cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Childhood R/R ALL and Lymphoma Subjects

This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in childhood patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.
* CD19+ leukemia or lymphoma
* Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
* Follicular lymphoma, previously identified as CD19+:
* Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
* ECOG result is 0, 1 or 2.
* With normal heart, liver and kidney functions.
* Negative serum DNA for EBV and CMV; negative antigen for HBV; negative serum antibody for HCV, HIV and syphilis.
* Negative in pregnancy test (female subject only).

Exclusion Criteria:

* ECOG result is 3, 4 or 5.
* Pregnant or lactating female
* Uncontrolled active infection
* Active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
* Previously treatment with any gene therapy products
* HIV infection
* Enrolled to other clinical study in the last 4 weeks.
* Subjects with systemic auto-immune disease or immunodeficiency.
* Subjects with CNS diseases.
* Subjects with secondary tumors.
* Subjects with tumor infiltration in liver, brain or GI tract.
Trial of Pemetrexed or Pemetrexed With Gemcitabine for Patients With Advanced Lung Cancer Who Are Not Eligible for Platinum-Based Chemotherapy and Have Not Previously Been Treated With Chemotherapy

This study is for elderly patients who haven't been given prior chemotherapy or for patients who cannot be treated with platinum based chemotherapy. The patients who are eligible for this study will have been diagnosed with advanced or metastatic non-small cell lung cancer. The patients will be randomly assigned to one of two treatment options: single agent pemetrexed or single agent pemetrexed with single agent gemcitabine following right after the pemetrexed treatment.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed NSCLC not amenable to surgery or radiotherapy of curative intent
* locally advanced or metastatic Stage IIIb (with N3 supraclavicular or T4 for pleural effusion) or IV NSCLC
* no prior chemotherapy
* measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Therasse et al. 2000)
* men and women greater than or equal to 70 years of age or patients who, in the investigator's opinion, are not eligible for platinum-based chemotherapy

Exclusion Criteria:

* have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* have symptomatic brain metastases
* have a history or presence of other malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
* are unable to interrupt therapy with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen, piroxicam, diflunisal, or nabumetone around each dose of pemetrexed (5 days for short-acting or 8 days for long acting preparations)
* are unable or unwilling to take steroids
* are unable or unwilling to take folic acid or vitamin B12 supplementation
* have clinically detectable (by physical examination) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
* have other serious concomitant illness or medical conditions according to investigator criteria, including but not limited to the following:

  * congestive heart failure or angina pectoris, except if it is medically controlled
  * previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or arrhythmias
  * active infection requiring iv antibiotics
  * active ulcer, unstable diabetes mellitus, or other contra-indication to corticotherapy
  * superior vena cava syndrome
Drug-Drug Interaction Study: ASP2151 and Ritonavir

ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to contracting other infections because of their compromised immune system. As HIV patients will be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one of the drugs that is commonly prescribed to HIV patients (ritonavir).


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
* Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.

Exclusion Criteria:

* Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
* Any of the following liver function tests higher than 1.5 times the ULN at the screening visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), ALP, bilirubin, gamma glutamyl transpeptidase (gamma-GT).
* Platelet counts outside normal limits.
* Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
* Clinically significant impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
* History of bleeding diathesis.
* Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.
* Presence or history of severe adverse reaction to any drug, history of multiple drug allergies (multiple defined as \>3), or sensitivity to trial medication.
* Use, during the 28 days before the first dose of trial medication, of any prescription medicine, or any other medicine or herbal remedy (such as St John's wort) known to interfere with the CYP3A4 metabolic pathway (unless judged as not clinical significant by the investigator and sponsor).
* Use, during the 7 days before the first dose of trial medication, of any over-the-counter medicine, with the exception of paracetamol (acetaminophen).
* Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months.
* Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.
* Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 10 cigarettes daily.
* Evidence of drug abuse on urine testing.
* Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.
* Blood pressure (BP) and heart rate (HR) in seated position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40_100 beats/min.
Helmet Non-Invasive Ventilation for COVID-19 Patients

Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypoxemic respiratory failure

This will be a pragmatic parallel randomized control trial that will compare helmet nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. The trial will be implemented in multiple centers.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed COVID-19
* Aged ≥14 years old at the participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years)
* Acute hypoxemic respiratory failure based on PaO2/FiO2 ratio \<200 despite supplemental oxygen with a partial or non-rebreathing mask at a flow rate \>10 L/min or above
* Intact airway protective gag reflex
* Able to follow instructions (e.g. squeeze hand on command, eye contact with care provider, stick out tongue on command, etc.)

Exclusion Criteria:

* Prior intubation during this hospital admission
* Cardiopulmonary arrest
* Glasgow coma scale \<12
* Tracheostomy
* Upper airway obstruction
* Active epistaxis
* Requirement for more than one vasopressor to maintain mean arterial pressure \> 65 mm Hg
* Pregnancy
* Imminent intubation
* Patients with do not intubate orders or equivalent
* Enrolled in another trial for which co-enrolment is not approved including trials on mechanical ventilation
* Patients already treated with helmet
* Patients with chronic carbon dioxide retention (PaCO2 \>45)
* Previous enrolment in this trial
* The primary cause of respiratory failure is not heart failure as judged by the treating team
VLDL-triglyceride Under Acute Hyperinsulinaemia

The purpose of the study is to investigate and compare the lipid metabolism in lean and obese individuals. We want to investigate the effect of postprandial hyperinsulinaemia on VLDL-triglyceride metabolism


Eligibility Criteria:
Inclusion Criteria:

- Written consent

Exclusion Criteria:

* Known diseases
* Alcohol abuse
* Smoker
* Regular use of medicine
PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Eligibility Criteria:
Inclusion Criteria:

* adults patients
* requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)
* patient covered by french health care system

Exclusion Criteria:

* patient refusal
* intubation for other causes (excluding hypoxemia)
* impossibility to measure pulse oxymetry value
* contraindication for NIV : vomiting
* NIV intolerance
* cardiac arrest during intubation
A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)

The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object. A larger DOF allows sharp images of closer objects and may provide improved vision at intermediate and near distances.

Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 scheduled study visits over a 7-8 month period. Of the 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Eligibility Criteria:
Inclusion Criteria:

* Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logarithm of the minimum angle of resolution (logMAR) (20/40 Snellen) or worse either with or without a glare source present (e.g., Brightness Acuity Tester)
* Preoperative regular astigmatism of \< 1.0 D in both eyes
* Clear intraocular media other than cataract
* Diagnosed with cataract in both eyes
* Planned cataract removal by routine small incision surgery
* Calculated lens power between 18.0 and 25.0 diopter (D) \[when targeted for emmetropia (0.0 D)\]
* Willing and able to complete all required postoperative visits
* Able to comprehend and sign an ethics committee-approved statement of informed consent
* Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator's medical opinion.

Exclusion Criteria:

* History of eye pathology and/or inflammation, as specified in the protocol
* Clinically significant/severe ocular surface disease that would affect study measurements based on Investigator expert medical opinion
* History of previous intraocular or corneal surgery
* Pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes
* Taking systemic medications that in the Investigator's best medical judgment may confound the outcome or increase the risk to the subject.
Retrospective Study of Ovarian Cancer Patients With Brain Metastasis

Ovarian cancer, especially epithelial ovarian carcinoma, has the highest mortality rate among the gynecologic malignancies. The majority of patients with epithelial ovarian carcinoma are diagnosed at advanced stage which has the overall survival rates of only 19-30%. As the advance in the managements which prolonged the overall survival, metastatic lesion in rare location such as brain was noted in few patients of ovarian cancer in recent years. In the retrospective study, the investigators will review the medical records of the ovarian cancer patients with brain metastasis in the investigators hospital to investigate the incidence, clinical courses, optimal managements and possible prognostic factors in the rare condition.

The ovarian cancer patient treated at the Department of Obstetrics and Gynecology of the National Taiwan University Hospital were retrospectively collected. The cancer registration database was searched for the patients with ovarian carcinoma who brain metastases were also diagnosed. The medical records of these patients were reviewed with particular attention to the results of histo-pathological and radiologic reports. Patients with other synchronous primary brain tumor were excluded. The initial management of primary tumor, including the surgery and adjuvant chemotherapy, and the clinical courses and disease status, such as remission, recurrence and progression, were all carefully reviewed. The intra-cranial lesions were all diagnosed by imaging studies, including brain computed tomography (CT) and magnetic resonance imaging (MRI) scans. Therapeutic strategies for the metastatic lesions in the brain were also reviewed. All statistical analyses were performed using the SPSS 13.0 statistical software for Windows. P\<0.05 was defined as statistical significance. Survival was measured from the time of initial diagnosis of brain metastasis until the date of death or last contact, and was presented by Kaplan-Meier curves.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ovarian cancer and brain metastasis
* Patients ovarian cancer from National Taiwan University Hospital

Exclusion Criteria:

* none
Brief Mindful Meditation Practice in Improving Quality of Life in Patients With Cancer Undergoing Radiation Therapy

This pilot clinical trial studies how well brief mindful mediation practice works in improving quality of life in patients with cancer undergoing radiation therapy. Brief mindful mediation practice may improve the well-being and quality of life of patients with cancer who are undergoing radiation therapy by increasing levels of mindfulness and reducing stress, anxiety/depression, and fatigue.

PRIMARY OBJECTIVES:

I. To investigate the feasibility of a clinical trial using a brief mindful meditation practice during radiation therapy.

SECONDARY OBJECTIVES:

I. To explore the measurable changes in quality of life, fatigue, and mindfulness while using a brief mindful meditation practice during radiation therapy.

OUTLINE:

Patients use brief mindful meditation practice (sitting meditation in which the mind is guided to focus in the present, thinking of your existence, and allowing sensations to arise with an openness and curiosity) over 12 minutes daily for 14 days during radiation therapy.

After completion of study, patients are followed up 4-12 weeks after completion of radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proven diagnosis of cancer any stage, based upon the following minimum diagnostic workup: History \& physical examination, including documentation of Karnofsky Performance Status of 70 - 100% for at least 60 days prior to study entry
2. Patients who are receiving a course of radiation therapy for curative or adjuvant intent
3. Patient who have reported fatigue moderate or higher fatigue (based on the 0-10 Fatigue scale, a fatigue score of 5 or; see Appendix III) while on radiation treatment
4. The patient must be an adult male or female 18 or older
5. Patient must be capable to read and speak English and provide study specific informed consent prior to study entry
6. No prior history of radiation therapy
7. No history of or current active drug/alcohol dependence
8. No patients being decisionally impaired
9. Patients who have home access to a computer, or compact disc audio player

Exclusion Criteria:

1. Patient is under the age of 18
2. Diagnosis of a non-malignant disease and receiving radiation for a pathological diagnosis that is non-cancer
3. Patient who have reported less than moderate fatigue (based on the 0-10 Fatigue scale, a fatigue score less than 5; see Appendix III)
4. Karnofsky performance status of less than 70% within the last 60 days prior to study
5. Prior history of radiation therapy
6. History of or active drug/alcohol dependence or abuse
7. Decisionally impaired patients
8. No access to a computer, or compact disc audio player
9. Patient who are unable to read and speak English
Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons

The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with HIV-1 and HSV-2.

Sexual transmission is responsible for the vast majority of HIV-1 infections among adults worldwide. In sub-Saharan Africa, the region hardest hit by the HIV-1 epidemic, HSV-2 prevalences of 30-50% have been seen in the general population with prevalence up to 90% in infected with HIV-1. HSV-2 is common in those with, or at risk for, HIV-1 infection, and HSV-2 reactivation increases HIV-1 acquisition and infectiousness. Recent studies have shown that suppression of HSV-2 has a sustained effect on lowering HIV-1 levels in blood plasma. New data have raised the question whether higher doses of HSV-2 suppressive therapy might be more effective at suppressing HIV-1 levels. Acyclovir and valacyclovir, chosen for use in this study, are safe and effective treatments for decreasing the frequency of HSV-2 reactivation and shedding. The standard dose of acyclovir is 400 mg twice a day. Valacyclovir, a drug that converts to acyclovir after absorption, delivers higher concentrations of acyclovir. 1.5 grams of valacyclovir, will be used to provide a higher dose of acyclovir, and will be compared with the standard dose of 400 mg twice a day of acyclovir.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 seropositive
* Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period
* CD4 cell count \>250 cell/µL
* Not otherwise eligible for antiretroviral therapy according to Uganda national guidelines
* Detectable HIV-1 plasma viral load
* HSV-2 seropositive
* Not intending to move out of the area for the duration of study participation.
* Able to participate in the study at the Partners in Prevention site in Thika, Kenya

Exclusion Criteria:

* Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
* Planned use of acyclovir, valacyclovir, or famciclovir
* Use of ganciclovir, foscarnet, or cidofovir
* Known medical history of seizures
* Serum creatinine \>1.5 mg/dL
* AST or ALT \>3 times upper limit of normal
* Hematocrit \<30 %
* Absolute neutrophil count \<1000
* Platelet count \<75,000
* History of thrombotic microangiopathy
* Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
* Participation in another HIV therapeutics trial
* For women, pregnancy as confirmed by a urine pregnancy test
eVusheld Assessment reaL wORld Effectiveness in the VA Health System

An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the Department of Veterans Affairs (VA) Health System.

This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.

The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the VA Health System.

Eligibility Criteria:
Inclusion Criteria:

1. Receipt of EVUSHELD under the FDA EUA for EVUSHELD
2. Eligibility to access EVUSHELD use under the EUA.

Exclusion Criteria:

* None
Beta Cell Function in (Pre) Type 1 Diabetes

This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes.

This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes. These criteria may help to determine the time point and type of prevention may contribute to the composition of homogeneous groups of study subjects (based on residual beta cell mass, homogeneous risk of beta cell destruction during intervention) and may lead to the identification of functional markers that could be used as surrogate endpoints. This may reduce the number of subjects needed to treat as well as the follow-up time necessary to study significant effects of the test substance.

Eligibility Criteria:
Inclusion Criteria:

* The following groups of first degree relatives of type1 diabetes patients with normal glucose tolerance during OGTT (5-39 years) will be included after informed consent on the basis of their antibody status (n = 40 per group):

  * IA-2A-positives;
  * Ab.-positives (positive for at least 2 different Abs. (IAA, GADA and/or ICA) and/or persistently Ab.-positive for 1 of these Abs;
  * persistently Ab.-negatives.
* 40 type 1 diabetes patients with the following criteria will be studied: 1) aged 12-39 years; 2) \< 4 weeks of insulin treatment; 3) auto-Ab.-positive; 4) polyuria since \< 6 months; 5) \< 10% weight loss over the last 6 months; 6) informed consent.

Exclusion Criteria:

* Pregnancy or lactation in women
* Use of illicit drugs or overconsumption of alcohol (\> 3 beers/day) or history of drug or alcohol abuse
* Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders
* Having received antidepressant medications during the last 6 months
* Treatment with immune modulating or diabetogenic medication (such as corticosteroids)
* Presently participating in another clinical study
* History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects