bioihbjkbjnl/mcl2 huggingface dataset:
First-In-Human Study of CU06-1004 Following Single and Multiple Ascending Doses in Healthy Volunteers
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is the first-in-human study of CU06-1004. The purpose of this phase 1
      study is to assess the safety and tolerability of single and multiple ascending oral doses of
      CU06-1004 in healthy adult subjects.
    


Intervention name(s): CU06-1004, Single dose; CU06-1004, Multiple doses; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of CU06-1004, 7 dose levels, oral capsule : 6 Cohorts (100mg, 300mg, 600mg, 900mg, 1200mg, 300mg bid) + 1 Cohort (Food effect)＊
＊Cohort S7(TBD mg) will receive a single oral dose of CU06-1004 or placebo under fed conditions. When administered under fed conditions, CU06-1004 or placebo will be administered following a high-fat/high-calorie breakfast. Cohort S7 will be conducted following completion of Cohort S5; Multiple doses of CU06-1004, 7 days, 3 dose levels＊, oral capsule
＊The dose levels, regimen (i.e., schedule), and conditions (i.e., fasted versus fed conditions) will be determined based on the safety, tolerability, and plasma PK data from SAD; Placebo matched to CU06-1004, oral capsule
Other intervention name(s): SAC-1004; CU06; CU06-RE; SAC-1004; CU06; CU06-RE
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A Single Ascending Dose(SAD) study with 7 Cohorts including 1 Cohorts for Food effect (FE) assessment with 8 subjects each (6 active and 2 placebo) and A Multiple Ascending Dose(MAD) study with 3 Cohorts with 8 subjects each (6 active and 2 placebo).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DME; Endothelial dysfunction blocker
Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing
Condition: Skin Graft
Study type: Interventional
Phase: Phase 1

Summary: 
      This prospective randomized trial evaluated the impact of autologous keratinocytes suspended
      in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that
      the treatment would speed and improve wound healing.
    


Intervention name(s): Autologous Platelet Rich Plasma; Keratinocyte suspension; Standard dressings
Intervention type(s): Biological; Biological; Other
Intervention description(s): Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.; Autologous keratinocytes isolated from skin biopsy suspended in platelet rich plasma before spraying.; Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin graft donor site healing; skin; wound; platelet concentrate; keratinocytes; burns
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris
    

Detailed description: 
      This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to
      evaluate the efficacy and safety of imsidolimab in adolescent and adult participants with
      acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of
      imsidolimab and explore the immune response to imsidolimab in participants with AV.
    

Intervention name(s): Imsidolimab; Placebo
Intervention type(s): Drug; Biological
Intervention description(s): Humanized Monoclonal Antibody; Placebo
Other intervention name(s): ANB019
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LI-36 Receptor; Interleukin 36; Imsidolimab
Treatment of the Osgood Schlatter
Condition: Osgood Schlatter Disease
MeSH terms: Osteochondrosis
Study type: Interventional

Summary: 
      The disease Osgood-Schlatter is most commonly found in sports teenager growing up apophysose
      accounting for 28.4% of osteochondrosis by Breck. It relates to 62% of osteochondrosis knee
      and affects adolescent girls between 10 and 12 and boys between 12 and 15 It is usually
      considered a benign pathology that cures in the majority of cases. However, in 5-10% of cases
      there is persistent residual pain in adulthood.

      The classic complication is the avulsion fracture of the tibial tuberosity in adolescents who
      continued his sports without restriction.

      The possible consequences are numerous including the presence of a free bone fragment at the
      insertion of the tendon originally described by Osgood the establishment of a genu
      recurvatum, a high kneecap or patella alta and an enlarged tibial tuberosity (ATT) annoying
      sport.

      The main two treatments are complete rest from sport activity or cast immobilization.

      The main objective is to compare these two technics according to the proportion of full
      sporting recovering at 12 months
    


Intervention name(s): cast immobilization group; complete sport rest.
Intervention type(s): Other; Other
Intervention description(s): Patients in this group will have their knee locked with a resin going from the ankle to the top of the thigh for 4 weeks, followed by 4 weeks without cast but with rehabilitation through physiotherapy.; Patients included in this group will follow the current standard procedure for this disease that is to say complete sport rest during 8 weeks including rehabilitation through physiotherapy, following the exact same technic as the experimental group .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cast immobilization; Complete rest; Osgood Schlatter
Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Condition: Valve Heart Disease
MeSH terms: Heart Diseases; Heart Valve Diseases
Study type: Observational

Summary: 
      The purpose of this pilot study is to obtain both near valve and downstream flow
      characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an
      existing patient population at Northwestern Memorial Hospital, to determine the hinge washout
      characteristics and downstream flow patterns of the On-X valve and compared to competing
      designs.
    

Detailed description: 
      Prospective, concurrent 4D flow Magnetic Resonance Imaging (MRI) and echocardiography of On-X
      and St Jude Medical (SJM) Masters HP or Carbomedics Carbo-seal or Carbo-seal Valsalva aortic
      valve replacement (AVR) patients will be performed. Echocardiography analysis will include:
      valve function (opening angle), pressure gradients, and degree of valve washout. MRI analysis
      will focus on downstream flow patterns (helicity and vorticity), energy loss, pressure
      recovery, and measurement of wall shear stress in the anastomosis regions.
    

Intervention name(s): MRI; Transthoracic echocardiography exam
Intervention type(s): Other; Other
Intervention description(s): Enrolled patients will complete a non-contrast cardiac MRI; Enrolled patients will complete a transthoracic echocardiography exam.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with aortic valve disease who within the last five years underwent AVR using the
        On-X aortic valve, SJM Masters HP, or Carbomedics aortic valves.
      
Keywords: mechanical heart valve; On-X
KeraStat(R) Cream for Radiation Dermatitis
Condition: Radiation Dermatitis
MeSH terms: Dermatitis; Radiodermatitis
Study type: Interventional

Summary: 
      The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream
      and collect data to inform a larger future trial.
    

Detailed description: 
      The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream
      and collect data to inform a larger future trial.

      The secondary objectives are to assess the safety and tolerability of KeraStat Cream in
      subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and
      how that compares to the current standard of care, and to estimate the amount of KeraStat
      Cream used per patient and coverage on skin.
    

Intervention name(s): KeraStat(R) Cream; Standard of care
Intervention type(s): Device; Other
Intervention description(s): KeraStat Cream is a cream wound dressing that contains 5% keratin.; Patients will be instructed to follow institutional standard of care for radiation dermatitis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin.
      Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which
      has a drug level profile that can be markedly altered by coadministration of known inhibitors
      of the BCRP transporter. With widespread use of statins as cholesterol-lowering agents,
      rosuvastatin is also a likely concomitant drug for participants who would potentially be
      treated with branebrutinib.
    


Intervention name(s): Rosuvastatin; Branebrutinib
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Rosuvastatin Calcium; Branebrutinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Esophageal Pressure Reliability to Estimate Pleural Pressure in Critically Ill Children
Condition: Mechanical Ventilation
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Background During ventilatory assistance, optimization of settings is critical to allow a
      personalized support and avoid over- or under-assistance. But little data are available in
      clinical practice to guide the adjustment of the support. In adults, esophageal pressure
      (PES) has been shown to be a reliable surrogate of pleural pressure (PPL) and clinical
      studies suggest that PES may be useful to guide the management of mechanical ventilation. In
      children, the PES measurement could have similar potential benefits, but beforehand the
      reliability of PES to estimate PPL needs to be assessed.

      Objective The primary objective of this study is to validate the reliability of PES directly
      monitored using a miniature catheter tip pressure transducer (Gaeltec® system) to estimate
      PPL, when compared to a gold standard, i.e the direct PPL measurement in situ.

      Method This is a prospective single center study. Children <18 years old, hospitalized in the
      pediatric intensive care unit, requiring invasive ventilation and with at least one chest
      tube will be included.

      Protocol A pressure transducer will be connected to the existing chest-tube and PES (measured
      by Gaeltec® and feeding tube), PPL, PAW, respiratory volume and flow will be simultaneously
      recorded.

      Expected results We expect that the PES-based methods will provide an accurate estimation of
      PPL. Once this tool validated, PES could be helpful to optimize mechanical ventilation in
      children, and further interventional trials would be warranted to evaluate if its use could
      allow a reduction of the ventilation support duration.
    


Intervention name(s): esophageal and pleural pressure measurement
Intervention type(s): Other
Intervention description(s): Esophageal pressure will be monitored by a dedicated catheter and pleural pressure will be measured into the chest tube already in place
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mechanical ventilation; Children; Esophageal Pressure; Pleural Pressure
Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers
Condition: Disc Degeneration
MeSH terms: Intervertebral Disc Degeneration; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The investigators will examine the prevalence of low-back pain and disc degeneration among
      Finnish elite skiers between 16 and 35 years of age and compare these findings with the data
      collected among healthy volunteers studied between 1994-2021.
    

Detailed description: 
      The study population will consist of Finnish elite cross-country skiers between 18 and 35
      years of age. Invitation letters will be sent to all skiers who are selected to national
      teams at season 2022-2023. The study population for the current study will be approximately
      100 individuals. Study protocol for the current study will consist of a semi-structured
      interview, clinical examination, lumbar spine MRI and patient reported outcome measures. All
      participants will sign an informed consent before commencement of the study. If a participant
      is younger than 18 years, also his/her caregiver will be asked for a signed consent.

      The interview comprised of questions about the athletes training volume and possible LBP
      without associated trauma. (suspension from training or competition due to LBP, possible
      contacts to health-care providers).

      Body height and weight were self-reported. Leg length inequality was assessed comparing the
      height of the left and right iliac crests in standing position with straight knees. Wooden
      blocks of different thickness (with 0.5 cm increment) were used for correction of possible
      leg length inequality. Symmetry of the back was measured in forward bending using a
      scoliometer.

      From MRI (high field 1.5 T) the signal intensity of the nucleus pulposus will be assessed
      both qualitatively and quantitatively. The midline T2-weighted images will be independently
      evaluated visually by three evaluators using a Pfirrmann classification. The quantitative
      nucleus signal intensities will be assessed by two evaluators using a relative measure
      comparing the signal intensity of the nucleus pulposus to that of the adjacent cerebrospinal
      fluid on T2-weighted images.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All skiers who are selected to the national teams at season 2022-2023.
      
Keywords: low back pain; disc degeneration; athlete; matched case control
Nebulized Procaterol Versus Nebule Salbutamol for the Treatment of Moderate Acute Asthma
Condition: Moderate Acute Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of nebule procaterol with
      nebule salbutamol in the treatment of moderate acute asthma.
    


Intervention name(s): Procaterol, Salbultamol
Intervention type(s): Drug
Intervention MeSH terms: Procaterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this study are to assess the safety, tolerability, pharmacokinetics
      (PK), and food effect of BLU-782 in healthy adult subjects.
    


Intervention name(s): BLU-782; Placebo; BLU-782 taken with food
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral capsules; oral capsules; oral capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study Evaluating The Safety and Tolerability of HTC-867 in Healthy Japanese Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized (a process that is used to decide whether you will take study
      drug or a placebo during the study), inpatient study which will assess the safety and
      tolerability of HTC-867 in healthy male Japanese subjects.
    


Intervention name(s): HTC-867
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Japanese
Effect of Toradol on Post-operative Foot and Ankle Healing
Condition: Ankle Fractures; Trauma Injury
MeSH terms: Ankle Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of Toradol for pain control in surgical orthopedic cases is currently a topic of
      interest within the field. The proposed study is a prospective randomized study evaluating
      postoperative pain, opioid requirement, complication/reoperation rates and nonunion rates in
      patients undergoing surgical treatment for isolated lateral malleolar fibula fractures.
      Patients will be randomized to either the Treatment Group (Toradol) or the Control Group
      (Non-Toradol). Both Toradol and non-Toradol drug regimens are currently prescribed by the
      Foot and Ankle Team at the Rothman Institute and this study will serve as a valuable
      comparison.
    


Intervention name(s): Ketorolac; No ketorolac
Intervention type(s): Drug; Other
Intervention description(s): the investigators aimed to evaluate the effect of postoperative ketorolac after ankle fracture surgery on postoperative opioid consumption, pain control, an patient satisfaction.; standard of care post operative pain management protocol
Other intervention name(s): Toradol
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Performance Evaluation Study for Clearblue Pregnancy Test
Condition: Pregnancy
Study type: Observational

Summary: 
      The purpose of this study is to collect urine samples and dating scan information from women
      who wish to become pregnant. Urine samples will be tested in the laboratory with the
      Clearblue Pregnancy Test and the results correlated with volunteer information.
    

Detailed description: 
      Approximately 800 female volunteers wishing to become pregnant will be recruited locally
      around 5 trial centers within the US.

      Daily urine samples and gestational age dating scan information obtained from the study will
      be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product
      assessment will involve testing of early morning urine samples collected by women during the
      cycle in which they conceived. Urine samples will be collected pre-conception to the end of
      the second trimester.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Eligibility:

        Ages Eligible for study: 18 - 45 years. Gender Eligible for study Female. Healthy
        Volunteers Yes.
      
Biospecimen description: 
      Daily early morning urine samples
    
Keywords: Pregnancy test; Wishing to become pregnant
Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the
      safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in
      healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of
      3 dose groups (low, medium, high). Within each of these dose groups, participants will be
      assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo
      (saline), or 1 dose of COVI-VAC and 1 dose of placebo. COVI-VAC or placebo is administered by
      drops into each nostril. Neither the participants nor the researchers will know whether
      COVI-VAC or placebo has been received.

      To assess the safety of the vaccine, each participant will record symptoms and oral
      temperature in a diary daily for 14 days after each dose. Safety laboratory tests, physical
      exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital
      signs will be measured. Adverse events and medication use will be recorded.

      Blood samples and intranasal samples will be collected to assess the immune response from the
      vaccine.
    


Intervention name(s): COVI-VAC; Placebo
Intervention type(s): Biological; Other
Intervention description(s): intranasal, live attenuated vaccine against SARS-CoV-2; normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: live attenuated; live attenuated vaccine; SARS-CoV-2; COVID-19