cyrilzakka/clinical-trials huggingface dataset:
Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts

This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.

The study will consist of the following 4 treatment groups.:

1. Standard dose Advagraf with angiotensin-converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) antihypertensive therapy
2. Standard dose Advagraf without ACEi/ARB antihypertensive therapy
3. Low dose Advagraf with ACEi/ARB antihypertensive therapy
4. Low dose Advagraf without ACEi/ARB antihypertensive therapy

Eligibility Criteria:
Inclusion Criteria:

* Subject is the recipient of a first or second deceased or living donor renal transplant (one kidney only)
* Subject must have at least one HLA-mismatch with the donor. HLA identical donor-recipient pairs are not eligible
* Subject understands either English or French
* If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

* Presence of donor specific antibody
* Subject who is currently participating in a study with investigational drug, or who has received investigational drug within three months prior to randomization. Observational studies are acceptable
* Subject who has lost a previous graft for immunological reasons less than one year from transplant
* Subject is pregnant or breastfeeding
* Subject receives a kidney lacking pre-implantation biopsy
* Subject has significant disease (e.g. malignancy or uncontrolled infection) or disability (e.g. cognitive defect) which prevents understanding of, or adherence to the protocol
* Subject who in the opinion of the Investigator, require ACEi/ARB therapy post-transplant for any indication
* Subject who requires induction with Thymoglobulin, Campath, antithymocyte globulin (ATG), antilymphocyte globulin (ALG) or any biological induction agent other than basiliximab. Unplanned post-transplant use of these prohibited drugs for clinical indications post-transplant is allowed
* Subject has plans to become pregnant within 2 years post-transplant
* Subject who has a positive T-cell or B-cell crossmatch. Subjects with a weakly positive B-cell cross-match that tests negative following DTT reduction are acceptable
* Subject who has a requirement for maintenance immunosuppressant therapy with the exception of low dose steroid or mycophenolate mofetil (MMF). A subject who is on low dose tacrolimus maintenance therapy will be eligible provided the tacrolimus is withheld at least 1 week prior to transplant
IVUS-guided DES Implantation in Coronary Calcification

Coronary calcified lesion is associated with a poor clinical outcome. Intravascular ultrasound (IVUS) provides anatomic information in detail about reference vessel dimensions and lesion characteristics including severity of diameter stenosis, lesion length, and morphology. Both randomized and observational studies have reported the clinical benefits of IVUS guidance for patients with chronic total occlusion (CTO), long lesions, acute coronary syndrome (ACS) with complex bifurcation lesions. Our previous ULTIMATE trial has demonstrated that IVUS-guided drug-eluting stent (DES) implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. However, the benefit of IVUS guidance in coronary severe calcification still remains unknown in the modern DES era.


Eligibility Criteria:
Inclusion Criteria:

1. Silent ischemia, stable or unstable angina, non-ST-segment elevation myocardial infarction \> 48 hours, or ST-segment elevation myocardial infarction \> 7 days;
2. De novo coronary lesion eligible for drug-eluting stent implantation;
3. Target lesion with severe calcification;

Exclusion Criteria:

1. Age less than 18-year-old;
2. Comorbidity with a life expectancy \<12 months;
3. Intolerant of antithrombotic therapy;
4. Significant anemia, thrombocytopenia, or leucopenia;
5. History of major hemorrhage (intracranial, gastrointestinal, and so on);
6. Chronic total occlusion lesion not recanalized;
7. Scheduled major surgery in the next 12 months;
8. Left ventricular ejection fraction \< 25%;
9. Uremia dependent on dialysis treatment;
10. Previous drug-eluting stent implantation in target vessel;
Comparison of Thoracic Manipulation and Muscle Energy Technique in Non-specific Mechanical Neck Pain

To compare the effects of Thoracic manipulation and MET in relieving pain.in improving Range of motion and in improving functional disability.

Neck pain is a common musculoskeletal disorder. Mechanical neck pain is also known as non-specific neck pain and is defined as the pain anywhere within the region bounded superiorly by superior nuchal line, inferiorly by an imaginary line through the tip of first thoracic spinous process and laterally by sagittal plane tangential to the lateral borders of the neck in which pain is provoked by sustained neck posture, neck movement, pain on palpation of cervical musculature without pathologies. In most patients, neck pain can be a common cause of disability: it is associated with daily activity limitations, reduction of work productivity and decrease in quality of life. Mechanical neck pain is commonly seen in people involved in occupation like computer processing, clerical job, students and people with sedentary life style awkward occupational posture, heavy lifting and physically demanding work.

thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine.

Muscle energy technique (MET) is a method of treatment that involves the voluntary contraction of subject's muscles in a precisely controlled direction, against a counterforce and producing post isometric relaxation through the influence of the Golgi tendon. MET is used to decrease pain, stretch tight structures muscle and fascia, reduce muscle tone, improve local circulation, and mobilize joint restriction

Eligibility Criteria:
Inclusion Criteria:

* Patients who present with a primary complaint of mechanical neck pain (defined as pain in the region between the superior nuchal line and first thoracic spinous process) with limited Range of motion.
* Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS).
* Subacute or chronic cases (4 -12 weeks)
* Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)
* Dull aching neck pain increased by sustained postures, neck movement

Exclusion Criteria:

* Patients with a positive history of trauma, fracture or surgery of the cervical spine.
* Neck pain with radiation to the arm and upper extremity
* Diagnosed cases of torticollis, and scoliosis
* History of osteoporosis, Any heart disease
* Taken previous physiotherapy session.
A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care

This study aims to analyse if intensive systematic treatment via internet and telephone during 4 months improved HbA1c for persons with type 1 diabetes which are already treated with CGM or FGM, and if the effect continuous for 1-2 years after the intervention stops. Time in Hypoglycaemia, treatment satisfaction, Diabetes distress and hypoglycaemia fear will even be analysed.

A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hbA1c ≥ 58mmol/mol and treated with CGM or FGM.

The control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.

The intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. They will receive help with analysing data and advice on how to improve their glucose values. They will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
* Clinical diagnosis of Type 1 diabetes
* Adult patients over 18 years of age
* HbA1c ≥ 58 mmol/mol
* Currently using CGM or FGM
* To have a possibility to download and share FGM/CGM data

Exclusion Criteria:

* Type 2 diabetes
* Diabetes duration \<1 year
* Long-term Systemic glucocorticoid treatment during the last 3 months
* Planned or changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy
* Current or planned pregnancy or breastfeeding during the next 12 months
* Planned move during the next 12 months making it not possible to participate in study activities
* Other reason determined by the investigator not being appropriate for participation
FC Patch Low: Metabolism Study

The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception.


Eligibility Criteria:
Inclusion Criteria:

* Healthy woman requesting contraception
* Normal cervical smear not requiring further follow-up
* History of regular cyclic menstrual periods
* Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods

Exclusion Criteria:

* Pregnancy or lactation - Obesity (Body Mass Index \[BMI\] \> 30.0 kg/m2)
* Any diseases or conditions that can compromise the function of the body systems
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Any disease or condition that may worsen under hormonal treatment
* Undiagnosed abnormal genital bleeding
* Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
Nursing Interventions on Stroke Patient Care: Quality of Life, Hopelessness, Anxiety and Depression

In our research, it was aimed to determine the effect of nursing interventions applied face to face at the time of discharge and then via tele-nursing method to the caregivers of patients in intensive care and diagnosed with stroke, on the quality of life, care burden, hopelessness, anxiety and depression levels of the caregivers. This research will be conducted as a randomized, pre-test, post-test single group intervention study, at the Neurology Intensive Care Unit of Sakarya University Training and Research Hospital, between March and June 2023. With a 95% confidence interval, 5% margin of error, 0.54 effect size and 95% representativeness of the population, the group was calculated as 47 people, and the sample was determined as 56 people in total, with 20% reserve. The sample of the study will be selected by simple random sampling method among the caregivers of stroke patients who meet the inclusion criteria and agree to participate in the research. During the discharge process, Information Forms, Zarit Caregiving Burden Scale, Beck Hopelessness Scale, Adult Caregiver Quality of Life Survey, and Hospital Anxiety Depression Scale will be administered face to face to the participants as a pre-test. 12 weeks after the first measurement, Zarit Caregiving Burden Scale, Beck Hopelessness Scale, Adult Caregiver Quality of Life Questionnaire, Hospital Anxiety Depression Scale will be administered as posttest. In addition to routine discharge training, participants will be provided with 'Education and Care Practices for Stroke Patients'. These applications; It will be performed for those who care for stroke patients in the hospital for a week, and then at home, twice a week, for a total of 7 weeks, via telenursing method. Written consent will be obtained from caregivers after explaining the purpose of the research and the purpose for which the results will be used. Participants will be informed that their information will not be shared with others and the confidentiality policy will be adhered to. In order to make comparisons before and after the training, participants will be asked to fill out data collection forms with a nickname they can easily remember and not forget in the pre-test. They will be asked to write the same pseudonyms when filling out the post-test data collection forms. Participants will be asked to fill out data collection forms individually, but it will be stated that they can contact the researchers if they have questions.


Eligibility Criteria:
Inclusion Criteria:

* Having a patient in the Neurology Intensive Care Unit with a diagnosis of stroke,
* The patient is at the stage of being discharged from the intensive care unit,
* Being literate,
* Having a smart phone and being able to use it,
* Having internet access and at least 4GB internet package,
* Volunteering to participate in the research.

Exclusion Criteria:

* Caregivers who are not reachable by phone calls at home,
* Caregivers who do not have continuity in home telenursing training and consultancy practices will be excluded from the study.
Thromboembolic And Bleeding Risks During anticoaGulant trEatment in Asian paTients With Atrial Fibrillation (TARGET-AF)

This study was design to investigate the efficacy and safety of NOAC therapy in Koreans

East Asians have demonstrated a higher bleeding tendency compared to Western populations during an anticoagulation. Consequently, East Asians have been prescribed as a relatively weaker treatment regimens based on this evidence. Therefore, the TARGET-AF study aims to verify the efficacy and safety of NOAC therapy in Koreans

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented AF on 12-lead ECG, Holter monitoring, or single-lead ECG recordings are eligible for enrollment.
* Based on AF treatment Korean guideline 19, AF patients who require NOAC treatment or are currently on NOAC treatment (within the past 3 months)
* Adults aged 18 or above who have provided consent for clinical information

Exclusion Criteria:

* Patients with moderate or severe mitral stenosis or mechanical prosthetic valve
Comparison of Different Automated External Defibrillation (AED) Training Methods

This study is a prospective, randomized trial that compares the effectiveness and retention of four different training methods for the use of an AED:

A. Traditional instructor based learning;

B. The use of a personal manikin with a DVD training to practice the necessary AED skills;

C. The use of a personal manikin with a DVD training to practice the necessary AED skills and additional scenario training;

D. Watching a 2.5 minutes DVD which shows the use of an AED.

It is hypnotised that there are no differences between these training methods, in which case method D is most efficient to reach large number of people to learn BLS/AED skills.

There are two interesting target groups to reach:

1. Younger people, as they might give the highest interest after training, as they normally live longer.
2. Older people as they are member of the most important group in risk and have therefore a higher change of being a witness of cardiac arrest.

As there might be differences in the results between different training methods than can be related to age, each training group is distinguished to three different groups:

1. 21 years of younger;
2. between 21 and 50 years;
3. older than 50 years.

It is hypnotised that there are no differences between younger and older students within each of the four training methods.


Eligibility Criteria:
Inclusion Criteria:

* willing to follow a BLS/AED course up to 2h

Exclusion Criteria:

* CPR training within the last five years
* professional health care provider
Retrospective Study of Effect of Adjuvant Chemoradiation of Gastric Carcinoma on Local Control and Survival

Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world.

The American Cancer Society estimates that about 26,560 cases of stomach cancer (16,160 in men and 10,400 in women) will be diagnosed in 2021. Median age at diagnosis is 68 years.

Decreases in gastric cancer have been attributed in part to widespread use of refrigeration. Other factors likely contributing to the decline in stomach cancer rates include lower rates of chronic Helicobacter pylori infection, thanks to improved sanitation and use of antibiotics, and increased screening in some countries.

Surgical resection is the principal therapy for gastric cancer, as it offers the only potential for cure.

Neoadjuvant chemotherapy has an established role in the management of gastric cancer. Perioperative chemotherapy, or postoperative chemotherapy plus chemoradiation, are preferred for localized gastric cancer. Because of lower toxicity, two-drug cytotoxic regimens are preferred for patients with advanced disease.

Adjuvant radiotherapy is associated with improvements in both overall and relapse-free survival and reductions in locoregional failure.

Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world.

The American Cancer Society estimates that about 26,560 cases of stomach cancer (16,160 in men and 10,400 in women) will be diagnosed in 2021. Median age at diagnosis is 68 years.

Decreases in gastric cancer have been attributed in part to widespread use of refrigeration. Other factors likely contributing to the decline in stomach cancer rates include lower rates of chronic Helicobacter pylori infection, thanks to improved sanitation and use of antibiotics, and increased screening in some countries.

Surgical resection is the principal therapy for gastric cancer, as it offers the only potential for cure.

Neoadjuvant chemotherapy has an established role in the management of gastric cancer. Perioperative chemotherapy, or postoperative chemotherapy plus chemoradiation, are preferred for localized gastric cancer. Because of lower toxicity, two-drug cytotoxic regimens are preferred for patients with advanced disease.

Adjuvant radiotherapy is associated with improvements in both overall and relapse-free survival and reductions in locoregional failure.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 70 years.
2. The World Health Organization Performance score 0-2.
3. Haemoglobin at least 10g/dl.
4. White blood cells at least 3000/mm3.
5. Platelets count at least 100000/mm3.
6. Bilirubin concentration no more than 25% higher than upper limit of normal .
7. Liver enzymes no greater than 2.5 times upper limit of normal.
8. Alkaline phosphatase no greater than 2 times upper limit of normal.
9. Creatinine concentration no more than 25% higher than the upper limit of normal .

Exclusion Criteria:

1. Second malignancy.
2. Prior abdominal irradiation.
3. Pregnant or nursing female.
Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection

The investigators hypothesize that abnormalities in thromboelastography (TEG) parameters in patients with liver, pancreas, biliary, esophageal, colorectal, and lung adenocarcinoma can serve as biomarkers for oncologic disease burden, cancer recurrence and overall survival as well as thrombotic and hemorrhagic post-operative complications. The investigators further hypothesize that there is histologic pathology correlates to pre-operative TEG abnormalities, and that it identifies patients with virulent tumor biology.

Aim 1: Evaluate the correlation between pre-operative TEG parameters and disease burden in patients with a new diagnosis of hepatopancreaticobiliary, esophageal, colorectal, and lung adenocarcinoma vs controls with no known malignancy.

Aim 2: Explore if pre- and post-operative TEG parameters vs routine clinical coagulation parameters (platelet count, prothrombin time \[PT\], partial thromboplastin time \[PTT\]) are predictive of pre- and post-operative thrombotic (deep vein thrombosis \[DVT\], pulmonary embolism \[PE\], stroke, myocardial infarct \[MI\]) and hemorrhagic complications.

Aim 3: Evaluate if correction of TEG parameters after surgery is predictive of curative resection and if the failure of TEG parameters to correct after surgery or chemoradiothearpy is predictive of cancer recurrence and overall survival.

Aim 4: Perform proteomic analyses on the tumor microenvironment of cancer tissue samples to investigate whether tumor histology and protein composition is associated with specific TEG derangements that have been previously correlated to poor outcomes, potentially identifying a specific subtype of pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma will be eligible for enrollment in the study
* 18 Years and older

Exclusion Criteria:

* Under 18 years old
* prisoners
* those unable to provide informed consent
* pregnant women
* and those undergoing emergent or urgent operative intervention at the time of diagnosis
Acute Effect of Salbutamol on Heart Rate and Blood Pressure During Exercise in Patients With Moderate or Severe Asthma and Healthy Subjects

Contextualization: Exercise is a common triggers of bronchospasm in patients with asthma and healthy subjects. To prevent these symptoms frequently they have to use Short-Acting Beta2-Agonists. However, the cardiovascular effects of salbutamol during and after exercise remain poorly known.

Objective: To evaluate the effect of salbutamol on heart rate and blood pressure during exercise in patients with moderate or severe asthma and healthy individuals.

Methods: A randomized, double-blind, crossover study will be conducted which 13 individuals with moderate or severe persistent asthma and 13 healthy individuals aged between 20 to 59 years.

Patients will perform a maximal effort test on 2 nonconsecutive days, with either 400mcg Salbutamol or 4 placebo puffs. The order of use of placebo or salbutamol will be drawn. During the protocol, heart rate, blood pressure, perception of exertion and peak expiratory flow will be monitored.


Eligibility Criteria:
Inclusion Criteria for asthmatics:

* Have the diagnosis of moderate or severe asthma according to the clinical criteria described in the literature
* Be between 20 and 59 years of age
* Being from the Asthma Assistance and Research Center (NAPA) of University of São Paulo Faculty of Medicine Clinics Hospital
* Have treatment at the outpatient clinic for at least 3 months,
* Have a stable clinical condition for at least 30 days
* Make use of the optimized medicine daily
* Read and signed the TCLE approved by the Ethics and Research Committee of the Ibirapuera University (UNIB) under opinion nº 1,574,833

Exclusion Criteria for asthmatics:

* Individuals diagnosed with another lung disease,
* Have psychiatric, musculoskeletal or cardiovascular diseases,
* Being smokers
* Being pregnant
* Practice regular physical activity.

Criterion for inclusion of healthy individuals

* Be between 20 and 59 years of age
* Healthy individuals
* Both genders
* Age between 20 and 59 years
* Read and signed the TCLE approved by the Ethics and Research Committee of the Ibirapuera University (UNIB) under opinion nº 1,574,833

Criteria for the exclusion of healthy individuals

* Pregnant women
* Smokers
* Psychic diseases
* Osteomuscular diseases
* Practitioners of regular exercise
* Physical Activity Readiness Questionnaire (PAR-Q)