Kornimate/medical-research-clean huggingface dataset:
wakix® (pitolisant) pregnancy registry

Conditions: Pregnancy Related; Narcolepsy

Summary: the wakix (pitolisant) pregnancy registry is a us-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

the wakix (pitolisant) pregnancy registry is a us-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. participation in the registry is voluntary and participants can withdraw their consent to participate at any time. data will be collected from enrolled pregnant women and the healthcare providers (hcps) involved in their care or the care of their infants, if applicable. the registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by hcps. only data that are routinely documented in patients' medical records during the course of usual care will be collected. no additional laboratory tests or hcp assessments will be required as part of this registry. the design of this pregnancy registry follows current fda guidance for designing and implementing pregnancy exposure registries.

Eligibility criteria:
inclusion criteria: * pregnant woman of any age * consent to participate * authorization for her hcp(s) to provide data to the registry * for participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy) * for participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy exclusion criterion: • occurrence of pregnancy outcome prior to first contact with the registry coordination center (rcc) (i.e., retrospectively enrolled)
kinematic- versus ligament-balanced mechanical alignment in tka

Conditions: Osteo Arthritis Knee

Summary: a promising new approach in total knee arthroplasty (tka) for severe osteoarthritis of the knee joint is the the kinematic aligned procedure (ka). this technique provides prosthesis-positioning based on natural and individual axes of movement. although first series have shown satisfying results, further verification by prospective studies and final meta-analyses will be required. thus, the kinematic alignment represents one of the few new developments in tka. provided that patients are willing to participate in the study, patients data are collected preoperatively and during routine follow-up examinations and evaluated prospectively. patients will receive either a conventionally mechanical aligned arthroplasty or a kinematical aligned tka, according to a randomized procedure. the kinematic alignment will be achieved by the use of custom-made cutting-blocks. therefore, the patients will undergo a computed tomography of the whole leg on the affected side. this is mandatory in order to provide the individually produced cutting blocks. in order to ensure comparability, patients are stratified regarding their age and gender before inclusion. outcome will be measured by the use of standard scoring systems regarding function, pain and rom (range of motion) three, six and 12 months after surgery. this study is a monocentric, prospective, randomized and controlled open study.


Eligibility criteria:
inclusion criteria: - severe osteoarthritis of the knee joint, intended for total knee arthroplasty exclusion criteria: - malalignment with varus of more than 5° or valgus malpositioning, joint instability
identification of new patient stratification tools in mss ras mt mcrc

Conditions: Advanced Colorectal Cancer

Summary: this is a translational, multicentre and multinational study. the aim of this study is to identify new patient stratification tools in microsatellite stable ras mutant metastatic colorectal cancer

the rational of colossus is to provide new and more effective stratification tools and therapeutic interventions, specifically tailored to mss ras mt mcrc patients

Eligibility criteria:
inclusion criteria patient status 1. ability to give signed informed consent prior to any study specific procedures and willing and able to comply with the protocol, 2. age ≥ 18 years, 3. ecog status of ≤ 2, 4. at least 16 weeks of life expectancy at time of entry into the study. disease-related 5. histologically confirmed stage iv mss ras mt mcrc as per standard diagnostic tests, 6. unresectable and measurable disease (at least one measurable target lesion) as per clinical and radiologic criteria (recist v.1.1), 7. no prior chemotherapy and/or radiation therapy for crc administered in the metastatic setting, 8. scheduled to receive or receiving soc chemotherapy with fluoropyrimidines and oxaliplatin +/- bevacizumab (baseline blood sample should be collected and questionnaires completed during pre-screening and before chemotherapy initiation), 9. availability of archival formalin-fixed paraffin-embedded (ffpe) tissue from: 1. preferred: surgical resection of the primary or metastatic tumour or 2. biopsy samples (biopsy taken at endoscope, needle core or surgical incision or excision) obtained from the primary or metastatic tumour. the archival ffpe tissue blocks must be obtained during initial diagnosis (before patient was exposed to any chemotherapy and/or radiation therapy). exclusion criteria 1. patient with crc that has received any therapy for crc before: 1. surgical resection of tissue that would be utilised in this study or 2. biopsy procedure for tissue that would be utilised in this study, 2. patient who has received any investigational product within 28 days of the first day of palliative chemotherapy administration, 3. patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent, 4. patient with clinical or laboratory contraindication to receive soc chemotherapy with fluoropyrimidines and oxaliplatin.
idus in cbd stone recurrence high risk patients

Conditions: Choledocholithiasis; Cholangiopancreatography, Endoscopic Retrograde; Ultrasonography

Summary: this study is designed to observed cbd stones cases with high recurrence risks applying idus or not during ercp. patients with cbd stone high recurrence risks were enrolled in this study, and prospectively randomized into iuds group and control group during lithotomy. operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded. symptoms and conditions after ercp were also followed up including blood amylase, routine blood test, abdominal pain, post-ercp pancreatitis, resection of gallbladder, recurrence of cbd stone and onset of cholangitis.

patients with cbd stone high recurrence risks were enrolled in this study, and prospectively randomized into iuds group and control group during lithotomy. high risks were defined as diameter of cbd\>1.5cm, number of calculi\>2, and lithotripsy. operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded. symptoms and conditions after ercp were also followed up including blood amylase, routine blood test, abdominal pain, post-ercp pancreatitis, resection of gallbladder, recurrence of cbd stone and onset of cholangitis.

Eligibility criteria:
inclusion criteria: * 1.clinical diagnosis of common bile duct stones 2.at least one of the following, diameter of cbd\>1.5cm, or number of calculi\>2, or lithotripsy during ercp exclusion criteria: * 1. clinical diagnosis of liver or biliary malignant tumor. 2. clinical diagnosis of duodenal malignant tumor 3. failure or unexpected termination of ercp 4. surgery history of gallbladder or bile duct.

Keywords: choledocholithiasis cholangiopancreatography, endoscopic retrograde ultrasonography bile ducts
attachment style of type 2 diabetics, and cognitive, social and emotional variables as explanatory factors of adherence to self-care behavior and diabetes control

Conditions: Type 2 Diabetes Patients

Summary: this study will expand the understanding of factors associated with adherence to self care and the diabetes control among diabetes type 2 patients. the theoretical framework of the study incorporates central variables from two theoretical models: a cognitive model of health behavior - "health belief model", and the stress and coping model. the study is innovative in its focus on the association between the patient's attachment style and adherence to self care and diabetes control, a topic less studied among diabetes patients, in addition to cognitive, social and emotional variables. further emphasis is upon a comparison of the study model between males and females.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * 40-70 years of age * hebrew speaking * members of maccabi healthcare services
study of the benefits of a short spa treatment on the elimination of residual lithic fragments after treatment

Conditions: Calculi, Urinary

Summary: current urological therapeutic modalities are represented by extracorporeal lithotripsy (ecl), rigid (urs) or flexible (urssple) uretero-renoscopy and percutaneous nephrolithotomy (pcnl). they make it possible to extract the vast majority of stones by minimally invasive techniques but leave behind small residual lithic fragments (fr) that can always cause pain, infection, or promote the development of a larger stone. a non-invasive technique that can help eliminate them would be of great benefit to many patients by avoiding painful recurrences and limiting reprocessing; combined with appropriate medical management, it would limit the rate of remote recurrences and long-term complications. the treatment called "hydro-posturotherapy" has been developed in some spas that are approved for kidney diseases such as vittel or capvern. it includes several modalities: posturotherapy, lumbar percussion and hyperdiuresis. the main objective is to compare at 3 months, on the unprepared abdomen (asp) and the low-dose scanner without injection, the elimination of kidney stone fragments under the effect of a short spa treatment with posturotherapy, lumbar percussion and controlled hyperdiuresis compared to the recommended standard treatment. the result will be assessed in 3 categories: complete elimination (sf: "without fragments" or "stone-free"), elimination of more than 50% of the fragments; elimination of less than 50% of the fragments.

randomized multicenter controlled clinical trial comparing hydroposturotherapy in short thermal cure with standard hyperdiuresis in patients with residual stones, especially lower caliciels after urological treatment. 5 inclusion centres * central hospital, nancy * nancy urology center * clinique de la croix du sud in toulouse * edouard herriot hospital in lyon the radiological images will be reviewed by the radiology department of the central hospital, nancy.

Eligibility criteria:
inclusion criteria: * major patients with urinary stones who have received minimally invasive urological treatment: extracorporeal lithotripsy (ecl), flexible uretero-renoscopy (urssple) and percutaneous nephrolithotomy (nlpc). * patients with kidney stones less than 4 mm in size who are not receiving minimally invasive therapy. * evaluation of the number, size / volume and location of calculations by asp \& tdm low-dose, without post-operative injection. * information and signature of informed consent. exclusion criteria: * patients refusing a spa treatment * contraindications to pth: morbid obesity, unbalanced hypertension, pregnancy, respiratory failure, dizziness, vascular and/or ocular disorders, poly-mediated unbalanced cardiovascular pathology, orthostatic hypotension, general condition of the patient incompatible with the treatment * patients with cacchi ricci disease * person under the protection of justice, guardianship or curatorship

Keywords: urinary lithiasis urological treatments spa treatment posturotherapy lumbar percussions hyperdiuresis
a randomized controlled trial comparing clinical effectiveness of smile versus smile xtra in myopia

Conditions: Myopia

Summary: to evaluate and compare the clinical efficacy, biomechanical stability, and optical quality of smile and smile xtra procedures in patients with myopia through a randomized controlled trial


Eligibility criteria:
inclusion criteria: 1. age 18-50 years 2. mrse (manifest refraction spherical equivalent) -6.00d to -10.00d with refractive changes within ±0.50d in past 2 years 3. cdva (corrected distance visual acuity) ≥ 20/25 4. myopia progression ≤ 0.50d/year for ≥2 years 5. rst (residual stromal thickness) ≥ 250μm after lenticule removal 6. contact lens discontinuation as per protocol exclusion criteria: 1. other eye diseases (keratoconus, glaucoma, etc.) 2. corneal scarring, cataracts affecting observation 3. systemic diseases affecting surgery compliance 4. prior ocular surgeries 5. pregnancy, breastfeeding, or menstruation 6. drug allergies to surgical medication
va hdl intervention trial (va-hit) ancillary study data analysis

Conditions: Coronary Disease; Heart Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Diabetes Mellitus, Non-insulin Dependent; Hypertension; Insulin Resistance; Obesity; Diabetes Mellitus

Summary: to evaluate additional cardiovascular risk factors using data from the va hdl intervention trial (va-hit).

background: the va hdl intervention trial (va-hit) was a multicenter, placebo controlled, randomized trial that showed that gemfibrozil significantly reduced major cardiovascular events in 2531 men with coronary heart disease, low levels of low density lipoprotein (ldl) cholesterol and low levels of high density lipoprotein (hdl) cholesterol. in addition to its unique lipid profile, the va-hit population also had a high prevalence of diabetes, impaired fasting glucose, or high fasting plasma insulin; central obesity; and hypertension, which are all components (together with high triglycerides and low hdl-cholesterol) of a constellation of risk factors known as the metabolic syndrome. since prior clinical trials have not enrolled this type of population, the va- hit database is a unique resource. design narrative: the study used the va-hit database to study additional risk markers that were measured in the study population of 2,531 men with coronary heart disease. specific analyses were: 1) the association between levels of glucose tolerance, insulin resistance and other features of the metabolic syndrome, occurrence of major cardiovascular outcomes, and gemfibrozil efficacy; 2) the effect of gemfibrozil on progression of carotid atherosclerosis, as measured by b-mode ultrasound; 3) the association between ldl particle size distribution and lipoprotein subclass distribution; homocysteine; lipoprotein(a); c-reactive protein, tissue plasminogen activator; fibrinogen; and factor vii; major cardiovascular outcomes and gemfibrozil efficacy. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
safety and pharmacokinetic assessment of orally administered tafamidis in healthy volunteers

Conditions: TTR Cardiomyopathy

Summary: this study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis


Eligibility criteria:
inclusion criteria: * healthy, males or females, 21 to 55 years old. * body mass index (bmi) of 17.5 to 30.5 kg/m2. exclusion criteria: evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). condition affecting drug absorption. blood pressure or ecg abnormalities. recent treatment with an investigational, prescription, or non-prescription drug

Keywords: pharmacokinetic pharmacodynamic
stress and recovery in frontline covid-19 workers

Conditions: Covid19; Stress; Wearables

Summary: the novel coronavirus (covid-19) pandemic has caused an unprecedented stress on healthcare systems in affected countries, and in particular, on the healthcare workers at the frontline working directly with covid-19 positive patients. numerous lines of evidence support the damaging impact of stress on our immune systems which increases susceptibility to infection. yet, the accurate measurement of immediate stress responses in real time and in naturalistic settings has so far been a challenge, limiting our understanding of how different facets of acute or sustained stress increases susceptibility. this study utilizes wearable technologies including an oura smart ring as well as semi-continuous passive and active biometric measurements carried out using individuals' own smartphones equipped with applications to track and transmit key data to measure frontline workers stress and recovery during a uniquely stressful and high-risk work environment.


Eligibility criteria:
inclusion criteria: * healthcare workers working directly with covid-19 patients, or whose work routines have been shifted from covid-19 * age over 18 years * able to speak, write and read english, given the app will be available only in english * able to provide informed consent * have a personal ios mobile phone (os11 and above). * own a personal wearable device including a fitbit, garmin, or oura ring (byod arm only) exclusion criteria: - prior covid-19 infection

Keywords: stress frontliner covid19 wearables
implementing the nyu electronic patient visit assessment (epva) for head and neck cancer in rural and urban populations

Conditions: Head and Neck Cancer

Summary: the pi and the research team developed the new york university (nyu) electronic patient visit assessment (epva) for head and neck cancer (hnc) as a patient-reported outcome measure (pro) for the early detection of uncontrolled symptoms. the epva is digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. the study aims to advance the science of cancer care delivery by testing the effectiveness of the epva as a digital patient-reported monitoring system for patients with hnc in real-world settings and identify implementation strategies that optimize the effectiveness of the epva in diverse rural and urban settings. the study hypothesis is that participants assigned to the epva arm will have better swallowing, taste and smell, and social function than participants assigned to usual care arm at 4 weeks after completing radiation therapy.


Eligibility criteria:
inclusion criteria (patient participants): * individuals with histologically diagnosed head and neck cancer (hnc) undergoing curative radiation therapy with or without chemotherapy * english or spanish speaking inclusion criteria (clinician participants): * clinicians (i.e., physicians, nurses, dentists, physician assistants, social workers, nutritionists, speech swallow therapists) caring for patients with head and neck cancer at the participating institutions exclusion criteria (patient and clinician participants): * any medical condition that could limit the participant's ability to provide informed consent and complete the questionnaires.
long-term follow-up of cognitive and functional evolutions of persons with isolated cognitive complaints or mild cognitive deficits

Conditions: Alzheimer Disease

Summary: dementia is a clinical syndrome that is the result of distinct underlying pathologies including alzheimer's disease (ad). despite more than two decades of research on prevention and treatment of dementia and aging-related cognitive decline, highly effective preventive and therapeutic strategies remain elusive. many features of dementia render it especially challenging. indeed development of disease occurs insidiously over the course of years or decade. in addition, the causes of dementia and determinants of its severity are likely multi-factorial. to overcome these challenges and better understand the causes and course of ad and related disorders, long term follow-up studies of persons at high risk of dementia are required including multidimensional and harmonized assessment of risk factors, phenotypes (cognition, neuropsychiatric symptoms, physical health, self rated health) and endophenotypes (blood markers, genetic markers, neuroimaging markers). this project proposes an extension of the follow-up of memento participants over 5 to 10 years with of focus on cognitive outcomes and comorbidities.


Eligibility criteria:
inclusion criteria: * participants aged over 18 year-old * being included in memento cohort * affiliated person or beneficiary of a social security scheme. * participants capable of expressing non objection * non objection expressed by the tutor for participants under tutorship * non objection expressed by the participant assisted by their guardian for participants under guardianship * non objection expressed by the trusted person (in accordance with art. l1111-6 of code de la santé publique) for participants without the capacity to express non-objection and who are not under legal protection measure exclusion criteria: * expressing opposition to participate in memento-plus

Keywords: alzheimer's disease related disorders mild cognitive impairment
an observational study of patients with metabolic syndrome and related conditions

Conditions: Metabolic Syndrome

Summary: target-metabolic is an observational research study to conduct a comprehensive review of outcomes for patients with metabolic syndrome and related conditions.


Eligibility criteria:
disease cohort inclusion criteria: - adult patients at the time of enrollment with a diagnosis of metabolic syndrome or related conditions by icd-10 code or with clinically calculated bmi ≥ 30 in the ehr/health system interface exclusion criteria: * death * manual removal (sponsor or site request) * no ehr interface encounter \> 3 years engaged cohort inclusion criteria: * adult patients diagnosed and managed for these conditions invited to participate * ability to provide written informed consent exclusion criteria: * patient expressed desire to withdraw consent to complete pros * failure to complete pros within 24 weeks of initial invitation * greater than 24 months lapse of survey completion after baseline surveys completed * additionally, the criteria detailed for disease cohort apply to the engaged cohort