cyrilzakka/clinical-trials huggingface dataset:
Austrian Multivessel Taxus-Stent Registry

The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel disease and multiple Taxus stent implantations in the "real world" stenting at 30 days, 6 and 12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to economic considerations, the secondary aim is to enhance experience in multivessel stenting with drug-eluting stents in order to improve short- and long-term outcomes of the patients with severe multiple coronary artery stenoses.

The objectives of the study are:

1. To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical follow-up after multivessel intervention with drug-eluting stents in a prospective patient cohort..
2. To determine the rate of in-stent restenosis, target lesion and target vessel revascularization (angiographic measures) 6 months in patients with multiple DESs in multiple lesions.
3. To investigate the clinical and angiographic outcomes after implantation of multiple DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal insufficiency) with known high restenosis and late complication rate.
4. To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic coronary multivessel disease
* possible percutaneous complete coronary revascularization
* age \>18 year
* significant coronary lesion at least in 2 vessels

Exclusion Criteria:

* acute myocardial infarction within 48 hours
* contraindications to clopidogrel, aspirin, heparin and taxol
* pregnancy or lack of protection against pregnancy or breast-feeding during the study
* hemorrhagic diathesis
* platelet count \<100.000/ml3
Canadian Anticoagulant Percutaneous Coronary Intervention Registry

Advances in mechanical intervention (PCI) and anticoagulation therapy have been the cornerstone of treatment of patients with coronary artery disease. However, the large diversity of approaches to anticoagulation during PCI introduces gaps in knowledge regarding management of cardiac patients. As such, we have initiated a national PCI registry to elucidate anticoagulant choice, dosing strategies, case selection dynamics, and clinical outcomes in the Canadian health care environment.


Eligibility Criteria:
Inclusion Criteria:

1. 18 or more years of age.
2. Undergoing PCI during treatment with LMWH
3. Provision of written and informed consent

Exclusion Criteria:

1. Language, medical, or psychiatric barriers that preclude understanding of informed consent process.
2. Patients in which the site investigator is unable to comply with completion of study documentation following PCI, i.e. patients with planned transfer to another hospital not participating in the registry.
3. Enrollment in a clinical trial involving another anticoagulant agent.
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes

This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.


Eligibility Criteria:
Inclusion Criteria:

* - Informed consent obtained
* - Type 1 diabetes mellitus for 12 months or longer
* - Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer
* - Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator
* - HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))
* - Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits

Exclusion Criteria:

* - Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors
* - Use of any medication, which in the investigator's opinion could interfere with the glycaemic control or affect the subject's safety.Premix insulin is not allowed
* - Known proliferative retinopathy or maculopathy requiring acute treatment
* - Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator
* - Uncontrolled/ untreated blood pressure at screening above 160 mmHg for systolic or above 100 mmHg for diastolic
* - History of acute or chronic pancreatitis
* - Screening calcitonin value equal to or above 50 ng/L
* - Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2)
* - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.

The goal of this double-blind prospective randomized clinical trial is to determine if the effect of intravenous erythropoietin is superior to the effect of intravenous methylprednisolone in cases of toxic optic neuropathy 4 weeks after therapeutic intervention.

The main question it aims to answer:

• Is there a difference in the visual recovery of toxic optic neuropathies treated with intravenous methylprednisolone in comparison with those treated with intravenous erythropoietin?

A double-blind prospective randomized clinical trial of treatment for toxic optic neuropathies comparing visual outcome of patients treated by standard treatment (intravenous methylprednisolone) vs intravenous erythropoietin.

Enrollment: 18. Randomized groups (2)

1. Standard treatment (intravenous methylprednisolone)
2. Intravenous erythropoietin

Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned

Eligibility Criteria:
Inclusion Criteria:

* Both genres.
* Age between 18 and 75 years.
* Clinical diagnosis of toxic optic neuropathy (afferent pupillary defect, acquired dyschromatopsia, visual loss and bilateral prechiasmatic field defect).
* Exposure with a temporal relationship of less than two weeks to a known toxicant for the function of the optic nerve.
* Up to 21 days from symptom onset.
* Informed consent signature.

Exclusion Criteria:

* History of previous optic neuropathy.
* History of additional ophthalmological or neurological pathology that has caused permanent visual loss.
* History of previous treatment with intravenous methylprednisolone or some other experimental treatment since the onset of symptoms.
* Poorly controlled diabetes mellitus.
* Poorly controlled systemic arterial hypertension.
* Hemoglobin \>16 mg/dL
* Patients with a history of thromboembolic event.
* Patients with a history of coronary heart disease, myocardial infarction or cerebral vascular event.
* Pregnancy or lactation.
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant

The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
* Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy

Exclusion Criteria:

• Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy
Effects of Different Omeprazole Dosing on Gastric pH in Non-variceal Upper Gastrointestinal Bleeding

The aim of the study is to identify the best method of omeprazole (OME) application with respect to intragastric pH, cytochrome P450 2C19 (CYP2C19) genotype and phenotype.

The patients with non-variceal upper gastrointestinal bleeding (NVUGIB) are prospectively enrolled. After the achievement of endoscopic hemostasis, the patients are randomized to 40-mg intravenous (i.v.) OME bolus injection every 12 h or 8-mg/h continuous i.v. infusion for 72 h after an 80-mg i.v. OME bolus administration. The intragastric pH is recorded for 72 h. The CYP2C19 variant alleles (\*2, \*3, \*17) are analyzed and the serum concentrations of OME and 5-hydroxyomeprazole (5-OH OME) are determined. The diagnosis of Helicobacter pylori infection was based on the results of the rapid urease test performed on stomach mucosa biopsies (antrum and angle) and on the results of the stool antigen test.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent must be obtained before any treatment or assessment is performed
* patients admitted with upper gastrointestinal bleeding (UGIB) symptoms to the Emergency Department of the University Hospital of Bialystok (Bialystok, Poland)

Exclusion Criteria:

* pregnancy
* age \>90 years
* lack of written consent
* recent treatment with certain medications, including PPIs, H2-receptor antagonists (H2RA), antacids, steroids, oral contraceptives, clopidogrel, prasugrel and clarithromycin
* the presence of variceal UGIB
* history of surgery of upper gastro-intestinal tract
Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy

Doctors are recruiting patients receiving care for lung cancer at the Wake Forest Baptist Comprehensive Cancer Center asking about needs and experiences during immunotherapy. Immunotherapy is a new treatment for lung cancer. The research is to better understand patients' perspectives on what immunotherapy is like and will provide important information to help understand the symptoms patients experience, the impact of treatment on daily life, ways that people adapt to the challenges of treatment, and services that may help people live better during treatment.

The overall primary objective of this pilot study is to describe patient-reported symptom burden, unmet supportive care needs, and use of and interest in supportive care services in stage IV non-small cell lung cancer patients undergoing first or second line immunotherapy and to identify psychosocial factors associated with these outcomes.

60 stage IV non-small cell lung cancer patients will be recruited through the Wake Forest Baptist Comprehensive Cancer Center. The study team will use purposive sampling to assure representation of patients at different stages in immunotherapy (i.e., initiating treatment, anticipating scan results, after onset of immune-related side effects).

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IV (per AJCC 7th edition) non-small cell lung cancer.
* Receiving first or second line immunotherapy.
* ECOG Performance status of 0-3.
* English-speaking

Exclusion Criteria:

* Unable to provide informed consent
Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

In Amyotrophic Lateral Sclerosis, dysphagia has a high incidence. With deterioration of swallowing function, percutaneous endoscopic gastrostomy (PEG) tube is recommended to ensure sufficient and safe oral intake. Dysphagia and PEG placement alter quality of life (QoL). However, QoL and attitudes toward PEG remain largely unexplored. The purpose of this study is to monitor the swallowing function in relationship to QoL and attitudes toward PEG tube insertion and feeding.

The purpose of this study is to monitor the deterioration of swallowing function in ALS patient population, and to explore its impact on QoL and attitudes toward PEG tube insertion and feeding in the course of the disease. It will take maximum of 60 minutes to fully evaluate the swallowing function and complete the questionnaires. The evaluation procedure will be repeated every 3 months until PEG tube insertion, which will allow us to closely monitor the swallowing function in a relation to attitudes toward PEG and QoL. The data obtained from this study should contribute significantly to the knowledge of QoL in ALS patients with dysphagia, and it will allow for a comparison of QoL in ALS patients with and without PEG tube. This study will also expand the understanding of attitudes in ALS patients and their relatives toward PEG, and the impact of those attitudes on the decision-making process.

Eligibility Criteria:
Inclusion Criteria for patients:

* 18 years of age or older
* diagnosis of ALS
* follow-up at University Medical Centre Ljubljana, Division of Neurophysiology, every 3 months
* be able to visit the study site for in-person procedures every 3 months

Inclusion Criteria for relatives:

* at least 18 years of age

Exclusion Criteria for patients:

* co-existing illness or disorder that could influence the swallowing function independently of the ALS diagnosis
* clinically significant cognitive deterioration or dementia at enrollment, as determined by the ALS study neurologist

Exclusion criteria for relatives:

* signs of probable cognitive deterioration or dementia at enrollment
Post-radiotherapy Rhinosinusitis in Children

Chronic rhinosinusitis (CRS) is a frequent complication of facial cancer treatment, mainly related to radiotherapy. However, while radiological involvement is frequent, clinical expression seems less important.

Few studies have investigated the incidence of this condition in the pediatric population while its evolution seems to be very chronic even if a partial improvement may occur with time.

Our objective is therefore to study the impact of CSR in children treated for cancer of the cervicofacial region, to evaluate its incidence and medium-term evolution in order to determine whether it is necessary to set up a specific follow-up in these patients.

The clinical impact of CSR is assessed by a specific SNOT 22 questionnaire in children treated for a head-neck mesenchymal malignancy in comparison with a control population consisting of children treated for a mesenchymal malignancy of non-head-neck location.


Eligibility Criteria:
Inclusion Criteria:

* Study population: all patients under 18 years of age managed for a head neck mesenchymal cancer between January 1, 2018 and December 31, 2024
* Control population: all patient under 1 years of age managed for non -head neck mesenchymal cancer between January 1, 2018 and December 31, 2024

Exclusion Criteria:

* Patients with hematological tumors;
* Patients with mucociliary pathologies or proven allergic rhinitis before the diagnosis of cancer
* Patients who have required surgical treatment that has removed more than half of the sinus cavities
* Tumor recurrence at the time of inclusion
* Sinus surgery between the last radiological check-up and inclusion
* Administrative reasons: inability to receive informed information.
Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

The investigators are investigating the use of a new cancer treatment called Irreversible Electroporation (IRE). This treatment delivers electrical energy between two needles placed in a cancer. The electrical energy causes cells to die. While this has been used in patients for different applications, the investigators are trying to understand how safe and well it works in colon cancer that has spread to the lung. Once the irreversible electroporation procedure is completed during the operation, the surgeon will then remove the cancer according to standard procedure. As part of the study, they will be measuring safety of the electrical energy delivered and will be reviewing the resected specimen under the microscope.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Colorectal cancer with oligometastatic colorectal cancer in the lung
* Lung lesion size is greater than 1 cm
* Patient will undergo surgical resection as per consultation with their thoracic surgeon and medical oncologist
* Patient is cleared to undergo paralytic anesthesia.
* Patients 18 years old and older

Exclusion Criteria:

* Patients with history of cardiac dysrhythmia
* Known heart failure (EF \< 40%)
* Pacemaker/defibrillator
* Patient's with any metallic cardiac implant
* Patient on anti-coagulation therapy and are unable to stop therapy for the perioperative period
* Women who are pregnant and/or nursing
Reach Out and Read (ROR) in the Neonatal Intensive Care Unit (NICU) Study

The goal of this clinical trial is to learn about the effects of the Reach Out and Read program on infants and their families in the neonatal ICU. The main goals of this study are:

* To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.
* To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
* To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
* To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores

Participants will complete three questionnaires that include demographic information, home literacy scores, the Postpartum Bonding Questionnaire and the State-Trait Anxiety Index; once at study enrollment, once at 36 weeks corrected gestational age, and once at 3 months corrected gestational age.

Researchers will compare the control group (standard care) and a group that receives Reach Out and Read education to see whether exposure to Reach Out and Read affects literacy behaviors, parental anxiety, and parent-infant bonding.


Eligibility Criteria:
Inclusion Criteria:

* Families of subjects born between 24w0d and 33w6d gestation
* Primary language is English or Spanish

Exclusion Criteria:

* Severe clinical instability such that the principal investigators do not think the infant will survive to 36 weeks gestation
Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency

The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form by parents or a legal representative
* Age less or equal to 12 years old
* Patients with inherited afibrinogenemia or severe inherited hypofibrinogenemia
* Negative results on HCG-based pregnancy test for females of childbearing potential (presence of menstruation)

Exclusion Criteria:

* Dysfibrinogenemia
* Acquired fibrinogen deficiency
* Suspected present or past anticoagulation inhibitor
* Personal history of venous or arterial thrombosis or thromboembolic event
* Co-morbidity with other/unrelated coagulopathies
* Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days
* Permanent treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs.
Safety Study of Maraviroc's Effect on Human Osteoclasts

This study is to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.

An observational study to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.

Eligibility Criteria:
Inclusion Criteria: Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine who meet all criteria following:

* Those whose primary care physician acknowledged the necessity of maraviroc treatment due to multi-resistance HIV strain that is confirmed to have CCR5 tropism.
* Those who are willing and able to consent to this study
* 20 years old or older

Exclusion Criteria: Cases applicable to ANY condition of the following:

* Those who are not suited for maraviroc (whose HIV strain to be CXCR4 tropism)
* Others who the principle investigator physician considered to be excluded
Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation

We want to demonstrate that modifications of the ventilation parameters are liable to improve the different characteristics of phonation (duration, intensity, prosody..) in neuromuscular patients who are dependent on non invasive ventilation.

Speech and communication quality depend on respiration efficiency. The respiratory involvement observed in neuromuscular disorders can impair speech quality in patients, while the underlying disease may also contribute to alter phonation.

Nowadays, the first line treatment of neuromuscular chronic neuromuscular respiratory failure is noninvasive ventilation (NIV). With disease progression, it is used with increasingly duration during daytime. In that situation, mouthpiece ventilation is preferred as it allows efficient ventilation while being more comfortable for patients who can chose when they want to be ventilated. However, in that situation, patients do not receive ventilatory support while they are speaking which puts them in a less favorable situation for speech. We think that pre-phonation inspiratory volume is an essential part of speech quality. Without mechanical ventilation, this volume is reduced as a consequence of respiratory failure but it is liable to increase significantly if the patient used the volume delivered by the ventilator .

We believe that phonation is improved by NIV by applying specific ventilation parameters in patients dependant on mechanical ventilation. The modification could be used by neuromuscular patients to improve speech quality; the patients would then be able to use their usual ventilatory support to improve phonation and modulation of their speech.

In this crossover open labelled, randomised study, done in a single center (home ventilation unit of the referral center of Hospital Raymond Poincaré HUPIFO (University Hospital of Western Paris and Ile de France) (Garches, France)), phonation characteristics will be studied in 3 situations (during spontaneous breathing without ventilatory support, with the usual NIV parameters, with speech-specific NIV parameters) during which speech trials will be performed.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (age \> or equal to 18)
* chronic restrictive respiratory failure due to neuromuscular disease
* spontaneous breathing autonomy of at least one hour during the days
* stable clinical state
* patient with middle school education level (able to read)
* patients using life support ventilator ((Astral 150 (ResMed®), Elysée (ResMed®), Trilogy (Philips Respironics®), VentilogicLS (Weinman®), Vivo 40 (Breas®), PB560 ou Légendair (Covidien®), Monal T50 (Air liquide system®))

Exclusion Criteria:

* refusal to participate
* unability to cooperate
* illiterate patients
* tracheostomised patients
* spontaneous breathing autonomy \< 1h
* cardiovascular instability
* not registered with the social security system