cyrilzakka/clinical-trials huggingface dataset:
Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL

Alloimmune-mediated platelet transfusion refractoriness(PTR) was usually caused by repeated blood transfusions and pregnancy and accounts for about 20-25% of PTR patients. Patients with acute leukemia need repeated platelet infusion in myelosuppression period after chemotherapy, and PTR incidence is more higher.PTR was associated with adverse events,including longer hospital stays,severe hemorrhages and an increased risk of early deaths and may have a negative impact on the success of HSCT. The current management of patients with PTR includes specific transfusion strategies, IVIG, rituximab,thrombopoietin-receptor agonists(TPO-RA) ,bortezomib or splenectomy,have been largely unsatisfactory. As we know, HLA antibodies are mainly secreted by the plasma cells. Researchers want to see if sequential infusion of CD19 and BCMA CAR-T cells can clear the B cells and plasma cells, can help increase platelet levels and reduce bleeding in patients with platelet transfusion refractoriness. To see if sequential infusion can increases platelet levels more after a transfusion. To see if it reduces the chance of bleeding. Adults 16-65 years old who diagnosed with acute leukemia in CR and alloimmune platelet transfusion refractoriness.

The patients will receive infusion of CAR T-cells targeting CD19 and BCMA to confirm the safety and efficacy of CD19 and BCMA CAR T-Cells Sequential infusion in acute leukemia with alloimmune-mediated platelet transfusion refractoriness.

Eligibility Criteria:
Inclusion Criteria:

* Ages 16-65 years inclusive.
* Ability to comprehend the investigational nature of the study and provide informed consent.
* Expected survival time ≥ 3 months (according to investigator's judgement)
* Acute leukemia in complete remission diagnosed with alloimmune-mediated PTR, characterized by all of the following:

Lack of adequate post-transfusion platelet count increment, defined by CCI \<7500/μl at 10-60 min, and CCI \<5000/μl at 18-24 hrs (in those who had a CCI at 10-60 min greater than or equal to 5000/μl) after at least 2 consecutive transfusions.

Presence of anti-HLA class A and/or B antibody.

* Left ventricular ejection fractions ≥ 0.5 by echocardiography.
* Creatinine \< 1.6 mg/dL.
* Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal.
* Total bilirubin \<2.0 mg/dL.
* karnofsky performance status ≥ 60.

Exclusion Criteria:

* PTR induced by other reasons(eg:DIC,fever,infection and splenomegaly)
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection
* Patients with HIV or syphilis infection
* Patients are pregnant or lactating
* Patients has a history of allo-HSCT
* Alloimmune-mediated PTR responsive to treatment with plasma exchange
* Alloimmune-mediated PTR responsive to treatment with rituximab or IVIG
* Grade III/IV cardiovascular disability according to the New York Heart Association Classification
* Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement)
Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT

Specific Aim 1: Conduct a pilot, small-scale randomized controlled trial to examine feasibility and preliminary efficacy of LTW, compared to TAU. Outcomes related to feasibility include percentage of eligible patients recruited, study attrition, study retention, and mental health and substance use treatment appointment attendance. Outcomes related to preliminary efficacy will include participation in screening, referral and treatment at baseline, compared to TAU.

Specific Aim 2: Conduct a randomized controlled trial to examine the effectiveness of LTW, compared to TAU. Outcomes related to effectiveness include screening, screening positive, referred to and attendance to treatment at baseline, compared to TAU.

Participants: 450 adult, pregnant or postpartum women

Intervention: Listening to Women is a mobile phone-based program designed to enhance delivery of Screening, Brief Intervention, and Referral to Treatment (SBIRT), an evidence-based approach for mental health and substance use screening and treatment for perinatal women. This program was created as a result of key informant interviews with obstetric providers and pregnant and postpartum women with opioid use disorders. The program utilizes mobile phone text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, home-based telemedicine mental health and substance use disorder treatment services.

Design: Specific aim 1: A two arm pilot RCT (N=35) with 2:1 allocation will examine feasibility and preliminary efficacy of LTW, compared to TAU. Specific aim 2: A RCT (N=415) with 1:1 allocation will examine effectiveness of LTW, compared to TAU.

This study is part of the HEAL Initiative (https://heal.nih.gov/).

Eligibility Criteria:
Inclusion Criteria:

1) age 18-41; 2) currently pregnant or postpartum; 3) if pregnant, receiving prenatal care; 4) English fluency; 5) owner of a cell phone with short message service (SMS) text-message based capability; 6) access to Wireless Fidelity (WIFI) and a device to allow audio and video teleconferencing; 7) able to provide informed consent.

Exclusion Criteria: None
Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events

The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs

Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia furthermore, most children presenting for AT have sleep-disordered breathing and obstructive sleep apnea syndrome (OSAS) caused by tonsillar hypertrophy which could aggravate the PRAEs specially with the use of the conventional sedatives as a premedication. A recent randomized controlled trial has shown that more than 50% of children premedicated with midazolam had experienced PRAEs . Midazolam and ketamine are commonly used as preoperative sedative drugs for pediatric populations. Ketamine is a safe and widely used sedative and analgesic in the pediatric emergency department (ED) with less profound effects on the upper airway and respiratory muscles. Intranasal ketamine administration is well tolerated and without serious adverse effects. The addition of ketamine to midazolam as a preoperative sedation to reduce the occurrence of PRAEs was not investigated before in children undergoing AT. The authors hypothesize that combination of ketamine to midazolam could offer optimum sedation condition while reducing the occurrence of PRAEs in children undergoing AT.

Eligibility Criteria:
Inclusion Criteria:

* Children both sexes male and female.
* Age from 3 to 12 years old.
* ASA grade I, II.
* undergoing elective AT procedures.

Exclusion Criteria:

* Congenital heart diseases (cyanotic and a cyanotic).
* Congenital syndromes affecting airway anatomy such as Pierre-Robin syndrome and Down syndrome.
* Severe lung diseases affecting either lung tissue such as pulmonary cystic fibrosis and idiopathic pulmonary fibrosis or affecting lung circulation such as pulmonary hypertension with marked limitation of Physical activity or inability to carry out any physical activity according to NHYA classification.
* Recent upper respiratory tract infection (less than two weeks).
* Neuromuscular diseases including cerebral palsy and epilepsy.
Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes". Algorithms to predict those outcomes have been developed by combining maternal characteristics (history, age, BMI, blood pressure), biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another prospective observational study ("PREDICTION study" NCT 02189148) is also ongoing, which aims to validate those algorithms at the first trimester of pregnancy.

Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates, allowing closer monitoring of high-risk patients and potential therapeutics under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes.

The objective of this study is to validate the predictive values of biophysical (maternal blood pressure); biochemical (sFlt-1, β-hCG, PlGF, and AFP) and ultrasonographic (cervical length, Doppler, 3D evaluation of the placenta, 3D nasal bone) biomarkers at several timepoints for the prediction of adverse pregnancy outcomes including preterm birth, preeclampsia, fetal growth restriction and intra-uterine fetal death.

These biomarkers will be evaluated at 14-16 weeks, 20-24 weeks and 30-34 weeks. Those specific gestational ages have been selected because they correspond to the typical clinical/hospital visits for prenatal blood and/or ultrasound screening.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous pregnant women participating in Prediction study (NCT02189148)

Exclusion Criteria:

* \<18 years old at recruitment;
* multiple pregnancies;
* fetal congenital malformation;
* positive for HIV or hepatitis C;
* fetal demise at recruitment;
* women planning a delivery outside the participating hospitals;
* women not able to provide an informed consent to the study.
Comparison of Success Rates of Femoral Artery Catheterization

The use of USI has eased practical application of interventional procedures, and reduced complications and procedure durations. For vascular interventions with ultrasound imaging, short- or long-section imaging of vascular structures is performed. Both techniques have their own advantages and disadvantages.

This study aims to compare the success rates of femoral artery catheterization using both imaging techniques.

The research will include newborns undergoing open heart surgery and patients requiring arterial monitoring in the neonatal intensive care unit. Eighty patients requiring femoral artery cannulation will be randomized with the closed envelope method and separated into two groups as USI with the in-plane technique (Group A) and USI with the out-of-plane technique (Group B). The intervention will be performed by a single experienced individual. The preparation duration, puncture duration, number of punctures, number of unsuccessful arterial punctures, development of hematoma and other complications will be recorded and the groups will be compared. If there are 3 unsuccessful attempts the procedure will be ended.1. Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling) EXCLUSION CRITERIA FOR STUDY VOLUNTEERS

1. Local infection
2. Coagulopathy CLINICAL END-POINTS (MEASURED VARIABLES)

1. Distance of femoral artery to skin, distance of femoral artery to inguinal ligament, femoral artery diameter, femoral artery and vein location properties 2. Preparation duration, number of punctures, complications developing during the procedure

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling

Exclusion Criteria:

1. Local infection
2. Coagulopathy
Penumbra Imaging Collaborative Study (PICS)

The primary aim of this study are to gather data on the "real world" experience of the Penumbra System and to determine if there is a correlate between the imaging-defined size of the ischemic penumbra at admission and patient outcome in patients already treated by the System. This will be accomplished by the collection of all available admission imaging data along with patient clinical and functional outcome results at 90-day follow-up to determine if a positive association exists between these variables. A secondary aim is to collect and summarize the 90-day functional outcome data for the purpose of sample size estimation for a potential randomized concurrent controlled trial. This will be accomplished by collecting the data on 90-day modified Rankin Scores (mRS) and all cause mortality.


Eligibility Criteria:
Inclusion Criteria:

* All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.
Observational Program Neo-Penotran® Forte

Vaginitis is the most common gynecologic diagnosis in the primary care setting. In approximately 90 percent of affected women, this condition occurs secondary to bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection.

Neo-Penotran Forte is registered for treatment of these most common vaginal infections. Efficacy and safety of this product is already established, and this observational study was designed to learn more about practical use of Neo-Penotran® Forte in real life setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years with previously taken decision of their gynecologist to prescribe Neo-Penotran Forte according to registered indications, and microbiological tests were performed.

Exclusion Criteria:

* Presence of contraindications according to package insert.
Safety Study of Single Administration Intravenous Treatment for Influenza

The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-7100, a candidate treatment for influenza.

Influenza A, a member of the Orthomyxoviridae family, is composed of a negative-sense,single-stranded and segmented ribonucleic acid (RNA) genome. An urgent need exists for new forms of treatment for influenza A based on (a) the known propensity of this virus to undergo both continuous low-level antigenic drift and less frequent but unpredictable major antigenic shift leading to pandemic disease, (b) the clear failure of vaccination, even when strains are reasonably matched, to prevent influenza-related illness in a significant proportion of vaccine recipients, and (c) the increased frequency of resistance to approved forms of therapy for influenza (eg, the adamantane derivatives and, more recently, the NA inhibitor, oseltamivir). AVI-7100 is an experimental phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). AVI-7100 specifically targets viral messenger RNA sequences. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-7100 in healthy human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and between the ages of 18 and 50 years in good general health
* Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
* Volunteers must be willing to undergo a urine screen for drugs of abuse

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
* Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection
Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.

A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-235. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease
* Pregnant or nursing females
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
* A positive urine drug screen at Screening or Day -1
* Current tobacco smokers or use of tobacco within 3 months prior to Screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
* History of regular alcohol consumption
* Participation in a clinical trial within 30 days prior to the first dose of study drug
* For Part 2 participants:

  * Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens-Johnson Syndrome \[SJS and Toxic Epidermal Necrolysis \[TEN\]) with HLA-B 1502 in this population
  * Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.
* For Part 2 and Part 3 participants, the following cardiovascular abnormalities:

  * QRS duration \>110 ms
  * Incomplete right bundle branch block or any complete bundle branch block
  * Heart rate \<40 or \>90 beats per minute (per vital sign capture while rested)
  * History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
  * Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
  * PR interval \>220 ms or any 2nd or 3rd degree AV block
  * Ventricular pre-excitation
* History of drug allergy to itraconazole or other azole antifungals; history of drug allergy to carbamazepine or carboxamide derivatives \[e.g. oxcarbazepine\]; known hypersensitivity to drugs structurally related to carbamazepine \[e.g.: tricyclic antidepressants\] or any of its excipients);history or known hypersensitivity to mefloquine, quinine, or quinidine
Vielight RX Plus for the Treatment of COVID-19 Respiratory Symptoms

The objective of this study is to obtain data on the efficacy of the Vielight RX Plus in decreasing time to recovery of symptoms in subjects with COVID-19. The study will be conducted among COVID-19 positive subjects at home in self-isolation via electronic data collection (EDC). There will be no physical contact between the subjects and the Qualified Investigator (QI) or other study staff. This study aims to demonstrate that the Vielight RX Plus is a useful adjunct to standard of care (SOC). We hypothesize that the Vielight RX Plus will accelerate recovery and reduce viral infection severity.

This study is conducted entirely online. At no point will study staff be in direct contact with participants. The study will be managed by an independent clinical research organization (CRO), supporting a Qualified Investigator (QI). Vielight Inc will supply the RX Plus devices free of charge and will sponsor the study.

Potential participants will be prompted to complete an online screening form if they are interested in participating. During the screening, the potential participant will be asked to upload a copy of their positive COVID-19 infection confirmation report and a valid ID. If the potential subject qualifies for the study, by statisfying all inclusion and exclusion criteria, the potential participant will then be prompted to complete an electronic informed consent form (ICF) via the electronic data collection (EDC) platform and will be enrolled into the study.

This is a 30-day, prospective, randomized study, with no blinding. 280 participants will be randomized into two groups: Group 1: Standard of Care; Group 2: Standard of Care + Vielight RX Plus treatment. In Group 2, the Vielight RX Plus will be administered for 20 minutes twice a day, separated by at least 6 hours for the first 5 days. For the subsequent 25 days, treatment will be once per day. The Vielight RX Plus will be positioned over the upper most part of the breastbone to stimulate the thymus gland and within one nostril.

During each of the 30-days, participants will be asked to complete a questionnaire to assess respiratory symptom severity, and log a daily dairy as well as oxygen saturation level (using a portable oximeter).

The primary measure is time to overall recovery in days.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of COVID-19 infection
* Experiencing moderate to severe respiratory symptoms
* Between 18-65 years of age

Exclusion Criteria:

* Need for hospitalization at the time of diagnosis
* Current need for supplemental oxygen or positive pressure support and/or has required supplemental oxygen or positive pressure support for \>or= 24 hours
* \>10 days since symptom onset
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Pregnant
* Positive for Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) or Human Immunodeficiency Virus
* Inability to electronically complete study questionnaires in English
Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray (γ-knife) can also be used to treat patients with PVTT. But there still lack of evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view of this, we aim to implement a randomized controlled study to find out an effective treatment for intermediate and advanced hepatocellular carcinoma patients with PVTT based on evidence-based research.


Eligibility Criteria:
Inclusion Criteria:

1. Child-Pugh class B liver function；
2. Preoperative ECOG criteria score of 0-2;
3. Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI);
4. Tumor thrombus in the second-order or more peripheral branch of portal vein;
5. Tumor number ≤5 and the sum of largests tumor diameter ≤15 cm;
6. The expected survival time \>6 months.

Exclusion Criteria:

1. Other anticancer treatment before treatment
2. Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
3. Patients with other diseases that may affect the treatment of this treatment
4. History of other malignant tumors
5. Patients who are participating in other clinical trials
6. Pregnant, lactating women