cyrilzakka/clinical-trials huggingface dataset:
PeRioperative Omega Three and the Effect on ImmuNity

Bowel cancer is the second most common cause of cancer-related death in the UK, with 50,000 new cases and over 15,000 deaths annually. Surgery is the mainstay of treatment and the most common complications are an infection of the wound or lungs. These can lengthen hospital stay, reduce the quality of life, and even increase the risk of death. Bowel cancer patients are often malnourished. Optimising nutrition with supplements such as fish-oils can improve the immune response of patients, helping prevent such complications, shorten hospital stay, improve quality of life and overall survival.

Bowel cancer is the second most common cause of cancer-related death in the UK, with 50,000 new cases and over 15,000 deaths annually. Surgery is the mainstay of treatment and the most common complications are an infection of the wound or lungs. These can lengthen hospital stay, reduce the quality of life, and even increase the risk of death. Bowel cancer patients are often malnourished. Optimising nutrition with supplements such as fish-oils can improve the immune response of patients, helping prevent such complications, shorten hospital stay, improve quality of life and overall survival. We are increasingly familiar with the term BMI, body mass index, which we use to categorise obesity in healthcare. A newer term in this realm is that of sarcopenia, a low muscle mass relative to your size, unrelated to your weight or fat density. This can be measured in a number of ways, including on a scan performed routinely in bowel cancer care, a CT scan. Evidence shows that people with low muscle mass, irrespective of their overall weight, experience more complications than those who have healthier amounts of muscle. We hypothesise that patients supplemented with fish oils both before and after surgery will experience an enhancement of their immune response, and subsequently encounter fewer infectious complications, a shorter length of hospital stay and improved quality of life. We also predict fewer patients having extra nutrition before and after surgery will develop sarcopenia and avoid the risks associated with that condition. The trial will only take place in those with bowel cancer who are planned to have a keyhole operation, as this is now the most commonplace approach to surgery. We plan to recruit 40 patients, 20 to receive the supplement, and 20 to form a comparison or control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal cancer undergoing elective laparoscopic colorectal resection.
* Adult aged 18 or over.
* Capacity to consent

Exclusion Criteria:

* Pre-existing diagnosis of Diabetes mellitus, requiring medication.
* Consumption of \> 3 alcoholic drinks/day
* Already on omega-3 supplementation
* Pregnant
* Patients on heparin infusion perioperatively
* Patients on immunosuppressive drugs
* Regular / Daily smokers
* Patients requiring a blood transfusion at any point day 7 pre-op to day 1 post operatively.
* Vegan or Vegetarian
* Allergy to cows milk or wheat
Effect of Aerobic Training and Ginkgo Biloba on Lipids Levels in HIV-positive Patients Undergoing Antiretroviral Treatment

The administration of antiretroviral drugs (ART) has significantly prolonged the life expectancy of people living with human immunodeficiency virus (HIV) and delayed the progression towards Acquired Immune Deficiency Syndrome (AIDS). However, this has led to the emergence of other conditions, such as dyslipidemia, among individuals undergoing ART. Dyslipidemia is commonly managed with statin therapy, which has not been reported to have pharmacological interactions with ART. Additionally, ginkgo biloba extract (GBS) has been observed to improve blood lipid concentrations, and aerobic exercise training (EXA) interventions have shown positive modifications in these values.

Given this context, the present study aims to investigate the potential positive effects of an aerobic training program and the consumption of ginkgo biloba extract on plasma lipid concentrations in HIV-positive individuals. The study seeks to provide insights into novel strategies for managing dyslipidemia in this population.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 60 years
* Diagnosis of HIV-1 infection
* Receiving antiretroviral therapy with a triple regimen (Biktarvy treatment)
* Undetectable viral load (\< 20 copies/mL) for the past 6 months CD4+ level \> 200 cells/μL
* Diagnosis of mixed dyslipidemia in the last three months, indicated by:

  * Total cholesterol ≥ 200 mg/dL
  * HDL cholesterol \< 40 mg/dL in men and \< 50 mg/dL in women
  * LDL cholesterol \> 100 mg/dL
* Triglycerides ≥ 150 mg/dL
* Possession of a mobile device or computer with internet access and necessary platforms
* Willingness to participate voluntarily in the study and provide written consent

Exclusion Criteria:

* Individuals who develop hypersensitivity or allergy to ginkgo biloba extract
* Failure to attend at least 80% of the physical exercise sessions (equivalent to missing more than 12 sessions)
* Lack of adherence to pharmacological treatment
* Participant's decision to discontinue the intervention
To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions

To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo for the Treatment of Cholestasis in Infants

To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution and other markers of parenteral nutrition-associated liver disease.


Eligibility Criteria:
Inclusion Criteria:

Neonates admitted to the Neonatal Intensive Care Unit (NICU) at University Hospital (UH) in San Antonio, Texas, who:

1. Are \>14 days old and \<24 months of age
2. Have a serum direct bilirubin of ≥2 mg/dL
3. Are receiving \<3 g/k/day of Intralipid via TPN
4. Are expected to remain hospitalized for at least an additional 21 days

Exclusion Criteria:

1. Have a congenitally lethal condition (e.g. Trisomy 13)
2. Have clinically severe bleeding not able to be managed with routine measures
3. Have evidence of a viral hepatitis or primary liver disease as the etiology of their cholestasis
4. Have other health problems such that survival is extremely unlikely even if cholestasis improves
5. Known allergy to eggs or fish products
6. Receiving IV Fish oil
7. Phenobarbital therapy at enrollment
Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery

A total of 46 patients scheduled for explorative laparotomy with the aim of radical debulking surgery for colorectal cancer will be randomized into two equal groups one will receive tranexamic acid and one placebo.

The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.


Eligibility Criteria:
Inclusion criteria

* ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery.
* Age above 18 years \& less than 65 years.

Exclusion criteria:

* Thrombophilia or any bleeding disorder.
* Previous or active thromboembolic disease.
* Family history of thromboembolism.
* Known Allergy to TA.
* Liver dysfunction.
* Preexisting renal dysfunction (serum creatinine \>1.2 mg/dL).
* Coronary stent insertion within a year prior to operation.
* Cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure),
* Lifelong warfarin therapy for thromboembolism prophylaxis.
Reduction in Symptoms After Laser Therapy With Acorn aHFS

This study evaluates the severity and duration of symptoms experienced after laser therapy comparing four post-procedure topical products. Each product is applied to an individual region of interest (5 cm diameter) on the back or décolleté according to randomization code after laser therapy. The subject, blind to the product applied to each of 4 regions of interest, assesses eight symptoms daily for 14 days. Photography is performed daily.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age: ≥18 and ≤60 years
* Any skin tone Fitzpatrick score 1-2 (light), 3-4 (medium), 5-6 (dark)
* Competent and willing to provide written, informed consent to participate in all study activities

Exclusion Criteria:

* Pregnant women
* Are participating/have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by Sponsor
* Use of retinoids 7 days prior to the procedure
* Active cutaneous infections in the treatment area
* Diseases that could inhibit healing, such as scleroderma, or other cutaneous conditions that could confound study results
* Subjects unable to communicate with the investigator and staff
* Any health condition that in the investigator's opinion should preclude participation in this study
Tocilizumab vs CRRT in Management of Cytokine Release Syndrome (CRS) in COVID-19

Some patients infected with the COVID-19 can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. Tocilizumab was first approved by the U.S. FDA in 2010 for rheumatoid arthritis and might now be used to treat serious COVID-19 patients with lung damage, according to China's National Health Commission updated its treatment guidelines in 7th version.Continuous Renal Replacement Therapy (CRRT) was recommended by China's National Health Commission treatment guidelines in 1st-7th version to control sever COVID-19 patients.

Tocilizumab doesn't directly kill the novel coronavirus. It's known as an inhibitor of the receptor of interleukin 6 (IL-6), a pro-inflammatory cytokine. In the disease COVID-19, the body may respond to the pathogen by overproducing immune cells and their signaling molecules in a dangerous phenomenon called cytokine release storm.It has been recently speculated that IL-6 as a main culprit in that immune over activation among COVID-19 patients, hence the Tocilizumab clinical trial was initiated. In 2017, the FDA also approved Tocilizumab to treat cytokine release syndrome (CRS), a form of cytokine storm caused by CAR-T treatment. The investigator's hypothesis was that Tocilizumab would be associated with better clinical outcomes, such as decreased systemic inflammation, improved survival rate, better hemodynamic and improved of respiratory distress.Systemic inflammatory response syndrome was one of the main indications for treatment with CRRT. So it is clinically significant to compare the efficacy and safety of Tocilizumab and CRRT in management of CRS triggered by COVID-19.

Eligibility Criteria:
Inclusion Criteria:

1. Agrees to the collection of oropharyngeal or anal swabs and venous blood per protocol.
2. Male or non-pregnant female adult ≥18 years of age at time of enrollment.
3. Has laboratory-confirmed novel coronavirus infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in oropharyngeal or anal specimen within 72 hours prior to hospitalization.
4. Illness of any duration, and at least one of the following:

   1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
   2. Clinical assessment (evidence of rales/crackles on physical examination) AND SpO2 ≤93% on room air, OR
   3. Requiring mechanical ventilation and/or supplemental oxygen, OR
   4. Sustained fever in the past 24 hours and unresponsive to NSAID or steroid
5. Serum IL-6 ≥3 times the upper limit of normal

Exclusion Criteria:

1. Alanine transaminase/aspartate transaminase (ALT/AST) \> 5 times the upper limit of normal.
2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) \< 30 ml /min/1.73 m\^2)
3. Hemoglobin\<80 g/L
4. Leukocytes\<2.0×10\^9
5. Platelets\<50×10\^9
6. Pregnancy or breast feeding.
7. Anticipated transfer to another hospital which is not a study site within 72 hours.
8. Expected life span does not exceed 7 days.
9. Allergy to any study medication.
Fecal Microbiota Transplantation for Pancreatitis

The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis and protecting the gut against pathogens by competing for nutrients, creating the intestinal biological barrier and modulating the host immune system.After the onset of acute pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and endotoxin translocation, which may cause infectious complications which are major causes of death in SAP patients.Recently,FMT was shown its efficacy in the treatment of gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the mechanism by which FMT results in cure of diseases has been poorly understood.This study aims to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier dysfunction.

Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention enema with fresh bacteria,thus stabilizing intestinal barrier dysfunction,minimizing bacterial translocation and preventing infectious complications.The investigators will further examine the effect of FMT on inflammatory markers，the predictors of Intestinal barrier injury and the incidence of infectious complications.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of acute pancreatitis from the First Affiliated Hospital of Nanchang University according to the Classification of acute pancreatitis-2012: revision of the Atlanta classification and definitions by international consensus
2. Onset of pancreatitis within \<=2 weeks
3. complicated with gastrointestinal failure. Gastrointestinal failure was defined if the patients were complicated with obvious abdominal distention, abdominal rumbling sound weakening or disappearance, no self-defecation as well as intra-abdominal hypertension.

Exclusion Criteria:

1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula
2. Pregnancy and lactation women
3. Not signed the informed consent
4. Diabetes and autoimmune diseases
5. Multiple organ failure. Organ failure was defined as a score of 2 or more using the modified Marshall scoring system including respiratory failure, renal failure and circulatory.
Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction

The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.

A randomized, non-blinded prospective intervention trial. Patients randomized to exercise intervention will undergo supervised aerobic training on ergometer cycle for 12 weeks whilst control group receives standard care. Before and after the intervention, all participants will undergo cardiac magnetic resonance imaging (cardiac MR) examinations, Ventilation/Perfusion Single Photon Emission Computed Tomography (V/P SPECT), Cardiopulmonary exercise tests, muscle biopsies and blood sampling.

Eligibility Criteria:
Inclusion Criteria:

1. Signs and symptoms of heart failure
2. Age ≥50 years
3. Stable chronic heart failure (no hospitalizations within past month, no new medications past month)
4. Able to understand and follow exercise prescription
5. Currently physically inactive (less than 150 minutes/week moderate intensity exercise)

Exclusion criteria:

1. Currently or within the past 6 months been involved in cardiac rehab with exercise
2. Devices or implants not compatible with magnetic resonance imaging or exercise testing
3. Any orthopedic or medical condition affecting participation in testing and training
4. Signs of acute ischemia during baseline cardiopulmonary exercise testing
5. Participation in other clinical trials that may affect results
6. Moderate or severe valvular disease
7. Atrial fibrillation
8. Moderate or severe chronic obstructive pulmonary disease
9. NYHA class IV
Reduced Ultrasound Counts in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones, joint capsule, tendons and ligaments leading to the consequential functional joint deterioration.

The main goal of RA treatment is to achieve disease remission. The treatment of RA consists of synthetic and biologic disease modifying drugs (DMARDs), being the second ones selected when low disease or remission is not achieved with the first ones. Therapeutic response monitoring in RA should be closely managed. It is classically based on clinical exploration and laboratory tests. During the last decade, the resolution improvement of musculoskeletal ultrasound (MSUS) imaging has led to the gradual incorporation of this technique in the evaluation and monitoring of patients with RA, mainly due to its better capacity to detect synovitis than clinical exploration . Ultrasound imaging is highly available, non-invasive, reproducible, affordable and well accepted by patients. Ultrasound doppler mode detects pathological synovial flow, which reflects synovial inflammation and has a demonstrated sensitivity to change in multiple longitudinal studies. Sonographic evaluation of patients with RA includes the detection of synovitis in B and Doppler mode in the joints accessible by ultrasound. There has been high variability in the literature regarding the number of joints that should be evaluated for an appropriate monitoring of the RA patients. The validity for monitoring the therapeutic response in long standing RA has been demonstrated in three reduced joint counts, including 12, 7 and 6 joints. However, in shorter evolution RA, the sensitivity to change of any of these reduced ultrasound evaluations has never been studied

Primary objectives

• To evaluate the sensitivity to change of the Doppler Ultrasound evaluation of 12, 7 and 6 joints counts in RA patients with more than 6 months and less than 5 years of evolution, which initiate an effective treatment for the disease according to indication (biologic DMARD in monotherapy or combined with methotrexate).

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders, ≥ 18 years of age
* Patients diagnosed with RA (according to the ACR 2010 criteria) with more than 6 months and less than 5 years of active evolution and DAS28 \> 3.2 or SDAI \> 11, which start treatment with biologic DMARD for the first time, according to the product's summary of products characteristics (SPC).
* Patients who have granted their written informed consent for the collection and review of their data.

Exclusion Criteria:

* Patients who are already participating in a clinical trial/s at the moment of participation in this study.
* Patients with rheumatic disease other than RA
A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer

To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18.
* Histological diagnosis of adenocarcinoma of rectum.
* Locally advanced/ poor prognosis primary rectal cancer defined by MRI criteria of any of the categories below;

  * Tumour within 2 mm of mesorectal fascia ie circumferential resection margin threatened
  * Any T3 tumour at/below levatores
  * T3c tumour at any other level ie tumour extends \>5 mm into peri-rectal fat
  * T4 tumour
  * Any T stage with 4 or more involved lymph nodes
* WHO performance status 0, 1 or 2.
* No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
* Adequate bone marrow function with platelets \> 100 X 109/l; WBC \> 3 X 109/l; neutrophils \> 1.5 X 109/l
* Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance \>50 ml/min.
* Adequate hepatic function with serum total bilirubin \< 1.5 X upper limit of normal range.
* No concurrent uncontrolled medical conditions
* No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
* Adequate contraceptive precautions if relevant
* Informed written consent

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Presence of metastatic disease or recurrent rectal tumour
* Renal impairment (creatinine clearance\<30 ml/min)
* Pregnancy or breast feeding
* Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
* Participation in any investigational drug study within the previous 4 weeks.
* Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months)
* Patients with any symptoms or history of peripheral neuropathy.
* Prior pelvic radiotherapy
Use of Virtual Reality Devices for Vestibular Rehabilitation

The aim of this study is to investigate the superiority of virtual reality-supported vestibular rehabilitation exercises over conventional vestibular rehabilitation exercises in patients with complaints such as vertigo, loss of balance, falling, and gait imbalance.


Eligibility Criteria:
Inclusion Criteria:

* Complaining dizziness and/or instability for more than 3 months
* Patients aged 18 and over and under 65

Exclusion Criteria:

* Ear disease, head injury
* Ototoxic drug use
* Neurological and psychiatric illness that causes cooperation disorder
* Patients with orthopedic and systemic disorders that prevent exercising
* Patients with active malignancies
* Diseases that affect the use of glasses (epilepsy, vision loss, etc.)