cyrilzakka/clinical-trials huggingface dataset:
Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.

This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.


Eligibility Criteria:
Inclusion Criteria:

* Participants are treatment-naïve or treatment-experienced with pegylatedinterferon (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.
* Participants may be enrolled up to 4 weeks after treatment initiation
* Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria:

None.
Phase II Clinical Trial of PD-L1 in Combination with Vinorelbine + Cyclophosphamide + Capecitabine (VEX) Metronomic Chemotherapy with or Without Radiotherapy for Advanced Triple-negative Breast Cancer.

Phase II clinical trial of PD-L1 in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.


Eligibility Criteria:
Subjects are eligible to be included in the study only if all of the following criteria apply:

1. Male or female who is 18 years of age or older on the day of signing the informed consent form.
2. Subjects with metastatic triple-negative breast cancer, with clear clinical data records; specific reference to the "American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines."
3. Have received less than or equal to 1 line of chemotherapy for metastatic breast cancer;
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 10 days before the start of study treatment;
5. Subjects must have at least one measurable lesion present; specific reference to the "Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)" guidelines;
6. Subjects may have previously received treatment with anthracyclines (e.g., doxorubicin, epirubicin) and/or taxanes (e.g., paclitaxel, docetaxel) as follows: a) The subject has used anthracyclines and/or taxanes during adjuvant and/or neoadjuvant therapy before breast cancer recurrence. b) The subject has experienced treatment failure during or after chemotherapy based on anthracyclines and/or taxanes. c) According to the investigator's judgment, the Subject is not suitable for anthracyclines and/or taxanes-based chemotherapy as a first-line treatment option.
7. Female subjects are not pregnant, not lactating, and agree to use necessary contraceptive measures.
8. Subjects are able to sign an informed consent form to participate in the study.
9. Have appropriate organ function, as detailed in Table 1; all screening laboratory tests should be completed within 10 days before the start of study treatment.
Combination Therapy for Neovascular Age Related Macular Degeneration

Exudative age related macular degeneration (ARMD) is most common cause of blindness in old population. It is clear that no single therapy addresses the multifactorial pathogenesis of the disease. Recently, studies of intravitreal anti-VEGF therapies such as pegaptanib and bevacizumab have shown the beneficial effect in visual acuity in the treatment of neovascular ARMD. However, the problem with these intravitreal injections is that therapy must be frequently administered for a prolonged but unknown period of time to maintain the benefit. Prolonged, frequent injections may be associated with additional safety risk,lack of convenience and high treatment cost.

Intravitreal steroid injection with anti-inflammatory properties limits any further VEGF upregulation initiated by the inflammation which has been known as one of the pathogenesis and causes of recurrence after the treatment of the neovascular ARMD.

The researchers hypothesize that the combined treatment of intravitreal bevacizumab and triamcinolone acetonide may decrease the recurrence rate after the treatment and obviate the frequent intravitreal injections in the treatment of neovascular ARMD.

In this study, the researchers will compare the recurrence rate of combined treatment of intravitreal bevacizumab and triamcinolone acetonide versus intravitreal bevacizumab alone in the treatment of neovascular ARMD.


Eligibility Criteria:
Inclusion Criteria:

* Neovascular ARMD confirmed with 90+ noncontact lens biomicroscopy, fluorescein angiography, ocular coherence tomography

Exclusion Criteria:

* Intractable systemic hypertension
* Recent myocardial infarct within 6 months at enrollment
* Recent cerebrovascular attack within 6 months
Metabolomic Analysis of Exhaled Breath Condensate in Asthmatics

Asthma is a chronic inflammatory airway disease. Significant heterogeneity exists in the clinical manifestations and treatment responses in these patients. Metabolomics is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. Compared with genomics or proteomics, metabolomics reflects changes in phenotype and therefore function. Up to now, few studies have evaluated the role of metabolomic analysis in the diagnosis and prognostic evaluation of airway disorders. Collection of exhaled breath condensate (EBC) is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the alveolar lining fluid. This study will apply metabolomics to examine the biomarkers in the EBCs, serum and urine specimens in adult asthmatics.

The aims of this study are: 1. Metabolomic profiling of the exhaled breath condensate (EBC), serum and urine specimens in adult asthmatics; 2. Correlation between metabolomic profiles of these specimens with the severity and control of asthma; 3. Comparing metabolomic profiles in asthmatics with different phenotypes and endotypes; 4.Comparing metabolomic profiles obtained from asthmatics during stable and acute exacerbation periods; 5. Comparing metabolomic profiles in asthmatics before and after inhaled corticosteroid therapy.

Eligibility Criteria:
Inclusion Criteria:

1. 20-90 years
2. Diagnosis of asthma based on the GINA guideline

Exclusion Criteria:

1. Patient with cancer
2. Patient with long-term ventilator use
Accuracy of CVC Depth Prediction in Internal Jugular Veins: The Difference Between The Andropoulos and ECG Methods

compare the accuracy of CVC depth prediction in internal jugular veins: the difference between the andropoulos and ECG methods

seventy two subjects were given informed consent before the study started. compare the accuracy of CVC depth prediction in internal jugular veins with two difference methods, the andropoulos method and ECG method.

Eligibility Criteria:
Inclusion Criteria:

* signing informed consent form
* indicated for CVC insertion
* has no contraindication for right internal jugular vein CVC insertion

Exclusion Criteria:

* has history of arrhythmia
* has cardiac malformation history
Mindful Self-Compassion to Assist Emerging Adults With Diabetes Transition to Adulthood

The transition from pediatric to adult care is particularly difficult for individuals with Type 1 diabetes. It is hypothesized that a mindfulness-based intervention for individuals making this transition will contribute to personal psychological well-being, superior participation in health care, and more tightly controlled blood sugar levels. Young adults with Type I diabetes will complete an eight-week training program in Mindful Self-Compassion. Intervention effectiveness will be assessed with both self-report and physiological measures. Assessments will occur at the start of the training program, end of the program, and three-months post-program.

This research will evaluate the consequences of an eight-week Mindful Self-Compassion (MSC) intervention on the psychological and physical well-being of 18 to 25 year-old individuals with Type 1 diabetes who are at an age of established risk. Participants will be randomly assigned to either an immediate intervention group or wait-list control group. All participants will be tested before and after the intervention on a battery of self-report measures designed to assess various aspects of self-care and psychological functioning. Blood samples will also be taken before and after the intervention to determine HbA1C levels. Participants will also receive a followup assessment three-months post-intervention to assess the durability of the effects. We expect MSC training to induce positive change in participants' diabetes management and personal well-being.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 and 25
* Obtain care for Type 1 diabetes

Exclusion Criteria:

* Psychologically or medically unable to complete the MSC program
Gastric Arterial Embolization for Weight Loss

Title: Embolization of Gastric Arterial Supply for Weight Loss

Sample size:

10 patients

Study Population: Morbidly obese patients who were seen by the bariatric surgery program at Toronto Western Hospital but are either not interested or not eligible for surgery.

Study Design:

Single center, randomized, prospective, non-blinded pilot study.

Study Duration:

12 months (November 2015 - December 2015).

Agent:

150-250 micron polyvinyl alcohol particles

Primary objective:

To further evaluate the safety of embolization of the left gastric and gastroepiploic arteries. To determine if either or both will result in significant weight loss and decrease in waist circumference among obese patients.

Primary objective measure:

The number of adverse events in a 1 year period will be recorded. The weight change from baseline will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Meet standard eligibility criteria for bariatric surgery. BMI of \>= 40 -or- BMI of \>=35 with one of the following comorbid conditions: hypertension, type 2 diabetes, obstructive sleep apnea, coronary artery disease

Exclusion Criteria:

Basic

Unable to provide informed consent (legally authorized representative is acceptable) Unable or unwilling to come for follow up appointments Age \< 18 or \>80 Weight \>400 lbs or 180kg due to weight limits on angiographic tables Moderate or severe allergy to iodinated contrast media not amenable to premedication as defined by the ACR contrast guidelines Pregnant, breastfeeding or actively trying to become pregnant in the next year Inability to lie flat for the duration of the procedure Limited life expectancy \< 1 year Patient enrolled in another interventional study, they will be permitted to enter this study 30 days after reaching the prior studies primary endpoint Arterial anatomy not feasible for intervention based on investigator assessment

Gastrointestinal

Pre-existing chronic abdominal pain History of inflammatory bowel disease History of gastroparesis Prior history of gastric surgery, embolization or radiation Prior or current history of peptic ulcer disease Significant risk factors for peptic ulcer disease including daily NSAID use, active smoking or active H. Pylori infection Abnormal upper endoscopy Hepatic Cirrhosis Portal venous hypertension Hepatic Bilirubin \> 2.0 mg/dL Albumin \< 2.5 g/L

Cardiovascular

Known aortic pathology such as aneurysm or dissection Peripheral arterial disease

Renal

Renal insufficiency as evidenced by estimated GFR \< 60ml/min.1.73m2

Hematologic/Immunologic/Oncologic/Infectious

Acute or chronic infection Active cancer or prior history of cancer \<10 years ago Autoimmune disease requiring immunosuppression Neutrophils \< 1.5 x 10\^9/L Platelets \< 50 x 10\^9/L INR \>1.7

Psychiatric

Major diagnosed psychiatric comorbidities such a major depressive disorder, schizophrenia, bipolar disorder that are deemed to likely interfere with follow up History of an eating disorder such as anorexia or bulimia
Effects of Memantine on Magnetic Resonance (MR) Spectroscopy in Subjects at Risk for Alzheimer's Disease

Recent data show that marked cell damage precedes the clinical manifestation of Alzheimer's disease (AD). Hence, targeting populations at risk with pharmacological interventions is a possible strategy to lessen the burden of the disease. Cognitively normal individuals with subjective memory complaints (SMC) manifest biological characteristics consistent with early AD and are at risk for future cognitive decline. Family history of AD also constitutes a risk. In a previous study the investigators showed that memantine slows down the accumulation of phosphorylated tau in normal SMC subjects. Using a multivoxel high field MR spectroscopy (MRS) technique, the investigators also demonstrated that memantine decreased hippocampal glutamate. Both these findings may be consistent with the drug's anti-excitotoxic activity. In this new project the investigators propose to treat a sample of 12 presymptomatic individuals at risk (SMC and family history of AD) with memantine. This will be a double blind, placebo controlled study with a control group (12 non-treated subjects). The investigators will determine whether the effects of memantine as assessed by cognitive performance and MRS are present after 4 months of treatment and persist 2 months after discontinuation. MRS will be used to evaluate the effect of memantine on levels of the neurotransmitter glutamate and neuronal viability marker N-acetylaspartate (NAA) in the hippocampus. The investigators will test the following hypotheses:

1. In subjects with SMC, memantine has modifying effects on brain biochemistry as reflected in MRS reductions in glutamate (reduced excitotoxicity) and increases in NAA (neuronal integrity).
2. The effects of the drug persist (as a marker of sustained neuroprotection) and can be measured 2 months after discontinuation of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* presence of subjective memory complaints without objective evidence of impaired cognition
* family history of Alzheimer's disease

Exclusion Criteria:

* major depression
* Parkinson's disease
* stroke
* seizures
* uncontrolled diabetes or hypertension
* current benzodiazepine use
* substance abuse
* contraindication for MRI
* contraindications for memantine
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

The PROMISE I Trial was a prospective, multi-center, single-arm, investigational feasibility study assessing the LimFlow System for the treatment of chronic- limb-threatening ischemia by creating an arterio-venous fistula in the below-the-knee vasculature. The study was run under an investigational device exemption (IDE G160156, NCT03124875).

Thirty-two subjects were enrolled under protocol revisions A, B, C, and D at seven sites in the United States between 5-July-2017 and 8-April-2019.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of critical limb ischemia with hemodynamic evidence of severely diminished arterial inflow of the index limb and Rutherford Classification 5 r 6
* Reviewed and approved for eligibility by the Investigator and the Independent Safety Committee (ISC)

Exclusion Criteria:

* Concomitant hepatic or renal insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder
* Severe heart failure, recent MI or stroke
* Significant peripheral edema or infection that may preclude insertion of a prosthesis or significantly impair wound healing
* Known allergies or contraindications to anti platelet therapy or device materials
* Immunodeficiency disorder or immunosuppressant therapy
* Life expectancy \< 12 months
Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System

The aim of this study is to evaluate the contribution of the vacuum suspension system in an ecological environment on the fitting's comfort compared to the vacuum suspension system inactive system in a multicenter prospective, randomized, double-blind, multiple N-of-1 trial.

In order to assess the therapeutic effect of the vacuum suspension system, given the heterogeneity of the population and the small number of patients eligible for the study, the multiple N-of-1 trial seems to us to be the methodology. The principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age.
* Unilateral transtibial amputation for more than 6 months.
* Equipped for more than 3 months with a Seal-in™ liner without the vacuum suspension system.
* Equipped with an ESAR(Energy Storing and Return) foot with the vacuum suspension system
* Patient meeting the criteria of ICF(International Classification of Functioning, Disability and Health) classification d4602 and/or d4608
* Presenting some discomfort in the socket evaluated by a SCS ≤ 7/10
* Absence of severe comorbidity
* Patient with a smartphone and a functional 4G connection

Exclusion Criteria:

* Cognitive impairment that does not allow instructions to be followed
* Have already been equipped with the evaluated vacuum suspension system
* Pregnant women
* Patient subject to a legal protection measure
* Patient not affiliated with social security
Internet-delivered CBT for Anxiety Related to Asthma

This is a randomized controlled trial to investigate efficacy of a internet-delivered CBT for anxiety related to asthma.

Asthma is one of the most common chronic diseases and is often associated with anxiety. In a two prior studies (ClinicalTrials.gov ID: NCT03158194; NCT03486756) a protocol for exposure-based cognitive behaviour therapy (CBT) for anxiety related to asthma was developed, and standardised to an internet-delivered format and tested for feasibility and acceptability as an internet-CBT. The aim of the current study is to evaluate the efficacy of exposure-based Internet-CBT for anxiety related to asthma compared to Treatment as Usual (TAU). The plan is to include 90 participants consecutively during 2020.

Eligibility Criteria:
Inclusion Criteria:

* asthma diagnosed by a physician
* worry about asthma or limitations in daily life due to asthma at

Exclusion Criteria:

* a serious psychiatric condition; e.g., suicidality, psychosis or severe substance addiction
* chronic obstructive pulmonary disease (COPD) or other chronic airway disorders other than asthma
Pediatric and Ambulatory Research in Infectious Diseases

Many ambulatory networks are mainly based on diagnoses made by first-line physicians not specifically trained to join the network. Here we aim to set up a surveillance network on pediatric infectious diseases with an investment in teaching with specific trainings of participating pediatricians, increasing in use of point of care tests, and automated data extraction from the computers of the pediatricians.

107 pediatricians among the 1400 members of the French ambulatory pediatric association, AFPA (Association Française de Pédiatrie Ambulatoire) were involved in this survey.To belong to the PARI network, pediatricians have to use the same software, Axi5-Infansoft (developed by CompuGroup Medical, Nanterre, France) for electronic medical record of children. The pediatricians were trained to the use of point of care tests and to the infectious diagnoses (otitis, pharyngitis, varicella, bronchiolitis, influenza, pneumonia, etc..). The study population consisted of all children under 16 years of age from the patient population for which an infectious disease was diagnosed.

Eligibility Criteria:
Inclusion Criteria:

* Children under 16 years of age with at least one infectious disease among:
* pharyngitis
* otitis
* pneumonia
* influenza
* bronchiolitisz
* varicella
* gastroenteritis
* enterovirus disease
* bordetella pertussis disease
* using the same same software, Axi5-Infansoft (developed by CompuGroup Medical, Nanterre, France)

Exclusion Criteria:

* parental refusal
Choir Singing in Aphasia Rehabilitation

This study evaluates the verbal, cognitive, emotional, and neural efficacy of a choir singing intervention in chronic aphasic patients and their caregivers. Using a cross-over RCT design, half of the participants receive a 4-month singing intervention during the first half of the study and half of the participants during the second half of the study.

BACKGROUND: Singing is a highly stimulating and versatile activity for the brain, combining vocal-motor, auditory, linguistic, cognitive, emotional, and social brain processes, both in the left and right hemisphere. The capacity to sing is often preserved in aphasia after stroke, and singing-based methods, such as Melodic Intonation Therapy (MIT), can be effective in rehabilitating speech production in aphasics. Also emotionally and socially, singing could provide a powerful alternative channel for aphasic patients to express their emotions and interact with others, but the communal or group-level use of singing in aphasia rehabilitation has not been systematically studied.

AIMS: The purpose of the study is to determine the clinical and neural efficacy of a novel choir singing intervention in subacute/chronic aphasia. Specifically, the targeted outcomes are (i) verbal and vocal-motor skills, (ii) cognitive skills, (iii) emotional functioning and quality of life, (iv) caregiver psychological well-being, and (v) structural and functional neuroplasticity. In addition, the capacity of singing and music learning in aphasia is explored.

METHODS: Subjects are 60 stroke patients with at least minor aphasia (≥ 6 months post-stroke) and their family members (FMs, N = 60) from Helsinki area recruited to a cross-over RCT study. Participants are randomized to two groups \[N = 60 in both (30 patients, 30 FMs)\], which receive a 16-week choir intervention either during the first (AB group) or second (BA group) half of the follow-up. The intervention is a combination of group training, which utilizes a novel combination of traditional senior choir singing and MIT-like speech training protocols, and home training in which the choir material is trained with a tablet computer. All patients are evaluated at baseline, 5-month, and 9-month stages with language, cognitive, and auditory-music tests and questionnaires. Half of the patients (N = 30) also undergo electroencephalography (EEG) and structural and functional magnetic resonance imaging (s/fMRI). FMs are evaluated with questionnaires.

Eligibility Criteria:
The following inclusion criteria are used in patient recruiment:

1. age over 18
2. Finnish-speaking
3. time since stroke \> 6 months
4. at least minor non-fluent aphasia due to stroke (BDAE Aphasia Severity Rating scale score ≤ 4)
5. no hearing deficit
6. no severe cognitive impairment affecting comprehension (the patient is able to understand the purpose of the study and give an informed consent)
7. no neurological / psychiatric co-morbidity or substance abuse
8. ability to produce vocal sound (through singing or humming).