Kornimate/medical-research-clean huggingface dataset:
baseline concentration of direct oral anticoagulant and incidence of adverse event measure and see (mas)

Conditions: Atrial Fibrillation; Anticoagulant-induced Bleeding

Summary: the mas study is an observational, multicentre, prospective cohort study in non valvular atrial fibrillation (nvaf) patients treated with one of the direct oral anticoagulants (doacs) available in italy for nvaf patients. the general aim is to deepen the knowledge of doac treatment in nvaf patients, by measuring the plasma concentration of anticoagulant drugs and their correlation with any adverse events that may occur during treatment.

the mas study is an observational, prospective cohort study, double blind, multicentre, international and no profit. anticoagulation clinics, affiliated or not to the italian fcsa, will be asked to take an active part in the study, provided they have the facilities for blood sampling and processing. 4000 consecutive nvaf outpatients, 1000 for each single drug, starting anticoagulation with one of the four doac (apixaban, dabigatran, edoxaban, rivaroxaban) will be enrolled at the moment of the first prescription. patients will receive the type and dosage of doac on the base of clinical characteristics at the discretion of the attending physician, as the normal clinical practice, and the study will not influence the decision of the type and dosage of doac. the primary study objective is to evaluate the possible relationship between doac anticoagulant levels at the trough, measured at steady state (within the first 2-4 weeks of treatment) and occurrence of bleeding and thromboembolic events during the subsequent one year follow up

Eligibility criteria:
inclusion criteria: * nvaf patients starting doac anticoagulation * age \> 18 years * ability to give written informed consent * availability, as part of the normal withdrawals, to the blood sampling for the study purpose * availability for 12-months follow-up exclusion criteria: * age \< 18 years * indication for electrical cardioversion at the moment of drug prescription * participation in phase ii or iii clinical trials * indication for treatment different from nvaf * not suitable to give or not giving informed consent * not available for blood collection or follow-up

Keywords: atrial fibrillation bleeding event thromboembolic event plasma concentration of drug
yoga intervention in head and neck cancer patients undergoing concurrent chemo-radiation

Conditions: Head and Neck Cancer

Summary: this is a randomized prospective pilot study assessing the safety and feasibility of two yoga interventions in head and neck cancer patients undergoing primary or adjuvant radiation with or without concurrent chemotherapy

primary objective: - to assess the safety and feasibility of hatha yoga in head and neck cancer patients undergoing treatment with primary or adjuvant radiation with or without chemotherapy.

Eligibility criteria:
inclusion criteria: * locally advanced, non-metastatic, histologically confirmed malignancy involving the head and neck region o larynx, pharynx, oral cavity, salivary gland, paranasal sinuses and unknown primary * age greater or equal to 21 years of age * planned for either definitive or adjuvant radiation therapy with or without chemotherapy o patients may have received induction chemotherapy or primary surgical resection prior to proceeding to radiation therapy * ability to understand english * daily access to the internet * willing and able to sign informed consent * willing and able to participate in yoga sessions as outlined in the study protocol exclusion criteria: * prior head and neck cancer radiation * patients who in the opinion of the treating physician are physically, medically or psychologically impaired to the point that participation is not deemed appropriate or feasible
continuous glucose monitoring and hypoglycemia unawareness in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: looking for strict normoglycemia in type 1 diabetes increases the risk of hypoglycemia, exposing to hypoglycemia unawareness. it has been shown that the early correction of hypoglycemia can help recovering the perception of hypoglycemia. the purpose of this prospective study was to assess the value of sensor-augmented insulin-pump therapy to treat hypoglycemia unawareness.

to confirm hypoglycemia unawareness, patients answered a questionnaire based on the items explored by the model of clarke 19 about hypoglycemia and hypoglycemia awareness. the eligibility of patients was confirmed by a blinded cg m recording using the trademark ipro ™ 2 sensor for 6 days. during this period the patient reported on a logbook the perception of their hypoglycemia, symptoms and how any hypoglycemia was corrected. hypoglycemic manifestations were divided into adrenergic (shakiness, anxiety, palpitations, sweating, hunger, nausea, headache, coldness and pallor) and neuroglycopenic effects (impaired judgment, moodiness, paresthesia, emotional lability, confusion, ataxia, double vision, amnesia, seizures and lethargy). the confrontation of hypoglycemia detected by the blinded cg m and self-reported hypoglycemia validated the diagnosis of hypoglycemia unawareness. patients used the paradigm® veo™ pump and glucose sensors (trademark : enlite®) with an hypoglycemia alarm set at sensor glucose value of 70 mg/dl while the lg s option was set to suspend insulin delivery at a sensor glucose value of 50 mg/dl or less. these thresholds allowed an active correction of hypoglycemia by the patient between 50 and 70 mg/dl. patients were educated to use the system and to treat and manage hypoglycemia. pump data were uploaded using the trademark medtronic carelink™ management software for diabetes during visits at 10 days (d10), 2 months (m2) and 3 months (m3). hypoglycemia awareness was assessed by an initial quiz that was repeated at m3 and 6 months (m6). a blinded cgm ipro ™ 2 was also realized at m3 to validate the modifications after sensor-augmented insulin-pump therapy.

Eligibility criteria:
inclusion criteria: * \>18 years * type 1 diabetes * had been treated with insulin pump for more than three months * had hypoglycemia unawareness with a hypoglycemia perception threshold below 60 mg/dl and/or had had at least one severe hypoglycemia event in the previous year exclusion criteria: * \> 18 years * any serious disease that could interfere with the study * pregnancy, * incompatibility with monitoring, * irregular management of diabetes, * hearing loss and low vision, * preventing them from using the devices

Keywords: type 1 diabetes hypoglycemia unawareness insulin pump continuous glucose monitoring systems low glucose suspend
sarcopenic obesity in neurodisabilities

Conditions: Sarcopenic Obesity; Spinal Cord Injuries; Stroke; Multiple Sclerosis; Traumatic Brain Injury

Summary: to describe the frequency and thresholds for sarcopenic obesity in neurodisabled persons and the fat and lean mass distribution based on various neurodisabilities


Eligibility criteria:
inclusion criteria: persons with * stroke / cerebrovascular disease * traumatic brain injury * multiple sclerosis * spinal cord injuries (including spinal cord lesions i.e. myelopathies etc.) exclusion criteria: persons with * heterotopic ossifications, * chronic administration of drugs, which promote fat increase * chronic administration of drugs, which promote bone or muscle loss * co-existing other diseases such as: endocrinopathies, muscular dystrophies, non-alcoholic fatty liver disease.

Keywords: sarcopenia sarcopenic obesity stroke sci tbi ms
sr34006 compared to placebo in patients who have completed 6 months of treatment for symptomatic pulmonary embolism or deep vein thrombosis

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Summary: patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur. in this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin k antagonists (acenocoumarol or warfarin) or once-weekly injections of sr34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly sr34006 injections or injections of a solution containing no drug (placebo). this trial will evaluate whether patients treated for an additional 6 months with sr34006 have fewer recurrences of blood clots when compared to patients treated with placebo. assignment to either sr34006 or placebo will be purely by chance. neither the patients nor their doctors will know which treatment is being given.


Eligibility criteria:
inclusion criteria: * patients with confirmed symptomatic pulmonary embolism (pe) or deep vein thrombosis (dvt) who have been treated with acenocoumarol, warfarin or sr34006 for six months * written informed consent exclusion criteria: * legal age limitations (country specific) * indication for anticoagulation other than pe or dvt * creatinine clearance (clcr) \<10 ml/min, severe hepatic disease, or bacterial endocarditis * participation in a pharmacotherapeutic study other than the van gogh-pe or dvt study within the prior 30 days * life expectancy \<3 months * patients in whom anticoagulation treatment for their index pe or dvt should be continued beyond 6 months * active bleeding or high risk for bleeding * uncontrolled hypertension: systolic blood pressure \>180 mm hg or diastolic blood pressure \> 110 mm hg * pregnancy, or childbearing potential without proper contraceptive measures, women who are breastfeeding.
inspiratory and expiratory muscle training in adolescent volleyball players

Conditions: Adolescent Development

Summary: this study will investigate the effects of inspiratory and expiratory muscle training on respiratory muscle strength, pulmonary function, and performance status in adolescent athletes

in the literature, it has been shown in a limited number of studies that respiratory muscle training in sports such as football, cycling, swimming, and rugby reduces athletes' perceived exertion levels. however, the effects of inspiratory and expiratory muscle training on respiratory muscle strength, pulmonary function, and performance status in adolescent athletes are still unclear. therefore, this study has been planned.

Eligibility criteria:
inclusion criteria: * athletes aged 12-18 who train at a submaximal level at least 3 days a week exclusion criteria: * adolescents with any history of chronic lung disease * unable to comply with the test and training * unwilling to participate in the study

Keywords: pulmonary functions muscle training adolescent health volleyball players
phase iii study to evaluate alirocumab in patients with hypercholesterolemia not treated with a statin (odyssey choice ii)

Conditions: Hypercholesterolemia

Summary: primary objective: to demonstrate the reduction of low-density lipoprotein cholesterol (ldl-c) by a regimen of alirocumab including a starting dose of 150 mg every 4 weeks (q4w) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin. secondary objective: * to evaluate the effects on other lipid parameters of alirocumab 150 mg q4w versus placebo. * to evaluate the safety and tolerability of alirocumab 150 mg q4w. alirocumab 75 mg q2w was added as a calibrator arm.

the core study duration was approximately 35 weeks per participant (screening: 3 weeks, double-blind treatment period: 24 weeks; follow-up: 8 weeks). participants who successfully completed the treatment period had the possibility to participate in an optional open-label treatment period with alirocumab 150 mg q4w until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first.

Eligibility criteria:
inclusion criteria: participants with primary hypercholesterolemia (heterozygous familial hypercholesterolemia \[hefh\] or non-fh) not adequately controlled with their non-statin lmt (either ezetimibe or fenofibrate) or diet alone. exclusion criteria: * ldl-c \<70 mg/dl (1.81 mmol/l) at screening for statin intolerant participants at very high cardiovascular (cv) risk; * ldl-c \<100 mg/dl (\<2.59 mmol/l) at screening for statin intolerant participants at high or moderate cv risk or, participants not fulfilling the statin intolerant definition at moderate cv risk; * ldl-c ≥160 mg/dl (≥4.1 mmol/l) at screening for participants receiving diet only or, participants not fulfilling the statin intolerant definition at moderate cv risk and receiving a non-statin lmt. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
investigate efficacy, safety, and pharmacokinetics of enzastaurin for the prevention of arterial events in patients with vascular ehlers-danlos syndrome.

Conditions: Vascular Ehlers-Danlos Syndrome

Summary: the purpose of this study is to investigate the efficacy of enzastaurin compared to placebo in preventing arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to intervention or mortality attributable to an arterial event in patients with veds confirmed with pathogenic heterozygous col3a1 gene mutations predicted to derive a mutant protein.

the primary efficacy endpoint of this study will be defined as the time to intervention for an arterial event (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) or mortality attributable to an arterial event, as adjudicated by an event committee, and will be analyzed for difference of active vs. placebo treatments on top of background standard of care, using survival statistical analysis. furthermore, secondary endpoints will include the rate of intestinal rupture, pneumothorax, and retinal detachment, as adjudicated by an event committee, safety and tolerability, as well as hospitalizations and health related quality of life (hqrl) measures.

Eligibility criteria:
inclusion criteria: 1. subjects aged 18 - 60 years old at time of initial screening. 2. adolescent subjects aged 12 - 17 years old, may be considered to enroll later in the clinical trial pending interim analysis. 3. diagnosis for veds (vascular ehlers danlos syndrome), with a confirmed and documented col3a1 genetic variant. 4. subject should be stable, having no veds-related vascular events within the past 3 months prior to enrollment. 5. confirmed use of contraception for both male and female participants. exclusion criteria: 1. inability to swallow or receive intact tablets. 2. currently being treated with cyp3a4 inhibitors within 4 weeks prior to enrollment. 3. known allergy or hypersensitivity to enzastaurin. 4. patient currently pregnant or breast feeding. other criteria will be reviewed at the first study visit to determine if you are able to participate in the study.
coronary ct angiography using 320-row volume ct in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the primary objective of this study is to analyze the diagnostic accuracy of coronary ct angiography using 320 simultaneous detector results in patients with atrial fibrillation.


Eligibility criteria:
inclusion criteria: * suspected coronary artery disease based on clinical findings or findings on other noninvasive imaging tests and planned coronary angiography within the next 14 days. * able to understand and willing to sign the informed cf. exclusion criteria: * creatinine of above 2.0 mg/dl * age below 50 years * women of child bearing potential (no hysterectomy, no menopause, or menopause since less than 12 months) must demonstrate a negative pregnancy test performed within 24 hours before ct. * inability to hold the breath for 10 seconds

Keywords: patients with atrial fibrillation
at-home exercise study for veterans with healed diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: foot ulcers and amputations are a common and feared complication for people with diabetes. people with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. at least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. the reasons for this increased mortality involve decreased mobility. people with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems which led to their ulcer are still present. once in remission, the current standard of care is to slowly increase ambulation. the problem is that people rarely return to the recommended level of mobility. the ability to safely maintain mobility with aging is critical. this pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. the investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control.

population: 25 veterans with a healed foot ulcer in the last 3-15 months site: va maryland health care system (vamhcs) study duration: approximately 2 years study design: randomized, outcome assessor blinded, clinical trial comparing a) a 12-week home-based exercise regimen to b) standard of care objectives: primary: to assess the feasibility and acceptability of the intervention. secondary: * the effect of the intervention on gait speed, * the effect of the intervention on other measures of mobility and function including six-minute walk distance, the modified physical performance test, steps per day and community mobility, and * the effect of the intervention on lower extremity strength, perfusion of the foot and glycemic control. treatment regimens: 12-week home-based exercise regimen to standard of care duration of participant's participation: up to 16 weeks

Eligibility criteria:
inclusion criteria: * adults \>= 50 years * diagnosis of diabetes * plantar foot ulcer which healed within the last 3-27 months * two feet (can have healed minor amputations of fore and midfoot) * willing to wear appropriately fitted footwear for exercise regimen * ambulatory without walker * willing to enroll in the podimetrics smartmat program * able to give written informed consent exclusion criteria: * unable to perform the exercise interventions (e.g. due to hearing or visual impairment) * anticipated foot surgery in the next 4 months * participating in another exercise program * current plantar foot ulcer or pre-ulcer * any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate safely

Keywords: clinical trial mobility diabetic foot ulcer
renal hypodysplasia : genetic and familial assessment

Conditions: Renal HYPODYSPLASIA, Nonsyndromic, 1

Summary: evaluation of the frequency of familial cases of renal hypodysplasia

dna collection from the propositus and its family. a questionnaire will be filled by the parents to seek other affected individual in the family.with another affected member, dna collection will be collected from the whole family. a renal ultrasound will be prescribed for the parents, brothers and sisters.

Eligibility criteria:
inclusion criteria : - children aged more than 3 months and less than 18 years old with a renal bilateral hypodysplasia set by renal ultrasound examination : * renal size \< -2ds * with/or hyperechogenicity or lack of cortical-medullary differentiation * with/or renal cysts exclusion criteria : * bladder uropathy or sus-bladder uropathy * recessive or dominant renal polycystic disease * bardet-biedl syndrome and other malformative syndromes except renal coloboma syndrome, renal cysts and diabetes syndrome rcad * lack of written informed consent
a phase iii study of covid-19 vaccine eucorvac-19 in healthy adults

Conditions: COVID-19

Summary: this is a phase iii, randomized, observer-blind, active-controlled, parallel group, multi-center study to compare the immunogenicity and safety of a preventive covid-19 vaccine eucorvac-19 to chadox1 in healthy adults aged 18 years and older


Eligibility criteria:
inclusion criteria: * individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent * female of childbearing potential who agree to use medically allowed methods of contraception during the study period * individuals who agrees not to perform blood donation and transfusion during the study period exclusion criteria: * individual being considered to be confirmed covid-19 * direct contact with covid-19 infected person within 14 days prior to the 1st dose of the ip * individuals at high risk of exposure to sars-cov-2 * individuals with clinically significant abnormalities in clinical laboratory tests, ecgs, and chest x-ray during screening * individuals with fever within 72 hours prior to the 1st dose of the ip or suspected other infectious disease or symptoms associated with other infectious disease * individuals with serious medical or psychiatric disease * history of sars-cov or mers-cov infection * history of allergic reaction or hypersensitivity reactions to any of components of the ip * history of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination * history of receiving organ or bone marrow transplant * suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination * history of vaccination against sars-cov, mers-cov, or sars-cov-2 * history of vaccination with test vaccine substance * treatment with immunosuppressants or immune modifying drugs * history of treatment with antipsychotics or opioid dependence * pregnant or lactating women * other reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator