cyrilzakka/clinical-trials huggingface dataset:
Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine.

The prilocaine is a very common local anesthetic that has the disadvantage of being metabolized to o-toluidine, a human carcinogen.

Hyperbaric 2% prilocaine (HP), recently developped, is increasingly used for spinal anesthesia in ambulatory surgery. But the formation of carcinogenic metabolites induced by the hyperbaric prilocaine is not yet known. The aim of this study is to investigate whether the intrathecal administration of 50 mg hyperbaric prilocaine induces also the formation of carcinogenic complexes such as urinary o-toluidine and hemoglobin adducts from o-toluidine in blood.


Eligibility Criteria:
Inclusion Criteria:

* Age : \> 18 years and \< 80years
* American Society of Anesthesiology (ASA) score : I-II
* Height between 160cm and 180cm

Exclusion Criteria:

* Cardiac Disease (Aortic stenosis, heart failure...)
* coagulation disorder (International Normalized Ratio (INR) \> 1.3; platelets \<80 000/mm³)
* Allergic to local anesthetics
* Smoker
Orsiro™ Drug Eluting Stent in Routine Clinical Practice

The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting Stent in Routine Clinical Practice


Eligibility Criteria:
Inclusion Criteria:

* Age 20 and more
* Intervention with Orsiro™ Drug Eluting Stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with Orsiro™ drug eluting coronary stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock
A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas

For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to compare the 18F-DOPA PET/CT scan with the MRI scan for identifying where the disease is that needs to be treated with radiation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥7 years.
* Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma.
* CT simulation, 18F-DOPA PET imaging, and standard of care pre-radiotherapy MRI scans to be performed at Mayo Clinic Rochester.
* Willing to sign release of information for any follow-up records.
* Provide informed written consent.

Exclusion Criteria:

* Patients diagnosed with WHO grade IV malignant glioma.
* Patients previously treated with radiation therapy.
* Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure).
* Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
Fecal Microbiota Transplantation for Ulcerative Colitis

Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to work by shifting the recipient's microbiota toward a eubiotic microbial community that resists colonization by pathogenic organisms or decreases its inherent inflammatory properties. Several studies now report its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT in Ulcerative Colitis (UC) have also met with some success. This is corroborated by several lines of evidence suggesting dysbiosis plays an important role in UC pathogenesis. While a recent study using FMT in patients with irritable bowel syndrome (IBS) and constipation found transplants persist for up to 2 years, the extent to which the microbiota is alterable in UC is not known. Indeed, there may be particular genetic or immunologic factors in UC leading to selection pressure preventing a change in the microbiota. As an initial step into investigating the potential efficacy of stool transplants for Ulcerative Colitis (UC), the investigators propose to determine the feasibility and stability of transplanted microbiota in a series of 10 patients with mild to moderate UC.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate UC.

Exclusion Criteria:

* Antibiotic exposure in the last 3 months.
* Biologic or immunomodulatory therapy within the last 3 months.
* Corticosteroid therapy or probiotics within the last 2 weeks.
* Severely active disease (defined as Mayo scores of 10 or greater, or patients with endoscopic disease activity scores of 3 or greater).
Pain Phenotyping of Patients With Bone Cancer Pain

The study aims to describe and quantify pain related to metastatic bone disease. The study will include 50 subjects with disseminated breast cancer and 20 healthy subjects. The pain will be described and quantified through (1) pain specific questionnaires, (2) quantitative sensory testing that assess sensory changes to cold, heat and mechanical stimulation of the skin overlying the metastatic site, and (3) conditioned pain modulation that investigates impairment of the endogenous inhibitory pain pathway in humans.

Cancer patients in palliative care point to pain as their most important and most feared symptom. Bone metastases are a common cause of cancer pain, and the patients are prone to transient severe pain exacerbations (breakthrough pain), which can occur spontaneously or be triggered by movement. Patients with bone metastases experience pain of such high intensity, that it affects not only physical activity, but also sleep, mood and social relations. This results in poor quality of life for the patients and poses an increasing clinical and socio-economical problem. The pain is difficult to treat and often requires high opioid doses which results in unacceptable adverse effects, and there is an unmet need of novel therapeutic options and treatment strategies.

Animal models of cancer-induced bone pain have suggested that pain arising from metastatic bone disease involve neuropathic and nociceptive pain mechanisms and, importantly, mechanisms that are specific to cancer-induced bone pain. Significant neuronal sprouting can occur at the metastatic site, and the inherent pain control system is found altered in animal models of cancer-induced bone pain; a system that can be exploited for treatment strategies and in the development of new analgesia. Yet, it is not known how the pre-clinical findings translate to patients.

Quantitative sensory testing is a psychophysical method that uses a battery of sensory stimuli with predetermined physical properties, thus allowing the capture and quantification of stimulus-evoked negative and positive sensory phenomena in humans. Conditioned pain modulation is a psychophysical experimental measure of the endogenous pain inhibitory pathway in humans, which can be used to detect an impairment of the descending inhibitory pain pathway.

This study aims to perform pain phenotyping of patients suffering from cancer-induced bone pain, through pain specific questionnaires, quantitative sensory testing and conditioned pain modulation.

Eligibility Criteria:
Inclusion Criteria:

* Woman
* Primary breast cancer
* Bone metastases
* Competent

Exclusion Criteria:

* Not fluent in spoken Danish
* Chemotherapy or radiation within the last 3 months
* Other chronic pain disease that may affect the quantitative sensory testing or conditioned pain modulation
* Alcohol or medicine abuse
* Pregnancy
Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus

This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of ARO-INHBE in adult participants with obesity (Part 1), and the safety, tolerability and PD of multiple doses of ARO-INHBE in adult participants with obesity with and without type 2 diabetes mellitus receiving tirzepatide (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Obesity, defined as Body Mass Index (BMI) between 30 to 50 kg/m2 at Screening
* At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
* Willing, able and motivated to comply with all study assessments and adhere to the protocol schedule, including adherence to a stable diet and exercise routine for the duration of the study
* No abnormal finding of clinical relevance at Screening that, in the opinion of investigator, could adversely impact subject safety or adversely impact study results
* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the endo of the study or last dose of study medication, whichever is later. Participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study medication, whichever is later.

Exclusion Criteria:

* Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening
* Use of GLP1R agonists (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening
* Use of non-GLP1R medications for weight loss within 3 months prior to Screening, including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate, and other prescription or over-the-counter medication or supplements taken for weight loss
* Obesity attributable, in the investigator's opinion, to medication use, endocrinologic or monogenic disorders
* History or prior surgical or device-based therapy for obesity
* Use of medications strongly associated with weight gain within 3 months prior to Screening
* Type 1 diabetes mellitus
* History of hyperthyroidism or thyroid-stimulating hormone (TSH) levels \<0.4 or \>6.0 mIU/L at Screening
* Evidence of clinically significant end-organ disease

Note: Other Inclusion/Exclusion criteria may apply per protocol
Dissociation Investigation Study in Sex Offenders

Background: Adverse childhood experience have been described in sexual offenders but the link with the offence need to be further investigated. Investigators postulate that one of the clinical moderating factors could be dissociative experience, a consequence of these early adverse experiences reactivated during the offence. The purpose of the study is to estimate the prevalence of clinical dissociation during the offence in a male adult population referred to our center for a sexual offence and to explore its correlations with epidemiological and clinical data (personal, legal history, psychiatric comorbidities), clinical trauma and dissociation, prognosis estimates.

The study will be proposed to the subjects after their usual clinical evaluation in the center for sexual offence and to extend this evaluation by a specific focus on childhood abuse and neglect trauma and dissociative history. After receiving complete information, the participants will sign the consent form and be referred to a unique on-site visit of approximately 2 hours long. During this visit, the participants will benefit from a psychiatric examination in search for clinical features of dissociation during the offence, lifetime dissociative experience, lifetime post-traumatic stress disorder; they will have to complete bioevaluation forms for dissociation (Dissociative Experience Scale) and childhood abuse and neglect (Childhood Experience of Care and Abuse). After this completion, they will benefit from a second part psychiatric examination, so as to complete the assessment and answer their questions if any.

Eligibility Criteria:
Inclusion Criteria:

* male subject referred to the center for having committed a sexual offense; social insurance affiliation

Exclusion Criteria:

* schizophrenia, mental retardation (IQ\<70)
Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy

The potential cardiovascular toxicity of tumor treatment and its resulting cardiovascular events have gradually become an important health risk for tumor survivors. Prevention and early identification of cardiovascular toxicity has now become one of the bottlenecks in improving the prognosis of cancer patients. Compared to conventional echocardiographic indicators, new ultrasound technology based on speckle tracking imaging (STI) has shown superiority in the diagnosis, risk stratification and prognosis evaluation of cardiovascular diseases. Crocin, one of the main active components of saffron, has been found protective effect on cardiovascular toxicity in basic studies. This is a randomized, double-blind, placebo-controlled, single-center clinical study to observe the effect of crocin on cardiovascular function caused by breast cancer treatment.

One hundred and twenty breast cancer patients planning to undergo radiotherapy or chemotherapy will be included and randomly divided into a crocin group and a placebo group to observe the effect of total saffron tablets on cardiovascular function in patients with early breast cancer radiotherapy and chemotherapy. Participants will take crocin or placebo (4 tablets/time, 3 times a day) during each cycle of chemotherapy for 8 days, started on the 1st day before radiotherapy/chemotherapy. Follow-up was performed every 3 months after enrollment, and the follow-up period was 6 months.

Primary study endpoints include the differences between groups in the difference in LVEF and GLS measured by echocardiography at the end of the experiment compared to baseline. Secondary study endpoint include the differences in the incidence rates of serum troponin exceeding the upper limit of normal value and NT-proBNP higher than the normal age reference value, the frequency and duration of chest tightness, chest pain and palpitation, the degree of arrhythmia and ST-T changes displayed by dynamic electrocardiogram, the other echocardiographic parameters (the E/e', global circumferential strain, global radial strain, 3D-GAS, LV torsion, LV rotation/derotation velocity, SDI, RVFWS, and indexes of left ventricular diastolic function and right ventricular function) at the end of the experiment compared to baseline between the two groups.


Eligibility Criteria:
Inclusion criteria:

1. Age 25-80 years old, female;
2. Patients diagnosed with breast cancer by histopathology;
3. Patients who plan to receive adjuvant radiotherapy/chemotherapy or combined adjuvant trastuzumab or pertuzumab targeted therapy;
4. Patients who completed at least 6 cycles of treatment after enrollment;

Exclusion criteria:

1. pregnant or breastfeeding women;
2. Patients with poor echocardiographic image quality;
3. Persistent atrial fibrillation and severe arrhythmia affect the collection and analysis of ultrasound data;
4. Patients who are participating in other clinical studies.
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers

The aim of this study is to measure the variations of serum and urinary hepcidin levels following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be postulated that erythropoietin could modulate hepcidin synthesis.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* male aged 18 - 30
* normal routine laboratory values
* normal ECG
* normal iron status

Exclusion Criteria:

* C282Y mutation of the HFE gene
* alcohol or tobacco consumption
Study of BMS-587101 in Patients With Moderate to Severe Psoriasis

The purpose of this clinical research study is to learn if BMS-587101 is effective on the treatment of Moderate to Severe Psoriasis. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria: Otherwise healthy individuals with a diagnosis of plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may be enrolled).

Men and Women Not of Child Bearing Potential (i.e. women who are postmenopausal or surgically sterile), women ages 18 to 75.

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Exclusion Criteria: Women of Child Bearing Potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.

Known or suspected infection, including infection with human immunodeficiency virus (HIV), hepatitis B or C viruses. Any recent infections requiring antibiotic treatment that completed within 4 weeks of enrollment.

Any known malignancy or history of malignancy within 5 years prior to enrollment, with the exception of basal cell or squamous cell carcinoma of the skin that has been excised with no evidence of recurrence (squamous cell carcinoma of other locations is exclusionary).

Any history of Guillane-Barre syndrome. History of keloid formation.

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Inflammatory Response With Different Lipid Emulsions In Parenteral Nutrition In Children After Bone Marrow Transplantation

Background and Aims: Nutritional support is considered an integral part of the supportive care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with omega-3 fatty acids can modify the inflammatory response. The aim of this study is to compare plasma cytokines levels in children after bone marrow transplantation using a lipid formula enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition.

Methods: A randomized double blinded controlled study including 14 children with BMT and requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha (TNF-α).


Eligibility Criteria:
Inclusion Criteria:

Term infants. Children with a stable medical condition. Children in need of parenteral nutrition for at least 10 days, except for the cardiac group would be at least 5 days.

Exclusion Criteria:

Premature infants Children over 14 years Children with hypersensitivity to egg ingestion or soy protein Children with severe insufficiency of an organ, Children with inborn error of metabolism, and any condition that does not allow random use of lipid emulsion type.
Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.

The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged 21-65 years
* healthy, good physical condition
* voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* use of anti-inflammatory or non-steroidal anti-inflammatory drugs
* previous history of cardiovascular disease or acute or chronic inflammatory disease
* use of antioxidant supplements or cholesterol-lowering agents
* change of diet habits or lifestyle (diet, physical activity, etc.)
* alcohol or substance abuse history
* use of nicotine or tobacco
* participation in another investigational study
Polymorphisms at Distinct Genetic Loci Affect Response to Anti-CD20 Monoclonal Antibody Therapies

This is a non-interventional, R01-funded pilot study that will identify serum and cellular markers in patients' blood samples that can be used as short-term biomarkers of rituximab response. We hypothesize that serum complement levels, activation of natural killer cells, and clearance of peripheral B-cells will be accurate biomarkers of rituximab response, and may be correlated with long-term outcomes.

This study does not involve the administration of study drug. This study will only require additional blood draws to identify how patients respond to rituximab and other anti-CD20 antibody therapy. It is expected that blood draws will occur on the same day in which an IV is placed to dose you with the anti-CD20 antibody or for other bloodwork being performed in order to avoid extra sticks.

If you take part in this study, you will have additional blood drawn at the following time-points surround anti-CD20 antibody therapy:

Pre Dose, Cycle 1

* Two 7.5 ml tubes (two teaspoons) of blood will be taken along with your other pre-chemotherapy bloodwork Post Dose, Cycle 1
* Two 5 ml tubes (three teaspoons) of blood will be taken Pre Dose, Cycle 2
* Two 5 ml tubes (two teaspoons) of blood will be taken Post Dose, Cycle 2
* Two 5 ml tubes (two teaspoons) of blood will be taken Pre Dose, Cycle 6
* Two 10 ml tubes (four teaspoons) of blood will be taken Post Dose, Cycle 6
* Two 10 ml tubes (four teaspoons) of blood will be taken

Note: Two tubes will be taken at each draw. If no blood was drawn in the prior 8 weeks, 10 ml of blood will be taken per tube. For the first 4 draws (at cycle 1 and cycle 2, pre- and post-), the amount of blood being taken is to ensure that the patient does not have more than 50 ml of blood taken within an 8 week period.

Eligibility Criteria:
Inclusion Criteria:

1. Any adult patient who has not received rituximab or other anti-CD20 antibody within the past year who is initiating rituximab or other anti-CD20 antibody treatment.
2. Treatment plan that includes at least two doses of anti-CD20 antibody and longitudinal follow up over at least a one-month time span.

Exclusion Criteria:

1. Hgb less than 8.0 g/dL or Hct less than 25% (transfusions or growth factors are permissible).
2. Treatment with any anti-CD20 antibody within the past 12 months.