cyrilzakka/clinical-trials huggingface dataset:
The VIDA After COVID Study

The purpose of this study is to objectively identify and address social determinants of health (SDOH) priorities and barriers in Latino patients who survived or are vulnerable to COVID-19, and to understand the consequences of COVID-19 survivorship in local Latino communities.


Eligibility Criteria:
Inclusion Criteria:

* Study population will be identified via community partnerships and peer referrals.
* Participants include Latino families in Southern Minnesota (Dover, Olmsted and Mower county, Minnesota) who survived COVID-19 after requiring ICU or hospital admission, and their families and/or their care partners, or Latino patients who are vulnerable to COVID-19, that have provided research authorization o identified via electronic health registries (following Institutional Review Board approved guidelines).

Exclusion Criteria:

* Families that do not identify as Latino.
* Those living outside Dover, Olmsted and Mower County, Minnesota.
* Those that do not provide written consent.
Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice

The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of these patients during the first 2 years of treatment. In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.


Eligibility Criteria:
Inclusion Criteria

* Women with a clinical diagnosis of postmenopausal osteoporosis
* Decision has been made to treat with denosumab 60 mg once every 6 months
* Have received their first injection of denosumab within 8 weeks prior to enrolling in this study.
* Appropriate written informed consent has been obtained (as required per local country regulations)

Exclusion Criteria

* Participating in ongoing or have participated in previous denosumab clinical trials
* Participation in other clinical or device trials in the last 6 months
* Contra-indicated for treatment with Prolia® according to the approved applicable local product label.
* Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent
FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)

This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).


Eligibility Criteria:
Inclusion Criteria:

* Between 12 and 70 years of age, inclusive.
* Body weight at least 45 kg (approximately 100 pounds).
* PAH that is either idiopathic/heritable (including PAH associated with appetite suppressant/toxin use); PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); PAH associated with collagen vascular disease; or PAH associated with HIV.
* Baseline 6-minute walk distance between 150 and 450 meters, inclusive.
* Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
* Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
* Reliable and cooperative with protocol requirements.

Exclusion Criteria:

* Nursing or pregnant.
* Received a prostacyclin within the past 30 days.
* PAH due to conditions other than noted in the above inclusion criteria.
* History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
* Use of an investigational drug within 30 days of Baseline.
Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease.

The main aim of this study is to demonstrate how disorders characterized by different types of "inflexibility", cognitive-affective type for Anorexia nervosa and motor one for Parkinson's disease, have an impact on how emotional stimuli are processed and on the transition within emotional states.

Although many psychometric models have been developed on emotions, affect measurements, which represent the measurement of behavioural, subjective and neuropsychophysiological changes associated with an emotional episode, still remains one of the most debated topics. Emotions are entities with blurred boundaries and with substantial idiosyncrasies that characterize their measurable manifestations. One of the most consolidated theoretical reference models for measuring affect is that of James Russel called the "Affective Core Model". According to this model, emotion arises when the undifferentiated and pre-reflective magma of affect (core affect) is attracted by an external (or internal) object that can be defined as emotigenic, i.e. capable of defining the nature of emotional experience by orienting it along two dimensions principal factors. The most used theoretical model for affect measurement is the one that describes an emotional episode in the light of two distinguishable continuous dimensions: that of hedonic value (identifies the degree of pleasantness of the emotional event), of a subjective nature, and that of arousal or psychophysiological activation. Although this model has been widely corroborated in various disciplines, there is still a lack of a clear description of the process that allows an individual to transition from one emotionally object-oriented state to another.

This project proposes and intends to validate a new modality of three-dimensional psychometric modeling of emotions, based on the intersection between the consolidated two-dimensional model of arousal-valence and a third purely cognitive component definable as mental flexibility, capable of including high-level cognitive processes, intrinsically connected with the emotional sphere, such as emotional intelligence (Emotional Intelligence, EI) and emotional regulation.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease
* Anorexia nervosa
* Written informed consent

Exclusion Criteria:

* Other psychiatric disorders
* Acute infectious diseases
* Chronic inflammatory diseases
* Other Disorders of central nervous system
* Pregnancy or breastfeeding
* tachy or bradyarrhythmias, other cardiac rhythm alterations that compromise the study of heart rate variability
Brain Responses to Visual Food Cues in Response to a Low Carbohydrate Diet

The aim is to profile and elucidate the hormonal and neurological system interaction to food related behavior. The stimulus used will include visual and taste (gustatory) stimuli. The study will profile induced correlations of metabolic parameters, gut hormones and brain region (ROI - regions of interest) activation and interaction. In this study we will use fMRI (functional MRI) to compare brain responses in obese, normal-weight and reduced weight subjects. The food stimuli will be blocked into specific categories to allow for investigation of different responses to alternating energy density foods. The response will be tested prior to and following a brief low carbohydrate dietary regimen.

The study will be a longitudinal study where the participants will come back twice on the same phase of the period- both visits in the luteal phase with a month between each visit. In this part of the study there will be 40 participants with a wider range of BMI. This phase of the study will include a nutritional intervention - the participants will be asked to have a carbohydrate restricted diet (60 grams of carbohydrate)- for a period of a month with no caloric restriction. Food records will be kept and followed and a ketone test (blood test) will be done on the morning of the study visits.

Eligibility Criteria:
Inclusion Criteria:

* Age 18- 45 years
* No contraindication to enter the MRI
* No significant visual problems that may hamper visualization of visual stimuli within the magnet
* No contraceptive hormonal replacement
* relatively regular menstrual cycle

Exclusion Criteria:

* contraceptive hormonal replacement
* under the age of 18
* over the age of 45
* pharmacological treatment that can effect brain response
* Irregular menstrual cycle
Accuracy of the LiverVision® Semi-automated Liver Volumetry Software

The LiverVision® software was designed to provide three-dimensional (3D) visualisation of the liver using Computed Tomography (CT) scans. It provides semi-automated volumetry measurements, vascular structure and territory tools.

Liver volumetry has been widely used in liver surgery and living donor liver transplantation to estimate the future liver remnant or the required liver volume for the recipient, respectively.

Liver volumetry is typically performed using CT imaging with specially designed software. Such manual measurements are time consuming and there is an ongoing debate whether the they reflect the actual liver volume when performed by radiologists or surgeons as well as according to the different software currently available in the market.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Living liver donors.

Exclusion Criteria:

* Recipients
Tonsillectomy and Primitive IgA Nephropathy in Children: Strasbourg Cohort and Assessment Practices in Inter North East Region

Primitive kidney disease IgA, represented by Berger's disease and rheumatoid purpura nephropathy, are the first cause of kidney failure from chronic glomerulonephritis: changes in 20 years to end-stage renal failure is described in 10 to 30 % of cases in Berger's disease and in 15 to 20% of cases in nephropathy HSP. These two pathological entities share biological and histological characteristics, as well as common pathophysiological mechanisms, particularly the production of abnormally glycosylated IgA1 promoting their proliferation in the mesangium. Tonsils part of Iga abnormal production sites that would be associated with an infectious stimulus, tonsillectomy has been studied as a possible treatment in primitive IgA nephropathy. The benefit of tonsillectomy is controversial: many Japanese studies demonstrate its effectiveness in terms of reduction of proteinuria, improved renal function in the long term regression of histological lesions and reduced risk of relapse following clinical remission whereas European studies do not suggest its effectiveness in treating IgA nephropathy. In this context, the aim of our study is to describe the scope of practice of tonsillectomy in the treatment of primary renal disease in IgA child in the inter East region and describe the short renal become Strasbourg end of the cohort that received this treatment.


Eligibility Criteria:
Inclusion criteria:

* Children with a clinical diagnosis and / or histological evidence of primary IgA nephropathy
* Follow the University Hospital of Strasbourg since 2009
* Having received a tonsillectomy in their care
* Children whose holders of parental authority does not oppose the use of clinical data from their child for research purposes

Exclusion criteria:

* Children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes
Model-informed Individualized Treatment of Anti-Infective Drugs in Patients With Spinal Infections

The purpose of this study is to describe the population pharmacokinetic characteristics in patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy, and to evaluate effectiveness and safety of these drugs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy.

Exclusion Criteria:

* Pregnant/lactating women.
* There are other factors that the researchers think are not suitable for inclusion
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
* Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
* A positive stool test for the presence of C. difficile within 60 days prior to enrollment.

Exclusion Criteria:

* A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
* Requires antibiotic therapy for a condition other than recurrent CDI.
* Previous fecal transplant prior to study enrollment.
* History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
* History of irritable bowel syndrome (IBS).
* History of chronic diarrhea.
* History of celiac disease.
* Colostomy.
* Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
* Life expectancy of \< 12 months.
* Compromised immune system.
The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR

It is generally assumed that renal blood flow is symmetric in the absence of renal artery stenosis. The importance of studying the function of both kidneys separately is because it cannot be assumed that they are functionally equal.The aim of the present study is to evaluate whether this is really in patients with essential hypertension and/or moderate kidneys loss.

To validate color Doppler ultrasonography of renal arteries for the assessment of renal blood flow (RBF), we comparing left and right RBF estimates and their sum (total RBF) by echo-Doppler with data obtained by 99mTc-DTPA scintigraphy in 50 patients with hypertension and/or moderate renal failure, compared with 30 normal control subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension
* Patients with moderate renal insufficiency
* Normal subjects

Exclusion Criteria:

* Patients with solitary kidney function
* Patients with renal artery stenosis
* Patients underwent renal angioplasty and stenting
Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS

Irritable Bowel Syndrome (IBS) is a widespread disease with variable symptoms that have an important impact on the quality of life. Despite the prevalence of IBS, its etiology and pathophysiology are still to be fully understood, but immune response is known to be involved. In this study, the investigators researched the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS), following a personalized an unrestricted-calorie diet.

The investigators enrolled 30 subjects with diagnosis of IBS, according to Rome-IV criteria, whose inflammatory markers were measured at baseline and after 6 weeks of dietary intervention. The subjects were monitored in a general practice outpatient setting (GP) and nutritional advice was offered remotely via two telephone sessions with a nutritionist. The researchers investigated the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS).

Data monitoring was ensured by an external monitor (Hippocrates Research, Genova, Italy).

All data entry was in accordance with GCP protocol, and AE were classified using CTCAE 4.0

Eligibility Criteria:
Inclusion Criteria:

* IBS (according to ROME IV criteria)
* blood analysis within 1yr with CBC, TSHr, ESR, CRP, urine, glucose
* attitude to change dietary habits
* willing to follow study protocol

Exclusion Criteria:

* low BMI (\<18.5 kg/m2)
* pregnancy
* restrictive dietary habits (e.g. veganism)
* positive FOBT
* faecal calprotectin \>200 mcg/g
* known or recurrent bowel infections
* known or recurrent UTI (\>3/yr)
* former diverticulitis
* alcohol abuse
* major concurrent disease (e.g. IBD, coeliac disease, eating disorder,...)
* pharmacological treatment with drugs that alter intestinal motility (e.g. PPI, metformin,...)
Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke

Approximately 30% of people with stroke experience symptoms of depression. Many may benefit from access to mental health services that target unhelpful thoughts, such as cognitive behaviour therapy (CBT), but go untreated due to lack of access to specialized care, costs, remote location, or stigma related to seeking care. Internet Cognitive Behavioural Therapy (ICBT) may overcome these barriers. The stroke ICBT program teaches skills such as challenging unhelpful thoughts, memory and attention, managing related physical symptoms, and pacing through a mix of online learning and weekly contact with a trained Guide. While the program's content was found to be acceptable among individuals after stroke, the program's effectiveness still needs to be evaluated. Thus, the primary purpose of this study is to evaluate if the stroke ICBT program will improve symptoms of depression compared to an attention control group. Individuals in both groups will answer questions about themselves and their injury and describe symptoms of depression, quality of life, and health service use to evaluate its impact on people's wellbeing. The study results will be useful in determining if the ICBT program is effective and whether it should be part of routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* Canadian residents;
* diagnosed with a stroke at least 6 months ago;
* endorsing symptoms of depression (PHQ-9≥5); 5) suicide risk score \<8 (Suicide Behaviours Questionnaire);
* speak and read English;
* able to access and be comfortable using computers and the internet;
* willing to provide a physician as an emergency contact.

Exclusion Criteria:

* significant cognitive impairment, a score of \<21 on the Telephone Interview for Cognitive Status;
* aphasia, with significant language impairment;
* currently involved in another psychotherapeutic intervention;
* present with a severe mental health disorder requiring in-person therapy (e.g., severe suicidal ideation, severe substance abuse, a recent history of psychosis or mania).
Study of PHA-848125AC in Adult Patients With Advanced/Metastatic Solid Tumors

The purpose of this open-label, multi center, Phase I study was to determine the safety profile of the oral compound PHA-848125AC administered according to two different schedules of administrations to advanced/metastatic solid tumor patients. Objectives of the study were to determine the maximum tolerated dose and the dose that can be recommended for Phase II investigations.


Eligibility Criteria:
Inclusion Criteria:

* Signed, written IRB-approved Informed Consent
* Histologically or cytologically confirmed relapsed or refractory solid tumors for which no standard therapy exists
* ECOG (WHO) performance status 0-1
* Life expectancy of at least 3 months
* Age \>=18 years
* A negative pregnancy test (if female in reproductive years)
* Acceptable liver and renal function
* Acceptable hematologic status
* 10. Previous cancer therapy is allowed with the exclusion of experimental CDK2 inhibitors. Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy must be completed within one month prior to study entry
* Use of effective contraceptive methods if men and women of child producing potential
* Capability to swallow capsules intact
* Grade \<=1 retinopathy

Exclusion Criteria:

* In the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
* Known brain metastases
* Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Pregnant or breast feeding women
* Unwillingness or inability to comply with procedures required in this protocol
* Known infection with HIV, active hepatitis B or hepatitis C
* Diabetes mellitus uncontrolled, or with clinical evidence of diabetic retinopathy, severe peripheral vascular disease or diabetic ulcers
* Current enrollment in another clinical trial
* Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation (lactose intolerance)
* Previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease, multiple sclerosis, stroke and cerebellar injury
* Gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption
* Chronic/intensive use of antacid or H2 receptor antagonists
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the investigator and/or the sponsor.