cyrilzakka/clinical-trials huggingface dataset:
Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload

This study has been designed to establish the efficacy and safety of deferasirox in patients with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant (HSCT).

The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of treatment with deferasirox, in patients with iron overload (defined with serum ferritin levels ≥ 1000 ng/ml and receiving \> 20 RBC concentrates) after allogeneic HSCT.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years of age and older
* Patients to undergo allogeneic HSCT between 6 and 18 months prior to inclusion.
* Patients with screening ANC \> 1000/mm3 and ferritin values ≥ 1000 ng/mL (ferritin values must be measured in two measurements at one-week intervals).
* Patients receiving at least 20 RBC concentrate units or 100mL/kg RBC during their lives.
* Patients giving their informed consent (prior to performing any study procedure)

Exclusion Criteria:

* Haemosiderosis not related to transfusion.
* Patients with concomitant active malignancy.
* Active known viral hepatitis or known HIV-positive.
* Mean levels of alanine aminotransferase (ALT) \> 5x ULN
* Treatment with any iron chelating agent after allogeneic HSCT.
* Uncontrolled hypertension.

Other protocol-defined inclusion/exclusion criteria may app
A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

The purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.


Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary osteoarthritis of the shoulder
* Age 40-75 years
* Patient capable of giving informed consent
* Patient agrees to comply with the study plan

Exclusion Criteria:

* Destruction of the proximal humerus
* Insufficient bone stock
* Deficient rotator cuff or earlier failed surgery of the rotator cuff
* Large muscle defects or insufficient blood supply in the affected arm
* Neuromuscular disorders
* Infection, untreated malignancy or transmittable disease preventing the patient from fulfilling the study
* Patient unwilling to comply with study regulations
* Patient with earlier allergic reaction to pyrocarbon
* Patient with known metastatic disease
* Patient who has been treated with more than 10 mg corticosteroids (e.g. Prednisone) daily within 3 months from surgery.
* Patient participating in other clinical study
* Patient in need of glenoid replacement
The EVARREST® Fibrin Sealant Patch Liver Study

To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age, requiring elective or urgent, open hepatic surgery.
* Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon
* Subjects or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)

Exclusion Criteria:

* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
* TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST® to blood flow and pressure during healing and absorption of the product;
* TBS with major arterial bleeding requiring suture or mechanical ligation;
* Subjects admitted for trauma surgery;
* Subject is a transplant patient for fulminant hepatic failure
* Subject with TBS within an actively infected field;
* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
* Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
* Subjects who are known, current alcohol and / or drug abusers;
* Subjects who have participated in another investigational medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;
* Female subjects who are pregnant or nursing.
Identification of Adverse Plaque Characteristics by Coronary MR Angiography

This is a pilot study to determine whether coronary magnetic resonance angiography(CMRA)can identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other substances found in the blood) seen on coronary computed tomography angiography(CCTA) and evaluate whether there is a relationship between the adverse plaque characteristics and the presence of coronary artery wall inflammation.

This pilot study will examine 20 stable patients who have undergone a clinically-indicated coronary computed tomography angiography (CCTA) for suspected Coronary Artery Disease. They will be invited to undergo a research coronary Magnetic Resonance Imaging scan with contrast(CMRA). Based upon the subject's heart rate, a beta blocker may be administered as its use has been shown to be effective in producing better images as it widens the arteries.

Researchers will use newly developed non-invasive coronary MRA techniques to compare information shown on the research CMRA with the clinical CCTA. While CCTA has been demonstrated to be able to provide data on adverse plaque characteristics (APC's), the ability of CMRA to evaluate these features is not established.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Ability to comprehend and sign informed consent
* Presence of a non-calcified or mixed plaque without high-grade stenosis in the left main or a proximal coronary artery segment AND at least one APC present in this plaque by CCTA (defined as LAP with \<30 Hounsfield units or PR with ≥10% increase in the maximal vessel diameter within the plaque as compared to a proximal reference segment as previously described10).

Exclusion Criteria:

* High-grade stenosis (≥50% stenosis of the left main artery or ≥70% stenosis of another proximal coronary segment);
* Coronary artery stent in the segment with the reference plaque
* Possible pregnancy
* Glomerular filtration rate \<45 ml/min
* More than 90 days between CCTA and CMRA study
* Any significant arrhythmia (e.g. atrial fibrillation, frequent ectopy)
* Significant asthma
* History of 2nd or 3rd degree heart block
* Allergy or known intolerance to beta-blockers
* Use of phosphodiesterase inhibitor (e.g. Viagra) within the last 48 hours
* Rapid heart rate (heart rate ≥90 beats/minute)
* Severe aortic stenosis (Aortic valve area \<1.0 cm2 or mean gradient \>30 mmHg)
* Systolic blood pressure \<100 mmHg
* Other contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia
Clinical Outcomes After Implementation of COntinuous Vital Sign Monitoring On the General Ward.

In 2018, continuous monitoring (CM) of 5 vital signs with a wearable device, including automated MEWS calculation within the EMR were introduced on the surgical and internal medicine ward of our hospital. Rather than taking the measurements manually, this enabled the nurses to periodically validate the continuously derived vital signs at the protocolled moments, and simultaneously get an automatically calculated MEWS reading,. Moreover, continuous vital sign monitoring provides single channel alarms and trends of the vital signs in between the regular measurement moments. Compared to periodic manual measurements and registration in the EMR, the continuous vital sign monitoring and automated MEWS calculations in the EMR may result in better identification of clinical deterioration, and may improve clinical outcome.

The primary objective of this study is to evaluate changes in total hospital and ward stay, "Total Events" during admission (rapid response team (RRT) calls and unexpected intensive care unit (uICU) admissions and deaths) after implementation of CM on the regular surgical and internal medicine wards. Secondary objective is to evaluate changes in MEWS scores at the moment of the uICU admissions, length of hospital, ward and ICU stay and the proportion of RRT calls that results in a ICU admission.


Eligibility Criteria:
Inclusion Criteria:

* Admission on Inclusion ward.

Exclusion Criteria:

* Opt out of file study
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies

Exclusion Criteria:

* Active, known or suspected autoimmune disease
* Active malignancy requiring concurrent intervention
* Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Other protocol-defined inclusion/exclusion criteria apply
Reproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT

To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional Time-Domain-OCT (TD-OCT).

* Trial with medical device


Eligibility Criteria:
Inclusion criteria: control group:

age 18yo or older, healthy

glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria: Exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmHg. Exclusion criteria in the glaucoma group were history of other optic neuropathies.

or severe optic media opacities.
Low Back Pain Patient Education Evaluation

Back pain is one of the most common of all symptoms. It is also a great cause of days lost from work and visits to health care providers. This study will develop and evaluate an approach to low back pain that allows subjects to talk with each other and with health professionals via an Internet discussion group. Results we will look at include health behaviors, such as exercise; health status, such as pain and disability; and health care use, such as number of visits to doctors and other health care providers. Anyone 18 years old or older who lives in the United States and has ongoing Internet access can take part in the study. All subjects must have back pain and meet the eligibility criteria listed below.

This study will develop and evaluate in a randomized trial a low back pain intervention that allows subjects to talk with each other and with health professionals via an Internet discussion group. The intervention consists of a book and a videotape and is based on interaction with other participants in the program and health professionals through a closed password protected moderated Internet discussion group. Outcome measures include health behaviors, such as exercise; health status, such as pain and disability; and health care use, such as number of visits to doctors and other health care providers. Patients will be randomized either to the treatment group and followed for 6, 12, 18, and 24 months with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Must live in the United States
* Must understand and write English
* Must have access to a computer with e-mail and expect to have this access for at least 3 years
* Must be 18 years old
* Must have seen a doctor for back pain at least once in the past year

Exclusion Criteria:

* Pregnancy
* Back surgery in the past 6 months
* Expectation of having back surgery in the next 6 months
* Back pain due to a car accident or other major injury within the last 6 months
* Back pain or sciatica due to systemic disease (inflammatory rheumatic diseases, tumor, or other)
* Major physical or mental health condition for which one is currently being treated that severely limits daily activities
* Terminal illness
* Receiving disability or workers compensation insurance payments for back pain or sciatica
* Presently involved in legal proceedings because of back pain or sciatica
* Difficulty with bladder or bowel control that began with back pain or sciatica
* No visits to a doctor in the past year for back pain or sciatica
* Numbness in crotch area that began with back pain or sciatica
* Age under 18
Cytosponge™ for Post-Chemoradiation Surveillance of Oesophageal Cancer

This is a feasibility study testing the use of the Cytosponge™ device in patients with known oesophageal cancer treated with pre-operative or definitive chemoradiation. All participants will receive one Cytosponge™ procedure at one time-point within 4-16 weeks after completion of chemoradiotherapy.

In this feasibility study, we are investigating a novel way to test for remaining or reoccurring oesophageal cancer following chemoradiotherapy. The technique used to test this is called a Cytosponge™. We will be testing the use of the Cytosponge™ to determine completion rate, safety and acceptability of the procedure.

Cytosponge™ is a capsule-sized device which contains an expandable, spherical mesh which is attached to a string. The capsule dissolves in the stomach after swallowing, releasing the sponge which is then retrieved by gently pulling the string after five minutes. As the sponge is pulled out it collects the cells from the lining of the gullet.

The Cytosponge™ will be processed for evidence of residual cancer through analysis of cellular atypia and molecular biomarkers. Where available, the results will be compared with histology.

Up to fifty patients will be recruited to the trial across 11 sites.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, Age \>/=16 years who

   1. have undergone pre-operative CRT as treatment for oesophageal cancer and due to undergo oesophagectomy or
   2. have undergone definitive CRT as treatment for oesophageal cancer
2. 4-16 weeks post completion of CRT
3. Dysphagia score 0-2 (Mellow Scale)\*
4. Able to swallow tablets
5. Physiologically fit for endoscopy
6. Written (signed and dated) informed consent
7. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.

Exclusion Criteria:

1. Known to have oesophageal varices or stricture requiring dilatation of the oesophagus.
2. Unable to temporarily discontinue anticoagulation therapy/medication prior to their procedure\*
3. Oesophageal stent
4. Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.

   * Patients on anti-coagulation therapy are eligible for the study as long as they are considered suitable candidates for endoscopic biopsy (follow local hospital procedures for management of patients on anticoagulation due to undergo endoscopy). If temporary discontinuation of anticoagulation is required, this should be after consultation with the patients clinical care team.
Elderly Patients With Acute Myeloid Leukemia (AML), Maintenance Phase After Complete Remission (CR)

Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of a Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit Patients With Poor Prognosis Acute Myeloid Leukemia (AML).

The disease-free survival (DFS) of the patients included in this study will be compared to the ones of the two previously reported groups of patients treated with the same LIA induction therapy

* The primary objective of this study will be to improve the DFS with an alternate schema combining azacitidine and lenalidomide in elderly fit patients with previously untreated AML and with high risk cytogenetics or secondary AML, who achieved either a complete remission after an LIA induction therapy
* The secondary objectives will be to determine the relapse incidence, overall survival, event free survival at 1 and 2 years of follow-up, toxicities of the treatment, incidence of infectious events.
* To define a gene expression and promoter methylation signatures associated with CR and absence of relapse when patients received azacitidine and lenalidomide. Gene promoter methylation and gene expression profiling will be performed at diagnosis, at CR, and after 2 courses of azacitidine and lenalidomide in order to give insight within the mechanisms involved by the use of these 2 drugs and to identify new epigenetic prognostic markers.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically confirmed acute myeloid leukemia (AML) with :

  * At least 60 years of age and fit for intensive chemotherapy: PS \<2 (ECOG)
  * Absence of significant co-morbidities
  * Less than 75 years\* of age
  * LAM with high risk features (blasts \> 20% in bone marrow)
  * Poor risk cytogenetics
  * Life expectancy \> 1 month
  * Affiliated to social security regimen
  * No granulocytic sarcoma as sole site of disease
  * Able and willing to provide written and signed informed consent

Exclusion Criteria:

* Total bilirubin \> 2 times upper limit of normal
* AST and ALT and/or alkaline phosphatase \> 4 times upper limit of normal if not in relation with AML.
* Factor V \< 50% without DIC (Disseminated Intravascular Coagulation)
* NYHA class III or IV congestive heart failure (Echo \< 40%, LVEF \< 50%),Unstable angina pectoris, Serious cardiac arrhythmia
* Renal failure not related to AML: serum creatinin \> 170 μmol/L or clearance of creatinin ≤ 50 mL/mn
* Known HIV 1- HIV 2 positivity
* Prior therapy with azacitidine or lenalidomide
* Psychiatric illness or social situations that would preclude compliance with study requirements
* Uncontrolled infection
* Urgent chemotherapy for DIC, spontaneous tumoral lyse syndrome, leucostase without cytogentic results
* Women who are pregnant or breastfeeding
* Women who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy
* Men who are unwilling or unable to use an acceptable method of birth control
Ayurvedic Treatment Package in Plaque Psoriasis

Psoriasis is a chronic, immune-mediated inflammatory skin disease that is associated with substantial impairment of physical and psychological quality of life. The conventional treatment protocols manages the condition but with remissions and relapses which create anxiety in patients. Many of the patients withdraw from active social life as the disease attains chronicity. Several studies are pointing towards a conjoint management strategy incorporating the traditional and alternate medical systems. In this regard, Ayurveda is commonly used by psoriatic patients in India. Considering this fact it is high time to conduct a study to scientifically evaluate the efficacy of Ayurvedic treatment protocol in managing psoriasis as well as its potential to improve the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis having age 18 years or more
* Patients with moderate-to-severe plaque psoriasis with a PASI score of 12 or higher
* Psoriasis diagnosed 6 months or more before study entry
* Those who are poorly controlled based on physicians assessment with topical treatments, phototherapy, systemic therapy, or a combination of these therapies.
* Participants who have given informed consent.

Exclusion Criteria:

* Participants with other systemic illnesses
* Lactating and pregnant mothers.
* Alcohol dependence/Narcotic dependence /Steroid dependence
* In the judgment of the investigator, unable or unwilling to follow the protocol and instructions
Role of Maternal Physical Exercise on Spontaneous Labor Onset

Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy as a method to enhance spontaneous labor.

At 38 weeks low-risk pregnant women, with singleton cephalic fetus and without previous cesarean delivery, were randomized into 2 groups: a control group without maternal physical exercise practice and a study group with 30 minutes of walking, 3 times a week at 4 Km/h. Induction of labor was performed at 41 weeks

Eligibility Criteria:
Inclusion Criteria:

* 38 weeks low-risk pregnant women
* singleton cephalic fetus
* without previous cesarean delivery

Exclusion Criteria:

* pathological pregnancy
* twin pregnancy
* previous cesarean section
Reversing Maladaptive Reorganization in Frail Brains

Neuroscientific models of maladaptive aging emphasize the loss of sensorimotor stimulation and reduced modulatory capacities as core processes in the development of maladaptive plastic changes of the brain and subsequent cognitive and bodily decline as determinants of frailty and multimorbidity in old age. The investigators plan to analyze anatomical, neurophysiological, and neuropsychological correlates of maladaptive plasticity in frail persons and plan to test how innovative interventions that target maladaptive plasticity alter brain function and neurocognitive skills. There are novel interventions that have been shown to target the neurocognitive deficits and enhance plasticity in brain areas that are affected first in the progress of aging. Specifically, sensory training has been employed to enhance relevant input to the brain and to improve neuromodulatory function and has yielded high effect sizes. The investigators will perform proof of concept studies to examine the utility of sensorimotor training and examine the role of brain-derived neurotrophic growth factor to enhance brain plasticity and memory functions, as well as their transfer to other cognitive domains. The investigators will implement motivational enhancement strategies using virtual reality in these treatments that can further boost training effects and plasticity, but have not been employed in these treatments so far. Biomarkers for the remediation of maladaptive changes will involve neuropsychological assessments, brain imaging, brain-derived neurotrophic factor (BDNF) levels, and BDNF genotype. Thus, the investigators will be able to comprehensively characterize dysfunctional plasticity and the specific mechanisms of the interventions that are employed and investigate innovative clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Frail individuals (Fried criteria)

Exclusion Criteria:

* Alzheimer or strong cognitive/dementia impairments, strong neurological impairments, age below 65