bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in
      patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using
      variables, such as daily urine volume and increase in interval body weights between
      hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days
      of hemodialysis or hemodiafiltration) at the dose fixed during the dose-escalation period
    


Intervention name(s): OPC-41061
Intervention type(s): Drug
Intervention description(s): The maximum number of days of administration will be 8 days (8 doses) in total 4 days each in the dose-escalation period and intermittant administration period. The investigational medicinal product (IMP) will be administered once daily after breakfast
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is an investigator-initiated study in which Dr. Nadeau wrote the protocol and received
      funding from an Astra Zeneca grant to direct, perform, and monitor the study on her own with
      Stanford staff. We hypothesize that the budesonide/formoterol combination improves the
      efficacy of budesonide alone.
    

Detailed description: 
      The study was designed such that 30 participants would be consented/enrolled into the trial.
      The intervention would only be applied if the participant developed a viral illness that met
      eligibility criteria during the study period.

      Only 10 of the 30 ppt. consented/enrolled developed a virus and were then treated according
      to study arm.

      A more detailed description can be obtained by contacting Astra Zeneca
    

Intervention name(s): Symbicort
Intervention type(s): Drug
Other intervention name(s): Budesonide
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Asthma
Adult Healthy Volunteers Study to Evaluate ALPN-101 Safety
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is testing the safety, tolerability, pharmacokinetics (PK--the amount of study
      drug in the blood), pharmacodynamics (PD), how the study drug affects the body) and
      immunogenicity (how the study drug affects the immune system) of single and multiple doses
      and dose levels of an investigational drug called ALPN-101.
    

Detailed description: 
      AIS-A01 is a phase 1, randomized, placebo-controlled, double-blinded study in healthy
      volunteers. It will be conducted at a single center and will enroll approximately 104
      participants. The study will have 2 parts:

        -  In Part A, participants will receive a single dose of study drug or placebo. Multiple
           dose levels of ALPN-101 will be evaluated.

        -  In Part B, participants will receive 4 doses of ALPN-101 or placebo--1 dose each week
           for 4 weeks. Multiple dose levels of ALPN-101 will be evaluated.

      In each Part, safety assessments will be performed throughout the dosing and follow-up
      periods, and multiple PK and PD samples will be collected.
    

Intervention name(s): ALPN-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single or multiple doses of ALPN-101 delivered via intravenous or subcutaneous injection. Ascending dose levels will be evaluated.; Single or multiple doses of placebo delivered via intravenous or subcutaneous injection, matched to ALPN-101 cohorts.
Intervention MeSH terms: ALPN-101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blinded, dose escalation to evaluate the safety, PK, and PD of single and multiple doses of ALPN-101
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Healthy Volunteers
Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study
Condition: Gastrointestinal Stromal Tumor of Stomach
MeSH terms: Gastrointestinal Stromal Tumors; Stomach Neoplasms
Study type: Interventional

Summary: 
      Patients with gastric gastrointestinal stromal tumors will receive robotic resection.
    

Detailed description: 
      Gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract.
      Approximately 60% of tumors develop in the stomach.Before, patients with gastric
      gastrointestinal stromal tumors would receive open or laparoscopic surgery. However,
      gastrointestinal stromal tumors located at special sites, such as cardia, were hardly
      treated. Recently, the robot was used to remove gastric gastrointestinal stromal tumors. In
      this study, the robot will be used to remove gastric gastrointestinal stromal tumors. Then,
      we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.
    

Intervention name(s): Robotic gastric gastrointestinal stromal tumors resection
Intervention type(s): Procedure
Intervention description(s): Robotic gastric gastrointestinal stromal tumors resection
Intervention model: Single Group Assignment
Intervention model description: This is a single group, open study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastrointestinal stromal tumors; Robot; manual suture
Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)
Condition: Glomerulonephritis, Membranous; antiPLA2R Positive
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open-label, multicentre study to characterize the safety and efficacy of the human
      anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous
      Nephropathy (newly diagnosed/relapsed/refractory)
    

Detailed description: 
      After treatment subjects will be observed for up to 1 year.
    

Intervention name(s): MOR202
Intervention type(s): Drug
Intervention description(s): Patients will receive 9 doses of MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing will occur weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
Intervention MeSH terms: Felzartamab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 2 cohorts by disease status (Cohort 1: Patients with newly diagnosed or relapsed membranous nephropathy; Cohort 2: Patients with membranous nephropathy refractory to immunosuppressive treatment)
Masking: None (Open Label)
Primary purpose: Treatment
Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin's Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD
      (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin
      Lymphoma.
    

Detailed description: 
      Dose-density has been shown to be an important factor for complete remission rate and
      longterm survival in lymphomas.

      The aims of this study were to find out whether intensification of ABVD (dd-ABVD) is feasible
      and can improve the outcome of patients with early stage Hodgkin Lymphoma. In view of
      emerging data on the role of early PET in defining prognosis in Hodgkin Lymphoma patients,
      the percentage of FDG-PET (fluorodeoxyglucose positron emission tomography) negativity after
      two cycle was chosen as the parameter to evaluate dd-ABVD activity.
    

Intervention name(s): dose dense ABVD
Intervention type(s): Drug
Intervention description(s): dose dense ABVD will be administered intravenously on day 1 and 8 every 21 days Chemotherapy regimen
Doxorubicin 25 mg/m2 i.v. day 1 and 8
Bleomycin 10 mg/m2 i.v. day 1 and 8
Vinblastine 6 mg/m2 i.v. day 1 and 8
Dacarbazine 375 mg/m2 i.v. day 1 and 8
Granulocyte colony-stimulating factor (G-CSF): days 9 to 14
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HL; Hodgkin Lymphoma; First line therapy
The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children
Condition: Sedation
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      The purpose of the study is to validate the diagnostic performance of the amplified
      pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in
      propofol sedated nonintubated children. To determine the sensitivity/specificity and
      positive/negative predictive value of the APS in detecting sedation-related adverse acute
      respiratory events in propofol sedated nonintubated children.
    


Intervention name(s): APS
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: propofol sedation; children; procedure sedation
A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Condition: Prevention; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the efficacy and safety of DU-176b compared with
      enoxaparin sodium for the prevention of venous thromboembolism in patients after elective
      total hip arthroplasty.
    


Intervention name(s): edoxaban; enoxaparin sodium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anticoagulants; Venous thromboembolism; Thromboembolism; Thrombosis; enoxaparin sodium; Embolism; Deep vein thrombosis; DU-176b; edoxaban; factor Xa; total hip arthroplasty
Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA
Condition: Cancer; Solid Tumor; Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Study type: Observational

Summary: 
      Nucleix EpiCheck® tests analyzes the methylation pattern in a panel of DNA methylation
      biomarkers and determines whether this pattern is consistent with cancer under test or with
      non-cancer tissue.

      This study is being performed as part of the development process of the Pan Cancer EpiCheck
      test which includes the identification of different methylation profiles in various cancer
      types and healthy controls.
    

Detailed description: 
      The aim of this study is to characterize methylation patterns that will distinguish cancer
      from normal samples and will be able to recognize the origin of the cancer by collecting
      cfDNA (circulating free DNA) from blood samples collected from patients with a new diagnosis
      of cancer and from healthy volunteers who do not have diagnosis or history of cancer.
      Identifying those methylation patterns may assist in the development of blood test that will
      be able to detect the presence and the origin of wide range of human cancers
    

Intervention name(s): Blood collection
Intervention type(s): Procedure
Intervention description(s): Peripheral blood collection via routine venipuncture
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The cases group will include subjects of at least 22 years old that were already diagnosed
        with cancer but did not yet undergo any surgery, chemotherapy, radiation or any other
        treatment for this cancer (i.e. treatment naïve subjects). Enrollment for this group will
        be stratified to enable representation of subjects with multiple tumor histological types,
        stage and grade.

        The control group will include healthy subjects, 45-80 years old. The subjects in the
        control group should be without any previous or current diagnosis of cancer except
        completely resected non-melanoma skin cancer.
      
Biospecimen description: 
      Plasma samples
    
Keywords: Cancer; Methylation; cfDNA; Solid Tumor; Hematologic Neoplasms
A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of
      single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose
      study to evaluate the PK, immunogenicity, and safety of mavrilimumab at doses of 100 and 150
      mg in healthy adult Japanese subjects. The study will be conducted at one site in Europe and
      subjects will be randomized in a 5:5:2 ratio to 100, 150mg mavrilimumab and placebo.
    

Intervention name(s): 100mg Mavrilimumab; 150mg mavrilimumab; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 100mg Mavrilimumab; 150mg mavrilmumab; Placebo
Intervention MeSH terms: Mavrilimumab; Antibodies, Monoclonal
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Volunteers, Rheumatoid Arthritis, mavrilimumab
Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers
Condition: Postoperative Pain Management
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      Given as a single perioperative injection, SKY0402 could provide adequate, continuous, and
      extended pain relief that could greatly simplify postoperative pain management, reduce the
      need for repeated administration, and minimize episodes of breakthrough pain.
    

Detailed description: 
      Subjects will be given either SKY0402 or placebo in response to a noxious stimulus, and the
      time to onset will be recorded.
    

Intervention name(s): SKY0402; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Local administration of SKY0402 followed by noxious stimulus; Local administration of Placebo followed by noxious stimuli
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pain management; postoperative
Development of a Comprehensive AP Training Curriculum for Adults
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      An e-learning training program is to prepare people with diabetes and their physicians on the
      use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).
    

Detailed description: 
      This project will develop and test a comprehensive, web based training system for the
      artificial pancreas (AP) prototype identified as eDAPT (electronic Diabetes Artificial
      Pancreas Training). This e-learning training program is to prepare people with diabetes and
      their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant
      (DiAs), a software platform for the development and outpatient testing of smart phone based
      systems for Closed Loop Control of diabetes. The e-learning training program will be used in
      adjunct to in-person training with study staff at the onset of a clinical trial. It will be
      especially important as the number of clinical sites that use DiAs continue to grow both in
      the United States and internationally. It is also a critical step in moving the DiAs closer
      to a commercial product. A validated training program is required to proceed with the Food
      and Drug Administration (FDA) for both pivotal clinical trials and commercial approval of the
      AP.
    

Intervention name(s): eDAPT on-line training program
Intervention type(s): Behavioral
Intervention description(s): A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  clinicians who manage patients on insulin pumps and continuous glucose monitors

          -  participants former study participants who have experience operating DiAs.

          -  participants who wear an insulin pump and continuous glucose monitor but have no
             experience DiAs.
      
Keywords: Diabetes Assistant (DiAs); Continuous Glucose Monitor (CGM); Insulin Pump; Human Factors; Focus Group; Artificial Pancreas (AP); eDAPT (electronic Diabetes Artificial Pancreas Training)
The Influence of Satiation Measures on the Portion Size Effect
Condition: Feeding Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to gain a better understanding of the satiation measures that
      influence human eating behavior in regard to intake of large portion sizes at a meal. The
      investigators hypothesize that satiation measures will influence the magnitude of the portion
      size effect at a meal. Additionally, other individual characteristics will be examined for
      their influence on the portion size effect. The portion size effect will be measured by
      serving a test meal once a week for four weeks in which the portion size of the entree will
      be varied.
    


Intervention name(s): 100% portion size; 125% portion size; 150% portion size; 175% portion size
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Entree portion size 100% of baseline; Entree portion size 125% of baseline; Entree portion size 150% of baseline; Entree portion size 175% of baseline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
DETECT and Retinal Outcomes in Hypertension
Condition: Hypertension; Retinal Disorder; Cognitive Impairment
MeSH terms: Retinal Diseases; Hypertension; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to study the impact of blood pressure on cognitive performance.
    

Detailed description: 
      Four groups will be evaluated for possible impact of blood pressure on cognitive performance
      and retinal damage.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Emergency department patients that meet the inclusion/exclusion criteria.
      
Keywords: Hypertension; Retinal Disorder; Cognitive impairment
Randomized Controlled Study of the Efficacy of Hypnosis Versus Relaxation and Control in Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      A randomized double-blind controlled two centers study. The primary objective of this study
      will be to show a superiority of hypnosis over relaxation on pain intensity in patients with
      neuropathic pain.
    

Detailed description: 
      The secondary objectives of this study are:

        -  to show a superiority of hypnosis and relaxation over control group on neuropathic pain.

        -  to show a lasting effect of treatment on neuropathic pain one week after the end of
           treatment.

        -  to evaluate the clinical predictors of response to hypnosis (nature of neuropathic
           symptoms, severity of anxiety and depressive symptoms, pain catastrophizing, coping
           strategies, emotional regulation, response to the first session, positive or negative
           emotional reaction at the end of hypnosis sessions).

        -  to evaluate the effect of hypnosis at long-term (1, 3 and 6 months after the end of
           treatment).

        -  to evaluate the effect of hypnosis on emotional processes.

        -  to compare hypnosis to relaxation on short-term effects on pain,

        -  to evaluate the quality of life and the impact of pain on daily life: sleep, mood,
           anxiety symptoms, analgesics consumption , neuropathic symptoms, affective component of
           pain and pain catastrophizing.

           35 patients will be enrolled in each arm, to obtain 105 in total (3 arms). Total
           duration for each patient: 8 months.
    

Intervention name(s): Hypnosis sessions; Relaxation group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 1 session per week during 8 weeks; 1 relaxation session per week during 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuropathic pain; Hypnosis; Relaxation
Short-term Metabolic Effects of Mirtazapine in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg
      mirtazapine per day in healthy subjects.
    


Intervention name(s): mirtazapine
Intervention type(s): Drug
Intervention description(s): 30 mg mirtazapine once daily for 7 days
Other intervention name(s): Remergil
Intervention MeSH terms: Mirtazapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: mirtazapine; metabolism; depression; Healthy males
A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of
      BBI-5000 capsules in healthy adult subjects.
    

Detailed description: 
      This is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate
      the pharmacokinetics (PK) and food effect of BBI-5000 capsules in healthy adult subjects.

      Participating subjects will receive a single oral dose of BBI-5000 followed by a washout
      period of 7-14 days between doses. The treatment period will be followed by 5-10 day
      follow-up period.

      PK and PD will be assessed by blood sampling through 72 hours postdose.

      Safety will be assessed through collection of vital signs, adverse events, physical
      examination, ECGs and clinical laboratory tests.
    

Intervention name(s): BBI-5000
Intervention type(s): Drug
Intervention description(s): BBI-5000 low dose, middle dose, or high doses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment