cyrilzakka/clinical-trials huggingface dataset:
Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)

The purpose of this study is to determine which pacing mode after coronary artery bypass grafting in patients with reduced left ventricular function is hemodynamically favorable.

Patients with severely reduced left ventricular function undergoing coronary artery bypass grafting (CABG) are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious whereas biventricular pacing improves cardiac output in patients with severely reduced left ventricular function and bundle branch block. The purpose of this study is to compare DDD-right ventricular, DDD-biventricular and AAI pacing in CABG patients with an ejection fraction less than 40% in a prospective randomized setting.

Eligibility Criteria:
Inclusion Criteria:

* Elective or urgent coronary artery bypass grafting
* Preoperative ejection fraction less than 40%

Exclusion Criteria:

* Existing permanent pacemaker or ICD
* Concomitant valve surgery
* Preoperative cardiovascular instability requiring intubation or IABP use
* Chronic renal failure requiring dialysis
* Failure to provide informed consent
Outcome of Cardiac Arrest Survivors

Early prognosis of cardiac arrest - nearly 40000 new cases per year in France - has been extensively studied, highlighting a poor outcome (less than 8% at hospital discharge). However, little is known on mid and long-term prognostic factors and how these patients do survive from the event.

Using a regional cohort, the aim of the study is to describe long-term survival rate of cardiac arrest survivors, and to assess the influence of treatment strategies on survival and functional outcome.

The collection of clinical and biological data of patients who experienced cardiac arrest and survive from hospital, including a regular follow-up with qualitative data (functional, neurological and quality of life) may provide important benchmark on the evolution of these patients and on the impact of acute interventions (such as cardio-pulmonary resuscitation, defibrillation, emergent coronary revascularization, neuroprotective treatments).

Using a large identified cohort of survivors of cardiac arrest, we aim to describe the qualitative long-term prognosis of these cardiac arrest patients (functional, neurological and quality of life status). Secondarily, we intend to identify the long-term prognostic factors, and particularly the role of early interventions, using a long-term and qualitative combined endpoint (vital status, functional scales, SF36).

This project is observational and will include all patients over 18 admitted alive after non-traumatic cardiac arrest in the area of Ile-de-France (France), whatever the cause of the cardiac arrest. Patients or their proxies, refusing their participation, will not be included.

We will collect all pre- and in-hospital information related to the event and performs prospectively interviews at 3 months and every year anniversary. The questionnaire will include vital status, cardiovascular events, medication and a complete qualitative report (SF36, ADL scale, OPC, CPC, social-professional activities).

This project will provide important data over time on the evolution of these patients. Findings will help in measuring the role of different strategies on long-term prognosis and consequently improve the overall management of cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Patients alive after resuscitation from a out-of-hospital cardiac arrest
* All causes for cardiac arrest
* Age above 18
* Informed consent from the patient or next of kin

Exclusion Criteria:

* Impossibility for communication after hospital discharge, whatever the cause (language, residence...)
* Follow-up refusal from the patient or next of kin
Pulmonary Vein Isolation Using Stereotactic Radiotherapy System for the Treatment of Refractory Atrial Fibrillation

The study aims to investigate the short-term (3 months) and intermediate-term (12 months) safety and preliminary efficacy of stereotactic radiotherapy for pulmonary vein isolation to treat refractory atrial fibrillation.

This is a single center, single arm, prospective and phase 1 clinical trial. Patients with refractory atrial fibrillation (AF) will receive single fraction stereotactic radiotherapy for pulmonary vein isolation. To minimize the potential risks associated with this innovative technique, the study has been designed in a stepwise dose escalation fashion under carefully observation by the investigators. The dose escalation is guided by 3+3 algorithm to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level than will be chosen as optimal dose of maximal effects. Low dosing levels with established safety profile will first be applied before administering higher dosing levels based on preclinical studies.

Safety is the primary endpoint of the study. Safety will be assessed by incidence and evaluation of any serious adverse evens using CTCAE V5.0 criteria associated with the procedure through 90 days (short-term) and 12 months (intermediate term). Efficacy will be evaluated by assessing atrial fibrillation recurrence (for paroxysmal AF) or AF burden (for persistent AF) after 90 days of blank period until 12 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

Paroxysmal or persistent atrial fibrillation. Age 55-89 Symptomatic, refractory to at least 3 antiarrhythmic drugs Failure from the previous catheter ablation of atrial fibrillation, or contraindicate /unwilling to undergo catheter ablation.

Anticoagulation for at least 3 months if CHA2DS2-VASc 2 or more.

Exclusion Criteria:

With concomitant atrial flutter, WPW syndrome or supraventricular tachycardia. With sustained ventricular tachycardia. With sick sinus syndrome or atrioventricular block fulfilling the indication of permanent pacemaker implantation.

Stroke or myocardial infarction within 8 weeks. Uncontrolled heart failure or unstable angina pectoris. Severe structral heart diseases. Severe pulmonary hypertension. Uncontrolled hypertension. Severe respiratory disease. Esophageal ulcer. Intracardiac thrombus by TEE. Pregnancy or have a preganancy plan. Others.
Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer

The purpose of this research is to understand if it is helpful for patients with mental illness to be connected to a psychiatrist and case manager at the time of cancer diagnosis.

It is challenging to cope with cancer. The investigators want to understand if it is helpful for patients with serious mental illness (SMI) to be connected to a psychiatrist and case manager when cancer is diagnosed. Many people with illnesses like major depression, schizophrenia and bipolar disorder face barriers to receiving high quality cancer care. It can be difficult to get to appointments, have many different doctors, and experience depression or worry. Better communication between the patient, the oncology team, and mental health providers may improve care. As for all patients, it is important for people with mental illness to have access to high quality cancer treatment that is patient-centered and coordinated. Having a case manager and psychiatrist at the cancer center who collaborates with the oncology team starting at cancer diagnosis may help patients to receive the cancer care that they need.

This study includes a single-arm open pilot (n=8) to pilot patient and caregiver measures and refine the intervention manual; a run-in period (n=6) to pilot the randomized trial procedures; and a randomized controlled trial (n=120) to compare the impact of the Bridge model with enhanced usual care on disruptions in cancer care.

Eligibility Criteria:
Patient Inclusion Criteria:

* Age ≥ 18 years old; Value ______
* Verbal fluency in English
* Serious mental illness (Schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with prior psychiatric hospitalization) confirmed by study clinician at consent
* Invasive breast, lung, gastrointestinal, or head and neck cancer (suspected or confirmed Stage I-III, or Stage IV cancer that can be treated with curative intent according to judgment by the oncologist.)
* Medical, surgical, or radiation oncology consultation at MGH Cancer Center within the past 8 weeks or a referral placed to the MGH Cancer Center and planned or recommended follow-up

Patient Exclusion Criteria:

* Have cognitive impairment severe enough to interfere with completing brief study assessments or providing informed consent (and does not have a guardian who can provide consent)
* Recurrence of the same cancer type

Caregiver Participants

* Age ≥ 18 years old; Value ______
* Verbal fluency in English
* Identified or confirmed by the patient or guardian as a caregiver
* Caregiver may be a relative, friend, or community mental health staff upon whom the patient relies upon for support and who accompanies the patient to medical appointments
* The caregiver should either live with the patient or have in-person contact with the patient once per week (on average)
* Patient or guardian must provide permission to contact caregiver
An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study

This open--label, multicenter, national observational study will investigate the effectiveness of standard of care treatment with peginterferon alfa-2a in participants with chronic hepatitis B (CHB). Participants who have never received any hepatitis B virus (HBV) treatment and participants previously treated with nucleos(t)ide analogs (NAs) are qualified for enrollment. The observation period is 48 weeks (peginterferon alfa--2a standard of care treatment) and for up to 24 weeks thereafter (72 weeks in total).


Eligibility Criteria:
Inclusion Criteria:

* HBeAg positive or HBeAg negative serologically proven CHB with or without cirrhosis (histologically verified at some point in the past)
* Baseline HBV DNA greater than (\>) 2000 IU/mL
* Elevated serum ALT \> upper limit of normal (ULN)
* Participants treated with previous NAs therapy are eligible for this study

Exclusion Criteria:

* Participants who have contraindications for peginterferon alfa-2a in accordance with the approved summary of product characteristics (for example, severe psychiatric diseases, immunological diseases, severe hepatic dysfunction or decompensated cirrhosis of the liver severe retinopathy or thyroid dysfunction, autoimmune hepatitis, history of severe pre-existing cardiac disease, or hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)
* Participants with ALT \> 10 times of ULN or evidence of hepatocellular carcinoma
* Participants with serological evidence of co-infection with hepatitis A virus, hepatitis C virus, human immunodeficiency virus, or hepatitis D virus
* Participants with decompensated liver disease
* Pregnant or breast-feeding women
* A history of liver transplantation or planned for liver transplantation
Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients

The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine "NAC" in COVID 19 patients.

This is a phase 3 trial enrolling subjects with newly diagnosed Corona virus disease 2019 ( COVID-19) infection who are classified as moderate cases and require hospitalization. Patients meeting eligibility criteria will be randomized either to receive oral N-acetylcysteine or not along with the institution treatment protocol . Treatment efficacy will be assessed using certain endpoints as follows:

1. Markers of inflammation and oxidative stress
2. Length of hospital stay
3. Need for ventilation
4. Mortality rate

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged more than 18 years
2. Documented COVID-19 infection (either performed on site or documented external report), only moderate cases will be included

Exclusion Criteria:

1. Known allergy or hypersensitivity to NAC
2. Pregnancy
3. Critically ill or mechanically ventilated patients
Popliteal Nerve Block for Achilles Tendon Repair Surgery

Surgery has traditionally been the mainstay of treatment for patients who experience acute Achilles tendon rupture, and anesthesia for this operation often includes a popliteal nerve block. However, the evidence basis for this practice is uncertain, and popliteal nerve block has associated risks such as peripheral nerve injury. This research study will evaluate the effects of popliteal nerve block on postoperative pain, recovery, and quality of life after Achilles tendon repair surgery, in order to better inform patient and provider decisions to receive or perform popliteal nerve block for this operation.

This research study will evaluate the effectiveness and safety of popliteal nerve block as an adjunct analgesic technique for Achilles tendon repair surgery. The protocol describes a prospective, double-blinded, randomized, and sham-controlled superiority trial conducted at Women's College Hospital in Toronto, Ontario, Canada.

Eligible and consenting patients will be randomized into study groups by a computer-generated sequence. Investigators and participants will both be blinded to patient assignment at the time of randomization as well as throughout treatment and assessment. Study groups will receive either a standard popliteal nerve block performed immediately before their surgery in the popliteus of the surgical knee, or a sham block with normal saline. Patients in both groups will receive preoperative and postoperative multi-modal analgesia management as per our institution's standard practice, and will be administered a general anesthetic in the prone position during their surgery.

Following Achilles tendon repair, data will be collected pertaining to patient pain, quality of life, recovery, and adverse events in the acute and subacute postoperative periods (in-hospital as well as through the use of a study diary following discharge home). Data from study groups will be compared to elucidate risks and benefits attributable to popliteal nerve block, in order to inform patient and provider decision-making in the perioperative period.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65
* ASA classification: I - III
* BMI \< 35 kg/m2
* Undergoing acute Achilles tendon repair surgery as a day surgery procedure

Exclusion Criteria:

* Pre-existing neurological deficits or peripheral neuropathy in the distribution of the tibial or common peroneal nerves
* Local infection
* Contraindication to regional anesthesia (e.g., bleeding diathesis, coagulopathy)
* Chronic pain disorders
* History of use of over 30 mg oxycodone or equivalent per day
* Contraindication to any component of a standard multi-modal analgesia
* Allergy to local anesthetics
* History of significant psychiatric conditions that may affect patient assessment
* Pregnancy
* Inability to provide informed consent
* Patient refusal of popliteal nerve blockade
* Prior Achilles tendon surgeries on the operative leg
Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma

Around 1/3 of patients with COPD have elevated eosinophil levels. However, the role of eosinophils in COPD has not been yet understood and is probably different in COPD and in asthma. The aim of this study was to assess the expression of selected surface markers on eosinophils and to assess the gene expression in eosinophils in COPD and asthma patients. We are planning to enrol 12 COPD, 12 asthma and 12 control subjects. Patients will undergo routine clinical assessment, spirometry, blood sampling and sputum induction. Eosinophils will be isolated from blood and sputum. Surface markers on eosinophils will be assessed in flow cytometry, gene expression will be assessed by RNAseq.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD according to GOLD 2019 or asthma according to GINA 2021
* Peripheral blood eosinophil count ≥ 100 / μL
* Age ≥40 years (COPD), ≥18 years (asthma)
* History of cigarette smoking: ≥10 pack-years (for COPD)
* Stable disease period (at least 3 months without exacerbation)
* Exclusion of parasitic diseases
* Informed consent to participate in the study

Exclusion Criteria:

* COPD and asthma overlap
* Use of systemic corticosteroids in the 3 months prior to the study
* Respiratory infection or exacerbation in the 3 months prior to the study
* Acute and chronic respiratory failure
* Concomitant diagnoses: systemic connective tissue diseases, malignant neoplasms, severe and / or uncontrolled cardiovascular diseases
* Use of immunosuppressive or immunomodulating drugs in the 3 months preceding the study
* Contraindications to sputum induction
* No consent to participate in the study
Vitamin-D Receptor in Laryngeal Squamous Cell Carcinoma

Laryngeal squamous cell carcinoma (LSCC) is the second most common primary malignant tumor of the respiratory tract after lung cancer and the second most common primary epithelial malignant tumor of the head and neck. The age of onset of LSCC is mostly between 50 and 70 years, with a male to female ratio of approximately 4:1 .According to estimates by the American Cancer Society, in the United States, approximately 12,470 new cases of laryngeal cancer will be diagnosed and 3,820 people will die from laryngeal cancer in 2022.

The nuclear vitamin D receptor (VDR) is involved in multiple pathways that have many points of convergence. Some of these pathways are implicated in carcinogenesis thus the suggestion that VDR has a role to play in the biology of cancer \[3\]. Recent evidence indicates that the active form of vitamin D (1alpha, 25-dihydroxycholecalciferol) (VD) exhibits several different effects on normal and cancerous cells, including up-regulation of anti- proliferation and pro-apoptotic factors, as well as inhibition of cell-cycle promoters and growth factor signaling pathways. Thus it is useful as an anti-neoplastic agent in several human malignancies.

Studies in cell and animal model systems, as well as clinical trials have recognized the potential usefulness of VD and VD analogues as agents that enhance the anti-proliferative/cytotoxic effects of chemotherapy and ionizing radiation. Thus, at concentrations that produce limited hypercalcemia, these agents may be used as adjuncts to conventional chemotherapy and radiotherapy. We aim to analyze the expression of VDR in LSCC to determine potential for active VD therapy in such patients.


Eligibility Criteria:
Inclusion Criteria:

1. Both endoscopic and excisional biopsy specimens.
2. All the studied cases include sufficient materials for the immunohistochemical study.
3. Complete clinical data

Exclusion Criteria:

1. Patients with recurrence of the primary tumor.
2. Patients with a history of preoperative chemotherapy and/or radiotherapy.
3. Insufficient or tiny tissue biopsies
Inhaled Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Hereditary Pulmonary Alveolar Proteinosis (PAP)

The purpose of this study is to evaluate the therapeutic efficacy of inhaled recombinant human GM-CSF in individuals with hereditary Pulmonary Alveolar Proteinosis (PAP) due to partial dysfunction of the GM-CSF receptor.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of PAP caused by bi-allelic mutations in CSF2RA or CSF2RB associated with impaired GM-CSF-R-alpha or GM-CSF-R-beta function, respectively, resulting in reduced but non-zero GM-CSF signaling
* Able and willing to give written informed consent / assent as necessary
* Clinically stable

Exclusion Criteria:

* Confirmed diagnosis of a disorder of surfactant production caused by bi-allelic mutations in ABCA3, SFTPB, or SFTPC
* Confirmed diagnosis of autoimmune PAP caused by a high level of GM-CSF autoantibody
* Confirmed diagnosis of secondary PAP caused by an underlying clinical disorder known to be associated with the development of PAP, e.g., inhalation of silica or titanium; myelodysplasia and others
* Treatment with any investigational agent in the 3 months prior to enrollment
* History of severe allergic or anaphylactic reactions to GM-CSF or other yeast-derived products
* History of asthma or other reactive airways disease
* Known active, viral, fungal, mycobacterial, or other infection
* A serious medical condition which, in the opinion of the investigator or data and safety monitoring committee, would make the patient unsuitable for the study
Vibrotactile Coordinated Reset (VCR): A Treatment for Early Stage Parkinson's Disease

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on early stage Parkinson's symptoms. VCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. Patients will be followed for two years.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 and older
2. Idiopathic Parkinson's disease Hoehn and Yahr stage I
3. Fluent in English
4. Appropriate social support if required during an off state.
5. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
6. Feels comfortable going off PD related medication during in person study visits
7. Lives in the United States

Exclusion Criteria:

1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
2. Any current drug or alcohol abuse.
3. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
4. Pregnancy, breast-feeding or wanting to become pregnant
5. Physical limitations unrelated to PD that would affect motor ratings
6. Craniotomy
7. Brain surgery
8. Patient is unable to communicate properly with staff (i.e., severe speech problems)
9. Excessive drooling
10. A type of hair style that would impede the use of an EEG cap
11. Sensory abnormalities of the fingertips
12. Nasal dysfunction unrelated to smell loss
Effect of Fluid Resuscitation and Microcirculation

Although the investigators take many measurements to monitor the fluid state of the patients, it is not known exactly whether the fluid has real effect on the organ perfusion. The main focus of fluid is to improve the organ perfusion. Recent research has focused on the investigation of sublingual microcirculatory alterations.

Is fluid responsiveness, what means a better cardiac output, equal to the need for fluid for a better organ perfusion? In hospital the investigators are now looking to the pump function of the heart, as there is not a better measurement. However this gives no information about necessity of giving fluids. A healthy volunteer also gives a better pump function of the heart after fluid, but that fluid is not necessary and gives no better organ perfusion. The question is: How many percent of the patients have a MFI score of \< 2.6, when the doctor on clinical basis plans to give fluid to the patient, improves organ perfusion after fluid, and is this correlated with an improvement of the cardiac output All intensive care patients who need extra fluid are eligible for this study. Before and after the fluid challenge we do SDF imaging sublingual. Per patient the investigators do this 1x in 24 hours. Concurrently, data on both patient characteristics (e.g. severity of illness) will be obtained Study population max 100 patients. Possible outcome: MFI \< 2,6 en SV \> 10% + MFI up MFI \< 2,6 en SV equal + MFI equal MFI \< 2,6 en SV \> 10% + MFI equal MFI \< 2,6 en SV equal + MFI up MFI \> 2,6 en SV \> 10% + MFI up MFI \> 2,6 en SV equal + MFI equal MFI \> 2,6 en SV \> 10% + MFI equal MFI \> 2,6 en SV equal + MFI up

Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* hemodynamic monitoring
* informed consent
* admission on ICU

Exclusion Criteria:

* no informed consent
* oral surgery