cyrilzakka/clinical-trials huggingface dataset:
Developing and Testing Delicious and Nutritious for the Old People

Meals-on wheels may play a major role in contributing to better nourishment and quality of life in older people, thus delaying costly hospitalisation. Still, dwelling, old adults who receive meals-on-wheels are a population at risk of undernutrition leading to a decreased quality of life.

Hypothesis Offering nutritious ELDORADO meals as meals-on-wheels to nursing home residents in 3 months is an effective way to increase quality of life.

Aim To improve quality of life and functional abilities in nursing home residents by offering nutritious ELDORADO meals.

Intervention The intervention group (n=50) will receive an optimized menu (in both sensory and nutritious aspects) for 12 weeks. In cooperation with the Copenhagen house of food and sensory staff, 19 main meals and 12 between-meals have been optimized based on nursing home residents' evaluations of sensory aspects. On a daily basis the menu will consist of 1 optimized main meal and 1 optimized between-meal, served for dinner. There will be no selective choice for the elderly. If a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen.

Control In comparison, the control group (n=50) will receive the same menu as the intervention group, however, the meals are not optimized on sensory and nutritious aspects. On a daily basis this menu also includes 1 main meal and 1 between-meal in 12 weeks. If a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen.

Eligibility Criteria:
Inclusion Criteria:

* Living at Skovhuset, nursing home in Hillerød municipality, Denmark.
* Collecting the "energy-dense diet" "ældrekost" with 40 % fat, with a main meal and a dessert/starter.
* Able to understand and follow instructions for the procedures of the study.
* Above 65 years.

Exclusion Criteria:

* Have chewing or swallowing difficulties.
* Have acute disease or acute change in chronic disease.
* Living after special nutritional standards e.g. vegetarian, have any food allergies, or if a participant is excluding common foods from their diet because of other reasons.
* Not able or willing to give informed consent.
Effect of Daily Stair Walking on Cardiovascular Health

Many adults find it difficult to perform physical exercise during leisure. The workplace may provide an optimal setting to encourage a healthier lifestyle. This study investigates the effect of daily stair walking at the workplace on cardiovascular health.

The main hypothesis is that daily stair walking for 10 weeks compared with a control group results in increased aerobic fitness.


Eligibility Criteria:
Inclusion Criteria:

* office worker

Exclusion Criteria:

* life threatening disease
* pregnancy
The Impact of Oncoplastic Breast Surgery on the Oncological Safety and Patient Satisfaction

The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques.

This non randomized prospective trial was conducted on 70 female patients presented to our tertiary referral breast unit -Ain Shams University hospitals with non metastatic breast cancer during the period from September 2012 to September 2013. All of them signed an informed consent to share in this study that was approved in the ethical committee held on April 2012 - Ain Shams University. Our patients were divided into 2 equal groups: group A (35patients) who underwent standard quadrantectomy, group B (35 patients) who underwent oncoplastic surgery. In group A all quadrantectomies were done by general breast surgeons while in group B the oncoplastic procedures were done by well trained oncoplastic breast surgeons not assisted by plastic surgeons. The following data were reported in all cases including: age, family history, tumor size, volume and weight of the specimen, location of tumor, margin length, (primary tumor, regional nodes, metastasis) staging, molecular subtype and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Stage 1, 2 breast cancer
* Non metastatic breast caner
* Singing informed consent

Exclusion Criteria:

* Metastatic breast cancer
* Stage 3, 4 breast cancer
* Inflammatory breast cancer
* Multicentric/multifocal disease
* Ductal carcinoma in situ
* Patients older than 60 years
* History of breast surgery in oncoplastic group
* Co-morbidity in oncoplastic group
* Patients more than 60 years old
Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates

Primary Aim: The aim of this study is to investigate the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (NEC) and sepsis in very low birth weight (VLBW) infants.

Secondary Aim: To improve outcomes of neonatal sepsis and NEC in the pe-terrms and to decrease their hospital stay.

Necrotizing enterocolitis (NEC) primarily occurs in premature and very low birth weight (VLBW) babies, the incidence varying from 5 to 10% in various neonatal intensive care unit (NICUs) .

Many researchers believe that an exaggerated inflammatory response mounted by immature intestinal epithelial cells in response to abnormal intestinal colonization plays a vital role in the pathogenesis of NEC and bacteria belonging to Enterobacteriaceae have often been linked to NEC .

Colonization with commensal bacteria soon after birth is essential for the development of normal intestinal function however, this process is often altered in premature babies in NICUs, leading to colonization with pathogenic bacteria .

Commercially available bovine colostrum has high concentrations of anti-infective factors such as immunoglobulins, lactoferrin, organism-specific antibodies, lactoperoxidase, insulin-like growth factors and transforming growth factors.

These components have substantial homology to their human counterparts . Bovine colostrums has been tried in the treatment of Escherichia coli and Shigella and Rotavirus diarrhea in children, Helicobacter pylori infection in children and E. coli intestinal infection in term and preterm neonates.

No major adverse effects were reported in any of the studies using bovine colostrum in infants and preterm babies .

In an in vitro study, the authors showed that bovine colostrum significantly reduces the adherence of various Enterobacteriaceae species known to be associated with NEC to human intestinal epithelial cells .

A randomized controlled trial has shown that the use of bovine lactoferrin reduced the incidence of neonatal sepsis .

Till date, there are no studies in neonates on the use of bovine colostrum for the prevention of NEC.

Eligibility Criteria:
Inclusion Criteria:

* Babies with birth weight ≤ 1500 g

Exclusion Criteria:

* Babies who have any contraindication for initiating milk feeds; who will fail to achieve adequate feed volume to be able to administer the study drug.
* Those with suspected/ proven gastrointestinal malformations.
* Preexisting sepsis (definite or suspect) or NEC at the time of enrollment.
* Those with a family history of an inborn error metabolism (that precludes exposure to proteins/lactose).
Platelet Reactivity And Clinical ThrombotIC Events Study

Platelet function testing has been considered for DAPT strategy adjustments to reduce the patient's risk of ischemia and bleeding. Although several previous RCT studies did not find any benefit in the detection of platelet function， the previous studies were mostly low-risk populations, and the P2Y12 receptor antagonists were simply clopidogrel, and the detection methods were relatively simple. Therefore, the need for platelet monitoring in high-risk ACS patients receiving new potent P2Y12 inhibitor ticagrelor, as well as the diagnostic threshold for different platelet function assays needs further study. In addition, due to the differences on the response to anti-platelet drugs between the East and the West, it is not appropriate to simply refer to the conclusion of the other party. However, as of now, there is no large sample randomized controlled study systematically focused on the applicability and status of platelet function tests in East Asian populations, especially Chinese populations.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years old;
2. There was a history of at least one acute coronary syndrome (ACS) attack within 14 days before enrollment, including unstable angina, non-ST elevation myocardial infarction, or ST-elevation myocardial infarction;
3. Being treated with aspirin and a P2Y12 inhibitor (clopidogrel or ticagrelor);
4. Plan to apply dual antiplatelet drugs (DAPT, aspirin + P2Y12 inhibitor) for at least 12 months;
5. Voluntary signature of informed consent

Exclusion Criteria:

1. In combination with other anti-platelet drugs, such as cilostazol;
2. Have received glycoprotein IIb/IIIa inhibitor within 72 hours before enrollment;
3. receving a P2Y12 inhibitor loading does less than 72h or maintenance (unloaded) less than 5d;
4. Plan to perform any coronary revascularization within 30 days;
5. The need for oral anticoagulants (warfarin, factor II or factor X inhibitors);
6. Predicted survival time \<12 months for patients with known severe progressive disease (such as malignancy) or extreme depletion of the disease;
7. pregnant women or pregnant people;
8. Any situation that may interfere with the research process, such as dementia, delirium, alcoholism, etc.;
9. expected to undergo surgery within 1 year;
10. Patients participating in other ongoing clinical studies
Translational and Clinical Aspects of Metabolic, Anabolic and Endothelial Dysfunction in Heart Failure

In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion

In patients with HF cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion (single dose).

The following parameters will be collected: routine clinical parameters, endothelial function, cardiac structure and function by echocardiography, non-invasively assessed cardiac output and hemodynamics, serologic and of cardiac and renal function, sympathetic and RAS activation, metabolism, anabolic hormone function, inflammation, fibrosis, oxidative stress and apoptosis.

15 patients each group in are adequate to detect a difference between groups and before vs after ghrelin administration in metabolism, anabolic function and endothelial function with a power of 90% and two-sided significance of 5%.

Eligibility Criteria:
Inclusion Criteria:

1. Current or past signs of clinical HF according to the Framingham criteria
2. LVEF\<40%
3. NT-proBNP \> 300 ng/L

Exclusion Criteria:

1. Inability to or unwillingness to provide informed consent,
2. Participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.
Humoral Immunity Study After a Booster Dose of Soberana Plus (FINLAY-FR-1A) Vaccine Against COVID-19

To evaluate the dynamics of IgG levels to the SARS-CoV-2 virus after a booster dose of Soberana Plus vaccine.

Prospective clinical study of evaluation of the immune response to booster dose of vaccine against COVID-19 using enzyme immunoassay using the Sunrise Tecan microplate photometer (Austria). The material is participants' plasma, obtained by the standard method. Blood sampling performed 4 times: immediately before the first dose of vaccine, on day 42, 90 days and 180 days after booster dose of vaccine. Booster dose of vaccine against coronavirus infection performing using approved and licensed vaccine Soberana Plus (Republic of Cuba). Venous blood sampling performing standardly. All study participants are informed about the study objectives and upcoming procedures, and all of them given informed written consent to participate the study.

A reagent kit manufactured by Vector-Best (Russian Federation) and designed for enzyme immunoassay for quantitative detection of SARS-CoV-2 class G immunoglobulins, SARS-CoV-2-IgG quantitative ELISA-BEST, D-5505 SARS-CoV-2-IgG (series 5, 6) РУ № РЗН 2022/17065Т used for immunoassay. The "SARS-CoV-2-IgG quantitative ELISA-BEST" reagent kit design uses recombinant full-length trimerized S glycoprotein (Spike) of the SARS-CoV-2 virus derived from a eukaryotic expression system. The protein molecule+ consists of two subunits, S1 containing the RBD domain and S2. The reagent kit "SARS-CoV-2-IgG quantitative ELISA-BEST" detects the pool of immunoglobulin class G synthesized to all antigenic determinants of protein S including the RBD-domain.

The quantification of the SARS-CoV-2 antibody assay is based on the WHO First International Standard (NIBSC code:20/136) and expressed in international units (BAU/ml).

Analytical characteristics of reagent kit "SARS-CoV-2-IgG quantitative ELISA-BEST (series 5, 6)" were: Linearity - within 90-110%, considering the analytical results at wavelengths 405 nm and 415 nm - within the concentration range IgG к SARS-CoV-2 10-5000 BAU/ml; Reproducibility: the coefficient of variation does not exceed 8%). The "opening" test - within 90-110% (samples with absorbances lower than 90% of the cut-off value are considered negative and samples with absorbances higher than 110% of the cut-off value are considered positive. The samples with absorbance in the range of 90-110% of cut-off value are equivocal). Analytical sensitivity - minimal detectable concentration of IgG to SARS-CoV-2 does not exceed 1.0 BAU/ml.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 y.o.;
2. More that 4 months after the previous vaccination against COVID-19;
3. No COVID-19 infection registered within 30 days prior to Soberana Plus administration.

Exclusion Criteria:

1. Age less than 18 y.o. or more than 80 y.o.;
2. Less than 4 months after the previous vaccination against COVID-19;
3. COVID-19 infection registered within 30 days prior to Soberana Plus administration.
The Effectiveness of Integrated Interactive Digital Health Application and Telemonitoring in Patients with Heart Failure and Reduced Ejection Fraction

Patient Source: Patients discharged from the cardiology ward with heart failure.

Intervention Group: Prior to discharge, patients will be provided with and instructed on how to use the "Intelligent Interactive Personal Management System for Heart Failure" as well as a "Bluetooth-enabled blood pressure monitor and scale for remote data transmission."

Control Group: Patients will receive standard medical care.

Assessment Method: The Health-Related Quality of Life Questionnaire (EQ-5D), Kansas City Cardiomyopathy Questionnaire (KCCQ-12), and Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) will be completed before discharge, and at 1 month, 6 months, and 12 months post-discharge. The average time to complete the questionnaires is 10-15 minutes. Additionally, cardiovascular events and readmission rates will be tracked and analyzed over a 1-year period.


Eligibility Criteria:
Inclusion Criteria:

Diagnosed with heart failure

Exclusion Criteria:

Inability to independently stand or get out of bed. Unstable condition
Exercise Study on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction

The aim of the study is to compare the effects of aerobic interval training and the IDF recommendations on physical activity on cardiac function and CV risk factors in patients with diabetes. The hypothesis is that AIT more than MCT, will improve myocardial dysfunction in patients with subclinical LV disease, improve both endothelial function and VO2max and thus reducing CV risk factors and CV disease. HbA1c will be more stable.

The aims of this study are to address the exercise prescription recommendations for patients with (T2DM) who have subclinical heart disease. The prescription recommendations will be assessed by randomising T2DM patients with subclinical heart disease to one of the following 2 groups for 3 months followed by a 9 month home-based program:

Moderate Intensity Exercise Group (ME). Home exercise equivalent to the present exercise recommendations of the International Diabetes Federation.

Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved through high-intensity interval training.

The investigators primary hypotheses are that in patients with type 2 diabetes and subclinical heart disease:

Moderate Intensity Exercise will:

Not significantly improve myocardial function compared to controls,

Despite significant improvement (compared to controls) in:

Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA)

Aerobic Interval Training Group will:

Significantly improve myocardial function compared to controls,

Significantly improve (compared to moderate intensity exercise group):

Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA)

Eligibility Criteria:
Inclusion Criteria:

* Patients 20-60 years with diagnose diabetes mellitus type 2 (without insulin) for less than 10 years and with diastolic dysfunction (E'\<8), will be included.

Exclusion Criteria:

* Overt CV disease
* History of CAD
* Moderate to severe valvular disease (AI MI 3-4, AS peak gradient \> 15 mmHg=2m/s)
* Atrial fibrillation or other severe arrhythmia
* Congenital heart disease
* Untreated hypertension \>140/90
* LVH
* Retinopathy
* Neuropathy
* Micro or macroalbuminuria
* EF \< 40%
* BMI \>35
* Ischemia at exercise echocardiography
* Disease or disability making training difficult.
An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction

Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears. Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes.

Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears.Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes. We predict there will be significant improvement in radiographic, clinical, and patient reported outcomes in patients undergoing SCR for extensive, primarily irreparable rotator cuff tears when AlloMend allograft is utilized.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are undergoing SCR for massive rotator cuff
* Adult patients (≥18)
* Pre-operative MRI obtained within 26 weeks prior to surgery
* Must have 3 out of 5 external rotation strength
* Must have intact teres minor

Exclusion Criteria:

* Worker's Compensation Case
* Persons with a mental or cognitive disability deemed significant enough that they would not be capable of complying with a restricted rehabilitation program or completing the outcome measures
* Patients with known contraindications to MRI
* Pectoralis major, pectoralis minor, deltoid, or latissimus dorsi dysfunction
* Acute fractures of humerus, clavicle, scapula
* Inability to speak and/or understand English

Intra-Op Exclusion Criteria:

* Anterosuperior escape of the glenohumeral joint due to a completely incompetent anterosuperior cuff and coracoacromial ligament (CAL)
* Unable to fix the graft on the humeral side utilizing a double row repair
* Inability to address subscapularis pathology
* Diffuse bipolar cartilage loss
Safety and Effectiveness and Effect on Quality of Life and Work Productivity of Humira in Patients With Psoriatic Arthritis in Clinical Routine

Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.

The primary objective of the Non-Interventional Study is to explore the therapeutic success, measured by improvements in the following target variables (with regard to the respective baseline value):

* The number of missed working days
* The self-assessed workability
* The severity of clinical symptoms (number of tender and swollen joints, C-reactive Protein and erythrocyte sedimentation rate respectively; total score Disease Activity Score 28, Psoriasis Area and Severity Index)
* The severity of functional impairment (Health Assessment Questionnaire)
* The health-related quality of life .

All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables (therapeutic success). Particularly the impact of previous biologic therapies on clinical target variables will be evaluated.

The secondary objective is to document the therapeutic success by the following variables:

* The number of physician visit
* The number and duration of hospitalization
* The number of days of impairment in non-occupational activities
* Pain, exhaustion/fatigue
* The reduction of number and dose of concomitant medication
* Patient's assessment of adalimumab therapy compared to previous therapies.

Target parameters for safety evaluation of adalimumab are:

* The evaluation of safety and tolerability by the documentation and analysis of serious adverse events (SAEs) and adverse events (AEs)
* Evaluation of safety and tolerability for subgroups of patients with common frequent concomitant diseases, especially diabetes type II, cardiovascular, liver, and renal insufficiencies, and related concomitant medications.

Eligibility Criteria:
Inclusion Criteria:

* Active and progressive psoriatic arthritis in adults with insufficient response to prior basic therapy

Exclusion Criteria:

* Hypersensitivity against the drug or one of the other ingredients
* Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
* Moderate to severe cardiac insufficiency.