Kornimate/medical-research-clean huggingface dataset:
corevalve™ evolut r™ 34 mm system registry (corevalve34)

Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation

Summary: with the introduction of the corevalve™ evolut r™ 34mm (medtronic™) prosthesis, patients with severe symptomatic aortic stenosis (as) and large aortic annulus have become eligible for transcatheter aortic valve implantation (tavi). the aim of this study is to detect the number of tavi candidates with large aortic annulus, and to evaluate the feasibility, efficacy, and safety of tavi using the corevalve™ evolut r™ 34mm.

with the current transcatheter valves available in the market, is possible to cover a wide range of patients with diverse and complex anatomies. nevertheless, there is a subgroup of patient with large aortic annulus (diameter \> 27 mm), in whom the implant of a transcatheter valve is not possible because there is no valve suitable for such as aortic annulus size. with the introduction of the corevalvetm evolutiontm r 34mm, patients with an aorttic annulus dimension up to 29 mm in diameter have become eligible for tavi. however, there is a lack of information regarding the number of patient with as and this particular anatomy of the aortic annulus. italian and dutch registries have reported a prevalence between 6.5 to 12.3% with large aortic annulus requiring the previous corevalvetm 31mm. yet, there is no reported data regarding this population of patients in spain. also, the clinical use of this larger prosthesis covers a wider range of aortic rings and may enchance the procedural challenges, such as a little margin for proper valve placement, more likelihood of interference with mitral valve function and damage to the cardiac conduction system during the prosthesis deployment. so far, no studies regarding clinical experiences with the corevalvetm evolutiontm r 34mm have been published. the scarce information currently available with this new device may be distant from those found in its daily clinical use in non-selected patients. the results of this spanish nationwide registry will help to answer a scientific need of information regarding acute procedural results and mid

Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years of age. * subject accepted participate and signed informed consent. * subject with severe symptomatic as patients selected for tavi by the heart team of each participating hospital. * patients anatomically suitable for the implantation of a corevalve™ evolut r™ 34mm with the approved indications by any feasible and appropriate vascular routes. * subject must agree to undergo all follow-up visits exclusion criteria: * high probability of non-adherence to the follow-up requirements. * explicit refusal of participation in the registry.

Keywords: tavr tavi aortic valve stenosis
a comparison of the retropubic (tvt) with the transobturator sling operation in the treatment of female stress urinary incontinence or stress dominated mixed urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. postoperative continence rates are achieved in up to 95%. currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. while the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). the aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure. * trial with surgical intervention


Eligibility criteria:
inclusion criteria: * urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra * with or without concomitant surgery for pelvic organ prolapse * with or without hysterectomy exclusion criteria: * no informed consent * no preoperative urodynamic investigation * mixed urinary incontinence with predominant overactive bladder * recurrent stress urinary incontinence after sling procedure * begin of treatment of overactive bladder less then a month ago or non stable condition * pregnancy * desires future childbearing * concomitant incontinence procedure like intravesikal injection of botulinumtoxin * preoperative postvoid residual urinary volume exceeding 100cc * coagulopathies
the faith! trial: a mhealth intervention to improve cardiovascular health among african-americans

Conditions: Cardiovascular Diseases; Physical Activity; Diet Modification; Lifestyle Factors

Summary: the purpose of this project is to apply a community-based participatory research (cbpr) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (cv) health and wellness digital application (app) prototype to improve cv health according to the american heart association life's simple 7 (ls7) framework among african-american (aa) adults within faith communities. the investigators hypothesize that the app-based intervention will be feasible and improve ls7 among aas from baseline to 6-months post-intervention.


Eligibility criteria:
inclusion criteria: 1. african american race/ethnicity 2. 18 years or older 3. own a smart phone 4. have basic internet navigation skills 5. have at least weekly internet access (i.e. at home, church, or other public access) 6. have an active email address 7. intake of fruits/vegetables less than 5 servings a day 8. no engagement in regular physical activity 9. able to engage in moderate physical activity exclusion criteria: 1. unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping 2. pregnant (due to associated hormonal and weight changes) 3. visual/hearing impairment or mental disability that would preclude independent app use
effectiveness of smart-video based game therapy and otago-based structured exercises in women with osteoporosis

Conditions: Osteoporosis

Summary: in this project, researchers evaluated the effects and differences of smart-video based game therapy and otago-based structured exercises in women with osteoporosis; aimed to evaluate their applicability in women with osteoporosis.

osteoporosis is a musculoskeletal disease characterized by decreased bone mass and deterioration of the microstructure of the bone. the aim of the study is to use smart-based video-based play therapy and otago-based structured exercises in women with osteoporosis; to evaluate the effect on bone quality, lower extremity muscle strength, balance, fear of falling, kinesiophobia and quality of life. working groups group 1: smart based video based game therapy group group 2: otago based structured exercise group group 3: control group participants who agree to participate in the study are first evaluated with the mental state assessment - standardized mini mental test and game therapy group with the simulator illness questionnaire and system usability scale, and if they meet the participation criteria, our study involves face-to-face interviews and blood and urine samples are routinely performed by the doctor on all patients at their first visit. bone quality will be evaluated using bone turnover markers. static balance with romberg test, dynamic balance with four square step test, functionality with timed up and go test, fear of falling with international fall activity scale, kinesiophobia with tampa kinesiophobia scale, muscle strength with myometer, quality life with european osteoporosis association quality of life questionnaire-41 will be evaluated.

Eligibility criteria:
inclusion criteria: * women in the climacteric period with osteoporosis between the ages of 45-65 * those with dexa t score \< -2.5 sd, * those who have independent ambulation, * those who have no history of falling in the last year * those with a mini mental test score of 24 and above exclusion criteria: * those who have participated in any exercise program in the last 3 months, * those who need support in ambulation, * those with a history of pathological fracture due to significant post-traumatic or malignancy, * those who have any systemic disease that may hinder the practices, * those with vestibular dysfunction, * for participants in the smart video-based game therapy group, those who are not suitable to use the system according to the system usability scale and simulator illness questionnaire

Keywords: game therapy rehabilitative game otago exercise
noninvasive glucose measurements - database and calibration compilation

Conditions: Diabetes

Summary: this study collected spectral raman data from diabetic patients. data was paired with validated capillary references as well as cgm/fgm readings. data was used to develop models for glucose prediction.

this trial constitutes three subprotocols: "the ouh protocol", "the home 1 protocol" and "the home 2 protocol" the investigation was initiated to collect spectral raman data paired with validated blood references. in the ouh protocol, capillary blood was analysed by abl 800 flex blood gas analyzer by radiometer. in the home 1 protocol, references were obtained by the finger pricking procedure from hemocue (radiometer). in the home 2 protocol, hemocue measurements were conducted along with continuous monitoring using dexcom g4/g5 device (dexcom) or freestyle libre (abbott) the data was collected from diabetic patients and optical coherence tomography (oct) readings were obtained from all subjects.

Eligibility criteria:
inclusion criteria: * subjects with and without diabetes including pregnant women exclusion criteria: * subject under 18 years of age * subjects not able to understand provided information * subjects without measuring sites * subjects with rash or wound on measuring sites * subjects with stained fingers, such a oil or nicotine * subjects not capable of holding arm/hand steadily on probe * subjects with thrombosis in arm/hand

Keywords: non-invasive glucose monitoring
overweight, quality of life and psychological difficulties in teenagers

Conditions: Obesity

Summary: obesity is a major public heath issue. it may have various impacts on a patient's life by causing psychological problems, altering a patient's quality of life,etc. these led to the investigators' hypothesis which is examining the psychological dimensions of a teenager suffering for obesity.

there are two groups in this study : healthy volunteers and teenagers suffering from obesity. patients and healthy volunteers will come to the nutrition clinic center naturalpha where the patient will complete a questionnaire. the included patients will also complete a questionnaire privately (without the presence of the parents), they will also be weighted and measured. no further tests or questionnaires will be given after the enrollment day.

Eligibility criteria:
inclusion criteria for obese teenagers : * patients aged between 11 and 16 years old at the moment of enrollment. * body mass index between the 1st and 2nd degree of the obesity zone (over the 97th percentile curve regarding corpulence curves of the plan national nutrition santé (pnns) based on the gender (boys/girls)) * the teenagers have an appointment in the pediatric unit of the saint vincent de paul hospital for an examination regarding excess weight inclusion criteria for average weighted teenagers : * patients aged between 11 and 16 years old at the moment of enrollment * body mass index located between the 3rd and the 97th percentile on the corpulence curves of the pnns * the teenagers and their parents have replied to and advertisement of the trial exclusion criteria for obese children : * body mass index over the 97th percentile curve on the corpulence curves of the pnns * handicapped teenagers exclusion criteria for average weighted children : * body mass index over the 97th percentile curve or under the 3rd percentile curve on the corpulence curves of the pnns * handicapped, asthmatic, obese or diabetic teenagers

Keywords: obesity quality of life teenagers psychological impact
prgf effectiveness for myofascial pain treatment in masticatory muscles

Conditions: Myofascial Pain

Summary: the investigators set up a randomized controlled clinical trial to evaluate the effectiveness of plasma rich in growth factors (prgf) injections into the masseter muscle trigger points for myofascial pain treatment. the investigators also seek to compare prgf injections effectiveness with local anesthetic injections. dry needling and local anesthetics injections release trigger point by disrupting the membranes of a tout band. however, the injected substance itself does not affect the pathophysiological mechanism of the trigger point. it is known that the platelets release growth factors who can enhance muscle regeneration processes and moreover reduce chronic pain. the investigators raised a hypothesis that prgf injections into the trigger points in masseter muscle can be an effective treatment method for the myofascial pain.


Eligibility criteria:
inclusion criteria: * adult patients. * diagnosed myofascial pain syndrome in one side of the masseter muscle (diagnosis is based on diagnostic criteria described by travell and simons: 1) palpable taut band, 2) spot tenderness in a taut band, 3) pain recognition. * patients have never had injections into their masseter muscle. exclusion criteria: * myofascial trigger points in other masticatory muscles. * head and neck region inflammations that causes pain. * temporomandibular joint pathology which causes pain. * trigeminal nerve neuralgia. * head and neck region oncological diseases. * myofascial trigger points in both sides of masseter muscles.
platelet rich plasma injection vs percutaneous tenotomy for common extensor tendinopathy

Conditions: Lateral Epicondylitis (Tennis Elbow)

Summary: this is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy.

this is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy. patients with a history of common extensor tendinopathy for greater than 3 months, refractory to conservative treatments, are randomized into one of two groups: injection with leukocyte rich platelet rich plasma or percutaneous tenotomy with the tenex system. both groups of patients are followed up in clinic at 1 week, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following the procedure to examine levels of pain or complications following both procedures.

Eligibility criteria:
inclusion criteria: * at least 3 months of lateral elbow pain * subjectively failed trial of physical therapy and counterbracing * identifiable pathology on ultrasound (one or more of the following: thickened or disorganized tendon origin, microtearing, edema, neovascularization exclusion criteria: * steroid injection within the last 3 months * previous surgery for common extensor tendinopathy * current treatment with analgesics * pregnant, non-english speaking, or illiterate individuals * history of anemia * history of bleeding disorder * anticoagulant use * history of cervical radiculopathy * hemoglobin less than 11 grams per deciliter * hematocrit less than 33% * platelet count outside of normal range of 150-400 x 1000 microliter

Keywords: common extensor lateral epicondyle tennis elbow
confocal laser endomicroscopy in ibs patients

Conditions: IBS; Food Intolerance

Summary: this study will assess dynamic effects of two major antigens on the duodenal mucosa by confocal laser endomicroscopy (cle). patients will be blinded to the antigens used (wheat, yeast). following cle it is planned to have a cross over exclusion diet with/without the antigens including a washout phase. furthermore, patients will undergo a 2 week fodmap diet to be able to compare results found of both diets and allow to understand whether our findings of food intolerance will be better and more precise than a common fodmap diet. post cle food challenge patients biopsies will be taken for histology. they will then be randomized into two groups and blinded to the diet they undergo. they will be provided with a supply of custom-made bread they will have for 2 weeks (custom made by a bakery in kiel). for one study arm bread will contain either wheat and yeast, for the other arm the bread will not contain these ingredients. the taste of the "normal" bread will be denaturised. crossover will take place after a two-week washout phase.


Eligibility criteria:
inclusion criteria: ibs according to the rome iii criteria moderate/severe refractory daily symptoms \>1year (fgid-c1) sub classified as ibs-d, constipation predominant (ibs-c) or mixed type (ibs-m) no past infection to trigger symptom no structural/ biochemical cause of their symptoms identified negative gastroscopy, colonoscopy including histology worsening symptoms after meals various exclusion diets - ineffective females not menstruating during cle no known allergy to methylene blue or fluorescein age \>18 years negative routine testing for food intolerance (or known lactose/fructose intolerance) positive informed consent exclusion criteria: no consent known reason for the abdominal pain and bloating other than lactose/fructose intolerance m. whipple known infectious gastrointestinal disease stricture in the upper gastrointestinal tract age \ 1.2 mg/dl) pregnancy or breast-feeding inability to obtain informed consent active gi bleeding known allergy to methylene blue or fluorescein participation in other clinical trials within the last 4 weeks
organization in acute atrial fibrillation post open heart surgery

Conditions: Atrial Fibrillation

Summary: a form of irregular heart rate called, atrial fibrillation (af) is a major clinical problem. it afflicts about 2 million americans and is the single largest heart related cause of stroke. however, despite 120 years of speculation and research, the mechanisms that cause af are poorly understood. acute af is also the most common irregular heart rate after open-heart surgery in patients. this is seen in as many as 30% of such patients and often results in a longer hospital stay. in this study we would like to study the pattern of atrial fibrosis (scar tissue in the heart) and an associated blood marker (a protein called pro-collagen-1) in those patients concurrently having open heart surgery.


Eligibility criteria:
inclusion criteria: 1. 18 years of age, male or female 2. able to provide consent 3. cardiac surgery, cabg of valve replacement or repair. exclusion criteria: 1. if af terminates within 1 hour of initiation. 2. if the patient undergoes electrical cardioversion and/or receives digitalis within the first hour of inclusion. 3. if the patients and/or their family or the primary caregiver choose to be excluded from the study anytime, even after the initial 24-hour period. 4. if the patient expires within 1 hour of inclusion into the study. -

Keywords: atrial fibrillation post open heart surgery
a study evaluating the efficacy and safety of abp 959 compared with eculizumab in adult participants with pnh

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this is a randomized, double-blind, active-controlled phase 3 study of abp 959 in participants with paroxysmal nocturnal hemoglobinuria.


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * historical diagnosis of pnh. * administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab. * hemoglobin ≥ 9.0 g/dl for at least 6 weeks before randomization. * lactate dehydrogenase \< 1.5 × the upper limit of normal at screening. * platelet count ≥ 50 × 10\^9/l. * absolute neutrophil count (anc) ≥ 0.5 x 10\^9/l (500/μl). * participants must be vaccinated against neisseria meningitidis. * participants must sign an irb/iec-approved icf before participation in any procedures. exclusion criteria: * known or suspected hereditary complement deficiency. * clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure \[new york heart association ≥ class iii\], serious uncontrolled cardiac arrhythmia), peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months. * evidence of acute thrombosis (liver doppler ultrasound of hepatic and portal veins). * known to be positive for human immunodeficiency virus. * woman who is pregnant or breastfeeding. * participant is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or participant is receiving other investigational agent(s). * participant has known sensitivity to any of the products to be administered during the study, including mammalian cell-derived drug products. * history of meningococcal infection. * presence or suspicion of active bacterial infection, or recurrent bacterial infection. * history of bone marrow transplantation. * red blood cell transfusion required within 12 weeks before randomization. * participant experienced ≥ 2 breakthrough events, (ie, signs and symptoms of intravascular hemolysis, that require dose and/or schedule adjustments of eculizumab) in the previous 12 months before screening.

Keywords: marchiafava-micheli syndrome paroxysmal cold hemoglobinuria
schizophrenia, antipsychotic treatment and the risk for diabetes mellitus

Conditions: Schizophrenia; Schizoaffective Disorder; Delusional Disorder

Summary: this preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. as part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls. regardless the treatment status, we collect the same neuroendocrine-immune data on the participants after 2 months.

this preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. as part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls. regardless the treatment status, we collect the same neuroendocrine-immune on the participants (patients and controls) after 2 months. thus, our study does not control treatment. patients take treatment in consultation with their physician. some of them even decide not to take any medications. at the 2nd visit, we do ask them about the the medications they are taking if any.

Eligibility criteria:
inclusion criteria: * psychotic disorder as per dsm-iv criteria of the american psychiatric association exclusion criteria: * diabetes, type 1 or 2 * prominent substance abuse (i.e. psychotic symptoms attributable entirely to substance use) * age above 50 or age below 14

Keywords: schizophrenia, psychosis, type 2 diabetes mellitus