Kornimate/medical-research-clean huggingface dataset:
effectiveness of gabapentin on chronic irritability in neurologically impaired children

Conditions: Neurologically Impaired; Irritable Mood; Signs and Symptoms, Digestive; Sleeplessness; Chronic Pain

Summary: this study is a prospective, randomized, double blind, placebo controlled, crossover clinical trial looking at whether gabapentin can provide symptom relief for chronic irritability in neurologically impaired children. the investigators hypothesize gabapentin ins beneficial and safe for children with chronic irritability that persists despite identification and appropriate management of symptom sources.

this is a randomized, placebo-controlled, cross-over study design of the effects of gabapentin on chronic irritability in neurologically impaired children. the study will involve a 22 day medication titration, followed by a 7 day stable dosing period and a 6 day medication taper period. after an additional 3 day washout period, the subject will cross-over to the remaining arm of the study. subjects will be evaluated for symptoms of chronic pain. since the subjects are generally non-communicative, the subjects will be evaluated by two questionnaires and the non-communicating children's pain checklist-revised, to be completed by their parent or primary caregiver. the primary aim is to determine if gabapentin provides symptom relief for chronic irritability in neurologically impaired children.

Eligibility criteria:
inclusion criteria: * male or female * 1 month to 16 years of age at enrollment * neurological impairment defined as subnormal (-2 s.d.) motor and/or cognitive ability from a variety of etiologies * chronic irritability defined as symptoms suggesting pain to the child's caregiver recurrently over a 4-week of greater time period * subject must have an acceptable surrogate capable of giving consent on the subject's behalf exclusion criteria: * children with resolved symptoms after treatment of identified sources of pain * identified potential source of irritability without adequate trial of appropriate management * ketogenic diet * renal insufficiency or failure * current treatment with gabapentin or pregabalin for another existing condition.

Keywords: chronic irritability chronic pain neurologically impaired gabapentin
evaluating the care burden of caregivers of patients with brain injury and determining the influencing factors

Conditions: Brain Injuries; Caregiver Burden

Summary: acquired brain injury is a general term including trauma due to head injury or postsurgical damage, vascular accident such as stroke or subarachnoid hemorrhage, toxic or metabolic cause such as hypoglycemia, cerebral anoxia, and infection or inflammation. however acquired brain injury leaves survivors with a considerable burden of physical, cognitive, emotional,behavioural and psychosocial limitations,these individuals often require healthcare, supervision, and support from professional or informal caregivers in some or all of their lives. therefore, this study have two primary aims: (1) to conclude the level of caregiver's life satisfaction and strain; and (2) to determine the factors predicting strain among the caregivers. i̇nvestigators believe this study can add to the literature and create awareness on the current state of caregiver's well-being in this part of the world.

patients will evaluate with respect to their demographic and clinical determinants. in the patient group, ambulation status, disability levels, cognitive status, neurobehavioral results, functional status will evaluate with the functional ambulation classification scale (facs), disability rating scale (drs), rancho los amigos cognitive scale-revised (rlas-r), neurobehavioral rating scale-revised (nbrs-r), functional independence measure (fim) respectively. all assessments will conduct and evaluate by the treating physicians during hospitalization. i̇nvestigators also will record the type of caregiving (family member or paid professional) and socio-demographic characteristics of the caregivers . sleep quality will be determined with pittsburgh sleep quality i̇ndex (psqi), quality of life with nhp (nottingham health profile), level and risk of anxiety and depression with hospital anxiety and depression scale, satisfaction level with the satisfaction with life scale , care burden with caregiver strain index (csi).

Eligibility criteria:
inclusion criteria for the patients: * have a nonprogressive, non-neurodegenerative acquired brain injury * able to read or understand the questionnaire * at least 18 years of age inclusion criteria for the caregivers: * primary caregiver of a patient diagnosed with acquired brain injury * at least 18 years of age * had provided care for at least one month * providing care to the patient for more than 4 h per day * did not have any major premorbid medical and psychological illnesses * able to read or understand the questionnaire exclusion criteria for patients and caregivers: * under 18 years of age * inability to read and understand questions.

Keywords: caregiver brain injury burden caregiver strain index
treatment of proximal interphalangeal joint injuries. clinical efficiency of syndactyly treatment and digital compression

Conditions: Finger Injuries

Summary: proximal interphalangeal joint injuries of the fingers may be treated in various ways and no treatment has been shown to be superior. the investigators wish to study the effectiveness of syndactyly versus digital splint when comparing joint mobility. the investigators also wish to study the effectiveness of finger compression in reducing edema and therefore allowing a greater arc of motion.

proximal interphalangeal joint (pipj) injuries of the fingers are a common occurrence. they may be treated various ways: strict immobilization in a finger splint for one to three weeks, syndactyly, no immobilization. immobilization is often responsible for joint stiffness whereas immediate mobilization might produce pain. injuries to the joints of the hand produce edema that is responsible for additional stiffness. compressive garment may be worn to limit the extent of the edema and help its resorption. although pipj injuries are frequent, their treatment does not benefit from a consensus. most studies are retrospective or aimed at a pediatric population. the investigators wish to evaluate the outcome of pipj injury after different treatments: either strict immobilization in a rigid splint for three weeks, of relative immobilization in a syndactyly for three weeks.the investigators also wish to study the effect of finger compression on edema resolution and finger motion. therefore there will be four treatment groups: syndactyly with and without compression, rigid splint with and without compression. the study will be conducted in the hand surgery unit of a university hospital in a prospective way. the assignment to a particular treatment group will be randomly performed. patients will be followed for 6 months.

Eligibility criteria:
inclusion criteria: * proximal interphalangeal joint injury with or without dorsal or lateral luxation * less than seven days after injury * injured joint stability * fracture of the palmar rim of the intermediate phalanx less than 30% of articular surface exclusion criteria: * palmar luxation of the proximal interphalangeal joint * fracture of the palmar rim of the intermediate phalanx greater than 30% of articular surface * injury to the central band of the extensor tendon * fracture other than palmar rim of the intermediate phalanx less than 30% of articular surface * non reducible luxation
efficacy of intensive cholecalciferol monitoring and supplementation on serum vitd levels in pediatric patients with cf

Conditions: Vitamin D Deficiency; Cystic Fibrosis; Bone Density, Low; Inflammation Chronic; Cystic Fibrosis in Children; Cystic Fibrosis Pulmonary Exacerbation

Summary: cystic fibrosis (cf) is an autosomal recessive disease caused by alterations in the cystic fibrosis transmembrane conductance regulator (cftr) gene, characterized by multisystemic alterations, mainly in the lung, intestine, sweat, and bile ducts. in addition to pulmonary involvement, the presence of exocrine pancreatic insufficiency also increases the risk of survival, as it is associated with malnutrition and deficiency of fat-soluble vitamins, such as vitamin d. vitamin d, in addition to its role in bone health, in the case of cf patients with chronic inflammation, it has been suggested that many of the cytokines that regulate the inflammatory response contain elements that respond to vitamin d, so vitamin d could play an essential role in the regulation of the inflammatory response in cf, which could favor lung function. however, more than 50% of cf patients present vitamin d insufficiency or deficiency, despite the different schemes suggested for supplementation in different age groups, which suggests that new strategies are needed to normalize vitamin d levels, which will allow us to see its clinical effect on the inflammatory response, by decreasing the number of exacerbations and thus perpetuating or improving lung function, as well as on bone mineral health.

randomized double-blind clinical trial in patients aged 5 to 18 years attending the cf comprehensive care clinic in mexico city. the intervention group will receive an intensification of vitamin d supplementation, with increments of 4000 iu depending on serum levels, the control group will receive supplementation according to the treatment guidelines of the cystic fibrosis foundation, and the dose will be doubled depending on serum levels. in both groups vitamin d levels will be measured at 3, 6, 9, and 12 months, spirometry and sputum culture will also be performed to evaluate the pulmonary function, densitometry to evaluate the bone mineral density and body composition, together with anthropometric evaluation and quantitative bone ultrasound at each visit, in the biochemical evaluation, calcium/creatinine ratio and alkaline phosphatase will be taken at each visit.

Eligibility criteria:
inclusion criteria: * cystic fibrosis exclusion criteria: * another chronic disease (hiv, cancer, renal failure) * 25-oh-vitd levels \ 30 ng/ml

Keywords: vitamin d cystic fibrosis pulmonary exacerbation vitamin d deficiency or insufficiency
eras vs conventional approach in peptic perforation-rct

Conditions: Peptic Ulcer Perforation; Perforated Bowel; Post-Op Complication; Emergencies; Perioperative Complication

Summary: this study compares 2 different ways of perioperative management in patients of peptic perforation. experimental arm is the eras arm( enhanced recovery after surgery) and the comparative arm is conventional arm.

while the conventional approach to perioperative management can potentially prolong the post operative hospital stay, eras(enhanced recovery after surgery), a multi-modal and multispeciality approach to perioperative management may reduce the length of hospital stay. in the preoperative period, patients will be counselled regarding the operative procedure and particulars of the perioperative management.in the intra-operative period short acting general anesthetic agents and short acting muscle relaxants will be used.intravenous fluid administration will be goal directed. after the operative procedure, bilateral rectus sheath block will be administered. patient will also receive post-operative nausea and vomiting prophylaxis. nasogastric tube will be removed immediately after the operative procedure. in the post operative period, patients will be encouraged to ambulate early. enteral nutrition will be initiated as early as possible. indwelling catheters will be removed in the early post-operative procedure.

Eligibility criteria:
inclusion criteria: 1. patient diagnosed with peptic perforation intra -operatively 2. perforation of size \<=1 cm 3. patient age more than 18 years 4. american society of anesthesiologists score of i or ii exclusion criteria: 1. refractory septic shock at presentation. 2. known chronic kidney disease/ chronic liver disease patients 3. pregnant patients. 4. patients with history of chronic steroid abuse. 5. intraoperatively * patient with coexistent peptic perforation with bleeding ulcer. * peptic perforation requiring procedure other than omental patch repair. * sealed perforations. * malignant perforation. 6. patient requiring positive pressure ventilator support post operatively for more than 12 hours. 7. patient requiring urinary catheterization for other indications. 8. coexistent neurological or psychiatric illness or unable to understand the study. 9. patient refusing for consent.

Keywords: eras emergency surgery fast track surgery perioperative care enhanced recovery after surgery
hears-nps: addressing hearing loss as a common unmet contributor of neuropsychiatric symptoms

Conditions: Alzheimer Disease; Dementia; Hearing Loss; Cognitive Impairment

Summary: this randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with alzheimer's disease and related dementias (adrd). the community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (nps), and care partner distress.


Eligibility criteria:
inclusion criteria: * age 60 - 100 years old * english-speaking * diagnosis of probable alzheimer's disease or other related dementia according to the core clinical criteria outlined in the national institute on aging (nia) and alzheimer's association guidelines * speech frequency pure tone average (0.5- 4 khz) \>25 db in the better-hearing ear; adult onset hearing loss * availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision * stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms exclusion criteria: * current self-reported use of hearing aid or amplification device * medical contraindication to use hearing aids ( e.g. draining ears) * inability to participate in the 1-month follow up
hypofractionated radiotherapy +chemotherapy+ camrelizumab as neoadjuvant therapy for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and ag combined with camrelizumab immunotherapy of borderline resectable/locally advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. age:18 to 75 years old, male or female; 2. eastern cooperative oncology group (ecog) performance status of 0-1; 3. tumor was located in the pancreas; 4. pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma; 5. no distant metastasis; 6. the pancreatic tumor is located more than 1cm away from the duodenum； 7. clinical assessment was locally advanced or critical for resectable. locally advanced pancreatic cancer diagnostic criteria: (1) due to tumor invasion, venous occlusion or involving a wide range of superior mesenteric vein branch of jejunum, cannot safely - superior mesenteric vein reconstruction. ② (pancreatic head/uncinate process tumors) tumor contact with superior mesenteric artery or celiac artery \> 180°. tumor contact with superior mesenteric artery or coeliac trunk artery \> 180°, tumor contact with coeliac trunk artery and invasion of abdominal aorta. critical for resectable pancreatic cancer diagnostic criteria: (1) contact with portal vein tumor - superior mesenteric vein \> 180 °, 180 ° or less or contact combined intravenous contour irregular or venous thrombosis, but safety is complete resection and reconstruction; the tumor contacted the inferior vena cava. ② (pancreatic head/uncinate process tumors) the tumors contacting the common hepatic artery, but not involving the celiac artery or the origin of the left and right hepatic arteries, can be completely resected and safely reconstructed; superior mesenteric artery tumor contact 180 ° or less; the tumor contacts the aberrant arteries (such as accessory right hepatic artery, alternative right hepatic artery, alternative common hepatic artery, etc.). (pancreatic body and tail tumors) tumor contact with superior mesenteric artery ≤180°; tumor contact with celiac artery ≤180°; 7.there was no history of immune system diseases, other malignant tumors, myocarditis, coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases, or systemic diseases other than those mentioned above. participants were willing to join in this study, good adherence and written informed consent. exclusion criteria: 1. patients who did not meet these inclusion criteria; 2. poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders; 3. the investigators think inappropriate.
the synergistic effects of home-management and intermittent preventive treatment of malaria in children

Conditions: Malaria

Summary: this cluster randomised trial is proposed to assess the clinical impact of adding a seasonal intermittent preventive treatment (iptc) schedule for children aged 3 -59 months to a home management of malaria (hmm) programme using aq+as in ghana. the study will be conducted in the kwaso sub district of the ejisu-juaben district of ghana in which 6 communities will be randomised to implement an iptc schedule alongside the hmm programme or hmm programme alone. the study will run in three phases; a preparatory phase to set up and obtain baseline morbidity data from a cross-sectional survey; an intervention phase and a post intervention phase of cross-sectional survey and data evaluation and dissemination. a cohort of 546 study children randomly selected will receive three full treatment courses of as+aq intermittently during the april - nov 2007 transmission season. community-based drug distributors (cdds) will administer all courses of iptc. the first dose of each course will be directly observed by the cdds who will educate mothers or caregivers to administer subsequent doses appropriately at home. follow up visits to homes will be done by cdds and field supervisors to ascertain adherence and to monitor adverse drug events. the incidence of clinical malaria and other secondary outcomes will be compared with those of another cohort of 546 study children who will not receive iptc but may be treated under the hmm strategy alone with as+aq when necessary during the observation period.


Eligibility criteria:
inclusion criteria: * a child in the study cohort will be eligible to receive a course of iptc (active or placebo) if the child has no fever (a temperature of 37•5o c or above) or history of fever in the last 24 hours. however, fever is only a temporary exclusion criterion. if a child has fever when he/she is due for an iptc course, treatment will be given for the fever and the iptc course given one month after the fever has subsided. this interval between treatment of fever episodes and administration of an iptc course is proposed in order to minimise the risk of overdosing since the same drug is used for both hmm and iptc. exclusion criteria: * a child in the study cohort will not be eligible to receive a course of iptc if: * the child has a clinical condition that may be classified as severe according to imci guidelines. * the child is known to suffer from chronic disease(s) e.g. sickle cell disease that might adversely affect the interpretation of study results. * the mother/caregiver withdraws consent.
consent for obtaining additional bone marrow specimens at time of diagnostic bone marrow procedure

Conditions: Brain Cancer; Cancer

Summary: the purpose of this study is to collect bone marrow samples for experimental studies.


Eligibility criteria:
inclusion criteria: * subjects who are having a bone marrow procedure done as part of their standard oncology work-up will be eligible to be consent on this study. exclusion criteria: * none.
safety of a sheath cryoprobe bronchoscopic transbronchial biopsy technique

Conditions: Lung Diseases

Summary: the purpose of this study is to evaluate the safety and collect data on the initial effectiveness of a 1.1mm flexible single-use cryoprobe with oversheath used for transbronchial lung biopsy via a bronchoscopic approach.

a smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that can be used for transbronchial biopsies. this device has the potential to gather larger and higher quality tissue samples than the standard method using forceps, and with potentially fewer complications than older, larger versions of the cryoprobe. this study does not involve randomization or assigning different patients to different procedures to compare. everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. the only difference from the standard of care approach is that the physician performing the transbronchial biopsy will use the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe. patients enrolled in this study will have data collected by research staff for up to 30 days after the bronchoscopic biopsy procedure is performed. this 30-day follow-up period is the standard of care following bronchoscopic biopsy procedures.

Eligibility criteria:
inclusion criteria: * male or female, ≥ 18-years-old * scheduled to undergo bronchoscopy with transbronchial biopsy as the standard medical care determined by their treating pulmonologist exclusion criteria: * pregnant or nursing females, or females of child bearing potential who refuse to take a pregnancy test prior to enrollment * individuals with current or recent systematic conditions, such as uncontrolled hypertension (systolic \> 200 mmhg or diastolic \> 110 mmhg), type 1 diabetes, severe pulmonary hypertension, acute kidney injury, stroke (within the last 6 months) or myocardial infarction (within the last 3 months) * presence of bleeding disorder * platelet count \<50,000 * current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable) * international normalized ratio (inr) \<1.5 * robotic bronchoscopy

Keywords: lung cryoprobe bronchoscopic biopsy
use of the bra as prevention of sternal wound dehiscence in cardiac surgery

Conditions: Cardiac Surgical Procedures; Wound Healing

Summary: the aim of the study was to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.

background: it is known that the size and support of the breasts are a specific problem in post-operative women of cardiac surgery by means of medium sternotomy. there is little evidence of the therapeutic action of the bra as a measure to prevent dehiscence of the surgical wound. aim: to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy. methods: randomised clinical trial; post-test control group in women undergoing cardiac surgery by mean sternotomy. groups: application of post-surgical or non-surgical breast bra. endpoint: incidence of dehiscence. other variables: sociodemographic, signs of infection, pain, related to assessment of the wound on admission. assessment of the surgical wound daily, at discharge, at month, 3 months and 6 months post discharge.

Eligibility criteria:
inclusion criteria: * over 18 years * cardiac surgery intervention in the germans trias i pujol university hospital with non-critical preoperative * surgical intervention performed throughout medium sternotomy exclusion criteria: * more than 72 hours admitted in an intensive care unit after surgery * cognitive impairment or severe physical disability * mastectomy * external wound occlusion with opsite® fixative absorbent dressing * emergency surgery

Keywords: cardiovascular nursing bra dehiscence sternotomy