Kornimate/medical-research-clean huggingface dataset:
trial in pediatric patients with familial adenomatous polyposis (fap)

Conditions: Adenomatous Polyposis Coli

Summary: to test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (fap).

per dmc recommendation, the study was terminated early (31oct2013) due to low enrollment and low endpoint accumulation rate. no safety concerns were involved in the decision to terminate the study.

Eligibility criteria:
inclusion criteria: * age 10-17 years * confirmed deleterious fap genotype based on central genetic testing or personal history ot \>2 colorectal adenomas and a parent with the diagnosis of fap and either a, b or c below a: non-attenuated fap genotype b: attenuated fap genotype and a personal history of colorectal adenomas and a first degree relative with fap c: no genotype identified with a personal history of \> 2 adenomas and have a parent with fap * less than 30 polyps, which need to be removed to render the colon polyp-free before study drug can be given exclusion criteria: * diagnosis of attenuated fap based on central genetic testing in the absence of a personal history of \>2 colorectal adenomas and a first degree relative (parent or sibling) with fap. * sensitivity to cox-2 inhibitors

Keywords: fap
effectiveness of botulinum toxin a in preventing scar formation and initial exploration of "optimal concentration"

Conditions: Scar

Summary: each year, millions of burn, trauma, or surgical patients worldwide suffer from scarring that severely affects their quality of life and social functioning. in order to prevent and treat diseases related to abnormal scar hyperplasia, clinicians and researchers have adopted various methods, such as scar grinding, surgical resection, drug injection in scar tissue, cryotherapy, laser and so on. however, these methods can not effectively inhibit the abnormal proliferation of scars and improve the adverse effects of existing scars on patients. to date, there is no accepted gold standard for the effective treatment and improvement of abnormal scar tissue.

through a large number of literature review and preliminary experiments, we summarized and found the following problems: a. the latest research on prevention of scar formation by botulinum toxin type a is only aimed at surgical wounds from the wound type, and there is no research on the scar prevention effect of trauma wounds. b. from the point of view of the study site, there is no study on the effect of scar prevention only on the head, neck, chest and other parts of the body. c. for the research results of botulinum toxin type a in the prevention of scarring, the current research focuses on the effectiveness of botulinum toxin type a at a certain concentration, and does not compare the effects of botulinum toxin type a at various concentrations.therefore, in order to explore the "optimal concentration" of botulinum toxin type a to prevent scar formation; to explore the effect of botulinum toxin a on scar prevention of traumatic wounds and surgical incisions. to explore the effect of botulinum toxin a on scar prevention in other parts of the body in addition to effective prevention of head, neck and chest scar, we intend to focus on the effectiveness and "optimal concentration" of botulinum toxin type a to prevent scarring, to determine the effect of this means on scar prevention, to provide new ideas for botul

Eligibility criteria:
inclusion criteria: patients with emergency trauma and skin swellings, with clear consciousness, no mental retardation or cognitive difficulties, agree to participate in this study, 12≤ age ≤ 65 years old exclusion criteria: allergic to botulinum toxin type a;pregnant, lactating women, patients who plan to get pregnant in the near future;patients taking retinoic acid, synthetic steroids, amino glycosides antibiotics, calcium channel blockers, cyclosporine and cholinesterase inhibitors; 4 neuromuscular diseases: such as myasthenia gravis, lambert-eaton syndrome, multiple sclerosis;5. patients with cardiovascular diseases, kidney diseases, liver and other basic diseases; 6 patients with infection at the injection site; 7 expect unrealistic patients.

Keywords: scar prevention botulinum toxin type a
ridge augmentation comparing a block allograft to a demineralized bone matrix allograft.

Conditions: Alveolar Process Defect

Summary: this study with compare the ridge dimension changes for a block allograft vs. a demineralized bone matrix moldable allograft.

the patients' treatment will be randomly assigned by coin toss done by the mentor immediately after flap reflection. the examiner will be blinded to the treatment and will not have access to information indicating treatment assignment. the examiner will never see the patient between the time of grafting and complete healing at 4 months. the surgical procedure will consist of the reflection of a split-thickness flap to expose the alveolar ridge. following complete exposure of the surgical site, vertical measurements will be taken with the acrylic occlusal stent in place, and horizontal measurements with a specially designed digital caliper. after initial surgical measurements, numerous cortical perforations will be performed with a round bur in the area of the augmentation. the control group will receive a block graft and bone screw for stabilization, with voids being filled by the optecure+ccc®. the test group therapy will include graft with the optecure+ccc® and the use of bone pin® for space maintenance. horizontal dimension will be established by graft dimensions, bone screws, or bone pins when necessary, for each planned implant area. longer span edentulous spaces will be divided into individual sites as follows: 5 mm from natural teeth to future mid-implant sites and 7 mm between two future mid-implant sites. the bone pins and bone blocks with bone screws will be placed to allow enough exposure for augmentation to achieve 9 mm horizontal width available for implant placement. vertical and horizontal measurements will again be taken with the acrylic occlusal stent and calipers prior to flap closure. an resorbable membrane will cover both test and control groups. a monofilament suture material will be used. the surgical procedures will be documented with clinical photographs.

Eligibility criteria:
inclusion criteria: * at least a one tooth area with a ridge defect, treatment planned to receive a dental implant. the site must be bordered by at least one tooth. * healthy person that is at least 18 years old. * patient understands and signs an informed consent approved by the university of louisville human studies committee. exclusion criteria: * patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment. * previous head and neck radiation or chemotherapy within the previous 12 months. * patients with known allergy to any of the materials that will be used in the study. * smokers. * patients who need prophylactic antibiotics prior to dental procedures. * patients on long-term steroid therapy or oral bisphosphonates \> 3 years or any iv bisphosphonates. * patients who are pregnant

Keywords: ridge augmentation bone regeneration guided bone regeneration partially edentulous
isokinetic muscular assessment after acl ligamentoplasty: study of factors predictive of muscle imbalance.

Conditions: ACL - Anterior Cruciate Ligament Deficiency; Muscle Weakness

Summary: despite advances in surgery and rehabilitation, the return to sport after anterior cruciate ligament (acl) reconstruction surgery remains a major challenge. challenge. among the objective criteria retained, the isokinetic muscle strength assessment is an increasingly practiced evaluation and it is recommended to carry out follow-ups at 3-4 months (intermediate) and at 6-8 months (final) after surgery. however, the factors associated with muscle imbalance are uncertain and the threshold values of the intermediate isokinetic strength test (3-4 months) are inconsistent. in a retrospective analysis, the investigators aim to assess the predictive criteria for muscle imbalance after acl reconstruction surgery.

the investigators aim to retrospectively studied all sports patients who had a muscle evaluation at 3-4 months and 6-8 months after anterior cruciate ligament (acl) reconstruction surgery since january 2016. the objective criterion were based on the international guidelines for muscle imbalance after acl surgery and return to sport, as a muscle deficit of less than 20% on knee extensor muslces and less than 10% on knee flexor muscles of the operated knee (vs. healthy). the investigators will study the predictive analysis of the intermediate muscle strength test to predict the risk of muscle imbalance on the final isokinetic muscle strength assessment. the investigators will also study the individual, injury and surgical criteria associated with muscle imbalance.

Eligibility criteria:
inclusion criteria: * patients who have had an acl reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery) * patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 3-4 months and 6-8 mnths after surgery respectively * patient who received the information form exclusion criteria: * patient who did not participate in all follow-up consultations and isokinetic muscular assessments * cognitive or sensory impairment making it impossible to understand the information form * neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery
clinical evaluation of three different universal adhesives in non-carious cervical lesions

Conditions: Tooth Diseases

Summary: the aim of this randomized, controlled prospective clinical trial is to evaluate and compare the performances of three different universal adhesives using a flowable universal composite resin in the restoration of non-caries cervical lesions over 48-month period.participants over 18 will be included to the study. oral hygiene instructions will be given before procedures. all the lesions will be restored by the same clinician who will not participate to the selection of patients for eligibility. each patient will receive at least three restorations and randomization will be applied using a table of random numbers. all lesions will be cleaned before restoring. adhesive procedures and restorations will be placed according to manufacturers' recommandation. the flowable universal composite resin will be placed in bulk and light-cured for 40 seconds. the restorations will be contoured and polished with optidisc discs (kerr coorporation, orange, ca, usa). patients will be recalled at baseline and will be recalled at control periods after placement.


Eligibility criteria:
inclusion criteria: * 18 years old with 20 teeth under occlusion. they will be required to have at least three nccls needed restoration in different teeth. all the nccls selected were in similar sizes varying between 1-3 mm. exclusion criteria: * patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.

Keywords: non-caries cervical lesion universal adhesives
a pilot study of optic nerve ultrasound following cardiopulmonary bypass

Conditions: Congenital Heart Disease; Congenital Heart Defect

Summary: the purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (icp) following cardiopulmonary bypass (cpb) using optic nerve sheath diameter (onsd), measured by non-invasive ultrasound. as direct measurements of icp are not feasible following cpb, onsd will be used as a correlate of icp. onsd has been shown to be effective in the icu and emergency room setting for detecting increased icp and is an accepted standard for such measurements. the primary hypothesis is that changes in icp occur following cpb without clinically appreciable signs and symptoms. these changes in icp will be reflected by changes in onsd. if there is a significant incidence of sub-clinical cerebral edema and increased icp postoperatively, these findings may impact postoperative hemodynamic and ventilation goals and techniques.


Eligibility criteria:
inclusion criteria: * patients less than 18 years of age undergoing cardiac bypass. exclusion criteria: * none

Keywords: cardiopulmonary bypass
negative pressure wound therapy (prevena) versus standard dressings for incision management after renal transplant

Conditions: Wound Complication

Summary: this study is a multicentre, partially-blinded randomised controlled trial, with site stratified block randomisation and partial blinding of outcome assessments. patients undergoing a renal transplant will be allocated to one of two treatment arms, where either a prevena device of appropriate size or standard dressing is applied to the closed incision. in the case that a patient requires bilateral incisions, both incisions will be allocated to the same treatment arm and counted as a single incision. primary: the primary objective of this study is to determine if the prevena incision management system reduces wound complications at the surgical site following renal transplant, when compared to standard dressings. secondary: secondary objectives of this study include identification of risk factors for wound complications at the surgical site, as well as re-operation, prolonged hospital stay, allograft survival, delayed graft function. this study will also assess pain, scar healing and quality of life in each treatment arm, and aim to complete a cost-benefit analysis of the prevena device in renal transplantation.


Eligibility criteria:
inclusion criteria: the participant: 1. is an adult ≥ 18 years old, regardless of comorbidities or bmi 2. is able to provide their own informed consent 3. will undergo open renal transplant surgery, including those who undergo dual renal transplant or simultaneous pancreas transplant. 4. will require a surgical incision(s) likely to be able to be covered completely by one or more prevena incision management systems. 5. is willing and able to return for the required follow up assessments. 6. if concurrently enrolled in a clinical trial it must not impact on patient health or the surgical incision site and the study must be documented exclusion criteria: the participant: 1. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives. 2. is not suitable for closure of the surgical wound, and as such the wound must be left open or an open npwt device is required. 3. is not willing to comply with the study procedures. 4. has an unforseen intraoperative event mandating additional management including a planned re-exploration. 5. has obvious intraoperative contamination of the surgical site. 6. has a wound with suspected ischaemia in the incision area, or inadequate haemostasis. 7. requires drains that cannot be covered by the prevena dressing.
effects of two aquatic training models in physiological parameters of elderly dyslipidemic women.

Conditions: Dyslipidemias

Summary: this study aims to compare the effects of two water-based training models in physiological parameters of dyslipidemic elderly women. thus, a randomized controlled clinical trial will be conducted in parallel with the participation of 45 dyslipidemic elderly women.

the women will be randomly divided into three groups: water aerobics training (wa), resistance aquatic training (wr) and the third is the control group (who will perform relaxation sessions under water). the three groups will attend classes during 10 weeks, with two weekly sessions of 45 minutes each. the wa and wr groups will use the same four exercises in their training. the wa group will be trained using the interval method, performing six blocks of five minutes each one, alternating four minutes at intensities corresponding to 90 to 100% of the heart rate corresponding to the second ventilatory threshold (hrvt2) and one minute at intensities between 80 and 90% hrvt2. the wr group will perform four to eight sets of 20 to 10 seconds along the macrocycle, always at maximal speed execution of the exercises. will be measured, before and after the period of 10 weeks of intervention, biochemical, cardiorespiratory, neuromuscular and hemodynamic variables, parameters of quality of life and depressive symptoms in addition to the cardiovascular risk score of the participants of the three groups. data will be described by means values and lower and upper limits, with a 95% confidence interval. comparisons between and within groups were performed using the method of generalized estimates of equations (gee), with bonferroni post hoc, adopting a 0.05 significance level.

Eligibility criteria:
inclusion criteria: * being female, aged between 60 and 75, sedentary (not practicing any kind of regular, supervised physical activity in the last three months), have any type of dyslipidemia. exclusion criteria: * women who are smokers, suffering from cardiovascular disease with associated complications and those with orthopedic diseases that prevented the practice of systematic physical exercise, users of hormone therapy drugs and lipid-lowering medications.

Keywords: dyslipidemias, aging water aerobics training resistance aquatic training lipid profile
multicenter international trial ring annuloplasty

Conditions: Mitral Valve Insufficiency

Summary: this clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an sjm® rigid saddle ring will be included. the primary objective of the study is to demonstrate the effectiveness of the sjm® rigid saddle ring when used in mitral valve repair procedures.


Eligibility criteria:
inclusion criteria: * patient requiring a mitral valve repair due to mitral degenerative or functional disease (note: patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study); * patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements; * patients are at least 18 years old. exclusion criteria: * patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve; * patient is pregnant or nursing; * patient has active endocarditis; * patient is actively participating in another study of an investigational drug or device; * patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...); * patients who are intravenous drug abusers, alcohol abusers, prison inmates or unable to give informed consent; * patients with a major non-cardiac evolving disease; * patients with a life expectancy less than 1 year; * patients are known to be noncompliant or are unlikely to complete the study; * any case in which mitral annuloplasty rings are not indicated;

Keywords: mitral valve heart valve valve repair valve disorder valve disease cardiac surgery
skillful neglect vs repair for subscapularis tear associated with posterosuperior cuff tears repair.

Conditions: Subscapularis Muscle Strain

Summary: the purpose of this study is to compare functional outcomes of skillful neglect \& arthroscopic repair of upper border subscapularis tear in la fosse type 1 and type 2 with biceps tenotomy in non-athletes,30 shoulders subdivided randomly into 2 groups, 15 patients in group 1 (patient treated by skillful neglect with biceps tenotomy) and 15 patients in group 2 (patients treated by arthroscopic repair with biceps tenotomy)

patients are randomized chosen then a shoulder arthroscope is done for all patients with biceps tenotomy but in group1 the investigators are neglecting the upper border tears and in group 2 the investigators are repairing upper border tears with anchors then after the procedure is completed the investigators will follow up by ases score

Eligibility criteria:
inclusion criteria: * patients with combined upper subscapularis border tear in lafosse type 1 and type 2. exclusion criteria: * glenohumeral arthritis. * patients with other intra-articular pathology like slap lesions. * neural damage (brachial plexus injury). * revision cases. * patient with subscapularis border tear type 3, type 4, and type 5.

Keywords: rotator cuff tear
workflow validation of an in-home auto-titrating mandibular positioner

Conditions: Obstructive Sleep Apnea

Summary: the purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

one treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. however, oral appliance therapy does not treat sleep apnea effectively in all individuals. in order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. the device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.

Eligibility criteria:
inclusion criteria: 1. minimum 18 years of age 2. participant has been deemed suitable for oral appliance therapy 3. prescription for oral appliance 4. adequate range of motion 5. adequate dentition 6. ability to understand and provide informed consent 7. ability and willingness to meet the required schedule exclusion criteria: 1. loose teeth or advanced periodontal disease 2. full dentures or dental implants

Keywords: oral appliance therapy
effect of atelocollagen injection in patients with calcific tendinitis

Conditions: Calcific Tendinitis of Shoulder; Atelocollagen

Summary: assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.

suitable participants based on the selection/exclusion criteria are randomly assigned to either the case group or the control group. consent is given right before the procedure. case group (atelocollagen injection group): ultrasound-guided barbotage followed by lidocaine and atelocollagen injection. control group (lidocaine injection group): ultrasound-guided barbotage followed by lidocaine injection." clinical outcomes will be assessed with functional scores on 6 months after injection.

Eligibility criteria:
inclusion criteria: 1. patients in whom calcification of 5mm or more is observed in plain radiographs. 2. in cases where concomitant medication is administered continuously during the clinical trial period, patients who have verified the exact prescribed medication taken within the last week and agreed to maintain the same amount throughout the study period. 3. individuals who have agreed to participate in this study and have given written consent themselves. exclusion criteria: * patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors, or fractures. * patients with hypersensitivity. * patients with a history of anaphylactic reactions. * patients with ongoing autoimmune diseases or a past medical history of such diseases, either in the patient or their family members. * patients who are allergic to transplants. ⑥ patients who are allergic to porcine (pig) proteins. ⑦ patients deemed unsuitable for this trial based on the judgment of the trial administrator, such as those with mental illnesses. ⑧ patients who have received intra-articular steroid or other injection treatments within one month prior to the procedure decision. ⑨ patients who are on concomitant medications that include oral steroids.