cyrilzakka/clinical-trials huggingface dataset:
Mass Balance Clinical Trial With TEV-56286

Mass balance clinical trial with TEV-56286

Primary objectives:

* To investigate the mass balance and excretion of TEV-56286 following a single oral dose of \[14C\]-TEV-56286
* To assess the pharmacokinetics following a single oral dose of \[14C\]-TEV-56286

Secondary objective:

- To evaluate the safety and tolerability of TEV-56286 following once daily multiple oral dose administration

The total duration of the clinical trial for each participant is expected to be approximately 59 days.

Eligibility Criteria:
Inclusion Criteria:

* No major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of the study drug, or surgery scheduled during the clinical trial including the follow-up period.
* No history of malignancy or treatment of malignancy in the last 5 years.
* No personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope of undetermined reason or previous treatment for high blood pressure.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* History of relevant drug and/or food allergies.
* Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton \[excluding spinal column\]), during work, or during participation in a clinical trial in the period of 1 year prior to screening.

NOTE- Additional criteria apply, please contact the investigator for more information
Evaluation of Changes in Visual Acuity in Patients With Diabetic Macular Edema (DME) Starting Treatment With an Approved Anti-VEGF Therapy

POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with central involvement to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-VEGF) treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 1 or 2 diabetes mellitus
* Patients diagnosed with DME with central involvement (defined as the area of the center subfield of optical coherence tomography \[OCT\])
* Patients for whom the decision has been made to treat with an approved anti-VEGF therapy prior to inclusion into the study
* Patients who received the first approved intravitreal anti VEGF treatment from October 01, 2012
* Patients who give informed consent in writing for study participation

Exclusion Criteria:

* Treatment with any anti-VEGF therapy prior to the start of the observation period (October 01, 2012) or enrolment into the study
* Participation in an investigational program with interventions out of clinical routine practice
Desensitization Protocol for Deceased Donor List

Purpose of the study:

The specific aims of this study are to evaluate overall efficacy and safety of the pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors affecting treatment outcomes in order to improve patient selection and treatment protocols for future patients.

Background:

Intravenous immunoglobulin (IVIG) infusion is one of several novel approaches to decrease antibody levels for highly sensitized kidney transplant candidates \[1, 2\]. This approach can potentially give a chance of kidney transplantation to end-stage renal failure patients who could never receive transplantation because of high levels of antibodies and persistent positive crossmatches to all potential kidney donors. Many transplant centers have used this strategy in order to increase transplant rates of highly sensitized patients with various levels of anti-HLA antibodies. However, the responses to the treatment seem to be different in each patient and factors affecting treatment outcome have yet to be determined.

Eligibility Criteria:
Inclusion Criteria:

* Recent (\< 3 months) high levels of anti-HLA antibodies (at least one cPRA ≥ 40%).
* Waiting time greater than 1 year for blood type AB, 2 years for blood types A, B, or O.

Exclusion Criteria:

* Female subject is pregnant or lactating.
* Subject has an uncontrolled concomitant infection or any other unstable medical condition (e.g., uncontrolled cardiovascular disease) that could interfere with the study objectives.
* Subject has an uncontrolled active hepatitis B, hepatitis C, or HIV infection.
* Subject has a current malignancy or a recent history of any malignancy that is deemed to be contraindicated to kidney transplantation.
* Subject has a psychiatric illness that, in the judgment of caring physicians, may interfere with study participation.
The Study Of Fluconazole For Vulvovaginal Candidiasis

As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical symptoms and signs of vulvovaginal candidiasis.
* Patients tested positive for Candida by fungal culture.
* Patients who can agree not to have intercourse up to 28 days after dosing.

Exclusion Criteria:

* Patients with a history of hypersensitivity to fluconazole.
* Patients with severe renal dysfunction.
* Patients with liver disorder.
Clinical Decision Support Algorithm to Predict Diabetic Retinopathy

Diabetic retinopathy (DR), a complication of diabetes, is a leading cause of blindness among working-aged adults globally. In its early stages, DR is symptomless, and can only be detected by an annual eye exam. Once the disease has progressed to the point where vision loss has occurred, the damage is irreversible. Consequently, early detection is quintessential in treating DR. Two barriers to early detection are poor patient compliance with the annual exam and lack of access to specialists in rural areas. This research is focused on developing and validating new, cost-effective predictive technologies that can improve early screening of DR. Our overall objective is to develop and implement an entire suite of tools to detect diabetes complications in order to augment care for underserved rural populations in the US and internationally.


Eligibility Criteria:
Inclusion Criteria:

For diabetic patients with DR:

* With 250.xx diabetes and 362.0x DR ICD-9 codes
* All variables are complete within the observation window

For diabetic patients without DR:

* With 250.xx diabetes ICD-9 codes
* Without 362.0x DR ICD-9 codes
* All variables are complete within the observation window
Study on the Combination Regimen of Dexamethasone Ifosfamide Cisplatin Etoposide in Patients With NK/T Cell Lymphoma

The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.

Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP.The investigators did this trial to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-75 years old
* Histological confirmed NK/T cell lymphoma
* ECOG performance status less than 2
* Life expectancy of more than 3 months
* None of major drugs in the trial (IFO,VP16,DDP) has been previously used
* Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
HD-tDCS for Pain Reduction in Post-Stroke Pain: a Randomized Crossover Trial

This study aims to assess the effectiveness of multichannel transcranial direct current stimulation (tDCS) in alleviating pain and to evaluate its safety in patients with central post-stroke pain (CPSP)


Eligibility Criteria:
Inclusion Criteria :

* Adults aged between 19 and 90 years.
* Diagnosed with first-ever stroke based on clinical observation and neuroimaging by a physician.
* Stroke lesion located in the cortex or subcortex \[basal ganglia (BG) or thalamus\].
* Fulfillment of mandatory criteria for pain (pain in the body part corresponding to central nervous system lesions, onset of pain immediately after stroke, confirmation that the pain corresponds to the lesion site, exclusion of other causes of pain such as peripheral neuropathic pain).
* Cognitive ability sufficient to understand and follow the instructions of the researcher.
* Voluntary consent to participate in the clinical trial and signed informed consent.

Exclusion Criteria :

* History of fractures or orthopedic surgeries on the affected side.
* Presence of significant pre-existing neurogenic disorders.
* Co-existing severe psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia.
* Complex regional pain syndrome (CRPS) diagnosed based on Budapest criteria.
* Other causes of pain in the affected area, such as peripheral nerve damage.
* Exclusion criteria for transcranial magnetic stimulation (e.g., pregnancy, cancer, patients with abnormal responses to stimulation, presence of intracranial metal implants, hypersensitivity to pain, history of seizures, or injuries/skin conditions at electrode attachment sites).
* Deemed unsuitable for participation in the study by the principal investigator.
Evaluation of the Fetal MPI in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome.

The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.

The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.

Study Hypothesis:

In women with non reassuring fetal cardiotocography, myocardial performance index may predict fetal distress accurately.

Study Question:

In pregnant women in the third trimester with abnormal cardiotocography, Does myocardial performance index predict fetal distress accurately?

Study Objectives:

This study aims to assess the accuracy of myocardial performance index in predicting fetal distress in pregnant women with non reassuring cardiotocography in third trimester.

Eligibility Criteria:
Inclusion Criteria:

1. Women between 30-40 weeks gestational age.
2. Women pregnant in singleton fetus.

Exclusion Criteria:

1. Multiple pregnancies.
2. Fetal congenital malformation.
Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex

Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines. Catecholamines may increase in patients with PVC. Metabolites of catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.

Premature ventricular complex is a very frequent arrhythmia. Suggested mechanisms for PVCs are reentry, triggered activity, and enhanced automaticity. Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines. Catecholamines may increase in patients with PVC. Half-lives of catecholamines are very short and rather changeable. Therefore, 24 hours urine levels of catecholamines are the more sensitive than plasma levels. Metabolites of catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.

Eligibility Criteria:
Inclusion Criteria:

* PVC's rate is more than % 5 in 24 hours rhythm recording

Exclusion Criteria:

* ischemic heart disease
* hyperthyroidism
* patients with low ejection fraction
Biobank for Cholestatic Liver Diseases.

This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC).

This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC).

Blood, saliva, stool, and urine samples will be collected periodically during patient visits or via a mail-home kit. Bile and bile duct cells will be collected during clinically necessary Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. Anticipated research will focus on multi-omics assessments of biospecimens to better define how these diseases start and progress in order to develop novel tests for early detection of complication and better disease prognostication.

Eligibility Criteria:
Inclusion Criteria:

PSC

* Patients diagnosed with PSC and who are between the age of 18 and 85 at time of enrollment in the study.
* The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings, and compatible liver biopsies if available.
* Patients with PSC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.
* Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.

PBC

* Patients diagnosed with PBC and who are between the age of 18 and 85 at time of enrollment in the study.
* The diagnosis of PBC will be based on standard PBC criteria including clinical and biochemical evidence of chronic cholestasis of at least six month duration, positive anti-mitochondrial antibodies in serum and compatible liver biopsies, if available.
* Patients with PBC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.
* Women with PBC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.

Controls

* Controls without history of PBC, PSC, or evidence of other chronic liver disease of either gender that participate in this study will be between the ages of 18 and 85.

Liver Disease Controls

* Patients without history of PBC or PSC but do have evidence of other chronic liver disease of either gender will be offered participation in this study if between the ages of 18 and 85.

Exclusion Criteria (all subjects):

* PBC or PSC patients with known and overlapping other chronic liver diseases
* Patients unable to provide informed consent
* Prisoners and institutionalized individuals

Exclusion Criteria (for bile collection during ERCP)

* PSC with orthotopic liver transplantation
* History of Roux en Y
CompuFlo® Assessment Study for the Epidural Space Verification

The purpose of this pivotal study is to demonstrate safety and effectiveness of the CompuFlo® Epidural Computer Controlled System (referred to hereafter as CompuFlo® Epidural) for the epidural space verification.

The CompuFlo® Epidural System is limited by federal law for investigational use only in United States of America and has received CE mark in European Union.


Eligibility Criteria:
Inclusion Criteria:

1. The Subject is at least 18 years of age at screening, but has not had their 91st birthday.
2. The Subject is required to have epidural procedure implemented as part of their standard medical treatment according to Principal Investigator assessment.
3. The Subject is willing to undergo the Informed Consent process prior to enrollment into this study.
4. The Subject is willing to participate in this study for at least 30 days after the epidural procedure implementation.
5. The Subject is willing to participate in this study for at least 3 days after the procedure.

Exclusion Criteria:

1. Contraindications for epidural procedure / anesthesia (circumstances where the risks associated with epidural procedures are higher than usual. These circumstances include, but are not limited to anatomical abnormalities, such as spina bifida or scoliosis, infection at or near the site of insertion, allergy to the anesthetic or intended drug, uncorrected hypovolemia, increased intracranial pressure etc.).
2. Patients presenting for emergency c-section or other emergencies.
3. Exclusive use of other treatments such as intravenous analgesia with opioids.
4. Prior back surgery in lumbar area that would prevent epidural access.
5. Preexisting neurological deficit that would interfere with dermatome identification.
6. The Subject observed seizure within 7 days prior to study enrollment.
7. Presumed and/or confirmed septic embolus.
8. The Subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region greater than 4 cm2.
9. The Subject previously participated in another investigational drug or device trial within the preceding 4 weeks.
10. Severe co-existing or terminal systemic disease that limits life expectancy or may interfere with study procedures.
11. The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection

The purpose of this study is to identify novel imaging markers for characterizing the biochemical profiles in synovial fluid and cartilage matrix in OA knee joints after intra-articular HA (Euflexxa) injection using high field NMR and MRI techniques.

We hypothesize that:

1. High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical changes within knee synovial fluid after HA injection;
2. Baseline HRMAS spectroscopy, in particular N-acetyl peaks, as well as early changes of glutamate will predict patient response of pain relief after HA injection;
3. MR cartilage T1p and T2 quantifications will provide sensitive measures for biochemical changes within knee cartilage matrix after HA injection. Specifically cartilage T1p and T2 will decrease in patients who respond to the treatment, indicating potential beneficial effects of HA injection to cartilage preservation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years
* Symptomatic knee OA as defined by the American College of Rheumatology criteria
* Kellgren-Lawrence grade I, II or III on prior x-rays (take within 6 months of screening visit)
* knee pain score \>40 mm on a 100 mm visual analogue scale for \> 15 days in the last month
* NSAIDs permitted if the dose has been stable for at least one month prior to baseline and stays stable during the study
* Have been recommended for Euflexxa treatment by physician
* Knee effusion based on clinical exam or imaging

Exclusion Criteria:

* Any contraindication to MRI (pregnancy, metallic fragments in the eyes, vascular clips, Pacemakers etc)
* History of knee replacement
* Known sensitivity or allergy to any component of Euflexxa
* Inflammatory arthritis
* Previously received viscosupplementation therapy within 6 months of study enrollment
* Intra-articular injection of corticosteroid to study joint within the past 3 months
* Arthroscopic or open surgery within the previous 12 months or planned surgery to the study joint
* Concomitant medications of oral/parenteral corticosteroids
* Morbid obesity defined as body mass index (BMI) \>40 kg/m2
* Active malignancy; an active systemic infection; recent high impact or high energy trauma (clinically defined) to the study joint
* Large knee effusion based on clinical exam or imaging
Bowen's Technique In Postural Neck Pain Among Dentist

No previous randomized control trial has investigated the effectiveness of Bowen's technique on health status in dentists suffering from postural neck Neck pain. Moreover, there is limited evidence and low agreement regarding the effect of Bowen's therapy on Neck pain. Thus, this study aims to answer the question: bowmen's technique is effective for improving Neck pain dentists' function by reducing pain, and disability, and improving posture, and health status, without need for ergonomic alternation?"

Bowen technique may be used for relaxation of tightening muscles in poor posture. The findings suggest that Bowen Therapy has inconsistent immediate effects on postural control and pain threshold in healthy subjects. Further studies are needed using symptomatic participants. No previous randomized control trial, to our knowledge, has investigated the effectiveness of Bowen's technique on health status in dentists suffering from postural neck pain. Moreover, there is limited evidence and low agreement regarding the effect of Bowen's therapy on neck pain. Thus, this study aims to answer the question: Bowen's technique is effective for improving neck pain dentists' function by reducing pain, and disability, and improving posture, and health status, without need for ergonomic alternation?"

Eligibility Criteria:
Inclusion Criteria:

* Both male and females
* Age between 25-50 years. ( House officers and Assistant professor)
* Working hours \>5 hours.
* History of cervical pain \>2 months.
* Year of practice =\<1 year
* Treated more than 5 patient a day

Exclusion Criteria:

* Cervical fracture
* Cervical radiculopathy
* Any surgery to neck and shoulder
* Rheumatoid arthritis
* Sever pain according to Numeric pain rating scale (NPRS)
* Long term anticoagulant or corticosteroid therapy
Health Parameters in Soccer Players and Sedentary Individuals After Consuming a Synbiotic

The main objective of this research was to carry out an experimental study, triple blind, on the possible immunophysiological effects of a nutritional supplement (Synbiotic, Gasteel Plus®, Heel España S.A.U.), containing a mixture of probiotic strains, such as Bifidobacterium lactis CBP-001010, Lactobacillus rhamnosus CNCM I-4036, Bifidobacterium longum ES1, as well as prebi-otic fructooligosaccharides, in both professional athletes and sedentary people. The effects on some inflammatory/immune (IL-1β, IL-10, and immunoglobulin A) and stress (epinephrine, nore-pinephrine, dopamine, serotonin, CRH, ACTH, and cortisol) biomarkers were evaluated, determined by flow cytometer and ELISA. The effects on metabolic profile and physical activity, as well as on various parameters that could affect physical and mental health, were also evaluated via the use of accelerometry and validated questionnaires.

This investigation was a triple blinded, randomized, placebo-controlled pilot study designed to identify the possible differing effects of the synbiotic Gasteel Plus® supplementation.

The participants were professional soccer players of the Second Division B of the Spanish League and sedentary students of the same sex and age range. Both study groups were randomly divided into two groups: a control group administered with placebo, and an experimental group administered with the synbiotic. Each participant was evaluated at baseline, as well as after the intervention which lasted one month. Only in the athletes group did the synbiotic intervention clearly improve objective physical activ-ity and sleep quality, as well as perceived general health, stress, and anxiety levels.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary individuals: students with low levels of physical activity (≤ 150 minutes/week),
* Athletes: semi professional soccer players

Exclusion Criteria:

* Participants were prohibited from consuming probiotics, prebiotics or fermented products (yogurt or other foods)
* Presenting injury or illness