cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate

The International multicenter FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN) trial is being executed. The trial is testing a short intervention (10 days of fenofibrate therapy) on 30-day outcomes in COVID-19. The overarching goal of this sub-study is to explore the impact of fenofibrate on key longer term phenotypes of vascular, cardiac and pulmonary health, integrated cardiopulmonary function, persistent/chronic symptoms and quality of life.

The International multicenter FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN) trial is being executed. The aim of this trial is to assess the impact of fenofibrate (administered for 10 days) to improve clinical outcomes in patients with COVID-19, assessed at 30 days. However, given the accumulating evidence of chronic / long term sequelae of COVID-19, it is important to assess the long-term impact of this intervention in this patient population. The overarching goal of this substudy is to assess the impact of fenofibrate on key intermediate phenotypes of vascular, cardiac and pulmonary health. We also aim to address the impact of fenofibrate therapy (administered during the acute COVID-19 episode as part of the parent FERMIN trial) on long-term integrated cardiopulmonary function, persistent/chronic symptoms and quality of life. We will accomplish this via enrollment of previous FERMIN participants from the University of Pennsylvania, in an phenotyping study designed to assess vascular, cardiac and pulmonary status several months after the index episode of COVID-19. We will perform these assessments \~6 months after initial randomization, among 40 FERMIN trial participants enrolled at the University of Pennsylvania.

Eligibility Criteria:
Inclusion Criteria:

• Having been eligible, enrolled and randomized in the parent FERMIN trial, completing all study procedures up to the 30-day time point (as specified in the parent protocol).

Exclusion Criteria

* Prisoners/incarcerated individuals;
* Pregnancy (potentially eligible patients of reproductive age will undergo a pregnancy test). This exclusion is due to the fact that pregnancy may confound the various cardiopulmonary phenotypes assessed in this study
* Inability to provide informed consent.
* History of cardiovascular disease (defined as heart failure, myocardial infarction, coronary revascularization, serious arrhythmia, stroke, or peripheral artery disease), glomerular disease or polycystic kidney disease prior to the index COVID-19 episode.
* Estimated glomerular filtration rate \<30 mL/min/1.73m2 prior to the index COVID-19 episode.
Gerontological Telemonitoring of Older Adults Living in Nursing Homes With COVID-19 Disease

Since the last 3 months the world copes with the novel coronavirus disease : Covid-19 emerged in China in the end of 2019. WHO declared the pandemic situation as a Public Health Emergency around the world on January 2020.

Firsts studies emphasized on higher risk to older adults to experience serious health consequences : hospitalizations and mortality, due to multimorbidity and multimedication. Nursing home resident are particulary frailer and vulnerable.


Eligibility Criteria:
Inclusion Criteria:

* Nursing home resident with Covid disease RT-PCR or Chest CT or rapid test
* Nursing home resident with Covid-19 disease symptoms :
* fever
* cough
* dyspnea
* SPO2\<95% in ambient air (or \<91% in COPD patient)
* Diarrhea
* Fall or balance disorder
* Confusion

Exclusion Criteria:

* Age \< 75 years
* Patient in respiratory distress
* No consent
Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions

Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be the first choice.

To compare the diagnostic accuracy of chromoendoscopy indigo carmine or acetic acid and NBI for differentiating neoplastic from non-neoplastic colorectal lesions, differentiating adenomas from carcinomas, and differentiating early carcinomas from invasive ones.

Included colorectal lesions consecutively distribute in a 1:1 ratio to 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with more than one lesion ≧ 6mm .

Exclusion Criteria:

* Patients with chronic inflammatory bowel disease, advanced cancer, insufficient bowel preparation, familial adenomatous polyposis (FAP)
* Lesions ≦ 5mm and submucosal tumor (SMT).
Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects

The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* 12-lead ECG demonstrating QTc \>450 msec at screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* History of orthostatic symptoms or orthostatic hypotension at screening.
* Pregnant or nursing females; females of childbearing potential.
Training Model to Advance Support of the Family as a Caregiving System in the Inpatient Oncology Setting

The purpose of this study is to provide a communication training program to inpatient nurses and social workers at Memorial Sloan Kettering Cancer Center in order to help them assist caregiving families. The importance of this training program is that it aims to teach nurses and social workers how and when to respond more effectively and compassionately to challenges faced by caregiving families. One of the goals of this program is to address family support needs during a patient's hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Participating Providers:
* Provider is an MSKCC acute care advanced practice nurse and/or inpatient social worker as per self-report.
* Plans to attend at least 4/6 the didactic training sessions, and 3/6 consolidation sessions as per self-report.

A patient will be approached if:

* Patient has been admitted to an inpatient service at MSKCC.
* Patient is able to designate at least one close person who is involved in the patient's care and is willing to participate. In the case that the patient is a minor (age 7-17 yrs), s/he will need to designate at least one close, adult person who is involved in the patient's care and is willing to participate.

Family members will be approached if:

* They were identified as a close other (including a family friend) involved in the care of an admitted patient on a participating provider's floor

Exclusion Criteria:

* Evidence of cognitive impairment severe enough to preclude completing survey instruments as per clinical or research staff judgment or EMR.
* Determined to not be appropriate for this study as per clinical judgment. Anyone, patient or family member, who is younger than 12 years old.
* Anyone, patient or family member, who does not speak English.
Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
* Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Must have at least 1 aspect of measurable disease, defined as one of the following;

  1. Urine M-protein excretion \>=200 mg per 24-hour, or
  2. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or
  3. Serum free light chain (FLC) assay: involved FLC level \>=10 mg per dL (\>=100 mg per liter) and an abnormal serum free light chain ratio (\<0.26 or \>1.65).
* All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) must be \<=Grade 1 at the time of enrollment, except for alopecia.
* Adequate organ function

Exclusion Criteria:

* Intolerant to daratumumab.
* Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
* Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.
* Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
* Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
* Prior allogenic stem cell transplant.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
* Corneal epithelial disease.
Concurrent Electronic Order Entry Variation Reporting Impact on Ordering Behavior

Display of information regarding utilization and quality to primary care physicians as they use our computer based system to order radiologic imaging (CT, MR, etc) will reduce unnecessary imaging.


Eligibility Criteria:
Inclusion Criteria:

* PCPs at MGH with patient panel \> 99 loyal patients

Exclusion Criteria:

* PCPs at MGH with patient panel \< 99 loyal patients
The Long Term Effect of Adjustable Spaatz 3 Intragastric Balloon on Weight Loss

This is an open-label trial investigating the effect of Spatz 3 intragastric balloon on weight loss on obesity and associated co- morbidities.

The study aim is to evaluate the effect of the intra gastric balloon on weight reduction and on related co- morbidities during 1 year of balloon implantation and a year following explantation.


Eligibility Criteria:
Inclusion Criteria:

- 1. Subjects willing to comply with study requirements and have signed an informed consent form.

2. Age 18-70 3. BMI ≥ 35 kg/m² or BMI ≥ 30 kg/m² and hypertension or diabetes mellitus 4. Documented negative pregnancy test in women of childbearing potential. 5. Women of childbearing potential agree to remain on contraceptives for the duration of their trial participation.

Exclusion Criteria:

* 1. Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to randomization (including GLP-1 analogs).

  2. Previous GI surgery that could preclude the ability to place the device. 3. Subjects with a history of abnormal GI anatomical findings documented on imaging study, which in the opinion of the investigator, may impair implantation of the IGB device 4. Subjects with severe GERD that are not responding to Proton Pump Inhibitor (PPI) 5. Known abnormal pathologies or conditions of the upper gastrointestinal tract.

  6. Subjects with symptomatic gallstones within 6 months prior to randomization 7. Coagulopathy defined as hgb \<10g/dl and platelet \< 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities 8. Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent) 9. Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) or any other drugs with bleeding as a potential side effect during the study duration.

  10. Subject is or has been enrolled in another investigational study within 3 months of participation into the current study 11. Subjects not residing within a 3 hour driving distance of the study center.
A Study of Minirin Melt in Patients With Nocturia

This is a confirmation of safety profile for Minirin Melt in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* nocturia

Exclusion Criteria:

* habitual or psychogenic polydipsia
* known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics
* moderate and severe renal insufficiency
* know hyponatremia
* syndrome of inappropriate ADH secretion
Real-World Disease Management and Outcomes in Chronic Myeloid Leukaemia

Chronic myeloid leukaemia (CML) diagnosis is based on the demonstration of a BCR-ABL fusion transcript expressed by the Philadelphia (Ph) chromosome by RQ-PCR and/or the demonstration of t(9;22)(q34;q11) by conventional karyotyping or interphase FISH. As per standard practice, response to therapy is monitored using either molecular or cytogenetic tests or both; specifically, patients are monitored by quantitative PCR on peripheral blood, supplemented by bone marrow karyotyping if it was clinically indicated. ABL kinase mutational analysis is carried out when the transcript ratio has increased over two sequential samples or on clinical demand. Testing for T315I mutation is also performed for patients who fail to respond to first line TKI and all patients who acquire TKI resistance over the course of their treatment.

Data collection is initiated six months after date of diagnosis; research nurses working to agreed operating procedures and data standards visit each of the 14 hospitals in the region and abstract a core clinical dataset from the patients' medical records. The information collected includes demographic details, baseline blood count data and first line treatment. All details are abstracted onto structured forms and entered onto the web-based system, which integrates Haematological Malignancy Research Network (HMRN) and Haematological Malignancy Diagnostic Service (HMDS) data. An important feature of data acquisition is the emphasis on primary source information; data from radiology reports, blood tests, clinical examination, and clinician summaries are recorded, enabling embedded algorithms in the database system to automatically generate stage and prognostic scores. Further data abstraction from the medical records has been undertaken to capture information on subsequent treatment lines. Information on date and cause of death were obtained from the National Health Service (NHS) Central Register.


Eligibility Criteria:
Inclusion Criteria:

• Adult (18+ years) patients newly diagnosed with CML in chronic phase (ICD-O-3: 9875/3) by HMDS between 1st September, 2004 to 31st August, 2019 whilst resident in the HMRN region and treated within the Network.

Exclusion Criteria:

None specified.
Livet Skal Leves (A Life to Live)

The overall objective of this project is to optimize the use of diagnostic methods and follow-up programs in infants with congenital heart defects (CHDs) in order to reduce death and complications

The project is designed as retrospective cohort study based on nationwide registry data of children born 2004-16. The project group has extensive experience of similar research, and includes representatives from different fields and levels of health care.

The results will provide a solid fundament for improvement of today's clinical practice, including development of knowledge-based routines in neonatal medicine and planning of health care services. Implementation is given particular attention, and will be managed in an interdisciplinary setting. The project will be of major relevance for the patients and their families as well as medical professionals at all levels of health care.

Eligibility Criteria:
Inclusion Criteria:

* Fetuses with severe CHDs who were identified by antenatal ultrasound screening, and where the pregnancy was terminated
* Children with severe congenital heart defects born in Norway 2004-18

Exclusion Criteria:

* Lack of parental consent
FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study

A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms

This is a multi-center observational study. Treatment and follow-up visits will be performed as per standard of care. The purpose of this study is to demonstrate that use of the FRED/ FRED Jr/ FRED X Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure.

150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patient older than 18 years old
2. Patient harboring a non-acutely ruptured intracranial aneurysm within the last 30 days of presentation:

   * for which use of FRED, FRED Jr or FRED X has been deemed appropriate
   * being the only aneurysm to require treatment within the next 12 months
   * and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized
3. Patient with a modified Rankin Scale (mRS) ≤ 2
4. Patient has received information about data collection and has signed and dated an Informed Consent Form

Exclusion Criteria:

1. Patient has suffered from an ICH within the 30 days prior to the procedure.
2. The aneurysm to be treated is associated with a cAVM
3. The aneurysm to be treated is in the posterior circulation
4. The aneurysm to be treated has a stenosis of its parent artery \>50%
5. Patient has another aneurysm previously treated with a stent or a flow diverter

   * on the same parent vessel at any time
   * on a different parent vessel, less than 3 months prior to the procedure (previously-implanted stents in the non-index proximal carotid are acceptable)
6. Patient with whom anticoagulant, antiplatelet or thrombolytic drugs are contra-indicated or test performed regarding AP medication administered is not efficient for the patient
7. Patient with known hypersensitivity to contrast products or nickel titanium, not treatable
8. Pregnancy or child breastfeeding
9. Patient unable or unlikely to complete required follow up
10. Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
11. Treatment with a flow diverter other than FRED/ FRED Jr/ FRED X or in addition to FRED/ FRED Jr/ FRED X is planned
Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group.


Eligibility Criteria:
Inclusion Criteria

To be eligible to participate in this study, all of the following criteria must be met:

* Subject is informed and given approved written Informed Consent Form (ICF).
* Subject is considered reliable and capable of adhering to the protocol.
* Subject must have a diagnosis of adult-onset moderate-to-severe RA of at least 6 months' duration as defined by ACR/EULAR 2010 classification criteria.
* Subject must have:

  * ≥6 tender joints (out of 68)
  * ≥6 swollen joints (out of 66)
  * CRP≥10.0mg/L .
* Subject must have had inadequate response to at least 1 synthetic DMARD.
* Subject is at least 18 years and less than 70 years of age at Visit 1 (Screening).
* Female subjects must either be:

  * postmenopausal
  * permanently sterilized or,
  * if of childbearing potential, must be willing to use at least 2 effective methods of contraception,
* Male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug.

Exclusion Criteria

Subjects are not permitted to enroll in the study if any of the following criteria is met:

* Subject has previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (IMP) under investigation in this study (UCB4940 and/or CZP).
* Subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens.
* Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection are excluded.
* Subject is at high risk of infection.
* Subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at Week 0.
* Subject has renal or liver impairment.
* Subject has a current or past history of gastrointestinal ulceration.
* Subject has active neoplastic disease or history of neoplastic disease.
* Subject has a concomitant diagnosis of any other inflammatory condition.
* Subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia.
Strategies to Increase Adherence to Physical Activity in a Phase III Cardiac Rehabilitation Program

This study consists of a randomised clinical trial of two parallel groups conducted in patients with ischaemic heart disease after completing phase II of Cardiac Rehabilitation (RHBC) at the Centro de Especialidades Mislata (CEM),Hospital Manises. The objective is to assess adherence to structured and unstructured physical activity in the long term (6 and 12 months). In addition to the usual recommendations in the Control Group (CG), a motivational programme will be added to the Intervention Group (IG), which will consist of establishing an individualised exercise plan reviewed monthly, in addition to maintaining continuous contact with the physiotherapist.

Regular physical activity is an important measure in the prevention of cardiovascular diseases. In the phase II Cardiac Rehabilitation programme, the acquisition of healthy lifestyle habits is taught and encouraged, with physical exercise as a fundamental pillar of the programme. Physical exercise should be maintained throughout life (RHBC phase III) in order to continue to produce cardiovascular benefits. However, few studies focus on strategies to increase adherence to physical activity, despite its benefits in disease control.

Motivation is one of the main barriers described by patients as well as the lack of contact with healthcare staff once the acute disease process is over. Therefore, we propose a simple, practical and economical intervention to increase adherence to physical activity, through a motivational programme, based on the establishment of objectives for each patient, carrying out an individualised physical exercise programme according to their preferences and needs, also establishing continuous contact with the physiotherapist to review and establish new objectives.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischaemic heart disease who have completed phase II of cardiac rehabilitation in CEM.
* Patients of both sexes.
* Patients classified as low, medium and high risk
* Age between 18 and 70 years at the time of the cardiac event.

Exclusion Criteria:

* Older 70 years old
Using Virtual Reality (VR) Models for Robotic Prostatectomy

A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care.


Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing robotic prostatectomy being performed by participating surgeon
* Patient is willing to be randomized between intervention and control arms

Exclusion Criteria:

* Patients with prior pelvic radiation
* Patients with prior androgen deprivation therapy
* Patients with prior localized ablative therapy
* Patients with prior TURP or other surgical BPH treatment