cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.

The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of the Multi-Electrode RF Balloon catheter. The study will evaluate the safety and effectiveness of the Multi-Electrode RF Balloon catheter used for ablation in patients with paroxysmal atrial fibrillation (PAF).

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation.

  1. At least two symptomatic AF episodes within last six months from enrollment.
  2. At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment.
* Failed at least one Class I or Class III antiarrhythmic drug.
* Age 18 -75 years.

Key Exclusion Criteria:

* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* Previous surgical or catheter ablation for AF.
* Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF \> 7 days.
* Any percutaneous coronary intervention within the past 2 months.
* Valve repair or replacement or presence of a prosthetic valve.
* Any carotid stenting or endarterectomy within the past 6 months.
* Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
* Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
* LA antero posterior diameter \> 50 mm.
* Left Ventricular Ejection Fraction (LVEF) \< 40%.
* Contraindication to anticoagulation (e.g., heparin).
* Myocardial infarction within the past 2 months.
* Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
* Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
* Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
* Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
* Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
* Life expectancy or other disease processes likely to limit survival to less than 12 months.
Measurable Residual Disease Detection Using Tumor-Informed CtDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck

This study will test the ability of a personalized blood test to determine which head and neck cancer patients will have a recurrence after treatment.

This is a two-arm, prospective, observational study of patients with human papillomavirus (HPV)-independent head and neck squamous cell carcinoma (HNSCC) who are receiving curative-intent treatment. Arm 1 will consist of patients who undergo surgery. Arm 2 will consist of patients who undergo chemoradiotherapy.

The study will test the following hypotheses:

1. That applying a tumor-informed minimal residual disease (MRD) assay after completion of curative-intent treatment will accurately discriminate between patients who will eventually experience recurrence (those are MRD positive) and patients who will remain disease-free (those who are MRD negative). The hypothesis is that patients who have detectable ctDNA following treatment-MRD positive patients-will experience recurrent disease within 2 years, while patients who have no detectable ctDNA-MRD negative patients-will remain disease free at 2 years.
2. That measuring MRD after completion of curative-intent treatment will provide a lead time from detectable to clinical diagnosis of recurrent disease of at least 3 months.

The primary outcome is 2-year DFS in patients with detectable vs no detectable ctDNA two weeks after treatment completion.

The study will accrue 75 patients, who will be followed for a minimum of 2 years.

Subjects will have blood draws before, during and following treatment at regular intervals for testing with the assay (Haystack MRD™)

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AJCC 8th edition Stage III-IVB mucosal SCC of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx.
* Available tissue for tumor-informed ctDNA panel creation.
* Definitive treatment with standard of care surgery or chemoradiotherapy is planned to be administered at Massachusetts Eye and Ear Institute (MEEI) or within the Massachusetts General Hospital (MGH) Cancer Center (including but not limited to the Boston, Danvers, and Newton-Wellesley locations).

Exclusion Criteria:

* Patients \<18 years of age
* Patients receiving non-standard of care therapy as determined by the clinical investigator
* Participants who have undergone prior surgical resection, excisional biopsy, radiation, and/or chemotherapy for the treatment of HNSCC. Prior incisional biopsies are permitted. Discrepant cases will be reviewed by study PI.
* Participants who are receiving any investigational agents at the time of enrollment.
* Participants with AJCC Stage IVC HNSCC, which includes patients with biopsy-confirmed distant metastatic HNSCC, including but not limited to metastatic spread to the lungs, bones, or liver.
* Active non-HNSCC malignancy.
* Active pregnancy during treatment.
Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer

This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced non-small cell lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based therapy either given concurrently or as separate regimens.

The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced non-small cell lung cancer. Secondary objectives include:

* To further evaluate the safety of EKB-569
* To explore additional clinical activity parameters
* To explore subject survival
* To evaluate the pharmacokinetics of EKB-569
* To assess subject reported outcomes

EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
* Histologic and/or cytologic diagnosis of locally-advanced or metastatic non-small cell lung cancer in subjects who are not curable by conventional therapy

Exclusion Criteria:

* Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas)
* Prior radiotherapy to \>25% of bone marrow
* Prior epidermal growth factor receptor-targeting therapy
A Trial of Oral Misoprostol for Labor Augmentation

This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.


Eligibility Criteria:
Inclusion Criteria:

* Clinical decision to augment labor
* Gestational age \> than or equal to 36 weeks
* Singleton gestation
* Cephalic presentation
* Reassuring fetal heart rate tracing
* Cervical dilation between 4 and 8 cm
* Ruptured membranes with clear amniotic fluid
* Intrauterine pressure catheter in place
* Less than 200 MVUs in a 10 minute period
* 5 or fewer contractions in a 10 minute period
* English or Spanish speaking patient

Exclusion Criteria:

* Non-reassuring fetal heart rate tracing at time of enrollment
* Meconium stained amniotic fluid
* Previous uterine incision
* Maternal fever (defined as greater than 37.9 C)
* Known fetal anomalies
* Placenta previa or unexplained vaginal bleeding
* Estimated fetal weight of 4,500 grams or more
* Abnormal maternal bony pelvis
* Grandmultiparity
Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy

The purpose of this study is to determine which of two approaches is helpful to support caregivers of patients undergoing Hematopoietic Stem Cell Transplant (HSCT) or Chimeric Antigen Receptors (CAR) T-cell therapy at Seidman Cancer Center. This study will take start before you begin treatment until 2 months after your hospital discharge.

This is a two-group, randomized pilot study to test the feasibility, acceptability, usability, satisfaction and preliminary efficacy of a behavioral (psychoeducation) intervention, as compared to a usual care (information from healthcare providers) control group, on caregiver outcomes. The control and intervention groups will receive the standard University Hospitals Seidman Cancer Center (SCC) binder of relevant information regarding care of the patient undergoing HSCT or CAR T-cell therapy. This information will be given to the caregiver by the health care provider. In addition, the intervention group will receive 6 individual sessions with an interventionist during all phases of HSCT or CAR T-cell therapy. The independent variable is group assignment.

The primary objective of this study is to explore the feasibility and acceptability of a psycho-educational intervention designed for caregivers of patients receiving HSCT (allogenic or autologous) or CAR T-cell therapy.

The secondary objective of this study is to explore the usability, satisfaction and preliminary efficacy of a psycho-educational intervention designed for caregivers of patients receiving HSCT (allogenic or autologous) or CAR T-cell therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * Has a diagnosis of blood cancer (leukemia, lymphoma, myeloma, MDS, MPN, CML, CMML) and is scheduled to undergo HCST or CAR T-cell therapy at SCC
  * Will receive HSCT or CAR T-cell therapy and follow-up care from a medical oncologist at University Hospitals Seidman Cancer Center (SCC)
  * Has English as their primary language
  * Provides consent for his/her own treatment and procedures
  * Has an identified caregiver (per SCC-HSCT and CAR T-cell therapy protocol) who will be involved in the patient's care post-HCST or CAR T-cell therapy
* Caregivers

  * An adult family or friend (at least 18 years old) of a patient scheduled to receive HSCT or CAR T-cell therapy at SCC
  * Identifies himself/herself as the caregiver who will be responsible for the patient's care post-HSCT or CAR T-cell therapy
  * Has English as their primary language
  * Is capable of providing informed consent
Mental Health Symptom Monitoring Utilizing the Cogito Behavioral Analytic Platform

The primary objective of this project is to test the acceptability and feasibility of a mobile application to facilitate mental health symptom monitoring and follow-up among Veterans. During the course of the study, the research application will be installed on participants' mobile phone. The application on the participants' phone will be recording data about their behavior. Participants will also be asked to complete bi-weekly surveys via the app.


Eligibility Criteria:
Inclusion Criteria:

* Veterans between the ages 18-89 years of age at the time of enrollment
* able to provide signed and dated informed consent
* has anandroid platform phone and is willing to use phone and personal data plan to participate

Exclusion Criteria:

* Participation in conflicting Rocky Mountain MIRECC interventional protocol
Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC) in Patients With Stable Type 2 Diabetes and Hypertension

To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of 2 treatment regimens of IW-1973 tablet (40 mg per day) administered orally for 2 weeks to patients with stable type 2 diabetes mellitus and hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ambulatory male or female
* Patient's body mass index score is \> 20 and \< 40 kg/m\^2 at the Screening Visit
* Women of childbearing potential must have a negative pregnancy test at the time of screening and check-in and must agree to use protocol-specified contraception throughout the duration of the study
* Patient's health is stable with no clinically significant findings on physical examination
* Patient has type 2 (ie, adult onset) diabetes mellitus diagnosed by a physician or nurse practitioner \> 6 months before the Screening Visit, is on a stable glycemic control medication, and protocol specified hemoglobin (Hb)A1c values at the Screening Visit
* Patient has hypertension diagnosed by a physician or nurse practitioner \> 6 months before the Screening Visit, and blood pressure (BP) within the protocol's acceptable range
* Patients must be on a stable regimen for hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), stable for 28 days
* Other inclusion criteria per protocol

Exclusion Criteria:

* Patient has a clinically significant active or unstable medical condition that, in the opinion of the Investigator, would preclude trial participation
* Patient is on medication(s) that, when co-administered with a sGC stimulator, could increase the risk of hypotension
* Patient has evidence of severe or active end-organ damage
* Patient is an active smoker or has used any nicotine-containing products (cigarettes, e-cigarettes, vape pens, cigars, chewing tobacco, gum, patches) during the 6 months before Check-in. Use of nicotine is excluded during the study until after the End of Trial Visit.
* Other exclusion criteria per protocol
Occupational Stress and Bipolar Disorder

Bipolar disorder is a mental disorder characterized by alternance of depressive and manic phases, separated by intercritical phases (euthymia). The majority of patients report occupation and professional difficulties. Sixty percent of bipolar patients are inactive . Indeed, according to the World Health Organisation, bipolar disorder is the second cause of days not worked.

Several factors are related to the lower professional functioning observed in bipolar patients: early age of onset, delay of diagnosis and treatment, recurrence of thymic episodes, residual symptoms and cognitive disorders during euthymia, side effects of mood stabilizers.

To our knowledge, no study has ever focused on well-being at work in French patients. However, suffering from a psychiatric disorder and the lack of support from colleagues and the hierarchy are risk factors for burnout, a growing health issue.

Patients with mental illness are often victims of stigmatization, which may involve the professional field. In addition, thymic recurrences may alter professional functioning of active patients: multiplication of work disruptions, conflicts with peers. Conversely work can be stressful, promoting thyic relapses. It is therefore essential to better understand the occupational stresses of active patients suffering from bipolar disorder in order to promote functional remission beyond clinical remission.

The aim of this study is to assess the level of stress and well-being at work in active French bipolar patients.

Socio-demographic, psychiatric and occupational data of 200 bipolar patients will be collected over a period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* out patients and inpatients in the Department of Emergency Psychiatry and Post Acute Care, CHU Montpellier, France
* to have completed the self-administered questionnaire on professional activity.

Exclusion Criteria:

* Deprived of liberty subject (by judicial or administrative decision)
* Protected by law (guardianship)
Predicting Development of Diabetes Mellitus in Patients Undergoing Allogeneic Stem Cell Transplant

This clinical trial studies the physiology and immunology of new-onset post-transplant diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose tolerance testing (OGTT), euglycemic hyperinsulinemic clamps, and immune assays will be used to define the mechanisms associated with abnormal glucose homeostasis following stem cell transplantation. Information from this clinical trial could be used to develop standardized screening procedures or to develop optimal treatment strategies for patients developing post-transplant diabetes mellitus.

PRIMARY OBJECTIVES:

I. To determine whether pre-transplant insulin resistance predicts for the development of new onset post-transplant diabetes mellitus (PTDM) in individuals without diabetes undergoing matched related donor (MRD) hematopoietic stem cell transplant (HCT).

II. To define the role of circulating tissue-specific Th1 cells in the development of PTDM.

III. To characterize the phenotype and function of circulating tissue-specific regulatory T cells (Tregs) in HCT recipients with or without PTDM.

OUTLINE:

Patients undergo OGTT and a standard 2-step euglycemic hyperinsulinemic clamp procedure prior to HCT. Patients then undergo repeat OGTT and a 2-step euglycemic hyperinsulinemic clamp procedure once after HCT between days 90-100.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing MRD allogeneic HCT
* DONOR: Donors undergoing stem cell collection for match related allogeneic stem cell transplant

Exclusion Criteria:

* Patients who have not received an allogeneic HCT
* Recent or current history of diabetes mellitus, defined as:1) diabetes therapy within 6 months of enrollment, or 2) fasting blood glucose at "pre-admit" (screening) visit \>= 126 mg/dL
* Pregnancy or breastfeeding
* Unrelated donor, umbilical cord blood, mismatched, or haploidentical transplants
* Patients receiving T cell depletion or thymoglobulin as part of their transplant
* Patients on established, chronic corticosteroid therapy (\> 5 mg /day of prednisone or prednisone equivalent) prior to transplant; established, chronic corticosteroid therapy is defined as daily dosing of \> 5 mg/day of prednisone or prednisone equivalent for at least 2 weeks prior to the start of conditioning/chemotherapy or plans to continue pre-transplant corticosteroids (\> 5 mg/day of prednisone or prednisone equivalent) indefinitely after transplantation
* Inability to give informed consent
* Any condition which, in the opinion of the investigator, might interfere with study objective
* Any reason which, in the opinion of the investigator, adds additional risk to the patient
* DONOR: Individuals not donating stem cells
* DONOR: Pregnancy or breastfeeding
* DONOR: Inability to give informed consent
* DONOR: Any condition which, in the opinion of the investigator, might interfere with study objective
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes

The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.


Eligibility Criteria:
Inclusion Criteria:

* Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan
* Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients \< 20 years of age

Exclusion Criteria:

* Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study
Improving the Diagnosis of Pneumonia in Emergency Rooms

A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of pneumonia caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tests Pneumonia. This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribo Nucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribo Nucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of pneumonia after POC tests.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted at hospital for pneumonia requiring, for the emergency physician, a microbiological examination with a "POC pneumonia kit."
* Patient who has freely signed the informed written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman, parturient or nursing
* Adult major under guardianship
* Patient deprived of liberty under court order
* Patient refusing or unable to sign the informed consent form.
Neurostimulation to Improve NOWS Outcomes

The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.

This study is designed as a randomized, double-blind, sham-controlled, multi-center, clinical trial in which neonates diagnosed with Neonatal Opioid Withdrawal Syndrome (NOWS) will be randomized 1:1 into one of two treatment groups:

1. Group 1: Active tAN + Morphine
2. Group 2: Sham tAN + Morphine

Morphine dosing for all infants will be managed by using the Finnegan Neonatal Abstinence Scoring System (FNASS), recorded every three hours.

After the participant exits the inpatient treatment phase of the study, they will enter the neurodevelopmental follow-up phase. The participant's parent or legal guardian will be contacted at 3, 9, 18, and 24 months of age to complete the Ages and Stages Questionnaire (ASQ-3) and the Sensory Profile 2 (SP-2). At 24 months, participants who fail in any sub-domain will be referred to their primary care physician for further neurodevelopmental assessment using the Bayley Scale of Infant and Toddler Development III (BSID-III) or other neurodevelopmental assessment.

Eligibility Criteria:
Inclusion Criteria

1. Neonates or infants \>33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy
2. Clinically stable without respiratory support (exception for nasal cannula)
3. Congenital syndromes may be included if the infants do not have major, unrepaired anomalies

Exclusion Criteria

1. Unstable infants
2. Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving
3. Major unrepaired congenital anomalies impacting respiratory or cardiovascular system
4. Cardiomyopathy
5. Abnormal ear anatomy preventing the device to fit
6. Infants diagnosed with iatrogenic NOWS
7. Infants two weeks of age or older (after birth)
8. Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing
9. Infants who are wards of the state
10. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
The Role of IL33/ST2 Axis in ARDS Patients

The main objective is the study of the role of IL33/ST2 axis in the pathogenesis of ARDS, it´s value as prognosis marker and as therapeutic target.


Eligibility Criteria:
Inclusion Criteria:

* ARDS
* Risk pathologies to develop ARDS (sepsis, pancreatitis, pneumonia, massive transfussion, politraumatics)

Exclusion Criteria:

* Age under 18
* Pregnancy
* Undergoing a clinical trial