Kornimate/medical-research-clean huggingface dataset:
the cardiovascular genetic and therapeutic implications of muscular dystrophy

Conditions: Muscular Dystrophy; Dilated Cardiomyopathy; Heart Failure

Summary: this study will have significant impact on muscular dystrophy patients as it promotes early screening for heart disease. with early identification, beneficial medical therapy can be started sooner, resulting in restoring and maintaining normal heart function. this is critical to the survival of these patients. we have reported previously that heart failure in all patients may have common mechanisms, the "final common pathway". heart failure is a significant health problem with 5 million people in the us carrying the diagnosis and accounting for 12-15 million office visits and 6.5 million hospital days per year. the number of deaths from heart failure continues to increase. the data from this study could impact patients worldwide with heart failure by offering new insight into an ever-growing disease population and lead to significant changes in how they are currently treated.

objective(s) and hypothesis(es): the objectives to be evaluated are as follows: specific hypothesis #1: heart disease, specifically dilated cardiomyopathy, can be identified early in patients with muscular dystrophy and allow for earlier institution of medical therapies specific hypothesis #2: non-invasive testing via magnetic resonance imaging (mri) and echocardiography can identify early systolic and diastolic dysfunction in patients with muscular dystrophy as well as document structural changes ("reverse remodeling") following institution of medical therapy specific hypothesis #3: serologic testing can identify early cardiac dysfunction prior to changes on magnetic resonance imaging or echocardiogram that can predict disease onset, risk stratify future cardiac morbidity and mortality, and response to medical therapy specific hypothesis #4: specific dystrophin mutations can be identified that predict the onset or protection against dilated cardiomyopathy specific hypothesis #5: construction and maintenance of a database of patients with muscular dystrophy can be established that will allow for future research in patients with muscular dystrophy, specifically in the area of gene therapy specific hypothesis #6: quality of life in patients with cardiac disease can be assessed and used to modulate therapy and also allow for noncardiac directed therapies that will improve overall well-being specific hypothesis #7: further understanding of neurohormonal profiles, responses to medical therapy, and dystrophin mediated cardiomyopathy will impact all patients with heart failure world-wide

Eligibility criteria:
inclusion criteria: * all patients with the diagnosis of muscular dystrophy. exclusion criteria: * patients that do not carry the diagnosis of muscular dystrophy.

Keywords: dystrophy cardiomyopathy
effect of an exploratory vehicle on meibomian gland dysfunction in patients with demodex

Conditions: Meibomian Gland Dysfunction; Demodex Infestation of Eyelid; Blepharitis; Demodectic Blepharitis

Summary: the purpose of this study is to evaluate and compare the effect of two dosing regimens, bid versus tid dosing, of an exploratory vehicle (ev) on meibomian gland dysfunction (mgd) in patients with demodex lid infestation.

this is a prospective, randomized controlled, three-arm, investigator- and interpreter-masked study. this study is intended to compare the effect of two dosing regimens of an exploratory vehicle on meibomian gland dysfunction (mgd) in participants with demodex lid infestation. approximately 12 participants will be enrolled in each arm. the administration period will last for approximately 85 days.

Eligibility criteria:
key inclusion criteria: * be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol * meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more mites with lash epilation of the upper and lower lids; have evidence of meibomian gland dysfunction; have at least mild erythema of the lower lid; have a tear breakup time of less than 10 seconds; and have intact partial to full meibomian glands in at least 33% of the total meibomian gland area of the lower lid key exclusion criteria: * have used lid hygiene products within 7 days of day 1 or unwilling to forego the use of lid hygiene products during the study * have used systemic antihistamines within 30 days of day 1 * have used artificial eyelashes, eyelash extensions, or had other cosmetic eyelash or eyelid procedures within 7 days of day 1 or be unwilling to forego their use during the study * contact lens wear within 7 days of day 1 or unwilling to forego contact lens wear for the duration of the study * be pregnant or lactating at day 1

Keywords: demodex
comparison of dynamic knee stability and functional outcomes in anatomical acl reconstruction at am or central position

Conditions: Rupture of Anterior Cruciate Ligament; Complete Tear, Knee, Anterior Cruciate Ligament

Summary: this is a prospective, randomized and double-blind clinical trial about anatomical single-bundle anterior cruciate ligament (acl) reconstruction. one of the most common causes of acl reconstruction failure is poor graft positioning. there is evidence that graft placement aligned with native insertion sites results in superior clinical outcomes. current anatomic acl reconstruction concepts highlight the importance of the native anatomy to restore physiological knee kinematics more accurately. this study aims to investigate clinical outcomes and dynamic knee stability with force platform and other functional tests after acl reconstruction in two different groups of tunnel position: anteromedial acl footprint (am) or central acl footprint. it was hypothesized that there would be clinical or dynamic stability differences between am or central tunnel groups in acl reconstruction.

tunnel position will be recorded and confirmed with postoperative computer tomography.

Eligibility criteria:
inclusion criteria: * physical activity classified by tegner scale ≥ 5 * absence of other associated ligament injuries in the operated knee * no acl rerupture or previous acl reconstruction in the same or other knee * absence of untreated lesions of the opposite knee * no obvious change in the alignment of the mechanical axis that required surgical correction * athletes of both gender with a minimum age of 18 years and maximum of 45 years * signature of the consent term (irb) * not be pregnant. exclusion criteria: * request to stop the study by patient at any time * fracture not associated with the surgical procedure * do not carry out the rehabilitation protocol as oriented by the sports medicine group.

Keywords: anterior cruciate ligament acl anterior cruciate ligament reconstruction outcome assessment outcome assessment, patient treatment outcome exercise test anatomic anatomical single-bundle force platform postural balance biomechanics ct scan x-ray computed tomography tomography diagnostic imaging knee knee injuries joint instability reconstructive surgical procedures knee surgery arthroscopy athletes sports medicine humans prospective studies randomized controlled trial
routinely collected clinical data and evaluation of antimicrobial target attainment

Conditions: Infections, Bacterial; Pharmacokinetics; Drug Monitoring; Drug-Related Side Effects and Adverse Reactions

Summary: the primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at imperial college healthcare nhs trust in whom drug concentration targets are achieved.

to address the challenge of antimicrobial resistance (amr) it is imperative that the current finite pool of antimicrobial agents is optimised, to maximise therapeutic success, limit the risk of drug toxicity, whilst minimising emergence of resistance. outside of the critical care setting it is not known how many patients are receiving optimal drug concentrations for the treatment of infection. this study aims to assess whether antimicrobial targets are being achieved in these individuals and explore how clinical co-variates and outcomes may relate to this. furthermore, it aims to identify priority groups and/or drugs where there are gaps in dose optimisation research and develop hypotheses which can be tested in observational studies. eligible participants will be enrolled and observed during their management of infection at imperial college nhs trust. after providing informed consent their clinical data will be collected from electronic healthcare records and they will provide samples that will undergo drug concentration analysis.

Eligibility criteria:
inclusion criteria: 18 years of age or above. * under follow-up for management of infection at imperial college nhs trust * received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently). * provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee): * delirium which may be caused or exacerbated by having an infection. * suspected/confirmed central nervous system infection. * critical illness requiring sedation and/or intubation and ventilation which is caused by or exacerbated by having an infection. exclusion criteria: * less than 18 years of age * severe anaemia (hb \< 70g/l) * platelets \ 1.5 or other known blood clotting impairment * patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study. * enrolled in a clinical trial which stipulates exclusion from other studies including observational studies. * patients with restricted liberty, prisoners or under legal protection.
assessment of an alpha-glucosidase inhibitor to block cardiac events in patients with mi and igt

Conditions: Impaired Glucose Tolerance; Myocardial Infarction

Summary: the purpose of this study is to evaluate whether an alpha-glucosidase inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with impaired glucose tolerance (igt) and old myocardial infarction.

type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in the coronary artery develops subclinically in a state of impaired glucose tolerance (igt). recently postprandial hyperglycemia as a feature of impaired glucose tolerance is recognized as a significant risk factor for coronary heart disease. so we designed a prospective randomized multi-center trial named assessment of an α-glucosidase-inhibitor to block cardiac events in patients with myocardial infarction and igt (abc study) to evaluate whether an α-glucosidase inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with igt and old myocardial infarction. 100 hospitals will participate in the abc study. patients with igt who have a history of prior myocardial infarction are randomly allocated to receive α-glucosidase inhibitor (voglibose) or a standard diet and exercise treatment. the number of patients to be recruited is 3000 and this study will continue for at least 2 years. the primary end-points are: 1. cardiovascular mortality and 2. hospitalization for cardiovascular events. effects in suppression of new diabetes development will also be evaluated. we should recognize igt as an important therapeutic target to decrease the recurrence of cardiovascular events. the abc study, a large scale multi-center trial in japan, will provide us with new evidence on how to treat igt patients with prior myocardial infarction.

Eligibility criteria:
inclusion criteria: 1. impaired glucose tolerance 2. history of myocardial infarction exclusion criteria: 1. type i diabetes 2. history of coronary artery bypass graft 3. severe liver and/or kidney dysfunction 4. history of allergic response to drugs 5. arteriosclerosis obliterans

Keywords: igt myocardial infarction alpha-glucosidase inhibitor re-infarction prevention
treatment for classical hodgkin lymphoma in children and adolescents

Conditions: Classical Hodgkins Lymphoma in Children and Adolescents.

Summary: reduction of the indication for radiotherapy (rt) in newly diagnosed patients with classical hodgkins lymphoma without compromising cure rates. investigation of a chemotherapy intensification randomisation in intermediate and advanced classical hodgkins lymphoma patients to compensate for reduction in rt.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed primary diagnosis of classical hodgkin's lymphoma. 2. patients under 18 years of age on the date of written informed consent. in specialized teenage and young adult (tya) units in australia, france, italy, new zealand and united kingdom patients up to under 25 years of age can also be enrolled. lower age limits will be country specific according to national laws or formal insurance requirements that may preclude very young patients. 3. written informed consent of the patient and/or the patient's parents or guardian according to national laws. 4. negative pregnancy test within 2 weeks prior to starting treatment for female patients with childbearing potential exclusion criteria: (patients with one or more of the following criterion are excluded) 1. prior chemotherapy or radiotherapy for other malignancies 2. pre-treatment of hodgkin's lymphoma (except for steroid pre-phase to a maximum of 7-10 days for emergency treatment of a large mediastinal tumour). 3. diagnosis of lymphocyte-predominant hodgkin's lymphoma 4. other (simultaneous) malignancies 5. contraindication or known hypersensitivity to study drugs 6. severe concomitant diseases (e.g. immune deficiency syndrome) 7. known hiv-positivity 8. residence outside the participating countries where long term follow-up cannot be guaranteed 9. pregnancy and / or lactation 10. patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment 11. current or recent (within 30 days prior to date of written informed consent) treatment with another investigational drug or participation in another interventional clinical trial
tirelizumab plus surgery vs surgery alone for recurrent nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: through open-label, single-center, randomised clinical trials, we intend to demonstrate that pd-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed recurrent nasopharyngeal carcinoma 2. the recurrence time is more than 6 months from the end of radiotherapy. 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. according to the tnm staging criteria of nasopharyngeal carcinoma (ajcc, 8th edition, 2017), rt1, rt2, rt3, and rt4 patients who can be completely resected by surgery as assessed by the surgical team. 5. resectable recurrent regional lymph node diseases (recurrent n1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. 6. given written informed consent. exclusion criteria: 1. has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness. 2. has known subjects with other malignant tumors. 3. has participated in other drug trials within 3 months of planned start of study treatment. 4. received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment. 5. suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses. 6. prior therapy with a pd-1, anti-pd-ligand 1 (pd-l1) or cytotoxic t lymphocyte-associated antigen 4 (ctla-4) agent. 7. has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll. 8. has a known history of human immunodeficiency virus (hiv), has hepatitis b surface antigen (hbsag) positive with hepatitis b virus (hbv) dna copy number of ≥1000cps/ml or hepatitis c virus (hcv) antibody positive. 9. has received a live vaccine within 4 weeks of planned start of study treatment. 10. pregnancy or breast feeding. 11. cannot complete regular follow-up. 12. local recurrence of nasopharyngeal carcinoma with distant metastasis

Keywords: recurrent nasopharyngeal carcinoma tirelizumab immunotherapy endoscopic surgery survival
impulsivity and parkinson's disease : a neuropsychology with magnetic resonance imaging study

Conditions: Parkinson's Disease

Summary: this study aims to characterize the nature of impulsivity in parkinson's disease (pd).


Eligibility criteria:
inclusion criteria : early onset pd patients and late onset pd patients with siblings available pd patients with or without impulse control disorders current or past treatment with dopamine agonists or levodopa pd patients without dementia age \< 80 ans exclusion criteria : early onset pd patients and late onset pd patients without siblings available pd patients with dementia age \> 80 years
evaluating allomax in immediate expander-based breast reconstruction study

Conditions: Malignant Neoplasm of the Breast; Acquired Absence of the Breast

Summary: the study is a prospective multi-centered cohort study designed to determine the safety and efficacy of allomax in immediate expander-based breast reconstruction. specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. the study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.


Eligibility criteria:
inclusion criteria: * patients having immediate breast reconstruction with tissue expanders * unilateral or bilateral reconstructions * ages 25 - 65 * all breast cancer stages and types exclusion criteria: * bmi \> 35 * active smokers * diabetics * history of radiation or planned radiation * immunocompromised patients
jc-virus (jcv) epidemiology in multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the objective of the study is to estimate the prevalence of anti-jcv antibodies in multiple sclerosis (ms) participants.

this is a cross-sectional, multi-center, multi-national, epidemiological study to estimate the prevalence of anti-jcv antibody in ms participants. this study will provide an estimate of the prevalence of anti-jcv antibody in the ms population and will investigate inter-country differences.

Eligibility criteria:
key inclusion criteria: * all candidates for this study must have the ability to understand the purpose of the study and provide signed and dated informed consent. * all patients with a diagnosis of multiple sclerosis (ms) of any type, irrespective of their treatment, are eligible to participate once. key exclusion criteria: * none note: other protocol defined inclusion/exclusion criteria may apply.
exploratory study to evaluate the efficacy of an occlusion based dentifrice in relief of dentinal hypersensitivity

Conditions: Dentinal Hypersensitivity

Summary: the purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by schiff and tactile sensitivity. this proof of concept study will compare the test dentifrice with three other treatment groups.

this will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design study in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline visit. participants will be assessed at baseline, four and eight weeks to monitor clinical efficacy and safety.

Eligibility criteria:
inclusion criteria: * participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study. * participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (yeaple ≤ 20 gram (g)) and evaporative (air) (schiff sensitivity score ≥ 2) assessments at the baseline visit. exclusion criteria: * specific dentition exclusions for test teeth 1. tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening. 2. tooth with exposed dentin but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentin. 3. sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator * use of a sensitivity dentifrice within 8 weeks of screening * individuals who require antibiotic prophylaxis for dental procedures