bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Absorption, Distribution, Break Down and Elimination and the Safety of 14C-Labeled Tozadenant
Condition: N/A, as Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate how tozadenant is absorbed, distributed, broken
      down and eliminated from the body. The compound to be administered will be radiolabeled. This
      enables the investigator to trace the compound in blood, urine, feces, expired air and track
      what happens to it.
    

Detailed description: 
      PD0026 is a Phase 1, single-center, open-label, single-dose study to investigate the
      absorption, distribution, metabolism, and excretion (ADME) of 14C-labeled tozadenant. The
      primary objective is to determine the mass balance and the pharmacokinetics (PK) of total
      radioactivity in 6 healthy male subjects following a single oral dose of 14C-labeled
      tozadenant. Secondary objectives are to determine the PK of Tozadenant, to identify and
      quantify metabolites of tozadenant, and to gain further information on the tolerability and
      safety of tozadenant.

      The variables related to the radiocarbon activity include the total radioactivity
      concentration in whole blood and plasma; the total radioactivity excretion in urine, feces,
      and expired air; and the corresponding PK parameters.

      The concentrations and the corresponding PK parameters of tozadenant over time will be
      determined in plasma, urine, and feces.

      In addition, the metabolites of tozadenant will be identified and quantified. The safety and
      tolerability variables include adverse events (AEs), vital signs, physical examination,
      standard 12 lead electrocardiogram (ECG) intervals, and clinical laboratory results.

      The study will consist of a Screening Period of up to 20 days (Days -21 to -2) and a Study
      Period of 15 days. Therefore, the maximum duration of participation from Screening until
      discharge from the clinic for a subject is 35 days.
    

Intervention name(s): tozadenant tablet; C14-tozadenant capsule
Intervention type(s): Drug; Drug
Intervention description(s): Active substance: tozadenant Pharmaceutical form: Tablet Concentration: 240 mg Route of Administration: Oral administration; Active substance: C14-tozadenant Pharmaceutical form: Capsule Concentration: 74 kBq (2 μCi) Route of administration: Oral administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: C14; Dosimetry; Mass balance; ADME
Cytological Diagnosis of Hepatic Angiosarcoma and Its Histopathologic Correlation
Condition: Hepatic Angiosarcoma
MeSH terms: Hemangiosarcoma
Study type: Observational

Summary: 
      Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint
      cytology is difficult due not only to its various cytomorphologic features but also clinical
      rarity. Vasoformative features, such as pseudo-acini, branching pseudo-capillary structure,
      and intracytoplasmic lumina, are clues to achieve the diagnosis. But these features are not
      always present. In order to find clues for cytological diagnosis of angiosarcoma, we
      collected cases of hepatic angiosarcoma to study their cytological features. And then
      compared these features with those in their histopathological biopsy or resection.
    

Detailed description: 
      Hepatic angiosarcoma is a rare hepatic malignant tumor. Although diagnosis of hepatic
      angiosarcoma by FNA cytology has been reported since 1982, followed by several studies, its
      cytomorphologic features were still not well recognized by cytopathologists because of its
      clinical rarity and various morphologic features.

      We reviewed literatures about cytomorphology of hepatic angiosarcoma by FNA. There are only
      11 cases retrieved in 10 articles searched from Medline. The sex M/F ratio was 6/4 (one
      unknown); age range was 56 to 79 years old. In initial cytological evaluation, four cases got
      angiosarcoma or consistent/suspicious angiosarcoma diagnosis. Positive for malignancy,
      sarcoma, and poorly differentiated spindle cell lesion were in one case respectively. One was
      diagnosed as atypical cells. Remaining three were unavailable by their reports.

      In cytological morphologic features, all but one met least 2 of 3 cytological cellular
      criteria of angiosarcoma cells: spindle cells, epithelioid cells, and pleomorphic cells. In
      cytological architectural features, 7 of 11 cases showed vasoformative structures; 5 of 11
      cases showed intracytoplasmic lumen or erythrophagocytosis. Ten of 11 cases had
      histologic/pathologic confirmation as angiosarcoma. One case reported interrelation of tumor
      structures and their own accompanied liver tissue in cell blocks.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients of a medical center in Taiwan; National Taiwan University Hospital (NTUH)
      
Keywords: angiosarcoma; Cytology; liver; cancer
A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
Condition: Dementia Family Caregiver
MeSH terms: Dementia
Study type: Interventional

Summary: 
      This study aims to evaluate a care empowerment program using virtual reality on dementia
      knowledge, attitude, care self-efficacy, empathy and caregiver burden of family caregivers of
      people with dementia.
    

Detailed description: 
      The majority of patients with dementia live at home and cared by their families in Taiwan.
      Most of family caregivers have limited knowledge and care skills of dementia, therefore they
      experience great stress and caregiver burden which may have negative impact on their physical
      and mental health.

      This two-group cluster randomised controlled trial aims to evaluate a care empowerment
      program using virtual reality on dementia knowledge, attitude, care self-efficacy, empathy
      and caregiver burden of family caregivers of people with dementia.

      The family care empowerment program consists of dementia care e-books, dementia virtual
      reality activity and family support group.

      The interventional group will receive the care empowerment program using dementia care
      e-books, dementia virtual reality activity and family support group.

      The control group will only receive dementia education manual and family support group with
      no dementia virtual reality activity.

      Both groups will be assessed for their dementia knowledge, attitudes, care self-efficacy,
      empathy and caregiver burden at baseline, month 3, and 4.
    

Intervention name(s): care empowerment program; dementia education
Intervention type(s): Other; Other
Intervention description(s): dementia care e-books, dementia virtual reality activity and family support group; dementia education manual and family support group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two-group cluster randomised controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: family caregiver; dementia; virtual reality; empowerment
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy
      and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in
      schizophrenia.

      Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive
      impairment,and aggressive behavior of treated schizophrenia patients.
    


Intervention name(s): t-VNS verum; t-VNS placebo
Intervention type(s): Device; Device
Intervention description(s): Active stimulation of the left auricle by t-VNS; Sham stimulation of the left auricle with the t-VNS device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenic disorders; psychosis; psychotic; dementia; delusional; delusions; hallucinations; residual-type schizophrenia; illusions; split mind; mental health disorder; schizoid; paranoid-type schizophrenia; disorganized-type schizophrenia; undifferentiated-type schizophrenia; catatonic-type schizophrenia; mental illness; tardive dyskinesia; neuroleptic malignant syndrome; NMS; antipsychotics; atypical antipsychotics; psychosocial treatments; rehabilitation
A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
Condition: Disorder Related to Renal Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical research study is to learn if belatacept (BMS-224818) is
      expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based
      immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The
      long-term safety and tolerability of belatacept based regimens following long-term
      administration in subjects who have received a kidney transplant
    


Intervention name(s): Thymoglobulin; Belatacept; Sirolimus; Tacrolimus; Mycophenolate Mofetil (MMF)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Induction therapy, IV infusion, All subjects will receive thymoglobulin 1.5-mg/kg i.v. infusion on Days 1 (day of transplant), 2, 3, and 4 (up to a maximum total dose of 6 mg/kg) i.v. infusion over at least 4 hours; Belatacept arms will receive i.v. belatacept (10 mg/kg) on Days 1 and 5, and then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, and 12), and then every 4 weeks through Month 6 (Weeks 16, 20, and 24). After 6 months, subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial; Sirolimus will be initiated at 5 mg/day on Day 1 (day of transplant) and continued through Day 2. The dosing will be adjusted subsequently to keep pre-dose (C0) levels at 7 - 12 ng/mL for the first 6 months, followed by 5 - 10 ng/mL thereafter; The recommended total initial dose of tacrolimus is 0.1 mg/kg/day in two divided doses orally up to and including week 52. Post week 52 subjects assigned to the tacrolimus arm will receive tacrolimus orally in accordance with local practice and the package insert until completion of the trial; Administered orally in a capsule or solution formulation in 2 divided doses on a consistent schedule in relation to time of day and meals. The dose should be 1 g bid; however 1.5 g bid may be administered at the investigator's discretion until completion of the trial
Other intervention name(s): BMS-224818
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Abatacept; Tacrolimus; Thymoglobulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney transplant
Growth-Health and Development in Children Exposed to Drugs During Pregnancy
Condition: Growth Failure; Mental Health Disorder; Foetal Exposure During Pregnancy
MeSH terms: Failure to Thrive; Mental Disorders
Study type: Observational

Summary: 
      "Children exposed to alcohol or drugs during pregnancy: Growth, health and development"
      Background Children exposed to drugs during pregnancy are at risk of developmental disorders.
      The scope and size of this problem is poorly known in Norway.

      Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is
      associated with more uncertainty. Withdrawal in the neonatal period has been perceived as the
      main problem. There is less knowledge about long-term outcome of exposure to drugs during
      pregnancy.

      Aim The aim of the study is to investigate the physical and mental health of children exposed
      to drugs during pregnancy. Identify the children's need for measures in the home and school,
      and how many of the children who are taken care of in fostercare.

      A sample of the children will be offered radiological examination of the brain (f-MRI). The
      purpose is to study the relationship between exposure to drugs, child development,
      environment and organic brain dysfunction.

      Design The project is a quantitative study. The relationship between exposure to drugs and
      development will be measured by questionnaires, clinical examination, neuropsychological
      tests and radiological examination (f-MRI).

      Children aged 2-15years who were referred, examined or treated for drug related problems at
      the Department of Pediatrics, Haukeland University Hospital will be invited to participate in
      the study.

      Information retrieval and examination of the children are expected to be completed during
      2011. Data analysis and further processing of data are expected to be completed during 2013.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children exposed to drugs during pregnancy are followed up at school age regarding mental
        disorders and status of their care situation.

        Approximately 130 children are invited to the study.
      
Keywords: Foetal Exposure During Pregnancy; Health; Growth
Study to Evaluate DNL151 in Subjects With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of multiple oral doses of DNL151 in subjects with Parkinson's disease.
    

Detailed description: 
      This study was previously posted by Denali Therapeutics. In July, 2022, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): DNL151; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral repeating dose; Oral repeating dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LRRK2; Movement Disorders
Bioequivalency Study of Torsemide Tablets Under Fasting Conditions
Condition: Edema
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide
      Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting conditions using a
      single-dose, 2-treatment, 2-period, crossover design.
    


Intervention name(s): Torsemide
Intervention type(s): Drug
Intervention MeSH terms: Torsemide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eptinezumab in Adults With Migraine and Medication Overuse Headache
Condition: Migraine; Medication Overuse Headache
MeSH terms: Migraine Disorders; Headache Disorders, Secondary; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients
      with the combined diagnosis of migraine and medication overuse headache
    

Detailed description: 
      Patients planned for randomization: 91 patients in the eptinezumab 100 mg group and 91
      patients in the placebo group.

      The total study duration from the Screening Visit to the Safety Follow-up Visit is
      approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled
      Period (12 weeks), an Open-Label Period (12 weeks) and a Safety Follow-up Period (8 weeks).
      Patient will receive investigational medicinal product (IMP) at the Baseline Visit with
      either eptinezumab or placebo by IV infusion and at week 12 visit.
    

Intervention name(s): Placebo; Eptinezumab
Intervention type(s): Drug; Drug
Intervention description(s): Placebo - solution for infusion; Eptinezumab - 100 mg, solution for infusion
Other intervention name(s): Lu AG09221
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CervIcal Cancer Screening Trial by Randomization of HPV Testing Intervention for Upcoming Screening （CITRUS Study）
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess efficacy of the screening with concurrent liquid-based
      cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.
    


Intervention name(s): LBC; LBC plus HPV DNA testing
Intervention type(s): Other; Other
Intervention description(s): Cervical cancer screening by using liquid based cytology as a standard screening modality; Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This study tests if semaglutide tablets of 50 mg can help people with obesity to lower their
      food intake compared to placebo. This study also tests how semaglutide 50 mg works on
      appetite, control of eating (such as cravings and restraints) and how long time the food
      stays in the stomach after a meal.

      In addition, how much semaglutide is in the blood will also be tested. Participants will
      either get semaglutide or placebo - which treatment participants will get is decided by
      chance. Participants will receive one semaglutide (or placebo) tablet per day during the
      20-week treatment period. The dose of semaglutide is slowly increased every 4 weeks during
      the study to reach the treatment dose of 50 mg semaglutide taken for 4 weeks.

      The study lasts for up to 29 weeks for each person and includes a screening period (up to 4
      weeks), a treatment period (20 weeks) and a follow-up period (total of 5 weeks after the last
      dosing). Participants will have 12 visits with the study doctors at the institute.
    


Intervention name(s): Semaglutide D Dose 1; Semaglutide D Dose 2; Semaglutide D Dose 3; Semaglutide C Dose 4; Semaglutide C Dose 5 (50 mg); Placebo (Semaglutide C); Placebo ( Semaglutide D)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally; Tablet given orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients
Condition: Hepatitis; Hepatitis B; Lymphoma; Hematologic Diseases
MeSH terms: Hepatitis A; Hepatitis B; Lymphoma; Hepatitis; Hematologic Diseases
Study type: Observational

Summary: 
      This study is a retrospective analysis to explore the incidence of hepatitis B virus
      reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of
      chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus
      infection.
    

Detailed description: 
      All eligible patients received prophylactic antiviral therapy during and within 6 months
      after chemotherapy in previous sudy. We did not assign specific interventions to the subjects
      in this study. The primary endpoint of this study is the incidence of hepatitis B virus
      reactivation after withdrawal of prophylactic antiviral therapy. The secondary endpoints
      include the incidence of hepatitis flare related to hepatitis B virus reactivation after
      withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival
      rate.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        lymphoma patients with hepatitis B virus infection diagnosed in Peking University Cancer
        Hospita
      
Biospecimen description: 
      serum hepatitis B virus DNA
    
Keywords: hepatitis; hepatitis B; lymphoma; Hematologic Diseases
Sintilimab Combined With Anlotinib in Advanced NSCLC With EGFR Uncommon Mutations
Condition: Lung Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was a single-arm, open-label, phase II study of PD-1 monoclonal antibody combined
      with anlotinib in the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR
      uncommon mutations. Twenty-one patients of NSCLC harboring rare EGFR mutations after previous
      treatments, including a platinum-based regimen and a targeted treatment (regardless of EGFR
      Ex20ins), were enrolled. Patients received sintilimab (anti-PD-1) combined with anlotinib
      (multi-target anti-angiogenesis). The primary endpoint was the objective response rate (ORR)
      based on RECIST 1.1. Secondary goals included progression-free survival (PFS), overall
      survival (OS), disease control rate (DCR) based on RECIST 1.1; safety Sex and tolerance.
      Exploratory objectives include the use of tumor tissue and plasma specimens to detect
      biomarkers predicting the efficacy of sidilimumab: including but not limited to tumor
      mutation burden (TMB), PD-L1 expression, etc.; exploring potential predictions in peripheral
      blood. Biomarkers for anti-group efficacy, including but not limited to TCR.
    

Detailed description: 
      This clinical trial (NCT04790409) entitled " Sintilimab Combined with Anlotinib in Advanced
      NSCLC with EGFR Uncommon Mutations" has been approved by the Ethics Committee of Zhejiang
      Cancer Hospital in June 12, 2019 (IRB-2019-81). Meanwhile, we registered our project
      information on the ClinicalTrials.gov PRS in June, 2019 and obtained the status of
      "approved". In this study, the first patient received treatment on August 26, 2019. However,
      due to inexperience and misunderstanding, we wrongly missed the next stage of "released" in
      PRS. Until we realize our mistakes, the initial release time can only be on 02/18/2021.
      Therefore, we amend the initial release time here.
    

Intervention name(s): sintilimab and anlotinib
Intervention type(s): Drug
Intervention description(s): This study was a one-arm, open-label, phase II study of PD-1 monoclonal antibody combined with ilotinib in the treatment of advanced EGFR rare-mutant non-small cell lung cancer (NSCLC). 21 patients enrolled in the study who underwent platinum-containing systemic chemotherapy and EGFR-TKI failure were enrolled in the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment