bioihbjkbjnl/mcl2 huggingface dataset:
BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to its
      vehicle in the treatment of moderate-severe acne vulgaris.
    


Intervention name(s): BLI1100; Vehicle cream
Intervention type(s): Drug; Drug
Intervention description(s): BLI110 topical cream; Vehicle topical cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moderate to severe facial acne vulgaris
Microarchitecture of Vitreoretinal Contact
Condition: Vitreoretinal Detachment; Vitreo-Retinal Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      Investigation of the vitreoretinal contact microarchitecture in the macular and paramacular
      zones of the human retina.
    

Detailed description: 
      Purpose: to study the features of the macular ILM, to study the features of the preretinal
      structures of the vitreous body of the Central retinal region, morphofunctional features of
      preretinal hyalocytes, and the mechanism of vitreoretinal adhesion.

      Study Protocol: examination of donor human eyes obtained from an eye Bank after sampling
      material for corneal transplantation.

      Research method: scanning electron microscopy (SEM) of the central retina (macular and
      paramacular zone): ILM, preretinal vitreous.

      Scientific hypothesis: vitreoretinal adhesion is provided not by laminin and fibronectin, but
      by the interweaving of vitreous collagen fibers between the epiretinal vitreous (more firmly
      fixed to the retinal surface) and the cortical vitreous.

      Expected results: determination of ILM thickness in the macular zone, microanatomy of
      preretinal vitreous strutcures, and possible mechanism of vitreoretinal adhesion,
      establishing the possibility of intravital synthesis of collagen fibers synthesis in the
      adult vitreous.
    

Intervention name(s): scanning electron microscopy
Intervention type(s): Other
Intervention description(s): scanning electron microscopy of the сentral retina and preretinal structures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: internal limiting membrane; human vitreous; vitreomacular adhesion; vitreoretinal contact; vitreoretinal interface; hyalocytes; collagen
Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic
Condition: Asthma; Dermatitis, Atopic; Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of
      pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic
      sensitisation and allergic disease at two years of age, compared to placebo.
    

Detailed description: 
      To investigate how probiotics given to pregnant women during the last 4 weeks of pregnancy
      and the first 4 months after birth influence the establishment and composition of the gut
      microflora in children from birth until two years of age.

      At the same time to investigate the relationship between gut flora composition and the
      development of the immune system.

      To investigate the relationship between supplement of probiotics to pregnant and
      breast-feeding women, the microbial composition of the gut flora in their children, the
      development of the childrens' immune system, and the prevalence of atopic sensitisation and
      atopic disease at two years of age.
    

Intervention name(s): Probiotic; placebo
Intervention type(s): Dietary Supplement; Biological
Other intervention name(s): Lactobacillus rhamnosus GG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention; Probiotics; Allergy; Hypersensitivity
GLP-1: Acute Effects on Kidney Function in Healthy Men
Condition: Kidney Functional
Study type: Interventional

Summary: 
      The purpose of this study is to investigate how Glucagon-Like Peptide 1 (GLP-1) affects
      kidney function in healthy young men. The hypothesis is that GLP-1 induces a positive effect
      on kidney hemodynamics.
    


Intervention name(s): Human GLP-1 (7-36) amide; Isotone NaCl
Intervention type(s): Biological; Biological
Intervention description(s): 2 hour IV infusion, 1,5pmol/min/kg.; 2 hours IV infusion.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3
      formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant
      hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and
      inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 3
      formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be
      acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all
      antigens.
    

Detailed description: 
      Participants will be randomized into 4 arms:

      AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol
      phosphate (PRP) conjugated to tetanus toxoid (PRP-T) and 10 mcg of Hepatitis B surface
      antigen (HBsAg)

      PR51 (3, 10): arm receiving vaccine formulation containing 3 mcg of polyribosylribitol
      phosphate conjugated to the outer membrane protein complex of Neisseria meningitides
      (PRP-OMPC) and 10 mcg of HBsAg

      PR51 (6, 10): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of
      HBsAg

      PENTACEL™ + RECOMBIVAX HB™: open-label control group receiving PENTACEL™ (licensed vaccine
      for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus
      influenzae type b) and RECOMBIVAX HB™ (licensed vaccine for hepatitis)
    

Intervention name(s): AR51 (12, 10); PR51 (3, 10); PR51 (6, 10); PENTACEL™; RECOMBIVAX HB™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg; vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg; vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg; licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label; licensed vaccine for hepatitis, administered open-label
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH
Condition: Non-Alcoholic Steatohepatitis(NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being
      developed for the treatment of obesity. CP-945598 is also being considered as a potential
      treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the
      steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of
      CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH
      patients and underwrite the safety of this compound prior to any further studies in NASH
      patients.
    


Intervention name(s): Active treatment; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks; Placebo as two tablets once daily for three weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Pharmacokinetic safety NASH patients
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females
Condition: Uterine Leiomyomata (Fibroids)
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the safety and tolerability of ascending
      single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide
      the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese
      female subjects.
    


Intervention name(s): PRA-027
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Accuracy of Tooth Modified Scan Bodies as a Novel Technique
Condition: Digital Technology; Dental
Study type: Interventional

Summary: 
      The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree
      of trueness of IOS impression for full arch cases.

      I
    

Detailed description: 
      The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree
      of trueness of IOS impression for full arch cases. TMSB is a scan body to which different
      teeth are attached directly as one piece, this may enhance the accuracy level by filling the
      gabs between ISB as well as acting as a stable artificial AI-easily recognized landmarks thus
      facilitating the scanning procedure. OS impression utilizing tooth modified scan bodies or
      conventional scan bodies result in the same degree of trueness as conventional verified
      splinted open tray impression. To our knowledge, it is the first time in the literature to
      utilize a novel scan body modified with directly connected teeth as artificial landmarks in
      vivo.
    

Intervention name(s): Tooth modified scan bodies; Conventional scan bodies
Intervention type(s): Device; Device
Intervention description(s): Tooth modified scan bodies are used during scanning for full arch implant cases.; Conventional scan bodies will be used for scanning the full arch implant cases.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Jaw relation; Scan body
Evaluation of the Efficiency of the Chronic Pain Management Training Program
Condition: Nursing Caries; Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The research will be conducted to evaluate the effectiveness of the web-based chronic pain
      management training program developed for nursing students. It is planned in a randomized
      controlled triple-blind design with the final year nursing students of the Nursing Department
      of Çankırı Karatekin University in a pre-test-post-test order.
    


Intervention name(s): chronic pain management education program; No intervention
Intervention type(s): Other; Other
Intervention description(s): The chronic pain management training program will be applied for 2 weeks. The training consists of 15 videos about theory and practice topics in chronic pain management. There are evaluation questions at the end of each video.; No intervention will be made.
Other intervention name(s): Experimental group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization: After applying the exclusion criteria to a total of 94 students, the students who accepted to participate in the study was randomly selected into two groups (A and B) of 35 students by simple random sampling by creating a computer-assisted simple random numbers table (www.randomizer.org). Selected students was randomly assigned so that the general academic achievement grades of both groups were homogeneous. The groups was randomly assigned to the intervention or control group by the code "A" and "B" by the software specialist.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Chronic pain; Nursing student education; Web-Technology based education
Vestipitant Or Vestipitant/Paroxetine Combination In Subjects With Tinnitus And Hearing Loss.
Condition: Tinnitus
MeSH terms: Hearing Loss; Deafness; Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      Tinnitus associated to hearing loss is a high prevalent audiologic disorder with important
      unmet needs as far as therapy is concerned. The present study is exploring the possible
      beneficial effects on tinnitus loudness or annoyance of a combination drug treatment aimed to
      increase the local inhibitory activity of neural circuitries involved in sound perception and
      generation. Modest effects have been reported after 8-12 weeks treatment with
      antidepressants, including high dose paroxetine (up to 50 mg/day). Biologic data suggests
      that the combination of increase of extracellular serotonin using an SSRI and of blockade of
      NK1 receptors using a novel NK1 antagonist may lead to a reduced tinnitus and, possibly,
      improved hearing acuity. To this aim, two 14 day treatment conditions, i.e., SSRI paroxetine
      (20 mg/day) plus the NK1 antagonist vestipitant (25mg /day) or vestipitant alone (25 mg
      /day), will be compared to placebo in patients suffering from tinnitus previously selected
      for their capacity to reliably score the transient attenuation of tinnitus loudness produced
      by lidocaine infusion. Effects on principal endpoints will be collected within 4 hrs from
      last administration, when the plasma levels of vestipitant are calculated to be in the range
      associated to pharmacodynamic effects on VAS anxiety and qEEG (>30 ng/ml). PK, safety and
      tolerability of the paroxetine-vestipitant combination was addressed with preclinical and
      Phase I studies, showing no relevant issue. The cross-over study will require approximately
      24 patients. Audiometry and computer-based Automated Psychoacoustics will be performed as
      instrumental endpoints to support subjective scores. A diary will be used at home to score
      tinnitus severity at home during the study.
    


Intervention name(s): Vestipitant; Vestipitant + Paroxetine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): NK1 receptor antagonist; NK1 receptor antagonist and SSRI; Placebo
Other intervention name(s): Vestipitant
Intervention MeSH terms: Paroxetine; Vestipitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: placebo; balanced; paroxetine; repeated dose; Hearing Loss; loudness; combination; Tinnitus; vestipitant (GW597599); randomised; annoyance; crossover
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers
Condition: Infectious Diseases; Bacterial Infections
MeSH terms: Communicable Diseases; Infections; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      single and multiple intravenous doses of BWC0977 when administered to healthy adult
      volunteers.
    

Detailed description: 
      This Phase 1 study is designed to assess the safety, tolerabilty and pharmcokinetics of
      single and multiple intravenous doses of BWC0977 when administered to healthy adult
      volunteers. This is a randomized double-blind, placebo-controlled, ascending dose,
      multi-cohort trial. A total of 64 healthy volunteers are expected to be enrolled into 8
      Cohorts. The study will be conducted in two phases: A single ascending dose (SAD) phase,
      followed by a multiple ascending dose (MAD) phase. In SAD, participants in Cohorts 1 - 5 will
      receive one dose of BWC0977 or placebo. In MAD, participants in Cohorts 6 - 8 will receive
      multiple doses of BWC0977 or placebo for 10 consecutive days at a dose deemed safe and
      tolerable as determined in the preceding SAD Cohorts. In both parts sequential cohorts will
      be exposed to increasing doses of BWC0977.
    

Intervention name(s): BWC0977; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAD Cohorts: Double-blind dosing will occur. Six participants will receive single doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.
MAD Cohorts: Double blind dosing will occur. Six participants in each cohort will receive multiple doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. Dosing will commence on the morning of Day 1. Dosing frequency to be confirmed based on safety, tolerability and PK data from SAD cohorts. Daily dosing will continue for a total of 10 consecutive days.; SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.
Other intervention name(s): Compounded solution minus BWC0977
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, combined single and multiple ascending dose (SAD and MAD) trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; BWC0977
Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study
Condition: Aortic Aneurysm, Abdominal; Surgery
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Interventional

Summary: 
      Basic animal research has demonstrated that exercise training can protect the myocardium from
      ischemia-reperfusion injury through several biological mechanisms . This effect of exercise
      training may be beneficial in the perioperative period when cardiac complications may arise.
      However, exercise induced cardioprotection is lost completely within 18 days of stopping the
      training program. This finding from animal research will be used to test the hypothesis that
      3 days of consecutive exercise with the last bout conducted within the last 24/48 hours prior
      to surgery, will have a cardioprotective effect . Specifically, exercise has been shown to
      protect cardiac myocytes against reperfusion induced oxidative stress and mitochondria
      against reperfusion induced damage. This exercise mediated cardioprotection is observed in
      short moderate duration ischemia (i.e. 5-20 min) and moderate to severe (i.e.20-60 min)
      ischemic insults. The effects of exercise induced cardioprotection have only been
      investigated at cell level and it has not been shown whether this will translate into a
      reduction in postsurgical reperfusion injury and associated complications. To study this
      potential cardioprotective effect the investigators will aim to recruit patients who have a
      high risk of receiving reperfusion injury during surgery. Specifically, the investigators
      will recruit abdominal aortic aneurysm patients where the risk of heart complications is
      high. There is also currently no evidence in the published literature with regard to the
      effect of preoperative supervised exercise.
    


Intervention name(s): Preoperative exercise
Intervention type(s): Other
Intervention description(s): Patients will perform 3 consecutive days of 60 min submaximal cycling exercise at a moderate exercise intensity. During the 60 min of exercise, patients will be provided with three equally spaced 3min rest periods
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery
Condition: Perioperative Inflammatory Response
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the present study is to quantify the degree of modulation, if any, in the
      perioperative inflammatory response associated with statins use. Specifically, we hypothesize
      that:

      In a population of patients undergoing elective orthopedic spine surgery, administration of a
      specific statin (Simvastatin, Zocor®, Merck Pharmaceuticals), will be associated with a
      decrease in perioperative inflammatory markers when compared to patients not taking statins
    

Detailed description: 
      Previous studies have reported activation of the body's immune system during the
      perioperative period.1 Typically, this "stress response" is limited and goes unnoticed by the
      patient and health care team. However, physiologic insults that occur during major surgery
      may elicit a more pronounced response known as the systemic inflammatory response syndrome
      (SIRS). Such a response is of great clinical consequence, as it is known to significantly
      worsen perioperative morbidity and mortality.1 HMG Co-A Reductase Inhibitors (hereafter
      identified by the common name, "the statins") are potent inhibitors of cholesterol synthesis,
      and their role in the treatment of atherosclerosis and prevention of coronary artery disease
      is well documented.2-5 Interestingly, data from animal studies have shown that statins have
      unique anti-inflammatory properties that are independent of their lipid lowering effects.6
      Recently, statin therapy has been associated with a reduced incidence of perioperative
      cardiovascular and neurologic complications in major vascular and thoracic surgery patients
      as well as improved outcomes in patients experiencing acute coronary syndrome (ACS).7-13 In
      all ACS patient populations studied, improvement in outcome has been attributed to coronary
      plaque stabilization, presumably a result of statins mitigating the local inflammatory
      response at the level of the coronary plaque.

      The purpose of this study is to quantify the magnitude of perioperative inflammation during
      major orthopedic spine surgery and determine whether statins alter this systemic physiologic
      response.
    

Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg po/nasogastric tube (NG) every day for 6 days; 1 pill po/NG every day x 6 days
Other intervention name(s): Zocor
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Plasma concentrations of inflammatory markers; C-Reactive Protein (CRP); Interleukin-6 (IL-6); Tumor Necrosis Factor-Alpha (TNF); Aspartate Aminotransferase (AST); Alanine Aminotransferase (ALT); Creatine Kinase (CK)