cyrilzakka/clinical-trials huggingface dataset:
A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body

The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.

The study was conducted to determine the recovery of \[14C\]-CORT125134 after the administration of a single oral dose of \[14C\]-CORT125134, to determine the routes and rate of elimination of \[14C\]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood. Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces. Safety and tolerability were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or healthy females of non-childbearing potential (surgically sterilized or postmenopausal \[defined as a woman of with at least a 12 month history of amenorrhea with a follicle-stimulating hormone (FSH) \>40 international units per liter (IU/L) in the absence of a reversible medical iatrogenic cause\])
* Age 30 to 65 years of age
* A history of regular bowel movements (averaging ≥1 and ≤3 stools per day)
* Must be willing and able to communicate and participate in the whole study
* Must provide written informed consent
* Male participants must agree to use an adequate method of contraception
* Participants are willing to abide by the study restrictions

Exclusion Criteria:

* Participation in a clinical research study within the previous 3 months
* Participants who have previously been enrolled in this study or participants who have previously been treated with CORT125134
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 milliliter (mL) of 40% spirit or a 125 mL glass of wine)
* Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 parts per million (ppm)
* Females of childbearing potential (female participants must have a negative urine pregnancy test)
* Male Participants with pregnant partners
* Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. The measurement includes exposure from the present study, and diagnostic x rays and other medical exposures, but excludes background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999.
* Positive drugs of abuse test result
* Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol) or herbal remedies in the 14 days before study drug administration. Hormone replacement therapy is not permitted
Validation of Continuous Noninvasive Haemoglobin Monitoring by the Radical 7 Pulse CO-Oximetry Monitor After in Vivo Adjustment.

Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery. An in vivo calibration has been introduced to the device after our team found its need. The uncalilbrated validation of the Masimo Radical 7 continuous haemoglobin monitor has been made in various papers, although it has been compared to point of care devices, thus introducing an error as such point of care devices although validated for haemoglobin determination, are not as accurate as the gold standard. The validation of the gold standard calibrated device has not been described yet.

When compared to the accepted gold standard (cyanmethemoglobin method, Coulter), accuracy and precision of the continuous haemoglobin monitor could be good enough to be used interchangeably with the gold standard.

Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery.

The in vivo calibration has not been adjusted to the gold standard haemoglobin determination in the literature yet.

Two blood samples will be withdrawn at the same time from an arterial line, one for the central laboratory and the other one for the POC device. At the same exact time the SpHb measurement will be recorded. At least eight samples are expected per patient. A maximum of 20 samples will be withdrawn per patient.

To compare bias, precision and limits of agreement among SpHb, LabHb and COoxHb the Bland Altman method will be used with multiple observations per subject when the true value varies. An error grid analysis will be made to know how it could affect to clinical decision making.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients.
* Surgery duration of at least two hours.
* Patients scheduled to surgery under general anaesthesia and muscle relaxation.
* Radial arterial line needed for blood pressure control or other reason not related to the study.

Exclusion Criteria:

* Radial arterial line not indicated / not possible to place.
* Sampling difficult or impossible.
* Need to reposition arterial line arm during surgery.
* Any illness that could influence the haemoglobin measurement.
Cell Therapy of Cancer With Allogeneic Blood Lymphocytes Activated With Recombinant Interleukin-2 (rIL-2) for Metastatic Solid Tumors

The present protocol is designed to investigate the potential application of allogeneic cell-mediated immunotherapy in metastatic solid tumors similarly to the well established graft versus leukemia (GVL) effects in patients with hematologic malignancies.

Patients with metastatic solid tumors resistant to conventional modalities will be eligible to participate in a treatment program based on the administration of non-myeloablative immunotherapy (i.e. fludarabine, Cytoxan) followed by interferon injections; subsequently the patients will be treated with mismatched alloreactive donor lymphocytes activated in vitro and in vivo with rIL-2. The aim of this study is based on the recognition of foreign tumor cell surface alloantigens.


Eligibility Criteria:
Inclusion Criteria:

Consenting patients (age \< 70) will be eligible for participation in the study involving selective anti-tumor immunotherapy provided the following criteria are met:

* Evidence of cancer not expected to be cured with conventional modalities
* Pediatric patients: Chemotherapy-resistant neuroblastoma stage 4 and sarcomas. Adult patients: Metastatic breast cancer, malignant melanoma, renal cell cancer and selected cases of ovarian cancer, gastrointestinal cancer, small-cell and non-small cell lung cancer with non-bulky metastatic disease, and metastatic prostate cancer.
* Patients with measurable disease evaluable for response with anticipated life expectancy \> 3 months.
* Patients must be \> 2 weeks off of anti-cancer or potentially immunosuppressive treatment.
* Adequate ambulatory performance status (Karnofsky \> 80%; ECOG 0-1) to enable outpatient treatment.
* Compliant and cooperative patients anticipated to be evaluable for response according to the investigator's assessment.
* HLA-compatible (fully matched or single locus mismatched) donor available for allogeneic stem cell transplantation.

Exclusion Criteria:

* Patients with bulky disease or patients with brain metastases resistant to chemo-radiotherapy.
* Patients with a significant history or current evidence of potentially severe cardiovascular or lung disease, or other disease or clinical condition that may not permit accomplishing the planned treatment or drawing conclusions.
* Hepatic and/or renal failure.
* Evidence of serious active infection requiring antibiotic therapy.
* Pregnancy.
* Contraindication for donation due to donor disease: HIV-1; hepatitis B surface antigen (HBsAg) positivity.
Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Satisfy all informed consent requirements;
* Diagnosed with open-angle glaucoma or ocular hypertension;
* Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
* IOP measurements in at least 1 eye as specified in protocol;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
* Any form of glaucoma other than open-angle glaucoma;
* Severe central visual field loss in either eye;
* Chronic, recurrent or severe inflammatory eye disease;
* Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
* Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
* Intraocular surgery within the past 6 months;
* Ocular laser surgery within the past 3 months;
* Any abnormality preventing reliable applanation tonometry;
* Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
* Other protocol-specified exclusion criteria may apply.
Electronic Record Assimilation and Subsequent Eradication of Hepatitis C

Given the disproportionately high risk of chronic hepatitis C virus (HCV) infection in the baby boomer cohort, population-based screening has been demonstrated cost effective. Compared to point-of-care testing, however, bulk health messages with coupled lab requisitions delivered directly to patients meeting screening criteria via patient portals could improve HCV screening at minimal cost.

The Centers for Disease Control and Prevention (CDC) and the United States Preventative Services Taskforce (USPSTF) recommend a one-time hepatitis C infection (HCV) screen in individuals born 1945-65 (baby boomer birth cohort) and in others with risk factors for infection. National adherence to this Grade B recommendation-carrying the same strength of evidence as mammography, and screening for depression, alcohol abuse, and type 2 diabetes-is estimated to be 13.8%. Efforts to increase screening and linkage to HCV care, and also to understand barriers to screening and linkage are therefore warranted.

One such intervention, direct-to-patient messages via electronic medical record (EMR), has been demonstrated to improve adherence in influenza and pneumococcal vaccination, colon cancer screening, immunosuppression after transplantation, among others, but has not been studied as a strategy to improve HCV screening rates within health systems.

Our institution, Stanford Health Care, comprises 86 distinct clinical sites with approximately 1.25 million outpatient visits per year. All clinical sites are linked with an EMR (Epic Systems Corp.) and patients are encouraged to opt-in to receive and send health-related messages through a secure internet and smartphone portal, MyHealth. Approximately 60% of patients at our institution are enrolled in MyHealth.

MyHealth additionally allows bulk-messaging of patients meeting specific characteristics, e.g. patients due for influenza vaccination. Bulk messages can be coupled with laboratory or radiology requisitions. Messages are delivered through the online portal, text message, e-mail, and/or smartphone application notification, depending on patient preference. Laboratory and radiology results are routed automatically to patients' primary care physicians for review.

The investigators propose to conduct a randomized study comparing the effectiveness of a direct-to-patient electronic health message on HCV screening coupled with a lab requisition, versus HCV screening initiated by primary care clinicians as part of routine clinical care alone.

Eligibility Criteria:
Inclusion Criteria:

* persons born between 1945-1965
* having an activated patient portal to receive secure messages (MyHealth)
* no prior HCV antibody test within our EHR (electronic health record), including externally accessible results

Exclusion Criteria:

* documented HCV viral load in our EHR
* diagnosis of chronic HCV in their problem list
Study on the Development of Neonatal Cerebral Blood Flow Based on Ultrafast Ultrasound Doppler Imaging

Recently, with the development of perinatal medicine in China, the establishment of neonatal intensive care unit (NICU) and the improvement of respiratory support technology, the survival rate of preterm and term neonates has been significantly improved. However, the brain development of preterm neonates is incomplete compared with that of full-term neonates. Therefore, during the extrauterine cultivation of preterm neonates, clinical intervention should be carried out according to their brain development to achieve the same development status as that of full-term neonates. There are many clinical inspection methods to monitor the brain development of preterm neonates, such as EEG, functional near-infrared spectroscopy imaging, etc. However, these technologies cannot assess the brain development of premature infants systematically and completely. Because of the existence of neurovascular coupling, brain function and cerebral blood flow are closely related, so the detection of cerebral blood flow can reflect brain development and brain function. Ultrafast ultrasound power Doppler imaging technology is an emerging, real-time, high-resolution microvascular imaging technology. In this study, we first used ultrafast ultrasound power Doppler imaging technology to image the cerebral blood flow of preterm neonates at different gestational ages to evaluate the development of cerebral blood flow of preterm and term neonates and provide guidance for the clinical intervention of preterm neonates.


Eligibility Criteria:
Inclusion Criteria:

* neonates without cerebral diseases

Exclusion Criteria:

* neonates with cerebral diseases
Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI

The purpose of this research is to examine changes in blood glucose control and metabolism in individuals with SCI and non injured controls at rest and during exercise after five days of exposure to IH. This response will be compared with breathing normal room air (a SHAM control).


Eligibility Criteria:
Inclusion Criteria:

SCI only:

1. Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury for at least one year.
2. ASIA Classification A-D Overweight or obese as classified by a Body Mass Index (BMI) (kg/m2) of ≥ 25.0 (CON) and ≥ 22.0 (SCI).

SCI and non injured control:

Resting SaO2 ≥ 95%

Exclusion Criteria (SCI and non injured control):

1. Currently hospitalized
2. Resting heart rate ≥120 BPM
3. Resting systolic blood pressure \>180 mm Hg
4. Resting diastolic Blood Pressure \>100 mmHg
5. Self-reported history of unstable angina or myocardial infarction within the previous month
6. Previous cardiac surgery or condition that evidences ischemic heart disease
7. Cardiopulmonary complication such as COPD
8. Pregnancy determined by urine testing in sexually active females.
Simplified Medical Abortion in Rural India

It is estimated that around 50 000 women die every year due to consequences of unsafe abortion (Singh et al, 2009). A majority of these deaths occur in low-income countries where access to safe abortion care is limited. Unplanned pregnancy and unsafe abortion thus place a huge burden on scarce medical resources. Any improvement in Comprehensive Abortion Care (CAC) would mean important improvements for the concerned women and their families (Singh, 2006) as well as for the societies at large. Recommended improvements concern increased access to the safest and most cost-effective methods such as medical abortion provided at primary level facilities (Singh et al, 2009). A Cochrane Review concludes that most randomised controlled trials within the field of medical abortion are conducted in high-income settings with good access to emergency health care services (Kulier et al, 2004). A simplified regime for medical abortion, which could be used at primary level facilities, would contribute to the reduction of maternal mortality and morbidity related to unsafe abortions globally. However, there is a knowledge gap in order to determine if a simplified follow up of medical abortion is equally effective as the standard procedure in a low-income setting. The results will provide evidence-based information to be used in revising training and service delivery guidelines' in order to reduce maternal mortality and morbidity in both low and high-income setting.


Eligibility Criteria:
Inclusion Criteria:

* women presenting with a positive urine test and uterine size equivalent to or up to 9 +0 weeks (63 days) of gestation
* opting for medical abortion and
* residing in an area where follow-up is feasible.
* woman agrees for a follow up contact at 10-14 days.

Exclusion Criteria:

* women with contraindications to medical abortions,
* haemoglobin level less than 85 (Hb \< 85) and
* age less than 18 years.
Mydriatic Drops After Combined Surgery

The study goal is to evaluate the influence of mydriatic drops on the development of posterior synechia after combined cataract and vitrectomy surgery.

Cataract and vitreoretinal disorders often coexist, and with up to 80 percent chance for cataract formation following vitreoretinal surgery within the first year, combined surgery of phacoemulsification, pars plana vitrectomy (PPV) and intraocular lens (IOL) implantation has become increasingly accepted.

The main advantages of combined surgery include better visualization during surgery and the elimination of the need for additional surgery, which translates to overall quicker visual recovery and cost-effectiveness. Like the more exercised, two-step procedure, the combined surgery was shown to be safe and effective with relatively few complications. However, one complication seen more frequently after the combined surgery is postoperative anterior chamber inflammatory response, and with it, the formation of posterior synechia, reaching an average of 18 percent.

The development of posterior synechia interferes with postoperative visualization of the fundus, thus diminishing an important advantage of the combined procedure. Moreover, in a few cases, it can even be complicated by angle closure glaucoma.

Currently, there is no consensus on whether postoperative treatment after combined surgery should include additional treatment to help prevent the formation of synechia. The frequency and severity of posterior synechia after a combined operation may be reduced using short-acting mydriatics. However, there is no sufficient data nor a prospective study to support this as common practice. It is, therefore, we sought to better evaluate the effect of topical short-acting mydriatics on the formation of posterior synechia after combined surgery and compare it with standard postoperative treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent combined cataract and vitrectomy surgery with IOL implantation.

Exclusion Criteria:

* History of uveitis prior to surgery.
The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain

Many methods have been used in to treat low back pain. In this study, we aimed to investigate the efficacy of dexketoprofen alone and in combination with methylprednisolone in the treatment of low back pain in the emergency department using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI).This prospective, randomized, single-blind study included 150 patients admitted to the emergency department of a university hospital. Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group D) and those receiving dexketoprofen + methylprednisolone treatment (Group DM). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 and under 65 years.
* The patients who presented to the emergency department with acute non-traumatic low back pain.
* Voluntarily agreed to participate in the study.

Exclusion Criteria:

* The patients who had used analgesics within the last six hours;
* Who has neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain,
* Who has a history of dexketoprofen-related gastrointestinal bleeding or perforation, referred pain, neoplastic pain, a history of allergies to medications used in the study (methylprednisolone and dexketoprofen), or vision problems;
* Who indicated a pain intensity of 3 cm or less on the 10-cm VAS scale line at the time of their presentation to the emergency department; pregnant and breastfeeding women;
* The patients who were illiterate.
Somatostatin Receptor Imaging in NPC, EBV Related Cancers

The study aims to describe the avidity of somatostatin receptors in locally advanced, metastatic and locally recurrent nasopharyngeal cancer (NPC) and to determine the proportion of NPC patients with high somatostatin receptor density that may benefit from future somatostatin targeted therapeutic trial plans. The investigators also aim to determine the presence of somatostatin receptors in other EBV related cancers.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced, metastatic or locally recurrent NPC that are going for FDG PET as part of their investigations
* Patients that have gone for Ga-68 DOTATATE imaging before are eligible for repeat imaging
* Histologically confirmed NPC
* Above 21 years of age

Exclusion Criteria:

* Patients below 21 years of age
* Pregnant and breast feeding ladies
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Lupus

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Lupus

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Lupus. This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Lupus. Patients with Lupus will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous T-Cell vaccine will be utilized created from the patient's own cells obtained by apheresis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Lupus
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur