cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease

EFFECTIVENESS OF COMBINED ANTICOAGULATION AND ANTITHROMBOTIC THERAPY VS ANTITHROMBOTIC THERAPY ALONE AFTER LOWER EXTREMITY REVASCULARIZATION FOR PERIPHERAL ARTERIAL DISEASE.

Anticoagulation and antithrombotic therapy is a crucial part of PAD management as it prolongs the patecy of grafts in open surgical revascularization procedures so its proper dosage and duration without increasing risks to the patient and maximizing the benefits is very important.

Currently literature in Pakistan regarding this problem couldn't be found so this study would help assessing the outcomes of anticoagulation and antithrombotic therapy in this population with respect to treatment options available and presentation variability of the peripheral arterial disease. Patients with PAD would be enrolled for 6 months and would be followed upto 12 months and then upto 24 months.

Eligible subjects will be randomized 1:1 to receive either rivaroxaban 5 mg twice daily plus aspirin 75 mg once daily or rivaroxaban-matching placebo twice daily plus aspirin 75 mg once daily stratified by type of procedure; the treatment assignment will be double-blinded. Randomization and study treatment will begin as soon as possible but no later than 10 days after a successfull lower extremity revascularization.

Patients will be prohibited from taking any additional antithrombotic therapy other drugs, including anticoagulants, doses of aspirin \>100 mg daily, vorapaxar, ticagrelor, prasugrel, or cilostazol. Enrolled subjects will be having symptomatic PAD defined by evidence of an abnormal ankle-brachial index ≤0.80 in either limb with an anatomy of occlusive disease of involving segments. Subjects would be randomized who had undergone a technically successful endovascular, hybrid, or surgical LER within 10 days and had achieved adequate hemostasis before randomization.

Eligibility Criteria:
Inclusion Criteria:

- all patients with PAD candidates for revascularization procedures

Exclusion Criteria:

1. planned long-term dual antiplatelet therapy (\>6 months),
2. clinical requirement for therapeutic anticoagulation,
3. recent acute limb ischemia or acute coronary syndrome,
4. medical condition that could increase the risk of major bleeding, significantly impaired renal function at baseline (estimated glomerular filtration rate \<15 mL•min-1•1.73 m-2),
5. any documented history of intracranial hemorrhage, stroke, or transient ischemic attack
Therapeutic Stockings to Prevent Foot Ulcers

1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.
2. To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.

We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 years old or older
* Diagnosis of Diabetes Mellitus\*
* History of diabetes related foot ulceration

Spanish-speaking subjects will be eligible to participate.

Exclusion Criteria:

* Active Charcot Arthropathy
* Gangrene, active infection
* Midfoot or higher level amputation
* Alcohol or substance abuse within 6 months
* Unreliable, unwilling or unable to comprehend informed consent
Neuromuscular Responses to Acute Beetroot Ingestion in Women Older Adults

Beetroot juice supplementation has shown the capacity for provoking different physiological effects (e.g. vasodilation and muscle contraction increments). However, the effects of beetroot juice ingestion on neuromuscular performance in women older adults are barely studied. In this randomized placebo-controlled study, we investigated the effects of beetroot acute supplementation in improving neuromuscular performance in women older adults

Beetroot juice supplementation has shown the capacity for provoking different physiological effects that could affect human performance (e.g. vasodilation and muscle contraction increments). Although this dietary supplement has been commonly used for improving sports performance in recreational or professional athletes, the scientific literature in older adults is scarce. Thus, in our knowledge, no previous studies have analyzed the side effects associated to ingestion in this population group. In this randomized placebo-controlled study, we investigated the effects of beetroot acute supplementation in improving neuromuscular performance and side effects associated with ingestion in women older adults.

Eligibility Criteria:
Inclusion Criteria:

* Women \>65 or \<85 years of age.
* In good health, as determined by the investigator's review of history.

Exclusion Criteria: (based in previous studies on this topic (doi: 10.1093/gerona/glaa311).

Men and women \<65 or \>85 years of age Unable to provide informed consent Current smokers Significant orthopedic limitations or other contraindications to strenuous exercise Those taking proton pump inhibitors, antacids, xanthine oxidase inhibitors, or on hormone replacement therapy Those taking anti-coagulants or on anti-platelet therapy History of neuromuscular disease (e.g., cervical spondylotic radiculomyelpathy, lumbar spondylosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and acquired demyelinating polyneuropathies) Cardiovascular disease (e.g., \> stage I hypertension, heart failure, myocardial infarction/ischemia significant myocardial or pericardial diseases (e.g. amyloidosis, constriction), Moderate or severe valvular disease, renal disease, liver disease, or anemia
Meal Distribution Across the Day in Female Nurses Working Shifts

This study assessed the meal distribution across the day (energy and macronutrient intake) and its relationship to the nutritional status of nursing professionals.

221 female nursing professionals from Brazilian University hospital were classified in three shifts: day shift (n=112), night shift (n=55), and day-night shift (n=54).

Food intake assessment (3-day 24-hour recall); Anthropometric variables (weight, height, waist circumference and hip circumference); Sleep time on working days and day off.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were regularly employed by the hospital, with 36-hours per week scheduke, not counting additional shifts and overtime work.

Exclusion Criteria:

* Volunteers who did not supply the necessary information for the development of the research and who were pregnant or lactating.
Healthy At Home Pilot

The objective is to conduct a pilot-feasibility trial of the "Healthy at Home" program, a multimodal intervention aimed at preventing acute care needs among COPD patients. The program will feature a digital platform and virtual pulmonary rehabilitation to facilitate complex care management of UMass Memorial Health Patients

The Healthy at Home project is a pilot program aimed at improving care for patients who have COPD. This pilot aims to establish how self-management using a digital application, mobile health services, and support from a wellness coach can help achieve this goal. Participation in this study involves participants downloading a smartphone app, answering questionnaires, and wearing a Fitbit everyday, including during sleep throughout the 6-month study period. The investigators will ask that participants share their medical records and healthcare visit information through the secure study app, to help better understand how to treat patients with chronic health conditions. Participants will additionally have the option to enroll in Wellinks, a program that helps patients manage their breathing and COPD symptoms and provides patients with at-home medical equipment, one-on-one personalized virtual support from specially trained clinicians and coaches, and a separate easy-to-use app for tracking and communication.

Eligibility Criteria:
Inclusion Criteria:

* Receives healthcare through UMass Memorial Health
* Is at least 18 years old
* Has a self-reported or EMR observed diagnosis of COPD
* Has access to a smartphone (iPhone or Android) to download and use the study app(s)
* Lives within the geographic area served by the Mobile Integrated Health program

Exclusion Criteria:

* Lacks capacity to consent
* Does not understand English
* Does not have internet access on their smartphone at home
* Are currently enrolled in another investigational clinical trial
* Are or have previously been enrolled in any Wellinks program
Effect of Surgical Approach on Postoperative Bleeding in Patien Arthroplasty

The study is, in accordance with current legislation, definable as monocentric Prospective Observational.

The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.

adult patients who will undergo surgery of hip arthroplasty.

Patients will undergo:

Preoperative T0: clinical visit/medical history, completion of the VAS questionnaire, Blood sampling to assess hemoglobin values Operative T1: hip arthroplasty surgery using one of the surgical approaches routinely used within our Institute T2 - Postoperative at 1 day from T1: VAS questionnaire, evaluation of any Adverse events T3 - Postoperative at 3 days from T1: blood loss based on the values of hemoglobin (Hb), assessment of any adverse events, and VAS questionnaire T4- Post operative at 45 days +/- 10 days from T1: evaluation of any events adverse, follow-up visit.

The presence of bleeding and pain after prosthesis surgery Hip injuries can affect the patient's condition in the postoperative period increasing the length of hospital stay and slowing down the rehabilitation process.

It is hypothesized that there are differences in terms of postoperative bleeding, Postoperative pain and hospital stay time between different approaches surgical procedures in the treatment of hip osteoarthritis with arthroprosthesis. The adoption of a Surgical approach that can reduce bleeding and pain could reduce the length of hospital stay in patients undergoing hip arthroplasty.

The primary outcome will be blood loss calculated on the basis of hemoglobin (Hb) on the third postoperative day.

Secondary objectives are postoperative pain assessment with questionnaire VAS and length of hospital stay according to surgical approach used (anterior Vs. posterolateral route). Also evaluate Any adverse events.

Adult patients who will undergo surgery of hip arthroplasty.

The inclusion criteria are:

* adult patients with coxarthrosis who are candidates for surgery hip arthroplasty
* Signing of the Informed Consent and consent to collaborate in all study procedures.

The exclusion criteria are:

* Minors
* Pregnant women (self-declaration)
* patients with BMI ≥ 30
* Non-acceptance of informed consent
* Patients with prior unilateral hip reconstructive surgery or Contralateral

Eligibility Criteria:
Inclusion Criteria:

* adult patients with coxarthrosis who are candidates for surgery hip arthroplasty
* Signing of the Informed Consent and consent to collaborate in all study procedures.

Exclusion Criteria:

* Minors
* Pregnant women (self-declaration)
* patients with BMI ≥ 30
* Non-acceptance of informed consent
* Patients with prior unilateral hip reconstructive surgery or Contralateral
A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
* Moderate to severe RA with a DAS28-ESR score \>3.2 points
* Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
* Oral corticosteroids (less than or equal to \[\</=\] 10 mg per day prednisolone or equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable dose regimen for greater than or equal to \[\>/=\] 4 weeks prior to baseline
* Permitted non-biologic DMARDs allowed if at stable dose for \>/=4 weeks prior to baseline
* Receiving treatment on an outpatient basis, not including tocilizumab
* Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
* Rheumatic autoimmune disease other than RA
* Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
* Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
* Prior history of or current inflammatory joint disease other than RA
* Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
* Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Evidence of serious concomitant disease or disorder
* Known active current or history of recurrent infection
* Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
* Active tuberculosis requiring treatment within the previous 3 years
* Positive for hepatitis B or hepatitis C
* History of or current active primary or secondary immunodeficiency
* Pregnant or lactating women
* Neuropathies or other conditions that might interfere with pain evaluation
* Inadequate hematologic, renal, or liver function
Examination of Cardiovascular Function/ Cardio Respiratory Interaction on Spontaneous Breathing Trials in Patients in the Prolonged Weaning

The aim of the present study is to determine the cardiovascular function/ cardio respiratory interaction on spontaneous breathing trials in patients with prolonged weaning.


Eligibility Criteria:
Inclusion Criteria:

* legal Age (≥18 years)
* written informed consent Prior to study participation
* patient in prolonged weaning with NYHA I-II and an actual positive Ventilator Screening test:

  1. PaO2 ≥ 60 mmHg at FiO2 ≤ 0.4
  2. PEEP ≤ 8 cmH2O
  3. Glasgow Coma Scale \> 13
  4. Temp. \< 38°C
  5. Hb \> 80-100 g/L
  6. less requirement on catecholamines (\<0.1µg/kg/min)
* and on these patients are already performed a spontaneous breathing trial with following result:

  1. abortion this spontaneous breathing trial \< 30min, but possible \> 10min
  2. reason for an abortion was NOT hypercapnia

Exclusion Criteria:

* weaning patients are assigned on Group 1-2
* patient with heart failure (NYHA III-IV) and/ or other cardiac comorbidity
* acute NSTEMI (non-ST-segment elevation myocardial infarction)
* pregnancy and breast-feeding
Managing of Missed Meal Bolus by HCL Systems

The goal of this interventional study is to compare glycemic outcomes after missed meal bolus in children and adolescents with type 1 diabetes (CwD) treated by one of the three most common used types of hybrid closed loop (HCL) systems - Medtronic MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS. The main questions it aims to answer are:

* Do the glycemic outcomes (area under the curve of glucose concentration change, maximal glucose rise from baseline, time to maximal glucose rise from baseline, CGM parameters) vary after missed meal bolus among different types of HCL systems?
* Does the type of insulin analog influence glycemic outcomes after a missed meal bolus?

Participants will have a precisely defined amount of enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast during eight different days under predetermined conditions. They will administer premeal bolus only for half of these meals.


Eligibility Criteria:
Inclusion Criteria:

* children with type 1 diabetes (CwD) 9.00-18.99 years old
* use of continuous glucose monitoring (CGM) \>70% of the time 14 days before a regular check-up in the outpatient clinic
* HCL use (MiniMed 780G, Tandem Control-IQ or Ypsomed CamAPS) \>3 months
* duration of T1D \>2 years
* baseline HbA1c level \<58 mmol/mol (7.5%)
* weight \> 30 kilograms
* without any medication influencing glycemia (f.e. gliflozins, systemic corticosteroids...)
* signed informed consent form with the study
Tapse/Pasp General Anesthesia

TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

Patients will be measured by transthoracic echocardiography in the preoperative period, 15-30 minutes before induction.

Basal hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until surgical incision.Patients with a 30% decrease in SBP from the baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. Patients will be divided into 2 groups: 'with' and 'without' hypotension.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent;
2. 18-75 years old
3. ASA Physical Status 1-3;
4. Patients planned for surgery

Exclusion Criteria:

1. The patient is pregnant
2. After cardiac surgery
3. Severe pulmonary hypertension
4. Severe valve disease
5. Hypertrophic or dilated cardiomyopathy
6. Presence of acute myocardial infarction
7. Patients with severe visual or hearing impairment/disability
8. ASA physical status IV or V
9. Ischemic heart disease, conduction disorder.
Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma

RATIONALE: Studying samples of bone marrow and blood from patients with cancer may help doctors find out the extent of disease.

PURPOSE: This research study is collecting bone marrow and blood samples from patients with metastatic choroid melanoma.

OBJECTIVES:

Primary

* Develop and validate a method of detecting tumor cells in the bone marrow and blood in patients with metastatic choroid melanoma.

OUTLINE: While patients are under general anesthesia for standard treatment of their disease, samples of bone marrow from the iliac crest and blood are collected. Samples are analyzed for the expression of tyrosinase and Melan-a via RT-PCR.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Choroid melanoma

  * Metastatic disease
* Planning to undergo general anesthesia

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* No contraindications to the collection of a bone marrow sample
* No patient deprived of liberty or under trusteeship (including guardianship)
* No social or psychological situations that preclude the ability to give consent

PRIOR CONCURRENT THERAPY:

* Not specified
Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke

Assessment of Therapeutic benefits and hazards of Mechanical Thrombectomy in Ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.

Stroke is an acute neurologic dysfunction of vascular origin with sudden or at least rapid occurrence of symptoms and signs corresponding to the involvement of focal areas in the brain.The two main types of stroke are ischemic and hemorrhagic.Thrombosis can form in the extracranial and intracranial arteries when the intima is roughened and plaque forms along the injured vessel.The endothelial injury permits platelets to adhere and aggregate, then coagulation is activated and thrombus develops at site of plaque.Blood flow through the extracranial and intracranial systems decreases, and the collateral circulation maintains function. When the compensatory mechanism of collateral circulation fails, perfusion is compromised, leading to decreased perfusion and cell death. Stroke is the third leading cause of death in the United States. Many people die each year from stroke in the United States.Stroke is the leading cause of serious, long-term disability in the United States. Nearly one fourth of strokes occur in people under the age of 65.High blood pressure is the most important risk factor for stroke. Intravenous recombinant tissue-type plasminogen activator is the only Food and Drug Administration approved treatment for acute ischemic stroke. Mechanical thrombectomy improves clinical outcomes in patients with acute ischemic stroke caused by a large vessel occlusion.There is no apparent benefit of intravenous thrombolysis to patients with ischemic stroke undergoing mechanical thrombectomy. The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 - 80 years old of both sex.
2. Acute ischemic stroke due to proved large-artery occlusion.
3. Ineligibility for IV thrombolysis.
4. A timeframe of ≤ 4.5 hours between stroke onset and the start of mechanical thrombectomy.
5. The patients included in this series should have an NIHSS score of at least 10 or fluctuating symptoms.
6. ASPECTS of 6 or \> 6
7. All patients will be undergoing CT/CT angiography before and after treatment

Exclusion Criteria:

1. Age older than 80 years or less than 18
2. Cerebral haemorrhage.
3. Acute infarction \> 1/3 of middle cerebral artery (MCA) territory on CT-scan.
4. A history of stroke in the last 6 weeks.
5. A time interval of \> 4.5 hours.
6. laboratory evidence of coagulation abnormalities.
7. Known arteriovenous malformation , neoplasm or aneurysm.
8. Woman at child bearing age who has a positive pregnancy test