bioihbjkbjnl/mcl2 huggingface dataset:
Double-blind, Randomized, Placebo-controlled Phase 3 Study of Etanercept in the Treatment of Psoriatic Arthritis and Psoriasis
Condition: Psoriatic Arthritis; Psoriasis
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a phase 3, double-blind, placebo-controlled, randomized, multicenter study in
      subjects with psoriatic arthritis (PsA) and psoriasis comprising 3 periods: a 24-week
      double-blind period, a ≤ 24-week maintenance period, and a 48-week open-label period. During
      the double-blind period, subjects were randomized equally to 1 of 2 regimens: etanercept 25
      mg twice weekly (BIW) or placebo, administered subcutaneously (SC). After the week 24 visit,
      subjects continued on blind-labeled therapy in a maintenance period until all subjects
      completed the double-blind period. After the maintenance period, all subjects received
      open-label etanercept 25 mg BIW.
    

Detailed description: 
      Previously presented data from 2 double-blind, placebo-controlled trials (Protocols 016.0612
      [Investigator IND] and 016.0030 [Immunex IND]) led to the approval of etanercept for reducing
      clinical signs and symptoms of PsA. One-year radiographic data from Protocol 20021630 led to
      an additional approval of etanercept for inhibiting structural progression in PsA.

      Data are used for the following purposes:

        -  To summarize the clinical efficacy and safety results previously described in the
           6-month clinical study report and the radiographic results previously described in the
           1-year clinical study report.

        -  To show the effect of etanercept on physical function in subjects with PsA and
           psoriasis, as measured by 2 patient-reported outcome measures (disability index of the
           Stanford Health Assessment Questionnaire [HAQ] and Medical Outcomes Study Short-form
           Health Survey [SF-36]). • To present the radiographic results at 2 years from baseline
           and the final clinical efficacy and safety results during the open-label period of the
           study.
    

Intervention name(s): Placebo; Etanercept
Intervention type(s): Other; Drug
Intervention description(s): Placebo; Etanercept
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Functional Test for a Drink Powder Alone and Combined Use With a Cosmetic Apparatus
Condition: Beauty Drink Powder; Cosmetic Apparatus on Skin; Skin Elasticity; Skin Dryness; Skin Moisture; Skin Evenness; Skin Firmness
Study type: Interventional

Summary: 
      This study is designed to observe human consuming effect of a beauty drink powder and
      combined use with a cosmetic apparatus. It is a randomized, double-blind, and placebo-control
      study. The target enrollment of subjects is 160 and 4 arms are included, a placebo control,
      drink powder alone, cosmetic apparatus alone, and drink powder plus cosmetic apparatus.
      Effects on skin dullness, skin tone unevenness, skin dryness, skin elasticity, wrinkle and
      fine line are evaluated. Both objective and subjective methods are used for efficacy
      evaluation. Data are collected at baseline, week 4, week 8, and week 12 after treatment.
    

Detailed description: 
      In this study, objective parameters are measured by the instruments as following: VisioScan
      VC20 is used for skin roughness and wrinkle assessment, chromameter CR-400 is used to assess
      skin color, skin gloss is assessed by Glossymeter, skin hydration is assessed by Corneometer,
      TEWL is assessed by Vapometer, and skin elasticity is assessed by Cutometer. VISIA-CR and
      VISIA-7 are used in skin radiation and wrinkle visualization.

      Clinical assessment is performed by expert visual grading on

        -  Skin evenness

        -  Skin radiance

        -  Skin elasticity

        -  Skin smoothness

        -  Skin firmness

        -  Skin moisture

        -  Skin plumpness
    

Intervention name(s): Beauty drink powder; Cosmetic apparatus
Intervention type(s): Dietary Supplement; Device
Intervention description(s): Beauty drink powder is designed as a oral beauty product to provide benefits to skin; This device is designed to let participants to experience brighter, softer, smoother skin and an energizing facial massage. A synergestic effect when combine with beauty drink powder is expected.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to four group during the study: a placebo control group, a beauty drink powder group, a cosmetic apparatus group, and a beauty drink powder + cosmetic apparatus group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Measuring Placebo Effect by Elimination and Investigating Mechanism of Action
Condition: Placebo Effect; Placebo Mechanisms of Action
Study type: Interventional

Summary: 
      We propose to measure the effect of placebo by elimination as well as by a "balanced placebo"
      design, determine its interaction with active drug, and explore whether placebo exerts part
      of its effect at the pharmacokinetics level.
    

Detailed description: 
      Placebos have been in use for centuries in medical practice. However, there is continued
      controversy regarding their effectiveness and mechanisms of action.

      The results of the study are expected to further our understanding of a widely used medical
      intervention, i.e., placebo, and of how to maximize its potential beneficial effect. It will
      also help assess the appropriateness of measuring the placebo effect by elimination, which
      has important ethical implications in relation to the design of randomized clinical trials.

      Comparison: caffeine vs placebo. Dependent variables:4 hours area under the curve (AUC) of
      pharmacodynamics endpoints as well as pharmacokinetics endpoints in a subgroup.
    

Intervention name(s): caffeine/placebo
Intervention type(s): Drug
Intervention description(s): caffeine or placebo, either overt or covert
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Placebo effect; Caffeine; Systolic BP; VAS
Effects of Pilates Exercises and Neural Dynamic Mobilization in Sciatica Patients
Condition: Sciatica
MeSH terms: Sciatica
Study type: Interventional

Summary: 
      The main purpose of the study is to find the effects of Pilates exercises and neural
      mobilization techniques on pain, flexibility and quality of life in sciatica patients. It
      will be a randomized controlled trial in which participants selected through non probability
      convenience sampling, to evaluate the effect of 6-week Pilates exercises versus neural
      dynamic mobilization techniques on pain, flexibility and quality of life in sciatica
      patients. Patients aged range from 18 to 65 years. The data will be collected from Service
      Hospital Lahore. Patients will have diagnosed with sciatica low back pain radiating down hip
      to knee, numbness, paresthesia and with positive SLR will include in this study whereas
      patients with considerable musculoskeletal deformity, previous hip, knee and ankle surgery
      and foot ulceration will be excluded from study .The participants will be randomly allocated
      to one of the two groups. Group A will perform Pilates mats exercises 30 minutes, two times a
      week and the Group B will perform neural dynamic mobilization for 15 minutes, two times a
      week, for 6-weeks respectively. Pain will be assessed by using BPFS, flexibility with
      Canadian sit to reach test and QOL with SF-36 questionnaire. SPSS software will be used for
      data entry and analysis.
    


Intervention name(s): Pilates Exercises; Neural dynamic mobilization
Intervention type(s): Other; Other
Intervention description(s): Pilates exercises will be perform for 15-30 minutes for one session 3 days a week for 6-weeks than after 6 week reassess the QOL, pain and flexibility.; Neural dynamic mobilization will be perform for 15-30 minutes for one session 3 days a week for 6-weeks after 6 weeks reassess the QOL, pain and flexibility.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Neurodynamic Mobilization
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers
Condition: Healthy Volunteers; Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label study will evaluate the pharmacokinetics, safety, and
      tolerability of emicizumab following a single subcutaneous (SC) administration to healthy
      Chinese subjects.
    


Intervention name(s): Emicizumab
Intervention type(s): Drug
Intervention description(s): Participants will receive a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab on Day 1.
Other intervention name(s): RO5534262
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Balance Changes After Chiropractic Adjustments in Health Adults.
Condition: Postural Balance; Musculoskeletal Manipulation
Study type: Interventional

Summary: 
      This study will examine the effect of upper and lower extremity manipulations on an upper
      extremity balancing task.
    

Detailed description: 
      Spinal manipulation has long been thought to have beneficial effects on posture, balance and
      proprioception; however, only a single study has investigated the effect of chiropractic
      treatment of the extremities on balance and posture. In a previous study, it was noted that
      lower extremity manipulation led to more ordered behavior on a dynamic, lower extremity
      balance task. It was also found that upper extremity manipulation led to less ordered
      behavior with same lower extremity balance task. Further studies are needed not only to
      validate this theory, but to further clarify the mechanism regarding specificity of
      manipulation to task.
    

Intervention name(s): Upper extremity manipulation
Intervention type(s): Other
Intervention description(s): An upper extremity (glenohumeral, humeroulnar and radioulnar joints, bilaterally) or a lower extremity (coxofemoral, tibiofemoral, and tibiotalar, bilaterally) manipulation series.
Other intervention name(s): Manipulation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be a patient and outcome assessor blinded, cross-over randomized clinical trial. Participants will randomized into two groups.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chiropractic manipulation; Extremity manipulation; Balance task
Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to characterize, as accurately as possible, the
      estimation of the difference in pre-pubescent growth velocities between subjects treated
      continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in
      the US, and placebo nasal spray as determined by stadiometry.
    


Intervention name(s): Fluticasone furoate nasal spray; Placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): Fluticasone furoate nasal spray 110mg QD; Placebo nasal spray
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinitis; fluticasone furoate nasal spray; growth
Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The incidence of heart failure grows as the population continues to age. Heart failure
      incidence approaches 10 per 1,000 persons after the age of 65. Although pharmacotherapy
      improves the treatment of heart failure it remains insufficient in preventing the progression
      of this debilitating disease. Cell based therapy has gained great strides over the last
      decade, launching cellular therapy into the mix of artillery for the treatment of chronic
      heart failure and coronary disease. While early pre-clinical work demonstrates that stem cell
      based therapy improves heart failure the exact mechanism in which these endothelial
      progenitor cells (EPC's) are recruited from the bone marrow, proliferate under the mediation
      of growth factors, and migrate to the injured tissues endogenously still remains obscured.
      Therefore in order for clinicians and scientist to impact heart failure treatment, a greater
      understanding of the physiological changes in EPC's and other modulators of cardioreparative
      process need further investigation.
    

Detailed description: 
      Heart failure remains a devastating progressive chronic disease in which pharmacotherapy is
      not often sufficient. Although cell based therapy is gaining publicity in the treatment of
      coronary artery disease and heart failure. Determining how endothelial progenitor cells are
      recruited, proliferate, and home to injured tissue is an important area of investigation.
      Equally important is determining factors which improve EPC stimulation and efficiency such as
      realistic levels of exercise and the modulation of various cardioreparative factors (VEGF,
      NRG-1, and SDF-1) within heart failure patients. Since the endogenous repair mechanism is
      down regulated in heart failure patients such efforts may uncover ways to tip the balance in
      heart failure back to normal reparative maintenance.
    

Intervention name(s): Physical Fitness; Walking Exercise Group
Intervention type(s): Other; Biological
Intervention description(s): Does intensity of aerobic walking exercise modify cardiac reparative factors; Walking Group will increase intensity, duration, and steps of walking per week.
Other intervention name(s): Quality of Life Questionnaires; Quality of Life Questionnaires
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cardiac Heart Failure Patients
      
Biospecimen description: 
      60 ml of blood will be used to measure baseline levels of EPC's, NRG-1, VEGF, and SDF-1.
      Repeat venipuncture will be done at Week 12. Approximately 60 ml of blood for the measurement
      of EPC's, NRG1, VEGF, and SDF-1.
    
Keywords: Physical Activity; Cardiac Heart Failure; Exercise Regimen; Cardioreparative Factors
A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors
Condition: Advanced Solid Tumors; Solid Tumors; Ovarian Cancer; Breast Cancer; Prostate Cancer; NSCLC; Pancreatic Cancer; Colorectal Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the
      current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed
      talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple
      dosing under fasting conditions in participants with advanced solid tumors. In addition, the
      effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be
      evaluated in fixed sequence after the 2 BE assessment periods.
    


Intervention name(s): TALZENNA capsule; Talazoparib soft gel capsule; Talazoparib soft gel capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Current commercial talazoparib formulation 1 mg once daily given under fasting condition; Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition; Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition
Intervention MeSH terms: Talazoparib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomly assigned to 1 of 2 sequences to receive Treatment A, B and C in different order as shown below. The first 2 periods will be for BE assessment, with the first period being 28 days and the following periods being 21 days. Period 3 will be a 21 day period to evaluate the food effect on the PK of the proposed talazoparib soft gel capsule formulation that will be included in the fixed sequence after the 2 BE assessment periods (for participants who can tolerate one high-fat/high-calorie meal). Participants must have received 21 consecutive days of continuous 1mg QD drug administration to be considered as completers of a treatment period, before moving on to the next scheduled treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PARP inhibitor; Talazoparib; Talzenna; BRCA mutation; ATM mutation; Pharmacokinetics; Bioequivalence; Bioavailability; Food effect
The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The goal of this randomized control trial is to study the impact of an electronic health
      record embedded tool's ability to facilitate shared provider-patient goal setting to promote
      lifestyle behavior change and prevent diabetes in primary care.
    

Detailed description: 
      The ADAPT (Avoiding Diabetes Thru Action Plan Targeting) trial is an innovative study that
      leverages persuasive technology to enhance the lifestyle behavior change counseling efficacy
      of primary care providers. Using principles of behavior change theory and persuasion
      technology, the multidisciplinary design team utilized in-depth interviews and in-vivo
      usability testing to produce a prototype diabetes prevention counseling system embedded in
      the electronic health record. The core element of the tool is a streamlined shared goal
      setting module within the electronic health record system. The system also utilizes a
      pre-encounter patient behavior change goals elicitation survey to help tailor the goal
      setting session to patient preferences and encourage shared decision making. The patients
      also interact with a website that collects their longitudinal behavior change data and
      visualizes their progress over time and in comparison to other study members. The ADAPT
      system utilizes the influential powers of goal setting, tailoring, reminders, social
      comparisons, testimonials and other methods to integrate evidence based behavior change
      principles and persuasion techniques into routine primary care clinical encounters. If
      successful, the ADAPT system may represent an adaptable and scalable technology-enabled
      behavior change tool for all primary care providers.
    

Intervention name(s): ADAPT tool
Intervention type(s): Behavioral
Intervention description(s): Use of ADAPT shared goal setting tool in EMR
Other intervention name(s): ADAPT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.
Condition: Hepatitis, Chronic; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics,
      safety and efficacy in subjects with no or inadequate response to prior treatment.
    


Intervention name(s): Small Molecule Agent (PF-868554); Small Molecule Agent (PF-868554)
Intervention type(s): Drug; Drug
Intervention description(s): Study drug will be administered 700mg BID in the fed state for three days.; Study drug will be given 450mg BID for a duration of 10 days.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Resistance to Lamivudine in HBV Egyptian Patients
Condition: Chronic Hepatitis B Virus Treatment
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Observational

Summary: 
      On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients
    

Detailed description: 
      Primarily: To study the correlations between the following parameters in adult Egyptian
      patients with chronic viral hepatitis B before treatment:

        -  ALT.

        -  HBeAg.

        -  HBV-DNA by quantitative PCR.

        -  Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify
           the impact of these parameters on viral breakthrough at 1 year of therapy.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National
        Hepatology & Tropical Medicine Research Institute in Egypt in the period from 2007- 2011.
      
Biospecimen description: 
      blood samples +/- tissue biopsy
    
Keywords: Hepatitis B virus; Lamivudine; Resistance to treatment
Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017)
Condition: Respiratory Syncytial Virus
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2A, double-blind, randomized, placebo-controlled study of molnupiravir
      (MK-4482) in healthy participants who have been inoculated with an experimental Respiratory
      Syncytial Virus (RSV) [RSV-A Memphis 37b]. It is hypothesized that MK-4482 will reduce the
      peak viral load (PVL) compared to placebo when given either before (prophylactic) or after
      (treatment) RSV-A Memphis 37b inoculation.

      Participants arrive at the study center for check-in between Day -3 and Day -1. The assigned
      treatment sequence (consisting of a combination of molnupiravir or placebo) begins Day -1.
      Participants receive viral inoculation with RSV-A Memphis 37b on Day 0, and depart on Day 12.
      There is a follow-up visit on Day 28.
    


Intervention name(s): Molnupiravir; Placebo; RSV A Memphis 37b
Intervention type(s): Drug; Drug; Biological
Intervention description(s): Four molnupiravir 200 mg capsules (800 mg total dose) taken twice daily by mouth.; Placebo capsule matched to molnupiravir taken twice daily by mouth.; RSV A Memphis 37b viral challenge given once by intranasal administration at a dosage of ~4 Log10 plaque forming units (PFUs).
Other intervention name(s): MK-4482
Intervention MeSH terms: Molnupiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment