Kornimate/medical-research-clean huggingface dataset:
face validity and cross-cultural acceptability of the fps-r in cameroon

Conditions: Pain

Summary: this study evaluates the face validity and cultural acceptability of the faces pain scale - revised in pediatric patients treated at mbingo baptist hospital, northwest province, cameroon. participants from the four major language/cultural groups evaluated at the hospital with a complaint of pain will trial the faces pain scale - revised and then undergo cognitive interviewing to assess comprehension and clinical accuracy.

twelve to fifteen pediatric patients complaining of pain from each of the four primary language groups treated at mbingo baptist hospital (grammar english, pidgin english, french, and fulfulde) will be enrolled in the study. each patient enrolled will trial the faces pain scale - revised (fps-r) in his or her native tongue, before receiving standard analgesic treatment as ordered by the provider caring for the patient. one to two hours post analgesia, the patient will be reassessed and the fps-r will be repeated. after completion of the second fps-r, an audio-recorded cognitive interview will be performed by trained study personnel. these recordings will be transcribed into english and analyzed on a question-by-question basis to evaluate for themes pertaining to comprehension and understanding, ease of use, and reliability, within the different language groups. enrollment in the study does not alter the routine pain management offered or received by patients. rather, the fps-r will be utilized on patients who are complaining of pain and who will be allocated to receive analgesia regardless of study enrollment.

Eligibility criteria:
inclusion criteria: * admitted to children's ward * complaint of pain exclusion criteria: * coma * traumatic brain injury * glasgow coma scale (gcs) \< 13 * cognitive delay * narcotic/opioid dependency

Keywords: pediatrics pain scale faces pain scale - revised cameroon
hand and engine-driven techniques for endodontic retreatment

Conditions: Pain, Postoperative

Summary: numerous instrumentation techniques have been suggested for the nonsurgical retreatment of teeth with primary failure of endodontic therapy in laboratory studies. however, there is limited clinical evidence about those different techniques. the objective of this study is to compare the prevalence and intensity of postoperative pain, as well as the success rate after endodontic retreatment with hand or engine-driven reciprocating instrumentation. a randomized clinical trial will be performed, considering two comparison groups: hand preparation with stainless steel instruments or engine-driven reciprocating preparation with the reciproc niti system (vdw, munich, germany), to verify which technique would lead to lower postoperative pain levels and higher endodontic success rates. secondary outcomes related to technique efficiency will be also registered, evaluating the capacity of filling material removal and the time spent on the clinical procedures. eighty individuals who need endodontic retreatment in single-rooted teeth will be selected (n=40/group). endodontic reintervention will be carried out in two visits. periapical radiographs taken after root filling removal protocols will be transferred to an image analysis software. then, the percentage of remaining filling material in relation to the total area of the root canal will be evaluated. the clinical time spent with the removal procedure protocol will be registered, in minutes, by a digital stopwatch. after each visit, postoperative pain will be assessed using a numerical rating scale. the record of pain and analgesic drug intake will be performed in 12, 24, 48 hours and 7 days after the clinical procedures. success rates will be evaluated after 3, 6, 12 and 24 months, through clinical and radiographic examination, considering the periapical index, a 5-point score system. data of both groups (percentage of remaining debris, operating time, postoperative pain, clinical and radiographic success) will be analyzed for normality by the shapiro-wilk test. assuming normal distribution, the data will be compared by t test. pearson's correlation coefficient will be applied to detect possible correlations between the evaluated outcomes. differences will be considered significant at p=0.05.


Eligibility criteria:
inclusion criteria: * good systemic and oral health; * requiring root canal retreatment in single-rooted teeth (one root and one root canal); * asymptomatic persistent apical periodontitis. exclusion criteria: * use of analgesics, anti-inflammatory drugs or other pain modulating drugs; * chronic systemic disease (eg: diabetes, hypertension, arthritis and renal dysfunction); * systemic disease that could interfere with bone quality; * pregnant or breastfeeding women; * teeth with untreated periodontal disease; * abnormal mobility and with excessively large or curved canals.
attitudes & college experiences

Conditions: Alcohol Abuse

Summary: high volume drinking by young adults has proven resistant to long term change, so new approaches are needed. given strong associations between alcohol-related attitudes and drinking behavior, the investigators adapt a theory-based attitude change strategy for use in alcohol prevention. this research tests the impact of a brief counter attitudinal advocacy activity on subsequent drinking and negative consequences.

the persistence of risky drinking among young adults in college calls for continued efforts to prevent harms related to alcohol. current prevention interventions have achieved some success, but rely on a single mechanism of change: correcting exaggerated drinking norms. the investigators propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance. to date, changing alcohol-related attitudes and the resulting attitude-behavior discrepancy has been underutilized as a behavior change strategy for alcohol abuse prevention. informed by an extensive literature showing strong and consistent associations between alcohol attitudes and drinking behavior, the investigators adapted a brief counter-attitudinal advocacy (caa) manipulation to the alcohol prevention context.

Eligibility criteria:
inclusion criteria: * 18-24 years of age * enrolled in the university's undergraduate four-year degree program * past month heavy episodic drinking (for men, \>5 drinks in one day, for women \>4 drinks in one day) * at least two self-reported negative consequence from drinking in the past month exclusion criteria: • status as a graduating senior

Keywords: alcohol intervention college students
vegan diets: the short-term effects on daily muscle protein synthesis rates as compared to omnivorous diets in older adults assessed by d2o.

Conditions: Sarcopenia

Summary: consumers are increasingly encouraged to consume more plant-based foods and lower their consumption of foods from animal origin. however, the consequences of such a transition on muscle mass still remains to be explored. this is of particular importance in the older population, where sarcopenia is highly prevalent. the aim of this randomized controlled cross-over study is to investigate the short-term effect of a 10-day controlled vegan diet on daily muscle fractional synthesis rates in comparison to a 10-day controlled omnivorous diet in 35 community-dwelling older adults. participants will follow a fully controlled vegan diet, directly followed by a fully controlled omnivorous diet for 10 days, or vice versa. researchers will compare the effect of the vegan diet to the effect of the omnivorous diet.


Eligibility criteria:
inclusion criteria: * aged 65-79 years old; * community-dwelling; * bmi 20-35 kg/m\^2. exclusion criteria: * following a vegetarian or vegan diet during the six months prior to the study; * following a diet that affects protein intake during the six months prior to the study; * participating in a structured exercise training program in the past three months; * 5% or more body weight loss during three months before the start of the study; * being diagnosed with one of the following: diabetes; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer; chronic obstructive lung disease (copd); * chronic use of medication that affects muscle function, e.g. corticosteroids, metformin, insulin; * the use of the following medicines: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole. * allergic or intolerant to any product included in the diets; * not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin d; * not willing or afraid to give blood or undergo a muscle biopsy during the study; * unwilling to eat a vegan and an omnivorous diet for ten days each; * currently a research participant in another trial or participated in a clinical trial during three months before the start of the measurement period; * not being able to understand dutch; * not having a general physician.
azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated p. falciparum malaria in children in africa

Conditions: Malaria, Falciparum

Summary: the primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- lumefantrine for the treatment of symptomatic, uncomplicated malaria due to p. falciparum in children in african countries.


Eligibility criteria:
inclusion criteria: * girls and boys ≥5 years to ≤12 years (cohort 1); and ≥6 to ≤59 months of age (cohort 2) with uncomplicated, symptomatic malaria as indicated by the presence of the following: * blood smears positive for monoinfection with p. falciparum and asexual parasitemia between 1000 -100,000 parasites/µl; * documented fever (38.0°c/100.4°f rectal or tympanic; 37.2°c/99.0°f axillary or 37.5°c/99.5°f oral) or history of fever (as reported by the legally acceptable representative) within the prior 24 hours; * appropriate for outpatient treatment; * blood glucose ≥60 mg/dl; * hemoglobin ≥6 g/dl or hematocrit ≥18% without signs of anemia-induced congestive heart failure (chf); * negative urine pregnancy test for females ≥10 years of age (and of child bearing potential) exclusion criteria: * peripheral blood smear positive for mixed infection with multiple plasmodium spp. * severe or complicated malaria including subjects with any of the following: * impaired consciousness (eg, obtundation, unarousable coma), seizures or abnormal neurologic exam suggestive of severe or complicated malaria; * known hemoglobinuria; * jaundice; * respiratory distress; * persistent vomiting; * gross hematuria, as reported by the subject's legally acceptable representative; * recent history of convulsions; * inability to drink or breastfeed; * unable to sit or stand as appropriate for age; * known pregnancy or breast-feeding or positive urine pregnancy test (females ≥10 years of age and of child bearing potential); * history of allergy to or hypersensitivity to azithromycin, any macrolide, chloroquine, artemether, any artemisinin derivative, lumefantrine; * any contraindication to any study drug including az, cq and al; * history of treatment with any antimalarial drug (such as halofantrine, chloroquine, quinine, mefloquine, malarone, sp, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment of a subject (and/or of the mother of a subject who is being breastfed) into the study; * known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the investigator would place the subject at increased risk to participate in the study.

Keywords: p. falciparum malaria drug treatment clinical trial
quality of life and psycological evaluation of patients affected by head and neck cancer

Conditions: Quality of Life

Summary: the prospective trial is to describe the quality of life and psychological effects in patients with head and neck tumor receiving curative intent treatment

the multicentric prospective trial is to evaluate the quality of life and psychological effects in patients with head and neck tumor treated by curative intent radiation therapy. the treatment consists in a conventionally fractionated intensity modulated radiotherapy (imrt) or until 2.2 gy per fraction with a total dose of 50-66 gy in post-operative setting and 66-72 gy in radical setting.

Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) in non-metastatic staging; * curative intent treatment (radiation therapy associated or not to chemotherapy; surgery associated or not to post-operative radiotherapy and chemotherapy); * performance status \< 2; * age ≥ 18 years; * good knowledge of italian language; * written informed consent
robot-assisted therapy and motor learning: an active learning program for stroke

Conditions: Stroke

Summary: stroke is the leading cause of long-term disability in older adults in the united states. at six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke each year continue to have motor impairments that inhibit functional use of the weaker arm during daily activities and negatively impact quality of life. rehabilitation robots provide clinicians with new treatment options to improve movement and arm function after stroke. the purpose of this pilot study is to develop and test a therapy called the "active learning program for stroke" (alps). we are combining this therapy program with robot-assisted therapy and a home program for the stroke-affected arm and hand.

little is known about how individuals learn to utilize robot-trained movements during upper extremity (ue) activities in the home and community and whether specific instruction can enhance motor learning and carry-over.. systematic reviews of robot-assisted therapy for the paretic ue confirm gains in motor capacity as measured by clinical assessments, but provide little evidence of improved ue performance during daily tasks and occupations. these findings may be attributed to the limited availability of rehabilitation robots to train the paretic hand and a primary focus on intensity of practice with little regard for other principles of motor learning and experience-dependent neuroplasticity. these principles, including the salience of training tasks, transfer of acquired skills to similar activities, and active engagement and problem solving, are key to task-oriented training paradigms in stroke (e.g. constraint-induced movement therapy) but have not been well integrated into robot-assisted therapy protocols. the transfer of robot-trained movements to ue activities within the home and community needs further exploration before widespread use in rehabilitation practice is expected.

Eligibility criteria:
inclusion criteria: * moderate ue hemiparesis (i.e. some ability to move shoulder, elbow \& hand and initial score on the fugl-meyer assessment (fma) between 21-50/66)) * intact cognitive function to understand and actively engage in the alps robotic therapy procedures (montreal cognitive assessment score \>/=26/30)12 during initial evaluation visit exclusion criteria: * no more than moderate impairments in paretic ue sensation, passive range of motion, and pain that would limit ability to engage in therapy * increased muscle tone as indicated by score of \>/= 3 on the modified ashworth scale; * hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the cognitive linguistic quick test 13 * aphasia sufficient to limit comprehension and completion of the treatment protocol * currently enrolled or has plans to enroll in other upper limb therapy/research during the study period * contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic ue

Keywords: robot-assisted therapy task-oriented training motor learning cognitive strategy training
dexmedetomidine vs ketofol on delirium in children undergoing congenital inguinal hernia repair

Conditions: Dexmedetomidine; Ketofol; Delirium; Hernia

Summary: the aim of this study is to compare the effect of dexmedetomidine versus ketofol on the incidence of the emergence delirium in children undergoing congenital inguinal hernia repair.

emergence delirium (ed) is a disturbance in a child's awareness or attention to his/her environment with disorientation and perceptual alterations including hypersensitivity to stimuli and hyperactive motor behaviour in the immediate post anesthesia period. propofol is a non-opioid, non-barbiturate, sedative-hypnotic agent with rapid onset and short duration of action \[12\]. ketamine is a phencyclidine derivative classified as a dissociative sedative that provides analgesia and amnesia. combination of ketamine with propofol reduces the sedative dose of propofol. the complementary effects of this combination are supposed to produce lower toxicity compared to each drug alone through decreasing required doses. ketofol; mixed ketamine and propofol has been shown to be effective in emergency room for procedural sedation and for induction for rapid sequence intubation \[13,14\]. this combination is also effective to prevent ed in pediatric patients undergoing simple surgical procedural in addition to the advantage of better hemodynamic stability. dexmedetomidine is a highly selective, alpha2-adrenergic receptor agonist that has been widely used for adult anesthesia and as a sedative in intensive care units. dexmedetomidine is safe in children due to its hypnotic, analgesic, sedative, and anxiolytic effects. it has been shown to improve intraoperative hemodynamic stability, minimize responses to stimuli, and reduce the need for other anesthetic agents.

Eligibility criteria:
inclusion criteria: * 60 children aged from 2 to 5 years * presented with congenital inguinal hernia * the american society of anaesthesiologists classification asa i-ii. exclusion criteria: * past medical history of mental illness or neurological illness. * renal or hepatic diseases. * severe hearing or visual impairment which may interfere with communication and physical decline. * congenital heart disease. * history of allergy to any of the study drugs.
prevention of incisional hernia by mesh augmentation after midline laparotomy for aortic aneurysm treatment

Conditions: Aortic Aneurysm

Summary: the research hypothesis for this study is to possibly reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy. the study is designed as a prospective randomised multi-centre trial, randomising patients in 2 groups concerning the surgical technique of the closure of the abdominal wall.


Eligibility criteria:
inclusion criteria: * all patients undergoing elective abdominal aorta aneurysm treatment through a midline laparotomy are eligible for the trial. * all patients should sign the informed consent. exclusion criteria: * patients below 18 years. * pregnancy. * emergency surgery for aortic aneurysm. * presence of mesh in the abdominal wall on the midline from previous operations asa score 4 or more.
the compass study: a study of volanesorsen (formally isis-apociiirx) in patients with hypertriglyceridemia

Conditions: Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with hypertriglyceridemia.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≤ 45 kg/m2 2. fasting triglycerides (tg) ≥ 500 mg/dl (≥ 5.7 mmol/l) at screening. 3. if on statin or fibrate, participants must be on stable, labeled dose for at least 3 months prior to screening. participants not receiving these drugs within 4 weeks prior to screening are also eligible. exclusion criteria: 1. type 1 diabetes mellitus 2. newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or hba1c ≥ 9.0% at screening 3. acute pancreatitis within 3 months of screening 4. acute coronary syndrome within 6 months of screening 5. major surgery within 3 months of screening 6. prior exposure to isis 304801 7. have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study
impact of the implementation of dance therapy workshops on the quality of life of adults with disabilities institutionalized within the medico-social establishments of the univi group

Conditions: Dance Therapy Workshop

Summary: dance is a multimodal activity involving motor, cognitive, sensory and sensory-motor skills as well as emotional and social skills. a growing body of research shows that the creative arts and physical exercise are able to alleviate disability, improve social interactions. the associative group univi wants to evaluate through this study the effects of the practice of dance on the quality of life of the disabled adults accomodates in social medical establishments of univi group

this research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is multicentric and longitudinal prospective. this is a before/after study to measure the effects of the implementation of a dance therapy activity on the quality of life of the adults with disabilities housed in the 5 establishments of the univi group. the dance therapy will be deployed in all the medico-social establishments participating in the study over a period of 12 weeks. to do this, dance therapists will be recruited to provide these classes. the dance-therapy will be carried out: * in groups of 10 to 12 people who have given their informed consent, * at least twice a week per group, * over a period of 30 to 45 minutes maximum twice a week for 3 months. several groups per establishment can be planned depending on the number of people who can and want to be included in the dance workshop. 940 participant in the study will be inclued and followed at 1 month, 3 months and 6 months after the end of the dance therapy workshops.

Eligibility criteria:
inclusion criteria: * adults with disabilities residing in medico-social establishments, including participant under guardianship or curatorship * informed consent to participate in the study * participant with a minimum of language skills to understand instructions and simple questions exclusion criteria: * contraindication to the practice of dance * adults with disabilities temporarily housed * severe cognitive and/or behavioral disorders that do not allow you to follow a dance workshop * permanent bed rest * non-affiliation to a social security scheme