cyrilzakka/clinical-trials huggingface dataset:
Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents

Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. 12-18 years
3. HCV RNA ≥ 104 IU/mL at screening.
4. Confirmed chronic HCV infection as documented by either:

   a. a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or
5. Screening ECG without clinically significant abnormalities.
6. Patients must have the following laboratory parameters at screening:

   * ALT (Alanine transaminase) ≤ 10 x the upper limit of normal (ULN)
   * AST (Aspartate Aminotransferase) ≤ 10 x ULN
   * Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female patients
   * Platelets \> 50,000 cells/mm3
   * INR (international normalized ratio) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
   * Albumin ≥ 3 g/dL
   * HbA1c ≤ 10%
   * Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
7. Patient has not been treated with any investigational drug or device within 30 days of the screening visit.

Exclusion Criteria:

1. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis).
2. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
3. History of solid organ transplantation.
4. Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome).
5. History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
6. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
7. History of significant pulmonary disease, significant cardiac disease or porphyria.
8. History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
9. Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1.
10. Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients.
Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis

Separated and expanded the CD4+CD25+CD127- Tregs from peripheral blood of autoimmune hepatitis patients and administrate the cells (5 x 106 cells/kg) into patients.

The trial will be carried out in autoimmune patients. The investigators will isolate CD4(cluster of differentiation)+CD25(cluster of differentiation25)+CD127(cluster of differentiation127)- Tregs from these patients, and expand them with IL(interleukin)-2 retinoid acid and anti-CD3(cluster of differentiation 3) /CD28(cluster of differentiation 28) beads. The patients will be subsequently treated with single infusion of CD4+CD25+CD127- Tregs (10-20 x 106 cells/kg).

In the clinical trials, the investigators will monitor the number of Tregs in patients at different periods, and to test their suppressive functions in vitro. Also the function and biopsy of liver will be processed to determine the efficacy of Treg therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Autoimmune hepatitis(according to the criteria defined by the international autoimmune hepatitis Group ,Hepatology, 2008;48:169-176)
3. Negative pregnancy test
4. Moderately active disease under standard treatment

Exclusion Criteria:

1. Hepatocellular carcinoma or other Malignancies
2. Pregnant or lactating women
3. Vital organs failure (Cardiac, Renal or Respiratory, et al)
4. Sepsis
5. Active thrombosis in the portal or hepatic veins
6. Concomitant psychiatric disease or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give informed consent
7. Surgery during the last 2 months or surgery planned during the study,
8. Participation in other biomedical research in the last 3 months or planned during the study.
Preoperative Hypnosis Versus Premedication in Gynecological Surgery

The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.


Eligibility Criteria:
Inclusion Criteria:

* Patient's age: over 18 years
* Patient care and follow-up at the regional maternity center of Nancy (CHRU of Nancy)
* Female patient for whom gynecological laparoscopic surgery is programmed and lasting longer than 1 hour (ovarian cyst, laparoscopy infertility, laparoscopic promontofixation, noncarcinogenic assisted laparoscopy hysterectomy, endometriosis, diagnostic laparoscopy, pyosalpinx, hydrosalpinx)
* Patient with Physical status score (ASA) score between 1 and 3
* With standardized anesthesia protocol
* Patient affiliated to a Social Security
* Patient has received complete information about the organization of the research and has signed her informed consent

Exclusion Criteria:

* Pretreatment by benzodiazepines
* Known hypersensitivity to Alprazolam® (including undocumented)
* Prohibition conditions to Alprazolam®: Severe respiratory insufficiency, Sleep apnea syndrome, Myasthenia, Severe acute or chronic hepatic impairment
* Ongoing major depressive episode
* Chronic use (\> 1 month) of benzodiazepines or morphine or analgesics of level 2
* Participation in a therapeutic trial 6 months before inclusion in this trial
* Patient referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code
Clinical Cross Reactions Between Anacardiaceae

The prevalence of food allergies has increased in recent decades, ranging from 1 to 3% of the general population. According to international literature and French national surveys, nuts today represent a group of allergens often associated with severe allergic reactions. They are responsible for 18 to 40% of deaths from food-related anaphylaxis.

Among all nuts, the prevalence of anacardiac allergies (mainly cashew and pistachio) continues to increase and has become a growing public health problem. Today, global production is estimated at 4.9 million tonnes of cashews and 1.1 million tonnes of pistachios. The resulting increased exposure may explain the increased prevalence of allergic reactions reported to these fruits. In addition, anaphylactic reactions to anacardiaceae are reported to be even more severe than those occurring in subjects allergic to peanuts.

Cashews and pistachios are known to exhibit immunological cross-reactions with one another. In fact, they have a strong sequential homology between their storage allergens Ana o 1 / Pis v 3 (7S vicilin, 78% homology); Ana o 2 / Pis v 2 (legume 11S, 80% homology) and Ana o 3 / Pis v 1 (albumin 2S, 70% homology). For this reason, some authors talk about the cashew / pistachio syndrome and associate the two allergenic sources by considering them as one, in clinical practice.

The diagnosis of allergy to nuts, and therefore to anacardiaceae, is based on a compatible clinical history, the presence of specific IgE (demonstrated by positivity to realistic skin tests and serum IgE assay), and positivity on the oral food challenge test.

In clinical practice, taking into account the cashew / pistachio syndrome, when the allergy work-up for cashew is negative, allergists tend to advise to reintroduce pistachio at home, considering the two allergens as sufficiently homologous to authorize such a practice. In this context, the investigators decided to check whether this practice, which is based mainly on in vitro homologies, is risk-free, based on the clinical experience of our center.


Eligibility Criteria:
Inclusion criteria:

* Patient evaluated at the Allergy Unit of the University Hospital of Montpellier (France)
* Suspicion of food allergy to Anacardiaceae
* Allergy work-up for cashew and pistachio including at least skin tests, and possible specific IgE and food challenge

Exclusion criteria:

- Patients included in other trials that don't allow them to be included in the present one
AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants


Eligibility Criteria:
Key Inclusion Criteria:

* Participant with clinical diagnosis of acne vulgaris, defined by:

  1. moderate acne on the face (acne Investigator's Global Assessment \[IGA\] =3); and
  2. with minimum of 20 inflammatory lesions and 25 non inflammatory lesions on the face (excluding the nose); and
  3. moderate to marked PIH on the face (Overview of Pigmentation Disorders hyperpigmentation scale 4-6); and
  4. no more than one acne nodule or cyst (greater than \[\>\] 1 centimeter \[cm\]) on face (excluding the nose)
* Participant with any Fitzpatrick Skin Type I to VI (target patient enrollment according to FST)
* Female participants of childbearing potential must have a negative urine pregnancy test (UPT) at Baseline visit
* Female participants of childbearing potential must agree to use an adequate and approved method of contraception throughout the study
* Female participant of non-childbearing potential
* Other protocol defined inclusion criteria could apply

Key Exclusion Criteria:

* Participant with severe acne (IGA \> 3)
* Participant with more than 1 nodule/cyst on the face (excluding the nose)
* Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne, acne requiring systemic treatment
* Participant with damaged facial skin that may interfere with study assessments
* Female participant who is pregnant, lactating or planning a pregnancy during the study
* Female participant of childbearing potential using combined oral contraceptives approved as acne treatments, in whom the dose has not been stable for at least 6 months prior to the Baseline visit
* Participant with known impaired hepatic or renal functions
* Participant with active or chronic skin allergies
Hyperfibrinogenemia After Major Trauma

Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg \> 4 g/L) and its time to onset.

In this study, investigators daily investigate fibrinogen plasma levels and fibrinogen antigen in severe trauma patients (Injury severity score \> 15) within the first ten days. Investigators then modelize hyperfibrinogenemia profiles according to severity of injuries and physiopathologic mechanisms. Finally, investigators determine predisposing risk factors to develop hyperfibrinogenemia and assess the impact of fibrinogen replacement therapy in initial phase of management of major trauma.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old.
* Polytrauma with ISS Score \> 15
* Hospitalized patients in reanimation unit \< 4h after trauma
* Informed consent

Exclusion Criteria:

* Patients in another study
* Pregnant or lactating women
Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee

The objective of this trial is to evaluate the effect of Aquamin F versus placebo on NSAID (non-steroidal anti-inflammatory drug) dose reduction in subjects with osteoarthritis of the knee.

Hypothesis 1: After 12 weeks of treatment, subjects taking Aquamin F will use significantly less NSAID medications for symptoms of osteoarthritis versus placebo alone.

Hypothesis 2: No significant differences will be seen for adverse events between the subjects taking Aquamin F or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 35 to 75, male or female
* Subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology 17,18
* Subjects who present with osteoarthritis of the knee as judged by symptoms and disabilities detectable through published, validated questionnaires or previous diagnosis by a physician
* subjects who are symptomatic with daily or near daily pain and stiffness from osteoarthritis
* subjects who are taking non-steroidal anti-inflammatory drugs (NSAIDs) prior to study enrollment
* subjects who are willing to stop NSAIDS and use acetaminophen for pain management during the trial
* subjects with screening WOMAC osteoarthritis index total score (transformed score) of not more than 75
* subjects with ability to comprehend and complete the questionnaires and forms
* subjects whose schedules permit clinical evaluations every four weeks
* subjects who are willing to stop taking calcium supplements, if any and to restrict consumption of high calcium food to 600mg (two dairy servings) per day
* subjects with a high probability of compliance with study procedures and test article consumption
* subjects willing and able to follow protocol guidelines and schedules and complete diaries
* subjects who are likely to abstain from taking unathorized supplements or participating in any other clinical trial or experimental treatment during this trial
* subjects with normal gastrointestinal digestion and absorption

Exclusion Criteria:

* subjects who have a history of inflammatory arthritis, gout, pseudogout, Paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or HIV infection
* subjects who are non-ambulatory or bedridden due to osteoarthritis
* subjects who are dependent on prescription drugs to control pain
* subjects on any other clinical trial or experimental treatment in the past 3 months
* subjects who are pregnant, lactating or at risk of becoming pregnant
* subjects who have received : intramuscular corticosteroid injection or systemic corticosteroid administration within 4 weeks prior to study enrollment, intra-articular corticosteroid injection within 2 months prior to study enrollment or intra-articular hyaluronic acid injection within 4 months prior to study enrollment.
Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer

The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.

All patients in this trial will receive either the investigational drug or capecitabine, a chemotherapy drug that is already approved to treat your disease. These drugs prevent tumor cells from dividing, so they may stop growing or die. The investigational drug in this clinical trial is a chemotherapy drug given through the vein once every three weeks. Patients who receive capecitabine will receive this drug by mouth for 14 days, every 21 days.

Eligibility Criteria:
Eligibility Criteria

In order to be eligible for this trial you must:

* Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery.
* Have received previous treatment with anthracyclines (e.g., adriamycin, Doxorubicin) and taxanes (e.g., paclitaxel, docetaxel, Taxol®, Taxotere®) for your breast cancer and your doctor has determined that these treatment are no longer of benefit to you.
* Be at least 18 years of age.
* Not be taking other treatments for your cancer at the time you enter this trial.
* Not be pregnant.

Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (e.g., lab tests, CT scans).
Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department

Background: Abdominal pain is one of the most common reasons for admission to the emergency department (ED). This study aimed to investigate the effect of point-of-care ultrasound (POCUS) performed during the initial evaluation phase of patients who presented to the ED with abdominal pain on diagnostic processes, length of stay (LOS) in ED, and hospitalization and healthcare costs.

Methodology: This prospective, randomized, controlled, parallel group study was conducted with patients who presented to the Sakarya Education Research Hospital ED with abdominal pain from October 2019 to March 2020. Patients were divided randomly into two groups: control group where standard diagnostic strategies were applied and the POCUS group where POCUS was performed together with standard diagnostic strategies. All data were analyzed using IBM SPSS 21.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* Patients who presented to the ED with abdominal pain
* Nontraumatic patients

Exclusion Criteria:

* permanent mental disability,
* age \<18 years,
* abdominal trauma within the last 24 hours,
* pregnancy, morbid obesity, repeated admissions,
* referral from an external center to the ED,
* missing patient information.
Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal Sarcoma

RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue in patients with retroperitoneal sarcoma. PURPOSE: This phase I trial is studying the side effects and and best dose of proton beam radiation therapy in treating patients with retroperitoneal sarcoma.

Detailed DescriptionPRIMARY OBJECTIVES:

I. To determine the feasibility and toxicity of proton radiotherapy for retroperitoneal sarcomas.

II. To determine the maximum safe proton radiotherapy dose for retroperitoneal sarcomas.

III. To determine the maximally tolerated dose of proton radiotherapy for patients with potentially resectable retroperitoneal sarcoma. (Pre-operative cohort) IV. To assess acute side effects from irradiation using proton beam therapy and dose/volume constraints that are derived from conventional radiotherapy. (Postoperative cohort)

SECONDARY OBJECTIVES:

I. To assess the clinical effectiveness of proton radiotherapy for retroperitoneal sarcoma.

II. To determine the long-term toxicity of proton radiotherapy to the abdomen and pelvis region.

III. To monitor for effects of proton treatment on tumor and normal tissues using radiographic imaging (both cohorts) or ex-vivo analysis of tissue samples (preoperative cohort only).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologic diagnosis of sarcoma in the peritoneum/retroperitoneum/pelvis are eligible for this study
* Patients must have either radiographic(pre-operative) or pathologic (post-operative) evidence of disease limited the peritoneum/retroperitoneum/pelvis without evidence of peritoneal sarcomatosis
* For pre-operative cases, the patient must be considered operable/resectable as judged by the attending surgeon (this is determined by an extensive radiographic and medical evaluation that includes but is not limited to: CT Chest and Abdomen with contrast, MRI/CT Brain and Medical/Cardiac Clearance)
* Patients should have an EGOC status of 0-2
* Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks (patients unwilling or unable to sign informed consent are excluded from the study)
* Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented

Exclusion Criteria:

* Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
* Pregnant women, women planning to become pregnant and women that are nursing
* Patients who experience surgical complications that prevent radiation from starting for 5 months or more, unless there is evidence of gross residual disease
Blood Salvage From Liver Donors: a Feasibility Pilot Study

Blood recovery is a common procedure that limits patient exposure to allogeneic blood products. Blood recovery is usually performed during different types of surgery, including cardiac and vascular surgery, or liver transplantation. Basically, the process utilizes blood cell savers and cell separators and is finalized to auto-transfusion. In our hospital, the blood recovery is carried out with the CATSmart continuous-flow device (Fresenius Kabi AG, Bad Homburg, Germany) that warrants the removal of \> 95% of heparin, potassium, free hemoglobin, and non-emulsifiable lipids. In liver transplantation (LT), before removing the organ from the donor, the blood is usually flushed out of the liver. Nonetheless, in some circumstances, donor blood cells may be transferred to recipients together with the solid organ during graft implantation. This is a feasibility study exploring RBC (red blood cell) concentrates obtained from the blood organ donor to support transfusion requirements in liver recipients. Donor RBC units are produced according to the quality standards recommended by the European Directorate for the Quality of Medicines \& HealthCare of the Council of Europe, with equivalent content of Hb and residual leukocytes as standard RBC products.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (≥ 18 years) receiving a liver transplant from deceased donors at Fondazione Policlinico A. Gemelli IRCCS are eligible for the study.
* Liver procurement at Fondazione Policlinico A. Gemelli IRCCS.
* Identical ABO group in donor and recipient.
* Signed written informed consent to study participation.

Exclusion Criteria:

* Age \<18 y.o.
* D-negative recipient with D-positive donor.
* Cytomegalovirus-negative recipient and cytomegalovirus -positive donor.
* Refusal to sign written informed consent to study participation.