bioihbjkbjnl/mcl2 huggingface dataset:
Drug-drug Interaction Study of Midazolam and AT-527 (R07496998)
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug-drug interaction study of midazolam and AT-527 (R07496998)
    


Intervention name(s): AT-527 550 mg + midazolam; AT-527 550 mg + midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: 2 mg midazolam Day 3: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening.
Days 4 to 6: 550 mg AT-527 administered twice daily (BID) Day 7: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening.
Other Names: AT-527 is also know as R07496998; Day 1: 2 mg midazolam Day 3: 550 mg AT-527 and 2 mg midazolam (with dosing offset by 2 hrs) in the morning and a second 550 mg AT-527 dose in the evening.
Days 4 to 6: 550 mg AT-527 administered twice daily (BID) Day 7: 550 mg AT-527 and 2 mg midazolam (with dosing offset by 2 hrs) in the morning and a second 550 mg AT-527 dose in the evening.
Other Names: AT-527 is also know as R07496998
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Physical Activity Loyalty Card Scheme
Condition: Health Behavior; Physical Activity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate the effectiveness of using incentives to
      encourage adults to be physically active.
    

Detailed description: 
      The investigators developed the Physical Activity Loyalty Card (PAL) Scheme which integrates
      a novel physical activity tracking system with web-based monitoring and nudge initiatives.
      The tracking system used Near-Field Communication (NFC) technology and a "loyalty card" (PAL
      Card) which contained a passive Radio Frequency Identification (RFID) tag. Sensors were
      placed along footpaths in the outdoor environment, in the gym and exercise studio, and
      participants scanned their PAL card at the sensor when doing physical activity (e.g.
      walking). A transaction (card ID, sensor ID, and timestamp) was recorded and sent via SMS to
      a secure data centre. Participants logged onto a personal account on the study website
      (www.palcard.co.uk) and received real-time feedback on various aspects of their physical
      activity including minutes, distance and calories expended.
    

Intervention name(s): Non-cash incentives; Self-monitoring physical activity levels
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants used their PAL card to self-monitor physical activity levels (intrinsic motivation) and minutes of physical activity were converted to points (1 minute of PA = 1 point; capped at 30 points per day) over the 12-week intervention period. Points were redeemed for rewards (extrinsic motivation) at week 6 and week 12.; For those in the 'No Incentive' arm, participants used their PAL card to self-monitor their physical activity levels but did not collect points or earn rewards.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: behaviour change; incentives; nudging; physical activity; self-monitoring
Evaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery
Condition: Knee Surgery; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine the minimum effective concentration of bupivacaine
      (EC50) in femoral block for analgesia by ultrasound after knee surgery.
    

Detailed description: 
      45 patients classified as ASA P1 or P2 aged between 18 and 65 candidates for elective knee
      operation via arthroscopy were included in the study. All patients received femoral nerve
      block guided by ultrasound with bupivacaine, 22 ml. The first patient at a concentration of
      0.25%. The other patients with higher or lower concentrations if the first patient has pain>
      3 or <3 on visual analogic scale respectively after awakening of surgical anesthesia. For
      surgical anesthesia each patient will undergo general anesthesia. At the end of the surgical
      procedure and anesthetic awakening patients will be evaluated for analgesia by verbal numeric
      scale. The modified Dixon method was used to find the EC50 and EC95 of bupivacaine for
      analgesia of femoral nerve block guided by ultrasound. Concentration still correlated with
      motor block and side effects.
    

Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Knee surgery; Femoral block; Bupivacaine; Ultrasound
Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose is to assess whether the use of microdrop instillation of phenylephrine 1.67% and
      tropicamide 0.33% maintains mydriatic efficacy while presents an improved safety profile
      compared with standard drops of phenylephrine 1.67% and tropicamide 0.33%, which is routine
      care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal
      intensive care unit.
    

Detailed description: 
      A pilot prospective randomized crossover clinical trial is conducted for assessing the
      mydriatic efficacy and safety of microdrops (6-7 μL) compared with standard drops (28-34 μL)
      for retinopathy of prematurity screening. A random number table was used to allocate
      participants into either a) receiving standard drop on their first and microdrop on their
      second screening examination a week later, or b) receiving microdrop first and standard drop
      a week later. The mydriatic agent contains phenylephrine 1.67% and tropicamide 0.33%, which
      derives from compounding the commercial phenylephrine 5% with the commercial tropicamide 0.5%
      in volume ratio 1:2.
    

Intervention name(s): Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)]; Standard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)]
Intervention type(s): Drug; Drug
Intervention description(s): 1 drop (6-7 μL) for 3 doses, 5 minutes' intervals; 1 drop (28-34 μL) for 3 doses, 5 minutes' intervals
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tropicamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: microdrops; mydriasis; dilating drops; retinopathy of prematurity; ROP; screening
Restoration® Modular Revision Hip System Post Market Study
Condition: Arthroplasty, Replacement, Hip
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.
    

Detailed description: 
      The two-piece modular revision stem components are intended to be used for primary or
      revision total hip arthroplasty, as well as in the presence of severe proximal bone loss.
      This study evaluates the System in revision cases only. The stems are intended to be used
      with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular
      components. These femoral stems are designed to be press fit into the proximal femur.

      In addition to demonstrating survivorship at 5 years, this study will seek to gain
      information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36
      general well-being assessment, and safety profile.
    

Intervention name(s): Restoration® Modular Revision Hip System
Intervention type(s): Device
Intervention description(s): Restoration® Modular Revision System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution
      compared to placebo and the relative effectiveness compared to Celecoxib.
    


Intervention name(s): Placebo to BI 1026706 solution; BI 1026706; Placebo to BI 1026706 tablet; Celecoxib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo to BI 1026706 solution; BI 1026706; Placebo to BI 1026706 tablet; Celecoxib capsule
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene
      Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing
      autologous stem cell transplant (ASCT).
    

Detailed description: 
      This study will be a multicenter, open-label, randomized, comparative, cross-over study of
      high-dose Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection
      conducted in 24 patients who have symptomatic MM and qualify for ASCT.

      During the Study Period, patients will be randomized to receive 100mg/m2 of either Melphalan
      HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection on Day -3 and the
      alternate drug product on Day -2. Blood samples for pharmacokinetic (PK) evaluation will be
      withdrawn through an indwelling i.v. cannula each day of melphalan dosing (Day -3 and Day
      -2).

      Following one day of rest after the myeloablative conditioning (Day -1), patients will
      receive an autologous graft.
    

Intervention name(s): Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection; Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized to receive 100 mg/m2 of Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and Alkeran for Injection on Day -2 prior to ASCT.; Patients will be randomized to receive 100 mg/m2 of Alkeran for Injection on Day -3 and Melphalan HCL for Injection (Propylene Glycol-Free)on Day -2 prior to ASCT.
Other intervention name(s): Evomela; L-PAM, L-Sarcolysin
Intervention MeSH terms: Melphalan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous stem cell transplantation
Treatment of Androgenetic Alopecia in Females, 12 Beam
Condition: Androgenetic Alopecia; Hair Loss; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam
      model for androgenetic alopecia in females when treatment is applied as directed.
    

Detailed description: 
      This is a randomized double-blind, sham controlled clinical study, evaluating changes in
      terminal hair count in the evaluation zone having evidence of androgenetic alopecia
      (miniaturized hair).

      The trial with 63 female subjects, who have been diagnosed with androgenetic alopecia, who
      are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of
      Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.

      Subjects will use the device on three non-concurring days a week as directed per device for
      26 weeks duration.

      Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).

      Safety analysis will be assessed based on the reports of adverse events during study.
    

Intervention name(s): HairMax LaserComb 2009 model 12 beam; Sham Device
Intervention type(s): Device; Device
Intervention description(s): HairMax LaserComb; Sham Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Hair Loss; Female Pattern Baldness
Peripheral Perfusion Index (PPI) as Monitor During Deliberate Hypotensive Anesthesia
Condition: Monitoring During Deliberate Hypotensive Anesthesia
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of
      hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue
      perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive
      new monitoring, can reflect the peripheral perfusion dynamics.

      This study is designed to explore the behaviour and trend of PPI during nitroglycerine
      induced deliberate hypotensive anesthesia in adult patients undergoing functional endoscopic
      sinus surgery (FESS).
    


Intervention name(s): peripheral perfusion index measurement
Intervention type(s): Other
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult male or females, aged between 18-50 years, ASA class I ans II
AR-12286 Fixed Dose Combination to Lower Elevated Intraocular Pressure
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-masked, randomized, controlled study assessing the safety and ocular
      hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to
      Travatan® Z in patients with elevated intraocular pressure
    


Intervention name(s): 0.25% AR-12286 / 0.004% travoprost; 0.5% AR-12286, 0.004% travoprost; 0.004% Travoprost
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Travoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Glaucoma; Ocular Hypertension
Genetic Polymorphisms Affecting Effect of High Intensity Training
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of the study is to investigate the effect of high intensity training on maximal
      oxygen uptake according to the genetic polymorphisms in healthy Korean volunteers.
    


Intervention name(s): High intensity training
Intervention type(s): Other
Intervention description(s): 9 weeks of supervised high intensity training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: High Intensity Training; Genetic Polymorphisms; Genome Wide association study; Single Nucleotide Polymorphism genotype; Subjects
Effect of Pembrolizumab (Keytruda®) on Biomarkers in Early Breast Cancer.
Condition: Breast Cancer; Triple Negative Breast Cancer; Hormone Receptor Negative Neoplasm
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study consists of 2 parts: a retrospective study, and a prospective clinical study with
      pembrolizumab (Keytruda®) (Phase 0).

        1. Retrospective study (S58910):

           This is a retrospective analysis to study the expression of PD-L1 in ER/PR negative
           breast tumors and to correlate this PD-L1 expression with tumor infiltrating lymphocytes
           (TILs), proliferation, expression of apoptosis and clinical outcome (development of
           distant metastases).

        2. Phase 0 study:

      This is a Phase 0 single center, open-label, non-randomized, study in patients with early
      breast cancer. Patients will be treated with one injection of Pembrolizumab (Keytruda®)
      administered intravenously at 200 mg 10 +/- 4 days before surgery. This phase 0 study will
      consist of 2 cohorts; cohort A will include patients who are scheduled for upfront surgery.
      Cohort A1 will include patients with Her2 negative tumors, Cohort A2 patients with Her2
      positive tumors and Cohort A3 with ER positive tumours. Cohort B will include patients who
      received neoadjuvant chemotherapy (with anti-Her2 therapy if Her2 positive) and who have
      clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on
      imaging estimated residual tumor size of at least 10 mm). Cohort B1 will include Her2
      negative tumors, Cohort B2 Her2 positive tumors and Cohort B3 ER positive tumors. The
      injection will be given in the oncological outpatient unit. Patients will be monitored
      carefully for the development of adverse experiences/events. Adverse experiences/events will
      be evaluated according to criteria outlined in the NCI Common Terminology Criteria for
      Adverse Events (CTCAE), version 4.0.
    


Intervention name(s): Pembrolizumab
Intervention type(s): Drug
Intervention description(s): Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2.
Other intervention name(s): Keytruda
Intervention MeSH terms: Pembrolizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Biomarker
SHARE Study 4: Financial Incentives for Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine different types of monetary incentive paradigms for
      weight loss.
    


Intervention name(s): Online weight loss + incentives for behavior 3 months; Online weight loss + incentives for weight loss at month 3; Online weight loss + Incentives for behavior 12 months; Online weight loss + Incentives for weight loss 12 months
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive monetary incentives for submitting their behavior change information into a study website; Participants will receive an incentive for meeting their weight loss goal at month 3.; Participants will receive incentives for submitting behavior change information over the course of 12 months.; Participants will be receive monetary incentives for reaching their weight loss goal at months 3 and 12.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the potential for cytochrome P450 (CYP) 3A4
      induction after dosing with INDV-2000 via use of midazolam as a probe.
    


Intervention name(s): INDV-2000; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Capsules administered orally twice a day; Midazolam syrup administered orally on Days 1 and 15
Other intervention name(s): C4X_3256
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
What Makes People Better at Describing Photographs?
Condition: Healthy Aging
Study type: Interventional

Summary: 
      This study is being conducted to learn more about how various personal and situational
      characteristics are related to the ability to provide verbal descriptions of photographs.
      Participants will perform a brief mental exercise, then see three photographs with
      instructions to describe each thoroughly. Participants will also complete several other
      surveys and measures. Collected data will give researchers a better understanding of how
      different variables relate to speech production.
    

Detailed description: 
      This study is being conducted to learn more about how various personal and situational
      characteristics are related to the the ability to provide verbal descriptions of photographs.
      Adult participants ages 18-30 and 65-80 will participate in videoconference calls during
      which they perform a brief mental exercise, then see three photographs with instructions to
      describe each thoroughly. Descriptions are to be 30 to 60 seconds in length and are audio
      recorded for later scoring. Participants will also complete several other surveys and
      measures, including some about anxiety, mindfulness, vocabulary, and demographics.
      Participation will take approximately 40 to 60 minutes. Collected data will be de-identified,
      and the aggregate data will give researchers a better understanding of how individuals'
      personality and cognitive traits and the mental exercise performed before the study relate to
      peoples' speech production performance.
    

Intervention name(s): Mental Exercise
Intervention type(s): Behavioral
Intervention description(s): Participants perform a 10 minute mental exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to one of two mental exercises before performing a picture description task and completing several other personality and cognitive measures
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: speech production; cognitive aging
A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it
      has on the symptoms of mild to moderate Alzheimer's disease. SB-742457 is a new treatment
      which is thought to increase the levels of certain chemicals in the brain that are often
      decreased in patients with Alzheimer's disease.
    


Intervention name(s): SB-742457
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alzheimer's disease; cognition global functioning; symptomatic; B-742457