bioihbjkbjnl/mcl2 huggingface dataset:
Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in
      2 groups of healthy subjects.

      Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A
      (CYP3A), upon the pharmacokinetics of olorofim .

      Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the
      pharmacokinetics of olorofim .
    


Intervention name(s): Itraconazole oral solution; Rifampicin Oral Capsule; Olorofim
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg once daily on Days 6 to 15; 600 mg once daily on Days 6 to 15; Single oral dose on Days 1 and 11
Other intervention name(s): F901318
Intervention MeSH terms: Itraconazole; Olorofim; Rifampin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Single-Dose Study of a New Formulation of BIIB061
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061
      in the new oral formulation in the fasted state in healthy male and female volunteers. The
      secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in
      the new formulation in this study population.
    


Intervention name(s): BIIB061
Intervention type(s): Drug
Intervention description(s): Capsule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral Remyelination
Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy
      and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.
    

Detailed description: 
      The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep
      apnea. The study is a three-period single-dose randomized crossover design in which patients
      will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3
      treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final
      crossover PSG for an end of study (EOS) Visit.
    

Intervention name(s): AD182; AD504; Placebo; Polysomnography
Intervention type(s): Drug; Drug; Drug; Diagnostic Test
Intervention description(s): Oral capsule administered before bed; Oral capsule administered before bed; Oral capsule administered before bed; for all arms
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Renal Parenchymal Core Needle Biopsy
Condition: Image-guided Biopsy; Complications; Kidney Glomerulus
Study type: Interventional

Summary: 
      Percutaneous image-guided parenchymal renal biopsy has been used to detect the different
      pathologies of renal parenchyma, to define the degree of reversible changes, and to define
      when the medical treatment fails. Percutaneous core needle renal biopsy has been reported to
      have a higher diagnostic yield compared to fine needle aspiration. Percutaneous core needle
      renal biopsy is usually based on tissue sampling under guidance of either sonography or
      computed tomography. Renal parenchymal biopsy can be done either with a coaxial or noncoaxial
      technique. In coaxial technique, the introducing needle is placed in the renal parenchyma;
      then, multiple tissue sampling can be performed throughout the same tract. Alternatively, in
      noncoaxial technique, biopsy needle is inserted repeatedly for each tissue sampling. Although
      there are some reports regarding the comparison of coaxial and noncoaxial methods of renal
      mass biopsy, comparison of the two methods in renal parenchymal biopsy has not yet been
      described in the literature. In this prospective study, the investigators sought to compare
      the procedural time and the complication rate of coaxial technique with those of noncoaxial
      technique in percutaneous renal parenchymal biopsy.
    


Intervention name(s): coaxial renal biopsy; noncoaxial renal biopsy
Intervention type(s): Device; Device
Intervention description(s): In this method, a larger introducing needle is used for the puncture. The introducing needle is advanced just to the outer cortex of the kidney, and the needle angle is adjusted so that the needle pathway became mostly in the renal cortex, then the biopsy needle is inserted throughout the introducing needle and at least 4 cores are obtained. In this technique, the skin surface is punctured only once during the procedure.; In this method, introducing needle is not used. Biopsy needle punctures the skin surface and the needle is advanced to about 10-15 mm into the renal cortex, and tissue sampling is done. After each sampling, the needle is removed and then for the next biopsy, the whole procedure is repeated until four cores being taken.
Other intervention name(s): 18-gauge semiautomatic biopsy system with the coaxial needle; Tasuku Laboratory, Tochigi, Japan; 18-gauge semiautomatic biopsy system without coaxial needle; Tasuku Laboratory, Tochigi, Japan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Lifelong oral anticoagulant (OAC) therapy is the preferred treatment for the prevention of
      thromboembolic events in the majority of patients with Atrial Fibrillation (AF). Adherence to
      medication is essential for valid treatment for OAC therapy.

      The study aims to explore whether the advanced educational intervention would improve the
      adherence to dabigatran.
    


Intervention name(s): Dabigatran
Intervention type(s): Drug
Intervention description(s): Dabigatran
Intervention MeSH terms: Dabigatran
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients newly diagnosed with AF within 1 month, under 75 years old, and newly
        prescribed with dabigatran on physician's decision per local labelling will be equally
        randomized to receive standard of care (routine clinical practice) or standard of care
        (routine clinical practice) with advanced educational intervention.
Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance
Condition: Human Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A recent study by Plenge et al. revealed that rhEpo treatment enhances skeletal muscle
      mitochondrial respiratory capacity in humans indicating a muscle ergogenic effect of rhEpo on
      aerobic metabolism. The main purpose of the present study is to determine if a shorter
      treatment period with micro-dose as well as low-dose rhEpo has similar effects on muscle
      mitochondrial function.

      Higher doses of rhEpo is known to increase cognitive performance, but it is not clear if
      lower doses of rhEpo have similar effects. A second purpose of the present study is to
      determine if micro-dose as well as low-dose rhEpo increases cognitive performance.
    

Detailed description: 
      Twenty-five healthy young male volunteers are randomized to either a low-dose rhEpo (60
      IU/kg/week), micro-dose rhEpo (20 IU/kg/week), or placebo control (saline) group. All
      subjects receive two subcutaneous injections per week for four weeks. Muscle biopsies are
      taken at the beginning and end of the study period. Mitochondrial function is measured in
      permeabilized fibres using high-resolution respirometry with the substrates malate (2mM),
      octanoyl carnitine (1.5mM), glutamate (10mM), succinate (10mM), under saturating [ADP] (5mM),
      and with the membrane uncoupler FCCP (1μM).

      On the first day before administration of rhEpo and after the four weeks' treatment the
      subjects are undergoing two cognitive performance-tests, Raven Standard Progressive Matrices
      (Raven), and Number Finder (NUFI). Weekly semi-structured interviews are conducted by a
      blinded interviewer focusing on experienced change in cognitive performance.
    

Intervention name(s): Low-dose rhEpo; Micro-dose rhEpo; Placebo Control
Intervention type(s): Drug; Drug; Other
Intervention description(s): 60IU/kg/week; 20IU/kg/week; Saline
Other intervention name(s): Recombinant Human Erythropoitin; Recombinant Human Erythropoitin; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Erythropoietin; Randomized controlled trial; Human volunteers; Mitochondrial function; Cognitive performance
Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Genetic counseling and using an interactive computer program may help women at
      risk for breast cancer make medical decisions about treatment.

      PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how
      well it works when given together with or without a medical decision-making computer program
      in women at risk for BRCA1 or BRCA2 mutations.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian
           cancer families.

        -  Evaluate the long-term impact of genetic counseling and testing on psychosocial and
           behavioral outcomes.

        -  Evaluate the relative impact of standard genetic counseling (SGC) versus SGC plus the
           interactive decision-aid (IDA) on medical decision-making.

        -  Evaluate the relative impact of SGC vs SGC + IDA on psychological well-being.

        -  Explore the mechanisms by which the SGC + IDA intervention impacts on psychosocial and
           behavioral outcomes.

      OUTLINE: This is a multicenter study.

      Eligible women are asked to participate in a baseline telephone interview over 30 minutes and
      then invited to a genetic counseling session over 1.5-2 hours that includes information about
      BRCA1/2 testing. Patients are then offered BRCA1/2 testing, and the test results (i.e.,
      mutation carrier vs noncarrier) are presented at a subsequent in-person individual genetic
      counseling session over 1.5-2 hours. Patients who tested positive for BRCA1 or 2 mutation are
      randomized to 1 of 2 counseling arms. All other patients proceed to follow up.

        -  Arm I (standard genetic counseling): No further counselor-initiated contact is
           scheduled.

        -  Arm II (individualized decision aid): Patients are asked to view an interactive computer
           program that is designed to help the patients make medical decisions based on their
           breast cancer risk.

      Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12
      months.

      PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.
    

Intervention name(s): counseling intervention
Intervention type(s): Other
Intervention description(s): subjects will receive genetic counseling
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer
Very Low Density Lipoprotein (VLDL) Triglyceride Metabolism in Exercise
Condition: Healthy
Study type: Interventional

Summary: 
      Purpose:

      To investigate VLDL-TG metabolism in exercise in healthy volunteers to determine the
      contribution of VLDL-TG in exercise and eventual gender differences
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Moderate Intensity Exercise (50 % af VO2max) for 90 minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Lipid metabolism; VLDL; Exercise; Lipid metabolism in exercise
Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting
      study inclusion/exclusion criteria are scheduled for 2 treatment visits. At each treatment
      visit, 1 of the 2 study treatments is self-administered to both eyes. Afterwards, efficacy
      and safety assessments are performed over a 3-hour period.
    


Intervention name(s): Pilocarpine Ophthalmic administered with the Optejet dispenser; Placebo administered with the Optejet dispenser
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser; Vehicle ophthalmic solution administered with the Optejet dispenser
Other intervention name(s): MicroLine
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Consumption of Eggs Rich in Lutein and Omega-3 Fatty Acids on the Macular Pigment
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin
      from lucerne protein concentrate and DHA from microalgae on the plasma levels of these
      compounds but also on the macular pigment optical density, whose elevation may be beneficial
      in the prevention of Age-related Macular Degeneration (AMD).
    


Intervention name(s): Nutritional study
Intervention type(s): Other
Intervention description(s): subjects consume 2 eggs per day during 4 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: eggs; Optical Macular Pigment; Age Macular Degeneration; study for the Age Macular Degeneration prevention
Longitudinal Study of Cognition With Niemann-Pick Disease, Type C
Condition: Niemann-Pick Disease, Type C
MeSH terms: Pick Disease of the Brain; Aphasia, Primary Progressive; Frontotemporal Dementia; Niemann-Pick Diseases; Niemann-Pick Disease, Type A; Niemann-Pick Disease, Type C
Study type: Observational

Summary: 
      Niemann-Pick Disease, Type C (NPC) is a rare neurodegenerative disorder with a wide clinical
      spectrum and variable age of onset. Classically, children with NPC demonstrate neurological
      dysfunction with cerebellar ataxia (an inability to coordinate balance, gait, extremity and
      eye movements), dysarthria (difficulty speaking), seizures, vertical gaze palsy (ability to
      move eyes in the same direction) motor impairment, dysphagia (trouble swallowing), psychotic
      episodes, and progressive dementia. There is no curative treatment for NPC and it is a lethal
      disorder. The purpose of this protocol is to obtain both baseline and rate of progression
      data on a clinical and biochemical markers that may later be used as outcome measures in a
      clinical trial. Specifically, this study will examine and characterize the longitudinal
      progression of neurocognitive symptoms of NPC with the goal of identifying early markers of
      disease progression that may be utilized in later trials to evaluate treatment efficacy.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Longitudinal observational study of cognition in patients with NPC. Subjects will be
        recruited from participants in an observational study currently in progress at NIH, and
        from subjects receiving clinical care at Mayo Clinic. Participants will be administered
        age-and functionally-appropriate neuropsychological test instruments annually to track
        cognitive changes over time, and to link these data to the subjects' scores on the NIH
        disability scale.
      
Keywords: Niemann-Pick disease type C; Lysosomal disease
Coordinated Endoscopic Colorectal Cancer Screening
Condition: Preventive Health Services
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The investigators aim to use a randomized design to test the effects of 1) tailored physician
      recommendations, relative to non-specific recommendations, and 2) coordinated physician
      office management systems on patient adherence to colorectal cancer screening
      recommendations.
    

Detailed description: 
      The investigators aim to use a randomized design to test the effects of 1) tailored physician
      recommendations, relative to non-specific recommendations, and 2) coordinated physician
      office management systems on patient adherence to colorectal cancer screening
      recommendations.

      To accomplish these aims, the investigators propose 1) to use existing physician
      practice-based computerized patient registration systems to define populations of 50 to 79
      year-old pri-mary care patients, 2) to use mailed questionnaires to determine colorectal
      cancer risk factor status and prior colorectal cancer screening history, 3) to use responses
      from mailed questionnaires to identify persons not adhering to colorectal cancer screening
      guidelines, 4) to use computer driven algorithms to help physicians prepare and deliver
      individually tailored and written colorectal cancer screening recommendations, and 5) to
      develop, implement, and evaluate a centralized service for delivering high quality screening
      flexible sigmoidoscopy.
    

Intervention name(s): Help with physician office and patient management; Tailored physician recommendation letter
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: colorectal cancer screening; sigmoidoscopy; colonoscopy
Real-world Study on Adjuvant Octreotide Therapy in pNETs
Condition: Pancreatic Neuroendocrine Tumor G2
MeSH terms: Neuroendocrine Tumors; Adenoma, Islet Cell
Study type: Interventional

Summary: 
      Adjuvant therapy in pancreatic neuroendocrine tumors (pNETs) after radical resection lacks
      evidence-based data and is controversial. Real-world data were clustered to validate whether
      the long-acting octreotide is a potential candidate for adjuvant therapy in high recurrence
      risk G2 pNET patients.
    

Detailed description: 
      Adjuvant therapy for pNETs was proposed as an unmet clinical need by the European
      Neuroendocrine Tumor Society Group in 2016.1The Clinical Practice Guidelines for pNETs in
      China recommended initiation of clinical trials to investigate the role of adjuvant therapy
      for patients with a high-risk of recurrence. To address this unmet clinical need, the
      investigators initiated this real-world study. The aim of the current study was to assess the
      impact of octreotide LAR as an adjuvant therapy in reducing recurrence and prolonging
      survival in Chinese non-metastatic pNETs patients at risk for recurrence.
    

Intervention name(s): Octreotide LAR
Intervention type(s): Drug
Intervention description(s): Octreotide LAR (Sandostatin® LAR, Novartis Pharmaceuticals Corporation) treatment by deep intramuscular injection at a dose of 30 mg every 28 days for 6-12 months。
Other intervention name(s): Sandostatin
Intervention MeSH terms: Octreotide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
R115777 in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have
      refractory or recurrent acute leukemia or chronic myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine toxicities and pharmacokinetics of oral R115777 in adults with
      refractory acute leukemia or accelerated or blastic phase chronic myelogenous leukemia. II.
      Determine the effect of R115777 on farnesylation within leukemia cells. III. Determine any
      clinical response (at least 50% decrease in circulating leukemia cells) to R115777 by these
      patients.

      OUTLINE: This is a dose escalation, multicenter study. Patients receive oral R115777 for 7-21
      days. Patients who achieve complete response (CR) or partial response (PR) following 1-4
      courses of treatment may receive up to 4 additional courses. Patients with stable disease may
      receive another 7-21 day course. If CR or PR is then achieved, patients may receive up to 4
      additional courses. Cohorts of 6-12 patients receive escalating doses of R115777 until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which between
      17% and 33% of patients experience dose limiting toxicity.

      PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
    

Intervention name(s): tipifarnib
Intervention type(s): Drug
Intervention MeSH terms: Tipifarnib
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; untreated adult acute lymphoblastic leukemia; untreated adult acute myeloid leukemia; adult acute promyelocytic leukemia (M3); secondary acute myeloid leukemia