cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients

This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.

The primary objective is to assess the changes in the GFR after 24 weeks of treatment between the group that was reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks and the group with maintained corticosteroid in stable kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen with corticosteroid to an Advagraf®-based immunosuppressive regimen with corticosteroid for kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen.

The secondary objective is to assess the creatinine clearance rate, acute rejection, satisfaction of medication and safety of the group with a 50% reduced dose of corticosteroid and the group in which the Advagraf ®-based immunosuppressive regimen with maintained corticosteroid.

Eligibility Criteria:
Inclusion Criteria:

* Had a kidney transplant at least 12 months before his/her enrollment in this study (including a kidney retransplantation).
* Underwent a CyA-based immunosuppressive regimen since his/her last transplantation. The CyA dose remained unchanged during the last four weeks before the subject's enrollment.
* The immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks before the subject's enrollment.
* GFR≥30 mL/min

Exclusion Criteria:

* Had received an organ transplant other than a kidney
* Had an acute rejection episode within 12 weeks before his/her enrollment in this study, or had an acute rejection episode within 24 weeks before his/her enrollment in this study that required anti-lymphocyte antibody therapy
* Had been diagnosed with new-onset malignancy after his/her transplantation, except for basocellular or squamous cell carcinoma of the skin that had been treated successfully
* The subject received a kidney transplant from full-HLA identical donor
* Known to have FSGS or MPGN Type II as an underlying disease
* Has elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigated site
* Has liver cirrhosis
A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-75 years (both inclusive) at time of signing informed consent
* Body mass index 20.0-29.9 kg/m\^2 (both inclusive)
* A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
* History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
* Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit, a repeated measurement is allowed
* Any blood draw in excess of 50 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
Brazilian Network for Lymphoma Registry

Currently there are no official data concerning incidence, progression and prognosis of patients with lymphoma in Brazil.This project aims the establishment of a network of 12 Brazilian Institutions to implement a Lymphoma Registry (RELINFO) with the Brazilian National Cancer Institute (INCA) as the Coordinating Center.We intend to develop and implement a computerized system for data entry and information management of patients with lymphomas. This will enable create a virtual registry of demographic, clinical, epidemiological, histopathological, molecular, and therapeutic data. This clinical record must be linked to histopathological and molecular diagnosis, allowing institutions that work in the context of the public health system have access to new technologies for early cancer diagnosis.We expect is that this record reliably portrays the scene of lymphomas in our state and will become a management model that can be replicated at the national level. Thus, the implementation of RELINFO will strengthen the multidisciplinary diagnosis, promote the standardization of clinical record of patients with lymphomas and provide subsidies to cooperative research projects between participating institutions.

Data collection and management:

For data collection will use a common system for all institutions participating.We developed a computerized tool that utilizes models of case report forms (CRF) and allows the inclusion and management of clinical, epidemiological, histopathological and molecular data. The clinical and laboratory data of patients included in RELINFO will be obtained from the hospital records. The integration of local databases allows constitute the RELINFO, conceived as a virtual database of patients with lymphoma. The INCA as Coordinating Center is committed to the security of this database.Standardization of diagnosisThis phase includes structuring a technological platform for the standardization of histopathologic diagnosis (establishing common routines in hematopathology) and the incorporation of molecular methods in the diagnosis of lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* All patients (adult or child) with diagnosis of Hodgkin's or non-Hodgkin lymphoma with available with available clinical, histopathology and treatment data
* Patient enrolled on study sites included on this project

Exclusion Criteria:

* Patients (adult or child) with other diagnoses of cancer
Pregnancy Outcomes in Congenital Myasthenie Syndrome

This is a retrospective study that follows the clinical evolution, the pregnancy and the post-partum perioad of female patients with Congenital Myasthenic Syndrome.

The aim of this study is to better understand the action of hormonal factors that are presumably incriminated for the fluctuation of the disease. The investigators would also like to better adress the issues of women with Congenital Myasthenic Syndrome, who desire a pregnancy : the possibility of decompensation, the problems that can arise during the course of the childbearing, the risk of foetal malformations.

Eligibility Criteria:
Inclusion criteria:

* Adult women
* Congenital myastenic syndrome genetically confirmed or with clinical compatible and electrophysiological evidence
* Written consent

Exclusion Criteria:

* Neurological or general pathology occurs significantly with the initiation and conduct of a pregnancy.
Dermal Substitution in Pediatric Burns

The standard treatment of deep dermal to full thickness burns is surgical removal of the burn followed by skin transplantation. Dermal substitutes are increasingly used in the treatment of deep burns to replace lost dermis. Preservation of the collagen and elastin in the acellular human dermal substitute Glyaderm provides a more elastic scar. It is unknown what the effect of Glyaderm on scar quality is in a solely paediatric population.

The objective of this case series is to investigate scar maturation and scar quality when applying Glyaderm in deep dermal to full thickness burns in a pediatric population aged ≤15 years old.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≤15 years old
2. Burn wounds requiring skin grafting
3. Written informed consent provided by

   1. The participant's parent(s)/guardian (\<12 years of age)
   2. The participant's parent(s)/guardian and the participant itself (12-15 years old)

Exclusion Criteria:

1. Burn wound of ≤30 cm2
2. Infected burn wounds: clinical symptoms in combination with positive wound swabs
3. Patients/parents with insufficient knowledge of the Dutch or English language, since they would not be able to complete the POSAS questionnaire.
Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment

The Montreal Cognitive Assessment (MoCA) is a screening test for detecting cognitive impairment that assesses several cognitive domains (attention and concentration, arithmetic and orientation, memory, etc.). The instructions as well as some test items of the MoCA are presented auditory (spoken). Consequently, performance on the MoCA may be co-dependent on hearing. Therefore, to rule out the possible negative influence of hearing loss on performance on the MoCA, a MoCA for individuals with hearing loss was recently developed. More specifically, the original MoCA was modified by providing the instructions audiovisually (spoken with visual support) as well as by replacing hearing-dependent items. Since replacing items may affect sensitivity and specificity, the MoCA for persons with hearing loss should be revalidated.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 60 years or older
* Individuals with normal vision (with lenses or glasses if needed)
* Individuals with age-related hearing loss
* Dutch-speaking individuals
* Individuals capable of giving consent to participate in the study themselves
* Individuals still residing in their own homes
* Individuals with an official diagnosis of dementia (Alzheimer's, vascular, or mixed) or mild cognitive impairment. This inclusion criterion applies only to the group with cognitive impairment.

Exclusion Criteria:

For individuals without cognitive impairment, the following exclusion criteria apply:

* (History of) neurological problems (brain tumor, epilepsy, history of stroke, etc.)
* Use of influencing medication (e.g., Ritalin and antidepressants)
Study Evaluating Sirolimus in the Treatment of Kidney Transplant

The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplantation
* Biopsy-confirmed chronic rejection
* Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

Exclusion Criteria:

* Transplant of any organ other than the kidney
* Current important infection
* Acute rejection within 12 weeks prior to inclusion
Self-help App and Wellbeing

Anxiety and worry are amongst the most common mental health difficulties. The Second Mental Health Study found a significant increase in the lifetime prevalence for GAD, from 0.9% to 1.6%. In addition, the Organisation for Economic Cooperation and Development found that among Singaporean students, 86% experienced anxiety levels that were significantly higher than the OECD average.

Past research revealed that individuals who worried more experienced decreases in life satisfaction. It was also found that worry and anxiety are significant predictors of one's psychological wellbeing .

In line with this trend, the market for wellbeing apps have been one of the fastest growing categories of apps ever since; with more than 10,000 on the market. Studies have shown that the use of wellbeing apps has been correlated with an improvement in mental wellbeing. However, due to the lack of research that focuses on disorder-specific evidence, there still exists debates around the effectiveness of wellbeing apps on anxiety and worry. In addition, the lack of research on the mediating factor of psychological mindedness in the relationship between the use of wellbeing apps and mental well-being, could be pivotal to the effectiveness of wellbeing apps.

To show the effectiveness of evidence-based wellbeing apps in targeting anxiety and worry, this study will employ the engagement of participants with a wellbeing app for a controlled period of 2 weeks before recording their mental wellbeing outcomes.This paradigm has been replicated extensively through multiple studies.

This study will use a between-groups experimental study design whereby participants will be block randomised into 2 conditions: Active control condition, and Anxiety condition. Each condition will be given a restricted version of the wellbeing app according to their treatment groups. Follow-up data will be collected at 2-weeks post intervention to establish efficacy of the intervention.

Objective 1: To evaluate the effectiveness of a wellbeing app self-help programme for reducing anxiety and worry.

Objective 2: To examine if psychological mindedness moderates hypothesised effects of wellbeing app usage and anxiety and worry.

Hypothesis 1: Participants in the intervention group will report significantly lower anxiety and worry than participants in the control group.

Hypothesis 2: Psychological mindedness will moderate the effect of the wellbeing app's self-help programme on anxiety and worry: Participants high in psychological mindedness will benefit more from the wellbeing apps than those with lower scores on psychological mindedness.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old for NUS students, or 21 for non NUS students

Exclusion Criteria:

* Participants who do not meet the age requirement
Incidence and Predictors of Post-TIPS Heart Failure in Patients With Cirrhosis

The purpose of this study is to conduct a prospective trial to investigate the incidence of heart failure in cirrhosis patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the the predictors and modififications of cardiac function.

Hyperdynamic circulation is a common Phenomenon in cirrhosis due to systemic and splanchnic vasodilatation, which may result cardic dysfunction and abnormal structure ,called cirrhotic cardiomyopathy(CCM). Transjugular intrahepatic portosystemic shunt (TIPS), as a effective technique to alleviates portal hypertension in cirrhotic patients, often be used to treat with refractory ascites and variceal bleeding which endoscopy and drug therapy are ineffective. However, owing to the increased shunting of blood from the splanchnic vascular bed into the central vascular bed, TIPS further exacerbates the hyperdynamic circulatory state, which may lead to heart failure.yet there are no convincing research to study the incidence of heart failure in cirrhosis after transjugular intrahepatic portosystemic shunt. The purpose of this study is to conduct a prospective trial to investigate the incidence of heart failure in cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the the predictors and modififications of cardiac function.

Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis
2. TIPS is placed successfully
3. Agree to participate in the trial

Exclusion Criteria:

1. Non-cirrhotic portal hypertension
2. Previous TIPS or surgical shunt
3. Medium to severe pulmonary hypertension
4. Heart failure
5. End-stage renal disease requiring hemodialysis
6. Respiratory failure
7. Malignancies with a life expectancy of less than 6 months
Effect of Waterpipe Size on Smoking Behavior and Exposures

This project will generate novel evidence regarding the effect of waterpipe size on smoking behavior, toxicant exposures and subjective experiences among waterpipe smokers. Findings from this project will help the FDA in developing waterpipe size-specific regulations to curb waterpipe smoking in the US and protect public health.


Eligibility Criteria:
Inclusion Criteria:

* regular waterpipe smokers (smoking at least once a week for the past 6 months)
* generally healthy and
* able to provide written informed consent; and willing to attend the 3 lab sessions

Exclusion Criteria:

* history of chronic diseases such as diabetes, high blood cholesterol, hepatic disease
* respiratory chronic diseases
* cardiovascular diseases including low or high blood pressure (BP)
SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction

The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.

The secondary objectives of this clinical trial are to study the ability of SAR407899 to shorten increase the time to erection duration of penile erection in male patients with mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of SAR407899 in these patients.


Eligibility Criteria:
Inclusion Criteria:

* male with mild to moderate erectile dysfunction for at least 6 months
* written informed consent

Exclusion Criteria:

* diabetes mellitus
* orthostatic hypotension
* hypogonadal testosterone level

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Regional Lung Inflammation and Expansion in Mechanically Ventilated Patients - a PET/CT Study

The goal of this study is to investigate acute respiratory distress syndrome (ARDS) and septic lung with positron emission tomography (PET) imaging and to examine the distribution of inflammation, as measured by neutrophil metabolic activity.


Eligibility Criteria:
Inclusion Criteria:

Group 1

* Mechanically ventilated patients scheduled to undergo a CT scanning for their routine clinical care
* More than 24 hours of mechanical ventilation
* Less than 15 days of mechanical ventilation if patient presents ALI/ARDS (in order to exclude the late, fibrotic, stage of ARDS)

Group 2

* Mechanically ventilated patients with a diagnosis of sepsis
* Less than 96 hours of mechanical ventilation

Exclusion Criteria:

* Age less than 18 years
* Hemodynamic instability, defined as: systolic blood pressure (SBP) \< 90 mmHg that is not adequately stabilized by vasopressors or inotropic agents. For these purposes, SBP will not be considered "adequately stabilized" if the dose of the vasopressor/inotrope has not been stable for at least one hour
* Hypoxemia, defined as: PaO2 \< 70 mmHg on an inspired oxygen fraction (FiO2) greater than or equal to 0.9; FiO2 greater than or equal to 0.8 at baseline
* Hemodynamic and/or respiratory instability (as defined, respectively, in 2 and 3), that develop when the patient is mobilized during routine nursing care such as repositioning/washing the patient or changing their bed linens
* Hemodynamic and/or respiratory instability (as defined, respectively, in 2 and 3), that develop when a 15-25 second respiratory pause is introduced as per the study protocol. This will be tested by inducing such a pause prior to transporting the patient
* Patients must be deemed by the treating clinical staff to be able to tolerate leaving the ICU for 90 minutes (40-60 minute imaging time + 30 minute safety margin). Treating MD, RT, and RN must all agree that the patient is stable for transport
* Any acute or chronic condition which, in the opinion of the investigator, might confound the imaging measurements (such as, but not limited to, severe bronchospasm, pulmonary infection, and lung tumor)
* "Air leaks" requiring tube thoracostomy (e.g., pneumothorax, bronchopleural fistula)
* Pregnancy (since this is a study which would expose a fetus to radiation risk)
* Patients who have neither an arterial nor a central venous line at the time of the enrollement
Bio-Repository of DNA in Stroke: an Epidemiological and Genetic Study

The Bio-Repository of DNA in Stroke (BRAINS) recruits all subtypes of stroke as well as controls from two different continents, Europe and Asia. Subjects recruited from the United Kingdom (UK) will include stroke patients of European ancestry as well as British South Asians. Stroke subjects from South Asia will be recruited from India and Sri Lanka. Subjects are also recruited in Qatar. South Asian cases will also have control subjects recruited.


Eligibility Criteria:
Cases

Inclusion Criteria:

* Patients should be aged \> 18 years at the time of enrolment.
* Diagnosis of haemorrhagic or ischemic stroke using World Health Organization guidelines confirmed by clinical examination and imaging (CT or MRI).
* All patients with cerebral arteriovascular malformations and aneurysms.
* South Asian or Caucasian ethnic backgrounds.
* Patient or relative written informed consent.

Exclusion Criteria:

* Unable to provide consent themselves or through surrogate.
* Stroke not defined on CT or MRI.

Controls

Inclusion Criteria:

* Patients should be aged \> 18 years at the time of enrolment.
* No previous history of stroke.
* able to provide written consent.
Elastography in Patients With Idiopathic Inflammatory Myopathies

The aim of our study was to assess the performance of compression-strain US elastography in patients with idiopathic inflammatory myopathies over time and to study these findings with clinical and functional parameters as well as biochemical and electromyographic tests.

This study will be carried out on four groups:

Group (I): twenty children diagnosed to have idiopathic inflammatory myopathies(IIM)

* Group (II): twenty adults diagnosed to have IIM
* Group (III):20 healthy children matching age and sex as first control group to children with IIM .
* Group (VI):20 healthy adults matching age and sex as second control group to adults with IIM.

All patients will be evaluated at baseline at \& 4-months follow up using Semi-Quantitative strain elastography

Eligibility Criteria:
Inclusion Criteria:

* to fulfill criteria of diagnosis of childhood and adult idiopathic inflammatory myopathies

Exclusion Criteria:

* Patients with age less than 2 years were excluded from the study due to inability to perform manual muscle testing and functional scales.
* The presence of a associated illness that may result in nerve or muscle affection
Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer

The purpose of this study is to evaluate clinical outcomes and adverse events of salvage treatment for locoregional recurrence of breast cancer.

The main questions it aims to answer are:

* Clinical outcomes after salvage treatment for locoregional recurrence
* Adverse events and quality of life after salvage treatment for locoregional recurrence
* Patient characteristics and treatment specifics which are related to the clinical outcomes and/or adverse events
* Molecular signature associated with treatment resistance

Participants will be assessed by multi-dimensional methods during and after radiation therapy:

* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
* Assessment for the adverse events according to CTCAE version 5.0
* Assessment for the molecular signature using residual tissue after pathologic diagnosis
* Assessment for the quality of life using questionnaires (BREAST-Q)


Eligibility Criteria:
Inclusion Criteria:

* Female patients with age 18 to 100.
* Previous standard definitive treatment for initial breast cancer
* Locoregional recurrence without distant metastasis
* Planned salvage treatment for locoregional recurrence
* Informed consent of the participant

Exclusion Criteria:

- Not anticipated for complying the study protocol