cyrilzakka/clinical-trials huggingface dataset:
Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fish oil and/or green tea may prevent prostate cancer.

PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing prostate cancer.

OBJECTIVES:

* Determine the cancer preventing effects of fish oil supplementation and green tea extract use on markers of alteration in lipid metabolism in prostate tissue samples.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (under 65 vs 65 and over). Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive oral fish oil three times daily and oral green tea extract twice daily.
* Arm II: Patients receive an oil placebo three times daily and oral green tea extract twice daily.
* Arm III: Patients receive oral fish oil three times daily and a placebo twice daily.
* Arm IV: Patients receive an oil placebo three times daily and another placebo twice daily.

Treatment in one of the above-listed arms continues for up to 20 weeks in the absence of disease progression or unacceptable toxicity.

All patients undergo a prostate biopsy on the last day of study treatment.

After completion of study treatment, patients receive a follow-up phone call at/around 30 days later.

PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.

Eligibility Criteria:
INCLUSION CRITERIA:

* Clinician recommends repeat biopsy of the prostate ("Repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate)

EXCLUSION CRITERIA:

* Definitive invasive prostate cancer on initial biopsy
* Significant active medical illness that in the opinion of the clinician would preclude protocol treatment.
* History of ventricular tachycardia or ventricular fibrillation
* Subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before Day 1 of study treatment
* Subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial
* Use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial.
* Subject reported allergy or sensitivity to fish oil, olive oil or green tea
* Subject reported history of hemophilia, van Willebrands disease or other bleeding disorder, except when the subject is evaluated by a hematologist who determines that fish oil supplementation is not contraindicated.
* Total bilirubin greater than institutional upper limit of normal
* Concurrent high risk study participation
Registry for Proton Beam Radiation Therapy

The goal is to collect information on each patient treated with proton beam radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

-Any patient receiving proton beam therapy is eligible for enrollment to this registry (regardless of diagnosis, age, other concurrent therapies, etc.) provided s/he consents to participate.
Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion

The aim of our study is to try to establish a relationship between preoperative fasting-related volume changes and tricuspid annular plane systolic excursion (TAPSE), and to determine whether there are changes in right ventricular functions due to preoperative fasting.

TAPSE (Tricuspid Annular Plane Systolic Excursion) is a parameter that easily measures apex-base shortening and provides specific information about global right ventricular (RV) function. It is less dependent on optimal image quality and serves as an easily measurable criterion compared to other RV function measurements. In this study, one day before the operation, transthoracic echocardiography (TTE) will be conducted on fasting patients, and if the preoperative fasting duration is appropriate on the day of the surgery, TTE measurements will be repeated and recorded. The study aims to evaluate the relationship between TAPSE and volume and determine whether there are any changes in right ventricular functions due to preoperative fasting.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2-3
* The patient must be between 18 and 75 years old.
* Perioperative hydration has not been administered.
* Preoperative sedatives have not been given.
* There should be no known heart disease.

Exclusion Criteria:

* The patient being pregnant
* Post-cardiac surgery
* Severe pulmonary hypertension
* Severe valve disease
* Hypertrophic or dilated cardiomyopathy
* Presence of acute myocardial infarction
* Non-sinus rhythm
Preemptive Analgesia in Cruciate Reconstruction

The aims of this study was to compare analgesic efficacy of preoperative administration of etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate ligament injury will randomized into 3 groups using opaque envelope. Both patients and surgeon were blinded to the allocation. All of the patients will be operated by one orthopaedic surgeon under regional anesthesia. Each group will be given either etoricoxib 120 mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain intensity, time to first dose of analgesic requirement and numbers of analgesic used for rescue pain control and adverse events will be recorded periodically to 48 hours after surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients with anterior cruciate ligament injury age 15-50 yr

Exclusion Criteria:

* previous knee surgery
Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation

A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body (basiliximab), mycophenolic acid (MPA), and mammalian target of rapamycin (mTOR) - inhibition with everolimus to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time-point of liver transplantation (OLT) with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing primary liver transplantation.
2. Patients older than 18 years.
3. Patients with a hepatorenal syndrome.
4. Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation.
5. eGFR \< 50 ml/min at the time point of transplantation.
6. Serum creatinine levels \> 1.5 mg/dL at the time-point of transplantation.

Exclusion Criteria:

1. Patients with pre-transplant renal replacement therapy \> 14 days.
2. Patients with a reason for renal impairment other than a hepatorenal syndrome.
3. Patients with a known hypersensitivity to mTOR-inhibitors.
4. Patients with a known hypersensitivity to mycophenolate acid.
5. Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies.
6. Patients with platelets \< 50.000/nl prior to initiation of therapy with mTOR inhibition.
7. Patients with triglycerides \> 350 mg/dl and cholesterol \> 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition.
8. Severe systemic infections and wound-healing disturbances.
9. Multiple organ graft recipients.
10. Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with everolimus.
11. Pregnant women will not be included in the study.
12. Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
13. Patients under guardianship (e.g., individuals who are not able to freely give their informed consent).
Anesthesia in Patients With Mitochondrial Disease

This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient.

Study subjects undergoing a routine medical care non-emergent procedure will be randomized into three different groups to receive one of the following anesthetic agents; Sevoflurane, Propofol or Dexmedetomidine.

The primary outcome of this pilot study is to evaluate and compare the incidence of adverse events in mitochondrial patients undergoing a diagnostic or therapeutic procedure up to 48 hours post anesthesia. The secondary outcome is to compare the metabolic derangements between three study groups by comparing changes in blood sugar, serum pH, serum bicarbonate, serum lactate and serum pyruvate levels before, during and after anesthesia in the groups.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must fulfill the following inclusion criteria:
* Subject is informed and given ample opportunity to consider his/her participation and has given his/her written consent.
* Subject is willing and able to comply with all study requirements.
* Subject is between 0 - 17 years of age.
* Subject has been diagnosed with mitochondrial dysfunction based on modified Walker criteria.
* Subject is scheduled to have a non-emergent diagnostic or therapeutic procedure for routine medical care requiring general anesthesia estimated to last at least one hour.
* Subject is classified ASA I - IV

Exclusion Criteria:

Subjects are not permitted to enroll in the study if any of the following criteria are met:

* Subject is older than 17 years
* Subject is pregnant
* Subject is a nursing female and
* Subject has participated in the same study within 48 hours
* Subject is allergic or has had any adverse effect to any of the study agents in the past
* Anesthesia time is less than one hour
* Subject is classified ASA V
Improving Adherence to Homework During Therapy

The purpose of this study is to expand Adhere.ly- a simple, HIPAA-compliant, web-based platform to help therapists engage clients in practicing therapeutic skills between sessions (homework) during mental health treatment by conducting a trial comparing standard therapy to therapy enhanced with Adhere.ly.


Eligibility Criteria:
Inclusion Criteria:

Providers:

* English-speaking
* Mental health providers who have obtained at least a master's degree in social work, counseling, clinical psychology, or related field
* Carry active mental health treatment caseloads in the U.S.
* Have a laptop, tablet, or smartphone with internet access

Clients:

* English-speaking
* Treatment-seeking adults ≥18 year
* Clinically elevated anxiety and depression as indicated by a score ≥10 on the GAD-7 and/or PHQ-8
* Have a laptop, tablet, or smartphone with internet access

Exclusion Criteria:

Client with self-reported:

* Active psychotic symptoms (e.g., hallucinations, delusions)
* Significant cognitive disability, developmental delays, or pervasive developmental disorder.
The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis

The objective of this trial is to assess if treatment with basiliximab allows subjects to taper off other immunosuppressive drug regimens without causing an increase in their uveitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of noninfectious intermediate, posterior or panuveitis of at least 3 months duration
* Treatment with greater than or equal to 20 mg/day of Prednisone at baseline or immunosuppressive drug score of greater than or equal to 5 at baseline
* BCVA by ETDRS protocol better than or equal to 20/200
* Intraocular pressure of 24 mmHg or less
* Anterior chamber cells and vitreous haze of less than or equal to 1
* Male or females, aged 12 or greater, body weight of 40 kg or greater

Exclusion Criteria:

* Prior treatment with Retisert
* Primary diagnosis of anterior uveitis, uveitis of infectious etiology or Behcet's disease
* Pregnancy or breast-feeding
* Increase in systemic immunosuppressive treatment regimen within 6 weeks before baseline
Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.

After inclusion, patients undergo intravenous infusion of 20 mg/Kg of amikacin with amikacin serum concentrations being monitored over the following 24 hours.

Randomization occures after this first amikacin infusion. Patients are randomized to group nebulized amikacin or intravenous amikacin. The three next days of the study patients recieve nebulized amikacin (or nebulized placebo) during mechanical ventilation and a placebo infusion (amikacin infusion in case of placebo nebulization) using a air driven jet nebulizer. Amikacin serum concentrations are monitored over 24 hours after each nebulization.

Patients are followed up during 10 days for safety and efficacy. The dose of amikacin to be nebulized is 60 mg/Kg for the first 6 patients (phase A), 80 mg/Kg for the next 6 patients (phase B) and 100 mg/Kg for the last 6 patients (phase C). Each phase is started after review of the results of the preceeding phase by an idependent safety and monitoring board.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to intensive care unit.
* Patients undergoing mechanical ventilation for more than 48H.
* Suspicion of ventilator associated pneumonia.

Exclusion Criteria:

* Allergy to amikacin or any compound of the medication.
* Body mass index \> 30 kg/m2.
* Myasthenia gravis.
* Acute or chronic renal failure.
* Vestibulo-cochlear disease.
* Pregnancy.
* Brain death.
Whole Body Vibration After Bariatric Surgery

Morbid obesity is defined as a complex chronic condition in which a person presents a body mass index above 40 kg/m2. This disease increases the risk of several co-morbidities and entails a reduction in life expectancy of 10 years. Its prevalence is increasing in developed countries and bariatric surgery has been suggested to be one of the best tools to counteract it. Nonetheless, this surgery also presents negative effects such as loss of bone mineral density (BMD) and muscle mass and an increased fracture risk. The aim of the present study is to elucidate the effects of surgery and a whole body vibration training (WBV) on body composition, physical fitness, microbiota and cardiometabolic markers. Twenty eight participants will undergo bariatric surgery and will be randomly allocated into a control group or a WBV group. The whole body vibration group will have a duration of 4 months in which participants will train three times per week (30 minutes per session). Measurements of body composition (dual energy x-ray and peripheral quantitative computed tomography), physical fitness (muscular strength, aerobic fitness and balance), gait biomechanics, cardiometabolic markers, gut microbiota, quality of life and physical activity levels will be registered in four different timepoints (1. Before the intervention, 2) 45 days after the surgery, 3) Six months after the surgery, and 4) 18 months after the surgery. The cost of the surgery and the exercise program will also be calculated to perform a cost-effectiveness analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients that are going to undergo Roux-en-Y gastric bypass with a Body mass index above 40 and below 180 kg.
* With an age between 18 and 50 years of age
* Living in the city of Zaragoza

Exclusion Criteria:

* History of cancer in the last 5 years
* Have a pacemaker or being diagnosed with a cardiac problem that disables the participant to take place in an exercise program
* To have suffered an acute myocardial infarction in the last 6 months
* To present uncontrolled hypertension
* Fracture in the last year
* Any other condition that the physician deems as a contraindication for performing supervised physical exercise
* Menopause
Development of Horse-Riding Program Model for Children With Cerebral Palsy

The purpose of this study is to develop healing riding algorithm applicable in rural riding centers and to apply this to children with cerebral palsy.

Horseback riding activities in Korea's riding centers have mostly centered on physical rehabilitation for children with special needs, including those with cerebral palsy, mental disabilities, and autism, with the program conducted by certified equine-assisted therapy instructors. However, there is no definite way to assess the ability of children for horseback riding and no standard riding program. Therefore, developing a assessment and program algorithm for healing horseback riding is expected to contribute to providing more activities for children with special needs and also for general people.

Children older than 4 years old or adolescent with cerebral palsy who voluntarily want to enroll this study would be enrolled.

Participants have 2 times of 30-minute horse riding program for 8 weeks, total 16 times of riding program in a local horse riding center.

Sample size assessment: Calculating for 20% of drop out, 16 patients were calculated to apply the assessment and applicable program.

Drop out: missing more than 2 lessons of horse-riding

Plan for missing data: not included

Statistical analysis plan: paired t-test for the outcome measures

Eligibility Criteria:
Inclusion Criteria:

* Children or adolescent with cerebral palsy
* GMFCS level I, II, III
* Body weight less than 80 kg

Exclusion Criteria:

* Medical condition who are not suitable for hippotherapy: severe osteoporosis, mental illness, not controlled seizure disorder etc.
* Social condition who are not suitable for hippotherapy
Analgesic Potentials of Preoperative Pregabalin,Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain

This study evaluates the effect of giving preoperative adjuvant drug as pregabalin or magnesium sulphate or a combination of both drugs to decrease postoperative morphine consumption and pain intensity in the first 24 hours in postoperative period . quarter of patients receive single dose oral pregabalin 300mg 1 hour preoperatively ,other quarter receive single intravenous Magnesium sulphate 50mg per Kg over 200ml saline over 20 minutes preoperatively , other quarter receive combination of both drugs , the last quarter receive placebo drugs . All patients receive 0.1mg per Kg intravenous morphine sulphate intraoperatively

Magnesium (Mg) acts on N-methyl-D-aspartate (NMDA) receptor as a non-competitive antagonist with antinociceptive effects.

Gabapentin is an alkylated analogue of gammaaminobutyric acid (GABA) developed primarily as an anticonvulsant drug. It was described as an analgesic drug for the treatment of neuropathic pain in the 1990s. Although it is named Gabapentin,it does not bind at the GABA A or GABA B receptor. It binds with high affinity for the α2δ subunit of the presynaptic voltage-gated calcium channels, which reduce calcium-dependent release of pro-nociceptive neurotransmitters in the pain pathways. Pregabalin is a structural analogue of GABA was introduced after Gabapentin. If we used these drugs in combination to opioids preoperatively as preventive analgesia may decrease postoperative opioid consumption and pain intensity.

Eligibility Criteria:
Inclusion Criteria:

1. ASA status of1 or 2
2. Patients undergoing thoracotomy
3. Body mass index (BMI): Less than forty and more than twenty.

Exclusion Criteria:

- 1. Known sensitivity or contraindication to drugs used in the study. 2. History of psychological disorders and/or chronic pain. 3. Patients receiving medical therapies that are considered to result in tolerance to opioids.

4. Significant liver or kidney diseases that will affects the pharmacokinetics of study drugs.
Feasibility of Evaluating XSTAT Use in the Prehospital Setting

This study evaluates the prehospital use of the XSTAT device to control bleeding in junctional wounds. Participants will be randomized to the use of XSTAT versus standard care.

The XSTAT® device injects small, rapidly-expanding cellulose sponges into the wound cavity using a syringe-like delivery system. In the wound, XSTAT® sponges expand and swell to fill the wound cavity, within 20 seconds of contact with blood, facilitating compression of bleeding structures. XSTAT® can be applied through skin wounds. The system can readily access deep vascular structures. While rapidly hemostatic, the hemostatic sponges are also relatively easy to remove. In the setting of junctional bleeding, XSTAT® may allow for hemostatic pressure generation from within the wound tract rather than from external compression (as with a tourniquet or manual compression).

Hemorrhage should be controlled as early as possible, ideally before reaching a trauma center or medical treatment facility. Given its small size, low weight, and ease of application, the XSTAT® device is well-suited for prehospital use, in both the civilian and military setting, and this is probably where the device's applicability lies.

The investigators anticipate that a full-scale trial will be conducted based on the questions this pilot study addresses, including the following:

1. the number of penetrating junctional zone injuries encountered in the prehospital civilian setting.
2. the feasibility of randomizing patients in the prehospital setting.
3. usability.
4. safety.
5. validation of the proposed primary outcome of an efficacy trial.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥15 years or estimated body weight ≥50 kg.
2. Penetrating junctional injury (femoral or axillary), with i. visible bleeding ii. too proximal to be controlled with a tourniquet
3. Patient will be taken to participating level I trauma center, directly from the scene

Exclusion Criteria:

1. Prisoners, children \<15 years old, known pregnant patients.
2. Patients receiving chest compressions (prior to XSTAT® use).
3. Patients with an opt-out bracelet.