cyrilzakka/clinical-trials huggingface dataset:
Atrial Fibrillation Monitoring on Patients With Lymphoma After Chemotherapy

This prospective cohort study is to investigate the incidence of atrial fibrillation after chemotherapy by aplying wearable ECG recoder and the risk factors on patients with newly diagonsed lymphoma

This prospective, single-centre, observational cohort study is disigned to enroll 100 newly diagnosed lymphoma patients who met the inclusion and exclusion criteria to monitor the onset of atrial fibrillation and other arrhythmias during chemotherapy by using wearable ECG recorder, and to evaluate the incidence of atrial fibrillation and related risk factors.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old;
2. Concurrent chemotherapy on patients with new-onset lymphoma: chemotherapy regimens containing anthracyclines;
3. The subject voluntarily signed the informed consent.

Exclusion Criteria:

1. With heart failure, acute stroke or acute coronary syndrome within 3 months before admission
2. With Atrial fibrillation on admission
3. Patient after pacemaker surgery
4. With mental illness or mentally disabled
5. Patients that the investigator considers as unsuitable for this test
Enterobacteriaceae Producing Extended-spectrum β-lactamases (ESBL) Decolonization Study

Multidrug-resistant Enterobacteriaceae producing extended-spectrum β-lactamases (hereafter called ESBLs) have emerged as an important cause of bloodstream infection in hospitalized patients and urinary tract infections in the community. As is the case with other multidrug-resistant organisms chronic colonization is frequent, in the case of ESBLs mostly intestinal and urinary carriage.

To the investigators knowledge no randomized, placebo-controlled clinical trial has been performed to study the efficacy of a systematic ESBL eradication strategy. Eradication of ESBL carriage would cause benefits for the individual patient - by reducing the risk of infection - and for the community - by reducing transmission. Even if eradication turns out to be impossible, transient suppression of ESBL might reduce the likelihood of transmission and thus still be beneficial from an ecologic perspective.

The purpose of the proposed study is to test the hypothesis that the administration of a 10 day course of oral antibiotics active against ESBLs can lead to decolonization of ESBL carriage in hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

Patients can be enrolled into the study provided that all of the following criteria are met:

1. Microbiologically documented rectal carriage of ESBL-producing Enterobacteriaceae, without signs and symptoms of active infection with ESBL-producing Enterobacteriaceae at any body site
2. Patient must give written informed consent to participate in the study. The informed consent can be given by the legal representative if necessary.

Exclusion Criteria:

1. Women who are pregnant or nursing
2. Active infection
3. Treatment with antimicrobial agents with activity against ESBL-producing Enterobacteriaceae
4. Contraindication to the use of one of the study drugs (e.g. renal insufficiency with creatinine clearance \< 30 ml/min)
5. Patient already enrolled in another study, or in the present study for a previous episode
6. Psychiatric disorder or unable to understand or to follow the protocol directions
7. Permanent indwelling urinary catheter that can not be changed
8. Resistance of the ESBL-producing Enterobacteriaceae to one of the study drugs
9. Known hypersensitivity to one of the study drugs
Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia.

Acute lymphoblastic leukemia (ALL) is a group of biologically heterogeneous diseases with diverse prognosis. Novel strategies for adult ALL have approached a CR rate of over 80%, which is similar to pediatric ALL. But the long term survival of adult ALL is only 30%-40%, much lower than pediatric patients.

In our trial, all the patients will first receive Vincristine 1.4mg/m2, max 2mg IV days 1,8,15,22, Daunorubicin 45mg/m2 IV days 1-3,Cyclophosphamide 750mg/m2 IV day 1 and prednisone 40-60mg/m2,by mouth days 1-14 (VDCP)regimen as initial induction therapy. If patients achieve complete remission after induction, they will be enrolled in our study for further consolidation and maintenance. If the tumor cells in bone marrow remain 5% to 20% after induction, the patients will receive VDCLP(VDCP+L-asparaginase 6000IU/m2 IV days5,7,9,11,13) and be enrolled until complete remission.

Rituximab is the main experimental intervention in our study.The consolidation regimen is HyperCVAD/MA or R-HyperCVAD/MA for totally 8 courses. The maintenance regimen includes 6-Mercaptopurine+Methotrexate for 24 months, Vincristine+Prednisone for the first 12 months, L-asparaginase in month 3 and 9 with or without Rituximab in month 6 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CD20-positive ALL
* Adequate liver function (bilirubin less than or equal to 1.5\*ULN, unless considered due to tumor), and renal function (creatinine less than or equal to 1.5\*ULN, unless considered due to tumor)
* Signed informed consent

Exclusion Criteria:

* Prior history of treatment with high-dose Ara-C, MTX or rituximab
* Pregnant or lactating women
* History of allergy to rituximab
* Unable to sign informed consent
* Active replication of HBV
* History of stem cell transplantation
Evaluation of Medical and Social Care for Elderly Patients, Between Hospital and Home: TEMPORARY ACCOMMODATION Out of Hospitalization by Nursing Home and Long-Term Care Units in Ile-de-France Region

Prospective, observational, non-interventional, comparative, multicenter RIPH3 study to investigate the impact of HTSH on length of hospital stay in referring sevices.

This is a multi-center study involving many hospital departments temporary accommodation at the end of hospitalization in several Nursing home/long term care units in Ile de France region. The temporary accommodation program was designed for elderly people living at home to find an accommodation solution in nursing home to meet a short-term need. Temporary accommodation beds are deployed and perpetuated in the Île-de-France region by the Regional Health Agency, physically grouped together in establishments within units with dedicated staff. The resources allocated to these beds have been increased. The aim of the study is to demonstrate the efficiency of the HTSH circuit, for elderly patients leaving hospital, in their medical and social care and the decision or not to return home.

Eligibility Criteria:
Inclusion Criteria:

Patient selection criteria Patient male or female at least 60 years of age, as initially defined with the Regional Health Agency , discharged from hospital, Oral expression of non opposition to participation in the study, documented in the medical record by the physician, Presenting a defined and feasible plan for returning home, Whose social/medical situation (stabilized) does not allow an immediate return home after hospitalization, Without behavioral disorders or psychiatric illness, with major aggression or wandering.

Caregiver selection criteria Person with an unpaid caregiving activity for their relative in HTSH, Person verbally expressing their non-opposition to participating in the study, and documented in the medical record of the patient they are helping, A person who is able to understand the study questionnaires and evaluations, and is able to answer them without the help of a third party.

Professional selection criteria Salaried professional, nursing or not, regularly and directly involved in the HTSH circuit, whether in hospital or in nursing home / long term care units, for at least 6 months, Oral expression of non opposition to participation in the study, documented by the establishment.

Exclusion Criteria:

Be already included in another clinical study, Benefit from a legal protection measure or be unable to express their consent, in accordance with article L1121-8 of the French Public Health Code.
Long-term Metazym Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)

This is a single center, open-label study of patients with late infantile MLD. All patients were previous treated 26 weeks in the phase I trial (EudraCT number: 2006-005341-11, NCT00418561). All patients will be offered continuing treatment in this study and will in this protocol receive 13 infusions, whereby the patients total have had 27 infusions of Metazym. One infusion will be given every other week. After a total of 52 weeks of treatment the subjects will continue treatment in a compassionate use protocol. Safety (AE/SAE) will be monitored at every visit.


Eligibility Criteria:
Inclusion Criteria:

The patients from the Phase I trial must meet the following criteria to be enrolled in the study.

* Subject's legally authorized guardian(s) must provide signed, informed consent prior to performing any study-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject)
* The subject and his/her guardian(s) must have the ability to comply with the clinical protocol

Exclusion Criteria:

* Spasticity so severe to inhibit transportation
* Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition that, in the opinion of the Investigator, would preclude participation in the trial
* Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial
* Use of any investigational product other than rhASA within 30 days prior to study enrolment or currently enrolled in another study which involves clinical investigations
Asynchrony in Operated Tetralogy of Fallot

The objective of this work is to estimate the correlation between the electrical activation of the VD measured by the CARTO electrophysiological mapping system and the mechanical activation of the VD measured by 3D echocardiography and 3D speckle-tracking. Our hypothesis is that there is a strong correlation between electrical activation and mechanical activation in patients with an operated Fallot tetralogy.

Fallot tetralogy is the most common cyanogenic congenital heart disease. Thanks to advances in surgery, most patients survive to adulthood but develop a failure of the function of the right ventricle and then of the left ventricle resulting in progressive heart failure and death of patients. Despite corrective surgeries in adulthood, including pulmonary valve surgery, heart failure remains a major problem. One of the mechanisms of this heart failure is the right intraventtricular asynchronism associated with the postoperative right branch block, which will secondaryly become complicated from an interventricular asynchronism for left intraventtricular, partly explaining the overall progressive failure of cardiac function. To date, there is no model for combining a combined analysis of electrical and mechanical activation in the same patients. Understanding these mechanisms would allow us to better understand the pathophysiology of heart failure in this population and to propose targeted therapies to prevent this asynchronism by adapting surgical techniques, or treating this asynchronism with electrical therapy such as bivascular resynchronization.

Each patient in each group will perform, according to standard practice, an electrophysiological exploration with mapping of the heart using the CARTO system, a cardiac MRI and a 3-dimensional transthoracic echocardiography.

The follow-up of each patient takes place during a scheduled hospitalization as part of the care. Their participation in the study only lasts for the duration of the hospitalization.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria in the Fallot group

* Male or female patient aged 18,
* Patient with Fallot Tetralogy operated.

nclusion Criteria in the Control group

* Male or female patient aged 18,
* Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia,
* Patient with a significant lack of heart disease.

Exclusion Criteria:

Exclusion Criteria in the Fallot group

* Patient with associated left heart disease,
* Patient with an acoustic window that does not allow for proper echocardiography,
* Patient with contraindication to MRI,
* Woman of childbearing age without effective contraception (HAS criteria) or Pregnant (ßHCG \> 20 IU/l) or nursing woman.

Exclusion Criteria in the Control group

* Patient with an acoustic window that does not allow proper echocardiography,
* Patient with MRI contraindication,
* Woman of childbearing age without effective contraception (HAS criteria) or Pregnant (ßHCG \> 20 IU/l) or nursing woman,
* Cardiac pathology detected during echocardiography.
SABR PRIMER - Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors

The study is being done to determine if stereotactic ablative radiotherapy (SABR) can control tumour growth for patients with metastatic breast cancer.

Secondary objectives will be overall survival, progression-free survival and time to switch of next line of systemic therapy.

Radiation-related adverse events will be assess, with a specific focus on dermatitis, lymphedema and brachial plexopathy.

The exploratory objective is to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.

Purpose:

The purpose of this study is to determine if stereotactic ablative radiotherapy (SABR) can provide effective locoregional control for patients with metastatic breast cancer. As secondary objectives, the investigators will assess the overall survival, progression-free survival and time to switch of next line of systemic therapy. The investigators will also assess radiation-related adverse events using CTCAE v5.0, with a specific focus on dermatitis, lymphedema and brachial plexopathy. Finally, as an exploratory objective, the investigators aim to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.

Primary Objective:

• Assess median, 1-year and 2-year locoregional control

Secondary Objectives:

* Assess median, 1-year and 2-year overall survival
* Assess median, 1-year and 2-year progression-free survival
* Assess median time to systemic therapy switch
* Assess radiation-related adverse events using CTCAE v5.0

Correlative Objectives:

• Correlate outcomes with peripheral blood-derived parameters

Research Design The trial is designed as a single-arm interventional study investigating stage IV breast cancer with persistent or progressive locoregional disease despite the use of standard systemic therapy A retrospective study will be conducted to create a matched cohort to compare locoregional control rates with patients who received conventional fractionated radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed AJCC 7th/8th edition Stage IV invasive ductal carcinoma or invasive lobular carcinoma of the breast.
2. Measurable disease in the breast, suitable to receive radiotherapy.
3. Receiving or planned to receive systemic therapy.

   a. The following should be held for the duration of treatment: cytotoxic chemotherapy, CDK4/6 inhibitors, T-DXd
4. Patients are allowed to have SABR for oligometastatic disease as clinically indicated
5. Age 18 or older
6. ECOG Performance Status 0-2
7. Life expectancy greater than 6 months
8. Able and willing to provide informed consent
9. Able to complete patient reported outcome questionnaires

Exclusion Criteria:

1. Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia, pregnancy
2. Previous history of locoregional radiotherapy to the ipsilateral breast
Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care

This study aims to analyze the effects of AI-based risk prediction for graft loss on the frequency of conversations about the treatment after graft loss, as well as the associated shared decision making process in post-kidney transplant care in a German kidney transplant center (KTC), as perceived by the patient, their support person and the clinician/physician. Second, it aims to explore changes in patient and support person recall at 12 and 24 months follow-up. Implementation barriers and enablers will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* patients with functioning kidney allograft
* \> 12 months after transplantation
* eGFR \< 30 ml/min/1.73m2 according to CKD-EPI 2021 formula
* at least 18 years of age
* ability to communicate in German
* regular follow-up at kidney transplant center

Exclusion Criteria:

* multi-organ transplantation
* eGFR \> 30 ml/min/1.73m2 according to CKD-EPI 2021 formula
* \<= 12 months after transplantation
* less than 18 years of age
* not able to communicate in German
* no regular follow-up at kidney transplant center
* enrollment in another interventional study less than 1 month before participation in this study
Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients

A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. There will be a dose escalation part and a dose expansion part.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced (unresectable and/or metastatic) HCC
* Patients with advanced HCC not amenable for surgical or loco-regional treatment
* At least one measureable tumor lesion that that has not been previously locally
* Patients with current cirrhotic status of Child-Pugh class A only (5-6 points with total bilirubin \< 2 mg/dL for dose-escalation) with no encephalopathy and no clinical ascites (ascites controlled by diuretics is also excluded in this study).
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient must meet required laboratory values at the screening
* Normal electrocardiogram at screening

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Invasion of the main portal vein and/or tumor involvement in more than 50% of the liver (applicable only for the dose-escalation part)
* Patients with Portal-caval shunts
* Prior or concomitant systemic anti-cancer treatment for advanced disease
* Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date for first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
* Cardiac or cardiac repolarization abnormality
* Patients with active Hepatitis B infection (HBsAg positive) that are not receiving antiviral treatment are excluded
* Patients with positive test for hepatitis C ribonucleic acid (HCV RNA)
* Loco-regional treatment within 4 weeks prior to initiation of study treatment.
Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome

The purpose of this study is to determine the efficacy of the interferential laser therapy in the wrist and hand pain and disability reduction and force improvement in the carpal tunnel syndrome. Subjects are patients diagnosed of carpal tunnel syndrome who have been prescribed laser therapy. Settings: Ramon y Cajal Hospital. Department of Rehabilitation. Physical therapy unit. Electrotherapy section. Occupational Therapy. Department of Neurology.

The spatiotemporal superposition of two independent and opposite beams of laser generates a constructive interference pattern that increases the therapeutic effects in the irradiated tissue. Patient suffering pain from diagnosed carpal tunnel syndrome will receive conventional or interferential laser therapy. This is a comparative randomized and double blind clinical study. Two identical lasers in near infrared range will be used. Frequency of sessions: daily. Irradiated technique: manual, contact and punctual. Pain will be evaluated by visual analog scale at rest and during analytical wrist movement. Disability will be evaluated by the DASH and BOSTON questionnaire. Evaluation will take place at pre and post-treatment times.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed of Carpal Tunnel Syndrome by means of an Electromyography Study.
* Patients with or not previous surgery.
* Patients with an age of 18 years or older.
* Patients having a signed informed consent.

Exclusion Criteria:

* Patients with severe hand traumatisms.
* Patients with cervical radiculopathy.
* Patients with Outlet Thoracic Syndrome.
* Patients bearing osteo syntheses material.
* Patients suffering tumoral pathology.
Intervening to Prevent Contextual Errors in Medical Decision Making

This study assessed whether a medical education intervention improves the quality of medical decision making in the care of patients with complex psychosocial -- or contextual -- needs that are essential to address when planning their care. A group of internal medicine residents were randomly assigned to participate in the seminar and practicum and then they, along with a control group that had not participated, were assessed for the quality of their clinical decision making and its impact on patient care. The study also assessed whether contextualization of care is associated with better patient health care outcomes

We enrolled 139 internal medicine residents at 2 VA hospitals, Jesse Brown and Hines, in a randomized controlled design. Half participated in a 4 hour seminar series integrated into their ambulatory curriculum. Each month a total of 8 residents participated. Following the intervention there were 3 levels of assessment: (1) All participants, intervention and control, participated in a brief exercise interviewing 4 standardized patients (SPs). Note that we separately enlisted the assistance of 8 attending physicians to assist with case development for these SPs. (2) The research team subsequently enrolled 3 real patients from each physician's practice with "red flags" such as poor adherence, or missed visits, suggestive of contextual issues that need to be addressed. Physicians were scored on their performance at identifying the underlying contextual factors that account for these red flags and on formulating an appropriate plan of care. (3) The coders prospectively defined successful vs. unsuccessful outcomes for each case. At the follow up visit data was collected on whether the desired outcome was achieved. The analysis compared the skills, performance and outcomes of the intervention compared with the control group to determine the efficacy of training residents to individualize care.

Eligibility Criteria:
Inclusion Criteria:

* Internal Medicine Residency with continuity of care clinics at either Jesse Brown or Hines VA Medical Centers

Exclusion Criteria:

* All resident physicians who do not meet inclusion criteria