cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma

This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules)
* Tumor accessible to intra-tumoral injections
* Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3

Exclusion Criteria:

* Are candidates for curative surgical excision or lymphadenectomy
* Prior non-surgical treatment within 4 weeks
* Known central nervous system (CNS) tumor involvement or metastases
* Hypersensitivity to MORAb-028
Tart Cherry and Omega-3's for Aromatase Inhibitor Musculoskeletal Symptoms

Both Tart Cherry and Omega 3 FAs have better side effect profiles compared to other commonly used medications for AIMSS, such as nonsteroidal anti-inflammatories, steroids, and serotonin norepinephrine reuptake inhibitors. Additionally, in our clinics we often find that patients tend to be more receptive to taking a supplement as opposed to an additional medication. Further, both Tart Cherry concentrate and fish oil have beneficial properties for helping with joint stiffness in general, in addition to other health issues like insomnia.

There is preliminary evidence in mouse models that when given together, these supplements may have an even greater anti-inflammatory effect than when taken separately14. Although to our knowledge, no human studies have tested this hypothesis. This study has been designed to test the hypothesis that Tart Cherry and fish oil when given in combination over a 12-week period could produce beneficial changes in joint function when compared to Tart Cherry or fish oil in isolation in an obese breast cancer population experiencing AIMSS. Secondary outcomes to be assessed include pain, functional performance, quality of life and cognition.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnosis (Stage I-III) with any hormonal status.
* Females aged ≥ 18 years.
* Currently receiving AI therapy.
* BMI ≥ 27.
* Clinical diagnosis of AIMSS.
* Omega-3 Index \&lt;8%.
* Average joint pain score ≥ 4 on the Brief Pain Inventory (BPI) within 7 days of enrollment.
* Written informed consent obtained from subject and ability and willingness of subject to comply with the requirements of the study.

Exclusion Criteria:

* Current use of anticoagulant medications (Including but not limited to Warfarin, Lovenox, Eliquis, Xarelto).
* Allergy to cherries or fish/fish products.
* Lifetime history of rheumatoid arthritis and/or inflammatory joint diseases (Including but not limited to reactive arthritis, ankylosing spondylitis, and psoriatic arthritis).
* Uncontrolled diabetes mellitus as determined by treating physician (with or without the use of glucose lowering medications and/or insulin).
* Lifetime history of stroke or transient ischemic attacks.
* New use or dose change of oral or topical analgesics in the previous 14 days. (Including but not limited to opioids, non-steroidal anti-inflammatories, acetaminophen, SNRI's, SSRI's, gabapentinoids, tricyclic antidepressants, and muscle relaxants).
* Oral or intra-articular steroid use in the previous 30 days (Including but not limited to dexamethasone, prednisone, methylprednisolone, triamcinolone, hydrocortisone).
* History of joint fracture or surgery of the symptomatic joint in the previous 6 months.
Shrunken Pore Syndrome: a Retrospective, Single Center, Cohort Study

To study the impact a difference in renal clearance of small and large molecules has on long-term survival.

Renal dysfunction is considered a major risk factor in cardiac surgery. Renal function has earlier been estimated by creatinine and more recently by cystatin C, both of which are analysed in a blood sample. New evidence seems to suggest that if the ratio between estimated renal function from cystatin C and creatinine is below 60% the patient has a higher rate of mortality irrespective of renal function. This syndrome is named Shrunken Pore Syndrome.

We study patients whom have undergone elective cardiac surgery at our institution and on whom we before the surgery has collected blood samples. They are all included in our in house patient registry and qulaity database and afterwards we match this data to our national tax registry to get data on mortality.

Our aim is to evaluate whether Shrunken Pore Syndrome influence mortality following elective cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective CABG and/or sAVR at the department of Cardiothoracic Surgery, Skåne University Hospital in Lund, Sweden between 1 January 2010 and 31 December 2015.

Exclusion Criteria:

* Emergency operation
* Redo operation
* Preoperatively missing cystatin C or creatinine
Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm

Persistent Atrial Fibrillation (AF) is a common and distressing cardiac arrhythmia and accounts for 1% of the healthcare budget in the UK and it's prevalence is rising. Symptoms of atrial fibrillation include palpitations, chest pain , shortness of breath and fatigue, with quality of life measures reduced for patients with persistent AF, increased stroke risk and increased all cause mortality rates. DC Cardioversion is used to restore normal sinus rhythm in patients with persistent AF. It has a high success rate but reoccurence of AF is common. The use of anti arrhythmic drugs (AADs) can augment the number of patients remaining in sinus rhythm at one year, with amiodarone currently the most superior. Unfortunately it can have serious side affects. Dronedarone is a related drug designed specifically to minimise the most serious side affects and is no approved and used prominently in the management of non permanent AF. However it has not yet been studied in a post DC Cardioversion population.

Patients in persistent AF who are referred for elective DC Cardioversionwill be randomised to receive either Amiodarone or Dronedarone to compare the ability to help maintain sinu rhythm post cardioverion in one NHS hospital. Patients will be followed up for a year post cardioversion to see if they stay in sinus rhythm.

Ho: there will be no difference in maintenance of sinus rhythm with the use of amiodarone or dronedarone


Eligibility Criteria:
Inclusion Criteria:

* • Patients with persAF requiring dc cardioversion.

  * Patients must be over 18 years old.
  * Patients give informed consent form prior to participating in this study.
  * Patients must be on warfarin for at least 4 weeks or a transoesphageal ECHO must be performed at the time of dc cardioversion.

Exclusion Criteria:

* • Patient is suffering with unstable angina in last 1 week.

  * Patient has had a myocardial infarction within last 2 months.
  * Patient is expecting or has had major cardiac surgery within last 2 months.
  * Patient is participating in a conflicting study.
  * Patient is mentally incapacitated and cannot consent or comply with follow-up.
  * Patient has NYHA class III/ IV heart failure.
  * Pregnancy.
  * Patient suffers with other cardiac rhythm disorders.
  * Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).
  * GFR\<30mls/min.
  * Patients has a contraindication to amiodarone or dronedarone
Effect of Cognitively Challenging Physical Activity on Executive Functions in Pediatric Cancer Patients

When it comes to exercise and sport for children and adolescents with cancer, there is often still the opinion that physical activity has a negative effect on the weakened body suffering from cancer. Many studies show that the opposite is the case: physical activity for children and adolescents with cancer do not jeopardise the success of treatment, but rather promote it. It has been shown that physical activity has a positive effect on motor skills, physical fitness, sleep quality, fatigue symptoms, body image and general quality of life in children and adolescents with cancer.

In addition, physical activity leads to an improved fat-to-muscle ratio, metabolic status, bone strength and reduces cardiovascular disease. Furthermore, various studies show that oncological patients with sarcopenia (loss of muscle mass) and frailty have a poorer response to their cancer therapy. This broad spectrum of effects of physical activity leads to improved and faster rehabilitation, is directly linked to the success of treatment and has led to exercise being an integral part of treatment in many paediatric oncology centres worldwide.

Furthermore, more exercise that includes playful cognitive tasks is expected to lead to improved attention, memory and academic achievement. Besides, it is important to try to get children to exercise at home outside of the inpatient setting. Hybrid (on-site and digital meetings) programmes also work for children and adolescents. Additionally, the research project offers sports counselling after the end of therapy to reintegrate the patients into everyday sporting life, be it in a club or at school.

The central question of the research project is: Does cognitive challenging physical activity developed for children and adolescents undergoing acute cancer therapy improve cognitive and motor performance compared to a control group receiving standard care?


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of parents / legal guardian and participants, where applicable
* Diagnosis of any type of cancer requiring chemo- and/or radiotherapy, or CNS surgery, expected to last a minimum of at least 6 weeks at the time of recruitment
* Age: 6-17.99 years at time of recruitment

Exclusion Criteria:

* Cognitive and physical disabilities that prevent participation in the intervention.
* Inability to follow the procedures of the study, e.g. due to language problems.
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
* Denied written informed consent from participants.
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.

This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate. Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis (RA) \> 3 months.
* On methotrexate (MTX) therapy =\> 3 months and on a stable dose for at least 4 weeks.
* Except for MTX, must have discontinued all disease-modifying antirheumatic drugs (DMARDs) for at least 3 months or 5 half-lives, whichever is longer.
* Body Mass Index (BMI) is 19 to 38, inclusive.
* Other than RA, subjects should be in good general health.

Exclusion Criteria:

* Evidence of anti-ABT-122 antibody on a serum sample taken at Screening.
* History of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any IgG containing product.
* History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days.
* History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.
* Subject has any medical condition or illness other than RA that is not well controlled with treatment.
Application of Chemical Sensors for Diagnosis of Inflammatory Bowel Diseases and Irritable Bowel Syndrome by Respiratory Samples

Discriminating irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD), especially with mild disease activity, is common clinical challenge. Most of the patients with suspected IBS have to go invasive procedures (colonoscopy/gastroscopy). In order to avoid invasive investigations, there is a search for noninvasive markers with the capacity to distinguish between IBS and IBD. Dr Hossam Haick (Department of Chemical Engineering, Technion) developed a system that combines nano-metals produced in his laboratory with electrical devices (transistors). The combination between a nanomaterial and an electrical transistor induces a change in its electrical behavior upon exposure to the material being examined; that is, a change in its electrical properties. The change in its electrical behavior is translated into a computerized graphic signal.

The electronic nose is composed of an air pump, a filter for filtering external contaminants and an array of sensors. Each sensor transmits a signal according to the materials it "knows" how to identify. Thus, it is possible to characterize most of the substance families characteristic of a certain disease, and the same system is designed for differential diagnosis of different diseases.

The purpose of the investigators study is to use the "electronic nose" to find bio-markers that will help to diagnose IBD and IBS without using invasive procedures.

The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50 controls). The patients included in the study will undergo an evaluation by a gastroenterologist after signing an informed consent and will answer a questionnaire.

The samples will analyzed in the laboratory of Dr. Haick.

The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50 controls). The patients included in the study will undergo an evaluation by a gastroenterologist after signing an informed consent and will answer a questionnaire.

The samples will analyzed in the laboratory of Dr. Haick.

Eligibility Criteria:
Inclusion Criteria:

* Patinets with IBD or IBS

Exclusion Criteria:

* Age under 18 y/o pregnancy, malignant and infectious diseases
Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis

The goal of this clinical trial is to find out which method is better for guiding iron treatment in adult patients with end-stage kidney disease (ESKD) on hemodialysis who have anemia.

The main questions it aims to answer are:

Can using reticulocyte hemoglobin equivalent (RET-He) to guide intravenous (IV) iron treatment be as effective as using transferrin saturation (TSAT)?

Does the method used to guide iron treatment affect outcomes such as death, heart problems, hospitalizations, infections, or the need for blood transfusions?

Researchers will compare RET-He-guided iron treatment with TSAT-guided iron treatment to see if RET-He works just as well and has similar or better outcomes.

Participants will:

Receive IV iron based on either RET-He or TSAT levels

Have blood tests done at the start, 3 months, and 6 months

Have their doses of iron and erythropoietin (a medication to treat anemia) adjusted based on the assigned protocol

Be monitored for clinical outcomes such as hospitalization, heart events, and infections


Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18-80 years)
* ESKD on chronic hemodialysis ≥ 6 months
* EPO therapy ≥ 6 months
* Hb \< 13.0 g/dL in male, \< 12.0 g/dL in female

Exclusion Criteria:

* Serum ferritin \> 800 ng/mL or TSAT \> 40%
* Active infection or malignancy
* Hematologic disease including thalassemia major, hemolysis, myelofibrosis or myelodysplastic disease
* History of marrow suppressive or immunosuppressive medications in past 6 months
* History of active heart failure and recent myocardial infarction /stroke in past 6 months
* History of GI or external bleeding or receiving blood transfusion in past 6 months
Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction

This is a parallel, randomized controlled trial comparing two types of patient positioning and their effect on radiologic measures (pre-surgery visit, in the operating room prior to surgery, at the conclusion of surgery, and at 3 weeks after surgery at patients' postoperative visits) as well as surgeon satisfaction (prior to the end of the surgery) and patient outcomes using patient self reported scales (pre-surgery, post surgery at 3 weeks follow-up).

The investigators are evaluating how patient positioning affects radiologic metrics as well as surgeon satisfaction (surgeon being blinded to positioning). Patients will be allocated to either a hyperlordotic or a standard positioning group by computer generated randomization. Surgeons will perform all of their standard techniques to promote lordosis with instrumentation. Adult patients, ages 18-65, undergoing lumbar surgical fusion will be asked to participate.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients, aged between 18 and 65 years of age
* Patients undergoing lumbar fusion for degenerative conditions

Exclusion Criteria:

* Patients \< 18 years of age or \> 65 years of age
* Patients who have a history of metastatic disease
* Patients who currently have a pending workman's compensation claim
* Patients who have had a previous spinal surgery
* Patients who have or have had a spinal infection
* Patients who have a spinal deformity, such as scoliosis
* Women who are pregnant
* Inpatients
E-health Intervention for Cardiac Rehabilitation

Cardiac rehabilitation (CR) is designed to increase healthy behaviours (e.g. physical activity, healthy eating, smoking abstinence) and reduce risk factors (e.g. high blood pressure \& cholesterol) in order to improve quality of life and health among people with heart disease. Unfortunately, few patients attend CR, often reporting several barriers to access including travel distance, parking fees and lack of time. Advances in technology have the potential to improve accessibility and delivery of CR programs, and improve patient empowerment. The University of Ottawa Heart Institute has developed an e-health program called the Virtual Cardiac Rehabilitation Program (VCRP); an online cardiovascular health management system (website \& Smartphone app) that provides strategies for the control and management of risk factors. The goals of VCRP are to: empower and educate patients; foster better communication between patients and their health care team; stimulate shared decision making; and, facilitate care coordination leading to better health outcomes. The VCRP provides patients with: real-time access to their health information, as well as tracking of risk behaviours and factors through integration with devices; a wellness plan; access to a personal on-line health coach; goal-setting notifications; on-line community forums; and, circle of care access to information. The aim of this project is to evaluate the effects of VCRP (with integrated fitness tracker) compared to a standard, home-based CR program. The study will look at changes in: patient empowerment; health behaviours; risk factors; quality of life; clinical outcomes; and, costs. The study will improve our understanding of: patient and provider needs; program usability; and shared decision-making. Results will inform the use of e-health programs such as VCRP into healthcare settings to improve patient empowerment, shared decision-making, and the ability to integrate wearable monitors to improve health behaviours.


Eligibility Criteria:
Inclusion Criteria:

1. Patient was hospitalized at the University of Ottawa Heart Institute (UOHI);
2. Patient has stable Coronary Heart Disease (CHD) or valvular disease;
3. Patient has been referred to Cardiac Rehabilitation (CR) and is a candidate an offsite program;
4. Patient has access to and regularly uses a smart phone, tablet or computer with Internet access;
5. Patient is ≥ 18 years of age (the age of consent in Ontario);
6. Patient is able to read and understand English or French (programs are available in both languages);
7. Patient is eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences \[ICES\]);

Exclusion Criteria:

1. Patient was hospitalized for heart failure, congenital heart disease, transplant or arrhythmia within the last 6 months;
2. Patient, in the opinion of the medical advisor (Dr. Andrew Pipe), manifests illness that would preclude participation in the interventions (e.g. cognitive impairment, active drug or alcohol dependence).
Prognostic Model of Rituximab in the Treatment of MN

The goal of this observational study is to explore the factors that can predict the prognosis difference in patients with idiopathic membranous nephropathy (IMN) under the treatment of rituximab. The main questions it aims to answer are:

* to explore the factors that can predict the prognosis difference in patients with IMN under the treatment of rituximab
* to establish a clinical prediction model and verify it to provide a reference for the early Participants will receive standard the treatment of rituximab treatment and will then be divided into remission and non remission groups based on the treatment effect after the standard treatment cycle. Blood, urine, and fecal samples were collected from patients to explore possible factors influencing treatment efficacy.

Researchers will compare \[remission group and non-remission group\] to see if the gut microbiota and its metabolites are factors that influence the efficacy of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years, the patient was diagnosed as idiopathic membranous nephropathy or anti phospholipase A2 receptor (PLA2R) antibody positive by renal puncture biopsy, and the clinical data were complete;
2. According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines in 2020, it conforms to the medium and high risks in the risk level of progression of renal function loss.
3. In general, they are in good condition, have a good understanding of their own conditions and physical conditions, have self-awareness, and can communicate well with others;
4. Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.

Exclusion Criteria:

1. There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins;
2. At the same time, immunoglobulin A nephropathy (IgAN), interstitial nephritis, acute nephritis and other renal pathological types were combined;
3. The medication was not standardized during the treatment process, accompanied by serious infection, acute renal injury and other complications, and serious cardiovascular, cerebrovascular, digestive and blood system diseases;
4. During follow-up, the patient cannot actively cooperate or accurately understand and express.
Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).

The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Submental fat (SMF) that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the SMF rating scale
* Good general health
* Signed informed consent

Exclusion Criteria:

* History of any treatment in the neck or chin area
* Loose skin or prominent platysmal bands in the neck or chin area
* Recent treatment with anticoagulants
* Presence of clinically significant health problems