bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)
Condition: Chemotherapy-Induced Nausea and Vomiting; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two
      formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults.
      Parts I to IV of this study will examine different doses of MK-0517 as well as two different
      formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare
      single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The
      primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or
      115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg
      oral aprepitant capsule in young healthy participants.
    


Intervention name(s): 90 mg MK-0517 (PS80); 100 mg MK-0517 (PS80); 100 MK-0517 (PS80) + 2 mg midazolam; 115 mg MK-0517 (PS80); 150 mg MK-0517 (PS80); 40 mg MK-0517 (non-PS80); 100 mg MK-0517 (non-PS80); 150 mg MK-0517 (Non-PS80); Placebo; 40 mg Aprepitant; 125 mg Aprepitant; 2 mg Midazolam
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes; MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes; MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517.; MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes; MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes; MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.; MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.; MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.; Placebo matching MK-0517; Aprepitant, oral, tablet, single dose; Aprepitant oral tablet, single dose; Midazolam oral tablet, single dose
Intervention MeSH terms: Midazolam; Aprepitant; Fosaprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cryoanesthesia for Intravitreal Injections
Condition: Ocular Anesthesia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The cryoanesthesia (CA) device is designed to provide anesthesia to a focal area on the
      surface of the eye immediately prior to intraocular injections.

      The investigators plan to carry out a pilot study to collect preliminary data on the
      effectiveness of the cryoanesthesia (CA) device in minimizing the pain caused by intravitreal
      injections (IVT).
    


Intervention name(s): Cryoanesthesia device; Lidocaine
Intervention type(s): Device; Drug
Intervention description(s): The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.; Lidocaine applied to the non-cryoanesthesia eye.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin
Condition: Skin and Connective Tissue Diseases
MeSH terms: Connective Tissue Diseases; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess steroid induced skin atrophy by sonography.
    


Intervention name(s): Clobetasol propionate 0.05 % ointment; Betamethasone dipropionate 0.064 % ointment; Petrolatum ointment
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Clobetasol; Petrolatum; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Chronic Hepatitis C and Insulin Resistance
Condition: Hepatitis C; Insulin Resistance
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Insulin Resistance
Study type: Observational

Summary: 
      Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with
      >200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity
      and heart disease are extremely common. This study will examine the relationship between
      insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to
      CHC
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Hepatitis C patients
      
Biospecimen description: 
      serum
    
Keywords: Insulin resistance; Liver fat; Muscle fat; Abdominal fat; Cytokines
Analgesic Effect of Liposomal Bupivacaine
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Brachial plexus blocks (BPB) are commonly used to provide regional anaesthesia for patients
      undergoing distal radial fracture surgery. Distal radial (DR) fracture surgery is a commonly
      performed orthopaedic surgery, and is usually associated with moderate postoperative pain.
      Poor postoperative pain control can impair rehabilitation, delay recovery and negatively
      impact outcomes after surgery. Liposomal bupivacaine (EXPAREL) is a multivesicular
      formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine.
      Liposomal bupivacaine can provide longer analgesia for up to 72 hours, and may therefore
      achieve greater analgesic efficacy compared to non-liposomal long-acting local anaesthetics.
      A number of clinical trials have studied the effect liposomal bupivacaine given as local
      infiltration. However, there is little evidence on liposomal bupivacaine for regional nerve
      blocks, and the use of liposomal bupivacaine for supraclavicular brachial plexus block -
      which is used for regional anaesthesia for distal radial fracture surgery - have not been
      studied before. This project is a randomized controlled trial to determine whether adding
      liposomal bupivacaine to long-acting local anaesthetics for supraclavicular BPB will improve
      and prolong postoperative analgesia in patients undergoing distal radial fracture surgery.
      Longer term secondary outcomes would be accessed including upper limb functional scores,
      chronic pain, and health related quality of life.
    


Intervention name(s): Bupivacaine Injection [Marcaine]; Bupivacaine Liposome 13.3 MG/ML [Exparel]
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine injection [Marcaine] is the standard treatment used in our hospital.; Bupivacaine liposome is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
8-Week Atopic Dermatitis (AD) Treatment Study
Condition: Atopic Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to investigate the clinical effectiveness of the Sponsor's experimental cream
      treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).
    

Detailed description: 
      This will be a 9-week, randomized, double blind, parallel comparison study consisting of a
      1-week washout phase followed by an 8-week treatment phase. This study will be executed by
      one clinical research company utilizing two test sites and up to 62 subjects with moderate or
      severe atopic dermatitis, ages 12-65, will be enrolled. Subjects that are enrolled will be
      placed on one of three products (e.g. Sponsor's Experimental Cream Treatment, a basic
      moisturizer, or a positive control - Desonide) and will be required to use the assigned
      product twice a day for the duration of the 8-week treatment phase.
    

Intervention name(s): Investigational OTC Cream; 0.05% Desonide; Placebo Cream
Intervention type(s): Drug; Drug; Other
Intervention description(s): Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.; Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.; Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Other intervention name(s): Desowen; Vehicle
Intervention MeSH terms: Desonide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized and balanced into one of the 3 treatment groups by their baseline SCORAD grade (moderate = 25-40 and severe = 41+) and ethnicity (black or non-black).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement
Condition: Pain Measurement
Study type: Interventional
Phase: Phase 4

Summary: 
      Background and aim: Postoperative pain is an adverse effect of oral surgeries and may
      therefore be prevented or minimized. This study compares the efficacy of preemptive ibuprofen
      and dexamethasone protocols in pain prevention and control after surgical implant placement.

      Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized
      clinical trial, 117 dental implants were placed. The groups received three different
      protocols 1 hour before surgery:

        1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);

        2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or

        3. placebo.

      Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to
      take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and
      visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate
      scale, hourly for the first 8 hours after surgery and three times a day on the following 3
      days.
    


Intervention name(s): Ibuprofen 600 mg; Dexamethasone 4 mg; Placebo; Acetaminophen 1000 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);; This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose); This group receives 1 hour before surgery placebo.; A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
Intervention MeSH terms: Acetaminophen; Dexamethasone; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Study of Refeeding to Optimize iNpatient Gains
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy, safety, and cost-effectiveness of lower
      calorie refeeding versus higher calorie refeeding in hospitalized adolescents with anorexia
      nervosa.
    


Intervention name(s): Higher Calorie Refeeding; Lower Calorie Refeeding
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anorexia nervosa; eating disorders; refeeding; adolescent medicine; nutritional rehabilitation
A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy Volunteers
Condition: P-glycoprotein; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy
      subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and
      P-glycoprotein induction on lenvatinib pharmacokinetics following single dose oral
      administration of 24 mg lenvatinib to healthy volunteers.
    

Detailed description: 
      This is a single-dose, open-label, sequential, three-period study in 15 healthy subjects to
      assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and P-glycoprotein
      induction on lenvantinib pharmacokinetics following single dose oral administration of 24 mg
      lenvatinib to healthy volunteers. The study will consist of two phases: Pretreatment and
      Treatment. The Pretreatment Phase will have two periods: Screening and Baseline 1. The
      purpose of the Screening Period is to obtain informed consent and to establish protocol
      eligibility. The purpose of the Baseline 1 is to confirm protocol eligibility. The Treatment
      Phase will have three periods: Treatment Period 1, Treatment Period 2, and Treatment Period 3
      with a Baseline 2 assessment prior to Treatment Period 2 and a Baseline 3 assessment prior to
      Treatment Period 3. The purpose of Baselines 2 and 3 are to confirm continued protocol
      eligibility. In the Treatment Phase, subjects will take a single oral dose of 24 mg
      lenvatinib on three separate occasions (Period 1, Day 1; Period 2, Day 15; and Period 3, Day
      43). In Period 2, Day 15, subjects will also take a single oral dose of 600 mg po rifampin.
      In Period 3, subjects will receive 600 mg rifampin po daily for 21 days (Period 3, Days 29 to
      49). On Day 43 of Period 3, subjects will take 24 mg lenvatinib in addition to the rifampin.
    

Intervention name(s): Lenvatinib
Intervention type(s): Drug
Intervention description(s): subjects will take a single oral dose of 24 mg lenvatinib on three separate occasions (Period 1, Day 1; Period 2, Day 15; and Period 3, Day 43). In Period 2, Day 15, subjects will also take a single oral dose of 600 mg po rifampin. In Period 3, subjects will receive 600 mg rifampin po daily for 21 days (Period 3, Days 29 to 49). On Day 43 of Period 3, subjects will take 24 mg lenvatinib in addition to the rifampin.
Other intervention name(s): E7080
Intervention MeSH terms: Lenvatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: P-glycoprotein; Healthy Volunteers
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
Condition: Latent Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis; Tuberculosis, Multidrug-Resistant
Study type: Interventional

Summary: 
      To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for
      developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT
      scan.
    

Detailed description: 
      Multidrug- or extensively resistant tuberculosis tuberculosis is a major public health threat
      worldwide and the global burden of drug-resistant tuberculosis is increasing. Drug-resistant
      tuberculosis is associated with long period and high costs for treatment, high rates of
      default, treatment failure and death.

      Drug-resistant tuberculosis should be diagnosed rapidly so as to reduce potential
      transmission. In the United States, at least one-fifths cases of multidrug-resistant
      tuberculosis can be linked to transmission. Close contacts to drug-resistant tuberculosis are
      at high risk for being transmitted and developing drug-resistant tuberculosis. There are two
      options suggested for close contacts to drug-resistant tuberculosis: preventive therapy and
      close observation. But both strategies are lack of sufficient evidence.

      Ultralow chest CT scan may be an alternative for early identification and risk stratification
      of developing active tuberculosis in close contacts to drug-resistant tuberculosis with
      minimal radiation exposure similar to that of chest x-ray.
    

Intervention name(s): Ultralow dose chest CT scan
Intervention type(s): Radiation
Intervention description(s): Ultralow-dose chest CT scan is performed using a 64-row multidetector CT system (Discovery CT750HD; GE Healthcare, Waukesha, WI) with 1.25-mm-thick axial slices at less than 1 mSv (volume computed tomography dose index: 0.39 milligray).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pulmonary tuberculosis; chest; ultralow dose computed tomography
Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, double-blind, randomized, placebo-controlled study of the safety,
      tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients
      receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or
      placebo) for a treatment period of 12-weeks.
    

Detailed description: 
      Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment
      of Type 2 diabetes. The investigational drug, HE3286, holds the potential to be the first in
      a new class of insulin sensitizers with a potentially novel mechanism of action that may
      improve the current therapeutic options available to a T2DM patient.

      This is a phase II, double-blind, randomized, placebo-controlled study of the safety,
      tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients
      receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or
      placebo) for a treatment period of 12-weeks. Changes in hemoglobin A1c (HbA1c) will be
      assessed over a treatment period of 12-weeks.
    

Intervention name(s): HE3286; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HE3286 10 mg per day (5 mg BID); Placebo capsules BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Metformin; HbA1c
Study of Exercise to Manage Distress During Breast Screening
Condition: Breast Cancer; Anxiety; Depression
MeSH terms: Depression; Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The breast cancer screening and diagnostic period is associated with heightened symptoms of
      anxiety and depression. Physical exercise has been found to effectively decrease these
      symptoms in healthy and diseased populations. This study aims to determine if a pre treatment
      exercise intervention can minimize symptoms of anxiety and depression in women undergoing
      screening for breast cancer.
    

Detailed description: 
      The breast cancer diagnostic process is associated with anxiety and depression. Physical
      exercise has emerged as an attractive non-pharmacologic approach to mitigating the
      psychological and physical sequelae of breast cancer and its treatments, however pre
      treatment interventions are not integrated into current practice. This study aims to
      determine the effectiveness and feasibility of a pre treatment exercise intervention in
      attenuating levels of anxiety and depression following breast biopsy and throughout the
      diagnostic period.
    

Intervention name(s): Moderate intensity exercise training; Self Management of exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6 weeks of moderate intensity exercise training (50 - 75% of heart rate reserve). Sessions are facility and home based and include cardiovascular warm-up, cardiovascular training, muscular conditioning, and flexibility exercises.; In addition to the 6 week exercise program (refer to Exercise Treatment Group), participants randomly assigned to the Self Management Group will learn strategies for the self management of exercise.
Other intervention name(s): Exercise; Treatment Group 1; Self Management; Self Regulation; Adherence; Treatment Group 2
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anxiety; Depression; Exercise; Breast Cancer; Biopsy; Screening; Diagnosis
A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the bioequivalence of olezarsen between 2 subcutaneous
      (SC) formulations [(autoinjector (AI) and vial] at 2 dose levels in healthy adult
      participants.
    

Detailed description: 
      This is a Phase 1, single-dose, randomized, open-label, two-period, crossover study in
      approximately 100 healthy participants. The study will consist of an up to 28-day Screening
      Period, two treatment periods of 15 days each - with the second treatment period starting
      28-42 days after the first begins - and a Post-Treatment Follow-Up Period lasting 91 days
      after the second treatment period begins. Eligible participants will be randomized to two
      dose groups (50 mg or 80 mg olezarsen). Participants will be dosed once at the beginning of
      each treatment period, one time using a single-use AI and one time using a single-use vial.
      Within each dose group, approximately half of the participants will be dosed with the AI
      first, with the other participants being dosed with the vial first.
    

Intervention name(s): Olezarsen
Intervention type(s): Drug
Intervention description(s): Olezarsen will be administered by SC injection.
Other intervention name(s): ISIS 678354
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other