Kornimate/medical-research-clean huggingface dataset:
nyx-458 in subjects with mild cognitive impairment or mild dementia due to parkinson's disease or lewy body dementia (cognition, memory, attention, thinking)

Conditions: Mild Cognitive Impairment; Mild Dementia; Parkinson Disease; Lewy Body Disease

Summary: a study to evaluate nyx-458 in subjects with mild cognitive impairment or mild dementia associated with parkinson's disease or prodromal or manifest lewy body dementia

the study will be a 16 to 18-week study, including a 2 to 4-week screening period, followed by a 12-week double-blind, randomized, placebo-controlled treatment period, and a 2-week follow-up period. subjects eligible for the study will be randomized to receive either nyx-458 or placebo.

Eligibility criteria:
inclusion criteria: * informed consent * diagnosis of parkinson's disease and mild cognitive impairment or mild dementia or diagnosis of mild cognitive impairment or mild dementia with lewy bodies * presence of subjective cognitive complaints by the patient * verifiable impairment, as defined a cgi-s (clinical global impression-severity) score of at least 3 (mildly ill). * score on the moca (montreal cognitive assessment) between 15 and 25, inclusive. * stable anti-parkinsonian regimen (if applicable) * has a study partner who can accompany the subject at specified study visits exclusion criteria: * clinically meaningful motor complications * current use of medications with primarily central nervous system activities * other clinically significant medical histories that may interfere with completing the study.
effect of magnetic current on ulcer healing

Conditions: Diabetic Foot Ulcer

Summary: this study aims to evaluate the effectiveness of magnetic current in the management of dfus as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group): 1- group a: pulsed electromagnetic field (pemf) group. 2- group b: control group. assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up. :

this study aims to evaluate the effectiveness of magnetic current in the management of dfus as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group): 1. group a: pulsed electromagnetic field (pemf) group. 2. group b: control group. assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up. outcome measures will include: 1. wound closure. 2. wound depth. 3. microcirculation.

Eligibility criteria:
inclusion criteria: * 1. the ankle brachial index should fall between 0.9 and 1.2 to reassure that arterial insufficiency was not causing or contributing to the nonhealing wound. 2. patients diagnosed with diabetes with unsatisfactory healing of ulcer(s) in the preceding 4 weeks. 3. wagner grade 1 or 2 ulcers on the foot without exposure of bone, muscle, ligaments, or tendons. exclusion criteria: - 1- ulcers secondary to non-diabetic etiology. 2- poorly controlled diabetes. 3- pregnancy. 4- patients wearing a pacemaker or with malignancy or history of radiotherapy. 5- patients who were taking medications that might affect their circulation or sensation and motor functioning and patients with any history of alcoholism were also excluded. 6- patients who had clinical signs of infection or were taking antibiotics at the time of enrollment.

Keywords: ulcer diabetic magnetic
antibodies in repeated influenza vaccination (ariva) study

Conditions: Vaccine Response Impaired

Summary: viruses with high mutation rates, such influenza or hiv, pose a major challenge for vaccine design. the current influenza vaccination strategy of yearly vaccination with adapted strains aims to maximally diversify the antibody immune response to prevent viral escape. there is, however, growing evidence, that repeated vaccination with very similar viral proteins might limit, instead of broaden, diversification and thereby reduce vaccine efficacy. the ariva study prospectively studies the immunological impact of repeated influenza vaccination on viral variant recognition and antibody responses in healthy subjects cross-sectionally and over three consecutive vaccination seasons.


Eligibility criteria:
inclusion criteria: * influenza vaccination (qiiv) independent of the study * age \>18 yo exclusion criteria: * no vaccination * current acute illness
assessment of hgi (hemoglobin glycation index) variability over time in patients living with diabetes using continuous glucose monitoring ( gap ouest )

Conditions: Diabetes Mellitus

Summary: the goal of this clinical trial is to learn about the variability of hgi (hemoglobin glycation index) over time in patients living with diabetes using a continuous glucose monitoring.


Eligibility criteria:
inclusion criteria: * major (adult subject over 18), with no upper age limit * enrolled in a social security scheme or beneficiary of such a scheme * agreement to participate (informed, written consent) * established diabetes (regardless the type of diabetes), known for at least 6 months at inclusion * regular user of a glucose monitoring system for at least 3 months. non inclusion criteria: * known hemoglobinopathy * inadequate use of the flash glucose monitoring system with a capture rate of less than 70% of interstitial glucose measurements, during the 3 months preceding the inclusion visit. * stage 5 renal insufficiency (ckd-epi less than 15 ml/min/1.73 m2) * pregnant or breast-feeding * major under guardianship, curatorship or safeguard of justice * any situation assessed by the investigator as potentially prejudicial to the participant's health as a result of participation in the study exclusion criteria: * treatment with corticosteroids in the 3 months preceding the visit * unusual acute situation (infection, very unusual physical activity, etc.) deemed significant by the investigator * pregnancy started
an evaluation of california's experiment with hope

Conditions: Drugs of Abuse

Summary: the phase i evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by california parolees assigned to the study group.

the california hope pilot program is being implemented under the authority granted in penal code 5058.1. the phase i evaluation is intended to assess whether or not frequent drug testing and immediate short-term incarceration for drug use and/or other violations and mandated drug treatment for multiple violations, reduces the recurrence of drug use and/or other violation behaviors by california parolees assigned to the study group compared with parole-as-usual.

Eligibility criteria:
inclusion criteria: * assigned to the sacramento metro iv parole unit. * released from a term of return-to-custody for a violation for, or involving, the use of drugs. * have a maximum controlling discharge date at least one year from the date of release from the return-to-custody term. exclusion criteria: * history of convictions for crimes that require registration under penal code section 290.

Keywords: drug use drug arrests incarceration
switching from cardiac troponin i to t

Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction; Acute Myocardial Ischemia; Myocardial Injury; Chest Pain; Heart Failure

Summary: cardiac troponin is central to the diagnosis of myocardial infarction and high-sensitivity cardiac troponin (hs-ctn) assays are the preferred choice for the assessment of patients with suspected acute coronary syndrome. since the introduction of hs-ctn assays in europe in 2010, most hospitals have switched from contemporary sensitive cardiac troponin assays to a hs-ctn assay. the implementation of hs-ctn assays has led to an increase in the number of patients identified with myocardial injury. although both hs-ctni and hs-ctnt assays are recommended in current guidelines, the impact of switching from a hs-ctni assay to a hs-ctnt assay on clinical practice is unknown. at this point, no studies have evaluated the impact of implementing sex-specific hs-ctnt thresholds on the diagnosis of myocardial infarction and outcome in clinical practice. the investigators propose to determine the proportion of patients with and without myocardial injury admitted to the hospital before and after implementation of a hs-ctnt assay and to evaluate the impact on investigations, care and clinical outcomes in consecutive patients with suspected acute coronary syndrome.


Eligibility criteria:
inclusion criteria: * age 18 years and over * symptoms of possible acute coronary syndrome * high-sensitivity cardiac troponin measured at presentation exclusion criteria: * insufficient clinical information to perform record linkage * previous enrolment in the study * patients with st-segment elevation myocardial infarction (stemi)

Keywords: acute coronary syndrome acute myocardial infarction myocardial injury high-sensitivity cardiac troponin t high-sensitivity cardiac troponin i biomarker acute cardiovascular care diagnostic pathways outcomes sex sex-specific thresholds upper reference limits
ontario multidetector computed tomographic (mdct) coronary angiography study (omcas)

Conditions: Coronary Arteriosclerosis; Cardiomyopathies; Heart Defects, Congenital; Heart Valve Diseases

Summary: multidetector computed tomographic coronary angiography (mdctca) has been recently demonstrated to be accurate and may be used as a potential alternative to conventional invasive coronary angiography, which requires cardiac catheterization, for the diagnosis of coronary artery disease. the purpose of this study is to see if mdctca can identify significant coronary artery disease as good as or better than conventional coronary angiography (cica). the study is designed to enroll 900 subjects and is being conducted in 6 hospitals in ontario. subjects scheduled for conventional cardiac catheterization and coronary angiography will receive an additional test using mdctca. the information gathered during the mdctca will be compared to the results of the scheduled conventional invasive coronary angiogram.


Eligibility criteria:
inclusion criteria: group 1 * valvular heart disease (mitral stenosis, mitral regurgitation, aortic stenosis or aortic insufficiency) or * congenital heart disease (i.e. vsd, asd, pda) or * cardiomyopathy or group 2 * intermediate probability of coronary artery disease (probability of 10-90%) after clinical evaluation and traditional non-invasive testing exclusion criteria: * age \< 18 years * lack of consent * renal insufficiency (gfr \< 60 ml/min) * allergy to contrast agent * refractory angina requiring urgent/emergent coronary angiography (as per treating physician) * pregnancy or breast feeding * uncontrolled heart rate * previous cabg or pci/stent * chronic atrial fibrillation * history of acute myocardial infarction, as defined by a creatine kinase (ck) level greater than 2 times normal with a troponin level above 4. * unable to perform 20 second breath-hold
btb graft harvest and donor site morbidity after acl reconstruction

Conditions: Anterior Cruciate Ligament Rupture; Donor Site Complication

Summary: the aim of this observational study is to examine the connection between bone-tendinous defects after btb graft harvest and the development of anterior knee pain.

the purpose of this study is to investigate the impact of bone-tendinous defects after acl reconstruction on the development of anterior knee pain. we will assess the presence and extent of bone-tendinous defects using mri scans, which will be conducted at two time points: 4 weeks and 1 year after acl reconstruction surgery. furthermore, we will compare the healing progress of the bone-tendinous defects observed on the mri scans. in addition, we will evaluate the correlation between the residual bone-tendinous defect and knee functionality by comparing the results with knee functional test (ikdc form, lysholm score, donor site morbidity score). all individuals participating in the study have provided their informed consent by signing the necessary documents prior to their inclusion in the research.

Eligibility criteria:
inclusion criteria: * hospitalized patients * diagnosed with acl rupture based on medical history and clinical examination * confirmed acl rupture on mri scans * a sufficient level of education to understand study procedures and be able to communicate with site personnel exclusion criteria: * multiligament knee injuries * both knees injuries * acl re-rupture * postoperative complications in the form of infection

Keywords: anterior cruciate ligament rupture autografts athletic injuries magnetic resonance imaging
the effects of vibration on hypoxia

Conditions: Hypoxia

Summary: the purpose of this study is: 1. to study the effect of whole-body vibration on partial pressure of oxygen in arterial blood (pao2), under hypobaric hypoxic conditions. 2. to study the effects of whole-body vibration and hypobaric hypoxia on visual contrast sensitivity. 3. to se if there is an increase in cytokines and other biomarkers under different hypobaric hypoxic conditions our main hypothesis is that whole-body vibration may cause pao2 to drop to a lower level, at a given altitude; than would be the case if there were no vibration present.


Eligibility criteria:
inclusion criteria: exclusion criteria: * stay at altitude over 2000 m last two weeks prior to study-start. * severe head injury * cardiovascular disease * lung disease * decompression sickness
a study to compare the amount of cp-690,550 that is absorbed into the blood of healthy subjects following oral administration of two different strength tablets of cp-690,550

Conditions: Arthritis, Rheumatoid

Summary: in this study, a 5 mg dose of cp-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. the amount of cp-690,550 available in the blood following administration of each tablet will be measured and compared. the overall aim of the study is to establish that a similar amount of cp-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .

this is a bioequivalence study for cp-690,550.

Eligibility criteria:
inclusion criteria: * healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs). * no evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb). exclusion criteria: subjects with 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). personal or family history of hereditary immunodeficiency (eg, severe - evidence of any clinically significant illness, medical condition, or disease. * evidence or history of any clinically significant infections within the past 3 months. * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Keywords: bioequivalence healthy volunteer study rheumatoid arthritis
a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of abbv-3373 in participants with moderate to severe rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis (RA)

Summary: this study will assess the safety, tolerability, and efficacy of abbv-3373 in participants with moderately to severely active rheumatoid arthritis (ra) on background methotrexate (mtx) compared with adalimumab.

this study consists of a 12-week double-blind active-controlled phase and a 12 week double-blind extension period. in the active-controlled period of the first 12 weeks of treatment, participants are randomized to receive either abbv-3373 100 mg intravenously (iv) every other week (eow) or adalimumab 80 mg subcutaneously (sc) eow according to a 2:1 ratio. at week 12, the administration of abbv-3373 was to stop to assess the durability of the observed clinical effects up to 24 weeks. participants randomized to abbv-3373 were to receive placebo injections, whereas participants randomized into the adalimumab arm were to continue their 80 mg dosing.

Eligibility criteria:
inclusion criteria: * participant has the clinical diagnosis of ra for \> 3 months based on the 1987 american college of rheumatology (acr) classification criteria or 2010 acr/european league against rheumatism (eular) criteria. * participant meets the following disease activity criteria: \>= 4 swollen joints (based on 28 joint count) and \>= 4 tender joints (based on 28 joint count) at screening and baseline visits and disease activity score (28 joints) (das28) c-reactive protein (crp) \>= 3.2 at screening. * participant has an incomplete response to methotrexate. participants must have been on oral or parental mtx therapy \>= 3 months and on a stable prescription of 15 to 25 mg/week (or \>= 10 mg/week in participants intolerant of mtx at doses \>= 15 mg/week) for \>= 4 weeks prior to the first dose of study drug. participant must be expected to be able to continue on stable dose of mtx for the duration of study participation. exclusion criteria: * participants previously exposed to adalimumab or other anti-tumor necrosis factor (tnf) biologics. * participants previously exposed to non-anti-tnf biologics or targeted synthetic disease-modifying antirheumatic drugs (dmards) for ra, with exception of participants exposed for less than 3 months and terminated not due to lack of efficacy or intolerability.

Keywords: rheumatoid arthritis (ra) abbv-3373 adalimumab
the effect of swallowing training for elderly people in the community

Conditions: Dysphagia

Summary: the goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

the investigators have designed a simple and user-friendly swallowing rehabilitation training method called "systematic simple swallowing training" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. it has shown promising preliminary efficacy. however, before we can promote its widespread adoption, a series of studies must be conducted to establish its effectiveness. the goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. all participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility criteria:
inclusion criteria: * age over 60 years old. * no hospitalization within the past six months. * with clear consciousness and able to cooperate with questionnaires and training. * the elderly people who voluntarily participate and agree to adhere until the end of the study. exclusion criteria: * complicated with severe liver and kidney failure, tumors, or hematological disorders. * physical disability. * difficulty in mobility.
safety and preliminary efficacy of recombinant activated factor vii in subjects with traumatic brain injury

Conditions: Acquired Bleeding Disorder; Trauma

Summary: this trial is conducted in asia, europe, middle east, and north america. the primary objective of the trial is to evaluate the safety of recombinant activated factor vii in patients with brain contusions. the secondary objective of the trial is to evaluate the preliminary efficacy of recombinant activated factor vii in preventing early haemorrhagic progression in contusive brain injury.


Eligibility criteria:
inclusion criteria: * contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by ct scan within 6 hours of onset * in british columbia and nova scotia, subjects must be = 19 years.
uncemented compared to cemented femoral stems in total hip arthroplasty

Conditions: Hip Fractures

Summary: the purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.

the study will randomize patients between an uncemented and cemented stem

Eligibility criteria:
inclusion criteria: * acute displaced femoral neck fracture * subject is aged between 65-79 years * independent walker with or without walking aides * subject is able and capable of providing consent to participate in the study exclusion criteria: * patients with rheumatoid arthritis * patients with an impaired cognitive dysfunction * patients with pathological fractures * patients with substance abuse * patients with fracture older than 36-hours on arrival at the a\&e * patients suffering from cancer * patients determined by principal investigator to be unsuitable for inclusion