bioihbjkbjnl/mcl2 huggingface dataset:
Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites
Condition: Autogenous Tooth Bone Graft; Immediate Implant Placement; Simvastatin
Study type: Interventional

Summary: 
      Recently, autogenous tooth graft (ATG) made from compromised teeth was applied in bone
      defects and resulted in a good clinical efficacy.(6) Moreover, it is more accepted by
      patients to use extracted teeth as a bone graft material, especially in the case of immediate
      implant placement. Simvastatin (SMV), known as a 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA)
      reductase inhibitor, is widely used to decrease serum cholesterol because of its safe and
      effective treatment. Apart from cholesterol-lowering effects, SMV is also found to promote
      osteogenic differentiation of bone marrow stem cells (BMSCs), suppress osteoclastic
      differentiation in bone tissue and promotes osseointegration around implants in animal
      studies. SMV is reported to enhance autophagy and alleviates the ROS of BMSCs in the
      osseointegration of implants. The present study will be carried out to evaluate the effect of
      SMV combined with ATG on bone formation around immediately placed dental implants.
    


Intervention name(s): immediate implant placement with ATBG and SMV; immediate implant placement with ATBG
Intervention type(s): Procedure; Procedure
Intervention description(s): immediate implant placement using ATBG as a graft material, with SMV; immediate implant placement using ATBG as a graft material without SMV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Evaluation Of Peri-Implant Emergence Profile Conditioned With Two Different Prosthetic Techniques
Condition: Dental Implants
Study type: Interventional

Summary: 
      The aim of this study is to evaluate and compare two prosthetic conditioning techniques to
      create natural-like peri-implant emergence profile.
    

Detailed description: 
      Twenty four patients having a non-restorable tooth will be rehabilitated with flapless
      immediate implant placement after tooth extraction. The emergence profile will be conditioned
      with either a stock or a customized healing abutment. A definitive screw retained restoration
      will be inserted 4 months postoperatively. Peri-implant tissues will be evaluated using pink
      and white esthetic score, radiographs and periodontal parameters at 3,6 and 12 months after
      implant placement.
    

Intervention name(s): Digitally Flip Technique; Stock Healing Abutment
Intervention type(s): Other; Other
Intervention description(s): A prefabricated shell will be made then after implant placement, the shell will be attached to a plastic abutment using flowable composite to make a customized healing abutment.; After implant placement, a stock healing abutment will be placed onto the implant and screwed on. It will be selected to be 1-2 mm above the gingival margin and slightly smaller in diameter than the intended final restoration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and
      tolerability of bezlotoxumab (MK-6072) in children aged 1 to <18 years of age with a
      confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial
      drug treatment. The primary hypothesis is that the area under the concentration-time curve
      from 0 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with
      bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of
      adults with bezlotoxumab.
    

Detailed description: 
      Historical adult pharmacokinetic data is from NCT01241552 and NCT01513239.
    

Intervention name(s): Bezlotoxumab; Placebo; Antibacterial drug treatment (ABD)
Intervention type(s): Biological; Drug; Drug
Intervention description(s): A single intravenous (IV) infusion of 10 mg of bezlotoxumab per kg body weight. Dose may then be changed based on results from initial 12 participants.; A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose.; ABD will be administered for 10-21 days including the duration of ABD prior to the screening visit, during the screening period, and after the infusion of study treatment, per institutional guidelines, at the investigator's discretion. ABD is defined as the receipt of oral metronidazole, oral vancomycin, intravenous (IV) metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.
Other intervention name(s): MK-6072
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Intranasal SB-705498 in Allergic Rhinitis (AR) Patients
Condition: Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms
      induced by an allergen chamber challenge.
    


Intervention name(s): SB-705498; FP; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12mg intranasal; 200ug intranasal; placebo intranasal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cardiovascular Risk Markers in Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Women with polycystic ovary syndrome (PCOS) are more often overweight or obese and are more
      insulin resistant than women without the condition and may be at greater risk of developing
      cardiovascular disease. It is not know whether it is the overweight and insulin resistant
      component of PCOS, or PCOS per se which leads to the greater cardiovascular disease risk. The
      aim of this study was to examine cardiovascular risk markers in women with PCOS versus a
      control population matched for body mass index (BMI), and or, insulin resistance
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women with PCOS and a control population of women matched for age and body mass index (BMI)
        and insulin resistance
      
Biospecimen description: 
      Plasma
    
Keywords: PCOS
Phlebotomy Study of Testosterone Undecanoate
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a
      single study site. Each study participant received a single oral TU dose immediately prior to
      a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of
      fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and
      post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.
    

Detailed description: 
      This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the
      influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood
      samples into various collection tubes from a small number of hypogonadal men dosed with a
      single oral TU dose in the form of a SEDDS formulation.
    

Intervention name(s): Oral Testosterone Undecanoate
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
Other intervention name(s): testosterone undecanoate
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Treatment Response in Dialysis Anaemia
Condition: Anaemia; Haemodialysis
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two
      current possible treatments for anaemia which are iron and erythropoietin stimulating agents
      (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and
      haemoglobin, but these markers are known to be inaccurate. The current clinical protocol
      therefore tends towards overuse of both agents which can be associated with toxicity, and the
      reliance on these markers prevents retrospective assessment of treatment responsiveness. This
      study is designed to investigate the factors which predict which agent would produce a better
      response. Patients with a fall in haemoglobin will be given treatment with either iron or an
      increased dose of ESA as they are currently, but allocated at random rather than by poorly
      performing biochemical markers. The iron treated and ESA treated groups can then be analysed
      for factors which predict response in o
    


Intervention name(s): Iron sucrose; Erythopoietin stimulating agent
Intervention type(s): Drug; Drug
Intervention description(s): 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl; Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
Other intervention name(s): Venofer; Neorecormon
Intervention MeSH terms: Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Haemodialysis; Anaemia; Iron; Erythropoeitin stimulating agents
Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448
Condition: Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a
      drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be
      measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a
      therapeutic agent for Non-Small Cell Lung Cancer.
    

Detailed description: 
      This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul
      National University Hospital (SNUH) Clinical Trial Center.

      It is expected to take approximately 39 days from the first dosing of Investigational Product
      until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with
      21 days of interval, and one visit will be needed for safety evaluation between 14-17 days
      from the last dosing of the Investigational Product.
    

Intervention name(s): YH25448 240mg
Intervention type(s): Drug
Intervention description(s): period 1: A single oral dose of YH25448 240 mg an overnight fast period 2: A single oral dose of YH25448 240 mg after a high-fat breakfast
Other intervention name(s): YH25448
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: YH25448; Non-Small Cell Lung Cancer
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the impact of gluten-free diets on symptoms and
      inflammatory markers in individuals with previous diagnosis of fibromyalgia (FM), as well as
      to identify the presence of non-celiac gluten sensitivity (NCSG) in individuals with FM.
      Patients with FM diagnosis will be kept on a gluten-free diet for a 10 weeks. In the 7th
      week, they will receive placebo capsules for 7 days and after washout, capsules containing
      gluten for another 7 days. A questionnaire based on Salerno protocol will be applied to
      evaluate the presence of NCGS in the beginning, 8th week and 10 week.
    

Detailed description: 
      Fibromyalgia (FM) is a chronic and widespread pain condition, usually accompanied by several
      associated symptoms such as fatigue, sleep disorder, headache, irritable bowel syndrome and
      mood disorders. Recent studies point to the possibility of gluten protein having a role in
      the development of FM symptoms in a subgroup of patients. Fourteen patients with FM diagnosis
      will be kept on a diet restrict in gluten-free foods for a period 10 weeks. At the 7th week
      they received rice protein isolate capsules (placebo) for 7 days, followed by a 3-day
      wash-out and a new challenge with capsules containing 8 g/day of gluten (corresponding to
      6,3g gluten protein) for another 7 days. In the initial period, at 8th week (final of placebo
      period) and after challenge with gluten (10th week), blood will be collected for analysis of
      inflammatory markers. Questionnaires will be carried out to evaluate the quantity and
      severity of FM symptoms and the impact of FM on daily routine. Inflammatory markers
      (IL-1bera, IL-6 and IL-10) will be evaluated in the blood. In the challenger period (gluten
      or placebo) questionnaires will be carried out to evaluate the quantity and severity of
      symptoms related to fibromyalgia and the impact of fibromyalgia on a daily basis. In
      addition, a questionnaire based on Salerno protocol was applied to evaluate the presence of
      NCGS.
    

Intervention name(s): Gluten; Rice protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: All participants received placebo capsules and, after that, gluten capsules.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Fibromyalgia; non-celiac gluten sensitivity
Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the therapeutic equivalence of Beclomethasone Dipropionate MDI (Inhalation
      Aerosol) 0.04 mg/ INH with the marketed QVAR® 40 mcg (Beclomethasone dipropionate
      hydrofluoroalkane (HFA)) and to demonstrate superiority of both active treatments over
      placebo.
    

Detailed description: 
      This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the
      reference product in terms of improvement in FEV1 measured before and after 4 weeks of
      treatment in adult patients with chronic stable asthma.
    

Intervention name(s): Test Product; Reference Product; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg; Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg; Placebo Product
Other intervention name(s): Test; QVAR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
      assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains
      uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller
      medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment
      with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks
      for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a
      52-week double-blind active treatment extension. The anticipated time on study treatment is
      up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study
      drug for all patients.
    


Intervention name(s): lebrikizumab; lebrikizumab; lebrikizumab; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): subcutaneous dose every 4 weeks; subcutaneous dose every 4 weeks; subcutaneous dose every 4 weeks; subcutaneous dose every 4 weeks
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
Condition: Emergence Delirium; Strabismus
MeSH terms: Delirium; Strabismus; Emergence Delirium
Study type: Observational

Summary: 
      Strabismus surgery for children is a very common procedure, with a high incidence of
      emergence delirium in the recovery room. Pain is often implicated in delirium. The primary
      aim of this study is to determine whether a single, intraoperative dose of methadone for
      outpatient ambulatory pediatric strabismus surgery reduces postoperative delirium.
    


Intervention name(s): Methadone
Intervention type(s): Drug
Intervention description(s): see desc above
Intervention MeSH terms: Methadone
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy children, aged 0-18 years, undergoing outpatient strabismus surgery under general
        anesthesia
The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.
Condition: Short Stature; Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Dwarfism; Endocrine System Diseases
Study type: Observational

Summary: 
      This project is designed to answer the question: Is there an acute IGFBP-3 response in normal
      children?

      Our specific hypothesis states that under the influence of growth hormone secretagogues,
      intact IGFBP-3 molecule will undergo proteolysis and liberate IGFBP-3 fragments, along with
      other components of the ternary complex. This proteolysis will result in measurable rise in
      IGFBP-3, which will indicate the subject's growth hormone status. Short children with growth
      hormone deficiency will not show an IGFBP-3 response.
    

Detailed description: 
      The diagnosis of growth hormone deficiency is problematic, given the shortcoming of the
      standard growth hormone stimulation test. This study is designed to investigate a new tool
      for the diagnosis of growth hormone deficiency.

      Ten short, prepubertal children, who fulfill the inclusion criteria, will undergo a
      two-secretagogue standard growth hormone stimulation test, and an insulin like growth factor
      binding protein-3 (IGFBP-3) stimulation test simultaneously. During this test, components of
      the ternary complex moieties, viz, insulin-like growth factor-I (IGF-I), IGFBP-3 and acid
      labile subunit (ALS) will also be measured along with growth hormone.

      The aim of this study is to detect an acute rise in IGFBP-3 of >15% from baseline.

      The importance of this study is that it inculcates the specificity and improved sensitivity
      of stimulated IGFBP-3 in the diagnosis of growth hormone deficiency.
    

Intervention name(s): IGFBP-3 Stimulation Test
Intervention type(s): Procedure
Observational model: Defined Population
Time perspective: Other
Keywords: Growth; Hormone; Deficiency
A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
Condition: Cardiomyopathy, Hypertrophic Obstructive; Left Ventricular Outflow Tract Obstruction
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Ventricular Outflow Obstruction, Left; Hypertrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 open-label pilot study is to evaluate the efficacy,
      pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects
      with symptomatic HCM and LVOT obstruction aged 18-70 years.
    


Intervention name(s): MYK-461
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Melatonin for Sleep in Children With Autism
Condition: Autistic Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Autistic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if liquid supplemental melatonin is an effective
      treatment for children with autism who have sleep problems related to insomnia (difficulty
      falling asleep).
    

Detailed description: 
      Sleep difficulties in children with autism spectrum disorders (ASD) are common reasons why
      parents seek medical intervention for their children. Identifying a safe and effective
      pharmacologic agent that promotes sleep in ASD would favorably impact the lives of these
      children and their families. In this study we plan to determine the dose-response,
      tolerability and any adverse effects of supplemental melatonin in 30 children with ASD.The
      melatonin dose levels are 1mg, 3mg, 6mg, and 9mg. After a 3 week baseline period, the child
      will begin melatonin at 1mg and will dose escalate every three weeks until he/she is falling
      asleep within 30 minutes of bedtime at least 5/7 nights per week. No child will take more
      than 9 mg of supplemental melatonin.
    

Intervention name(s): supplemental liquid melatonin; flavored liquid or liquid supplemental melatonin
Intervention type(s): Drug; Drug
Intervention description(s): Liquid melatonin will be given to the parent. There are 4 dose levels (1mg, 3mg, 6 mg, and 9mg)of melatonin that will be used at 3 week intervals. The child will start with 1mg and the dose will be increased at 3 week intervals until the child is falling asleep within 30 minutes of bedtime on 5/7 nights per week. Once this goal is reached the child will stay on that dose through the remainder of the study.; Single blind for parents at initial 3-weeks dose period of 1 mg melatonin for 18 children where 3/18 children will receive placebo and 15/18 children will receive melatonin study drug. Each bottle will be labeled as: Flavored liquid placebo/or liquid melatonin. After this initial 3-week period all children will receive known melatonin in bottles that state this.
Other intervention name(s): Natrol brand liquid melatonin; Inert flavored liquid manufactored by PharmaCare in Mt. Juliet TN. A certificate of analysis is on file for this compounded liquid.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Autism; children; sleep; insomnia