cyrilzakka/clinical-trials huggingface dataset:
Rosuvastatin Interethnic PK Study

Statins are the first-line and most commonly prescribed drugs for the prevention of cardiovascular diseases and stroke in the world. Our preliminary studies suggest that Caucasians might have a higher risk of developing potentially life-threatening drug-drug interactions than Asians when taking statins. Drug-drug interactions occur in the body when two or more drugs interact in a way that alters their effectiveness and/or toxicity. These interactions are becoming an increasingly severe problem with statin usage since patients at higher risk for cardiovascular diseases also take statins combined with many other drugs, such as antihypertensive and diabetic drugs. Our study is aimed at understanding the molecular factors and providing a sound basis for the interethnic dosage and response differences for statins.

Drug-transporting proteins in intestine and liver tissues are responsible for taking up statins into the blood. It is hypothesized that there are interethnic function differences of these proteins and that they account for differences in statin blood levels between Caucasians and Asians and the frequency and/or severity of their respective drug-drug interactions. A clinical study will be conducted with Caucasian and Asian subjects undergoing gastric bypass surgery so excess intestine and liver tissue can be acquired as part of the standard procedure. Protein levels will be quantified in the tissues and correlate them with different statin blood levels.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that are scheduled for bariatric surgery.
* Subjects that are able and willing to donate surplus intestinal tissue.
* Subjects with solute carrier organic anion transporter \*1 (SLCO1B1) and breast cancer resistant protein (BCRP) 421CC genotypes.
* White/Caucasian/European and Asian/East Asian heritage individuals, male or female, 18 years of age or older.
* BMI between 30-55 kg/m2
* Be able to read, speak, and understand English(UCSF) and Chinese(Taiwan).
* Subjects capable of providing informed consent and completing the requirements of the study.

Exclusion Criteria:

* Subjects with active liver and kidney problems, severe cardiovascular diseases, type I diabetes, advanced pulmonary disease, and cancers.
* Subjects on chronic prescription or over the counter medication that have previously been reported to exhibit drug-drug interactions with rosuvastatin and cannot be stopped two weeks prior to and during the study, including gemfibrozil, cyclosporine, atazanavir, lopinavir and ritonavir.
* Subjects incapable of multiple blood draws (HCT \< 30mg/dL).
* Subjects with a history of rhabdomyolysis.
* Subjects with a history of drug-related myalgias.
* Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias.
* Subjects with a history of GI bleed or peptic ulcer disease.
* Subjects with a recent history of trauma.
* Subjects who smoke tobacco or have ongoing alcohol or illegal drug use.
* Subjects who are pregnant, lactating, or trying to conceive during the study period.
* Subjects allergic to rosuvastatin or any known component of the medications.
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels, drug effects, and immunogenicity of BMS-986326 after infusion or injection in healthy participants. The results of this study will guide the selection of the dose range, dosing frequency, and the route of administration for future studies of BMS-986326 in participants with immune-mediated diseases.


Eligibility Criteria:
Inclusion Criteria:

* In good health, as determined by the investigator based on a physical examination at screening
* Body mass index (BMI) ≥ 18 and ≤ 30 kg/m\^2 at screening
* Afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg and supine diastolic BP ≥ 50 and ≤ 90 mmHg and heart rate ≥ 50 and ≤ 90 bpm at screening
* Male participants are eligible to participate in cohorts (A1-B3).Women not of child bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3 and C1-C2) Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3 and C1-C2)
* Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Women who are pregnant or lactating
* History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
* History of serious adverse reaction or hypersensitivity to any (subcutaneous) SC- or (intravenous) IV-administered biological therapeutic, including IV immunoglobulins and human blood products

Other protocol-defined inclusion/exclusion criteria apply
Safety Evaluation of Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients

Propofol is often used for sedation in children undergoing magnetic resonance imaging. The investigators will perform a chart review of 4 month of activity (about 100 cases) and review the incidence and severity of adverse events of this sedation technique.

Magnetic resonance imaging in children, especially under 6 years of age, is often performed under sedation. Propofol is a common drug used in this settings. In our institution, sedation is most often done by a propofol bolus of 2-5 mg/kg in order to reach a deep level of sedation as defined by Coté et al. If judged necessary by the attending anaesthesiologist, a additional propofol bolus of 0.5-1 mg/kg may be given. For longer lasting exams, the attending anaesthesiologist can chose to use a continuous infusion of propofol. The investigators will review the charts of 4 month of magnetic resonance imaging, which will give us a cohort of about 100 patients. Baseline characteristics, detailed sedation technique used will be recorded. Adverse events defined as:

* Oxygen desaturation measured by transcutaneous oximetry SpO2≤94%
* hypercapnia measure by end-tidal CO2 \>45 mm Hg
* movement of the patient

Assuming a non-normal distribution (tested by a Kolmogorov-Smirnov test), variables will be reported as median and interquartile range. Statistical tests will be done by non-parametric tests, Mann Whitney U. Non continuous variables will be analyzed by a Chi-square test.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients scheduled for MRI under sedation by an anaesthesiologist
* Age \< 16 years

Exclusion Criteria:

* Age \> 16 years
* Sedation performed by a non-anesthesiologist
Educational Strategy in Exchange Transfusion

Abstract

Background: Exchange transfusion is a highly complex procedure that requires high levels of expertise. Paediatricians trainees do not have adequate training because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusions that allow the students to develop competencies to perform the technique in an appropriate and safe way.

Methods/design: A randomized parallel single-blind clinical trial with allocation by simple randomization to the educational intervention (simulation or a digital didactic environment). Students from the paediatric specialization who volunteer to participate will be included. A practical evaluation of the procedure will be performed through a simulated scenario using a standardized clinical case. The main outcome is defined as the result of evaluation using the Objective Structured Clinical Examination; superior performance will be defined when the percentage is greater than or equal to 85%, and nonsuperior performance will be defined when the result is less than 84%. The chi-square independence test or the Fisher exact test will be used to evaluate the effect of the interventions. Multivariate analysis will be performed using a non-conditional logistic regression model. Stata 14 ® software will be used.

Discussion: Exchange transfusion is a procedure that requires expertise to achieve adequate outcomes. The inclusion of new educational strategies, such as simulation and digital didactic environments, is seen as a training option that can improve performance in clinical skills, reduce adverse events and increase the level of trust.


Eligibility Criteria:
Inclusion Criteria:

* o Men and women of legal age who are students enrolled in a paediatrics specialization programme at Colombian university medical schools.

  * Students in any year of specialization in paediatrics.

Exclusion Criteria:

* Students who are, as part of their curriculum, in a rotation outside the country.
YSPSL for Prevention of Delayed Graft Function Part A

Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced kidney injury and resultant DGF. PSGL-1 is a ligand for P-, E-, and L-selectin. It has been reported that that YSPSL (rPSGL-Ig) blocks P-selectin and, to a lesser degree, E- and L-selectin. Both sPSGL-1 and YSPSL (rPSGL-Ig) have been shown in animal models to reduce both cytokines and tissue damage associated with ischemia reperfusion and to improve renal function post-transplant. Therefore, the current phase I/II clinical study is designed to assess the safety and efficacy of YSPSL (rPSGL-Ig) in preventing DGF in patients undergoing cadaveric kidney transplants and to determine a dose for future pivotal studies.

This will be a multicenter, single-dose, dose-escalation study. The study will be in 2 parts: the first, Part A, will be an open label evaluation of single doses of four dose cohorts and the second, Part B will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation study of two dose cohorts. Patients who are undergoing cadaveric kidney transplantation and are at risk for development of DGF, based upon known risk factors, will be eligible to participate in the study. A maximum of 24 patients will be enrolled in Part A of the study. 60 patients will be enrolled in Part B.

Eligibility Criteria:
Inclusion Criteria:

* primary cadaver renal transplants Other inclusion criteria delineated in protocol

Exclusion Criteria:

* Full criteria delineated in protocol Patient has a planned transplant of a donor kidney from a non-heartbeating donor; Patient has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant) or from donors \<6 years of age; Patient has a planned transplant of a kidney from a donor who has received investigational therapies designed to reduce the impact of ischemia/reperfusion (I/R) injury, DGF, or other donor-related immune events; Patient is planned to receive a living donor kidney; or Patient is planned to receive an ABO-incompatible donor kidney.
Health Promotion and Fitness for Younger and Older Adults With SMI

The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only.

The three specific aims of this study are to:

1. To compare the treatment groups with respect to improvement in physical fitness outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and (b) indicators of physical fitness.
2. To compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy.
3. To explore differences in the treatment groups with respect to psychosocial functioning, health status, and acute service use, and the effects of selected demographic, clinical, and health behavior variables on primary outcomes.

Individuals with SMI die 10-25 years earlier than the general population and have disproportionately greater rates of medical comorbidity and disability associated with high rates of obesity, sedentary lifestyle, metabolic syndrome, and poor dietary habits. Despite greater costs and adverse outcomes associated with the combination of mental illness and poor physical health, little attention has been paid to the development of health promotion interventions designed to address the needs of the high-risk group of people with SMI. This study is testing an innovative approach to reducing these problems and developing a program that will potentially have a downstream effect on early mortality for the vulnerable population of people with SMI.

Eligibility Criteria:
Inclusion Criteria:

* age 21 or older
* serious mental illness defined by an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia
* persistent impairment in multiple areas of functioning (e.g., work, school, self-care)
* body mass index (BMI) greater than 25
* able and willing to provide informed consent
* on stable pharmacological treatment (same psychiatric medications over prior 2 months)

Exclusion Criteria:

* residing in nursing home or other institution
* diagnosis of dementia or significant cognitive impairment (MMSE\<24)
* unable to walk one city block
* pregnant or planning to become pregnant within the next 18 months
* unable to speak English
* terminal illness with life expectancy\<1 year
* current diagnosis of an active substance dependence disorder
Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.


Eligibility Criteria:
Inclusion Criteria:

* women in active labor

Exclusion Criteria:

* known contraindications to epidural analgesia
* moderate to severe systemic illness as evidenced by an American Society of Anesthesiologists (ASA) score of 3 or higher.
* known abnormalities of the spinal column
* any neurologic illness
* multiple gestations, fetal abnormalities or fetal presentation other than vertex
* recent history of analgesic usage
* an inability to communicate in English or French
* Body Mass Index greater than 40
* patients in pain requesting an immediate epidural
Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function and Cognition in CKD

The study is primarily designed to examine the effect of 16 weeks of prebiotic supplementation (resistant starch)and moderate intensity aerobic training on markers of inflammation in stage 3-4 patients with chronic kidney disease.

The primary aim of the proposed study is to determine whether the consumption of a prebiotic supplement (resistant starch) coupled with moderate intensity endurance training over 16 weeks leads to reductions in key inflammatory markers in stage 3-4 predialysis CKD patients and whether this reduction is associated with favorable changes in vascular function and indicators of stress and emotional reactivity.

The investigators hypothesize that supplementation with the prebiotic (resistant starch) will lead to normalization of the microbiome of our sample of patients with chronic kidney disease (CKD) and reduce key markers of inflammation. Reductions in these biomarkers will be associated with favorable changes in cardiovascular variables along with indices of stress and emotional reactivity. Moderate intensity aerobic training will have an additive anti-inflammatory effect along with the consumption of the resistant starch.

Eligibility Criteria:
Inclusion Criteria:

* stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2),
* ages of 30-75 years old,
* Must be capable of complying with and following the study protocol(diet and exercise)
* Must be capable of independently giving informed consent

Exclusion Criteria:

* kidney transplant
* currently in a structured exercise program
* on antibiotic therapy within the last month
* On a probiotic or prebiotic supplement within the last month
* a GI disorder that prohibits the use of resistant starch (ie. high-amylose corn starch, which resists digestion
* HIV positive
* gastric by-pass surgery
* clostridium difficile
* marijuana user
* lupus
* rheumatoid arthritis
* Hepatitis C
* Post-traumatic stress disorder
* deep vein thrombosis
* pancreatitis
Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy

Acute cholecystitis is frequent in the elderly, or in patients with gall stones. Most cases of severe or recurrent cholecystitis need surgery as final therapy. Today, the performed procedure in most cases for cholecystectomy in the western world is laparoscopic cholecystectomy. Only in some cases an open surgery has to be performed. Unclear is, what time point is best, concerning outcome and morbidity of the patient, immediate surgery or initial conservative therapy using antibiotics and symptomatic therapy with cholecystectomy later on. Today the performed procedure is mainly chosen by the fact, what doctor sees the patient first, surgeon or gastroenterologist. This study is performed to evaluate if one therapy is superior.


Eligibility Criteria:
Inclusion Criteria:

* Patients of age \> 18 years
* Patients with acute cholecystitis based on three of the following signs

  * abdominal pain in the upper right quadrant
  * Murphy's sign
  * leucocytosis \> 10 /ml
  * rectal temperature \> 38 °C or \< 36.5 °C plus
  * cholecystolithiasis (stones / sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall)
* Immediate antibiotic therapy (400 mg Moxifloxacin i.v. once a day)
* Laparoscopic cholecystectomy possible within 24 hours after presentation of the patient
* Informed consent

Exclusion Criteria:

* ASA IV and V (table 2)
* Septic shock
* Perforation or abscess of the gall bladder
* Impossibility of laparoscopic surgery (further surgery, surgeon, ...)
* Additional need of antibiotics due to secondary disease
* Known intolerability of Moxifloxacin
* Known or possible pregnancy, breast feeding
* Life-threatening diseases (life-expectancy \< 48 hours)
* End-stage liver disease (Child-Pugh C)
* Psychiatric or severe neurologic disease
* Relevant bradycardia or other symptomatic arrhythmias
* Significant cardiac disease
* Known long QT-disorders
* Electrolyte disorders, especially hypocalcemia
* Known intolerability of chinolones
* Earlier participation in this trial
Ureteral Stenting After Retrograde Intrarenal Surgery for Renal Stones

Several studies evaluated the benefit of a short-term external ureteral catheter (UC) compared to double-J (DJ) ureteral stent after flexible ureteroscopy (URS); the results were controversial. These studies had combined analyses of ureteral and renal stones with a high risk of selection bias. Studies comparing external UC and DJ stent after flexible URS for isolated renal stones are lacking.

In the present study, the investigators will compare the outcomes of using a one-day external UC versus a DJ internal ureteral stent for ureteral drainage after retrograde flexible URS (retrograde intrarenal surgery "RIRS") for renal stones. The investigators aim to identify the best ureteral drainage method after RIRS regarding stone clearance, complications, and stent-related symptoms.


Eligibility Criteria:
Inclusion Criteria:

• Adult patients of either gender in whom RIRS was the primary modality.

Exclusion Criteria:

* Pregnant women
* Active urinary tract infection
* solitary kidney
* Concomitant pathology that need intervention in the same setting
* Patients with surgical incidents that indicate double-J stenting (Residual sizable fragments, ureteral false passage, ureteral mucosal laceration, ureteral perforation, and calyceal rupture).
Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder

The purpose of the study is to collect more data about performance and safety of the device called "IrisFITTM PFO occluder". This data will be used to help more patients who will accept treatment with this device in the future.

Patients will undergo routine examination, procedure and follow-up. Related data will be collected and kept in a way that patient info is well protected.

This is a Post Market Clinical Follow-up study. Informed consent will be obtained from the patient or from a legally authorized representative of the patient at screening. The patients will be screened (pre-procedure) to determine eligibility for the study. At screening, patients will be assessed for study eligibility by the inclusion/exclusion criteria through their medical history, demographics and transthoracic echocardiography (TTE). Participating patients will have their PFO closed using the IrisFITTM PFO Occluder device. The patients will undergo a clinical examination, electrocardiogram (ECG), clinical laboratory assessment and transthoracic echocardiography (TTE). All periprocedural procedures will be performed according to site´s standard of care.. The efficacy and safety of the devices will be assessed by ECGs, vital signs, physical examination and TTE, which will be done at 1day, at 1month and at 6 months post procedure. Safety will also be assessed at 12 months by telephone visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are according to current international or local guidelines (and future revisions) and per physician discretion scheduled for interventional treatment of PFO.
* Patients who are willing and capable of providing informed consent and participating in all testing/or follow procedure associated with this study.
* Patients who are eligible for treatment with IrisFIT PFO occluder device. (Per physician discretion and device IFU).

Exclusion Criteria:

* PFO tunnel length \<1 mm
* Women of childbearing potential who are or plan to become pregnant during the time of the study (method of assessment upon physician's discretion)
* Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
Safety and Efficacy of Radiotherapy Plus Sintilimab for HCC With Portal Vein Tumor Thrombosis

The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.

The patients were divided into two groups. The first group: the single dose of radiotherapy was 200 cGy, once a day, the total dose was 5000 cGy. The second group: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.
2. Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches)
3. Has at least 1 measurable lesion
4. Age ≥18 years
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. Adequate organ function
7. Child Pugh class A
8. Life expectancy ≥12 weeks.
9. Antiviral therapy per local standard of care for hepatitis B
10. Woman of child bearing potential must have a negative pregnancy test
11. Must use acceptable form of birth control while on study

Exclusion Criteria:

1. Has previously been performed by raditotherapy for the area to be treated.
2. With extrahepatic metastasis
3. History of hepatic encephalopathy or liver transplantation
4. Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive
5. Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes
6. Has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment
7. With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable
8. Evidence of active pulmonary tuberculosis (TB)
9. Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
10. History of allergic reactions to related drugs