cyrilzakka/clinical-trials huggingface dataset:
Pemetrexed and Temozolomide in Treating Patients With Relapsed Primary Central Nervous System Lymphoma （PCNSL）

In this trial, we will treat relapsed PCNSL with temozolomide, pemetrexed. Our objective was to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.

The best reported outcomes of PCNSL treatment are high-dose methotrexate-based chemotherapy combined with whole-brain radiation therapy (WBRT). Despite aggressive therapy, however, nearly 50% of patients will relapse within 24 months of diagnosis. Furthermore, the application of high-dose methotrexate-based regimen is complex, needing be hydrated, alkalified and detoxified, and treatment-related toxicity mortality is severe. In an attempt to improve upon these poor results and reduce treatment-related side effects, we will treat about 15-20 relapsed PCNSL patients who was fail in high-dose methotrexate-based chemotherapy. Our objective is to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary CNS lymphoma.
* ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1.
* Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease.
* Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI.
* Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment.
* No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast.
* No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry.
* No ocular lymphoma by slit lamp examination.
* Must have adequate organ function as defined by the protocol: Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min; Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN.Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl.
* Age \>/= 18 and \</= 75 years.
* Signed written informed consent prior to study entry.

Exclusion Criteria:

* Patients with human immunodeficiency virus seropositivity and systemic lymphoma manifestation.
* Serious uncontrolled concurrent illness.
* Previous brain radiotherapy, systemic chemotherapy.
* Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol.
* Any evidence of prior exposure to Hepatitis B virus.
* Unable to comprehend the study requirements or who are not likely to comply with the study parameters.
* Pregnant (confirmed by serum or urine β-HCG) or lactating.
Video Games to Track Cognitive Health

The purpose of this study is to assess cognitive function using a rapid, portable, computerized neurocognitive testing device in a wide variety of clinical settings.

Investigators will recruit participants from public places using the convenience sampling method. Informed consent will be obtain from all participants/parents as well as assent from minors. Participants will be asked to complete a brief yes/no questionnaire before the study begins. Participants will be asked to complete a 10 minute battery of tests consisting of simple video games designed to measure cognitive health. No personally identifiable information will be collected during the tests and all test data will remain anonymous. Data will be stored on servers with HIPAA-level security. No participants will be asked to modify their normal behavior in any way. No feedback or results will be given to participants. The tests will not be distressing in any way. To meet the objective of detecting cognitive impairment, investigators will test a broad array of participants from ages 10 through 99 in several different settings in parallel. The targeted cognitive stressors of advanced age, head injuries, physical strain, sleep deprivation, alcohol ingestion, and marijuana ingestion will be compared to healthy baseline controls. Collectively, these experiments aim to yield an end- deliverable of a rapid, non-invasive, portable piece of software that can be used to detect cognitive impairment.

A subset of participants will be asked to take the tests up to three times, so the total testing time is a max of 30 minutes. A subset of participants will be asked simple auxiliary questions, such as "Estimated in minutes, how long was your exercise or workout?". A subset of participants will be asked to wear a FitBit device to monitor their heart rate. A subset of participants will be asked to take a breathalyzer test (BACtrack S80).

Eligibility Criteria:
Inclusion Criteria:

* Aged 10 or older
* Function of both hands

Exclusion Criteria:

* Inability to speak English or Spanish
* Inability to read English or Spanish
* Unable to provide informed consent
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.

Phase 3 study to evaluate the effiacay and safety of YYC506

Phase 3 study to evaluate the effiacay and safety of YYC506 in patients with complex dyslipidemia where LDL-C is properly controlled but TG and HDL-C levels are not regulated by Atorvastatin alone.

Eligibility Criteria:
Inclusion Criteria:

* A man or woman over 19 years old.
* LDL-C properly controlled, TG, HDL-C is not properly controlled
* Sign on ICF prior to study participation

Exclusion Criteria:

* History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
* Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
* Severe renal impairemnet (Creainine clearance \< 30mL/min) etc.
Chronic Evaluation of Respicardia Therapy

The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.

The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study.

It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.


Eligibility Criteria:
Inclusion Criteria:

* Candidate is at least 18 years old
* Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:

  * Apnea-Hypopnea Index (AHI) greater than or equal to 20 events/hr
  * Predominantly central origin (central apnea events comprise 50% or more of all apnea events)
  * Limited obstructive events (obstructive apneas comprise less than 20% of the AHI)

Exclusion Criteria:

* Candidates who are pregnant
* Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2
* Candidates with severe COPD
* Candidates with a history of cerebrovascular accident (CVA), myocardial infarction, coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to the study
* Candidates with unstable angina
* Candidates with history of primary pulmonary hypertension
Whole Blood Biospecimen Collection for Subjects With Fanconi Anemia

The primary study objective is to collect biospecimen samples (e.g., blood) from participants diagnosed with Fanconi Anemia. The biospecimens will be used to create a biorepository that can be used to identify disease associated biomarkers and potential targets with immune and multi-omics profiling. The disease sample collection and analysis will be the foundation for an extensive network of biospecimen access and linked datasets for future translational research.


Eligibility Criteria:
Inclusion Criteria:

* The participant is willing and able to provide written informed consent
* The participant is willing and able to provide appropriate photo identification
* Participants aged 18 to 85
* Participants have been diagnosed with Fanconi Anemia complementation group A

Exclusion Criteria:

* Participants who are pregnant or are nursing
* Participants with a known history of HIV, hepatitis, or other infectious diseases Participants who have taken an investigational product in the last 30 days Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma

The purpose of this study is to find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
* High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System,89 i.e., stage 4 with (any age) or without (\> or = to 18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
* The patients are in \>2nd CR/VGPR, including no measurable MIBG-avid soft tissue tumor assessable for response.
* Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

* Creatinine \> 3.0 mg/dL
* ALT, AST and Alkaline Phosphatase \> 5.0 times the upper limit of normal
* Bilirubin \> 3.0 mg/dL
* Patients with grade 3 or higher toxicities (using the CTCAE v34.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. Patients must have normal blood pressure for age.
* Progressive disease
* History of allergy to mouse proteins
* Active life-threatening infection.
* Human anti-mouse antibody (HAMA) titer \>1000 Elisa units/ml.
* Inability to comply with protocol requirements.
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)

A single center, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland.) in at least 30 healthy adult subjects under fasting conditions.

This will be a single-dose, open-label, randomised, two-period crossover study with orally administered 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland) on two separate occasions conducted under fasting conditions in healthy male and female subjects at a single study centre.

The study will comprise:

* Thiopurine methyltransferase (TPMT) testing;
* Screening period of maximum 28 days
* Two treatment periods (each of which will include a PK profile period of 12 hours) separated by a wash-out period of at least 3 calendar days (minimum number of days based on half-life of the analyte) and maximum of 14 calendar days between consecutive administrations of the IMP
* A post-study visit 7-10 days after the last dose of the last treatment period of the study.

Subjects will be randomly assigned to treatment sequence, prior to the first administration of IMP.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers.
* No significant medical history or conditions that may interfere with the study.
* Adequate contraception.

Exclusion Criteria:

* Volunteers who may be likely to have the inherited mutated NUDT15.
* Subjects with a deficient, low or intermediate TPMT enzyme activity.
* Disease that may interfere with the safety of the participant or the study outcome measures.
* Participants who want to procreate in the next 6 months.
GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.


Eligibility Criteria:
Inclusion Criteria:

- Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.

Exclusion Criteria:

- Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit
Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects

This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.


Eligibility Criteria:
Inclusion Criteria:

* Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause
* Investigator sites will review entire list of inclusion criteria with potential subjects

Exclusion Criteria:

* Any known prior exposure to botulinum toxin type B, or known adverse reaction or sensitivity to botulinum toxin type A, or known sensitivity to any of the MYOBLOC solution components.
* Prior botulinum toxin treatment to the salivary glands at any time
* Investigator sites will review entire list of exclusion criteria with potential subjects
Pilot Trial of Supplemental Vitamin A and Nicotinamide

The goal of this clinical trial is to assess the feasibility and safety of oral nicotinamide (NAM; a derivative of vitamin B3 \[niacin\]) and vitamin A in a high-risk population of kidney transplant recipients with a history of skin cancer to generate preliminary data for future cancer prevention clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or greater;
* Either History of 2 or more histologically confirmed invasive cutaneous SCCs in the past 2 years or
* At least one previously billed Healthcare Common Procedure Coding System code 17004 (destruction of 15 or more benign or premalignant lesions of the integumentary system);
* Understands, reads, and writes English proficiently.

Exclusion Criteria:

* Liver disease;
* Active peptic ulcer disease;
* Recent myocardial infarction;
* Hypotension;
* Internal malignancy within past 5 years;
* Renal impairment with eGFR\<15 mL/min/1.73 m2;
* Being unable for follow up due to social reasons;
* Gorlin's syndrome or other genetic skin cancer syndrome;
* Huge number of current skin cancers;
* Metastatic SCC or invasive melanoma within the past 5 years;
* Pregnancy or lactation;
* Need for ongoing carbamazepine use (which could have a possible interaction with NAM);
* Use of acitretin or other oral retinoids within the past 6 months;
* Use of supplemental NAM, niacin, vitamin A, or beta carotene within the past 6 months;
* Field treatment for actinic keratoses (AKs) within the previous 4 weeks;
* Use of topical steroids.
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil

Durvalumab as maintenance in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real World Data from an Expanded Access Program in Brazil


Eligibility Criteria:
Inclusion Criteria:

1. Patients with unresectable stage III NSCLC who completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression
2. Patients who have participated in the Durvalumab EAP in Brazil and have received at least one dose of Durvalumab in the EAP..
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)

The metabolic syndrome is a highly prevalent disorder, which causes atherosclerotic cardiovascular disease and is closely associated with insulin resistance. The alteration of the secretion of adipocytokines from accumulated visceral adipose tissue in the obese induces insulin resistance. The purpose of this study is to identify gene polymorphisms that confer susceptibility to the metabolic syndrome and to make up a new health guidance program based on genetic risk assessment. About 25% of male employees over 45 years old in a certain company are diagnosed with the metabolic syndrome in medical examination. We, the researchers at Nagoya University, will analyze gene polymorphism and various biomarkers of over 3500 company employees.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects who work for a certain company
Liquid Nutritional Supplement on Malnutrition Hospitalized Patient

The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years old to 60 years old
* malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
* agreed to participate

Exclusion Criteria:

* malignancy
* chronic kidney disease stage III-V
* decompensated hepatic cirrhosis
* allergic to milk or lactose intolerance
* could not be randomised and participate in this study by clinical judgement
Scale Validation Study for Prediction of Relapse and Short Term Rehospitalization in Patients With Schizophrenia

The purpose of this study is to establish and validate a scale/model that can be used to evaluate the duration of time and factors between short term hospital treatment and subsequent relapse periods in patients with schizoaffective/schizophreniform disorders.

This is an epidemiological (study of the distribution and determinants of health-related states or events in defined population), multicenter (study conducted at multiple sites), observational (study in which patients are observed), cross-sectional (observation of all patients at one specific point in time), prospective (in which the patients are first identified and then followed forward as time passes) study. The sources of information in the study are units medical short stay psychiatric hospitalization or the acute care of the whole country, and clinical data of the patient at discharge. No intervention will be provided in this study. The general data (age range, gender, highest level of educational attainment, level of family support, substance abuse, events stressors, type of schizophrenia according to DSM-IV criteria \[Diagnostic and Statistical Manual fourth\], etc) of approximately 2000 schizophrenia and schizoaffective disorder / schizophreniform patients will be collected in this study. No special tests will be done during the study. The study will collect patients' data in electronic data collection workbook and model validation will be used at 6 and 12 months to confirm no relapse / hospitalization. The study observation period corresponds to the 3 years preceding the current relapse and current income (current hospitalization period) and 12 months after admission.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Schizophrenia or Schizoaffective disorder of more than 2 years evolution and who find themselves admitted in a Short-Term Psychiatric Hospitalization Unit or Acute Unit

Exclusion Criteria:

* Other patients with a psychiatric pathology different to schizophrenia, schizoaffective/schizophreniform disorders
* Patients with schizophrenia or schizoaffective/schizophreniform disorders of 2 years, or less evolution
* Pregnant, lactating, or planning to become pregnant within the next 12 months
Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects

This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.

This study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. At the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. Subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit
* Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline
* A PGA score of ≥ 2 at screening and baseline
* Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
* Must not be pregnant
* Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

Exclusion Criteria:

* Psoriasis other than plaque variant
* Any sign of infection of any of the psoriatic lesions
* Immunocompromised at screening
* Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN)
* Screening total bilirubin \> 1.5x ULN
* Current or chronic history of liver disease
* Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
* Major surgery within 8 weeks prior to baseline or has a major surgery planned during the study
* Known history of clinically significant drug or alcohol abuse in the last year prior to baseline
* Use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation
* History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion may interfere with the subject's participation in the study, interpretation of results, safety of the subject or ability to understand and give informed consent
* Pregnant or lactating females.
* History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
* Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)