cyrilzakka/clinical-trials huggingface dataset:
QuadraMune(TM) for Prevention of COVID-19

QuadraMune(TM) is a nutritional supplement which has previously been demonstrated to possess antiinflammatory and immune modulatory activity based on in vitro and pilot in vivo studies. The current clinical trial aims to assess in a 500 volunteer trial the efficacy of QuadraMune(TM) in reducing infection in individuals at high risk of COVID-19.

QuadraMune(TM) is composed of 4 natural ingredients.

Pterostilbene is an analogue of resveratrol, and has been shown to possess antiinflammatory activity. Additionally, this compound suppresses macrophage activation while enhancing NK activity.

Epigallocatechin gallate (EGCG) is one of the active ingredients in green tea and has been shown to act as an activator of T cells, and a suppressor of neutrophil mediated inflammation.

Sulforaphane is derived from broccoli and studies have shown that it protects lungs from inflammatory pathology.

Thymoquinone, which is chemically related to hydroxychloroquine, possessing antiviral effects and increases NK activity.

QuadraMune is a combination of these ingredients and is believed to possess superior in vitro and in vivo therapeutic properties as compared to when the ingredients are administered individually.

The study aims to assess preventative effects of QuadraMune(TM) administration for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study Male or female patients 18 years of age or older that are considered to be high-risk individuals.
* High-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities.
* Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)

Exclusion Criteria:

* Refusal to provide informed consent Any previous positive test for COVID-19 by RT-PCR Symptomatic for COVID-19 Diarrhea prior to the start of treatment Type I or II diabetes Atherosclerotic Coronary Artery Disease

Any contraindication for treatment with hydroxychloroquine including:

Hypoglycemia G6PD deficiency Porphyria Anemia Neutropenia Alcoholism Myasthenia Gravis Skeletal muscle disorder Maculopathy Changes in the visual field Liver disease, with ALT/AST \> 2.5 upper limit normal and total bilirubin \>2.5 upper limit normal Psoriasis Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.
Immunonutrition in ERAS Protocols in Gynecologic Oncology

A patient with oncological pathology of any type because of impaired digestion and nutrient absorption, decreased intake, and increased nutrition requirements has an increased risk of malnutrition and moderate to severe weight loss.In the present study the investigators will evaluate the impact of perioperative immunonutrition supplementation on the postoperative outcomes.

Malnutrition has a major effect not only on the postoperative course of cancer surgery but can also complicate or even limit administration or compromise the effectiveness of other treatments such as chemotherapy or radiotherapy in the perioperative period. Immunonutrition is a type of artificial nutrition based on the use of some types of macro- or micronutrients.The purpose of this review was to evaluate the use, indications, and effects of these formulas in oncologic surgical patients in real time and to identify the types of patients who can benefit from enteral immunonutrition.

Eligibility Criteria:
Inclusion Criteria:

* women with any gynaecologic malignancy enrolled in surgical list of our institute
* must be able to consume oral supplements.

Exclusion Criteria:

* women that are not able to follow ERAS protocol due to medical reasons
* patients with severe disease that cannot compromise with protocol
Expanding Access to Comprehensive Geriatrics Care Via Telehealth

The overall objective of the TeleGRACE project is to improve the care and outcomes of older Veterans with a recent inpatient stay by expanding access to the evidence-based GRACE program, by evaluating a telehealth implementation.

The TeleGRACE evaluation will focus on three primary aims and a secondary aim:

Primary Aim 1: To examine the effectiveness of the TeleGRACE program, the investigators designed a randomized controlled implementation trial (RCT) powered for the primary outcome of 90-day all-cause mortality. The investigators will also examine its effectiveness for the secondary outcomes including 90-day readmissions, 1-year ED utilization (VA and non-VA), 1-year all-cause readmissions, 1-year mortality, as well as patient, caregiver, and staff satisfaction. The investigators hypothesize that patients who receive TeleGRACE will have lower 90-day mortality than patients in usual care.

Primary Aim 2: to examine the implementation of the TeleGRACE program. The implementation strategy is reflecting \& evaluating. Implementation outcomes are based on the REAIM framework and include reach, efficacy (Aim 1), and implementation (total number of Veterans served, fidelity).

Primary Aim 3: to conduct a business-case analysis (BCA). The business case analysis will calculate the net financial savings or loss for TeleGRACE as the difference in the overall intervention costs and savings due to downstream benefits for patients receiving TeleGRACE versus usual care controls.

Eligibility Criteria:
Inclusion Criteria:

* Veterans discharged from the Indianapolis VA medical center (VAMC) for an medical/surgical diagnosis (excludes substance use disorder-related admissions; excludes planned admissions) within the prior week
* Age 70 years
* Not enrolled in home-based primary care (HBPC)
* Not enrolled in hospice
* Not in dialysis
* Primary care visit within VA in the prior 2 years
* Not residing in nursing home, skilled nursing facility, or CLC.
* Living \>20 miles but \<60 miles from the Indianapolis VAMC facility
* CAN score 95th percentile for mortality or missing CAN score
* Discharged from the hospital alive

Exclusion Criteria:

* Patients who have been randomized to the control arm after their index hospitalization who become readmitted to the hospital may not be re-randomized.
* By definition, GRACE patients are not eligible for TeleGRACE due to the drive distance \>20 miles from the Indianapolis VAMC
* Enrolled in home-based primary care (HBPC)
* Enrolled in hospice
* Dialysis (hemodialysis or peritoneal dialysis)
* Residing in nursing home, skilled nursing facility, or CLC.
* Living \<20 miles or 60 miles from the Indianapolis VAMC facility
Deep Friction Massage for Intercostal Pain in Patients With Heart Disease

Studies show that chest pain is a common complaint presented in both general practice and in emergency units. Musculoskeletal causes are common, but frequently overlooked. No studies about treatment of chest pain from the intercostal muscles were found by search in medical literature databases. The purpose of this study is to evaluate the effect of two different physical therapy interventions on intercostal pain in patients with stable heart disease.

The hypothesis was that deep friction massage combined with heat-pack is more effective than heat-pack only.


Eligibility Criteria:
Inclusion Criteria:

* increasing chest pain during a cardiac rehabilitation class
* stable coronary disease
* new re-vascularisation is not planned

Exclusion Criteria:

* unstable coronary disease
* not able to perform the study
* abuse of drugs or alcohol
* participating in other ongoing study
Effects of External Electric Stimulating in Individuals With Urinary Incontinence After Prostatectomy

The aim of this study is to investigate effects of external electric stimulating in individuals with urinary incontinence after prostatectomy.

Urinary incontinence (UI) is common in men after prostotectomy, and patients' quality of life is adversely affected. In addition, electric stimulation (ES) can be played an important role in the management of UI . However, there are limitations in clearly demonstrating the effects of ES on men with UI after prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Being a male individual with stress or stress-dominant mixed UI symptoms after undergoing prostatectomy surgery for prostate cancer in the urology clinic
* Being over 40 years old
* Being 24 and over with Mini Mental Test results in individuals over 65 years of age.
* Not having residual cancerous tissue
* Volunteering to participate in the study

Exclusion Criteria:

* Having serious cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients, etc.)
* Having sensory loss
* Having an ongoing urinary infection
* Having only urgency urinary incontinence
* Using a pacemaker
* Receiving active cancer treatment (radiotherapy, chemotherapy)
* Lack of evaluation parameters
* Not continuing the treatment regularly
Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma

To clinically assess the effectiveness of diode laser versus sclerotherapy in the treatment of oral pyogenic granuloma.

A randomized-controlled clinical trial conducted on 20 patients with oral pyogenic granuloma. Patients were assigned into two groups. Group I treated by diode laser1; group II treated by injection of ethanolamine oleate2 as sclerosing agent. All patients were clinically assessed for pain, bleeding during surgery and healing quality; 1st week, 2nd week and 4th week. The patients were followed up after 3 months from the end of treatment.

Background: Pyogenic granuloma (PG) is one of the most common reactive hyperplasia that causes soft tissue enlargement. It affects skin and oral mucosa. The traditional treatment for oral PG is conservative surgical excision with cold blade together with the removal of causative irritant or source of trauma. Bleeding susceptibility, healing quality and pain represent common complications following surgical excision of pyogenic granuloma. Sclerosing agents are widely used in the treatment of pyogenic granuloma as it is a conservative non painful procedure. The use of lasers in dentistry have grown in the last 4 decades. It has proved its efficacy in the treatment of pyogenic granuloma.

Study objective: Study will be conducted to evaluate healing quality of using diode laser versus sclerotherapy (Ethanolamine oleate) in the treatment of oral pyogenic granuloma.

Materials and Method: This randomized controlled clinical trial will include 20 patients with pyogenic granuloma, divided equally into two groups. Group-I (test group) will be managed by application of diode laser. Group- II (control group) will be managed by injection of ethanolamine oleate as sclerosing agent on weekly injection visits. Patients of both groups will be evaluated intraoperatively for bleeding severity and postoperatively in terms of pain at the 2nd and 7th day and healing quality.

Results: Results will be tabulated and statistically analysed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both genders diagnosed clinically and confirmed histologically with oral pyogenic granuloma.
2. Size of the lesion not less than 5mm.
3. Patients included in the study will be having gingival pyogenic granuloma as it is the most common site for its occurrence.
4. Patient age ranges from 19 to 50 years old.

Exclusion Criteria:

1. Patients with uncontrolled diabetes.
2. Immuno-compromised patients.
3. Patients with renal disease.
4. Patients having coagulation disorders.
5. Patients having allergic reaction to any of the sclerosing drug constituents.
6. Pregnant and lactating women.
Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution

This study will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis

Phase I clinical trial which will include ten patients currently undergoing chronic peritoneal dialysis treatment. Patients will be hospitalized for the study. The study will consist of replacing conventional peritoneal dialysis solution with a sodium-free 500 ml solution with 30% icodextrin and 10% dextrose with a dwell time of 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Patients covered by the Mexican Social Security Department.
2. Adults over the age of eighteen.
3. Patients with chronic kidney failure undergoing replacement therapy with peritoneal dialysis.
4. Patients with a functional peritoneal dialysis catheter.
5. Patients undergoing peritoneal dialysis that was stable in the most recent month (ongoing peritoneal dialysis as an outpatient or ongoing cyclic peritoneal dialysis)
6. Patients who wish to participate and who sign the informed consent.
7. If the peritoneal dialysis catheter and the transfer line are compatible with the peritoneal dialysis bag that has a simple luer male connector.
8. If treating doctors consider their patient to be clinically euvolemic.
9. If patients have undergone a peritoneal equilibrium test and their dialysis prescription has not been changed since the test was carried out

Exclusion criteria:

1. Diabetes mellitus type 1 or uncontrolled diabetes (a1c hemoglobin greater than 8%).
2. Active infection.
3. Serum sodium prior to the study less than 130 mmol/l.
4. Serum bicarbonate prior to the study less than 18 mmol/l.
5. Patients who have been prescribed standard peritoneal dialysis who only use solutions with the lowest amount of dextrose
6. Hemoglobin less than 8 g/dl.
7. Active bleeding.
8. Patients prescribed peritoneal dialysis who use a 4.25% dextrose solution at least once a day.
9. Patients with a membrane defect or mechanical defect.
10. Diastolic dysfunction with an increase in filling pressure according to the echocardiogram.
11. Patients with active or suspected peritonitis according to the clinical criterion or their treating doctor.
Modified Triple Osteotomy for Acetabular Dysplasia

Steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young adults with three incisions to increase the coverage; however the amount of correction remained questionable due to ligamentous attachments that hinder the rotation. The investigators modified the technique with two anterior incisions and ramus cuts close to inferior acetabulum. The purpose of this study is to compare these two techniques in femoral head coverage


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic acetabular dysplasia in adolescent or young adult
2. Closed triradiate cartilage
3. Minor coxarthrosis with Tonnis grades at 1 or 2

Exclusion Criteria:

1. High subluxation or complete dislocation of the hip joint
2. Severe osteoarthrosis
3. Combined with proximal femoral osteotomy that changed the femoral neck shaft angle (such as varus or valgus osteotomy)
Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition

The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events. We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients. The non-interventional group of healthy controls was included for comparison.

Intravenous lipid emulsions (LEs) are an indispensable part of home parenteral nutrition (HPN). All commercially obtainable LEs are applicable for HPN in providing a source of energy and essential fatty acids. The originally used soyabean oil-based LE (Intralipid) have been suspected of being associated with a higher risk of pro-inflammatory lipid-mediator production due to their high content of n-6 polyunsaturated fatty acids. The more modern mixes of soyabean oil, and/or olive oil, and/or fish oil LEs with beneficial responses compared with Intralipid are available. Given that there are no clear clinical recommendations for LE application in HPN, we performed this cross-over design, phase 4 study comparing ClinOleic, Lipoplus or SMOFlipid in chronic intestinal failure patients with additional escalation of fish oil using Omegaven.

Eligibility Criteria:
Inclusion Criteria:

* Home parenteral nutrition patients in need of parenteral nutrition administration \> 4 days/week
* Parenteral duration expectancy \> 8 months
* Stable clinical condition without any complications in the past 2 months
* Written consent from the subject

Exclusion Criteria:

* Known hypersensitivity to any of the active substances or excipients
* Unstable conditions
* Active cancer or its treatment
* Established immunodeficiency
* Advanced organ dysfunction from chronic disease
Coping Strategies and Responsiveness to a Brief Online Intervention During COVID-19 Pandemic

The present study investigates the efficacy of a brief and cost-effective video-intervention that combines bottom-up elements of deep breathing and third-wave cognitive behavioral therapy techniques (i.e., mindfulness and compassion) on coping strategies during the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Being healthy
* Previous participation (maximum elapsed time: 2.0 years) in a study conducted by the same research group and incorporating cardiac autonomic assessment at rest

Exclusion Criteria:

* Self-reported development of cardiovascular disease since previous assessment
* Use of psychotropic medications or medications affecting the autonomic nervous system
Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects

The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal.

Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2 \& \< 45 kg/m2

Exclusion Criteria:

* Diabetes
* Lipid lowering drugs
* Liver-, Kidney- and/or Heart Disease
* Serious Hypertension (160/110)
Bladder ARFI (Acoustic Radiation Force Impulse) Study

Urinary bladder fibrosis (thickening and scarring) is fairly uncommon in children. Traditionally, the presence of urinary bladder fibrosis has been confirmed directly with bladder biopsy or using urodynamic testing. In this study we will use ultrasound scanning and ARFI (acoustic radiation force impulse) wave velocities to potentially identify any urinary bladder wall fibrosis.

Urinary bladder fibrosis (thickening and scarring) is fairly uncommon in children. Traditionally, the presence of urinary bladder fibrosis has been confirmed directly with bladder biopsy or using urodynamic testing.

We will use ultrasound ARFI (acoustic radiation force impulse)-derived shear wave velocities to potentially identify the presence of urinary bladder wall fibrosis. We hypothesize that shear wave velocities found within the bladder wall will increase with increasing evidence of fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or younger
2. Have an order for urodynamic testing from your doctor

Exclusion Criteria:

1. Adults
2. Unwilling to sign consent form
Longitudinal Natural History Study of Patients With Peroxisome Biogenesis Disorders (PBD)

The Peroxisome Biogenesis Disorders (PBD) are a group of inherited disorders due to defects in peroxisome assembly causing complex developmental and metabolic sequelae. In spite of advancements in peroxisome biology, the pathophysiology remains unknown, the spectrum of phenotypes poorly characterized and the natural history not yet systematically reported. Our aims are to further define this population clinically, biochemically and genetically. The investigators will prospectively follow patients from Canada, the US and internationally, and collect data from medical evaluations, blood, urine and imaging studies that would be performed on a clinical care basis. For patients who are unable to attend our clinic, we will collect all medical records and images since birth as well as subsequent records/images for the next 5 years or until the end of the study. Clinical data from medical records will be banked in our Peroxisomal Disorder Research Databank and Biobank. The investigators will use this information to identify standards of care and improve management.

Participants have the option to be seen in consultation at the McGill University Health Centre in Montreal, Canada, on a yearly basis. This includes a consultation in Genetics, Nutrition, Neurology, and Ophthalmology (OCT and FAF exams). All medical records and images will be collected, retrospectively and prospectively, until the end of the study, and entered anonymously in a database. Biospecimens will be collected to identify new biomarkers. Candidate drugs will be evaluated for recovery of peroxisome functions in cultured fibroblasts.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PBD or
* Single peroxisome enzyme/protein defect with phenotype similar to PBD

Exclusion Criteria:

* Not a PBD
* Not a single peroxisome enzyme/protein defect with phenotype similar to PBD
Can Imaging Techniques Contribute to the Proper Insertion of Double-lumen Tubes?

In thoracic surgery, one-lung ventilation using a double-lumen tube (DLT) is often performed to protect dependent lung and provide comfortable surgical conditions. However, serious complications and adverse events can be encountered during DLT placement. One of the most important steps to avoid these drawbacks is to choose the appropriate size of DLT. The width of the trachea can be measured by using different imaging methods such as computed tomography (CT) and ultrasonography (US) to predict the appropriate DLT size. CT can also contribute to the proper placement of DLT by giving us the length of the trachea and main bronchi. In this study, we hypothesized that the size of the DLT can be determined more accurately by measuring the trachea diameter by using US and CT before DLT intubation. At the same time, we aimed to determine whether the evaluation of tracheobronchial anatomy with CT would contribute to the placement of DLT at a more appropriate level.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo elective thoracotomy or video-assisted thoracic surgery with general anesthesia with DLT intubation
* BMI 18 - 35 kg/m2
* Age 18 - 80 years old

Exclusion Criteria:

* Mallampati score 3 and 4
* History of tracheostomy, tracheal deviation, or distortion
* Emergency surgery