cyrilzakka/clinical-trials huggingface dataset:
Impact of a Physical Exercise Program on the Self-care Capacity of People Hospitalized for Heart Failure

The objective of the study is to evaluate the effectiveness of a self-care program that integrates physical exercise with components of aerobic and muscular strength training in improving functional capacity and muscular strength in people hospitalized for decompensated heart failure, in a clinical stabilization phase

The main question it aims to answer is:

Is the Self-care program that integrates physical exercise with aerobic and muscular strength training components effective in improving the capacity for self-care in people hospitalized for decompensated HF, in the clinical stabilization phase?

In this randomized clinical trial, the Self-Care program will be applied in the experimental group. The ERIC-HF program will be applied in the control group. The ERIC-HF is a program of exercise only with an aerobic component.

Participants will complete these programs during their hospital stay and various assessment instruments (quality of life, functional capacity, capacity for self-care, muscle strength) will be applied at admission, at discharge and one month after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Participants: Clinical diagnosis of decompensated HF, regardless of etiology or ventricular function;
* Participants: Be over 18 years old;
* Participants: Be able to provide informed consent.

Exclusion Criteria (participants):

* Osteoarticular pathology that causes physical limitations that prevent the performance of physical exercise;
* Existence of intravenous inotropic medication;
* Uncontrolled auricular or ventricular arrhythmias;
* Chest pain in the last 8 hours;
* Heart rate greater than 120;
* Dyspnea at rest;
* Uncontrolled blood pressure - Systolic blood pressure greater than 180mmHg or diastolic blood pressure greater than 110mmHg;
* 2nd or 3rd degree atrioventricular block;
* Oxygen need at a rate greater than 3L/min;
* Glycemic decompensation in the last 12 hours.
Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients

The aim of this trial is to find out if immune responses to HIV can be boosted in individuals who start medicines soon after being infected. If immune responses can be boosted to the virus, this may allow the body to control HIV without the need for medications. This study is designed to test a new strategy for boosting immune responses to HIV and to evaluate if these responses allow people to have control of HIV without medicines.

The novel strategy used in this trial is to mix a peptide vaccine with dendritic cells from individuals. The dendritic cells are normal cells in the blood that boost immune responses. In HIV uninfected people, dendritic cells have been found to strongly activate the types of immune responses that may be important in controlling HIV.

HIV infected and HIV uninfected individuals in this study will receive one shot of dendritic cells alone followed by three monthly shots of dendritic cells plus vaccine. We will monitor the immune responses to the peptide vaccine during this time period. After completing the vaccinations, HIV infected patients will stop their HIV medications and their immune status (CD4 count) and viral load will be monitored closely over 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

Both HIV infected and HIV uninfected individuals are eligible for this study.

* CD4 cell count of 400 cells/mm3 or greater at study entry
* If HIV infected, initiated anti-HIV medicines within 120 days of infection
* If HIV infected, HIV viral load \< 50 copies/ml for at least 3 months prior to study entry
* Current medication regimen for at least 3 months prior to study entry
* A particular blood type (HLA-A\*0201)
* Acceptable methods of contraception

Exclusion Criteria:

* Received investigational drug or vaccine within 30 days prior to study entry
* On other immune-based therapy (e.g., interleukin-2, alpha interferon, immunoglobulin, thalidomide) within 30 days prior to study entry
* Megesterol acetate within 30 days prior to study entry
* Immunization within 4 weeks of study entry
* If hepatitis B virus (HBV) uninfected and at high risk for HBV infection, the patient will not be eligible until he or she has completed an HBV vaccine series.
* Unstable or severe medical condition, including active opportunistic infection requiring treatment
* History of Hashimoto's thyroiditis
* Cancer requiring chemotherapy within 6 months prior to study entry
* History of radiation therapy to axillary lymph nodes
* Significant laboratory abnormalities at study entry
* Pregnant or breastfeeding
* History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, scleroderma, mixed connective tissue disorder)
* Allergy to gentamicin, tobramycin, streptomycin, or amikacin
The Effectiveness of Two Nursing Programs on the Surgery-related Pressure Injury

Introduction: This study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions.

Methods: This study adopted a true experimental research design with a convenience sampling method from the operating rooms of a teaching hospital in a northern region. The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care). Measurements include basic personal attributes, risk factors, grade, time, and location of occurrence related to surgery-related pressure injuries.


Eligibility Criteria:
Inclusion Criteria:

* 20 and more years old
* Over 4 hours lying flat on the operating table (eg., orthognathic surgery, microtia reconstruction surgery, etc.)
* Those who are conscious clearly and can communicate in Mandarin and Taiwanese
* Those with agree to participate in this study

Exclusion Criteria:

* Those whose skin is red, swollen, hot, painful, redness, rash, purple spots, bruising, scaly skin, damaged, etc.
* Refuse to participate in the study
The Effect of Dual Tasking on Physical and Cognitive Functions in Patients With Parkinson Disease

The ability of performing multi-tasking procedures is impaired in patients with Parkinson's disease. In this study, our goal was to detect the effects of dual-task training with treadmill training on walking and balance and to compare its effects on quality of life, cognitive functions and risk of fall, to treadmill training alone.


Eligibility Criteria:
Inclusion Criteria:

The patients with Idiopathic Parkinson Disease on medication who has

* Hoehn-Yahr 1-3
* Mini Mental Test score 20 and above
* Functional Ambulation Category 2 and above
* No changes in medication in last 3 months
* No rehabilitation programme in last 3 months

Exclusion Criteria:

* Diagnosis of Parkinsonism other than Idiopathic Parkinson Disease
* Global aphasia
* Severe cognitive dysfunction
* Other neurologic/orthopedic diseases
* Limiting cardiovascular or pulmonary disease
* Visual impairment
* Hearing loss
Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated

The purpose of the study is to determine whether therapeutic education can improve the quality of life of the child from 8 to 12 years old suffering of food allergy.

This study also show us if therapeutic education has an effect on the quality of life of child's family.

Food allergy affects 5 - 6% of children. The major risk is anaphylaxis by ingestion of the forbidden allergen. The child and his family have to learn to deal with this risk. Therapeutic education can help the children to take care of their allergy.

Food allergy limits the child socialisation, leads to anxiety/fear, and impairs health-related quality of life. In the day of today, there is no cure treatment. Also, improve the quality of life is one of the goals of the food allergy management.

The impact of therapeutic education on quality of life has never been studied. We intend to study the impact of therapeutic education on the quality of life of children from 8 to 12 years old with IgE mediated food allergy.

Our hypothesis is the quality of life can be improved by therapeutic education.

Eligibility Criteria:
Inclusion Criteria:

* IgE mediated food allergy
* Child from 8 to 12 years old (included)
* Family who can have an internet access
* Children which parents have received study's information
* Child who can have a medical examination before inclusion (art. L.1121-11 du CSP).
* Patients who have a medical insurance.

Exclusion Criteria:

* Non IgE mediated food allergy
* Child with chronic disease, except asthma and atopic dermatitis
* Patients who already had a therapeutic education for food allergy
* Patient already included in another study
Endobronchial Ultrasound Needle Aspiration With and Without Suction

The main purpose of the present study is to compare the diagnostic yield of different aspiration techniques in Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) in the diagnosis of hilar/mediastinal adenopathy

The role of ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for the diagnosis of hilar/mediastinal adenopathy is well established. However, different aspiration techniques are available and it's not clear if there's a significant difference between suction vs no suction aspiration. Of great interest is the role of different aspiration techniques in EBUS-TBNA in determining the diagnostic yield for histopathological evaluation, including molecular biology and PD-L1 amplification assessment in lung cancer diagnosis.

In this context, no comparative studies between suction and no suction aspiration have been performed; moreover, considering only suction techniques, no studies evaluated if there's a difference between aspiration with EBUS dedicated syringe and manual aspiration through Cameco syringe. It is very important for clinical practice to definitively assess the non inferiority of no suction techniques in EBUS-TBNA in terms of diagnostic yield, and to provide information regarding the quality of histologic sample to define the best diagnostic strategy.

The study is focused on a minimum of 306 patients who have at least one hilar/mediastinal lymph node \> 1 cm on CT scan or hypermetabolic on FDG-PET in at least one approachable lymph nodal station for which a diagnostic cyto-histological assessment is required for clinical purpose. Patients will be randomized 1:1:1 (no suction : passive suction with EBUS dedicated syringe : manual suction with Cameco syringe) by a computer-generated random-allocation system to undergo EBUS-TBNA with one of the three different aspiration techniques. The pathologist provides a final diagnosis and, as secondary endpoint, a qualitative assessment of the sample quality using both a binary and a semi-quantitative score.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18years;
* presence of at least one hilar/mediastinal adenopathy \>1 cm on short axis assessed by contrast-enhanced CT scan and/or hypermetabolic adenopathy assessed by FDG-PET;
* ability to give an informed consent

Exclusion Criteria:

* coagulopathy or bleeding diathesis that cannot be corrected;
* severe refractory hypoxemia;
* unstable hemodynamic status;
* inability to give an informed consent
Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus Vulgaris

Comparing the effect of injecting autologous platelet rich plasma and triamcinolone acetonide in the erosions of buccal mucosa of pemphigus vulgaris patients.

Ten (Pemphigus vulgaris (PV) patients will be enrolled in this study. The clinical disease score of the patients will be assessed using the pemphigus disease area index (PDAI). Three milliliters of blood will be withdrawn from each patient. The blood will be centrifuged and the platelet rich plasma (PRP) will be extracted. Patients will receive autologous PRP injections for one side of buccal mucosa and triamcinolone acetonide 10mg/ml at the other buccal mucosa at biweekly intervals for 3 months. The degree of pain and clinical improvement of each buccal mucosa will be assessed by an investigator who does not know the nature of injection in each buccal mucosa. Therefore the investigation doing the injection will not be blind but the other investigator assessing the results will be blind also the patients will be blind.

Eligibility Criteria:
Inclusion Criteria:

* Pemphigus vulgaris patients having bilateral erosions in the buccal mucosa.

Exclusion Criteria:

* Pemphigus vulgaris patients who do not have oral erosions.
* Pemphigus vulgaris patients who have received intralesional steroid injection in their buccal mucosa.
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes

The aim of the trial is to evaluate the effects of the SGLT2 inhibitor, dapagliflozin, compared to metformin on annual decline in eGFR when used as first line therapy in people with Type 2 Diabetes.

This study is a randomised, double blinded clinical trial and will be undertaken in primary care and community sites across Australia and tertiary care centres in Sri Lanka. Following a 4-week active run-in period, eligible participants will be randomised to either dapagliflozin 10mg daily, or metformin XR 2000mg daily in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2D;
* Aged ≥18 years;
* Body mass index \> 18.5 kg/m2;
* Drug naïve, or managed with metformin monotherapy and willing to be randomised to either dapagliflozin or metformin;
* eGFR ≥45 ml/min/1,73m2; and
* Signed informed consent.

Exclusion Criteria:

* Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; or
* There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor; or
* They have clearly documented coronary artery disease (defined as a previous acute coronary syndrome, coronary stent or bypass surgery) or clearly documented heart failure (defined on the basis of a hospital admission, specialist diagnosis or an echocardiogram or other imaging modality); or
* Pregnant or breast-feeding.
Improved Stroke Outcome at 6 Months

The investigators implemented a structured chain of acute stroke care with early integrated rehabilitation. The mortality at 6 months was lower (12%) compared to 23% in the International Stroke Trial (IST) and 39% (67%) of the patients were dead or dependent, which is superior compared to international data.

Background/Aim of the study: To further reduce the 6 months stroke morbidity and mortality in a high volume stroke hospital and to compare the results with national and international data.

Methods: 204 consecutive stroke patients are analyzed in a prospective study in a single center teaching institution. The intervention consists of a structured therapeutic chain of 290 collaborating GPs, a standardised acute hospital proceeding overlapping with an early integrated neurovascular rehabilitation within the same institution. Primary endpoints include death and dependence at 6 months, secondary endpoints are the length of hospital stay (LOS) and the quantitative analysis of physical and psychosocial impairments. The data are directly compared with the same endpoints of the Swiss subgroup of the international stroke trial (IST) and recent international data.

Results: At 6 months, mortality is significantly lower with 12 % (compared to 23 % in the IST trial) and only 39 % (67 %) of the patients are dead or dependent. Stroke severity is similar as in other study populations. Median LOS is 15 days in the acute clinic and 39 days in the rehabilitation institution. The psychosocial outcome compares favorably to a matched control group.

Conclusions: A structured chain of acute stroke treatment overlapping with an early integrated rehabilitation is superior compared to national and international ischemic stroke trial data.

Eligibility Criteria:
Inclusion Criteria:

* An acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding (ICB)) with the signs and symptoms of an acute stroke according to the World Health Organisation definition of acute stroke within the last 12 hours without the need or possibility of a neurosurgical intervention;
* No thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial)
* The informed consent of the patient or, if not possible, of the next of kindred
* Living at home before the event
* Lack of participation in another trial

Exclusion Criteria:

* Transient ischemic attack (TIA) resp. full recovery within 24 hours after the event
The CARO Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Healthy Subjects

A controlled dietary intervention study will be carried out based on the stable isotope method the investigators have developed to quantify both the absorption of beta-carotene and its bioconversion to retinol in oil and in a mixed diet. For 6 weeks the participants will consume 2 capsules/day, 7 days/week with each capsule containing 50-mg \[13C10\] beta-carotene and 50-mg \[13C10\] retinyl palmitate. For three weeks they will consume a diet with high levels of beta-carotene in vegetables and fruits and for the other 3 weeks they will consume a diet with low levels of beta-carotene in vegetables and fruits supplemented with an extra amount of beta-carotene in oil. Samples of blood and faeces will be taken.

The study hypothesis is that the absorption of beta-carotene in oil in comparison with the absorption of beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators want to measure the influence of the food matrix of vegetables and fruits on the absorption of beta-carotene in healthy humans on a western diet.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 50 years old
* Body mass index (BMI) between 18 and 25 kg/m2
* Willing to consume the controlled diet and not consume other food items
* Willing to consume the cooked meal at the research facility and the bread meals and snacks at home (distributed to the participants)
* Willing to consume the capsules every day

Exclusion Criteria:

* Hematological diseases and chronic diseases including cancer, renal insufficiency, liver disease, diagnosed gastrointestinal disorders, or surgery of the gastrointestinal tract
* Use of (oral) drugs suspected of interfering with fat-soluble-vitamin absorption
* Smoking
* Excessive alcohol consumption (\>30 g/d)
* Consumption of vitamin or carotenoid supplements 6 weeks before and during the study
* Not too low or high levels of serum beta-carotene and retinol
* Normal hemoglobin, hemocytometry, creatinine, ALAT, alkaline phosphatase, and cholesterol blood values (compared with laboratory references)
* Pregnancy
TRUfill®'s Line in Intracranial aNeurysm Embolisation

The objective of this study is to evaluate the long term efficacy and safety of the CODMAN TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or non-ruptured aneurysms in real-life routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient presenting one or more ruptured or non-ruptured intracranial aneurysms assessed by angiography
* Patient implanted with one or more CODMAN TRUFILL® coils
* Patient agree to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and have received information letter.

Exclusion Criteria:

* Patient who does not accept to take part in the study after being informed
* Patient already enrolled in a clinical trial involving experimental medication or device.
Clomiphene Citrate Stair-Step Protocol

A RCT will be conducted to compare the traditional clomiphene citrate regimens for ovulation induction with the stair-step protocol. Sixty women will be included after obtaining their written informed consent and will be randomized into either of the 2 groups.

This study is a randomized clinical trial (RCT) will be conducted in Ain Shams University maternity hospital at infertility clinic within a period of 6-8 months.

All patient are previously diagnosed as PCOs according to the Rotterdam conference of 2003.

All patients will be devided according to computer based program into two groups First group: Patients with traditional protocol

Traditional protocol:

Clomiphene citrate (clomid) (50mg) will be given for 5 days (days 3-7). Transvaginal ultrasound from 9th-20th every other day if ovulation occur the patient will be excluded if no ovulation, we will wait for the next menses and increase the dose to (100mg). if no ovulation occurred increase the dose to (150mg) in the next cycle if no ovulation increase the dose to (200mg) TVUS from 9th-20th ovary other day. If no ovulation we will wait for next cycle and increase the dose to (250mg) and so till 6 cycles .

Second group: Patient with stair step protocol Follicular development will be monitored using transvaginal ultrasound at 11-14 day after (50mg) clomiphene for 5 days if there is no response (no follicle \>10mm), so, (100mg) clomiphene will be initiated immediately for 5 days and ultrasound will be repeated 1 week after the first ultrasound. If there is no response, (150mg) clomiphene will be initiated immediately for another 5 days and TV/US will be performed 1 week after the second TV/US .

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-35 years.

  * Body mass index (BMI/m2) 26-35 kg/m2
  * Normal hystrosalpingogram (HSG).
  * Normal Prolactin level.
  * Normal semen analysis.

Exclusion Criteria:

* - They underwent ovarian drilling.
* Other factors infertility.
* AUTOimmune diseases as thyroid disorders and systemic lupus erythematosus.
Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)

Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome.

Patients recruited by year:

2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from CHF, NYHA II-IV class
* LV lower than 35% to LV lower than 45%

Exclusion Criteria:

* Patients with additional disease with life-expectancy of less than 2 years