groups, the bis probe will be inserted before induction, but for the control group, the bis monitor will be closed, while for the intervention group, anesthesia will be titrated according to the bis value to maintain the bis value in the range of 40-60. in the group with an open bis, the anesthesia protocol is the use of anesthetic gas, and the anesthetic drug will be adjusted to the bis value range of 40-60 or bis-guided, while the anesthesia protocol used in a closed bis is carried out like general anesthesia without using bis. the bis value will be recorded minute by minute according to the extraction feature of the bis machine after surgery. the total use of anesthetic agents, duration of surgery, and intraoperative hemodynamics will be recorded through anesthesia status. the patient will follow the progress until the patient is discharged from the hospital

Eligibility criteria:
inclusion criteria: * patients aged 30-60 years with an asa tolerance of 1-2 who will undergo general anesthesia techniques * operation duration \> 3 hours * the patient agrees to take part in the study. exclusion criteria: * continuous intraoperative use of ketamine, magnesium sulfate, dexmedetomidine, lidocaine agents * massive bleeding that causes hemodynamic disturbances * severe electrolyte disturbances * severe liver or kidney function disorders * the patient was decided not to extubate in the operating room

Keywords: deep hypnotic state anesthesia postoperative complication neurosurgical disorder
factors affecting the results of treatment of patients with colorectal cancer

Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancer; Colorectal Adenocarcinoma; Colorectal Neoplasms Malignant; Rectal Adenocarcinoma

Summary: the study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.


Eligibility criteria:
inclusion criteria: * histologically proven primary adenocarcinoma of bowel; * all patients who have indications for surgical treatment of colorectal cancer based on the decision of the oncological council; * signed informed consent with agreement to attend all study visits; exclusion criteria: * unresectable tumor or contradictions to surgery; * indications for chemotherapy or radiation therapy prior to surgery; * patient withdrawal from the trial or loss of follow-up; * emergent operation; * pregnancy.

Keywords: colorectal cancer rectal cancer colon cancer colorectal surgery anastomotic leakage postoperative complications recurrence rate cancer-specific survival recurrence-free survival
pre-hospital lung ultrasound impact on diagnosis

Conditions: Acute Heart Failure

Summary: acute heart failure (ahf) is a major reason patients seek emergency care and is a significant public health burden. the ability to differentiate ahf from other etiologies of dyspnea remains a challenge as symptoms and physical exam findings overlap, especially in the pre-hospital setting where diagnostic tools are not readily available. the inability to differentiate ahf from other causes of dyspnea leads to misdiagnosis, delays in diagnosis, and ultimately delays in appropriate treatment. delays in initiating hf therapies is associated with poor outcomes including higher rates of in-hospital mortality and longer hospital length of stay. optimizing treatment for ahf in the pre-hospital setting is associated with increased survival and lower rates of hospital re-admission. thus, accurate diagnosis and early treatment for ahf in the pre-hospital setting remains a critical unmet need. lung ultrasound (lus), through assessment of b-lines, allows for an easy and accurate method for detection of pulmonary congestion seen in ahf patients. although multiple studies have shown lus is easy to learn, there is a paucity of data assessing clinical impact of lus in the pre-hospital setting. the investigators hypothesize that the use of lus by pre-hospital personnel will improve accuracy for detecting ahf in the pre-hospital setting when compared to usual care (no lus). specific aims: to determine if the use of pre-hospital lus improves diagnostic accuracy for detecting ahf in patients transported by emergency medical services (ems) for acute dyspnea when compared to usual care (no lus).

prospective, randomized study using a phased implementation on patients being transported by ems to the hospital for acute dyspnea. the investigators will include adults (\>17yo) with a chief complaint of dyspnea and at least one of the following: bilateral lower extremity edema, orthopnea, wheezing or rales on auscultation, increased work of breathing, tachypnea (rr\>20) or hypoxia (oxygen saturation \ 100.4f), systolic blood pressure \ 2 b-lines in a zone in each hemi-thorax). a hospital diagnosis of ahf versus not hf will be determined through independent chart review by two blinded physicians and will serve as the criterion standard for final diagnosis. diagnosis by paramedics, whether lus was used, and treatment given pre-hospital will be tracked in eso (an online ems clinical documentation system). for the primary aim the investigators will compare pre-hospital provider diagnosis to final diagnosis to determine accuracy with and without the use of lus. expected results: the investigators anticipate the use of prehospital lus will improve diagnostic accuracy for detecting ahf. this pilot study will set the groundwork for future larger studies assessing the clinical impact of prehospital lus.

Eligibility criteria:
inclusion criteria: * adult patients (\>17yo) with a chief complaint of shortness of breath. exclusion criteria: * we will exclude patients with hypotension (sbp \ 100.4f, trauma or who are pregnant.

Keywords: ultrasound prehospital
neural correlates of sensory specific satiety

Conditions: Satiety Response; Functional Neuroimaging; Obesity

Summary: sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination.the rewarding effect of sugar will be investigated in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. a gustatory stimulation paradigm designed to induce sensory specific satiety for glucose will be employed. the aim is to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior.

sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination. since changes in taste, smell and appetite are commonly observed in obesity, previous studies investigated the relation of sensory specific satiety to weight gain, but observed conflicting results. to gain a more detailed understanding of the relationship between sensory specific satiety and weight homeostasis, we will examine the rewarding effect of sugar in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. we will employ a gustatory stimulation paradigm designed to induce sensory specific satiety for glucose. during fmri scanning, glucose and water are applied orally using a gustometer. furthermore, relevant hormonal satiety parameters are measured, as well as dietary behavior and food preferences in everyday life. this will allow us to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior. a better understanding of factors contributing to the development and maintenance of overweight are crucial for the development of new treatment options for obesity.

Eligibility criteria:
inclusion criteria: 1. bmi between 17,5 and 35 kg/m². 2. over age of 18 years. 3. right-handedness. 4. normal or corrected-to-normal vision. 5. capacity to consent. exclusion criteria: 1. history of head injury or surgery. 2. history of neurological disorder. 3. severe psychiatric comorbidity. 4. lifetime or current medical illness that could potentially affect appetite or weight (including eating disorders diagnosis) 5. smoking. 6. current psychotropic medication. 7. inability to undergo fmri scan (e.g. metallic implants, claustrophobia, pacemakers). 8. pregnancy.

Keywords: fmri sensory specific satiety