bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2a Study of the Safety, Tolerability, and Pharmacokinetics of Topically Administered PRN473 (SAR444727) in Patients With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Ph2a study that consists of a double-blind, intra-patient placebo-controlled
      treatment period and an open-label uncontrolled treatment period with objective to evaluate
      the safety, tolerability, PK and preliminary efficacy of PRN473 in up to 40 patients with
      mild to moderate AD.

      On Day 1 (Baseline) of the Blinded Period, 2 target lesions with a difference no greater than
      1 point in Total Sign Score (TSS) will be randomly assigned to treatment in an intra-patient
      1:1 manner, one lesion to PRN473 and the other to matching placebo.

      Participation will take approximately 13 weeks, including up to a 5-week screening period, a
      6-week treatment period, end of study assessments 1 day after last dose, and a safety
      follow-up phone call 2 weeks after last dose.
    

Detailed description: 
      Study duration per patient is approximately 56 days including a 42-days treatment period.
    

Intervention name(s): PRN473 (SAR444727); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): White to off-white gel suspension; White to off-white gel suspension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Staccato® Granisetron Multiple Dose PK
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To examine the tolerability and safety of AZ-010 following 7 days of dosing (up to 3 mg) in
      healthy volunteers To characterize the pharmacokinetics of AZ-010 following 7 days of dosing
      (up to 3 mg) in healthy volunteers
    

Detailed description: 
      A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and
      Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
    

Intervention name(s): 0.5mg AZ-010; 1mg AZ-010; 3mg AZ-010
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo; Subject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo; Subject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo
Other intervention name(s): Staccato Placebo; Staccato Placebo; Staccato Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Disc Degeneration
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the safety and preliminary efficacy of intradiscal
      injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and one sham
      control in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one
      lumbar level from L3 to S1.
    

Detailed description: 
      This is a Phase I/II, randomized, double-blind, sham-controlled, parallel-group, multi-center
      study in subjects with single-level, symptomatic lumbar intervertebral disc degeneration (>6
      months) and unresponsive to conservative therapy for at least 3 months. The study will
      compare single intradiscal injections of high and low dose IDCT with one sham control group.

      6 study visits will be completed by all subjects; screening, day 1 (injection day), week 4,
      week 12, week 26 and week 52. The subject will be assessed for safety and efficacy utilizing
      VAS, ODI and JOABPEQ questionnaires alongside radiographic evaluations. The study will have a
      6 month follow-up and a 6 month extension period (total 1 year).
    

Intervention name(s): IDCT; Sham
Intervention type(s): Biological; Procedure
Intervention description(s): Discogenic Cells + Sodium Hyaluronate Vehicle; Needle puncture under the muscular layer in front of the intervertebral disc
Other intervention name(s): Injectable Disc Cell Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to assess the effect of BMS-986142 on the single-dose PK
      parameters of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin, probe drugs for
      (cytochome P450) CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-glycoprotein (P-gp), respectively.
    


Intervention name(s): BMS-986142 200mg; BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin); BMS-986142 350mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Flurbiprofen; Digoxin; Midazolam; Omeprazole; Montelukast
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants
Condition: Pertussis; Diphtheria; Tetanus; Poliomyelitis; Haemophilus Influenzae Type b
MeSH terms: Influenza, Human; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active
      immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive
      infections caused by Haemophilus influenzae type b. However there are currently no clinical
      data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule.
      This study is designed to provide safety and immunogenicity data to support the use of
      Pediacel™ according to a 3, 5, and 12 months schedule.
    


Intervention name(s): DT5aP-IPV-Hib 5-component Pertussis vaccine; Infanrix® -IPV+Hib
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): Pediacel™; Infanrix®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Haemophilus influenzae type b;; Corynebacterium diphtheriae;; Clostridium tetani;; Bordetella pertussis;; poliovirus types 1, 2 and 3;; Vero cell;; Influenza;; Diphtheria
Pulmonary Disease in a Psychiatric Inpatient Population
Condition: Chronic Obstructive Airway Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Purpose: Patients with mental health disorders have a reduced life expectancy, compared to
      the general population. The shorter life expectancy is caused by natural and unnatural death.
      In general, patients with a mental disorder tend to have a more unhealthy lifestyle, than the
      general population, characterized by e.g. lack of exercise and smoking.

      Hypothesis

      Chronic obstructive pulmonary disease (COPD) is underdiagnosed in psychiatric inpatients
      There is a higher prevalence of COPD in psychiatric inpatients compared to the general
      population Screening of patients with one respiratory symptom and a smoking history, has the
      same sensitivity regarding to diagnosis of COPD, as screening all patients with a smoking
      history

      Method:

      80 psychiatric inpatients will undergo spirometry with reversibility test and COPD Assessment
      Test (CATest). Furthermore, patient history regarding respiratory symptoms and smoking will
      be taken into account.
    


Intervention name(s): Spirometry with reversibility test
Intervention type(s): Procedure
Intervention description(s): Spirometry with reversibility test and CATest questionaire. following will be measured FEV1 L/s FVC L/s FEV1/FVC ration
Other intervention name(s): MicroLoop handheld transportable spirometer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: COPD; Psychiatric inpatient; Smoking
The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the potential interaction between metformin and
      exercise in order to optimize clinical guidelines for treatment of T2D.
    

Detailed description: 
      Physical activity is a first line treatment for patients with type 2 diabetes (T2D ),
      however, the vast majority of patients with T2D do not achieve satisfying glycemic control
      with physical activity alone, which is why pharmacological treatment with metformin is most
      often initiated. It is known that metformin and exercise both activates AMPK, which results
      in many different metabolic effects. Because of this similarity, an interaction between
      metformin and exercise is plausible, but knowledge in the area is sparse. With this study the
      investigators aim to look at the individual and combined effects of metformin and exercise in
      order to investigate whether an interaction occur. An Interaction will have tremendous
      clinical importance for patients with T2D given current guidelines where the vast majority of
      these patients are recommended both exercise and metformin treatment.

      The investigators hypothesize that metformin treatment reduces self-selected exercise
      intensity, which may be explained via decreased mitochondrial complex 1 function, increased
      blood lactate levels, heart rate and RPE during exercise. Furthermore exercise-induced
      AMPK-activation is reduced with metformin treatment.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 17 days treatment with metformin; 17 days treatment with placebo
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp
Condition: Postoperative Pain
MeSH terms: Dental Pulp Necrosis; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium
      Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT)
    

Detailed description: 
      When the treatment itself appears to initiate the onset of pain and/or swelling, the result
      can be very distressing to both the patient and the operator. Patients might even consider
      postoperative pain and flare-up as a benchmark against which the clinician's skills are
      measured. Prevalence of postoperative pain or flare-up is, therefore, one of the influencing
      factors when making a clinical decision. Better management of postoperative pain increases
      the patients' confidence in dentist's skills and gives positive attitude toward dental
      profession. In cases with necrotic pulp, the incidence of pain becomes higher, hence testing
      which intracanal medication is more effective in decreasing the bacteria present within the
      root canal and subsequently pain is crucial.
    

Intervention name(s): Silver nanoparticle/Calcium hydroxide; Silver Nanoparticles in gel form; Calcium Hydroxide Intracanal medication
Intervention type(s): Combination Product; Drug; Drug
Intervention description(s): Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide; Intracanal medication composed of silver nanoparticles in gel form; Calcium hydroxide intracanal medication
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Imaging Dopamine Function and Its Impact on Outcome After Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      This study will examine resting dopamine function as well as dopamine response in the brain
      as it interacts with medicines normally prescribed to subacute Traumatic Brain Injury (TBI)
      patients.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Traumatic Brain Injury patients in Inpatient Rehabilitation
      
Keywords: TBI
A Study of SHR6390 in Advanced Solid Tumor Patients
Condition: Neoplasm
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      SHR6390 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this
      study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in
      Chinese advanced solid tumor patients by using a "3+3" dose escalation.Preliminary efficacy
      will be also investigated in this study.
    


Intervention name(s): SHR6390
Intervention type(s): Drug
Intervention description(s): SHR6390 either 25, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg given orally, QD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neoplasm, Cycline-Dependent Kinase
Pemetrexed, Cisplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways
      to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may make
      tumor cells more sensitive to radiation therapy. Giving pemetrexed together with cisplatin
      and radiation therapy may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when
      given together with cisplatin and radiation therapy in treating patients with stage III or
      stage IV esophageal cancer or gastroesophageal junction cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To establish the maximum tolerated dose of pemetrexed disodium in combination with
           cisplatin and standard-dose radiotherapy in patients with stage III or IV esophageal or
           gastroesophageal junction carcinoma.

      Secondary

        -  To specifically characterize the toxicity profile of this regimen.

        -  To investigate, preliminarily, the anti-tumor activity of this regimen, as measured by
           standard response criteria (RECIST criteria), in patients with measurable disease.

      OUTLINE: This is a dose-escalation study of pemetrexed disodium.

      Patients receive pemetrexed disodium IV over 10 minutes on days 1, 15, and 29 and cisplatin
      IV over 10 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external beam
      radiotherapy once daily, 5 days a week, for up to 6 weeks.

      After completion of study therapy, patients are followed for 30 days and then every 3 months
      for 1 year.
    

Intervention name(s): cisplatin; Pemetrexed; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Standard weekly dose; Biweekly pemetrexed dose escalation; Weekly standard dose radiation therapy
Other intervention name(s): CDDP; Pemetrexed disodium; RT
Intervention MeSH terms: Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III esophageal cancer; stage IV esophageal cancer
A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to assess changes in exposure to selected harmful and
      potentially harmful substances related to tobacco/nicotine use when adult smokers switch from
      their usual brand of combustible cigarettes to the myblu e-cigarette, for up to 56 days. This
      study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in
      healthy adult smokers.

      Some subjects will be selected to take part in additional procedures as part of a
      pharmacokinetics (PK) sub-study.
    

Detailed description: 
      Subjects are randomized to either continue smoking conventional cigarettes, or switch to use
      the myblu e-cigarette. Within the "myblu" arm, subjects were assigned to one of four variants
      of the myblu e-cigarette, having different flavors and nicotine strengths. Initial product
      assignment for each subject was based on preference as a method to enhance compliance. To
      further improve compliance through Day 56, subjects may have been allowed to choose to switch
      to another variant of the myblu e-cigarette, or to continue using the same e-liquid selected
      initially.
    

Intervention name(s): Continue-smoking; myblu Tobacco 2.5%; myblu Tobacco 4.0%; myblu Honeymoon 2.5%; myblu Honeymoon 4.0%; JUUL 5%
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Ad-libitum use of subjects' usual brand combustible cigarette; Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine; Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine; Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine; Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine; Ad-libitum use of JUUL 5% e-cigarette
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Pharmacokinetic Study Comparing EG12014 and Herceptin (Trastuzumab) in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to assess the pharmacokinetic similarity of EG12014
      (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1:
      Herceptin® 150 mg powder for concentrate for solution for infusion) and the United States
      (Reference IMP 2: Herceptin® 440 mg powder for concentrate for solution for infusion) after
      intravenous infusion over 90 minutes of a single dose of 6 mg/kg trastuzumab in 3 parallel
      groups of healthy male subjects.
    


Intervention name(s): EG12014; EU-sourced Herceptin; US-sourced Herceptin
Intervention type(s): Biological; Biological; Biological
Intervention description(s): EG12014, single-dose IV infusion over 90 min at 6 mg/kg; EU-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg; US-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vascular and Neuro-inflammatory Effects of Endurance Exercise Training in African Americans
Condition: Vascular Health; Autonomic Function
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of endurance exercise training on arterial
      structure and function, and to examine potential mechanisms producing changes in arterial
      structure and function in young (18-35 years of age) African Americans when compared to
      Caucasians.
    

Detailed description: 
      African-Americans are at greater risk than Caucasians for developing hypertension,
      cardiovascular disease, stroke and renal disease. This is likely related to arterial
      dysfunction including greater arterial stiffness, and reduced microvascular reactivity of
      resistance arteries in African-Americans. In addition, African-Americans have higher levels
      of inflammatory markers, and a greater sympathoexcitatory response to various stressors. This
      imbalance between sympathetic and reduced parasympathetic activation may directly affect
      vascular function and potentiate a greater inflammatory response, further altering key
      structural and functional properties of the vascular wall. The overall aim of this proposal
      is to test the effects of endurance exercise training on arterial structure and function, and
      to examine potential mechanisms producing changes in arterial structure and function in young
      (18-35 years of age) African Americans when compared to Caucasians. We will examine these
      effects at rest and following a high intensity (maximal cycle ergometry) sympathoexcitation
      at both pre- and post-intervention time points, since sympathoexcitation may elucidate
      changes not evident at rest. Because African-Americans have higher levels of arterial
      stiffness, lower microvascular reactivity, greater responses to sympathoexcitation, greater
      levels of inflammatory markers and greater vasoconstrictive tone, we hypothesize that
      African-Americans will show differential responses to exercise training and benefit more
      compared to a matched group of Caucasians.
    

Intervention name(s): Endurance Exercise
Intervention type(s): Behavioral
Intervention description(s): 8 weeks of Endurance exercise training, 3-4 times per week, 45-60 minutes perr session
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Arterial stiffness; Endothelial function; Autonomic function; Inflammation