cyrilzakka/clinical-trials huggingface dataset:
A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated:

* Males or females, of any race, between 18 and 55 years of age, inclusive.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight \>50 kg.
* In good health.
* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated:

* Significant history or clinical manifestation of any major system disorder, as determined by the investigator (or designee).
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
* History of alcoholism or drug/chemical abuse within 2 years prior to Check in (Day 1).
* Abnormal laboratory values considered clinically significant by the investigator
* Clinically significant abnormal 12 lead ECGs
* Personal history of unexplained syncopal events, or family history of long QT syndrome or sudden unexplained death in a young person.
* Pulse rate \<50 bpm or systolic blood pressure \<110 mmHg.
* Alcohol consumption of \>21 units per week for males and \>14 units for females.
* Positive urine drug screen or positive alcohol breath test result or positive urine drug screen.
* Positive hepatitis panel and/or positive human immunodeficiency virus test. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing or 5 half lives (if known), whichever is longer, prior to dosing.
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
* Have previously completed or withdrawn from this study or any other study investigating omaveloxolone, and have previously received the investigational product.
* Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence

This study is designed to measure the impact of Satraplatin plus radiation therapy to the bed of the prostate in patients who have developed biochemical failure of their prostate cancer. The main objective of this study is to determine the maximum tolerated dose and dose limiting toxicity for the combination of satraplatin and radiation therapy and to determine the recommended dose for subsequent Phase II trials.

\*\*\*\*Please Note: Dr.Howard Sandler's site will be open to accrual shortly, Dr. Sarantopoulos's site in San Antonio is open and recruiting patients.\*\*\*\*

There were approximately 232,000 cases of prostate cancer diagnosed in the US in 2005. Most patients present with localized disease and undergo curative therapy, either radical prostatectomy (RP) or radiation therapy (RT). Although most men are cured after this therapy, approximately 30,000-50,000 annually in the US will develop recurrence after RP. For most of these patients, recurrence will be defined by biochemical recurrence (BCR), a rise in PSA with no other documented evidence of recurrence. Patients with BCR typically receive radiation therapy to the prostate bed. However, about 50% of these patients will develop distant recurrence outside of the pelvis and require systemic therapy.

Satraplatin is a third generation orally administered platinum compound. Early clinical studies demonstrated activity in tumors of the ovary and lung in addition to prostate cancer. Satraplatin has shown activity in prostate cancer in Phase II studies and has been evaluated in a pivotal Phase III study (The SPARC trial)as a single agent as second line therapy.

Eligibility Criteria:
Inclusion Criteria:

* Over or equal to 18 years of age.
* ECOG performance status less than or equal to 1
* Adequate organ function.
* History of radical prostatectomy with histopathologic documentation of adenocarcinoma of the prostate.
* PSA over or equal to 0.2 ng/ml or less than or equal to 0.4 ng/ml. This includes patients whose PSA never becomes detectable. PSA progression must be measured by two consecutive samples, each separated by over or equal to 7 days. The PSA values of the two consecutive sample values must be greater than the previous (baseline) value, not greater than each other.

Exclusion Criteria:

* Known sites of measurable prostate cancer or bone scan positive for metastatic prostate cancer. (patients with a positive Prostascint scan will not be excluded)
* Prior therapy for prostate cancer except RP and neoadjuvant hormonal therapy. This includes chemo, hormonal (except neoadjuvant), RT, and biologic therapy.
* Lack of physical integrity of the upper GI tract, malabsorption syndromes, or inability to tolerate or absorb oral medications, including Crohn's disease and ulcerative colitis.
* Other concurrent immunotherapy, RT, chemotherapy,or ancillary therapy considered investigational (utilized for non-FDA approved indications and the context of a research investigation)and any chemotherapy not included in the study protocol.
Low-dose Versus a High-dose Sublingual Buprenorphine Induction

This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week.

This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week. Thereafter, they will be treated according to the MATClinics usual schedule of clinic visits. The number and timing of visits may vary according to whether the participant is still using illicit opioids. Follow-up visits for the study will be at one and three months.The primary objective is to determine whether patients randomly assigned to low versus high dose induction regimens are more likely to complete the 7-day induction period. Secondary outcomes are the number of patients who develop precipitated withdrawal or other adverse events, experience subjective opioid withdrawal symptoms, use adjunctive medications (hydroxyzine, loperamide, dicyclomine, clonidine, ibuprofen, methocarbamol, trazodone, ondansetron) provided by the clinic, recommendation of the medication induction scheme to other patients, and treatment retention at 1- and 3- months post induction.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female (≥ 18 years of age) persons with a DSM-5 diagnosis of OUD;
* Must have a fentanyl positive urine test;
* Able to come to the clinic every day for the first week of treatment.

Exclusion Criteria:

* No exclusionary medical history or mental health issues as determined by the admitting provider; e.g., patients with untreated or unstable serious mental illness, including psychotic disorders;
* Alcohol withdrawal requiring pharmacological management;
* Urine positive for buprenorphine, benzodiazepines, or methadone; 4. Enrolled in a methadone treatment program in the past 14 days; 5. Inability to pass a study enrollment quiz.
Insulin Resistance in Severely Obese Patients

This study aims to understand the biological processes that link obesity to diseases including insulin resistance and diabetes. Our approach involves studying the health of patient undergoing weight loss either via weight reduction surgery or by medically supervised liquid formula diets. Patients must be enrolled in a weight treatment program at Emory Bariatrics, Emory University, Atlanta GA, to be eligible for this study. This study does not cover the cost of treatment at Emory Bariatrics. The hypothesis is that decreases in adipose-tissue derived factors during weight loss will be related to improvement in insulin function.

Severe obesity affects 4.7% of the U.S. population. A significant number of these individuals suffer from impaired glucose tolerance and type II diabetes due to insulin resistance (IR). Although it is generally accepted that the accumulation of intraabdominal (IA) fat increases the risk of developing IR, the mechanisms responsible for this phenomenon are not yet understood. In addition, the role of subcutaneous (SC) fat towards the etiology of IR - protective, inert or detrimental - is still under debate. This is because SC adipose tissue releases adipocytokines (IL-6, leptin, TNF- ) that have been demonstrated to impair insulin action. In individuals who are severely obese, hyperinsulinemia may induce an exaggerated production of adipocytokines from IA compared to SC fat stores. Our specific aims are: (1) to determine relative contribution of abdominal SC fat versus IA fat to systemic levels of IL-6, leptin and TNF- in lean and in severely obese individuals; (2) to determine the effects of systemic adipocytokine concentrations on whole body as well as tissue sensitivity to insulin. Hypothesis: (a) In the context of severe obesity, IA fat produces increased quantities of IL-6, leptin and TNF- compared to SC fat; (b) In severely obese patients undergoing weight loss, whole body and tissue IR can be predicted by changes in systemic adipocytokines. Methods: Adipose tissue content of IL-6, leptin and TNF- will be determined by ELISA in biopsies obtained from IA and SC fat stores in lean and severely obese patients. Computer tomography-determined areas of IA and SC fat will be related to changes in systemic adipocytokines at baseline and 6-mo following weight loss therapy. Changes in systemic IL-6, leptin and TNF- will be assessed from measurements made at baseline and following 6-mo weight loss. For this time period we will also determine changes in whole body (via IVGTT) and tissue sensitivity to insulin (via glucose uptake into muscle and fat). Relationships between systemic adipocytokines and IR will be assessed using uni- and multivariate correlation analysis. These novel studies will determine whether hypersecretion of adipocytokines by IA versus SC adipose tissue induces IR in patients with severe obesity.

Eligibility Criteria:
Inclusion Criteria:

Enrolled in weight treatment program at Emory Bariatrics

Exclusion Criteria:

Male Smoker
Performance of Endoscopic Submucosal Dissection According to the Sedation Method

Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. In the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. However, there are several limitations to the study including retrospective design. The investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.


Eligibility Criteria:
Inclusion Criteria:

1. Age, between 20 and 80
2. Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection
3. ECOG performance status 0 or 1
4. American Society of Anesthesiologist Physical Status 1, 2, or 3

Exclusion Criteria:

1. Previous subtotal gastrectomy
2. Previous gastrostomy
3. Repeated endoscopic submucosal dissection
4. Three or more synchronous lesions
5. Allergy to midazolam, propofol, fentanyl, or remifentanil
6. Pregnancy or breast milk feeding
7. Active infection
8. Significant cardiopulmonary disease
9. Active hepatitis or severe hepatic dysfunction
10. Severe renal dysfunction
11. Severe bone marrow dysfunction
12. Severe neurologic or psychotic disorder
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm

A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients (18+ years of age) with clinically suspected MIBC, without lymph node or distant metastases, written informed consent

Exclusion Criteria:

* Unable or unwilling to undergo mpMRI
* Unfit for TURBT
* Unfit for definitive treatment with curative intent
* A history of cancer, including bladder cancer, except non-melanoma skin cancer or prostate cancer on active surveillance
Citriodiol® and Impetigo

This study aims to investigate the efficacy and safety of topical p-menthane-3,8-diol (PMD)-rich Corymbia Citriodora oil (Citriodiol®) in children with impetigo. Citriodiol® is already known to be effective as an insect repellent and is safe in its topical application. The investigators have also found in our laboratory that it is bactericidal against Staphylococcus aureus, the bacteria responsible for causing impetigo. Parents are always searching for a natural alternative to antibiotics (the current gold standard treatment for impetigo), and the investigators believe Citriodiol® could provide this possible alternative.

The extract of lemon eucalyptus, a common plant, has since the 1970s been used in commercial insect repellent products. Recently, it has been shown that lemon eucalyptus has potent anti-bacterial and anti-fungal effects that should assist in the treatment of inflammatory conditions such as impetigo. Our aim is to investigate this further by investigating the safety and efficacy of this product in the treatment of Impetigo.

A randomised, double-blinded, three-armed pilot study, involving a total of 30 patients will be recruited from the dermatology outpatient department clinic at Royal North Shore hospital for this study. These patients will be between the ages of 12 months and 12 years with a clinical diagnosis of Impetigo.

The three treatment groups will include a 2% or 5% topical p-menthane-3,8-diol (extracted from lemon eucalyptus) and a topical Mupirocin arm, which will be applied topically twice a day till resolution of symptoms. Follow-up will occur weekly until resolution of symptoms, which is expected within 2 weeks. Photographs, disease severity assessment and lesional swabs for culture will be taken at recruitment and as progress.

Eligibility Criteria:
Inclusion Criteria:

* age between 12 months and 12 years
* dermatologist-confirmed impetigo
* written informed consent provided by parents

Exclusion Criteria:

* impetigo requiring oral/systemic therapy
* diagnosis of another form of staphylococcal or streptococcal disease (eg, cellulitis, erysipelas, abscess)
* serious local infection (eg, cellulitis, abscess, wound infection) or systemic infection
* oral or topical antibiotics
* known allergy to topical insect repellents
* patients receiving systemic corticosteroids, immunosuppressive agents, radiation therapy, chemotherapy within 1 month prior to entry into study
* history of any clinically significant or poorly controlled cardiac, haematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, psychiatric, and/or other major disease as determined by the investigator
* current enrollment in any other trial of an investigational drug within 30 days prior to study drug administration
* other unspecified reasons, in the opinion of the investigator that makes the patient unsuitable for enrollment.
Monitoring Analgesia by ANI (Analgesia The Nociception Index)

The objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. This period is defined by a 20% increase in FC and / or PAS (the only gold standard today).


Eligibility Criteria:
Inclusion Criteria:

* patient with IBD
* Scheduled surgery: laparotomy or laparoscopic resection with high risk of laparo-conversion

Exclusion Criteria:

* patient included in another current study or the previous month
* urgent surgery
* toxicomania or receiving opioids preoperatively
* pregnant woman
* psychosis
* betablocker treatment
* diabetic dysautonomia
* non-sinus heart rate
* pacemaker heart transplant
MRIdian "RADAR" Trial

The main purpose of this study is to see if treating cancer with the magnetic resonance imaging guided adaptive radiotherapy (MRIdian) can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants ages ≥ 18.
2. Solid tumors causing MESCC for which surgery is an option as first-line treatment.
3. Tumor histologies eligible for treatment include breast, prostate, sarcoma, melanoma, gastrointestinal types, NSCLC and renal cancers. Other solid malignancy types are also allowed at discretion of investigator if not specifically excluded by criteria.
4. MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement.
5. Bilsky scale ≥ 1c MESCC with tumor ≤ 1 mm from the spinal cord or cauda equina nerve roots anywhere from C1 to terminus of cauda equina on screening MRI.
6. Protocol defined MESCC must involve no more than 3 contiguous vertebral levels. MESCC can involve multiple non-contiguous spinal canal regions within those 3 contiguous vertebral levels.
7. Karnofsky performance score ≥60
8. Survival prognosis ≥3 months
9. Medical status allowing surgery.
10. Neurologic exam within 1 week prior to registration and again within 1 week of first treatment to rule out severe neurologic deficits caused by disease at site of cord compression.
11. Patients with mild to moderate cord neurologic signs are eligible if they are improved or stabilized by steroid. These neurologic signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function).
12. All patients must be ambulatory.
13. Numerical Rating Pain Scale within 1 week prior to registration (back pain permitted for enrollment)
14. Spine instability neoplastic score \< 14

    a. An exception to this criterion may be made if the patient is evaluated by a spinal surgeon and the surgeon defers surgery.
15. Willing and able to undergo daily MRI during treatment
16. Willingness and able to use an acceptable method of contraception during the study and for at least 6 months after stopping the therapy.
17. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
18. History and physical within 2 weeks prior to registration
19. Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

1. Unknown primary histology
2. Patients with rapid neurologic decline.
3. Bony retropulsion causing neurologic abnormality
4. Non-ambulatory patients.
5. Prior radiation to the involved site.
6. Inability to have an MRI
7. Pre-existing or concomitant neurological problems not related directly to MESCC (e. g., neurologic deficits due to brain metastases)
8. Very radiosensitive tumor histology (e.g., myeloma, seminoma, germ cell tumors, leukemia, and lymphoma)
9. Patients with impaired decision-making capacity.
Impact of Vitamin D on Acute Ischemic Stroke Prognosis

This is a registry for all patients admitted to hospital settings with Ischemic stroke in Mansoura University Hospital. The registry will capture patients' data, investigations and vitamin D level on admission. Follow-up is taking place using MODIFIED RANKIN SCALE


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed ischemic stroke not older than 48 hours

Exclusion Criteria:

* Ischemic stroke due to accidents or any trauma
Simultaneous Integrated Boost FDOPA Positron Emission Tomography (PET) Guided in Patients With Partially- or Non-operated Glioblastoma

Glioblastoma (GBM) is the most common primary brain cancer in adults. Surgery, chemoradiotherapy (temozolomide TMZ) and then adjuvant TMZ is the standard treatment. But, most patients relapse in a median time of 8-9 months; the median overall survival (OS) ranged from 15 to 18 months.

Some frail patients received hypofractionated radiation and concomitant and adjuvant TMZ. For some, the radiation dose is not optimal. Moreover, recurrences develop mainly in the initial tumor site. These two reasons justify increasing the dose. To limit the movements of these fragile patients, the method consists of increasing the dose without increasing the number of sessions by using the Simultaneous Integrated Boost (SIB) which increases the dose in targeted volumes while the rest of the volume receives a minimum dose. A phase I trial showed the possibility of increasing the dose in SIB up to 80 Gy in a part of the GBM enhanced on MRI.

FDOPA PET detects certain more aggressive tumor areas, areas likely to recur. Integrating them into the SIB seems appropriate. A phase II trial showed the interest of SIB guided by FDOPA PET in terms of progression-free survival but without impact on OS. This study differed from the one the investigators propose, because a dose and conventional fractionation, identical to that of the European Organization for Research and Treatment of Cancer/National Cancer Information Center (NCIC/EORTC) protocol were delivered, the gliomas were unmethylated MGMT, less likely to respond. Studies with SIB and hypofractionation are often retrospective and for others, hypofractionation was debatable and the dose increase was not based on PET capture but on MRI. However, a prospective phase II study, with SIB and hypofractionation, not integrating FDopa PET has demonstrated the relevance of SIB.

In this project, the investigators propose to use the integrated boost technique (SIB) guided by PET FDOPA to increase the radiation dose in GBM, in patients either fragile and partially operated, or only biopsied and for whom the prognosis is the most pejorative.


Eligibility Criteria:
Inclusion Criteria:

* Unfit patient without indication to the STUPP protocol :

Cohort 1 : Non-operable patients and ≥ 18 years old or ≤ 70 years old and Karnofsky Index (KI) ≥ 50% on inclusion AND Result of a biopsy available Cohort 2 : Patients \> 70 years old and Balducci score I or II and KI ≥ 60% on inclusion AND Partial resection (defined on the remnographic criteria of postoperative MRI) OR biopsy result available

* Histologically proven glioblastoma
* Increased metabolism of amino acids in PET FDOPA allowing contouring the Biological Target Volume (BTV)

Exclusion Criteria:

* Patients with an indication for irradiation according to the STUPP protocol (fit patient)
* Patient with a contraindication to MRI or PET
* Limit of the provisional target volume or Planning target volume (PTV), second PTV \< 2 cm from the chiasm and the optic nerves
* Absence of uptake of FDopa