Kornimate/medical-research-clean huggingface dataset:
effect of a post-operative protocol of early mobilization on functional recovery and postoperative complications after immediate internal pudendal artery perforator flap reconstruction for irradiated abdominoperineal resection defects: a prospective, randomized and controlled clinical study.

Conditions: Rectal Cancer

Summary: major abdominal oncology surgery is associated with substantial postoperative loss of functional capacity, and exercise may be an effective intervention to improve outcomes. the aim of this study was to assess efficacy, feasibility and safety of a supervised postoperative exercise programme in patients undergoing immediate internal pudendal artery perforator flap reconstruction for irradiated abdominoperineal resection defects. we will perform a open label, parallel-arm, randomized trial in patients who underwent immediate internal pudendal artery perforator flap reconstruction for irradiated abdominoperineal resection defects in a tertiary university hospital. patients will be randomized to an early mobilization postoperative programme based on supervised aerobic exercise, resistance and flexibility training or to standard rehabilitation care - bed restriction for 5 days. the primary outcome will be inability to walk without human assistance at postoperative day 5 or hospital discharge.the secondary outcomes will be incidence of surgical complications, ability of walk assessed for the 6-minute walk test, incidence and intensity of fatigue measured by piper's revised fatigue scale, improvement of quality of life measured by euroquol-5d-5l questionnaire, incidence of deep venous thrombosis.


Eligibility criteria:
inclusion criteria: 1. patients undergoing immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection . 2. age ≥ 18 years. 3. agreement to participate and signature of the informed consent form by the patient and / or family. exclusion criteria: 1. acute myocardial infarction (in the last 30 days) or unstable angina. 2. uncontrolled cardiac arrhythmia. 3. symptomatic severe aortic stenosis or other symptomatic severe valve dysfunction. 4. congestive heart failure nyha iii or iv. 5. hemodynamic instability. 6. venous thromboembolism. 7. pericarditis, endocarditis or myocarditis. 8. aortic dissection. 9. septic shock. 10. need for renal replacement therapy. 11. thyrotoxicosis. 12. presence of bone metastasis. 13. osteomioarticular and neurological conditions that make it impossible to carry out the exercise program designed for this study. 14. palliative procedures. 15. inability to perform the exercises due to musculoskeletal or neurological changes.
electroacupuncture treatment of behavioral and psycological symptoms in patients with alzheimer's disease

Conditions: BPSD (Behavioral and Psycological Symptoms of Dementia); Alzheimer's Dementia

Summary: this study aims to establish a prospective case registration research platform for electroacupuncture in treating behavioral and psychological symptoms in patients with mild to moderate alzheimer's disease, and to investigate the dose-effect relationship and cost-effectiveness of electroacupuncture for these symptoms.

to establish a prospective case registration research platform aimed at treating mild to moderate alzheimer's disease patients presenting with behavioral and psychological symptoms. this platform will document the electroacupuncture treatment process, conduct regular assessments using neuropsychiatric questionnaires (npi) and the alzheimer's disease cooperative study - clinical global impression of change scale (adas-cgic), and compare the effects of different parameters, treatment frequency, and duration of electroacupuncture on therapeutic outcomes for various behavioral and psychological symptoms in alzheimer's disease patients. furthermore, it aims to investigate the influencing factors of electroacupuncture treatment for behavioral and psychological symptoms.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for ad in the nia-aa standard; 2. clinical dementia rating scale ≤2 points; 3. accompanied by at least one psychobehavioral symptom, npi：frequency × degree ≥1 point; 4. sign informed consent. exclusion criteria: 1.there are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal
evaluate the efficacy and safety of dwj108j

Conditions: Central Precocious Puberty

Summary: this study aims to evaluate the efficacy and safety of dwj108j (leuprorelin acetate 11.25 mg) in patients with central precocious puberty.

the drug in this study is called leuprorelin. it is administered as a 3 month subcutaneous depot injection. leuprorelin is used to treat children who have central precocious puberty. this study will look at whether leuprorelin can stop early central precocious puberty.

Eligibility criteria:
inclusion criteria: 1. exhibited pubertal response of lh (peak ≥ 5 iu/l) during gnrh stimulation test at screening 2. diagnosis of central precocious puberty 3. for boys, those under 10 years old and for girls, those under 9 years old, based on visit 2 (enrollment), with tanner stage 2 or above 4. difference between bone age (greulich and pyle method) and chronological age ≥ 1 year 5. in cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent exclusion criteria: 1. following conditions at visit 1(screening) : conditions related to pseudo precocious puberty, incomplete precocious puberty, dysfunction of pituitary, adrenal, thyroid, or reproductive glands, growth disorders or bone diseases that could affect bone growth, brain tumor, pituitary adenoma 2. requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis 3. prior treatment with gnrh analogues 4. hypersensitive to the investigational drug for this clinical trial or gnrh analogues 5. prior or current therapy with growth hormone 6. has taken the following medications within 8 weeks of visit 1 (screening): sex hormone medications, sex hormone antagonists, steroids (local application is allowed; oral formulations are not allowed if taken within 3 days continuously, and use within 2 weeks of screening is prohibited), herbal medicine 7. meets the following criteria based on screening test results: ast, alt levels exceed twice the upper limit of normal, creatinine levels exceed 1.5 times the upper limit of normal, bone age is above 11.5 years 8. any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study
single dose pharmacokinetic (pk) study

Conditions: Angelman Syndrome; Fragile X Syndrome

Summary: the trial is a phase 1 single dose pk study in adolescent subjects with fragile x syndrome (fxs) or angelman syndrome (as). * the primary objective of the study is to evaluate the pharmacokinetics (pk) of ov101 following a single 5 mg dose of ov101 in adolescents with fxs or as. * secondary objectives are to determine the safety and tolerability of a single 5 mg dose of ov101 in adolescents with fxs or as.


Eligibility criteria:
inclusion criteria: 1. adolescents with confirmed clinical and previous molecular diagnosis of fxs or as, age between 13 to 17 years, inclusive. 2. subjects must assent to participation in the study (if appropriate), have a parent or legal guardian/representative capable of providing informed consent on behalf of the subject, and commit to participate in all assessments described in the protocol. 3. subjects must be receiving a stable dose of concomitant medications 4. subjects should be able to complete study assessments. 5. subjects who are non-sterile must agree to either remain completely abstinent or to use two effective contraceptive methods from screening until 7 days after the last dose of study treatment. 6. subjects must have a parent or other reliable caregiver who agrees to accompany the subject at all study visits and provide information about the subject as required by the study protocol, and ensure compliance with the protocol. exclusion criteria: 1. inability to swallow a capsule. 2. poorly controlled seizures 3. clinically significant abnormal ecg at the time of screening. 4. positive result on serum or urine pregnancy test for women of child-bearing potential (have experienced menarche) who are not using a dual method of contraception (e.g., condoms plus oral contraceptives), with abstinence being an accepted method. 5. allergy to gaboxadol or any excipients 6. concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a degree that would limit participation in the study 7. history of suicidal behavior or considered a high suicidal risk by the investigator. 8. any medical, psychological, social disorder(s), or other conditions - including seizure disorder
integrated mindfulness-based cognitive behaviour therapy versus cognitive behaviour therapy for provoked vestibulodynia

Conditions: Provoked Vestibulodynia

Summary: this randomized trial, nicknamed the comfort (cognitive therapy or mindfulness for treatment of pvd) study, will compare the effects of an 8-session group mindfulness-based cognitive therapy (mbct) to an 8-session group cognitive behavioural therapy (cbt) for women with provoked vestibulodynia (pvd). women with pvd will be randomly assigned to attend either eight sessions of group mbct or cbt. each session is 2.25 hours long and spaced 1 week apart. the purpose of this study is to determine whether the 8-session mbct intervention for pvd is no worse than an 8-session cbt intervention for decreasing women's pain intensity, sexual distress, catastrophizing and hypervigilance towards pain.

purpose: the purpose of this study is to determine whether an 8-session mbct intervention for pvd is no worse than an 8-session cbt intervention for improving women's pain intensity and reducing their sexual distress, catastrophizing and hypervigilance towards pain. the investigators will also examine whether pain improvements at follow-up are mediated by changes in self-compassion and mindfulness (in the mbct arm only) and moderated by pre-treatment credibility, personality, and anxiety sensitivity. hypotheses: 1. at follow-up (4 weeks, 6 months and 12 months post-treatment), women in the mbct arm will experience a greater decline (vs. pre-treatment) in vestibular pain intensity compared to women in the cbt arm. 2. at follow-up (4 weeks, 6 months and 12 months post-treatment), women in the mbct arm will experience a greater decline (vs. pre-treatment) in sex-related distress, pain catastrophizing, hypervigilance, and self-reported pain during intercourse/other penetrative sex compared to women in the cbt arm. 3. the investigators hypothesize that improvements in pain intensity during vestibular touch will be mediated by changes in self-compassion and mindfulness in the mbct arm only at 6 and 12 months follow-up. 4. the investigators hypothesize that pre-treatment credibility, personality, and anxiety sensitivity will significantly moderate improvements in pain intensity during vestibular touch at 6 and 12 months follow-up. 5. the investigators hypothesize improvements in both arms on the "patient global impression of change scale" and significantly greater improvements in the mbct arm relative to the cbt arm at follow-up (4 weeks, 6 months and 12 months post-treatment).

Eligibility criteria:
inclusion criteria: * diagnosis of provoked vestibulodynia (pvd) * 19 years of age or older * premenopausal * fluent in english * during the study, women must agree not to change any medications they are taking for pvd. exclusion criteria: * unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain * being uncomfortable and unwilling to participate in a group setting.

Keywords: provoked vestibulodynia dyspareunia vulvodynia mindfulness cognitive behavioural therapy
evaluation of optical coherence tomography in dentistry

Conditions: Dental Caries; Tooth Demineralization

Summary: optical coherence tomography (oct) is a medical diagnostic tool, providing non-invasive, non-radiative and high resolution imaging. oct has been established since many years in ophthalmology. in dentistry the diagnostic potential of oct is currently increasingly being noticed. this clinical study includes two individual trials: (i) longitudinal assessment of surface sealant thickness using optical coherence tomography and (ii) comparison of crevicular fluid levels of inflammatory cytokines after the application of surface sealants.

trial 1: evaluation of the abrasion behavior of the orthodontic surface sealants pro seal®, opal®seal, and protecto®caf2nano. the quadrants of 20 participants will be randomly assigned to four study groups. using a split mouth design three commonly used orthodontic surface sealants (pro seal®, opal®seal, and protecto®caf2nano) and a bonding primer (transbond xt) which is used as a control will be applied to the labial surfaces of the teeth of the respective quadrants. the thickness changes of the orthodontic surface sealants and the development of enamel demineralization will be monitored at the day of the application and five additional time points (t1= 1 month, t2= 3 months, t3= 6 months, t4=9 months, t5= 12 months) using oct. trial 2: evaluation of adverse effects of orthodontic surface sealants. 15 quadrants of the trial group described above (trial1) will be randomly selected and gingival crevicular fluid (gcf) will be sampled in the respective quadrants at the day of bracket bonding prior (t0) and at three additional time points (t1= 30 min, t2= 60 min, t3= 90 min) after the application of surface sealants or the bonding primer, respectively. analysis will be performed using magnetic luminex screening assays for il-8 (interleukin 8), and il-10 (interleukin 10) and examined for inflammatory cytokines after the application of surface sealants.

Eligibility criteria:
inclusion criteria: * orthodontic treatment need * informed consent from all patients and their parents or legal guardians after explaining of the study exclusion criteria: • withdrawn consent
pain assessment in children with cerebral palsy through parasympathetic tone analysis.

Conditions: Cerebral Palsy; Pain; Children

Summary: this study evaluates analgesia nociception index (heart rate variability based index) and its variations after painful stimulations in children with cerebral palsy : acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy).

cerebral palsy (cp) is the most common cause of motor handicap in childhood. cp is caused by damage to the developing brain, resulting in limits in movement, posture, or communication ability. cp affects about one newborn on 450. pain management is one of the major expectations of cp patients (la foundation motrice, 2009) but in this population, pain is not recognized and inadequately treated. autonomic nervous system (ans) is the automatic part of our nervous system regulating vital functions like cardiac beats or respiration. it is divided in sympathetic and parasympathetic. analysis of heart rate variability (hrv) allows isolation of variations due to parasympathetic and their study. works from the cic-it 807 lead to creation of an index called ani (analgesia nociception index), which is very sensitive to pain. it is validated on adults (jeanne, 2012). it could be helpful to assess pain in cp, particularly in patients with communication disabilities. it is important to study this new tool in cp children before developing clinical applications. main objective of this study is to demonstrate that ani is relevant in cp children and that it is sensitive to pain like in adults. population will be 40 cp children (6-18y) receiving rehabilitation therapy in specialized centres. duration of the study is 2 years. parent's consent should be obtained. investigators will record heart rate of children in 3 conditions in their rehabilitation centres: usual position, acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy). parameters will be calculated in cic-it 807 lab (heart rate, ani). values of ani and heart rate before and after painful stimulations will be compared. correlation between ani and results of usual pain assessment tools (rflacc scale, visual analog scale) or characteristics of the population will be analyzed. lille university hospital and cic-it 807 lab will collaborate with 2 pediatric rehabilitation centers: centre marc sautelet and zuydcoote hospital. expected result is that ani is relevant to cp children. clinical applications are multiple: pain assessment, adaptation of medical equipment.

Eligibility criteria:
inclusion criteria: * cerebral palsy * rehabilitation care with physiotherapy and/or toxinum botulinum injections * absence of identified autonomic nervous system disease * parental and children (if applicable) consent obtained * french national health system cover exclusion criteria: * baseline respiratory frequency \> 30/min * beta-blockers or atropinic treatment * pacemaker, cardiac rhythm disease * diabetes mellitus

Keywords: autonomic nervous system cerebral palsy pain children
iop lowering effect of plt versus slt in naiv oag patients

Conditions: Open Angle Glaucoma,; Ocular Hypertension

Summary: to investigate the effect of patterned laser trabeculoplasty (plt) compared to selective laser trabeculoplasty (slt) on intraocular pressure (iop) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension. values for iop will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment. * trial with medical device


Eligibility criteria:
inclusion criteria: * intraocular pressure (treatment naiv or after 4 weeks wash-out phase) \> 21 mm hg * visible angle structures over 360° on gonioscopy * age = 18 years exclusion criteria: * intraocular inflammation * patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy) * monocle situation * anterior chamber lenses (incl. iris claw) * secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)
evaluation of post-operative biochemical recurrence in patients submitted to radical prostatectomy under general opioid-free anesthesia compared to conventional general anesthesia

Conditions: Prostate Cancer

Summary: the use of opioids facilitates angiogenesis and has a proven action in the immune system, mainly in the reduction of natural killer cell activity, favoring the migration of neoplastic cells and inhibiting humoral and cellular immunity. these factors may contribute to recurrence and tumor metastasis. therefore, could opioid-free anesthesia help reduce tumor recurrence? this is a prospective randomized controlled clinical trial in which patients undergoing radical prostatectomy will be evaluated by conventional means, which have moderate and high d'amico criteria for tumor recurrence. in the operating room, patients will be monitored, receive peripheral venoclysis and then randomized into two groups: in group i, the anesthetic induction will be done with pre oxygenation with 100% o2, propofol, cisatracurium, lidocaine and fentanyl; in group ii the induction will be done with the same doses of propofol, cisatracurium, lidocaine and placebo. in both groups maintenance of general anesthesia will be with propofol 1% target infusion controlled with model of marsh target-controlled infusion plasma between 2.0 and 3.0 mcg / ml, ketamine, lidocaine and dexmedetomidine. both groups will receive blockade of the transverse plane of the ultrasound guided ultrasound, group i with placebo (saline 0.9% 20 ml on each side) and group ii with ropivacaine 0.375% 20 ml on each side. and the postoperative analgesia will be based on anti-inflammatory and opioid analgesics (pca of morphine) according to the analgesic pain scale of the patients. in the postoperative period, patients will be followed up for 2 years with serial doses of prostate specific antigen (psa) to diagnose tumor recurrence (2 psa measures\> 0.2 ng / ml) and will be evaluated in relation to analgesia, need for analgesia of rescue with morphine, satisfaction with the anesthetic technique, adverse effects (nausea and vomiting). the primary objective is to evaluate tumor biochemical recurrence after radical prostatectomy in patients undergoing opioid anesthesia compared to patients anesthetized without opioids. the secondary objectives are to evaluate the quality of analgesia with the two techniques, patient satisfaction with perioperative period, quality of anesthetic recovery and adverse effects (nausea and vomiting, pruritus and drowsiness). thus, to answer the hypothesis raised, 146 patients will be needed (73 in each group).


Eligibility criteria:
inclusion criteria: * prostate cancer; * intermediate to high risk of recurrence by d'amico criteria (gleason scale \> or = 7; psa \> or = 10) exclusion criteria: * patient refuse; * atrioventricular blockade; * coagulopathy; * other procedure at same time.

Keywords: general anesthesia cancer recurrence opioids analgesics neoplasm
application of computer-assisted navigation in total knee arthroplasty: a randomized pair-matched double-blind trial

Conditions: Knee Arthritis

Summary: objective: the purpose of this study is to evaluate the application of computer-assisted navigation in total knee arthroplasty (tka ) by comparing it with conventional tka. methods: gemini mk ii implants (link, germany) were used. vectorvisionâ ct-free navigation system (brainlab, germany) was employed for the tka. for each subject, computer-navigation tka and the conventional tka were separately performed on two knee joints. the operative method and order of the operations were decided on a randomized basis. all the patients and doctors conducting follow-up study and performing imaging measurement were blind to selection of the operation. student t test was used for statistical analysis. hypothesis: computer-assisted navigation system can significantly improve the accuracy of tibial and femoral cuts on coronal and sagittal planes.


Eligibility criteria:
inclusion criteria: * plan for simultaneous bilateral tka. exclusion criteria: * plan for unilateral tka.
safety and efficacy of valsartan vs atenolol and hydrochlorothiazide combination on blood flow in hypertensive patients

Conditions: Hypertension

Summary: this study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.


Eligibility criteria:
inclusion criteria: * caucasian; male or female outpatients and age between 40-65 years of age, inclusive. * at visit 2 all patients must have a mean sitting diastolic blood pressure (mssbp) of ≥ 90 mmhg and \< 110 mmhg. exclusion criteria: * if a single reading for arterial hypertension in mssbp \> 180 mmhg or msdbp \> 110 mmhg at any visit after randomization. * inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization. * known history of hypotensive symptoms or orthostatic hypotension. * concomitant use of statins or statin intake during the four weeks prior to visit 1. * known keith-wagener grade iii or iv hypertensive retinopathy. * a history of heart failure (nyha ii-iv).

Keywords: hypertension valsartan atenolol hydrochlorothiazide microcirculation arterial compliance pulse wave analysis