cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
* Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
* HCV treatment-naive or treatment-experienced
* Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)

Key Exclusion Criteria:

* Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non HCV etiology
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Topical Pharyngeal Anesthesia in Sedated Esophagogastroduodenoscopy

At recent, the number of patients who underwent sedated esophagogastroduodenoscopy has been on the increase. For such patients, whether topical pharyngeal anesthesia is needed remains to be controversial. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline for non-anesthesiologist administration of propofol for GI endoscopy have not made any recommendation, because the role of pharyngeal anesthesia during propofol sedation for upper digestive endoscopy has not been assessed. Our study aimed at investigating whether topical lidocaine pharyngeal anesthesia could benefit patients who underwent esophagogastroduodenoscopy under propofol sedation.

Propofol sedation has been widely applied in endoscopic examinations. For such patients, whether lidocaine topical pharyngeal anesthesia should be administrated is still in doubt. Considering the fact that lidocaine anesthesia may cause airway narrowing and anaphylaxis, it is important to clarify the role of lidocaine topical pharyngeal anesthesia in esophagogastroduodenoscopy under propofol sedation. Our study could test whether lidocaine topical pharyngeal anesthesia should be performed in sedated esophagogastroduodenoscopy in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 Years
* Patients who have indications for esophagogastroduodenoscopy
* American Society of Anesthesiology risk class 1, 2 or 3

Exclusion Criteria:

* Patients \<18 years
* Patients with thrombocytopenia (platelet count \< 50,000/microL) or elevated International Normalized Ratio (INR \> 1.5)
* Hemodynamic instability
* Pregnancy and lactation
* Patients who are unable or unwilling to give an informed consent
Effects of Nigella Sativa on T Cells and Cytokine Profile in Pediatric SLE Patients

The goal of this clinical trial is to learn if Nigella sativa oil works to improve SLEDAI Score in SLE pediatric student. It will also learn about the Treg, T helper cells, and cytokine of the patient. The main questions it aims to answer are:

Does Nigella sativa oil lower the SLEDAI Score in pediatric patient? How does the effects of Nigella sativa oil on Treg cells, T helper cells, and cytokine in pediatric patient? Researchers will compare Nigella sativa oil group to a placebo group (a look-alike substance that contains no drug) to see if Nigella sativa oil works to treat SLE in pediatric patients.

Participants will:

Visit the clinic once in the beginning for pre treatment checkups. Take Nigella sativa oil or a placebo every day for 8 weeks. Visit the clinic once every 4 weeks for checkups. Visit the clinic after 8 weeks for post treatment checkups.

SLE in paediatric patients requires long-term treatment with several side effects. Nigella sativa is known to have immunomodulatory effects. Our study aimed to investigate the immune-modulatory effects of Nigella sativa oil on T lymphocyte activity, inflammatory cytokine profile, and improvement of SLEDAI score in our patients. This was a placebo-controlled clinical trial of Nigella sativa oil administration in 32 paediatric SLE patients who were tested before and after treatment. The study subjects were randomly assigned. Patients had blood samples taken to be tested for T cell ratio, percentage of a number of cytokines (IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-17, and IL-10) using flow cytometry and CBA (Cytometric Bead Array), and SLEDAI score at the beginning of the study and after treatment. They were treated with 1 gram of N. sativa oil capsules and 1 gram of placebo daily for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric SLE patients aging between 1 and 18 years old according to the 2010 ACR-EULAR criteria
* Being under treatment with prednisone, hydroxychloroquine, and mycophenolic acid
* Not receiving any biological agent or cytokine inhibitors for at least 2 months prior to the intervention

Exclusion Criteria:

* Patients with any metabolic disorders (diabetes mellitus, Cushing's syndrome, and thyroid dysfunctions), any kidney or liver diseases, chronic inflammatory diseases (including inflammatory bowel diseases),
* Patients with history of taking antioxidant or anti-inflammatory supplements 2 months prior to the interventions
Genetic Influences on Statin Blood Concentrations in African Americans

This study intends to determine the effects of genetic polymorphisms on statin response and daily systemic exposure (24-hour area under the time-concentration curve) of statins in African-American patients.


Eligibility Criteria:
Inclusion Criteria:

* African-American patients taking a statin metabolized by CYP3A (e.g., atorvastatin, simvastatin, or lovastatin)

Exclusion Criteria:

* Age less than 18 years
Effectiveness of an 8-week Posterior Shoulder Stretching Program on Varsity-level Overhead Athletes

To Determine whether an eight-week posterior shoulder stretch was effective in increasing dominant arm internal rotation(IR) and horizontal adduction (HAd) range of motion (ROM) in a group of overhead athletes identified as having tightness of their posterior shoulder structures.


Eligibility Criteria:
Inclusion Criteria:

* varsity level athletes involved in volleyball, tennis and swimming with internal rotation deficit of greater than or equal to 15 degrees

Exclusion Criteria:

* previous surgical procedure or fracture of either shoulder or presently receiving treatment for condition affecting either shoulder
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart.

The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for at least 12 months
* Current treatment with any basal bolus insulin for at least 12 months
* HbA1c below or equal to 10.0%
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* For Japan only: Minimum age is 20 years
* For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)

Exclusion Criteria:

* Use of any other antidiabetic drug than insulin within the last 3 months
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
* Cancer and medical history of cancer
Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study

The purpose of this study is to determine whether isotretinoin is helpful in treating patients with an adverse cutaneous drug eruption known as toxic epidermal necrolysis (TEN).

Toxic epidermal necrolysis (TEN) is a potentially life-threatening skin disorder characterized by widespread redness, blistering and peeling of skin.

Currently, supportive care in the standard treatment for patients with TEN. Isotretinoin, an FDA-approved medication commonly used for treating severe acne induces differentiation of certain inflammatory cells and thus may potentially be helpful in treating patients with TEN.

This is a randomized, placebo-controlled, double-blind, pilot study comparing the efficacy and safety of isotretinoin versus placebo in treating subjects with toxic epidermal necrolysis (TEN).

Approximately 40 subjects who satisfy all inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either isotretinoin or placebo which they will take for up to 14 days. The end of the study is defined as the time the subject is discharged from the hospital. Participants will primarily be assessed for percent body surface affected (BSA) and number of days of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

1. 18 - 69 years of age
2. Has biopsy-proven toxic epidermal necrolysis (TEN)
3. If female, should not be of childbearing potential defined as:

   * Have not had menstrual periods for 12 months in a row (menopause) OR
   * Had bilateral oophorectomy or total hysterectomy OR
   * Have a ovarian disorder that would make pregnancy not possible

Exclusion Criteria:

1. Unknown HIV status and unwilling to undergo HIV testing
2. Women of childbearing potential
3. Pregnancy
4. Breastfeeding
5. Fasting serum triglyceride levels \>25% of upper limit of normal
6. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase levels \>2× upper limit of normal (ULN)
7. Known allergy to isotretinoin
8. History of suicidal attempt, psychosis, major depression or other serious mood disorders
9. Currently taking vitamin A supplements, tetracyclines, phenytoin, corticosteroids, IVIg or St. John's Wort
10. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
11. Participation in an interventional study within the past 30 days.
Urinary NGAL Acute Kidney Injury After Stored Red Blood Cells Transfusion in Critically Ill Patients.

The study aims to explore the association of the novel urinary bio marker NGAL with the age of PRBCs(packed red blood cells) transfusion in critically ill patients.

The investigators will measure the urinary NGAL in all patients who received blood transfusion in the intensive care unit during the study period. The age of PRBCs transfusion will be correlated with the incidence of AKI. The rise of NGAL and serum creatinine will be used to diagnose AKI (Acute Kidney Injury).

Eligibility Criteria:
Inclusion Criteria:

* Any patients admitted to the intensive care unit.

Exclusion Criteria:

* patients who have established AKI at the time of recruitment
Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation

This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).

This study plans to investigate the relationship between cognitive status pre-procedure, as assessed using the Montreal Cognitive Assessment (MoCA) administered on a tablet, and clinical outcomes at 3 months as assessed by the VARC2 criteria, in patients undergoing transcatheter aortic valve implantation (TAVI)

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* Scheduled to undergo TAVI
* Provide informed consent
* Able to understand French

Exclusion Criteria:

* subjects under legal guardianship or other legal protection
* subjects with documented severe dementia
* subjects with anticipated poor compliance
* subjects unable to understand French sufficiently well to perform the MoCA test
* pregnant women
* subjects within the exclusion period of another study
Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain

To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of patients with spinal cord injury.

This is a randomized, placebo-controlled, double-blinded trial. Sixty spinal cord injured subjects with neuropathic pain will be randomized into two groups. The subject in the Treatment Group will receive lithium carbonate tablet, while the Control Group will receive placebo tablet. Neither the subjects nor the physicians know which group the subjects are allocated.

Each subject will receive 6 weeks of oral lithium carbonate or placebo. In the Treatment Group, the dose will be adjusted according to the serum lithium level. While in the Control Group, the dose will be adjusted based on the dummy serum level report.

The outcome will be assessed during visits at 1 week, 2 weeks, 6 weeks and 12 weeks, and a phone call follow-up at 24 weeks from the start of the medication. The primary outcome measure is the severity level of pain. The efficacy and safety will be analyzed by comparing the results of the Treatment Group with those of the Control Group

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65;
* Diagnosis of traumatic spinal cord injury;
* Clinically diagnosed neuropathic pain;
* Pain severity is at least 4 on a 11-point numeric rating scale at screening;
* Pain present regularly for at least 6 weeks before enrollment;
* Able to understand instructions and provide reliable pain assessments;
* Subjects who are voluntarily signed and dated an Ethics Committee approved informed consent form;

Exclusion Criteria:

* Significant renal, cardiovascular, hepatic, infectious or psychiatric disease;
* Significant brain injury with neurological deficits;
* Debilitation or dehydration;
* Addison's disease;
* Recent (within 1 week) or current use of anti-diuretics or other drugs that interacts with lithium, such as tricyclic antidepressants, nonsteroidal antiinflammatory drug and tetracyclines;
* A history of substance or alcohol abuse within past 1 year;
* A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period;
* Current pregnant or breast feeding, or female who has childbearing potential but is not willing to use an approved method of birth control;
* Participation in any drug study in the last three months;
* History of oral lithium intake for any reason; or
* any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Assessment of DHA On Reducing Early Preterm Birth

The purpose of this study is to determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).

Docosahexaenoic acid (DHA) is a nutrient found in some fish and eggs and its intake in US diets is typically low. Because DHA is important for early brain development, it has recently been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants in this study are guaranteed to receive at least 200 mg/day of DHA.

Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to predict which births will occur before 34 weeks. In an earlier study conducted at the University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had fewer births before 34 weeks of pregnancy with fewer complications of preterm birth.

This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA (1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before 34 weeks of pregnancy). Individual participation in this study is expected last about 5 months.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females 18 years and older 12 to 20 weeks gestation at study entry
* Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
* Available by telephone
* Able to speak and read in either English or Spanish language

Exclusion Criteria:

* Expecting multiple infants
* Gestational age at baseline \<12 weeks or \>20 weeks
* Unable or unwilling to agree to consume capsules until delivery
* Unwilling to discontinue use of another prenatal supplement that contains greater than or equal to 200 mg DHA per day
* Women with allergy to any component of DHA product (including algae), soybean oil or corn oil
F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer

The purpose of this study is to demonstrate that realization of guided biopsies by multimodal imaging with 18F-fluorocholine PET / CT and MR Imaging/spectroscopy would allow to increase the rate of detection prostate cancer compared with the current approach and give an information about location and tumoral volume before surgery.:

1. To evaluate the utility of F-18-FCH-PET/CT and MR imaging with 3-D MR spectroscopy in detecting, localizing, and estimating the volume of initial primary prostate cancer as compared to the current standard work-up using TRUS-guided biopsy. All imaging findings will be correlated with "gold standard" step slice histological examination. The hypothesis is that the combination of noninvasive imaging will improve the preoperative work-up as compared to the current approach.
2. To evaluate FCH-PET for the restaging of prostate cancer after biochemical relapse in a large patient cohort. This will run in parallel to the work-up of primary prostate cancer, as the FCH radiopharmaceutical will be available during the time of study at absolutely no cost to patients or CHUV. A number of studies have demonstrated the benefits of F-18-FCH-PET/CT for these patients and this indication is currently not reimbursed by Swiss obligatory health insurance providers.

Eligibility Criteria:
PRIMARY PROSTATE CANCER

Inclusion Criteria:

* Age ≤ 80 years
* Karnofsky index ≥ 80
* First prostate biopsy
* Presence of at least one of the following:

  * Total PSA 10 ng/mL
  * Total PSA 2.5-10 ng/mL with free-PSA \<20% and/or PSA velocity 0.75 ng/mL/year
  * Suspicious hypoechoic lesion at TRUS and/or suspicious finding at digital rec¬tal examination
* Informed signed consent.

Exclusion Criteria:

* Impaired capacity to consent
* Coexistence of clinically-proven prostate cancer
* Neoadjuvant hormonal treatment (including 5-α reductase inhibitors)
* Contraindications to surgery
* Contraindications to MR Imaging (see below)

PROSTATE CANCER RELAPSE

Inclusion Criteria:

* Age ≤ 90 years
* Karnofsky index ≥ 80
* Previous treatment for prostate cancer
* No clinical recurrence based on standard work-up (abdominal / pelvic CT, MRI, and bone scintigraphy)
* Biochemically proven relapse of prostate cancer (PSA \> 0.2 ng/mL after prostatectomy, nadir PSA+2 ng/mL (Phoenix definition) or ≤ 3 successive rising PSA levels (ASTRO definition) after curative radiotherapy).
* Informed signed consent.

Exclusion Criteria:

* Coexistence of another clinically-proven cancer
* Contraindications to surgery or radiation therapy treatment
Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon

This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator.

Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.

Study Design:

Randomized-controlled clinical trial. Patients will be enrolled within 4 days of mechanical ventilation and randomized 1:1 to titration of PEEP based on esophageal balloon pressures or based on the "High PEEP" ARDSnet PEEP/fraction of inspired oxygen (FiO2) table. All patients will have esophageal balloons placed with baseline measurement of Ptp. Patients randomized to the intervention arm will then undergo titration of PEEP based on Ptp measurements to achieve "Optimal PEEP," defined as end expiratory Ptp of 0 to +2 cm water (H2O).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index greater than or equal to 40
* Acute respiratory failure requiring mechanical ventilation

Exclusion Criteria:

* Refusal to give consent by the subject or their legally authorized representative
* Abdominal compartment syndrome
* Chest tube for pneumothorax
* Having been on a ventilator for \>4 days
* Suspicion of or known intracranial hypertension
* Anticipated extubation within 24 hours
* Chronic ventilator dependence
* Condition that precludes placement of an esophageal balloon (esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter, severe thrombocytopenia or coagulopathy)
* Incarceration
A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943

The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 30 kg/m2
* History of at least 1 self-reported unsuccessful dietary effort to reduce body weight

Exclusion Criteria:

* Change in body weight of greater than 5 kg (11 pounds) within 3 months prior to start of study
* Any of the following treatments for obesity within 1 year prior, or plan to undergo any of these during the study period: liposuction, cryolipolysis, or abdominoplasty
* Prior or planned bariatric or gastric sleeve surgery, endoscopic therapy, or device-based therapy for obesity
* Type 1 or Type 2 Diabetes, history of ketoacidosis, or hyperosmolar state
* Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2
* Acute or chronic hepatitis
* Had within 90 days prior: acute myocardial infarction, cerebrovascular accident (stroke), coronary artery revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure
* History of active or unstable major depressive disorder or other severe psychiatric disorder within 2 years prior
* History of chronic or acute pancreatitis
* Blood transfusion or severe blood loss within the last 3 months or hemoglobinopathy, hemolytic anemia, sickle cell anemia
* Clinically significant multiple or severe drug allergies
* Started treatment with or changed dose within 12 months prior any medications that are associated with significant weight gain
* History of substance use disorder