cyrilzakka/clinical-trials huggingface dataset:
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 60 years or older
* Measurable non-metastatic and non-inflammatory breast cancer
* Tumor of 2 cm or larger
* ER and/or PgR positive tumor
* Co-morbidity index 0 - 3, e.g., no other serious medical condition

Exclusion Criteria:

* Prior medical therapy for a malignant disease, including aromatase inhibitors
* Distant metastasis
* Need for chemotherapy
* Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri)
* Treatment with a non-approved drug within 30 days
Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices

This research project is aimed to assess the implementation, effectiveness, and sustainability of a pediatric-based intervention aimed at reducing families' unmet material needs (food, housing, employment, childcare, household utilities, education) in pediatric practices throughout the United States.

The investigators prior work has focused on developing a pediatric primary care-based intervention, WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education), aimed at addressing poor families' material needs - food security, employment, parental education, housing stability, household heat, and childcare - by systematically screening for these needs and referring families to existing community-based services. To date, the investigators have tested WE CARE primarily in community health centers (CHCs); their randomized controlled trial (RCT) demonstrated WE CARE's efficacy on parental receipt of community-based resources. However, over 80% of low-income children receive care from providers in traditional pediatric practices (i.e. non-CHCs). The investigators therefore will conduct a large-scale, Hybrid Type 2 effectiveness-implementation trial in eighteen pediatric practices in the US. A stepped wedge study cluster RCT design will be used to implement WE CARE in all practices using two common strategies used to integrate systems-based interventions into primary care - a previously facilitated "on-site" strategy in which content experts provide training sessions and on-going consultation; and a self-directed "web-based" method modeled after the American Academy of Pediatrics' practice transformation strategy. The proposed study's specific aims are to: 1) demonstrate the non-inferiority of the self-directed, web-based strategy for implementing WE CARE, in comparison to the facilitated on-site strategy; 2) demonstrate WE CARE's effectiveness on increasing parental receipt of community resources; and 3) assess the sustainability of WE CARE in pediatric practices. The investigators hypothesize that WE CARE will have equivalent fidelity via the two strategies. Based on prior work, the investigators hypothesize that WE CARE will significantly increase parental receipt of community resources three months post-visit compared to usual care. The investigators also expect WE CARE to be sustained 1.5-, 2-, and 2.5-years post-implementation; they expect to gather data from over 2,700 chart reviews, 2,520 parent-child dyads, and 360 providers and office staff. This proposal has significant public health implications for the delivery of primary care to low-income children.

Eligibility Criteria:
Inclusion Criteria:

* Parents/legal guardians (aged at least 18 years) of children aged 2 months through 10 years whose child presents for a health supervision visit

Exclusion Criteria:

* Foster parents, parents who speak neither English or Spanish, and previously enrolled parents
Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia

The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk

The COVID-19 pandemic led to the suspension of consultations and hospitalization of the majority of patients followed in the Rheumatology Department of the Limoges University Hospital.

The department therefore implemented a strategy for the management of patients with chronic inflammatory rheumatism (CIR) during this period, which allowed maintaining contact with patients in the patient database.

During this telephone call, an CIR-Covid19 questionnaire was fulfilled in order to prioritize patients requiring rapid management.

The strategy is based on the use of the available health reserve, i.e. volunteered medical students to provide patient management assistance. These students were trained with face-to-face learning in the rheumatology department given by residents on chronic inflammatory rheumatism to remind them of all the elements of diagnosis and management. They had an interview with a senior rheumatologist from the Department to present the questionnaire and its objectives , to give them advice regarding communication with patients, as well as information about the COVID-19 infection and recommendations of the French Rheumatology Society for CIR patients. The students were trained with quizzes on practical situations, with feedback on the answers.

The information's collected in the questionnaire were based on the patients' feelings. Telephone communication does not allow an assessment of disease activity according to validated criteria as it requires a clinical examination.

The opinion of the referring rheumatologist was requested by the patients or by the medical student at the end of the telephone call, depending on the information collected. At any time, the medical students could call upon to senior doctors from the department or residents in case of difficulties.

943 patients were thus contacted between 14/04/2020 and 28/04/2020. They were able to benefit from an optimized management according to the context of the COVID19 pandemic.

These questionnaires were analyze in order to assess the need for specialized follow-up during this period and to evaluate the impact of COVID19 on this population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic inflammatory rheumatism who answered the RIC-COVID19 survey during the telephone call set up by the Rheumatology Department of the Limoges University Hospital during the confinement.

Exclusion Criteria:

* Patients objecting to the use of their data
The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery

The sternotomy has some influence on the respiratory system after cardiac surgery, considerably increasing the risk of perioperative and postoperative breathing.

There is respiratory preparation before cardiac surgery using local physiotherapeutic guidelines.

The aim of the study is to have a quantification of this preparation spirometry: before starting the preparation and at the end of the preparation (right before surgery) by comparing the spirometric and pulse oximetry information. The prospective study will be conducted on 25 patients, who will be selected consecutively without randomization.

Eligibility Criteria:
Inclusion Criteria:

* Patient with indication of cardiac surgery

Exclusion Criteria:

* Patient with a Body Mass Index (BMI) \> 30
* Restrictive patient
* Obstructive patient
* Asthmatic
* Chronic Obstructive Pulmonary Disease (COPD)
* History of pulmonary fibrosis, tuberculosis
* Coronary patients with stenosis of the common trunk.
* Emergency and lifesaving surgeries
* History of thoracic trauma
* Severe kyphotic patients
* History of radiotherapy
* Patients with neuromuscular disease
* Patients with thoracic cage involvement (pectus excavatum, post thoracic surgery)
* Patients with emphysema
* Patients with dilated bronchi
SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

The purpose of this study is to compare the effectiveness of two different interventions for medication-assisted treatment (MAT) adherence: Contingency Management (CM) and Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM).

The investigators seek to compare the effectiveness of these two different interventions for MAT adherence by first refining and piloting CM and BSM adherence approaches, then conducting a Sequential Multiple Assignment Randomized Trial (SMART) to assess sequential, individual, and combined effects across MAT initiation and maintenance.

In order to tailor treatment to individual's needs, the study will follow a sequential multiple assignment randomized trial (SMART) design: In stage 1, participants are individually randomized (1:1) to BSM or CM. Adherent buprenorphine-naloxone participants complete treatment in the arm they were originally assigned to, but non-adherent participants are re-randomized (1:1) to either switch to the other intervention or add the other intervention in this part-factorial SMART.

Eligibility Criteria:
Inclusion Criteria:

* Present with symptoms of Opioid Use Disorder
* Eligible of receipt of buprenorphine-naloxone medication as determined by Study Doctor
* Access to a telephone

Exclusion Criteria:

* Under 18 years old
* Unable to understand spoken English
Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy children with a diagnosis of dysphonia age 3-18 years.
2. Dysphonia must be present for at least one month duration.
3. May have vocal cord nodules present.
4. Pre-enrollment flexible fiberoptic laryngoscopy must not show any potentially life-threatening cause, including but not limited to laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms.
5. Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel).
6. Caregiver must be able to read, write, and understand English.
7. Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study.

Exclusion Criteria:

1. Dysphonia must not be due to a potentially life-threatening cause, such as laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. This will be determined by visualization with flexible fiberoptic laryngoscopy.
2. Dysphonia must not be due to an acute upper respiratory infection.
3. Must not have been treated with proton pump inhibitor medication in the past 12 months.
4. Inability of child to cooperate with recording of voice for analysis.
5. Inability of caregiver to read, write, and understand English.
6. Mental retardation, cognitive impairment, or developmental delay.
7. History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.
Galectin-3 as a Biomarker in Patients With Chagas Disease

The purpose of this study is to analyze the efficacy of Galectin-3 as a biomarker on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.

Previous studies indicate that activated macrophages secrete Galectin-3, a molecule that is involved in the development of fibrosis and tissue rearrangement in the liver, kidney and the heart. Its plasmatic levels are increased on patients with acute decompensated heart failure. These observations suggest that measuring levels of Galectin-3 in patients with cardiac diseases can be useful to determine their prognosis. To investigate the role of this new biomarker in Chagas Disease, we will study a Chagas Disease population (including patients with the indeterminate and cardiac form of the disease). The assessment of the prognostic value of Galectin-3 will be done through the comparison between its plasmatic levels and each patients's clinical evaluation, disease severity, inflammatory biomarkers and cardiac function tests.

The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including:

* Collection of Blood samples for biochemical analysis;
* Electrocardiogram;
* Holter Electrocardiogram;
* Echocardiogram;
* Treadmill Test;
* X-Ray Imaging;
* Magnetic Resonance Imaging;
* Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* Chagas Disease diagnosis confirmed by 2 different serologies
* Diagnosis of indeterminate form or cardiac form, with and without ventricular dysfunction.

Exclusion Criteria:

* Significant valve disease defined as aortic stenosis with a gradient of VE/Ao \> 50 mmHg
* Mitral stenosis with a valve area inferior than 1,5 cm2
* Severe or moderate aortic and/or mitral regurgitation
* Chronic use of immunosuppressive agents
* Dialysis treatment of terminal renal failure
* Fever on the last 48 hours or evidence of systemic infection in activity according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine)
* Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
* Any other comorbidities that impact patient's survival within the next 2 years
* Liver disease in activity
* Continuous use of steroids as treatment for COPD
* Hematologic, neoplastic or bone diseases
* Homeostasis disturbances
* Inflammatory diseases or chronic infectious diseases
Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer

Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC

Study Drug:

TAS-102 (trifluridine and tipiracil hydrocholoride) and bevacizumab

Dosing Details:

Starting dose of TAS-102 is 35 mg/m2 administered orally twice daily, after meals, for 5 days a week with 2 days rest for 14 days, followed by 14 days rest (1 treatment cycle).

Bevacizumab 5 mg/kg intravenously every 14 days. The treatment cycle repeats every 28 days. Patients may take TAS-102 plus bevacizumab until they exhibit progression of disease, withdraw consent, or experience unacceptable toxicity.This is a single arm study. All patients receive the same study treatment.

Eligibility Criteria:
Inclusion criteria:

* Written informed consent
* Histologically proven, unresectable, evaluable metastatic colorectal cancer
* 16 to 20 weeks of first-line therapy with oxaliplatin, and/or irinotecan-based flourorpyrimidine-containing chemotherapy plus Bevacizumab
* Patients must have stable disease (or better) during the initial induction chemotherapy with first-line chemotherapy.
* No progressive disease at the time of initiation of maintenance therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
* Adequate organ and marrow function
* Women of child-bearing potential and men must agree to avoid pregnancy
* Patient must start maintenance therapy at least 14 days after the last administered induction chemotherapy but no later than 30 days.

Exclusion Criteria

* Patients whose tumors have progressed on first-line treatment
* Patients with active concurrent malignancy, other than superficial, non-invasive squamous cell carcinoma of the skin or uterine cervix, within the past three years.
* Women who are pregnant or lactating
* Unstable heart disease
* Uncontrolled active infection requiring antibiotics within one week prior to first dose.
* Patients with active CNS malignancy.
* Persistent protein in the urine
* Patients with bowel obstruction or uncontrolled vomiting.
* Patients with serious psychiatric or medical conditions that could interfere with treatment.
Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)

Morbidity and mortality of ICU patients is increased by the development of a "immunosuppression" systemic (IS). This IS develops in the early hours of hospitalization and is responsible for severe infections, including viral reactivations (Cytomegalovirus or Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and mortality in intensive care units. In clinical practice, they are searched at the onset of organ failure or unexplained fever. The investigators wish to conduct this research in the stroke patients to assess the predictive power of these viral reactivations on the duration of mechanical ventilation.

PCR for herpes simplex virus in blood and in tracheal aspirate (Day-1, Day-7 and Day-15) - clinicians are blinded to the results PCR for Cytomegalovirus in blood and in tracheal aspirate (Day-1, Day-7 and Day-15) - clinicians are blinded to the results

Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation in intensive care unit
* Acute brain injury (trauma, subarachnoid haemorrhage, stroke, infection) with Glasgow Coma Scale \<= 12
* Age between 18 and 75 years
* Mechanical ventilation \> 24 hours

Exclusion Criteria:

* encephalopathy post anoxy
* active cancer
* Immunosuppresseur treatment
* pregnancy
* history of autoimmune disease
Molecular Genetics in Infantile Spasms

Infantile Spasms syndrome (ISs) is a characterized by epileptic spasms occurring in clusters with an onset in the first year of life. West syndrome represents a subset of ISs that associates spasms in clusters, a hypsarrhythmia EEG pattern and a developmental arrest or regression. Aetiology of ISs is widely heterogeneous including many genetic causes. Many patients, however, remain without etiological diagnosis, which is critical for prognostic purpose and genetic counselling. In the present study, the investigators performed genetic screening of 73 patients with different types of ISs by array-CGH and molecular analysis of 5 genes: CDKL5, STXBP1, KCNQ2, and GRIN2A, whose mutations cause different types of epileptic encephalopathies, including ISs, as well as MAGI2, which was suggested to be related to a subset of ISs.


Eligibility Criteria:
Inclusion Criteria:

* Infantile spams or West syndrome

Exclusion Criteria:

* brain malformation
* clinical features of tuberous sclerosis
* abnormal metabolic assays
Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing

Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators.

The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing.

Comparison of the effect of an atrioventricular hysteresis function with a mode switch to atrial pacing on the right ventricular pacing percentage in a multi-centre, prospective, randomized, single blinded, cross-over study.

Eligibility Criteria:
Inclusion Criteria:

Indication for the implantation of a dual-chamber pacemaker

Exclusion Criteria:

Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator
A RCT to Compare OHRQoL Outcome for SLB and CB

The objective of this prospective study is to compare these two treatments (conventional brackets v.s. self-ligating brackets) in malocclusion to determine which treatment will provide the better oral health related quality of life (OHRQoL) outcomes for patients during the initial orthodontic treatment compared with pretreatment.


Eligibility Criteria:
Inclusion Criteria:

* malocclusion patients
* age between 12 to 40 years
* suitable for orthodontic treatment using either self-ligating brackets or conventional brackets.

Exclusion Criteria:

* Any surgery performed in the previous days,
* Previous temporomandibular joint arthrotomies,
* Fewer than 20 teeth total or fewer than 10 teeth in each arch,
* Unstable residence or travel restrictions,
* Periodontal disease judged to be severe by the surgeon,
* Pregnancy,
* Previous mandibular surgery, and
* Inability to follow instructions or the study protocol.
Hybrid Treatment of Type B Aortic Dissection

Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent implantation is superior over standard thoracoabdominal aortic repair.

Main hypothesis of this study is that thoracoabdominal aortic repair combined with bare metal stent implantation is better permanent neurological deficits, perioperative bleeding, malperfusion of viscera over conventional thoracoabdominal aortic repair.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic aortic dissection type B
* Aortic size in descending thoracoabdominal aorta (TAA) \> 55 mm

Exclusion Criteria:

* concomitant cardiac pathology
* concomitant oncology diseases in the last 5 years
* acute aortic dissection
* aortic size in visceral zone \>45 mm
* connectivity tissue diseases
Safety Study of Inhaling Carbon Monoxide in Healthy Volunteers

Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.

This preliminary study will be conducted in ten healthy volunteers to monitor for blood levels and adverse effects that occur at different durations of exposure of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation.

We hypothesize that healthy volunteers will be able to tolerate 1 hour doses of 250 ppm of CO with minimal side effects. It is also anticipated that for each dose of CO administered, the blood levels of CO will remain well under poisonous levels. Finally, we anticipate blood levels of CO will return to baseline level within 24 hours following the last dose of CO.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, age \> 18 years.
* Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
* No prior smoking history.
* BMI between 16 and 30 inclusive.
* In good health as per medical history, physical exam, vital signs \& ECG.

Exclusion Criteria:

* Exposure to carbon monoxide during the 48 hours prior to the study day.
* Occupational exposure to CO.
* Significant disease that may put the volunteer at risk because of participation in the study or may influence the results of the study or the volunteer's ability to participate in the study.
* Baseline blood level of COHb \>2%.
* Patients with underlying lung disease such as asthma or COPD.
* Baseline oxygen saturation \<92% on room air.
* Planned pregnancy, already pregnant or breastfeeding.
* Participation in another clinical trial within 2 months prior to study.