cyrilzakka/clinical-trials huggingface dataset:
A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection

The purpose of this study is to assess the safety and effectiveness of rilpivirine hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human immunodeficiency virus type 1 (HIV-1) infection.

This is an open-label (all people know the identity of the study medication), multi-center, observational (study in which the investigators/ physicians observe the patients and measure their outcomes) study. The total duration of the study will be 3 years, and approximately 60 patients who would use rilpivirine hydrochloride in routine clinical practice with a dosing regimen stipulated in the product insert (ie, 25 mg once a day) will be enrolled. As this is an observational study, assessment of patients will be based on the accepted clinical practice in the Philippines. Patients will be monitored from baseline and throughout the 48-week (2nd, 4th, 8th, 12th, 24th, 36th and 48th weeks) treatment period of rilpivirine hydrochloride.

Eligibility Criteria:
Inclusion Criteria:

* Filipino patients
* ARV naive patients with HIV-1 infection who are assessed by the physician to be eligible for treatment with ARVs
* Patients who voluntarily signed the informed consent form

Exclusion Criteria:

* Patients receiving drugs known to prolong QTc intervals, medicinal products with a known risk of Torsade de Pointes and anticonvulsants, systemic dexamethasone, proton pump inhibitors
* Any previous treatment for HIV
* Previously documented HIV-2 infection
* Patients with viral load of \>100,000 HIV-1 ribo nucleic acid (RNA) copies/ml
* Severely ill patients like those with acute acquired immune deficiency syndrome (AIDS)-defining illness or other major concomitant - disease prior to enrolment
* Patients with severe hepatic impairment
* Known hypersensitivity to rilpivirine hydrochloride
* Pregnant or breastfeeding females
MRI in Renal Tumors

Diagnostic imaging for renal masses of unknown nature using conventional imaging modalities such as 3 phase contrast-enhanced computed tomography (CT) is not always conclusive. After (partial) nephrectomy, 10-20 % of the resected tumors show benign histology which could not be identified on diagnostic imaging. With improved imaging techniques available, leading to improvements in characterisation of renal tumors, the number of unnecessary resections may be reduced. The objective of this study is to assess the ability to discriminate oncocytoma from RCC based on the ADC distribution parameters with addition of, tumor volume, and patient demographic characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Radiologic diagnosis of renal tumor based on previous ultrasonography, CT or MRI examinations.
* Signed Institutional Review Board (IRB) approved informed consent form.
* Being at least 18 years of age.
* Histopathologically confirmed renal tumor diagnosis.

Exclusion Criteria:

* Relative contra indications for MRI (metal device/foreign bodies, claustrophobia);
* Active renal or perirenal infection;
* Minor and/or incapacitated adult.
Home Visits for Patients at Risk for Appointment No-shows

Unused clinic visits due to patient no-shows continue to plague American healthcare as a large source of waste and avoidable constraint on access. The average no-show rate across 105 studies was 23% though with wide variation (4% to 79%). No-show behavior has adverse effects on patients, providers, and healthcare organizations' operational and financial outcomes. Patients that miss clinic visits are more likely to need acute care and suffer poor health outcomes. There have been increasingly sophisticated efforts focused on predicting which patients are likely to no-show. This can allow for tactful over-booking and/or patient outreach. At Hopkins, investigators have implemented a novel machine learning based approach for identifying those patients at high-risk for no-show. Offering home visits for patients who are most likely to no-show is an appealing strategy to connect medical providers with patients who need care but are otherwise unlikely to receive it. Yet, it is unclear if this would be helpful to engage patients in their care, and encourage subsequent attendance, or if it would encourage future missed appointments, fostering a reliance on possible ongoing home visits. This study would link existing efforts with no-show prediction to home visits by internal medicine residents and evaluate its clinical impact. Patients at high-risk for no-show will be randomized into the control arm where patients will be called to remind patients of their visits. Those randomized into the intervention arm will be offered a one time home visit in lieu of their in-person visit to help understand barriers to in-person care and build rapport. Outcomes evaluated include future in-person show rates and healthcare cost/utilization


Eligibility Criteria:
Inclusion Criteria:

* One or more poorly controlled chronic medical illness
* More than one chronic illness, regardless of its level of control
* Acute illness

Exclusion Criteria:

* No documented medical illnesses (acute or chronic)
* Single well controlled chronic illness
Management of Venous Thromboembolism in France: a National Survey Among Vascular Medicine Physicians

In France, venous thromboembolic (VTE) disease is usually managed by vascular medicine physicians (VMP). The national OPTIMEV study, conducted more than 12 years ago among VMP practicing in hospital and in the community described the management of VTE in routine clinical practice. Since then a large number of practice changing studies have been published. This includes trials that have validated the use of direct oral anticoagulants (DOAC), the new standard of care of VTE, as per new national and international guidelines. Management of VTE in 2019 appears to be significantly different from the one that prevailed more than 10 years ago when the last national survey was conducted. It is therefore important to have an update on the routine clinical practice management of VTE by VMP. In this perspective the investigators aim to conduct a national survey among VMP practicing in France


Eligibility Criteria:
Inclusion Criteria:

* vascular medicine physicians who are active members of the SFMV (French Society of Vascular Medicine)
* vascular medicine physicians registered as willing to do medical research

Exclusion Criteria:

* vascular medicine physicians who refuse to provide consent
* vascular medicine physicians who are retired
* non-practicing vascular medicine physicians
Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of schizophrenia based on DSM-5® at the time of informed consent
* Patients who are able to be hospitalized for the protocol-defined hospitalization period
* Patients with a body mass index \[BMI = body weight (kg)/height (m)²\] of 18.5 kg/m² or higher and lower than 35.0 kg/m² at screening
* Patients who, in the judgment of the investigator, have stable psychotic symptoms maintained by administration of an antipsychotic within the dosing range indicated below, before commencement of IMP administration \[Upper limit of dose and regimen\] Antipsychotic medication comprising no more than 2 active components, and a daily dose equivalent to ≤600 mg/day of chlorpromazine
* Patients who are able to finish the high-fat meal specified in this protocol within 20 minutes

Exclusion Criteria:

* Patients with a concurrent mental disorder besides schizophrenia who are judged by the investigator to be unsuitable for participation in the trial
* Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of investigational medicinal product (IMP) administration
* Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior

  * Patients who answered "yes" to Question 4 "Active Suicidal Ideation with Some Intent to Act, without Specific Plan" or Question 5 "Active Suicidal Ideation with Specific Plan and Intent" regarding C-SSRS suicidal ideation at screening (for the past 6 months) or at the Period 1 baseline examination (since the last assessment)
  * Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at the Period 1 baseline examination (since the last assessment)
  * Patients who present a serious risk of suicide based on the judgment of the investigator
* Patients who have previously undergone gastrointestinal surgery that could affect PK evaluation
* Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and PK assessments.
* Patients who are using clozapine at the time of informed consent
* Patients whose clinical symptoms have worsened to the point where use of prohibited concomitant therapy or medication is required during the washout period for prior medication
* Patients whose cytochrome P450 2D6 (CYP2D6) phenotype is judged to be either poor metabolizers (PM) or Unknown based on the results of CYP2D6 genotyping at screening
Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer

The purpose of this study is to determine if the use of magnetic resonance imaging (MRI) for breast cancer translates into better surgical outcomes. MRIs may help ensure that as little healthy tissue is removed as is possible and may help prevent the need for additional surgical procedures.

We propose that the role of preoperative staging-MRI in breast cancer be studied by following the occurrence of negative margins at first surgery and the volume of resection in a randomized prospective study. The need for re-excision is an objective marker of satisfactory local surgery and is available as soon as the final pathology report is back. We propose that the closest margin and the rate of re-excision be used as the primary outcome measures to evaluate the contribution of MRI. In addition, since cosmetic preservation is one of the goals of breast conservation, we propose that cosmetic outcome be used as the secondary outcome measure. The visual analogue scale for cosmetic outcome varies between observers and with time; however, the volume of tissue that is excised is an objective surrogate of cosmetic outcome.15 Since the excised volume is dictated by the tumor volume, the only variable under the surgeon's control is the volume of benign tissue excised in order to obtain negative margins. Hence, in this study, we propose to use a volume index of excised margins as an outcome measure for cosmesis. The index value will be calculated for each subject by adding the two measurements of benign margin for each of the three dimensions measured and multiplying them to produce a volume index for each subject.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed breast cancer patients
* Breast cancer patients identified as conservation candidates by their surgeons

Exclusion Criteria:

* Patients with a history of prior breast cancer treatment (recurrence)
* Patients with breast cancer diagnosis during pregnancy (women who could bear children must have a negative pregnancy test before beginning this study)
* Patients with documented sensitivity to gadolinium (contrast agent used during MRI)
* Patients who weigh more than 350 pounds (weight limit on MRI machine)
* Patients who receive neoadjuvant chemotherapy
* Patients with renal insufficiency (serum Cr \> 1.5) due to the danger of nephrogenic systemic sclerosis with the administration of Gadolinium
Non-invasive Nervus Vagus Stimulation in Patients With COVID-19 and ARDS

Critical ill COVID-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. An imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. The nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes.

Aim of this study is to evaluate whether Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients.

Introduction:

Critical ill COVID-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. An imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. The nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes. A method to stimulate the nervus vagus, is the non-invasive Nervus Vagus Stimulation with AuriStim.

Aims:

Aim of this study is to evaluate whether Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients.

Methods:

All patients admitted to ICU at Klinik Favoriten with COVID-19 and moderate to severe ARDS are asked to partcipate. After written consent, a randomisation in Treatment-group (Vagal Nervus Stimulation 4 times a day for each 3 hours until transfer to nomal ward or death) or Non-Treatment-Group is done. In case of stimulation, side effects or intolerance are documented. After discharge or death of the patient, outcomeparameters are evaluated (need of mechanical ventilation, hospital stay, mortality, etc.) and compared between patients of Treatment-Group and Non-Treatment-Group.

Eligibility Criteria:
Inclusion Criteria:

* positive SARS-CoV-2 RT-PCR
* Acute respiratory failure requiring non-invasive respiratory support (NIV or high flow Oxygen)
* PaO2/FiO2 \<200

Exclusion Criteria:

* Age \<18 years
* Pregnancy (to be excluded using Serum betaHCG in women of childbearing age)
* Signs of infection, eczema or Psoriasis at the application site
* Active malignancy
* Implanted cardiac Pacemaker, deficrillator or other active implanted electrical devices
* Patient unable to consent
* Heart rate \<60/min
* Known vagal hypersensitivity
* History of hemophilia
A Stand-alone Therapeutic Music-with-Movement Programme for People With Cognitive Impairment

The number of people living with cognitive impairment is increasing at an exponential rate. More than 100,000 older people are living with dementia in Hong Kong. Alarmingly, about 60% of long-term care residents or day-care centre users are living with dementia, nearly all of whom experience anxiety, depression, or other behavioural and psychological symptoms that place heavy demands on healthcare support and jeopardize their quality of life.

A standalone Music-with-Movement system is developed by integrating innovative and communication technology to facilitate the delivery of an evidence-based music-with-movement intervention. The technology employed are music library, 6-axis motion-sensing music instruments, wireless charging, and RFID.

This study aims to evaluate the changes in health outcomes (cognition, psychosocial well-being and perceived support) of older adults after receiving the service delivered by the trained staff using the standalone music-with-movement system.

Methods:

1. Aims and objectives:

   1. to evaluate the feasibility of the system supporting staff from elderly care institutes in leading musical activities (i.e., recruitment, retention, and acceptability);
   2. to evaluate the engagement of the participants in the intervention; and
   3. to preliminarily examine the health conditions of older adults with cognitive impairment.
2. Methods:

   1. Design: Single-group pre-and-post-test design
   2. Participants: Older adults with cognitive impairment.
   3. Setting: Elderly care institutes, such as daycare centres, community centres, and/or nursing homes.
   4. Sample size: 750 participants.
   5. Outcomes: Recruitment rate, attrition rate, acceptability, any adverse events, engagement in the intervention, health outcomes (social support, frailty, health-related QoL, MoCA).
   6. Data analysis strategies:
   7. Ethical consideration: Approval has been obtained from the University (HSEARS20211026009)

Eligibility Criteria:
Inclusion Criteria:

* Older adults with cognitive impairment
* In a stable medical condition

Exclusion Criteria:

* With critical medical or psychiatric problems
* Those with uncorrectable hearing impairment
Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry

In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. After years numerous patients may develop bioprosthesis failure, requiring valve reintervention. Significantly burdened ones are oftentimes disqualified or not referred to surgery redo. An emerging treatment method for these patients is transcatheter mitral valve-in-valve implantation as an alternative to re-operation. This technique is applied with the use of devices previously dedicated to transcatheter aortic valve implantation (TAVI). Recent papers prove that transcatheter mitral valve replacement (TMVR) is a safe and effective procedure when performed in a selected group of high-surgical-risk patients. However, data regarding the Polish population are limited. Therefore, the aim of the study is to create a nationwide registry, collecting data from all Polish centers performing TMVR in order to describe the population of patients developing mitral bioprosthesis failure, evaluate their follow-up after TMVR as well as results of the transcatheter valvular intervention and identify potential limitations of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
* Qualification for TMVR by decision of the local Heart Team
* Patient provided written informed consent

Exclusion Criteria:

- Disqualification from TMVR
Complement Inhibitor Eculizumab in Clinical Islet Transplantation

This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant.

This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant. Ten patients from 2 centres (Uppsala University Hospital and Karolinska University Hospital in Stockholm) will be transplanted. The purpose of the study is to investigate if selective complement inhibition by eculizumab combined with standard anticoagulation during and after transplantation can further reduce the extent of early tissue loss after portal infusion of islets.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 to 65 years of age
* Patients able to provide written informed consent
* Absent stimulated c-peptide (\< 0.1 nmol/L). This includes also previously islet-transplanted patients with no detectable c-peptide.
* Patients at fear of severe hypoglycemia
* Female patients of child bearing potential must have a negative pregnancy test (s-β-HCG) and must be practicing an effective, reliable medical accepted contraceptive regimen while on eculizumab treatment and to study end at 75 days.
* Patients vaccinated against Neisseria meningitides or patients accepting adequate antibiotic prophylaxis

Exclusion Criteria:

* Body mass index \> 30 kg/m2
* Untreated proliferative diabetes retinopathy
* Recipient of any other concomitant organ transplantation - Glomerular filtration rate \< 50 mL/min before first islet transplantation
* Positive T-cell cross-matching by Complement Depending Cytotoxicity (CDC)
* Pregnancy or lactating
* Active ongoing infection, bacterial or viral
* Unresolved meningococcal disease
* Known bleeding disorder
* Known complement disorder
* Have received any other investigational drug within 30 days before inclusion
* History of drug or alcohol abuse within the last year
Dysfunctional Breathing in Difficult Asthma.

We plan to use the Life Shirt to record tidal volume, respiratory rate and breathing pattern over a 6 hour period in patients admitted with difficult asthma. The Life Shirt will also be used to collect the same data over the same time period in a group of healthy controls. This data will then be correlated with the assessment of the supervising consultant as to whether the patient has any element of dysfunctional breathing contributing to their symptoms. It is hoped that the data obtained may in future be used to offer treatment to those patients with dysfunctional breathing.

Hypothesis

Dysfunctional breathing patterns are more prevalent in patients with a diagnosis of difficult to treat asthma than healthy volunteers.

Design

This will be an open, prospective study, recruiting sequential patients admitted electively to undergo the difficult asthma protocol (DAP). These patients are generally admitted during a period of stability, but still have significant symptoms despite asthma therapy. Healthy volunteers will be recruited from hospital staff and their family and friends.

We will recruit patients over a 12 to 18 month period and hope to enrol 60 patients. On the final day of their 4 day admission, patients will be asked to wear the life vest from 0800hrs. During the morning they will undergo a 6 minute walk to test to assess their responses during exercise. They will also be reviewed by the supervising consultant to discuss the results of their investigations. While wearing the shirt, the patient will be asked to keep a diary of their activities and symptoms. The Life Shirt can be removed by the patient at the time of discharge.

20 Healthy volunteers will be recruited from the hospital staff. They will be asked to wear the life vest while undertaking their normal daily activities. They will also undertake a 6 minute walk test.

Tidal volume, minute volume and respiratory rate will be recorded at rest and during exertion, aided by the patient diary. Breathing pattern and features of dysfunctional breathing, such as frequent sighs, will also be noted. This will subsequently be correlated with the assessment of the supervising consultant with regard to the presence of dysfunctional breathing.

Data will also be analysed with regard to whether there are any differences between healthy volunteers, patients felt to have asthma, and those felt not to have asthma by their admitting consultant.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of difficult asthma

Exclusion Criteria:

* Current breastfeeding