Kornimate/medical-research-clean huggingface dataset:
effects of vitamin d supplementation on obesity, inflammatory and metabolic markers

Conditions: Overweight; Hypovitaminosis D

Summary: 46 eligible overweight women with hypovitaminosis d are assigned to either vitamin d or control group using block randomization method. vitamin d3 pearl (zahravi pharma co, tabriz, iran) containing 50000 iu cholecalciferol or placebo are administered weekly for 12 weeks. participants in both groups are structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study.

for the randomized controlled clinical trial (rct), the first fifty eligible women were assigned to either the vitamin d or placebo group using the block randomization method. each vitamin d3 pearl (zahravi pharma co, tabriz, iran) contained 50000 iu cholecalciferol and was administered weekly for 12 weeks according to guidelines for treating vitamin d deficiency. placebo pearls (zahravi pharma co, tabriz, iran) had the identical appearance, taste, and smell as the vitamin d pearls and could only be identified by the package code. the placebo pearls were administered similarly. to keep the study double-blinded, an assistant who was not involved in assessments managed the randomization and supplement assignment procedure. participants were structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study. they were also asked to inform the researcher before taking any new medications. all participants were provided with a moderately reduced diet (a reduction of 300 kcal per day) based on their basal weight. the nutrigenetic study investigated 75 eligible women (including the vitamin d group and the last fifty women who entered the study). the nutrigenetic study protocol was the same as that mentioned above for the vitamin d group in the rct. compliance was ensured by weekly text messages and voice calls to remind the users of the supplement on the given day. in addition, the supplement and placebo pearls were presented in two visits; once at the baseline visit and then after six weeks. pearls packs were collected from each subject (at week 6 and week 12) to check if all the pearls were consumed as recommended. during the first and last visits, anthropometric and laboratory assessments were performed for all subjects. the primary outcomes are improving anthropometric, inflammatory, and metabolic markers of overweight women with hypovitaminosis d.

Eligibility criteria:
inclusion criteria: * low serum vitamin d level \<30ng/ml * 25\<bmi\<30 kg/m2 * age: 20-50 * free of chronic diseased such as cancer, diabetes, cardiovascular disease, renal diseases, gastrointestinal diseases, no multivitamin supplement intake, no change in weight in the last 3 months exclusion criteria: * getting pregnant during the study * suffering from thyroid disorders and other diseases mentioned during the study * not taking supplements weekly
oral versus intravenous tranexamic acid

Conditions: Blood Loss; Blood Transfusion

Summary: the goal of this randomized clinical control trial is to determine whether oral txa dosing in tha/tka result in more blood loss and more transfusions compared to iv txa dosing in patients undergoing tha/tka under neuraxial anesthesia. the main questions it aims to answer are: does oral txa dosing in tha/tka result in more blood loss compared to iv txa dosing? does oral txa dosing in tha/tka result in more transfusions compared to iv txa dosing? participants will be randomly assigned to either get the oral txa (1950mg) or the iv txa (1g) on their day of surgery. researchers will compare these groups to see if any differences emerged. 200 tha patients (100 oral, 100 iv), 200 tka patients (100 oral, 100 iv).

tranexamic acid (txa) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. the use of txa in total hip arthroplasty (tha) and total knee arthroplasty (tka) has resulted in dramatic decreases in operative blood loss and transfusion rates, revolutionizing the field of arthroplasty. the use of txa, now common, has made autologous blood donation programs largely obsolete. additionally, it has made perioperative blood transfusion uncommon. while aaos guidelines suggest that all three available preparations of txa (oral, iv, topical) are effective, preferred route of dosing varies by provider and institution. these preferences are based on habit, understanding of pharmacodynamics, and logistical issues regarding effective dosing. oral txa is the cheapest option, but some surgeons prefer iv dosing due to concerns regarding efficacy and controlled dosing. in this study, we seek to compare the efficacy of a single pre-op oral dose of txa to a single pre-op iv dose of txa.

Eligibility criteria:
inclusion criteria: * patients undergoing total hip arthroplasty (tha) through a posterior approach * patients undergoing total knee arthroplasty (tka) * patients between 18-80 years of age exclusion criteria: * patients with \>80 years of age * patients with a bmi over 40 * patients undergoing general anesthesia * patients with a history of major ipsilateral joint surgery * patients on pre-operative anticoagulation or anti-platelet drugs (other than aspirin) * patients with a history of bleeding disorders * patients with platelets less than 100/nl * patients with new-onset/active atrial fibrillation * patients with a history of myocardial infarction in the past year * patients with a history of a stroke in the past year
a trial on the efficacy, safety and immunogenicity of live-attenuated influenza vaccine (laiv)

Conditions: Influenza

Summary: this study is a multicenter, randomized, double-blind, placebo-controlled, phase ⅲ trial to evaluate the efficacy, safety and immunogenicity of a single dose of live-attenuated influenza vaccine(laiv) among healthy children and adolescents aged 3-17 years.

this study is a multicenter, randomized, double-blind, placebo-controlled, phase ⅲ trial to evaluate the efficacy, safety and immunogenicity of a single dose of live-attenuated influenza vaccine(laiv) among healthy children and adolescents aged 3-17 years old. the subjects will be randomized in a 1:1 ratio of laiv to placebo. each subject will be vaccinated with a single dose of laiv or placebo. for evaluation of efficacy, subjects meeting the protocol-defined clinical case definition the 14th day post-vaccination will have a nasal swab collected for testing by rt-pcr or virus culture for evidence of influenza virus infection. all adverse events will be collected 30 minutes, 0-30 days after vaccination and all serious adverse events during the entire trial period. blood samples will be collected from a part of subjects before vaccination and at the 30th day after immunization. serum samples will be centrifuged for detection of antibodies to h1n1, h3n2, and influenza b.

Eligibility criteria:
inclusion criteria: 1. healthy children and adolescents aged 3-17 years old. 2. informed consent obtained and signed by subjects or legal guardians prior to screening. children or adolescents aged 10-17 yrs need sign informed consent by themselves. 3. willing to participate for the planned duration of the study, including availability for follow-up. exclusion criteria: 1. any investigational or unregistered product (drug, vaccine or device) was used within 30 days, or planned to be used during the trial. 2. have been vaccinated with any influenza vaccine within 6 months, or plan to be vaccinated during the trail. 3. immunosuppressive agents or other immunomodulatory drugs (defined as continuous use for more than 14 days) were used over a 3-month period. 4. immunoglobulins and / or any blood products were used within 3 months, or planned to be used before blood collection. 5. history of guillain-barré syndrome; history of hypersensitivity to any component of the laiv, including egg or egg products. 6. severe allergic reactions after vaccination (including anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis). 7. acute diseases , infections or febrile diseases (axillary temperature ≥37.1℃) on the day of vaccination. 8. obvious coagulation dysfunction or history of anticoagulant therapy 9. aspirin is being used(salicylates are a potential risk factor for reye syndrome) 10. known or suspected immune deficiency diseases or immunosuppressed 11. heart disease, respiratory diseases (including severe rhinitis, nasal deformities, polyps, etc.), liver disease, kidney disease, mental disorders, chronic infections etc.

Keywords: influenza vaccines laiv
reversal of ketamine pharmacodynamic effects with naloxone

Conditions: Pain

Summary: the purpose of this study is to determine whether the analgetic and other effects effect of ketamine are partly mediated through opioid receptors

ketamine er et dissociative anaesthetic closely related with phencyclidine (pcp). phencyclidine is a non-competitive nmda-antagonist, and it is assumed that the pharmacodynamic mechanism of action for ketamine is the same. receptor binding studies shows that ketamine has affinity to many receptor types, including opioid mu and kappa receptors. ketamine has only about 25 times lower affinity for kappa receptors than for the nmda-receptor complex. naloxone is a specific antagonist for opioid receptors and block both mu og kappa receptors. a dose of naloxone 10 times larger than required to block mu receptors is required to block kappa receptors. experiments with naloxone suggest that ketamine is not a mu agonist, but experiments with sufficient large naloxone doses to block kappa receptors have not been carried out in humans.

Eligibility criteria:
inclusion criteria: * females of norwegian caucasian origin who needs surgical removal of impacted third molars exclusion criteria: * anamnestic information regarding psychiatric diagnosis regarding mother/father or brother/sister concommitant medication other than oral contraceptives hypersensitivity towards nsaid/opioids/study drugs females with suspected or confirmed pregnancy lactating females surgery lasting more than 60 minutes

Keywords: pain naloxone ketamine third molar surgery
68ga-fapi pet/ct in patients with various types of cancer

Conditions: Tumor; Positron-Emission Tomography; Metastasis

Summary: to evaluate the potential usefulness of 68ga-dota/nota-fapi-04 positron emission tomography/computed tomography (pet/ct) for the diagnosis of primary and metastatic lesions in various types of cancer.

subjects with various types of cancer underwent 68ga-dota/nota-fapi-04 pet/ct either for an initial assessment or for recurrence detection. tumor uptake was quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy of 68ga-dota/nota-fapi-04 pet/ct were calculated.

Eligibility criteria:
inclusion criteria: * (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include mri, ct, tumor markers and pathology report); (iii) patients who had scheduled 68ga-dota/nota-fapi-04 pet/ct scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the clinical research ethics committee. exclusion criteria: * (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
molecular biology in the identification of pathogens at reimplantation in the two-stage treatment of periprosthetic infections

Conditions: Periprosthetic Joint Infection (PJI)

Summary: the goal of this observational study is to measure the diagnostic accuracy of the multiplex pcr technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment according to two-stage protocol for pjis. this evaluation will be conducted by comparing the results obtained by multiplex pcr with those derived from standard culture examination.

the data that will be collected are: 1. pre-implantation data: timing of infection, bacterial population involved, type of surgery (primary or revision implantation). baseline characteristics of patients, such as gender, age, history of previous interventions (including date, number and type of interventions), comorbidities, asa score, and lifestyle habits (such as smoking and alcohol) will also be recorded. local problems of the operated limb and investigations performed, including instrumental and laboratory tests, will be documented. 2. data on explant surgery and postoperative course: details of whether or not spacer cement was used according to the two-stage protocol, the type of spacer cement used, the occurrence of intraoperative complications and the characteristics and duration of postoperative antibiotic therapy will be recorded. results of molecular investigations will be documented, both pre-operative on ultrasound aspirate, intraoperative and 15 days after discontinuation of antibiotic therapy. results of histological and culture examinations of the preoperative and intraoperative aspirate, postoperative complications will be included. 3. data related to reimplantation: timing of reimplantation, result of molecular, culture, and histological examinations on intraoperative specimens, post-reimplantation antibiotic therapy, intraoperative and postoperative complications, clinical status at follow-up (recurrence/persistence of infection), and duration of follow-up.

Eligibility criteria:
inclusion criteria: * diagnosis of periprosthetic infection of hip, knee, shoulder on primary or already revised implant. * treatment of infection with two-stage protocol. * obtaining informed consent * age ≥18 years exclusion criteria: * isolates obtained during explantation not included in multiplex pcr panel

Keywords: multiplex pcr
dexmedetomidine to lessen intensive care unit (icu) agitation

Conditions: Delirium

Summary: the primary aim of the dahlia trial is to determine, in patients with icu-associated delirium and agitation who are otherwise pathophysiologically stable (as defined), the number of ventilator-free hours in the incident icu admission in the 7 days following commencement of trial medication, in patients randomised to receive dexmedetomidine or placebo while receiving all other aspects of standard care. the null hypothesis assumes no difference in the median number of ventilator-free hours in this icu admission in the following 7 days, between patients receiving dexmedetomidine and placebo for icu-associated agitation and delirium.


Eligibility criteria:
inclusion criteria: patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible, and in the opinion of their treating intensivist their agitation is so severe as to make lessening their sedation unsafe. these criteria will be objectively quantified as follows: * they have required either mechanical restraint and/or anti-delirium or sedative medication in the 4 hours prior to seeking consent and * their confusion assessment method for the icu (cam-icu) test is positive for delirium in the 4 hours prior to seeking consent and * their motor activity assessment scale (maas) score is 5 or more in the 4 hours prior to seeking consent, confirming psychomotor agitation and * their sofa score is less than or equal to 5 in the 4 hours prior to seeking consent, predicting a mortality or around 5%. exclusion criteria: * age less than 18 years old * pregnancy or breastfeeding * advanced dementia (in the premorbid state requiring professional nursing care) * open or closed head injury * death is deemed imminent and inevitable * the patient has previously been enrolled in the dahlia study * patients who could not be extubated, or who would be intubated within the following 48 hours, even if delirium or agitation were corrected. this will include: * patients receiving high dose opioid for analgesia (not sedation) ( \> 40 mg/morphine/day) * patients shortly to return to the operating theatre * patients undergoing repeated invasive procedures, in whom it is desirable to maintain deep sedation * patients likely to require ongoing airway protection or control, or ventilatory support (for example, spinal patients with an inadequate vital capacity) * known allergy to haloperidol or alpha 2 agonists

Keywords: delirium intensive care unit dexmedetomidine
virtual reality validation tool for cognitive rehabilitation, oriented project for people with psychosocial disabilieties

Conditions: Mood Disorders

Summary: randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the consultation and psychosomatic psychiatry center of the university hospital of cagliari (san giovanni di dio civil hospital) with a diagnosis of mental disorder. the investigators propose a vr intervention of 3 months with 2 weekly session of cerebrum (cognitive remedy intervention with virtual reality) first to the group a and then to the group b.

background: cognitive remedial interventions have been found to be effective in the treatment of various psycho-social disorders. the use of virtual reality as a rehabilitation tool has been showing various scientific evidences in recent years like in cardiovascular, neurological and musculoskeletal rehabilitation. in mental health evidence they seem to be concentrated in the rehabilitation of social cognition in people with schizophrenia diagnosis and psychotherapy. the aim of this study is to evaluate the feasibility and the effectiveness of the first cognitive remedial toll in virtual reality (cerebrum) for people that has experienced in mental health. methods: randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the consultation and psychosomatic psychiatry center of the university hospital of cagliari (san giovanni di dio civil hospital) with a diagnosis of mental disorder. the investigators propose a intervention of 3 months with 2 weekly session of cerebrum first to the group a and then to the group b

Eligibility criteria:
inclusion criteria: * age from 18 to 75; * diagnosis of psychosis and / or mood disorder according to dsm-iv (american psychiatric association, 2000). * both sexes; * users who sign the informed consent; * users under protection for which the informed consent is signed by the guardian exclusion criteria: * the non-satisfaction of the inclusion criteria; * the diagnosis of epilepsy or serious eye diseases, due to the risk associated with the excessive stimulation of virtual reality

Keywords: virtual reality remediation mental health recovery
hit training in the frail elderly.

Conditions: Sarcopenia; Aged; Exercise; Preoperative Care

Summary: this pilot study aims to investigate whether high intensity interval training can result in rapid improvements in physical fitness amongst the frail elderly (over 70 years old). participants will undergo a wide range of physical fitness measures followed by a four week exercise protocol. determination of improvement will be by repeated testing of the physical measures taken for baseline. the primary outcome measure will be anaerobic threshold. there will also be a subgroup of participants who will undergo muscle biopsy and d2o ingestion to allow an insight into the mechanistic basis behind exercise training response in this age group.


Eligibility criteria:
inclusion criteria: * aged over 70 years. * sufficient mobility to be able to exercise on a static exercise bike. * availability for the entire trial period. * sufficient capacity to consent for the trial. exclusion criteria: * participants under the age of 70 years. participants with a significant past medical history of: * myocardial infarction (within last 6 months) * unstable angina * heart failure (nyha class iii/iv) * uncontrolled hypertension (bp\>160/100) * previous stroke/tia * severe respiratory disease inc. known pulmonary hypertension(\>25 mmhg), forced -expiratory volume in 1 second \<1.5l. * brittle asthma / exercise induced asthma * known cerebral aneurysm or abdominal aortic aneurysm. * cognitive impairment, which may reduce individuals' ability to provide informed consent. * inclusion in a recent study which included any form of exercise, taking a drug or ionising radiation. exclusion criteria pertaining specifically to muscle biopsies: * current use of anticoagulation (i.e. warfarin/clopidogrel/rivaroxaban) * any pre-existing clotting disorders known to the patient (i.e. haemophilia). * family history of severe bleeding requiring medical intervention. * any musculoskeletal deformity or skin conditions making the taking of a biopsy unsuitable as deemed by the medical practitioner taking that sample. * lack of capacity to fully consent for the procedure.
vaginal cuff dehiscence following total laparoscopic hysterectomy: laparoscopic vs. transvaginal cuff closure

Conditions: Surgical Wound Dehiscence

Summary: post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication. the investigators will compare transvaginal versus laparoscopic closure of the vaginal vault at the end of a total laparoscopic hysterectomy, in order which of these two modalities of suturing is associated with a lower risk of dehiscence.

a post-hysterectomy vaginal cuff dehiscence is defined as a partial or total separation of the margins of the vaginal cuff closure, following hysterectomy. the recognition of the complication is made on a clinical basis. the investigators will compare the percentage of dehiscence among women who had transvaginal vs. laparoscopic suture of the vault. the investigators will also compare the two modalities in terms of: * duration of the vaginal closure * risk of bleeding from the vaginal cuff * risk of post-operative pelvic infection * risk of re-operation * dyspareunia * total vaginal length * vaginal cuff prolapse.

Eligibility criteria:
inclusion criteria: * patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy exclusion criteria: * patients with gynecological malignancy (uterine and/or adnexal)

Keywords: vaginal dehiscence
multimodal analgesia strategies after major shoulder ambulatory surgery

Conditions: Tendon Injuries

Summary: this study evaluates the addition of tramadol, or nefopam or opioid to paracetamol and ketoprofene in the treatment of pain in adults after shoulder ambulatory surgery. in a first step, 30 patients will receive tramadol as rescue analgesia in combination with paracetamol and ketoprofene, while the other will receive nefopam or opioid in a sequential analysis that will be performed every 20 patients using the qor 40 survey.

multimodal analgesia using acetaminophen with non steroidal anti inflammatory is commonly used for pain relief after ambulatory surgery. tramadol achieves pain relief when rescue analgesia is needed after this surgery, but induces side effects (nausea, vomiting, discomfort, sleep disorder...). other drugs could be used to reduce the side effects of tramadol and improve postoperative experience : nefopam or opioid (immediate or delayed release medication). using a survey that describes pain, comfort, emotion or physical status (qor 40), the investigators analyse the impact of various multimodal strategies using tramadol or nefopam or opioid that is necessary to improve postoperative experience.

Eligibility criteria:
inclusion criteria: * shoulder surgery * under general anesthesia with an nterscalenic block * written informed consent * age \> 18 years exclusion criteria: * age \< 18years * emergency surgery * refusal * drug or opioid abuses

Keywords: shoulder surgery analgesia opioid