cyrilzakka/clinical-trials huggingface dataset:
Renin and Prorenin in Pregnancy

To determine the role of the prorenin-renin-angiotensin-aldosterone system (RAAS) in normal and hypertensive pregnancy.

BACKGROUND:

The renin-angiotensin system is involved in the physiology of pregnancy in two ways. Circulating angiotensin II affects blood pressure, renal hemodynamics, and uteroplacental blood flow. Abnormalities in angiotensin II production rates in hypertensive pregnancy contribute to the hemodynamic changes seen in the disease. Additionally, there is a form of the renin-angiotensin system in kidney, ovary, and placenta whose function is regulated by prorenin. Prorenin, activated by a specific receptor, is involved in the regulation of steroid hormone biosynthesis and renal and uteroplacental blood flow.

The study was conducted in response to a Request for Applications on Research on Hypertension in Pregnancy jointly released in 1986 by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development.

DESIGN NARRATIVE:

The study was longitudinal in design. Measurements were made of glomerular filtration rate, renal plasma flow or uterine blood flow. To define first trimester changes, studies were conducted on in vitro fertilization and ovarian failure patients who had a broad spectrum of plasma prorenins. Since interrelated changes in renin and prostaglandins may participate in the pathogenesis of hypertensive pregnancy, RAAS, prostaglandins, and uteroplacental flow velocity profiles were monitored during a placebo-controlled trial of low-dose aspirin in chronic hypertensives.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Health Education for Women With Breast Cancer

The sedentary lifestyle in women with breast cancer generates a problem for public health. An alternative that has been used to reduce sedentary behavior are interventions with the use of information technology, as well as projects with health education can cause lifestyle changes. However, little is known about the effect of these interventions on self-awareness and self-care in women with breast cancer. This aim of study is evaluate the effect of health education on sedentary behavior, lifestyle, physical activity level, nutrition, self-esteem, anxiety and depression, quality of life, pain, functional capacity, and strength in women with breast cancer. This is a study the 12 weeks, with patients being treated for breast cancer, distributed for two groups: Group Health Education Recommendations and Control Group.

This is a clinical trial with patients being treated for breast cancer, the sample will be randomly distributed into two groups: Group Health Education Recommendations (GRES) and Control Group (CG), which will remain in usual care. The intervention will last for 12 weeks, where GRES will receive health education recommendations in person and via social media. The endpoints of this study are sedentary behavior, lifestyle, physical activity level, nutrition, self-esteem, anxiety and depression, quality of life, pain, functional capacity, and strength. Evaluations will be performed at baseline, after 6 weeks, and after 12 weeks. Data will be analyzed by multivariate, comparing the effects of group, time, and interaction in SPSS software version 24.0, with α=5%.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years or older;
* Diagnosed with breast cancer;
* Ongoing breast cancer treatment (chemotherapy, radiotherapy and/or hormone therapy);
* Have daily access to a smartphone.

Exclusion Criteria:

* Women having another type of cancer;
* Perform physical training for three months before the intervention;
* Has medical contraindication to perform any type of physical activity;
* Have filled in yes on the PAR-Q and medical contraindication;
* Without cognitive conditions to use a smartphone or answer questionnaires;
* Illiterate women.
A Study to Investigate the Appearance and Disappearance of ASP3652 in Blood and Spinal Fluid in Healthy Male Subjects

The purpose of this study is to evaluate the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK) of multiple doses of ASP3652 in healthy young Caucasian male subjects. Also to evaluate the plasma and CSF pharmacodynamics (PD) of multiple doses of ASP3652 in healthy young Caucasian male subjects and to assess the safety and tolerability of multiple doses of ASP3652 in healthy young Caucasian male subjects.

Screening takes place between Day -22 to Day -2. Subjects are admitted to the clinical on Day -1 and remain until Day 12.

On Days 5 to 9, subjects receive twice-daily doses of ASP3652, and a single dose on the morning of Day 10. Subjects fast for 10h before the morning dose on Days 5 to 9 and they are served the first standard meal 1h after the morning dose.

A spinal tap is used to collect cerebrospinal fluid (CSF) on Day 1 and Day 10. A plasma sample for PK sample is obtained before first dosing on Day 5. To confirm steady-state concentrations of ASP3652 in plasma, blood samples are obtained before the morning dose on Days 7, 9 and 10, and before the evening dose on Days 5, 7 and 9. On Day 10, a PK profile of ASP3652 in plasma is obtained for up to 48h after the morning dose and for up to 24h in CSF.

Profiles of several enzyme substrates in plasma and seminal fluid (exploratory) are obtained on Day 1 and Day 10 up to 24h in CSF and up to 48h in plasma, before the morning and evening dose on Days 5, 7 and 9 in plasma.

Vital signs, 12-lead electrocardiograms (ECGs), safety laboratory assessments, adverse events (AEs) and concomitant medication are monitored throughout the investigational period until the ESV.

Eligibility Criteria:
Inclusion Criteria:

* Subject is white and of Caucasian origin.
* Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
* Male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.

Exclusion Criteria:

* Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.
* History of excessive bleeding or bruising.
* Abnormalities of coagulation screen including platelet count, prothrombin time (PT) and activated partial thromboplastin time (aPTT).
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi

This study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger Chinese population who will receive isavuconazole treatment in a post-marketing setting.

This is a single arm, prospective, multi-center study. This study is seeking Chinese patients with proven, probable or possible Invasive Fungal Disease (IFD) caused by Aspergillus species or other filamentous fungi. All the participants will receive isavuconazole treatment. The longest treatment duration in this study is 84 days (up to 180 days for participants diagnosed with IM).

The primary objective is to characterize the safety and tolerability of isavuconazole through observing the treatment emergent adverse events.


Eligibility Criteria:
Inclusion Criteria:

* proven, probable, or possible IFD caused by Aspergillus species, Mucorales species or other filamentous fungi
* body weight \>40 kg at screening

Exclusion Criteria:

* either chronic aspergillosis, aspergilloma, or ABPA
* Advanced HIV infection with CD4 count \< 200 or acquired immunodeficiency syndrome-defining condition
* people who are unlikely to survive 5 days or participants on mechanical ventilation
* severe hepatic impairment (Child-Pugh Class C)
* familial short QT syndrome
* Concomitant use of efavirenz, ritonavir, etravirine, rifampicin/rifampin, rifabutin, nafcillin, ketoconazole, or St. John's Wort in the 5 days prior to first administration of study intervention
Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus

If etiologies of temporomandibular disorders (TMD) are various, parafunctions become more and more important. Treatment of patients presenting TMD is based on conservative and reversible therapeutics. The behavioural reeducation of these patients which aims at decreasing their parafunctions is a treatment often performed.


Eligibility Criteria:
Inclusion Criteria:

* Male and female over 18,
* Patient who was informed about the protocol and who did not refuse to take part in the programme,
* Patient who suffers of dysfunctions of masticatory apparatus: myofascial pain, joint clicking or crepitations, disc deplacement with reduction, mandibular limitation and/or deviation,
* Patient who presents more or less obvious parafunctions, which are associated or not to other etiologies
* Patient consulting for the 1st time for TMD

Exclusion Criteria:

* Persons over 18 who are under legal protection (guardianship), persons who are deprived of their freedom,
* Patient who is already followed in the consultation of dysfunctions of masticatory apparatus and who is under treatment,
* Patient who is under treatment of occlusal splint (not in the framework of the consultation of TMD
* Patient with pains other than orofacial pains (cephalalgia, neuralgia, vascular algia of the face, migraine),
* Patient who needs a treatment other than a behavioural reeducation (pharmacological treatment, occlusal splint , addressed to another therapist, prosthetic treatment)
Impact of Tools for the Development of Patient Centered Care at Hospital

A national context for patient centered care development exists in France at hospital with strong support for the implementation of operational patient centered care tools. Patient centered care is a global vision of patient or family management promoting the respect of patient freedom, of patient listening and of patient needs. Patient centered care is an important issue of quality and security of care. The FORAP (Fédération des Organismes Régionaux et territoriaux pour l'Amélioration des Pratiques et des organisations) and the la HAS (High Authority of Health) have developed and validated five tools promoting patient centered care at hospital.

They can be implemented one by one or in association according to hospital situation. Hospitals should identify the association of tools fitting the most to their objectives and the actions already done.

The objectives of the project are to analyse the effectiveness of the implementation of HAS - FORAP tools on the development of patient centred care at hospital and to analyse the individual and organisational determinants of their effectiveness. It focuses on acute care hospitals that have the choice of the combination of tools and that are followed during two years with combined quantitative and qualitative analyses. Quantitative assessment are based on validated indicators on patient satisfaction, patient centred care development and organizational context. Qualitative data collection are realised in each included hospital and combine individual interviews and focus groups including Physicians, nurses and managerial staff.


Eligibility Criteria:
No specific eligibility criteria for health care professionals

Eligibility criteria for patients:

Inclusion Criteria:

* Patients hospitalized for a minimum of 2 consecutive nights
* Patients contact details known after hospitalization end

Exclusion Criteria:

* Anonymous patient
* Patient deceased during hospitalization
* Patient non resident in France
Patients With Chronic Knee Pain Treated With Conventional Radiofrequency of the Genicular Nerves

Management of chronic knee pain remains a challenge to the treating physician. A radiofrequency treatment of the genicular nerves is a not yet established but promising technique. This procedure is minimal invasive and has few adverse events. For these reasons it can be advantageous and fulfilling the unmet needs of these chronic knee pain patients warranting further research of its efficacy.

To investigate this efficacy, all patients treated with radiofrequency ablation in the multidisciplinary chronic pain center between 1 September 2017 and 31 December 2019 with exclusion of patients with chronic widespread pain, will be retrospectively analyzed in a single-center cohort.

This project has as primary objective the evaluation of treatment success of a conventional radiofrequency treatment of the genicular nerves in patients diagnosed with chronic knee pain due to osteoarthritis of the knee or persistent post-surgical pain (PPSP) at six weeks post treatment. Secondary objectives are evaluation of treatment effect at a third time point at the end of the inclusion period, subgroup analysis of treatment success based on indication to treatment, evaluation of subjective functional improvement and change in analgesics, estimation of the duration of effect of the treatment and adverse events.

This study includes all patients treated with radiofrequency ablation in the multidisciplinary chronic pain center in Ziekenhuis Oost-Limburg, Campus Sint-Barbara between 1 September 2017 and 31 December 2019 with exclusion of patients with chronic widespread pain.

The main study outcome is the proportion of patients with a global perceived effect of at least 50% at 6 weeks post intervention. Secondary outcomes include reduction in pain intensity, measured by Numeric Rating Scale (NRS) at six weeks and at a third time point, global perceived effect at a third time point, subjective change in physical functioning, duration effect of the treatment, use of strong opioids, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves

Exclusion Criteria:

* A negative diagnostic block with lidocaine 2% 1 ml of the three genicular nerves defined as less than 50% pain reduction
* Chronic widespread pain
Development of Training Programs for Nursing Competency Reinforcement to Spread Trauma Intervention

This study aims to improve the trauma intervention competency of nurses through online-based training of the nursing intervention program for trauma-experienced subjects. The specific goals are as follows.

1. Based on Swanson's Caring Theory, develop an online training program for nurses to spread trauma nursing intervention and improve competency.
2. Evaluate the effects of the developed program's workbook and online training on nurses' trauma-related knowledge and attitude, self-efficacy, and professional quality of life.

Of the 42 subjects who enrolled in the study, 1 dropped out before intervention, resulting in 41 participants who completed all interventions and surveys.


Eligibility Criteria:
Inclusion Criteria:

* Those who have a nurse's license
* Those who work at the Mental Health Welfare Center
* Those who can access the program through a computer or mobile
* Those who understand the purpose of the research and voluntarily agree to participate in the research

Exclusion Criteria:

- Those who do not agree to participate in the study
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors

This randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related fatigue in breast cancer survivors. Supplementation with omega-3 fatty acid may help reduce cancer-related fatigue in breast cancer survivors.

PRIMARY OBJECTIVE:

I. To collect preliminary statistical data (mean changes and standard deviations) on two omega-3 supplementation (omega-3 fatty acid) regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing cancer-related fatigue (CRF) in fatigued breast cancer survivors.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive low-dose omega-3 fatty acid supplementation orally (PO) twice daily (BID) and placebo PO BID for 6 weeks.

ARM II: Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

ARM III: Patients receive placebo PO BID for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past
* Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer
* Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin)
* Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine
* Be able to read English
* Able to swallow medication
* Give written informed consent

Exclusion Criteria:

* Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®)
* Be taking anticoagulant medication (does not include aspirin)
* Have sensitivity or allergy to fish and/or shellfish
* Have sensitivity or allergy to soy and/or soybeans
* Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue
Multimodal Retinal Imaging of Cerebrovascular Stroke

The hypothesis is that in patients with stroke, abnormalities of retinal microvascularization shown on color fundus photography and the depletion of retinal capillary density evaluated by OCT-A are markers of acute impairment of microcirculation of the central nervous system and are correlated with lesions on brain imaging.

Patients hospitalized for stroke MRI-confirmed, will be included. An ophthalmologic assessment including color fundus photography (CFP) and OCT-A will be carried out after stabilization and at 3 months follow-up. Outcomes assessor will be blinded.


Eligibility Criteria:
Inclusion criteria:

* Acute ischemic stroke
* With cerebral microangiopathy (defined by a SVD score \> 1)

Exclusion criteria:

* Acute hemorrhagic stroke
* Anophthalmia
Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury

This study evaluates the use of remote ischaemic preconditioning for the prevention of dialysis induced cardiac injury. The study uses four arms to test different frequencies of application to ascertain which, if any, is most successful at reducing dialysis induced cardiac injury.


Eligibility Criteria:
Inclusion Criteria:

1. Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
2. Male and female, age≥16 years old.

Exclusion Criteria:

1. Not meeting inclusion criteria
2. Exposure to haemodialysis for \<90 days prior to recruitment
3. Severe heart failure (New York Heart Association grade IV)
4. Cardiac transplant recipients
5. Mental incapacity to consent
6. Declined to participate
7. Taking cyclosporin
8. Taking ATP-sensitive potassium channel opening or blocking drugs
Vitamin D in Bronchiolitis Obliterans Syndrome

Vitamin D deficiency occurs in around 50% of our transplant population. Preventive treatment with Vitamin D (D-cure) can reduce the prevalence of Bronchiolitis Obliterans Syndrome after lung transplantation

* Prospective, interventional, randomized, double-blind, placebo-controlled trial.
* Clinical setting (tertiary University Hospital).
* Investigator-driven, no pharmaceutical sponsor.
* Lung transplant recipients.
* Add-on of study-drug (placebo or vitamin D) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
* 1:1 inclusion ratio (placebo:Vitamin D).
* Randomisation at discharge after informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Stable LTx recipients at discharge after transplantation.
* Signed informed consent
* Adult (age at least 18 years old at moment of transplantation)
* Able to take oral medication

Exclusion Criteria:

* Prolonged and/or complicated Intensive care unit-course after transplantation.
* Early (\<30 days post-transplant) post-operative death
* Major suture problems (airway stenosis or stent)
* Retransplantation (lung)
* Previous transplantation (solid organ)
* Multi-organ transplantation (lung+ other solid organ)
ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients

The principal aim of this prospective observational study is to investigate the cognitive function of breast cancer patients that use AI, comparing it with age-matched healthy controls, utilizing cognitive assessments and functional magnetic resonance imaging (fMRI). Additionally, the project seeks to establish correlations between cognitive function and other estrogen deprivation symptoms, including vasomotor symptoms, and to evaluate a possible correlation with endothelial damage studied through Angio Optical Coherent Tomography (angio OCT).

Patients will be recruited during follow up visits at the iatrogenic menopause outpatient clinic. After informed consent, the will be asked for detailed demographic data, medical, oncological and gynecological history. Hypoestrogenism symptoms will be collected through validated questionnaires. The cognitive assessment will be performed on the same day, by trained staff. The fMRI and angioOCT will be booked and performed depending on patient and clinic availability.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients undergoing endocrine adjuvant therapy with AI, with or without GnRH agonists, depending on menopause status at diagnosis (cases only)
* At least 18 years old
* Good comprehension of oral and written Italian language

Exclusion Criteria:

* incomplete ovarian suppression (cases)
* previous neoplastic diseases other than the presently treated breast cancer for cases
* known neurological or psychiatric disorders
* use of hormonal contraception or hormonal replacement therapy (controls)
Virtual Reality in the Management of Pain in Pediatrics: a Multi-center Randomized Clinical Trial (RealPED)

The goal of this clinical trial is to test if the use of virtual reality glasses reduces the pain and anxiety that children feel when they perform a blood test.

Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate, and the children will be divided into two groups. In the control group, the analysis will be done in the usual way (for example, distracting with questions) and in the intervention group, the analysis will be done while the children use virtual reality.

The satisfaction of parents and nursing will also be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Children between 7 and 12 years old who attend participating centers for scheduled blood tests.
* Consent to participate by signing the informed consent.

Exclusion Criteria:

* Children younger than 7 years old.
* Children older than 12 years old.
* Children that don't sign the informed consent.
* Children with psychomotor and neurocognitive delay.
* Children with visual or hearing impairment.