cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on patients with CLL/SLL.

The hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.

Treatment consists of dose escalations of lenalidomide and ibrutinib and fixed doses of rituximab. A small expansion cohort to include 10 patients will follow once the recommended phase II dose is found.

Eligibility Criteria:
Inclusion Criteria:

* Previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma that requires treatment
* No prior systemic treatment within 4 weeks of enrollment
* No corticosteroids within 2 weeks prior to study entry
* Measurable disease must be present
* No concomitant anti-cancer therapies
* ECOG status \</= 2
* Patients with HIV infection are eligible
* Patients with treated CLL or SLL in CNS are eligible
* Non-pregnant and non-nursing
* Life expectancy greater than 60 days
* Adequate bone marrow, kidney and liver function
* No major surgery within 28 days or minor surgery within 5 days of starting treatment

Exclusion Criteria:

* History od Richter's transformation
* History of prior allogeneic transplant
* Radioimmunotherapy within 1 year of enrollment
* Prior Bruton's tyrosine kinase inhibitor or lenalidomide
* History of allergic reactions to compounds similar to ibrutinib, lenalidomide or rituximab or hypersensitivity
* active or uncontrolled autoimmune hemolytic anemia or ITP
* Transfusion-dependent thrombocytopenia or bleeding disorders
* Active hepatitis B or C infections
* History of known Human Anti-Chimeric Antibody positivity
* History of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
* History of uncontrolled seizures
* Autoimmune disorder that requires active immunosuppression
* Stroke or intracranial hemorrhage within last 6 months
* History of congestive heart failure, myocardial infarction, unstable angina, uncontrolled arrhythmia or any Class 3 or 4 heart disease in the last 6 months
* No prior malignancy except if treated with curative intent with no active disease for more than 3 years; adequately treated non-melanoma skin cancer or cervical cancer in situ
* using warfarin or similar Vitamin K antagonists Unable to swallow capsules or disease significantly affecting gastrointestinal function or inhibiting small intestine absorption
The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Selected 400 cases of women with primary breast cancer who were treated with operation randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

The investigators selected 400 cases of women with primary breast cancer who were treated with operation randomly,then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Pathological confirmation of breast cancer
3. Tumor stage(TNM):T2-4bN0-3M0
4. ER(+) and/or PR(+).
5. Premenopausal woman.
6. Age≥40 years
7. Measurable disease as per RECIST criteria
8. Karnofsky≥70
9. Laboratory criteria:

   * PLT≥100\*109/L
   * WBC≥4000/mm3
   * HGB≥10g/dl
   * ALT and AST\<2\*ULN

Exclusion Criteria:

1. Presence of metastatic disease.
2. Inflammatory breast cancer.
3. Bilateral breast cancer.
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
5. other malignant tumor (concurrent or previous).
6. Pregnant woman.
7. Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
8. Any severe systemic disease contraindicating chemotherapy.
Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

The purpose of this study is to compare the efficacy of two variants of cognitive behavioral therapy (CBT) (cognitive therapy (CT) and acceptance and commitment therapy (ACT)), for the treatment of generalized social anxiety disorder.

We are recruiting a clinical sample of patients who meet diagnostic criteria (per DSM-5) for the generalized subtype of social anxiety disorder. Participants are randomly assigned to the two active intervention conditions; no placebo or sham treatments will be employed. Assessments take place at baseline, pre-treatment, mid-treatment, post-treatment, and at 3- and 12-months follow-up; participants also complete a brief weekly assessment of functioning. Treatment is administered individually by trained graduate students in clinical psychology, directly trained and supervised by the PI and Co-PI. Participants receive 12 weekly 1-hour long sessions. The study design is a 2 (treatment condition) by 5 (assessment occasion) mixed factorial design.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria)
* aged 18-65
* working fluency in English
* residence in the greater Philadelphia area.

Exclusion Criteria:

* Pervasive developmental disability
* acute suicide potential
* inability to travel to the treatment site
* schizophrenia or other psychotic disorder
* current substance dependence
* Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of social anxiety disorder.
Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery

The goal of this prospective pragmatic randomized clinical trial is to determine if preoperative administration of tranexamic acid (TXA) reduces bleeding during and after major colorectal surgery. The primary questions are:

* Does TXA reduce bleeding during and after surgery (change in hemoglobin from before surgery to lowest value after surgery within 30 days)
* Does TXA reduce bleeding complications within 30 days of surgery (blood transfusion, return to the operating room or procedural intervention for bleeding, death due to bleeding)
* Does TXA increase the risk of thromboembolic complications within 30 days of surgery (cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism)

Researchers will compare preoperative TXA to no TXA to answer the above questions.

Participants who receive TXA will receive 1 g TXA IV at the beginning and end of surgery in the operating room.


Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 years or older
2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery

Exclusion Criteria:

1. Creatinine clearance less than 30 mL/minute
2. Long-term dialysis
3. Known defective color vision (color blind)
4. Pregnancy
5. History of venous or arterial thromboembolism, or active thromboembolic disease
6. Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.
Assessment of PENG Block Analgesia Versus Intra-articular Infiltration in Hip Prosthesis Surgery

After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours.

Pain management (analgesia) after hip prosthetic surgery remains a challenge. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact.

The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits.

A new peripheral nerve block, the PENG block has shown very encouraging results on postoperative analgesia quality.

In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration during mini-invasive anterior hip prosthesis surgery.

Each year, around140 000 patients undergo total hip arthroplasty. After hip arthroplasty, pain intensity is maximum within the first 6 hours and is then estimated to last between 36 and 72 hours. However, more and more patients want to no longer suffer after surgery. Indeed, if postoperative pain is moderate at rest, it is often exacerbated by movement. Severe pain occurs in 50 % of patients at rest and in 70% of patients during mobilization.

Pain management (analgesia) after hip prosthetic surgery remains a challenge for the anesthesiologist. A bad analgesic treatment can result in delay in mobilization/ambulation and thus increase duration of patient's stay which can have a significant economic impact. Quality analgesia is therefore essential to reduce post-operative pain and improve functional rehabilitation in patients undergoing hip surgery.

The different recognized analgesia techniques (intra-articular infiltration and peripheral nerve blocks) are effective but have shown certain limits: rapid and non-lasting effect of analgesia or poor targeting of all nerves of hip joint.

A new peripheral nerve block, the PENG block, identified during a recent anatomical study in 2018, has shown very encouraging results on postoperative analgesia quality on several small series of patients.

In this context, this research is based on the hypothesis that ultrasound-guided PENG block could provide more effective analgesia than intra-articular infiltration and therefore reduce the intraoperative opioid consumption during mini-invasive anterior hip prosthesis surgery under general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over 18 years old.
* Patient scheduled for hip prosthesis placement via the anterior approach

Exclusion Criteria:

* Patient with local anesthesia contraindication.
* Patient with a high level of dependency, defined by level 1 or 2 of Iso Ressources Group (GIR).
Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center

The purpose of this study is to determine whether glaucoma drop aids will be cost-effective in delivery of ophthalmic medications by improving medication compliance, visual function, and even decreasing medication waste in the patient population at Boston Medical Center (BMC).

Patients being treated for their glaucoma at BMC's Yawkey Eye Clinic will be selected according to the inclusion and exclusion criteria. The three drop aids used in this study will be the Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator. Patients will be randomly placed on one of these drops aids for a total of 3 study groups or the no drop aid control, for a total of 4 groups. Prior to use of the drop aid, patients will be instructed on how to use the drop aid by a resident physician and a pre- intervention intraocular pressure check will be performed by the resident physician using an applicator. Intraocular pressure is the only adjustable risk factor for glaucoma; thus, glaucoma treatments slow progression of glaucoma by reducing intraocular pressure. In addition, patients will be requested to deliver their drops with the drop aid with every use. Furthermore, each patient will record the number of days taken to complete the glaucoma medication bottle while using the drop aid. At the 3 and 6 week marks, the patient will fill out a satisfaction survey. Patients will need to return to the clinic at the 6 week mark and can fill out the satisfaction survey at the clinic in addition to checking the intraocular pressure post-intervention. Thus, the number of subject contact will be two, pre and post-intervention, the duration of participation for each subject will be 6 weeks, and the patient will also be required to fill out two satisfaction surveys. The effectiveness of the drop aids will be compared to the two controls and measured with any changes in intraocular pressure readings, length of time to medication completion, and patient satisfaction according to the surveys.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or greater
* Currently on the same topical medication for treatment of glaucoma for a minimum of two months
* Patient of Boston University eye Associates
* Agrees to use the drop aid with each delivery, return to the clinic after 6 weeks of using the drop aid, document completion of medication drops and fill out survey at the end of the 6 weeks

Exclusion Criteria:

* Less than age 18 years
* Changes glaucoma medication within the past two month or recent glaucoma surgery
* Older than 89 years of age
* Not a patient of the Boston University eye associate
Evaluation of a Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF

The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.

It has been shown that the withdrawal of treatment follows with a flare of the disease in a short time after the suspension but it has not been evaluated in controlled trials if remission could be maintained with a lower dose. A multicenter, national, open-label, randomized and controlled clinical trial of 3 years duration (2 years for inclusion + 1 year follow-up) is proposed to address this issue. The study will include 190 patients with Spondylarthropathies in stable treatment with any single anti-TNF agent and compliance with criteria of clinical remission for at least 4 months. Patients will be randomized to intervention or control arm, with stratification according to the antiTNF product thet were receiving prior to inclusion. Patients will be followed with the calendar of visits recommended by the Spanish Society of Rheumatology for clinical practice. The proposed hypothesis is of non-inferiority of the experimental arm with dose reduction versus the control arm with standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients with Spondylarthropathies according ASAS group criteria.
* Patients under treatment with anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab) who present established clinical remission
* Patients to give their informed consent to participate in the study

Exclusion Criteria:

* Patients with secondary Spondylarthropathies
* Patients with Spondylarthropathies and predominantly clinical of peripheral arthritis which receive anti-TNF therapy by peripheral symp tons.
* Patients with Spondylarthropathies and other associated diseases that hinders or modify the clinical evaluation of the patient (fibromyalgia, chronic inflammatory disorders...)
* Patients with bowel inflammatory disease
* Patients under chronic therapy with anti-TNF therapy who received the patterns of reduction that will be explored in the experimental group, or low doses or most spaced that those in the experimental group before study inclusion
Longitudinal Imaging in Patients With Large Vessel Vasculitis to Predict Further Disease Course

Longitudinal imaging in patients with large vessel vasculitis to predict further disease course

This explorative longitudinal prospective observational study is to explore different aspects of vessel wall characteristics as detected by magnet resonance imaging (MRI) techniques and positron emission tomography/computer tomography (PET/CT) in patients with large vessel giant cell Arteriitis (LV-GCA) for their usefulness as predictive factor for future giant cell arteritis (GCA) relapse. It analyses parameters in PET/CT and MRI in patients with GCA at treatment stop which correlate with GCA relapse within the first 6 months after treatment stop.

Patients included in the established local GCA database (BARK) will be screened for eligibility. Aortal imaging is performed during routine care according to established guidelines at diagnosis and during Follow Up at least every two years and before treatment stop.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of GCA and having a diagnosis of LV-GCA confirmed by imaging (PET/CT)
* Informed consent to the local GCA cohort BARK
* Followed for GCA treatment in the outpatient department.

Exclusion Criteria:

* Known hypersensitivity or allergy to Gadolinium (Gd)-based MRI contrast agents.
* Patients with cardiac pacemakers, intra cranial clips, metallic foreign bodies or other not MR-compatible implants (e.g. pumps etc.).
* Renal failure or severely impaired kidney function (eGFR \< 30 ml/min /1,73 m2)
* Epilepsy.
A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy

This study has the objective of providing compassionate use access to omalizumab (Xolair) and to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain symptomatic despite optimal therapy according to GINA step 4 treatment guidelines.


Eligibility Criteria:
Inclusion Criteria:

* male or female, ≥ 6years of age;
* who have a diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria;
* severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per Canadian Asthma Consensus Report (1999));
* Subjects having successfully completed one of the following protocols: CIGE025A011E3, CIGE025A2425, CIGE025AIA05;
* elevated immunoglobin E levels

Exclusion Criteria:

* significant systemic disease
* pregnancy or lactation
* an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
* history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
* current treatment with warfarin (Coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.
Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Has known or suspected peripheral vascular disease
* Is scheduled for X-ray angiography

Exclusion Criteria:

* Has any contraindication to magnetic resonance imaging
* Is scheduled for any procedure before the X-ray angiography
* Had previously had stents placed bilaterally in the region to be imaged
Is Hemodialysis Associated With Cardiac Markers Change?

Hemodialysis (HD) triggers recurrent and cumulative ischemic insults to the brain and the heart. Cooled dialysate may have a protective effect on major organs and improve hemodynamic tolerability of dialysis. The aim of the study was to compare HD with cooled dialysate with routine dialysis in terms of hemodynamic stability and levels of high sensitivity Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis


Eligibility Criteria:
Inclusion Criteria:

* Patients with renal insufficiency treated with dialysis for a period of at least three months.

Exclusion Criteria:

* Patients who experienced myocardial infarction during the three months prior to the start of the study
* Patients who underwent vascular surgery during the last month
* Patients who experienced chest pain at rest during the last week before the start of the trial - Patients who had to discontinue dialysis prematurely due to hemodynamic instability.
Exercise Training and Thrombotic Risk in Post-menopausal Women

At menopausal transition, the risk of cardiovascular diseases increases. This is partly due to aging, but largely also the loss of estrogen, which has many positive effects on the circulation and protects against cardiovascular diseases. It has been suggested that the loss of estrogen may have a negative impact on the otherwise well-documented health promoting effects of exercise training, and that the time after menopause may be crucial for the effect of exercise training on the vascular function, and therefore also for the risk of thrombosis. Literature regarding the effect of exercise training on the risk of thrombosis is limited, and especially in women.

The purpose of the present study is to investigate whether the same effects of exercise training in relation to thrombosis is achieved if the exercise is initiated early compared to late after menopause. The aim is to provide knowledge-based recommendations regarding exercise. Teams sports will be used as the training intervention, because team sports benefits physical health and also includes a social element.

Part of the novelty of this project is to link functional measurements of cardiovascular health at whole body level to cell studies. Cells will be isolated from muscle samples obtained from the post-menopausal women before and after the training intervention. This will enhance the understanding of the changes that occur after prolonged loss of estrogen on thrombotic risk and vascular function, and whether exercise training can alter these parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age: 50-70 years
* Physical activity ≤ 2 hours per week (except transportation by bike or by walking)
* BMI ≤ 30

Exclusion Criteria:

* Age \<50 years
* Injuries that prevent the performance of team sports
* Participation in other clinical projects
* Smokes or has smoked within the last 10 years
* On hormone therapy
* Not entered menopause
* Has chronic diseases that are not expected, cf. the groups sought. Including heart problems, atrial fibrillation, cancer, immune diseases and previous strokes with functionally significant sequelae
* Being treated with oral steroids
* Has alcohol / drug abuse or is being treated with disulfiram (Antabus)
* Is unable to understand the contents of the document with informed consent or the experimental procedures