bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Study of INO-4212 With or Without INO-9012, Administered IM or ID Followed by Electroporation in Healthy Volunteers
Condition: Ebola Vaccine
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates whether INO-4212 and its components INO-4201 and INO-4202 administered
      intramuscularly (IM) or intradermally (ID) followed by electroporation (EP) will be well
      tolerated and immunogenic.
    

Detailed description: 
      This study will test the safety, tolerability, and immunogenicity of the DNA vaccine,
      INO-4212 and its components INO-4201 and INO-4202 in healthy volunteers. INO-4201 contains
      the DNA sequence that codes for past Ebola Zaire virus outbreak strains, and INO-4202
      contains the DNA sequence that codes for the current Ebola virus outbreak strain. When given
      together, the DNA vaccine is called INO-4212 and contains the DNA sequence of both the
      previous and the current outbreak strain. Another ingredient called INO-9012 which contains
      the DNA sequence for interleukin-12, will be given in a subset of subjects to help boost the
      body's immune response when given with the vaccine.

      Following administration of vaccine, a specialized medical device, CELLECTRA®, will deliver
      brief electrical pulses in a process known as electroporation (EP), to help move more DNA
      into cells more efficiently. The study will evaluate whether INO-4212 and its components may
      be able to generate protective immunity against Ebola Zaire, evaluate the relative ability of
      IM versus ID administration to elicit immune responses and evaluate whether vaccine
      administered with INO-9012 can generate greater immune responses.

      The Ebola vaccine under study will be tested in approximately 240 healthy adult volunteers.
    

Intervention name(s): INO-4201; INO-4202; INO-4201; INO-4212; INO-4212 + INO-9012; INO-4201 + INO-9012
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): INO-4201 delivered IM followed by Electroporation; INO-4202 delivered IM followed by Electroporation; INO-4201 delivered ID followed by Electroporation; INO-4212 delivered IM followed by Electroporation; INO-4212 + INO-9012 delivered IM followed by Electroporation; INO-4201 + INO-9012 delivered ID followed by Electroporation
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Ebola; Vaccine
A Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Rhinoconjuncitivis Sensitized to Olea Europaea
Condition: Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was designed according to the draft of allergenic product regulation published by
      Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of
      subcutaneous immunotherapy with Olea europaea pollen extract in patients with
      rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy
      parameters will be evaluated: immunoglobulin level changes and skin reactivity
    

Detailed description: 
      An study conducted througout Spain with 4000 allergic patients (Alergoloógica 2005) showed
      that 47% of patients with rhinoconjuncitivits and 51% of asthmatic patients were sentitized
      to olive pollen. This gives us an idea of the importance of this allergen sensitization in
      Spain.
    

Intervention name(s): Allergovac depot with Olea europaea pollen extract
Intervention type(s): Biological
Intervention description(s): Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly increasing dose injections at the initiation phase plus 3 maintenance monthly injections.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles
Condition: Wrinkle; Periorbital; Tixel 2; Fractional; Resurfacing
Study type: Interventional

Summary: 
      A Prospective, Multicenter, Single-Arm Clinical Study of 51 study subjects who are seeking a
      procedure to reduce the appearance of the peri-orbital wrinkles. Up to 5 investigational
      centers in Israel and the United States will participate in the recruitment. Each study
      subject will receive four (4) treatments with Tixel in a monthly interval. Follow-up will
      occur 1 month and 3 months following last treatment.
    

Detailed description: 
      A Prospective, Multicenter, Single-Arm Clinical Study of 51 subjects who are seeking a
      procedure to reduce the appearance of the periorbital wrinkles, and meet study eligibility
      criteria, and have provided informed consent will be enrolled in the study. Up to 5
      investigational centers in Israel and the United States will participate in the recruitment.
      Each study subject will receive 4 treatments with Tixel in a monthly interval. Follow-up will
      occur at 1 month and 3 months following the last treatment.

      The clinic visits will be as follow:

        1. Baseline (1st tx)

        2. Phone-call visit (3 days after the first treatment)

        3. 4wk (2nd tx)

        4. 8wk (3rd tx)

        5. 12wk (4th tx)

        6. 4 weeks after the last treatment (1st FU)

        7. 12 weeks after the last treatment (2nd FU= 3 months FU, primary endpoint and study
           completion visit) Primary Efficacy Endpoint is the comparison of the proportion of
           subjects with a ≥ 1-score improvement on the FWCS at the 3-month visit compared to
           baseline as determined by at least 2 out of 3 blinded Independent Photographic
           Reviewers.

      Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit
      after treatment.
    

Intervention name(s): Tixel 2
Intervention type(s): Device
Intervention description(s): Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement.
Intervention model: Single Group Assignment
Intervention model description: All participants will undergo treatment with Tixel 2 Device - 4 treatments, 4 weeks apart and 2 Follow Up visits
Masking: None (Open Label)
Primary purpose: Treatment
Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This project investigates the effect of ACE-inhibition on cellular metabolism by gene
      expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril
      intake.

      This should contribute to our understanding of the pathomechanisms involved in diabetes and
      the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome.
    


Intervention name(s): ramipril; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral intake; placebo
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy of Diazoxide in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out if Diazoxide can partly retain insulin production in
      newly diagnosed type 1 diabetes patients.
    

Detailed description: 
      At the time of diagnosis most subjects with type 1 diabetes retain significant endogenous
      insulin secretion as assessed by C-peptide measurements. Although not sufficient for the
      needs of the individual, residual insulin secretion is important for metabolic control, for
      avoidance of hypoglycemic episodes and, perhaps, for protection against diabetic
      complications. To retain residual endogenous insulin secretion in type 1 diabetes is thus
      highly desirable.

      Residual insulin secretion deteriorates during the course of type 1 diabetes. The underlying
      autoimmune process is a major determinant of deterioration.

      However, also measures that do not directly target the immune system could be beneficial. The
      DCCT study randomised subjects with type 1 diabetes to either intensive or conventional
      insulin treatment. The intensive insulin treatment markedly retarded deterioration in
      C-peptide levels during 5 years of observation. The favourable effect could be due to lesser
      hyperglycemia per se. Alternatively, the effect of intensive insulin treatment could be
      secondary to lesser degree of over-stimulation of the patients' beta-cells.

      It is by now established that relief from over-stimulation by diazoxide favourably affects
      beta-cell function and that such treatment can retard a decline in residual insulin secretion
      in subjects with newly diagnosed type 1 diabetes. Diazoxide has been used in clinical
      practice for > three decades without major safety concerns.

      Disturbing, albeit reversible, side effects are halting long-term studies with diazoxide in
      type 1 diabetes. The researchers find that lower and intermittent (i.e. night time) dosing of
      diazoxide produces no measurable side effects in subjects with type 2 diabetes.

      This is a double blinded placebo controlled study, with 35 participants with newly diagnosed
      type 1 diabetes are randomised into either placebo or Diazoxide for 6 months. The patients
      will be followed up after intervention for at least 12 months.

      Beta cell function and glycemic control will be monitored.
    

Intervention name(s): diazoxide
Intervention type(s): Drug
Intervention MeSH terms: Diazoxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: type 1 diabetes; beta cell rest; diazoxide; insulin secretion
Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel
Condition: Acne
Study type: Interventional
Phase: Phase 1

Summary: 
      Study designed to assess the safety and plasma PK of tretinoin and its metabolites from
      topically applied IDP-120 gel.
    

Detailed description: 
      An Open-label study designed to assess the safety and plasma PK of tretinoin and its
      metabolites from topically applied IDP-120 gel.
    

Intervention name(s): IDP-120 Gel
Intervention type(s): Drug
Intervention description(s): Gel
Other intervention name(s): Gel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF
Condition: Atrial Fibrillation; Ablation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Tachycardia; Atrial Flutter
Study type: Interventional

Summary: 
      Catheter ablation has proven to be an effective treatment option in patients suffering from
      symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major
      steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2)
      modification of left atrial and eventually right atrial substrate by ablation of complex
      fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary
      veins, around the left atrial appendage, at the mitral annulus and the septum.

      When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial
      tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the
      significance of the AT is unclear.

      In the following study we examine the hypothesis that an ablation of AT occuring during CFAE
      ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF
      or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).
    


Intervention name(s): Ablation; Cardioversion
Intervention type(s): Procedure; Procedure
Intervention description(s): Ablation of atrial tachycardia; Cardioversion of atrial tachycardia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; ablation; atrial flutter
Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor
      Cells Therapy for Knee Osteoarthritis.
    

Detailed description: 
      A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose
      Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.

      This is a randomized,single-blind, double-blinded,phase I clinical trial. Subjects who are
      with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly
      distributed 1:1:1 to different dosage group after signing the ICF and screening tests.The
      treatment will accept Allogenic ReJoinTM at the first and fourth week.The duration of the
      therapy is 48 weeks.
    

Intervention name(s): Mesenchymal progenitor cells
Intervention type(s): Biological
Intervention description(s): Biological: Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra-articular use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Obesity-related Genes in Taiwanese Undergoing Weight Loss
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid; Weight Loss
Study type: Observational

Summary: 
      To investigate:

        1. Associations between miRNA and insulin signaling-related gene expressions in abdominal
           adipose tissues in obese subjects.

        2. Differences in miRNAs expressed by intrabdominal omental adipose tissues between
           genders.
    

Detailed description: 
      Compared the differences in microRNA expressions of abdominal adipose tissue in morbid obese
      male and female subjects to elucidate the possible regulatory role of microRNA in insulin
      signaling-related gene expression levels and its association with biochemical markers. We
      hope to find a miRNA that can be used to predict the syndrome associated with obesity.
    

Intervention name(s): gender
Intervention type(s): Genetic
Intervention description(s): Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery.
Other intervention name(s): BMI were all over 40 kg/ m2
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were
        obtained from men (n = 9) and women (n =10) who underwent bariatric surgery. Their BMI were
        all over 40 kg/ m2, and ages between 19-63 years.
      
Biospecimen description: 
      Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were
      obtained from men and women who underwent laparoscopic bariatric surgery.
    
Keywords: abdominal adipose tissue; microRNA
Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency
Condition: SBS - Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a repeated dose, open label trial investigating safety, efficacy, PD and PK of FE
      203799 in 8 patients with SBS. The patients will receive a subcutaneous (SC) dose of 5 mg FE
      203799 once weekly for 4 consecutive weeks, and efficacy parameters and PK will be assessed
      after the fourth dose. Safety follow up assessments will be performed 4-6 weeks after the
      last dose.
    

Detailed description: 
      This is a repeated dose, open label trial investigating safety, efficacy, PD and PK of FE
      203799 in 8 patients with SBS . The patients will receive a subcutaneous (SC) dose of 5 mg FE
      203799 once weekly for 4 consecutive weeks, and efficacy parameters and PK will be assessed
      after the fourth dose. Safety follow-up assessments will be performed 4-6 weeks after the
      last dose.

      The first two administrations of trial drug will be performed at the clinic, while the third
      dose can be either self-administered by the patient or administered at the clinic if the
      patient prefers to travel to the site or other considerations make a site visit preferable.
      The fourth administration of trial drug will be performed at the clinic just prior to
      assessment of efficacy parameters in the treatment balance study.

      Prior to each administration of trial drug, liver function parameters will be analysed and
      assessed. During the entire trial, patients who develop extremely high or persistently
      elevated liver enzymes following trial drug administration will be discontinued from the
      trial.

      The patients will complete a diary with data on trial drug administration performed at home,
      local tolerability and adverse events (AEs).
    

Intervention name(s): FE203799
Intervention type(s): Drug
Intervention description(s): FE203799 5 mg subcutaneous once weekly
Other intervention name(s): GLP 2 analogue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201
      in the treatment of pediatric subjects with bilateral middle ear effusion who require
      tympanostomy tube placement.
    

Detailed description: 
      This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study
      of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear
      effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was
      evaluated relative to sham (empty syringe).

      Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion
      requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were
      examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral
      middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without
      bilateral effusion on the day of surgery were not randomized and were considered screen
      failures.

      Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1
      allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years
      or >2 years.

      Subjects are to visit the study site for safety assessments and otoscopic examination on Days
      4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy
      endpoint occurred on Days 4, 8, and 15.
    

Intervention name(s): OTO-201; Sham
Intervention type(s): Drug; Drug
Intervention description(s): Single, intratympanic injection; Simulated single, intratympanic injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: otitis media; otorrhea; middle ear effusion; tympanostomy tubes
Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to
      Assess the Efficacy and Safety of SKCPT in Patients with knee Osteoarthritis
    


Intervention name(s): SKCPT; Celebrex
Intervention type(s): Drug; Drug
Intervention description(s): the randomly assigned subjects took the study drug for 12 weeks; the randomly assigned subjects took the study drug for 12 weeks
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 (SRD (Single-rising dose)):

      The primary objective of this trial part is to investigate the safety and tolerability of BI
      1015550 in healthy male subjects following oral administration of single rising doses.

      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single
      dosing.

      Part 2 (MRD (Multiple-rising dose)):

      In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550
      in healthy male subjects following oral administration of multiple rising doses.

      Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple
      dosing.
    


Intervention name(s): BI 1015550; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part 1 - single rising dose. Part 2 multiple rising dose; Part 1 - single rising dose. Part 2 multiple rising dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment