cyrilzakka/clinical-trials huggingface dataset:
Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

To test if multimodal analgesia with different analgesic medication offer better pain relief, lesser side effects and is safe compared to conventionel opiod analgesia after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* age\>18
* any cardiac procedure with sternotomy
* able to give informed consent

Exclusion Criteria:

* cardiac surgery without sternotomy
* peripheral neuropathy
* neurological disease
* psychiatric illness
* history of GI bleeding
* chronic pain (i.e. back pain, cancer, arthritis)
* serum creatinine \>150 μmol/l
* hepatic disease with elevated liver enzymes (SGPT and SGOT elevated to 1.5 times maximum normal value)
* allergic to study medication
* alcohol abuse
* abuse of narcotics or medication
* pregnancy
* participation in other clinical trials
* insufficient language skills
* In addition intensive care unit (ICU) stay for more than 24 hours was used as a pre-defined post randomization exclusion criteria, because prolonged ICU stay and ventilator treatment would interfere with study analgesic protocol.
Urology of Virginia Case Series

The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer.

The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI).

These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy.

In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.

This trial will enroll nine men with an indication for a prostate biopsy.

The primary objective of the study is to provide guidance to clinicians who will be using the ExactVu system on the appearance of suspicious foci, and the difference between the appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.

The study is being conducted based on the hypothesis that a series of same-subject comparisons will clearly demonstrate the differences in appearance between the modalities.

Procedures in the study are:

* obtain informed consent for the subject
* image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain radiologist's report
* perform biopsy procedure using micro-ultrasound (this may be conducted in a separate subject visit)
* prepare biopsy specimens for pathology
* record all procedure details in a case report form, including pathology and mpMRI reports

The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities.

Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and percentage of cancer in sample), and risk score identified on imaging. Both of these values are per-sample, with 12 systematic samples per subject plus any additional targeted samples warranted by standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. All men ≥ 40 years age and \<80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer.
2. PSA\<50
3. Clinical stage \< cT2c

Exclusion Criteria:

Patients will be excluded from being included in the investigation if any of the following is true:

1. Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
2. Men with known prostate volume (from prior imaging) of \> 60cc
3. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
4. Men who are unable to provide their own informed consent
5. Men who have contraindications to MRI or gadolinium chelate contrast
Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors

Crohn's disease (CD) is a life-long inflammatory bowel disease disease with an unknown pathogenesis. The ultimate goal of therapy is to modify the natural history of CD thus reducing complications. Thalidomide is a small molecule with immunomodulatory and anti-angiogenetic properties. It is currently approved for the treatment of erythema nodosum leprosum, an immunological complication of leprosy and multiple myeloma. It has also been used in several other inflammatory diseases of the skin and of the mucosal membranes, such as Behcet disease, oropharyngeal ulcers in AIDS, cutaneous lupus, and graft versus host disease. Many case series and one pediatric randomized controlled trial proved the efficacy of thalidomide in the treatment of children with CD refractory to standard treatments. In these patients, clinical remission was achieved in about 50% of the cases and was maintained for a mean time superior of 3 years. Mucosal healing after 52 weeks of treatment was observed in 40% of the patients in clinical remission. Moreover, thalidomide was found to have a steroid-sparing effect and to decrease the need for surgical interventions. The clinical and endoscopic efficacy of thalidomide was also observed in children with failure to respond or intolerance to anti-TNF biological drugs.

The aim of this multicentric prospective randomized controlled is to evaluate the efficacy and safety of thalidomide vs infliximab in changing the natural history of CD in patients with poor prognostic outcome. Moreover, the study will evaluate the immunological and genetical mechanisms of CD, the mechanisms of action thalidomide in CD and will the pharmacokinetics, metabolomics and pharmacogenomics of thalidomide, and their impact on thalidomide safety and effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Age at diagnosis \<18 years and \>=6 years
* New diagnosis of CD based on Porto criteria
* CD with inflammatory phenotype (non-penetrating, non-fistulizing) and with no need for surgery except for perinal fistulas
* Presence of at least one of the following risk factors for poor prognosis:

  * fistulizing perianal disease
  * pan-enteric disease
  * disease extension \> 60 cm
  * severe growth delay (height z-score \< -2 DS)
  * severe osteoporosis (z score \< -2 DS)
  * hypoalbuminemia (\< 3g/dL) or high C-reactive protein (2 times higher the normal range)
* Acceptance of the Risk Evaluation and Mitigation Strategy (REMS) program for reducing the teratogenic risk.

Exclusion Criteria:

* ongoing pregnancy
* presence of peripheral neuropathy
* HIV
* patients with transplanted organs
* ongoing major infections or other severe diseases
* participation to other experimental studies.
Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen

Tranexamic acid has been shown to be effective in reducing blood loss and transfusion in orthopedic surgery. It remains unknown the ideal therapeutic regimen. The goal of this study is to compare 3 dosage regimen of tranexamic acid in patients submitted to major orthopedic surgery.

There is ongoing debate, however, around optimal perioperative tranexamic acid dosing, which varies widely.

A large number of studies comparing tranexamic acid to placebo, overall blood loss and transfusion requirements are both reduced by ≈30%. A well designed tranexamic acid trial will provide answers to the best regimen dosage for perioperative tranexamic acid use. It will benefit patients by reducing allogeneic transfusions and their associated risks and costs, thus adding value to the care delivered.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 anos
* Total ankle arthroplasty
* Total knee arthroplasty
* Weight \>50 kilogram

Exclusion Criteria:

* Allergy and Hypersensitivity to tranexamic acid
* Thromboembolic events history
* Epilepsy
* Acute kidney injury, Glomerular Filtration Rate \< 50 ml/min
* Coagulation disorders
* Surgical reintervention
* Blood transfusion refusal
A Combination Therapy Study of MK-2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010)

This study will investigate the safety and tolerability of combination therapy with MK-2206 and AZD6244 (selumetinib) and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) for this drug combination in the treatment of participants with locally advanced or metastatic solid tumors. Preliminary efficacy data will also be collected.

The primary hypotheses for this study are that: 1) the Dose-limiting Toxicities (DLTs) observed in participants with locally advanced or metastatic solid tumors after administration of combination therapy with MK-2206 and AZD6244 will be dose-dependent and allow for identification of the MTD, and 2) oral administration of combination therapy with MK-2206 and AZD6244 to participants with advanced solid tumors will be generally well-tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Participant has confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or therapies known to provide clinical benefit, or for whom efficacious standard therapy or any other therapy known to provide clinical benefit does not exist
* Participant has no history of prior cancer, except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no evidence of disease for 5 years
* At least 18 years of age
* Participant is able to swallow oral medications
* For participants enrolled in the MTD expansion cohorts, must have a diagnosis of Kirsten rat sarcoma viral oncogene homolog (KRAS) tumor-type non small-cell lung cancer (NSCLC). Additional tumor types (with specific mutations) may be added to the MTD expansion cohorts after discussion between Sponsor and Investigator

Exclusion Criteria:

* Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks of entering the study
* Participant is currently participating in or has participated in a study of an investigational compound or device within 30 days or 5x the compound's half-life of Cycle 1, Day 1
* Participant has known central nervous system metastases and/or carcinomatous meningitis
* Participant has a primary central nervous system tumor or spinal cord compression
* Participant is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse
* Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study
* Participant is human immunodeficiency virus (HIV) positive
* Participant is has history of hepatitis B or C or active hepatitis A
* Participant has a history or current evidence of heart disease
* Participant has uncontrolled high blood pressure
* Participant has poorly controlled diabetes
A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation

The aim of the study is to evaluate the effects of food intake on the plasma concentration profile of YNO-5920/YM529 in post menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Post menopausal women (at least 2 years after menopause)
* Body weight: more than 40.0 Kg and less than 70.0 Kg
* BMI: more than 17.6 and less than 30.0

Exclusion Criteria:

* Receives investigational drug within 120 day before the study
* Blood donation before the study
* With abnormal laboratory values
Evaluation of the Efficiency of ESWT and Custom İnsoles Produced With Podometric Measurement in the Treatment of Painful Heel Spurs (ESWT: Extracorporeal Shock Wave Therapy)

The aim of the study; to determine the effectiveness customized insoles produced by podpmetric analysis and ESWT in patients with painfull heel spur and to determine the superiority of the treatments to each other.

Heel spurs are the most common cause of heel pain in adults. Pain that occurs in heel spur and radiates to the soles of the feet is characteristic of this disease. The pain is most severe in the first steps after rest. Patients typically complain of severe pain on the first steps after getting out of bed in the morning. The pain is partially relieved after a few steps, but may increase again after intense activities. Typical pain history and examination findings are important to diagnose heel spur, and the diagnosis is confirmed by lateral x-ray. Generally, most patients with heel spurs benefit from conservative and medical treatment, and only a few need surgery. These treatment methods include many options such as activity and shoes modifications, topical and oral NSAIDs, insoles, stretching and strengthening exercises, various injections. TENS, ultrasound, electrotherapy modalities that can be used in therapy to relieve pain and promote healing.

Although many studies have been done for ESWT and insoles, there is not any study that comperes these two modalities. In this study, our aim is to investigate the effects of using ESWT and customized insoles alone or together on pain and foot functions in patients with heel spurs.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65 years
* Pain in the heel for at least 3 weeks
* Confirmation of the diagnosis with lateral foot radiography

Exclusion Criteria:

* Be younger than 18 and older than 65
* Patients with systemic rheumatological disease (rheumatoid arthritis, ankylosing spondylitis etc.)
* Entrapment neuropathy in the lower extremities
* Systemic active infection
* Malignancy
* Pregnancy
* Coagulopathy
* Patients who have had a previous heel injection of steroids
* Patients who received physical therapy from the heel area in the last 6 weeks (TENS, ultrasound, hotpack, etc.)
* Inserted cardiac pacemaker
* Underweight, obese, and morbidly obese according to BMI
* Patients using NSAIDs and myorelaxants continuously
Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults

Subjects will be asked to participate in a four day research study of the immune system effects and safety of short-term acute dosing of Cold-fX.

The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on the immune system compared to a placebo (dummy pill). Safety of the acute dosing will be determined through various blood tests carried out during the study.

Eligible volunteers from Hackensack University Medical Centre will be randomly assigned to either the treatment or placebo group with equal numbers in each group.

The treatment will consist of taking three capsules of CVT-E002 (600mg) or placebo three times daily on Day 1, two capsules of CVT-E002 (400mg) or placebo three times daily on Day 2 and one capsule of CVT-E002 (200mg) or placebo three times daily on Day 3.

A fasting blood sample will be collected on all 4 days of study participation. Immunological assays and blood chemisty safety tests will be performed on the samples. Serum samples will also be collected and stored until futher analysis for various cytokines.

Any adverse events experienced during this study will be documented.

Eligibility Criteria:
Inclusion Criteria:

* General good health
* Willing to adhere to the requirements of the protocol, including availability for follow-up visits
* Willing and able to sign written informed consent

Exclusion Criteria:

* Individuals with known HIV infection
* Individuals with malignancy
* Individuals with a history or symptoms of unstable cardiovascular disease
* Individuals with renal abnormalities
* Individuals having a history or symptoms of pulmonary disease
* Individuals having acute or active chronic liver disease
* Individuals having neurologic or psychiatric disease
* Individuals having active tuberculosis
* Individuals having multiple sclerosis
* Individuals having bleeding disorders
* Individuals with planned surgery over the course of the trial or having had major surgery in the past 6 mo.
* Individuals with a history of alcohol/drug abuse
* Pregnant and lactating women
* Individuals on prescribed medication with the exception of oral contraceptives
* Individuals with Crohn's disease, Lupus, Rheumatoid arthritis, Colitis or any other auto-immune disease
* Individuals using natural health products or dietary supplements for 2 weeks prior and during the trial
* Individuals having allergies to ginseng or to any known component of the drug product or placebo
* Smokers (smoking \> 10 cigarettes/day)
* Alcoholics (drinking \> 10 drinks/week)
Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve

This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.

This study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. Bayesian methods will be used for the design and analysis of this study. The Bayesian model will determine if the data for the valve configurations are poolable. Bayesian methods also provide a means of determining the appropriate stopping time for the study based on the amount of information generated. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic Valve by establishing the following:

* adverse effect rates
* clinical status as indicated by NYHA functional classification
* hemodynamic performance

Eligibility Criteria:
Inclusion Criteria:

* The patient requires replacement of the aortic and/or mitral valve (Note: Patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, valve repair, are eligible for this study).
* The patient (or legal guardian) has signed a study-specific informed consent, agreeing to the data collection and follow-up requirements.
* The patient is of legal age in host country.

Exclusion Criteria:

* Patient already has a prosthetic valve, other than the aortic and/or mitral valve being replaced at this time.
* The patient requires replacement of the tricuspid or pulmonary valve.
* The patient is pregnant or nursing.
* Patient has active endocarditis.
* Patient is actively participating in the study of an investigational drug or device.
* Patient has had an acute preoperative neurological event.
* The patient is undergoing renal dialysis.
* Patient is an intravenous drug abuser, alcohol abuser or prison inmate.
* Patient has an inability or unwillingness to return for the required follow-up intervals.
* The patient had the SJM Epic Valve implanted during the clinical study but then had the bioprosthesis explanted.
Resuscitation Failure, Oxidative Stress, and Necroptosis as Mortality Predictor in Septic Patient

Resuscitation failure, oxidative stress and necroptosis were able to predict mortality in septic patient

This prospective cohort study was conducted at resuscitation room and ICU of Mohammad Hoesin hospital, a single tertiary teaching hospital in Palembang, South Sumatera. This study was started after ethical and location authorization were unleashed in February to August 2019. Inclusion criteria were patients aged 18 years old or above who met Sepsis-3 definition and diagnosed with sepsis. Exclusion criteria were patients whose family did not give any consent to participate, not treated at the ICU, had a late diagnosis (\>24 h), pregnant, and diagnosed with brain dead. Drop out criteria including patients who died \<4 h after diagnosed and could not be followed in 28 days. Investigators were trained to identified all eligible subjects. All the subjects had a standard resuscitation and their blood was taken to be examined at the laboratory. Subjects were observed in 28 days whether there were any mortality or not. Failed resuscitation defined by examined lactate level ≥ 2 mmol/L or lactate reduction \<20%. Data was statistically analyzed with STATA™

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 years old or above
* Diagnosed sepsis using Sepsis-3 definition

Exclusion Criteria:

* Participants whose family did not give any consent to participate
* Not treated at the ICU
* Had a late diagnosis (\>24 h)
* Pregnant
* Brain dead
Dietary Protein Preferences of Adolescent Athletes

This is a survey study to gauge the interest of young athletes ages 12-19 in plant-based protein products. The teen competitive athlete is a core target for the Gatorade brand and, as such, understanding their preferences and what drives their choices is vital for the brand's continued growth.


Eligibility Criteria:
Inclusion Criteria:

* Male and female student-athletes between the ages of 12-19 years
* Athlete must currently participate in a sport at the middle/high school level
* Athlete must be able to speak, write, and read English
* Athlete must own a smartphone with access to internet and text message service (to complete survey)
* Athlete (and parent/guardian, if under 18 years of age) must understand the study procedures and be willing to sign the informed consent form providing consent/assent to participate in the stud

Exclusion Criteria:

• Athlete must not be employed by, or have a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product
Investigating Physiological Adaptations to Weight Loss

The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.


Eligibility Criteria:
Inclusion Criteria:

* males and post-menopausal females
* aged over 18 years
* BMI 27-40kg/m2
* weight-stable

Exclusion Criteria:

* major comorbid medial condition (including diabetes)
* taking medications known to affect weight
* smoking
Human Repeat Insult Patch Test to Evaluate Personal Lubricants

The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.


Eligibility Criteria:
Inclusion Criteria:

* good health as determined from screener
* signed and dated informed consent
* signed and dated HIPAA Form

Exclusion Criteria:

* subjects on test at any other research laboratory or clinic
* known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs
* pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study
* pre-existing other medical conditions (e.g. adult asthma, diabetes).
* treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test
* chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs \[except for therapeutic maintenance dosage of aspirin\], antibiotics, steroid inhalers, etc.)
* known pregnant or nursing women