Kornimate/medical-research-clean huggingface dataset:
total wrist denervation: survival study and functional outcomes

Conditions: Wrist Arthritis; Survival

Summary: the purpose of the study is to evaluate the long-term effectiveness of total wrist denervation on pain by assessing the surgery survival. the residual functional wrist's quality and the patients' satisfaction will also be evaluate.

the degenerative diseases of the wrist are numerous and include both post-traumatic osteoarthritis lesions and inflammatory diseases. in any case, one of the main reasons for consultation is pain. in case of inefficiency of a well-conducted medical treatment (splints, anti-inflammatories, infiltrations), surgical management remains difficult because of the multitude of treatments that can be offered: partial or total arthrodesis of the wrist, prosthetic arthroplasties, pyrocarbon implants or proximal row carpectomy. but these treatments are heavy and can potentially be sources of complications such as stiffness, loss of strength or progressive wear of the implant. total wrist denervation is an alternative since 1966. the original technique follows an anatomical study of the innervation of the upper limb. this technique has been proven to significantly improve pain without major after effects. several teams demonstrated a decrease in pain associated with conserved strength and mobility, but few studies have studied the long-term results of this technique, especially on the absence of residual pain. the purpose of this study is to evaluate the long-term effectiveness of denervation on pain by assessing the surgery survival, the residual functional wrist's quality and the patients' satisfaction.

Eligibility criteria:
inclusion criteria: * patient undergoing total wrist denervation between january 1995 and december 2013 at brest chru, performed by the same senior surgeon exclusion criteria: * patient who had another intervention at the same time (confounding factor) * refusal expressed by the patient to participate in the study

Keywords: long-term result denervation
artificial valve endocarditis reduction trial

Conditions: Aortic Valve Disease; Mitral Valve Disease; Endocarditis

Summary: the purpose of this study is to investigate whether the silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (pve).

the purpose of this study is to investigate whether the silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis. the null and alternative hypotheses of this study are: * ho: patients receiving sjm masters series valves with silzone coating will have an equal incidence of pve when compared to those receiving the conventional cuff. * ha: patients receiving sjm masters series valves with silzone coating will have a reduced incidence of pve when compared to those receiving the conventional cuff.

Eligibility criteria:
inclusion criteria: * the patient requires an isolated mitral, isolated aortic, or double (aortic and mitral) valve replacement * the patient is a candidate to receive an sjm (st. jude medical) masters series valve(s) with either the conventional cuff or the cuff with silzone coating * the patient (or legal guardian) has signed a study-specific consent form agreeing to the randomization, data collection, and follow-up requirements exclusion criteria: * the patient has a medical condition which contraindicates implantation of the sjm masters series with silzone coating * the patient already has a prosthetic valve other than the valve being replaced at this time * the patient requires a tricuspid valve replacement

Keywords: artificial heart valve mitral heart valve aortic heart valve endocarditis aortic valve disease requiring replacement mitral valve disease requiring replacement
danish nausea study in advanced cancer-epidemiology: a danish multicenter trial to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer.

Conditions: Advanced Cancer; Nausea; Emesis

Summary: the study aims to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer not receiving chemotherapy or irradiation.


Eligibility criteria:
inclusion criteria: 1. advanced cancer 2. age ≥ 18 years 3. ability to read and understand the forms required for the study 4. life-expectancy more than 2 weeks. 5. nausea score ≥ 'a little' on the extended eortc qlq-c15-pal (item 9) exclusion criteria: 1. surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days. 2. chemotherapy or radiation therapy within the last 4 weeks 3. symptoms of increased intracranial pressure or cerebral metastasis. if this is suspected, a normal mri scan of the cerebrum is needed before inclusion 4. radiologically confirmed ileus, or strong clinical suspicion evaluated by the study investigator 5. pregnancy
antibiotics against amyloid angiopathy

Conditions: Cerebral Amyloid Angiopathy

Summary: we will perform a randomized clinical trial with minocycline. minocycline is an antibiotic of the tetracycline family and known to modulate inflammation, gelatinase activity and angiogenesis, which we know are central mechanisms in caa-pathology. our aim is to prove in a randomized clinical trial in a translational setting that minocycline treatment (duration 3 months) can decrease markers of neuroinflammation and the gelatinase pathway in the cerebrospinal fluid (csf) of persons with d-caa (n=30) and sporadic-caa (n=30).


Eligibility criteria:
inclusion criteria: * age ≥18 years for d-caa and age ≥55 years for sporadic-caa * probable-caa according to the modified-boston-criteria or genetically proven d-caa * ≤ 2 ich (occurrence of ichs at least 1 year ago) and presence of ≥ 2 lobar microbleeds +/-cortical superficial siderosis * written informed consent exclusion criteria: * previous allergic reactions to minocycline * modified rankin score ≥3 * contraindications, such as: * contraindications for 7t mri as determined by the 7tesla safety committee. examples of possible contra-indications are: claustrophobia, pacemakers and defibrillators, nerve stimulators, intracranial clips, intraorbital or intraocular metallic fragments, cochlear implants, ferromagnetic implants, hydrocephalus pump, intra-uterine device, permanent make-up, tattoos above the shoulders. in case of specific contra-indications for 7t a 3t will be made instead. - specific contraindications for checkerboard fmri: seizure within prior year, photosensitive epilepsy, noncorrectable visual impairment. - contraindications for lumbar puncture: compression of the spinal cord, signs and symptoms of increased intracranial pressure, local infections of the skin at the puncture site, a coagulopathy or thrombocytopenia (\<100). (use of acetylsalicylic acid, nsaids, cox2 inhibitors or low-molecular-weight heparin are no contraindications for lumbar puncture.) * pregnancy/breast feeding * liver/renal failure * use of antibiotics \<1 month * sle or other diseases known to generate inflammatory responses * previous/current/planned use of retinoids (since this is related to increasing risk of increased intracranial pressure) * current use of anaesthetics like methoxyflurane, agents inhibiting peristalsis, barbiturates, carbamazepine or fenytoïne
impact of three body positioning strategies in the drainage fluids after coronary artery bypass surgery

Conditions: Coronary Artery Disease

Summary: to investigate different strategies of body positioning associated to early corporal mobilization and verify the impact int the time and quantification of thoracic and mediastinal drainage, pulmonary complications and time of intensive care units in hospitals stay. after first six hours post extubation in the first postoperative day and after evaluation and inclusion in the study, patients were randomized in three groups for receiving different strategies of body positioning associated to early mobilization with help of bed hill rom (hill rom batesville@): group 1: control (gc n=33); group 2: continuous lateral rotation group (trcl n=34); group 3:positioning in sitting and orthostatic (ort n=34).

coronary artery bypass surgery can lead to pulmonary complications like pleural effusion and pneumonia. these complications increase the length of stay and the immobility time. the investigators aim was to assess the impact of early mobilization of fluids drainage of chest tubes and the incidence of pulmonary complications. a prospective, randomized study included 101 patients divided in three groups. in the control group (cg:n=33) the patients were seated in armchair in the first 48 hours postoperative time. the group (trcl n=34) a continuous rotational bed therapy was instituted six hours post extubation in the first 24 hours and it comprised with by consecutive cycles of lateral rotation to the left and right side, and supine position with 30 seconds for pauses (using a hill rom rotational bed device) witch stopped when need to perform routine measurements the hemodynamics measurements and clinical controls by nursing crew.the group ( ort n=33) following the sequential steps t1: sitting in the bed for 2 hours, t2: sitting on the bed with their feet on the floor for 2 minutes and t3: the patients stoos up and walked on the spot for 2 minutes. hemodynamics and oxygenation measurement before and after each intervention.

Eligibility criteria:
inclusion criteria: * first postoperative day of cardiovascular surgery 6 hours after extubation * efve\> 35% * writen inform consent exclusion criteria: * neurological alteration * hemodynamics instability with pam \< 60 mmhg * blood * pneumothorax or broncopleural * arritymias

Keywords: mobility coronary artery bypass positioning body
sealant-dk: longevity and efficacy of 6 resin sealants used for sealing permanent teeth in children and adolescents

Conditions: Dental Caries

Summary: background: occlusal caries is the main reason for restorative therapy in the young permanent dentition, but restorations have limited survival time and may also weaken the tooth. an intact fissure sealing is an effective preventive treatment of occlusal caries lesions and may be used therapeutically to arrest the caries progression. however, the major challenge with fissure sealants is the frequent need for re-treatments, mostly due to inadequate retention. purpose: to quantify the longevity and effectiveness of the 6 resin sealants used prophylactically and therapeutically in permanent molar teeth. study design: the study is carried out as a prospective, clinically controlled study with split-mouth design, where each of the 60 dentists/dental hygienists from 13 municipalities in denmark uses 2 of the 6 sealants. the treatments are examined clinically and radiologically after 1, 2, 3, and 5 years.

the choice of the two materials is randomized and carried out so that all materials are used equally frequent and with an even distribution between dentists and dental hygienists.

Eligibility criteria:
inclusion criteria: * children and adolescents 5-14 years of age * children with 2, 4, 6 or 8 molars assessed to be in need of prophylactic or therapeutic sealing * the radiographic penetration of the occlusal caries lesion must be limited halfway through the dentin exclusion criteria: * in case the occlusal surface is restored with communication between the restoration and the included lesion * subjects with chronic diseases that could affect their caries pattern * pain in teeth

Keywords: occlusal caries resin fissure sealant longevity effectiveness
parent's satisfaction and evaluation of postsurgical outcomes in unilateral cleft lip / palate newly born infants with / without vacuum formed nasoalveolar molding aligners : a controlled clinical trial

Conditions: Cleft Lip and Palate

Summary: newborns with unilateral cleft lip/ palate will be treated pre-surgically by vacuum formed aligners in order to evaluate its effect on nasoalveolar complex.

newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive vacuum formed aligners while control group will not receive vacuum formed aligners. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.

Eligibility criteria:
inclusion criteria: * non-syndromic infants with complete unilateral cleft lip and palate * infants less than 3 months of age * males and females. * infants with displaced alveolus * patients whose parents provided written consent for the study. exclusion criteria: * patients above 3 months of age * syndromic, malnourished and systemically ill infants. * patients with bilateral cleft lip and palate. * incomplete cleft lip. * medically compromised patients * patient's/guardians who will be unwilling to go through the pnam therapy
efficacy/safety of urogynecology synthetic mesh surgery

Conditions: Pelvic Organ Prolapse; Stage III and IV High Grade Pelvic Organ Prolapse

Summary: this is a retrospective cohort study, aiming at analyzing the efficacy and safety of mesh surgery in pelvic organ prolapse. the synthetic mesh for pelvic organ prolapse include transvaginal mesh or laparotomy, laparoscope, or robotic-assisted laparoscopic sacrocolpopexy with mesh augmentation. the investigators would like to evaluate the efficacy and safety, such as recurrence rates and complication rates for women who underwent urogynecology mesh surgery.

gynecologic mesh, including transvaginal mesh and mesh used in abdominal or laparoscopic sacrocolpopexy, has been used for pelvic organ prolapse since its debut in the us in 2005. it provides higher success and satisfaction rate than traditional colporrhaphy, but mesh-related complications, such as pain, mesh exposure and bleeding, have been reported. u.s. food and drug administration issued a safety update in 2011 to inform the public that serious complications associated with synthetic mesh for the transvaginal repair of pop were common. taiwan fda and associated committees decided that the use of gynecologic mesh should be regulated. thorough study and evaluation are needed.

Eligibility criteria:
inclusion criteria: * pelvic organ prolapse patients with objective / subjective voiding dysfunctions * underwent surgery for symptomatic pop ≥ stage ii (pop-q system) exclusion criteria: * patients with a history of pelvic radiation. * patients with a history of vesico-/recto-/urethra-vaginal fistula * patients unable to be followed up.
outcome analysis in septorhinoplasty

Conditions: Rhinoplasty; Nasal Obstruction; Esthetics

Summary: a prospective observational cohort study that measures pre- and postoperative outcome of septorhinoplasty by means of patient-related outcome measures (proms: nose, face-q, utrecht questionnaire, schnos and bddq-as) as well as with functional tests (nar, ar, pnif).

introduction: in an ent setting, septorhinoplasty is frequently performed for both functional and aesthetic reasons. therefore, pre- and postoperative evaluation of patients' 'total' satisfaction regarding their nasal appearance and functional result is paramount. objectives: to measure the pre- and postoperative functional and aesthetic outcome in patients undergoing an external septorhinoplasty. design, setting, participants: a prospective observational, longitudinal outcome cohort study in a single private hospital centre is set up. all participants are patients undergoing an external septorhinoplasty for functional and aesthetic reasons. exposures: the nasal obstruction symptom evaluation scale (nose), utrecht questionnaire, the face-q satisfaction with nose, face-q satisfaction with nostrils, schnos score and bddq-as score, are administered to patients preoperatively and at 3, 6 and 12 months postoperatively. also functional tests (nasal anterior rhinomanometry (nar), peak nasal inspiratory flow (pnif) and acoustic rhinometry (ar) will be performed preoperatively and postoperatively at 6 and 12 months. patient demographics, nasal history, and outcomes will be analyzed. main outcome and measures: the primary outcome will measure longitudinal postoperative changes in nasal obstruction and aesthetic satisfaction: * change between pre- and postoperative results of nose and face-q questionnaires, utrecht questionnaire, schnos and bddq-as score (time frame: at inclusion and at 3, 6 and 12 months postoperatively) * change between pre- and postoperative values of nar, pnif and acoustic rhinometry (time frame: at inclusion and at 6 and 12 months postoperatively) secondary outcome * correlation between proms and functional tests * correlation between change in functional tests and the surgical methods used

Eligibility criteria:
inclusion criteria: * at least 18 years old * patients eligible for external septorhinoplasty: patients seen in consultation because of nasal obstruction were evaluated. patients who had symptoms of nasal obstruction for at least 1 year that were the result of an identifiable anatomical cause such as septal deviation, turbinate hypertrophy, internal valve collapse, or external valve collapse were included in the study. exclusion criteria: * \< 18 years * mental or physical incapacity to answer the questionnaires * nasal fracture or surgery in the past year * nasal cocaine use in the past year

Keywords: nasal function septorhinoplasty patient-reported outcome rhinomanometry acoustic rhinometry peak nasal inspiratory flow esthetics
acceptability of nutrient supplements among women and children in bangladesh

Conditions: Malnutrition

Summary: the study aims to confirm the acceptability of lipid-based nutrient supplements (lns) for use as nutritional supplements for pregnant and lactating women (plw) or infants and young children (iyc) and micronutrient powder (mnp) for use as nutritional supplements for infants and young children in bangladesh.we hypothesized that at least 75 percent of the test dose of lns and mnp offered to plw and iyc will be consumed by them.

the study will be conducted in three steps. step 1 will be a test-feeding to compare the acceptability of each "version" of the lns-child (lns-child with cardamom flavor, lns-child with no added flavor),lns-plw (lns-plw with cumin flavor, and lns-plw with no added flavor) and mnp to the others in terms of taste, smell and texture, as well as amount of the test-dose consumed. in step 2, participants in the phase 1 trial will receive a 2-week supply of one of the lns products or mnp, which they will consume daily in their homes for 14 days under real-life conditions. in step 3, focus group discussions will be held with participants to discuss different aspects of infant and child feeding and discuss best ways for the lns or mnp product to be used in the context of bangladesh.

Eligibility criteria:
inclusion criteria for lns-plw arm: * pregnant women in their second or third trimester (in case of third trimester pregnancy, the expected date of delivery is not within three weeks) or lactating women with a child between 3 days and 6 months of age * at least 18 years of age * no life-threatening pregnancy-related complications (e.g., pre-eclampsia, antepartum hemorrhage) * apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection) * living in the study area for at least 6 months * planning to remain in study area for at least the following three weeks. exclusion criteria for lns-plw arm: * known allergy to peanuts or other food products (as reported on the screening questionnaire) inclusion criteria for lns-child and mnp-child arm: * children 6-24 months of age * consuming solid foods for at least the past 30 days * apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection) * no known allergy to peanuts or other food products (as reported on the screening questionnaire by the mother/primary caregiver)\[lns-child only\] * planning to remain in study area for at least the following three weeks. exclusion criteria for lns-child and mnp-child arm: * severely malnourished \[mid-upper arm circumference (muac) \< 115 mm\]

Keywords: acceptability lipid-based nutrient supplements micronutrient powder malnutrition
comparison of the efficacy of a biological implant to reinforce overlapping sphincter repair versus overlapping sphincter repair alone

Conditions: Fecal Incontinence; Anal Incontinence

Summary: the aim of this study is to compare the efficacy of biodesign™ surgisis® tissue graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.


Eligibility criteria:
inclusion criteria: * female * age 18 years or older * fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles * fecal incontinence severity score of 10 or more * fecal incontinence episodes of 4 or more over a 2 week period exclusion criteria: * history of diabetes * history of allergy to porcine derivatives * history of infection in the anal area (abscess, fistula) * history of inflammatory bowel disease * history of hidradenitis suppurativa * history of immunosuppression * history of hiv positivity * history of radiation to the study site within the last 12 months * patients who cannot travel to keep follow up appointments * patients who are prisoners * patients who are mentally handicapped * patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding * patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment. * patients with a fiql baseline score of ≤ 4 * patients participating in another clinical trial for the same indication * patients unwilling to give informed consent
'cancer patients better life experience'

Conditions: Melanoma

Summary: the purpose of this study is to compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (capable). it is expected that by using the capable ehealth tool, patients' fatigue worsens less significantly (10 points) in the first 3 months follow-up than observed in usual care.

this is a prospectively enrolling, explorative cohort study in melanoma patients, eligible for or on treatment with ici therapy. the explorative cohort receives the capable smartphone application and a multi-sensorial smartwatch. patients will be asked to use the system for minimum of three to maximum of six months after enrolment. questionnaires on health-related quality of life (such as fatigue) and user experience will be administered to the patients on baseline/before start treatment (t0), three months (t1) and six months (t2). results of this interventional study will be compared with a historical cohort consisting of melanoma patients (p20mel; nl75996.031.20) with the same inclusion criteria as this study population, but receiving standard care (e.g. without the capable app).

Eligibility criteria:
inclusion criteria: * \>18 years of age * sufficient understanding of the dutch language * participants or their caregiver can use a smartphone (upon patient's consent) * histologically confirmed stage iii or iv melanoma who receive treatment with immune checkpoint-inhibitors, according to the clinical guidelines. exclusion criteria: * included in a clinical trial * \>12 months on active treatment