Kornimate/medical-research-clean huggingface dataset:
paroxysmal nocturnal hemoglobinuria (pnh) registry

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this study is a collection of data to evaluate safety and characterize progression of paroxysmal nocturnal hemoglobinuria (pnh).

collection of data to evaluate safety and characterize progression of paroxysmal nocturnal hemoglobinuria (pnh).

Eligibility criteria:
inclusion criteria: * patients of any age, including minors, with a diagnosis of pnh or a detected pnh clone, including patients previously treated with soliris or ultomiris and withdrawn from treatment. patients who are minors must have parent/legal guardian consent and must be willing and able to give assent, if applicable as determined by the ethics committees/institutional review boards. upon attaining adulthood, these patients must be re-consented. * ability to comprehend and sign consent to have data entered in the pnh registry. exclusion criteria: * inability or unwillingness to sign informed consent. * patients currently enrolled in an interventional clinical trial for treatment of pnh cannot be enrolled in the registry at the same time.

Keywords: pnh paroxysmal nocturnal hemoglobinuria soliris eculizumab ravulizumab ultomiris
surgiphor vs saline joints

Conditions: Prosthetic-joint Infection

Summary: this study will be an open-label superiority, multicenter, single-blind, controlled randomized clinical trial investing the role of a pvp-i irrigation solution (surgiphor) in reducing the risk of acute pji in the 90 days following total hip and knee revision arthroplasty.


Eligibility criteria:
inclusion criteria: 1. patient ≥18 years old 2. male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females 3. subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 icm criteria 5) 4. subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the investigator, sub-investigator or other designated study staff member has explained the study procedures, risks, and contact information. subjects not willing to sign consent form to be randomized must be willing to sign alternate consent form to allow prospective data collection in the non-randomized arm of the study exclusion criteria: 1. subjects with known allergies to iodine or any other ingredients in surgiphor 2. subjects unwilling to sign informed consent 3. subjects, for health reasons or other, in the opinion of the investigator, with a life expectancy less than one year, which is the follow-up period of the study
pivotal study in her2 negative, locally recurrent or metastatic breast cancer

Conditions: Metastatic Breast Cancer; Locally Recurrent Breast Cancer

Summary: this is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of her2 negative, locally recurrent or metastatic breast cancer.


Eligibility criteria:
key inclusion criteria: * histologically confirmed breast cancer * metastatic breast cancer currently of stage iv disease or unresectable locoregionally recurrent breast cancer * refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy * at least 14 days from the completion of any previous cancer therapy * adequate organ function * life expectancy of 3 months or more * willing and able to comply with the protocol and able to understand and willing to sign an informed consent key exclusion criteria: * previously treated with eribulin * peripheral neuropathy grade ≥3 * receipt of prior cxcr4 therapy * receipt of colony stimulating factors (csfs) filgrastim, pegfilgrastim, or sargramostim, or radiation therapy within 14 days prior to study day 1 * history of allergic reactions attributed to compounds of similar chemical or biologic composition to balixafortide or eribulin or other agents used in the study * breast feeding or pregnant * patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, known congenital long qt syndrome, qt interval corrected with fridericia's formula (qtcf) ≥470 msec at baseline in the absence of bundle branch block, or currently taking drugs at known risk of prolonging the qt interval or causing torsades de pointes
adaprev in digital flexor tendon repair

Conditions: Tendon Injuries

Summary: this study is being undertaken to verify the safety and performance of adaprev™, a class iii medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. subjects are randomised to either adaprev or standard care and attend visits for 26 weeks following surgery. this clinical investigation will recruit 44 subjects in the uk at up to 10 clinical trial sites.


Eligibility criteria:
inclusion criteria: - subjects aged 18 years and above with complete division of the flexor digitorum profundus (fdp) tendon in zone ii. exclusion criteria: * subjects with additional complicated injuries * subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair * subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred. * subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial. * subjects with conditions which may delay healing. * subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit. * females who are pregnant
mckenzie versus william exercise for non specific low back pain in adolescents

Conditions: Non Specific Low Back Pain

Summary: mckenzie exercise versus williams exercise on decreasing pain in adolescent with non specific low back pain low back pain is uncommon in the first decade of life,but prevalence increases steeply during the teenage years; around 40% of 9-18-year olds in high-income, medium-income, and low-income countries report having had low back pain. nslbp represents about 85% of lbp patients seen in primary care. non-specific low back pain is one of the most common health problems and is the leading cause of disability in young adults. during school age, the overall risk of low back pain is similar to adults, with prevalence rates as high as 70% to 80% by the age of 20 years old non-specific low back pain is defined as low back pain not attributable to a recognisable, known specific pathology. understanding back pain in adolescents is crucial to obtain timely diagnosis and determine appropriate treatment. proper treatment and management of lbp in the adolescent years can minimize back pain lasting into adulthood non pharmacological treatments are emphasised over pharmacological interventions in the management of persistent non-specific low back pain. natinal institute for health and care excellence(nice) 2016 draft guideline endorses self-management, exercise, manual therapy, psychological therapies, combined physical and psychological programmes, return-to-work programmes, and radiofrequency denervation. back exercises can be an inexpensive and easy option of treatment for nslbp and proven to be effective. mckenzie extension exercise and william flexion exercise are the most common types of back exercises. selection the appropriate treatment method is important. so this study will be aimed to compare between mckenzie and william's exercises in order to find which method has better effect on adolescents with nslbp.


Eligibility criteria:
inclusion criteria: * age range from 14 to 18 years. * diagnosed as non-specific low back pain. * medically and clinically stable. * all participants are within normal range weight and height. exclusion criteria: adolescents have one or more of the followings will be excluded: * any spinal deformities. * history of spinal or pelvic surgery. * specific spinal pathologies as cauda equina syndrome, cord compression, infection, fracture, neoplasm, inflammatory disease, whiplash associated disorders and vertebro-basilar insufficiency. * any visual or auditory problems that interfere with the rehabilitation program. * children with significant mental or psychological problems that interfere with understanding instructions.

Keywords: adolescents, balance, low back pain, mckenzie exercises, and william's exercises.
quickopttm study - using the quickopttm method for timing cycle optimization

Conditions: Heart Failure

Summary: quickopttm optimization method provides a quicker, simpler and reliable alternative to standard echocardiography methods for optimization of sensed av, paced av and v-v delays in patients with crt-p devices


Eligibility criteria:
inclusion criteria: * patient meets current crt-p indications and be implanted with an sjm crt-p device with v-v timing and a compatible lead system * patient is able to provide written informed consent for study participation exclusion criteria: * patient has limited intrinsic atrial activity (≤ 40 bpm) * patient has persistent or permanent af * patient has a 2o or 3o heart block * patient is unable to provide analyzable echocardiogram images * patient's life expectancy is \<12 months * patient is \<18 years old * patient is pregnant * patient is on iv inotropic agents

Keywords: crt heart failure optimization timing cycle optimization methods
inpatient penicillin delabeling for low-risk patients

Conditions: Penicillin; Drug Allergy

Summary: this study seeks to enroll patients admitted to a children's hospital with identified penicillin allergy. a screening checklist is performed to identify patients with very low or low risk histories of penicillin allergy to offer direct oral challenges to the antibiotic class to de-label patient's with drug allergies.

this is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a children's hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion.

Eligibility criteria:
inclusion criteria: * patients \>2 years * patients identified via emr as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy exclusion criteria: * female patients aged \>8 years of age * patients with hemodynamic instability * patients identified with moderate or high risk histories per protocol * patients currently taking oral antihistamines in 48 hours prior to direct challenge * patients currently taking oral steroids in 48 hours prior to direct challenge * patients currently receiving medications for nausea, shortness of breath,
conversational hypnosis for peripherical veinous access (hypnacess)

Conditions: Vascular Access Site Pain

Summary: the peripherical veinous catheterization is required for anesthesia. however, it's a painful procedure and causes stress or even phobia. hypnosis can be seen as an interesting tool. conversational hypnosis needs no training. it is used by script, which makes it easier. the working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access. the main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. a nurse anesthetist is reading the conversational script or standard script during the procedure. the nurse anesthetist is untrained for hypnosis. the secondary objective are the level of anxiety, patient satisfaction within the perioperative period (evan g questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use.


Eligibility criteria:
inclusion criteria: * digestive endoscopy procedure under general anesthesia in one of the participating centers * patient speaking and understanding french * patient affiliated or entitled to a social security scheme * patient who received enlightened information about the study and who co-signed, with the investigator, a consent to participate after a minimum period of reflection exclusion criteria: * patient with deafness * patient with cognitive impairment * pregnant and / or breastfeeding patient * patient with dissociative disorders (contraindication to hypnosis) * patient suffering from a pathology which can cause chronic pain * patient receiving analgesia or anxiety drug * patient under justice, curatorship or tutorship * patient deprived of liberty by judicial or administrative decision
the effect of yoga and stabilization exercises in individuals with chronic low back pain

Conditions: Low Back Pain

Summary: although exercise has been shown to be effective in low back pain in the literature, there is no conclusion about which exercise is superior to the other. although there are studies showing positive effects of spinal stabilization exercises and yoga approach on pain level, disability level and quality of life in patients with chronic low back pain, studies evaluating the effectiveness in many other aspects are insufficient. therefore, this study aimed to investigate the effects of spinal stabilization and yoga exercises on pain, functional status, metabolic capacity, kinesophobia and sleep quality in patients with chronic low back pain.


Eligibility criteria:
inclusion criteria: * chronic non-specific low back pain diagnosis * having pain that persists for at least 12 weeks * 25-65 age range exclusion criteria: * scoliosis with a cobb angle of more than 20º * history of previous surgery for the lumbal region * having an additional diagnosis such as spondylolisthesis, spinal stenosis, spondylolysis * presence of neurological deficits * metastatic state presence * presence of neurological deficits due to diabetes * presence of metabolic problems such as thyroid, hypertension, coronary artery disease * the presence of inflammatory problems involving the spine

Keywords: spinal stabilization exercise yoga low back pain
flow-mediated arterial dilatation, hypertension, endothelin-1 and sicam-1 in obese adolescents

Conditions: Obesity; Hypertension; Adolescent Obesity

Summary: obesity in adolescents is associated with the development of cardiovascular disease and type 2 diabetes mellitus. in order to detect early development of cardiovascular disease, early detection of the endothelium of obese adolescents is needed. endothelium dysfunction is an early stage of developing atherosclerosis, which can be a predictor of cardiovascular disease development in the future. flow mediated dilatation (fmd) is a non-invasive method that can measure endothelium function and predict the risk of cardiovascular disease, which is not only able to measure artery diameter, but also provides function index of nitric oxide (no) in the endothelium. fmd is negatively related to bmi. meanwhile, endothelin-1 (et-1) is thought to play a role in the pathogenesis of insulin resistance, because when its levels increase, et-1 can cause a condition of hyperinsulinemia. et-1 was found to be high in patients with cardiovascular disorders, as well as in obese and diabetic subjects. alternative methods for assessing endothelial function by measurement of biomarkers of activation and endothelial dysfunction such as soluble intercellular adhesion molecule-1 (sicam-1). levels of sicam-1 have been found to be related positively to age, systolic and diastolic blood pressure, hypercholesterolemia, hypertriglyceridemia and inversely to estrogen. furthermore, associations have been found between sicam-1 and cardiovascular mortality in both healthy individuals and populations at high risk. the aim of the study was to evaluate fmd, concentrations of et-1 and sicam-1 in adolescents with a presence of obesity and hypertension and to compare these with controls (obesity and non hypertension), as well as to analyze the correlations between fmd, et-1, sicam-1 and blood pressure values.

this study is cross sectional study with observational analytic that evaluates fmd, et-1 dan sicam-1 in obese adolescents with hypertension compared to obese adolescents without hypertension and normal adolescents. the subjects are 70 adolescents (obese and normal) aged 13-18 years, healthy, not undergoing any medication, not smoking and not drinking alcohol, which are further divided into 3 groups: obesity with hypertension, obesity without hypertension and normal. examination includes blood pressure examination, brachial ultrasound and blood sampling to measure levels of profile lipid, blood glucose, et-1, and sicam-1. blood sample of subjects were taken by laboratory employee of the general hospital in surabaja, indonesia.

Eligibility criteria:
inclusion criteria: * obesity * healthy * study in junior or senior high school in surabaja city exclusion criteria: * smoking or consuming alcohol * suffering from infections, inflammation, autoimmune diseases, cancer, chronic diseases, and endocrine disorders * consuming steroids or hormone therapy

Keywords: obesity flow-mediated arterial dilatation hypertension sicam-1
study with gft505 (80mg) versus placebo in patients with type 2 diabetes mellitus

Conditions: Type II Diabetes Mellitus

Summary: this study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with gft505 (80 mg/d) on glycosylated haemoglobin a1c (hba1c) and fasting plasma glucose. and to assess the tolerability and safety of once-a-day administrations of oral doses of gft505 for 12 weeks in patients with type 2 diabetes mellitus.

the study period per patient is 16-20 weeks maximum and is conducted as follows : * run-in period: 2 weeks or 6 weeks for patients under fibrate treatment at screening (4 weeks fibrate wash-out + 2 weeks placebo run-in); * treatment period: 12 weeks; * follow-up period: 2 weeks.

Eligibility criteria:
inclusion criteria: * male or post-menopausal female (defined as \>12 months since last menstrual period) or surgical menopause. if hormonal replacement therapy, it should be stable at least for 6 months prior to screening. * body mass index ≥27 and ≤45 kg/m². * drug-naive patients with type 2 diabetes mellitus (non insulin dependent diabetes). patients should not be treated by insulin or other diabetes medication for the last 3 months prior to screening. patients treated for less than 4 weeks with insulin may be included in the study. * hba1c ≥ 7.0% and \<9.5%. * antibody glutamate decarboxylase acid (anti-gad) negative for patients aged less than 40 years. exclusion criteria: * type i diabetes mellitus. * blood pressure \> 160 / 95 mmhg. * lipid-lowering drugs such as fibrates. * fasting plasma glucose (fpg) ≥ 240 mg/dl. * triglycerides (tg) \> 400 mg/dl.

Keywords: diabetes mellitus, type 2 glucose metabolism disorders metabolic diseases cardiovascular diseases ppars ogtt
evaluation of an incentive-based intervention to improve 90-day adherence in pap-naive patients

Conditions: Obstructive Sleep Apnea

Summary: this is a prospective, randomized, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to pap therapy.

this is a prospective, randomized, two-arm, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to therapy. randomization will include an allocation ratio of 2:1 (control:treatment). participants will be recruited based on evidence that they are struggling to achieve adherence to therapy after the first 3 nights of usage. two 'site to participant' contacts are required during this study. these contacts can either occur at the clinical site or remotely (e.g., by telephone). during the initial contact, their interest in the study and eligibility will be confirmed, then they will be consented, asked to complete the baseline questionnaire, and their demographic information will be collected on case report forms (crfs). participants randomized to the intervention (group b) will be provided with information and assistance in downloading restful to their smartphone and registering with wellth. at the final contact (90 days), the participant will be asked to complete an end of study questionnaire and the investigative staff will collect pap therapy data for the trial period and record it on crfs. participants in group b will have access to the restful app discontinued. this completes the participant's active participation in the study.

Eligibility criteria:
inclusion criteria: * adult participants (≥ 18 years of age) * new diagnosis of osa * prescribed cpap or apap for treatment of osa * prescribed a resmed flow generator compatible with airview * owns a smart phone and is willing to download an app on their phone * willing and able to give informed consent * can read and comprehend written and spoken english exclusion criteria: * have used pap therapy in the past * have been prescribed bi-level or adaptive servo-ventilation therapy * are participating in another app-based research study * cannot participate for the full duration of the study (at least 90 days) * participants who have a medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this study, or constitutes an unacceptable risk to the participant for the duration of the study
nurture: a program for mothers with histories of disordered eating

Conditions: Eating Disorders

Summary: nurture is a collaborative pilot study for mothers of children under the age of 3 who have suffered from disordered eating in the past. it is coordinated by the university of north carolina at chapel hill, duke university and virginia commonwealth university and sponsored by the national institute of mental health. nurture hopes to promote confident parenting and a positive meal times.

mothers who have struggled with disordered eating or body image struggles are often concerned how best to provide proper nutrition to their child and/or model healthy eating behavior. we have developed a curriculum that provides information about how to establish healthy eating patterns and social support for mothers with children under three years of age. the curriculum will be delivered in a support group format led by co-therapists affiliated with the unc eating disorder program.

Eligibility criteria:
inclusion criteria: * has met lifetime dsm-iv criteria for anorexia nervosa (an), bulimia nervosa (bn), or eating disorder not otherwise specified (ednos: including subthreshold an, bn, and purging disorder, but excluding bed) * bmi \> 18.5 maintained for at least three months * has not met threshold criteria for an or bn in the previous 28 days according to the eating disorders examination, although subthreshold status or active residual symptomatology will not preclude entry * age 18 or older * has a child between the ages of 1 month and 2 years, 12 months old exclusion criteria: * alcohol or drug dependence in the past year * current significant suicidal ideation reported during the assessment or on the bdi-ii at baseline * developmental disability that would impair the ability of the participant to benefit from the intervention * psychosis, including schizophrenia, or bipolar i disorder * any families who have been the subject of social service inquiries

Keywords: disordered eating parenting mothers