bioihbjkbjnl/mcl2 huggingface dataset:
Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction
Condition: Temporomandibular Joint Disorders; Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose of the study is to compare clinically, radiographically and biochemically the effect
      of intra- articular injection of hypertonic dextrose with a stabilization appliance and the
      intra- articular injection of 2 ml of liquid phase concentrated growth factor with a
      stabilization appliance as a prolotherapy for temporomandibular joint anterior disc
      displacement without reduction.
    

Detailed description: 
      Twenty four patients with anterior disc displacement without reduction will be selected from
      those attending the Prosthodontic Department, Faculty of Dentistry, Alexandria University and
      diagnosed clinically and by magnetic resonance imaging. Patients will be randomly assigned
      into 2 study groups each comprising 12 patients. Group I will receive an intra-articular
      injection of hypertonic dextrose in conjugation with a maxillary CAD/CAM full-arch hard clear
      acrylic stabilization appliance while group II will receive an intra-articular injection of
      LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization
      appliance.
    

Intervention name(s): Hypertonic Dextrose Solution; Liquid Phase Concentrated Growth Factor (LPCGFs)
Intervention type(s): Drug; Biological
Intervention description(s): Patients in this group will receive an intra-articular injection of 12.5% hypertonic dextrose solution, once every month for three consecutive months, in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.The point of needle entry will be 1 cm below the apex of the zygomatic arch and guided by ultrasound to ensure intra-articular injection in the superior joint space.; Patients in this group will receive single intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation
Condition: Endoscopic Retrograde Cholangiopancreatography (ERCP); Bile Duct Cannulation
Study type: Interventional

Summary: 
      This research project will compare the use of the double wire technique with the placement of
      a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut
      papillotomy. Currently, the data supporting either of these approaches is limited to the
      referenced case series. More data on the success and complication rates of these techniques
      are needed. The investigators believe either of these approaches would be preferred by less
      experienced endoscopists to precut papillotomy. Consequently, it is important to
      differentiate these techniques and identify which patients may benefit from one or both.
    


Intervention name(s): Pancreatic duct stent; Pancreatic wire placement
Intervention type(s): Procedure; Procedure
Intervention description(s): Placement of a pancreatic duct stent to facilitate bile duct cannulation; Placement of a pancreatic wire to facilitate bile duct cannulation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Patients undergoing endoscopic retrograde cholangiopancreatography for the first time; Particular focus on patients who meet predefined criteria for a difficult bile duct cannulation
ET-01 in Subjects With Lateral Canthal Lines, LCL-208
Condition: Lateral Canthal Lines; Crow's Feet
Study type: Interventional
Phase: Phase 2

Summary: 
      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Detailed description: 
      This product is being tested for its ability to reduce lateral canthal lines, also known as
      Crow's Feet.
    

Intervention name(s): botulinum toxin, Type A; Vehicle
Intervention type(s): Biological; Biological
Intervention description(s): topical liniment; Vehicle Formulation
Other intervention name(s): ET-01
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: sequential cohort, dose escalating study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
NOX-A12 First-in-human (FIH) Study
Condition: Autologous Stem Cell Transplantation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first time NOX-A12 will be administered to man. The principal aim of this study
      is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous
      (IV) doses to healthy male and female subjects. This information, together with the
      pharmacokinetic and pharmacodynamic data, will help establish the doses and dosage regimen of
      administration suitable for subsequent studies in the patient population.
    


Intervention name(s): NOX-A12; NOX-A12
Intervention type(s): Drug; Drug
Intervention description(s): single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg; single IV dose, at efficacious dose level
Other intervention name(s): olaptesed pegol; olaptesed pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stromal cell-derived factor-1 (SDF-1); L-oligonucleotide aptamer; Spiegelmer
Stationary Bike Study
Condition: Vertigo; Concussion; Dizziness
MeSH terms: Vertigo; Dizziness
Study type: Interventional

Summary: 
      Investigators will use a stationary bike protocol to investigate whether patients with post
      concussion syndrome benefit from adding exertion training to a vestibular rehabilitation
      program.

      Investigators examine the effect of aerobic exercise testing and training on individuals with
      concussion who are currently experiencing symptoms and examine the effect of aerobic exercise
      in combination with traditional vestibular rehabilitation.
    

Detailed description: 
      This is a randomized controlled single blind pilot study testing the hypothesis that the
      combination of aerobic exercise plus vestibular rehabilitation will result in greater
      reduction of symptoms of dizziness and imbalance compared to vestibular rehabilitation alone.
    

Intervention name(s): Vestibular Rehabilitation + Aerobic Exercise; Vestibular Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Subjects in the experimental group will undergo traditional Vestibular Rehabilitation as well as participate in an aerobic exercise training program.; The control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Vestibular; Rehabilitation
Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2)
Condition: Chronic Hepatitis D Infection
MeSH terms: Hepatitis D; Hepatitis D, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      An Open-label, Dose-ranging Study to Evaluate the Safety and Efficacy of Lonafarnib with
      Ritonavir Boosting +/- Peginterferon alfa-2a in Patients Chronically Infected with Delta
      Hepatitis (HDV) (LOWR-2).
    

Detailed description: 
      Chronic delta hepatitis is a serious form of chronic liver disease caused by infection with
      the hepatitis D virus (HDV), a small RNA virus that requires farnesylation of its major
      structural protein (HDV antigen) for replication. Up to sixty subjects with chronic delta
      hepatitis will be randomized to receive one of ten different doses of lonafarnib. Dosing will
      occur over 12-48 weeks, and during that time, evidence of antiviral response will be assessed
      by frequent measurements of HDV-RNA. The primary therapeutic endpoint will be an improvement
      in quantitative serum HDV RNA levels after treatment with lonafarnib therapy. The primary
      safety endpoint will be the ability to tolerate the drug at the prescribed dose for the
      treatment duration. Several secondary endpoints will be measured, including side effects, ALT
      levels, and symptoms. Therapy will be stopped for intolerance to lonafarnib. This study is
      designed as a Phase 2a study assessing the safety, tolerance and antiviral activity of nine
      dosing combinations of lonafarnib with ritonavir boosting with and without peginterferon
      alfa-2a (PEG IFN-a).
    

Intervention name(s): lonafarnib; ritonavir; Pegylated interferon-alfa-2a
Intervention type(s): Drug; Drug; Drug
Intervention description(s): antiviral farnesyl transferase inhibitor; CYP 3A4 inhibitor, lonafarnib booster; immunomodulator
Other intervention name(s): Sarasar, EBP994, LNF; Norvir, RTV; Pegasys; PEG IFN-alfa-2a; Peginterferon alfa-2a; PEG IFN-a
Intervention MeSH terms: Interferons; Ritonavir; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Lonafarnib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy, safety and tolerability of increasing doses of GK
      Activator (2) in patients with type 2 diabetes whose condition has not been optimally
      controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their
      previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for
      12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a
      target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is
      <3 months, and the target sample size is 100-500 individuals.
    


Intervention name(s): GK Activator (2)
Intervention type(s): Drug
Intervention description(s): 25-200mg po bid for 20 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Non-Commercialism Policy in Seattle Schools
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This pilot study on the impact of a non-commercialism policy in Seattle schools will assess
      and evaluate obesity-related health outcomes of a real-life policy decision, recently voted
      on and adopted by the Seattle School Board. The policy reduces the exposure to advertising
      and other marketing pressures, including those from commercial food vendors.
    


Intervention name(s): reducing exposure to marketing pressures
Intervention type(s): Procedure
Primary purpose: Prevention
Keywords: obesity in school aged children
Identification of Polymorphisms Involved in the Metabolism of Propofol
Condition: UGT1A1*28 Polymorphism
Study type: Interventional
Phase: Phase 4

Summary: 
      Identification of Polymorphisms Involved in the Metabolism of Propofol
    

Detailed description: 
      Propofol inside and outside the operating room during anesthesia is a drug widely used. In
      terms of efficacy and side effect profile of propofol knows if properties are insufficient
      data on the metabolism. Propofol typically undergoes biotransformation by microsomal enzymes
      in the liver. For most of the administered dose, takes place glucuronidation by UGT1A9
      enzyme, while the remaining portion is oxidized with CYP2B6 hydroxylation reactions. However,
      these enzymes are involved in the metabolism of propofol are enzymes highly polymorphic.
      Polymorphisms occurring in these enzymes; the effects of propofol, side effects and drug
      needs to show individual differences in terms of causes. Determination of the genetic
      background of individuals and personal anesthetic regimen improved. Thus, useful person drug
      resistance, increased incidence of side effects can be reduced. In particular, be aware of
      some mutations, such as propofol infusion syndrome mortal side effects can be prevented. The
      main purpose of this study, these individual differences are thought to be the cause of
      polymorphic variation in UGT1A9 and CYP2B6 gene to determine. Especially in the UGT1A9 gene
      mutations that may be associated with ethnic structure can be observed. In Caucasian,
      African-American communities and polymorphisms of this gene has been shown in Japanese. So
      all of them as a result of the genetic structure of any society can be considered as its own.
      Therefore, this study aimed to determine the genetic polymorphism of Turkish society
      has.Physiological factors such as age and sex between persons of different answers to the
      causes of propofol. Another object of this study was the identification of these factors can
      lead to different answers which is to present the relationship between polymorphisms.
    

Intervention name(s): propofol
Intervention type(s): Drug
Intervention description(s): Propofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed.
Other intervention name(s): pofol
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Propofol; Polymorphism; UGT1A9; CYP2B6
Pharmacokinetics Study of NI-071
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and
      infliximab(the comparator) in Japanese healthy volunteers
    


Intervention name(s): NI-071; Infliximab
Intervention type(s): Biological; Biological
Intervention description(s): 100mg/vial; 100mg/vial
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the
      effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and
      pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers
    


Intervention name(s): Acebutolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Acebutolol; Placebo capsule(Capsules filled up with lactose)
Other intervention name(s): Acebutolol 200 mg capsule (Acetanol®); Placebo capsule(Capsules filled up with lactose)
Intervention MeSH terms: Acebutolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SLCO2B1 genotype; effect of apple juice
Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL)
Condition: MDS; AML; ALL; BAL
Study type: Interventional
Phase: Phase 2

Summary: 
      Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its
      efficacy in treating aggressive acute leukemias. In addition, evidence is that it is
      well-tolerated with manageable side effects especially in elderly patients. Thus, replacing
      Fludarabine with Clofarabine in a reduced intensity transplant regimen may provide a regimen
      with increased anti-tumor activity without adding significant risks of toxicity.The purpose
      of this study is to evaluate the efficacy and the safety of clofarabine in combination with
      IV busulfan and ATG as the backbone of a reduced intensity conditioning regimen for
      allogeneic stem cell transplantation for the treatment of patients with high-risk MDS/AML or
      ALL not eligible to conventional or standard myeloablative allo-SCT.
    


Intervention name(s): Clofarabine in combination with IV busulfan and ATG
Intervention type(s): Drug
Intervention description(s): A conservative approach has been used for the determination of the dose due to the high risk studied population, e.g., decrease to 30 mg m²/day for a 4-day course of clofarabine. Clofarabine will be started at Day -8 to allow improvement of liver function tests, if any, by time of allo-HSCT. Clofarabine (C) 30 mg/m²/day for 4 days (day -8 to day-5). Busilvex (B): 3.2 mg/kg/day for 2 days (day -4 and day-3)Thymoglobuline (T): 2.5 mg/Kg/day for 2 days (day -2 and day-1). Graft (G) at day 0 GVHD prophylaxis: Cyclosporine 3 mg/kg/day starting day-1. Genzyme provided supplies of clofarabine for all patients included in the study.
Intervention MeSH terms: Busulfan; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MDS; AML; ALL; RIC; clofarabine; allo-HSCT; high-risk MDS/AML
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Insufficiency; Chronic Renal Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate how the levels of a single dose of CTAP101 changes in the body
      over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances
      (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with
      vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
    


Intervention name(s): CTAP101 Capsules; CTAP101 Injection
Intervention type(s): Drug; Drug
Intervention description(s): Single dose oral administration; single IV injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure
Safety and Immunogenicity of TBC-M4, a MVA HIV Vaccine Alone or in a Prime-Boost Regimen With ADVAX DNA HIV Vaccine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated
      immune (CTL) responses.
    

Detailed description: 
      Two vaccine candidates will be used in two different prime-boost regimens: ADVAX (DNA) +
      TBC-M4 (MVA) and TBC-M4 (MVA) alone. Both these vaccines have already been tested in humans
      and both were found to be well tolerated and immunogenic. Approximately 32 volunteers (24
      vaccine /8 placebo recipients) will be included in the study.
    

Intervention name(s): ADVAX; TBC-M4; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Receive 4mg ADVAX at Months 0, 1, and 2 (Biojector), and receive boost of 5x10^7 pfu TBC-M4 (IM); Receive 5x10^7 pfu TBC-M4 (IM) at Months 0, 1, and 6.; Group A (n=4) will receive the ADVAX placebo (formulation buffer) via Biojector.
Group B (n=4) will receive the TBC-M4 placebo (formulation buffer) via IM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV
Effect of Television Viewing and Exercise on Appetite, Satiety, and Food Intake in Children
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study was to describe the effect of 30 min TV viewing with or without
      simultaneous moderate exercise using a treadmill on subsequent subjective appetite,
      satiation, and food intake in normal weight 9 to 14 year old children. It is hypothesized
      that TV viewing during exercise immediately before mealtime affects food intake regulation
      through its effect on the control of appetite and satiation.
    


Intervention name(s): Exercise; TV viewing; Sitting quietly
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 30 min of moderate exercise on a treadmill; watching TV (animated children's programming) for 30 min; Sitting quietly for 30 min
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: children; television; exercise; food intake; appetite; satiation