cyrilzakka/clinical-trials huggingface dataset:
CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial

This is a prospective, randomized, multicenter study comparing the relative efficacy and safety of cryoablation of PVs using the Arctic Front Advance® balloon catheter with antiarrhythmic therapy in patients with persistent AF.

The ablation of pulmonary veins is a very effective treatment for the treatment of paroxysmal atrial fibrillation. The benefit of the isolation of pulmonary veins in persistent atrial fibrillation seems to be minor and the level of scientific evidence available requires additional clinical trials to define the value of ablation in this type of patients.

The symptomatology of atrial fibrillation recurrences is variable among patients and among differens moments in the same patient. Pharmacological treatment and ablation have been used to reduce the symptomatology of atrial fibrillation recurrences and to increase the proportion of asymptomatic recurrences. Different forms of electrical monitoring of the heart rate are used to evaluate the effectiveness of an intervention. Frequents monitoring periods provide the information of the heart rate and the effect of any intervention.

The "Confirm RX heart monitor® (Abbott)" is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function. This implantable Holter automatically detects and saves atrial and ventricular arrhythmic episodes. The device can be analyzed in person or remotely, and can help to make decisions regarding anticoagulant and antiarrhythmic treatment of patients, while representing a powerful research tool for evaluate the effectiveness of different therapeutic options.

This is a prospective, randomized, multicenter study that compares the relative efficacy and safety of cryoablation of pulmonary veins using the Arctic Front Advance® balloon catheter with antiarrhythmic treatment in patients with persistent atrial fibrilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent persistent atrial fibrilation

Exclusion Criteria:

* Patients with atrial fibrilation for more than one year at baseline
* Atrial fibrilation prior ablation
* Age\> 75 years or \<18 years
* Hyperthyroidism
* Hypertrophic cardiomyopathy
* Severe valvular disease (stenosis or regurgitation)
* Carriers of cardiac valves
* Anteroposterior diameter of left atrium\> 50 mm (left parasternal long axis)
* Contraindications for anticoagulation
* Left atrial thrombus
* Anemia
* Active infection
* Pregnancy
* Atrial fibrilation secondary to transient, avoidable or correctable causes (hyperthyroidism, pneumonia, pulmonary embolism, drugs, hydroelectrolytic alterations ...)
* Life expectancy of less than 24 months
* Participation in another non-purely observational study
* Patients unable to understand treatment and / or study and / or providing adequate informed consent
* Any condition, that in the opinion of the physician responsible for the patient, contraindicates any of the treatments of the study
* Microalbuminemia
Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy

Optimal non surgical treatment of prostate cancer requires dose escalation which is frequently provided by adding a brachytherapy "boost" to a short course of external beam radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR) brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA) recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that it is associated with a more favorable toxicity profile and improved quality of life.

Men with intermediate or high risk prostate cancer who are technically suitable for prostate brachytherapy based on prostate size and voiding function and who are interested in this modality of treatment will be approached for randomization between either high dose rate (single 15 Gray) or low dose rate permanent seed implant (110 Gray) brachytherapy. Baseline International Prostate Symptom score, Quality of Life Assessment and International Index of Erectile Function will be recorded and then every 3 months for the first year and every 6 months to 3 years. Androgen deprivation treatment is allowed for 6 or 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Upper tier intermediate risk with at least 2 of the following factors

  1. Tumor-Nodes-Metastases Tumor stage T2B or greater
  2. Gleason Score 7
  3. PSA \> 10
  4. \> 50% of the biopsies positive
* OR High risk prostate cancer with one of the following factors

  1. T3a
  2. Gleason Score8-10
  3. PSA \>20
* Positive prostate biopsy within 6 months (reviewed centrally)
* International Prostate Symptom Score \< 16
* Prostate volume \< 60 cc
* Negative staging CT and Bone scan within 3 months prior to registration
* History and physical examination within 90 days prior to registration
* European Cooperative Oncology Group performance status 0-1 prior to registration
* Age \>45
* Patient suitable for procedure under anesthesia

Exclusion Criteria:

* Prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration
* Previous prostatectomy, cryotherapy or High Intensity Focussed Ultrasound for prostate cancer
* Previous pelvic irradiation or prostate brachytherapy
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD)


Eligibility Criteria:
Inclusion Criteria:

* Male and female, 18 - 70 years of age
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)
* Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control
* History of meeting DSM-IV-TR criteria for any of the following:

  * Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
  * Any depressive episode with psychotic or catatonic features
  * Panic disorder with or without agoraphobia
  * Obsessive-compulsive disorder
  * Schizophrenia, schizoaffective, or other psychotic disorder
  * Bulimia or anorexia nervosa
  * Presence of borderline personality disorder or antisocial personality disorder
  * Mental retardation, dementia, amnesia, or other significant cognitive disorders
* Patients who are considered a suicide risk
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants

The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
* Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) \> 80 mL/min/1.732 m2

Exclusion Criteria:

* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
* Positive anti- John Cunningham virus (JCV) antibody test at Screening
* History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy

Other protocol defined inclusion/exclusion criteria could apply
Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05233)(COMPLETED)

This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641) compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and require less allergy rescue medications during ragweed pollen season.


Eligibility Criteria:
Inclusion Criteria:

* Must have a clinical history of significant ragweed-induced allergic rhinoconjunctivitis of at least 2 years duration, with or without asthma and have received treatment during the previous RS.
* Must have a positive skin prick test response to Ambrosia artemisiifolia at Screening Visit.
* Must be positive for specific immunoglobulin E (IgE) against Ambrosia artemisiifolia at Screening Visit.
* Must have an forced expiratory volume in 1 second (FEV1) of at least 70% of predicted at Screening Visit.
* Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor

Exclusion Criteria:

* Clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during or potentially overlapping the RS.
* Clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed.
* Receipt of an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
* Clinical history of severe asthma.
* Asthma requiring medium or high dose inhaled corticosteroids.
* History of anaphylaxis with cardiorespiratory symptoms.
* History of chronic urticaria and angioedema.
* Clinical history of chronic sinusitis 2 years prior to the Screening Visit.
* Current severe atopic dermatitis.
* Breast-feeding, pregnant, or intending to become pregnant.
* Had previous treatment by immunotherapy with ragweed allergen or any other allergen 5 years prior to Screening Visit.
* History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (except for Ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine.
* History of self-injectable epinephrine use.
CNS Changes Following Stroke

The objective of this study is to better understand the structural and functional changes that the CNS undergoes following stroke and how these changes relate to clinical measures. Both macroscopic and microscopic changes of the brain and the spinal cord will be examined in stroke patients and compared to healthy controls. In terms of structural plasticity, we aim to identify MR biomarkers that allow predicting the course of the patient's neurological status and accurately describe the course of the disease and the recovery. Importantly, we aim to investigate which factors scale the patients' symptoms.

In terms of functional plasticity, we will combine fMRI with behavioural motor and sensory testing to understand i) the structural and functional interplay between spinal and supraspinal neural circuits after stroke possibly driven by beneficial plasticity/regeneration vs. maladaptive plasticity/degeneration and ii) which clinical and behavioural determinants drive functional hand representations in the primary somatosensory and motor cortices to be maintained and which determinants drive reorganisation of functional representations following sensory input loss. We will further investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, aim to better understand the mechanistic underpinnings of functional reorganisation.


Eligibility Criteria:
Inclusion Criteria - Patients:

* Age 18-80
* Stroke (\> 3months)
* Signed informed consent

Exclusion Criteria - Patients:

* Contraindications to magnetic resonance imaging
* Neurological impairment of body function impairments not induced by stroke
* BMI \> 40
* Pregnancy
* Claustrophobia

Inclusion Criteria - Healthy subjects:

* Age 18-80
* Signed informed consent

Exclusion Criteria - Healthy subjects:

* Contraindications to magnetic resonance imaging
* Pregnancy
* Neurological illness
* Impairment of body function induced by stroke
* Claustrophobia
* BMI \>40
A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects

This is a single and multiple dose study in healthy male and female (of non-child bearing potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib. Fostamatinib is being developed for the treatment of rheumatoid arthritis.

A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) Japanese subjects
* 20 to 45 years of age
* Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg

Exclusion Criteria:

* History or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
* Any clinically significant illness, acute infection, known inflammatory process, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
* Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
* Previous participation in a fostamatinib study
Ozone Auto-hemotherapy for COVID-19 Pneumonia

This is a multicenter, randomized, controlled, open-label clinical trial testing the use of ozone auto-hemotherapy in hospitalized patients with Covid-19 pneumonia.

Eligible patients will be randomly assigned to receive either ozone auto-hemotherapy plus standard treatment, or standard treatment alone.

Patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. Standard treatment will be the one used in each hospital participating in the trial.

All analyses will be done according to the intention-to-treat principle


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19 confirmed by positive polymerase chain reaction (PCR) for Severe Acute Respiratory Syndrome (SARS-COV-2) in respiratory tract sample, plus pneumonia confirmed by imaging tests and arterial oxygen saturation (SpO2) \<94% with ambient air or a partial pressure of oxygen to fraction of inspired oxygen (pO2/FiO2) ratio \<300 mmHg or SpO2/FiO2 ≤ 315.
* Acceptance to participate in the study and signing of the informed consent.

Exclusion Criteria:

* Patients who have received treatment with any form of ozone therapy 6 months before admission to the hospital.
* Patients who have previously been treated and have experienced some type of adverse reaction to ozone therapy.
* Patients aware of having a deficiency of Glucose-6-phosphate dehydrogenase.
* Patients with clinically decompensated chronic comorbidities, independently of COVID-19.
* Patients suffering from any psychiatric disorder specified in axis I of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), other than major depression.
* Patients who are not able to clearly understand the objectives and methodology of the study.
* Pregnant or lactating patients.
Comparison of Pamidronate With Zoledronic Acid for Transplant Related Bone Loss Prevention

The purpose of this trial is to see whether zoledronic acid is better than pamidronate to treat low bone density in heart and lung transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* reduced bone density as indicated by a bone density T score \<-1.in either the lumbar spine or femoral neck
* have undergone or are on the waiting list for heart or lung transplantation
* are receiving adequate calcium and vitamin D therapy
* have provided written informed consent prior to participation in the trial

Exclusion Criteria:

* untreated hypogonadism, hypothyroidism or hyperthyroidism
* acute or major organ rejection or intercurrent illness
* pregnancy or breastfeeding
External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether external-beam radiation therapy is more effective with or without indinavir and ritonavir in treating patients with brain metastases.

PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to see how well it works compared to external-beam radiation therapy given together with indinavir and ritonavir in treating patients with brain metastases.

OBJECTIVES:

* Compare the efficacy, in terms of time to treatment failure at CNS level and 4-months treatment failure rate, in patients with brain metastases treated with external-beam radiotherapy in combination with indinavir sulfate and ritonavir versus external-beam radiotherapy alone.
* Prospectively investigate the efficacy of a potentially antiangiogenic agent, indinavir sulfate.
* Investigate the antineoplastic activity of indinavir sulfate in combination with ionizing radiation in cancer patients with metastatic disease to the brain.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks (10 doses total). Patients also receive oral indinavir sulfate and oral ritonavir twice daily for 35 days beginning at day 1 of radiotherapy.
* Arm II: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks (10 doses total).

Patients complete quality of life questionnaires, including QOL-30 and the Mini Mental Status Examination, at baseline, 2 weeks after completion of radiotherapy, and at 1 and 3 months after completion of study treatment.

After completion of study treatment, patients are followed periodically for at least 4 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic cancer with brain metastases

  * Biopsy of brain metastases is not required
* All cancer types allowed, except for the following:

  * Prostatic adenocarcinoma
  * Sarcoma
  * Melanoma
  * Germ cell carcinoma,
  * Small-cell lung cancer
* Measurable disease by MRI of the brain
* Not requiring immediate surgical decompression (may qualify after surgery, if remaining measurable brain lesions)

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2 (corresponds to recursive partitioning analysis groups I or II)
* Life expectancy \> 4 months
* Able to understand the aim of trial and to comply with follow-up
* No HIV seropositivity

PRIOR CONCURRENT THERAPY:

* Prior dexamethasone allowed provided it is tapered before initiation of study radiotherapy
* Not requiring cytotoxic treatment within 3 months after study radiotherapy
* At least 1 week since prior and no concurrent phenytoin
Application of Multi-probe PET/MR Imaging in the Diagnosis and Evaluation of Alzheimer's Disease

Alzheimer's disease (AD) is the most common cause of cognitive impairment, and its diagnosis requires a comprehensive analysis of the results of medical history, neuropsychological evaluation, imaging and laboratory tests. Among them, it has been widely recognized that amyloid PET imaging is used in the early diagnosis of AD, tau protein PET imaging is used in the assessment of the progression of AD, and the glucose metabolism PET imaging is used in the assessment of nerve damage. MRI can provide structure, blood perfusion, neural network connection damage and other information through multi-sequence scans. With the help of the PET/MR multi-modal imaging platform and multi-probe imaging technology, it can provide more sensitive and accurate imaging information for early diagnosis and disease assessment of AD, and provide a basis for clinical treatment decision-making.

Cognitive impairment is a common neurodegenerative disease. The incidence of Alzheimer's disease (AD) in people over 65 years old is close to 5%, which brings a heavy burden to society. Relying only on medical history and neuropsychological evaluation, the early diagnosis and differential diagnosis of AD are difficult, and further imaging and laboratory tests are needed. This project will use PET/MRI, the most advanced imaging platform, to design a prospective clinical research program, combined with multi-sequence MRI and multi-probe PET imaging, to evaluate suspected or diagnosed AD patients. Through multi-parameter analysis of the structure MRI, function MRI (3D ASL, BOLD, DTI), metabolism PET (18F-FDG) , Aβ (11C-PIB) and tau (18F-PM-PBB3) PET, combined with clinical information, to evaluate the value of multi-modal imaging for early diagnosis and differential diagnosis of AD, to assist the clinic in the adjustment of early intervention measures and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the core clinical diagnostic criteria for Alzheimer's disease as defined by NIA-AA for mild cognitive decline or probable Alzheimer's disease.
* Subjects are able to understand and sign the informed consent voluntarily, with good compliance.

Exclusion Criteria:

* Have contraindications to PET/MR examination.
* Clinically clear history of stroke.
* Have a history of bipolar disorder or depression.
* Patients with severe heart, liver, and kidney dysfunction.
* Pregnant or lactating women.
* Patients refuse to sign the informed consent.
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatient, 18-70 years of age
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder
* Minimum score of 20 on Hamilton Rating Scale for Anxiety

Exclusion Criteria:

* Women who are pregnant or who will be breastfeeding during the study
* Patients with a history of:

  1. Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
  2. Any depressive episode with psychotic or catatonic features
  3. Panic disorder with or without agoraphobia
BIO|STREAM.ICM France

The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system

The BIO\|STREAM.ICM submodule will recruit a subset of patients with syncope with uncertain origin and cryptogenic stroke without history of atrial arrhythmia from the existing population enrolled in the BIO\|STREAM.ICM registry. The submodule study is designed to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR System.

Eligibility Criteria:
Inclusion Criteria:

* Indication for ICM device in accordance with the European guidelines: syncope with uncertain origin or cryptogenic stroke without history of atrial arrhythmia
* Enrolled in the BIO\|STREAM.ICM registry

Exclusion Criteria:

* Life-expectancy is less than 3 months
* Already implanted with BIOMONITOR