Kornimate/medical-research-clean huggingface dataset:
infinity™total ankle replacement follow-up

Conditions: Arthritis, Rheumatoid

Summary: study title infinity™total ankle replacement follow-up (itar) study design prospective, multi-site, multi-year post-market clinical follow-up study study group primary/unilateral and/or bilateral total ankle arthroplasty subjects implanted with infinity™ total ankle system number of subjects 150 with 9 sites

the primary outcome measure of this post-market clinical observational study is to collect data relating to the infinity™ total ankle system survivorship at 10 years. the secondary outcome measures are to characterize the improvements after implantation over a 10 year period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments (x-rays) the outcome measures collected in this study will be analyzed and reported as required for local, regional, and country requirements (i.e., regulatory authorities and notified bodies).

Eligibility criteria:
inclusion criteria: * be 21 years of age or older at the time of surgery; * diagnosed with unilateral and/or bilateral ankle joint disease; * diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis; * willing and able to consent to participate (written, informed consent; * willing and able to attend the requested follow-up visits; * a clinical decision has been made to use infinity™ total ankle system replacement prior to enrollment in the research. exclusion criteria: * subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement; * subjects requiring revision total ankle replacement of the ankle being considered for study.
influence of monopoly game on subtle behaviors

Conditions: Psychosocial Influence on Cardiovascular Disease; Cardiovascular Disease

Summary: the purpose of this research study is to investigate how social standing in a game of monopoly may influence behavior.

participants will be asked to fill out questionnaires/surveys and health measures will be collected throughout the study visit. these health measures will include: blood pressure, heart rate, height/weight, waist circumference, percent body fat, resting metabolic rate, and salivary cortisol. breakfast will be provided and then a 40-minute game of monopoly™ will be played, and lunch will be provided after the game. participants will be given an accelerometer to measure movements, and a food diary to be used for a 24-hour period. once the 24-hour monitoring period has been completed, the participants will be finished with the study activities. the accelerometer and food diary will be returned by either bringing them to the investigators or mailing the items back to the investigators.

Eligibility criteria:
inclusion criteria: * hispanic american adolescents born in the united states * have played monopoly before exclusion criteria: * clinical depression * a diagnosis of cardiovascular disease (active or within the past 6 months), cancer (active or within the past 2 years, except non-melanoma skin cancer), diabetes (type 1 or 2), active or chronic infections, gastrointestinal disease, active kidney disease, lung disease, uncontrolled psychiatric disease * an eating disorder or severely restricted diet * use of tobacco products * substance abuse disorder * take any medications known to affect appetite or body composition * participation in any weight-reduction programs, weight-loss diets, or other special diets within the previous 3 months * experience of weight loss or gain of 10 pounds or more of body weight in the past 6 months for any reason except post-partum weight loss * current/anticipation of pregnancy during study * currently nursing or within 6 weeks of having completed nursing

Keywords: social status hispanics energy balance stress
post-market observational study zenith® t-branch™

Conditions: Aortic Aneurysm; Thoracoabdominal

Summary: the zenith® t-branch™ thoracoabdominal endovascular graft study is a post-market observational study to evaluate the performance of the zenith® t-branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.

both retrospective and prospective patients will be enrolled

Eligibility criteria:
inclusion criteria: * treated with the off-the-shelf zenith® t-branch™ thoracoabdominal endovascular graft * signed informed consent exclusion criteria: * inability or refusal to give informed consent by the patient or a legally authorized representative

Keywords: thoracoabdominal aortic aneurysm endovascular fenestration branch off-the-shelf
retrospective and prospective evaluation of scapulohumeral comfort, aesthetic result and quality of life

Conditions: Breast Cancer

Summary: the dorsalis major flap is an interesting therapeutic option in breast reconstruction because of reliability and reproducibility. in recent years, the minimal flap technique has been developed, which consists of removing only a portion of the of the large dorsal muscle to reduce the painful and functional sequelae of this surgery. the objective of this prospective study is to evaluate the functional and aesthetic results in patients who have undergone who have undergone this procedure (prospective cohort) or who will undergo this procedure or prosthetic reconstruction (prospective cohort). the investigators also wish to evaluate the quality of life of patients after reconstruction with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.

retrospective cohort : * clinical data reconstruction and follow-up up to 1 year * dash questionnaire * breast q * aesthetic evaluation (patient and surgeon and other health professional) prospective cohort : * clinical data reconstruction and follow-up up to 1 year * dash questionnaire (pre-op, at 6 month and at 12 month) * breast q(pre-op, at 6 month and at 12 month) * aesthetic evaluation (patient and surgeon and other health professional) (at 6 month and at 12 month)

Eligibility criteria:
inclusion criteria: 1. patients with a desire for breast reconstruction 2. indication for mastectomy or with a history of mastectomy, with or without preservation of the skin skin, 3. breast reconstruction procedure by ldpm performed between january 2017 and september2021, (retrospective cohort ) 4. breast reconstruction procedure by ldpm or by prosthesis performed from february 2022 (prospective cohort) 5. information to the patient and collection of her non-opposition 6. affiliation to a social security system, or beneficiary of such a system exclusion criteria: 1. performance of a breast reconstruction by a technique other than ldpm or prosthesis 2. patient opposed to the use of her data for research 3. person in an emergency situation, adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to express his consent, 4. impossibility to submit to the medical follow-up of the trial for geographical, social or psychological psychological reasons.
long term safety of vedolizumab (mln0002) in patients with ulcerative colitis and crohn's disease

Conditions: Ulcerative Colitis; Crohn's Disease

Summary: this was an open-label study to provide an opportunity for participants with ulcerative colitis (uc) who previously completed study c13002 (nct01177228), and for treatment-naïve participants with uc or crohn's disease (cd) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.

this was a phase 2, multiple-dose, open-label study of vedolizumab administered intravenously (iv) every 8 weeks. the study population included treatment-naïve ulcerative colitis (uc) or crohn's disease (cd) participants, as well as 38 uc participants who had tolerated vedolizumab well during study c13002 (nct01177228). in the original study protocol, all participants were randomized to receive vedolizumab at doses of either 6 mg/kg or 10 mg/kg. with the implementation of amendment 1, the assigned doses of vedolizumab were decreased to 2.0 mg/kg and 6.0 mg/kg. to implement the dose changes, instead of randomizing all participants across both doses, those who rolled over from study c13002 were reassigned to receive the 2.0 mg/kg dose and all participants who entered c13004 naïve to treatment were to receive the 6.0 mg/kg dose, starting on the next scheduled dosing day. also, if participants assigned to the 2 mg/kg dose experienced flare, they were to receive the higher 6 mg/kg dose. in the results analyses for this study, participants are grouped according to the lowest dose received, i.e., 2.0 mg/kg or 6.0 mg/kg vedolizumab.

Eligibility criteria:
inclusion criteria: * confirmed and active ulcerative colitis (uc) or crohn's disease (cd) * crohn's disease activity index (cdai) score of 220 - 450 for participants with cd * partial mayo score of 2 - 7 for participants with uc * patient should be appropriate candidate for biologic therapy per guidelines * up-to-date on cancer screening * no severe systemic disease * patients with evidence of abscess * agree to comply with study procedures including contraception exclusion criteria: * low lymphocyte counts * history of imaging abnormalities, multiple sclerosis (ms), brain tumor or other neurological illness * active or recent serious infections * recent treatment with biologic (i.e., remicade) or investigational drug * impending surgery * any participants with vedolizumab human anti-human antibody (haha) titers ≥1:125 or with a previous immediate hypersensitivity reaction during or shortly after vedolizumab infusion
a study of dacomitinib (pf-00299804) in patients with advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with non-small cell lung cancer. the study includes two groups of patients, those whose tumor has a documented t790m mutation, and those without this mutation. all patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.


Eligibility criteria:
inclusion criteria: * evidence of histologically confirmed, advanced nsclc (stage iiib/iv). * evidence of t790m mutation to enroll in cohort a. * evidence of measurable disease by radiographic technique. * adequate organ function. exclusion criteria: * patients with t790m mutation who stopped any prior egfr-directed therapy without evidence of disease progression. * symptomatic brain metastases. * uncontrolled or significant cardiovascular disease. * pregnant or breastfeeding.

Keywords: non-small cell lung cancer t790m mutation. dacomitinib
plasma pharmacokinetics and safety of lnz101 and lnz100 ophthalmic solutions in healthy adult subjects with presbyopia

Conditions: Eye Diseases; Presbyopia; Refractive Errors; Brimonidine Tartrate; Aceclidine; Ophthalmic Solutions

Summary: this is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of lnz101 and lnz100.

to characterize the plasma pharmacokinetics and safety profile of lnz101 and lnz100 ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia

Eligibility criteria:
inclusion criteria: * each subject must: 1. be able and willing to provide written informed consent and sign a health information portability and accountability act (hipaa) form prior to any study procedure being performed; 2. be able and willing to follow all instructions and attend all study visits; 3. be 45-75 years of age of either sex and any race or ethnicity; 4. be presbyopic in both eyes; exclusion criteria: * each subject must not: 1. have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol; 2. have any active systemic or ocular disorder other than refractive disorder; 3. have prior, current or anticipated use of any contact lenses during study participation; 4. have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption; 5. have anticipated inability to stay confined on required study days;
process evaluation of a residence-based sars-cov-2 testing participation pilot

Conditions: Covid19

Summary: mixed-methods process evaluation of a residence-based asymptomatic sars-cov-2 testing participation pilot

regular testing for sars coronavirus 2 (sars-cov-2) is an important strategy for controlling virus outbreaks on university campuses during the covid-19 pandemic but testing participation rates can be low. the residence-based testing participation pilot (rb-tpp) was a novel intervention implemented at two student residences on a large university campus in the uk over four weeks. the aim of the pilot was to increase the frequency of asymptomatic sars-cov-2 saliva testing onsite. this process evaluation aimed to determine whether rb-tpp was implemented as planned and identify implementation barriers and facilitators. a mixed-methods process evaluation was conducted alongside the rb-tpp. evaluation participants were students (who opted in, or out of the rb-tpp) and staff with a role in service provision or student support. monitoring data were collected from the intervention delivery team and meeting records. data were collected from students via an online survey (n=152) and seven focus groups (n=30), and from staff via individual interviews (n=13). quantitative data were analysed descriptively and qualitative data thematically.

Eligibility criteria:
inclusion criteria: * student is living in one of the two participating halls of residence. * staff with operational or student support role. * consents to participate. exclusion criteria: * student is not living in the hall of residence at the start of the rb-tpp. * does not consent to participate.
dietary protein requirements on unbalanced diets

Conditions: Obesity; Overweight

Summary: the objective of this study is to determine ad libitum daily energy and protein intake, energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, also as a function of age, gender, bmi and fto polymorphisms.

following the protein leverage hypothesis, energy intake may be a derivative of protein intake. therefore, in response to an unbalanced menu relative to the usual daily intake target, protein intake should be prioritized. individuals may over-consume carbohydrate and fat of a menu containing a lower ratio of protein to carbohydrate and fat until the daily intake target amount of protein is ingested, and not the target of total energy intake because of a deficit of protein intake. in contrast, individuals may under-consume energy when the menu has an increased protein to carbohydrate and fat ratio. the protein leverage hypothesis requires evidence for why protein intake is more important than carbohydrate or fat in relation to food intake regulation.

Eligibility criteria:
inclusion criteria: * bmi 18-35 kg/m2 * age between 18-70 years * healthy * non-smoking * not using a more than moderate amount of alcohol (\> 10 consumptions/wk) * weight stable (weight change \< 3 kg during the last 6 months) * not using medication or supplements except for oral contraceptives in women exclusion criteria: * not healthy * smoking * using a more than moderate amount of alcohol * not being weight stable * using medication or supplements except for oral contraceptives in women * do not meet the criteria for bmi and age * pregnant or lactating * allergic for the used food items

Keywords: energy intake protein requirement satiety protein leverage hypothesis
characterization of bovine adrenal medulla as a model of non-histaminergic itch

Conditions: Itch

Summary: with this experiment, the experimenter wish evaluate the role of trpa1 on non-histaminergic itch induced by bam8-22

with this experiment, the experimenter wish evaluate the role of trpa1 on non-histaminergic itch induced by bam8-22 2 (bovine adrenal medulla), which is found naturally in the human body and which has proved to evoke itch. to evaluate the role of trpa1 it will be used a trpa1 agonist

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids or other drugs * previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.) * moles, wounds, scars or tattoos in the area to be treated or tested * lack of ability to cooperate • * current use of medications that may affect the trial such as antihistamines and pain killers. * skin diseases * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
one month dose response study of azd1981 in asthma patients uncontrolled on inhaled steroids

Conditions: Asthma

Summary: the primary objective of this study is to evaluate efficacy of azd1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.


Eligibility criteria:
inclusion criteria: * six months history of asthma * daily use of inhaled glucocorticosteroids * fev1 40-85% of predicted normal * reversibility; increase in fev1 more than 12% and 200 ml post-bronchodilator exclusion criteria: * other clinically relevant disease or disorders * history of smoking of more than 10 pack years * respiratory infection within 30 days

Keywords: asthma
optical coherence tomography angiography (oct-a) and central serous chorioretinopathy (csc)

Conditions: Central Serous Chorioretinopathy

Summary: optical coherence tomography angiography (oct-a) is a noninvasive imaging technique that allows one to see blood vessels in the retina. the investigating team used this approach in patients with acute, recurrent and persistent subtypes of central serous chorioretinopathy (csc) to check for possible choriocapillaris hypoperfusion. the presence or absence of these microvascular changes was explored in both eyes of the patients and compared to a control group of healthy volunteers. the possibility of a correlation between choriocapillaris flow deficits, age and spontaneous resolution of serous retinal detachment was also evaluated. this study was conducted in an effort to improve one's understanding of this disease and other pachychoroid disorders.


Eligibility criteria:
inclusion criteria: * patients with acute, recurrent or persistent forms of central serous chorioretinopathy exclusion criteria: * patients with chronic central serous chorioretinopathy were not eligible for inclusion
immersive virtual reality based training for rehabilitation of subacute stroke

Conditions: Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial

Summary: the investigators will conduct a single-blind, randomized controlled trial of 60 patients with subacute stroke. patients will be randomly assigned into a control group and an intervention group. the intervention group will participate in immersion vr training for 3 weeks. the control group will receive for traditional rehabilitation training for 3 weeks. then, the patients will be reevaluated to determine changes in upper extremity function, cognitive function, cortical and subcortical activation patterns, and performance of activities of daily living after the baseline assessment.


Eligibility criteria:
inclusion criteria: 1. having had an ischemic stroke in the first time 2. age 30 to 80 years old 3. first stroke within 2 month 4. gcs score \>8 5. the upper-limb function brunnstromⅱ、ⅲ exclusion criteria: 1. hemorrhage or transient ischemic attack(tia) 2. important organs such as heart, lung, liver, kidney function decline or failure 3. previous history of brain neurosurgery or epilepsy 4. had severe cognitive impairments or aphasia, which made the participants unable to understand the instructions given by the investigators 5. with claustrophobia and body with metal (such as metal teeth, etc.) are not suitable for to mri scanning
single and combined modality trans-oral robotic surgery in early oropharyngeal cancer

Conditions: Cancer Head Neck

Summary: multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (uk only).

the score study is a international multicentre cohort study investigating the local recurrence free survival outcomes in patients undergoing transoral robotic surgery with and without adjuvant therapy for early stage (t1-t2) oropharyngeal squamous cell carcinoma (opscc). important secondary objectives include assessment of other survival measures (overall, disease free and disease specific), determination of a safe margin "cut off" that minimises the risk of local recurrence, and reporting the rate of early post-operative complications and mortality. retrospective score patients will optionally contain an exploratory radiomic and radiology morphological analysis to ascertain high risk features of positive margins and local recurrence following tors for early oropharyngeal cancer. additionally, the score study will contain a prospective exploratory molecular analysis of consenting patients to help further define opscc molecular characteristics in those who experience recurrence and those who do not, in addition to assessing levels of circulating tumour dna in before and after tors procedures.

Eligibility criteria:
inclusion criteria: * 18 years and older. * primary tumour within the oropharynx (defined as tonsil, soft palate, tongue base, lateral and posterior oropharyngeal walls) * histologically confirmed squamous cell carcinoma. * p16 positive or negative tumours * index cancer treated with tors with or without adjuvant therapy. * early pt1-t2 stage oropharyngeal scc * tors performed on or before 31st december 2021 for the exploratory analysis only: * ability to consent to molecular analysis study * ability to consent to radiomic/ imaging study (as required for international centres) exclusion criteria: * moderate to advanced stage t3-t4 oropharyngeal scc * tors performed for diagnostic, recurrent, or palliative intentions. * prior history of head and neck cancer or radiation therapy at any time * known distant metastatic disease. * nasopharyngeal, thyroid, cutaneous, and non-scc head and neck cancers.

Keywords: robotic surgical procedures margins of excision oropharyngeal neoplasms local neoplasm recurrence recurrence free survival