bioihbjkbjnl/mcl2 huggingface dataset:
Enamel Matrix Derivative in Non-surgical Periodontal Treatment
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effect of enamel matrix derivative in addition to
      scaling and root planing in comparison to scaling and root planing only in periodontitis
      patients that have already undergone initial periodontal therapy and are in periodontal
      maintenance.
    

Detailed description: 
      Enamel matrix derivative (EMD) have already been widely applied as a regenerative
      bio-modulator in periodontal surgery and have been demonstrated to enhance periodontal
      regeneration. Recently, also its flapless, non-surgical application has been shown to have
      beneficial effects when applied during initial therapy of periodontitis.

      The present study is designed as a single-blinded randomized controlled clinical trial. We
      plan to include a total of 50 periodontitis patients that have already undergone initial
      periodontal therapy, but still show remaining sites with increased periodontal probing depth
      (PPD). Patients will be randomly allocated at a 1:1 ratio to either scaling and root planing
      (SRP) in combination with EMD application into the affected pockets (test group, n=25) or to
      SRP only (control group, n=25). Before treatment, as well as after 3, 6 and 12 months, we
      plan to assess site-specific periodontal parameters as well as whole-mouth oral hygiene
      indices. Furthermore, we intend to evaluate gingival crevicular fluid, as well as parameters
      representing periodontal disease activity.
    

Intervention name(s): Emdogain® FL; Scaling and root planing
Intervention type(s): Device; Other
Intervention description(s): Emdogain® FL is an enamel matrix derivative intended for subgingival and topical application in conjunction with scaling and root planing procedures to provide regeneration of tooth support lost due to periodontal disease. Emdogain® FL has been shown to be effective in residual pockets with probing depths from 5mm to 9mm with no furcation involvement in patients with adequate plaque control. Emdogain® FL has also been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.; Scaling and root planing procedures as part of non-surgical periodontal therapy involves mechanical removal of dental plaque and calculus using curettes and sonic scalers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Enamel Matrix Derivative; Periodontitis; Non-surgical periodontal therapy
Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Malnutrition, including muscle wasting commonly occurs in children with cystic fibrosis (CF),
      negatively influencing their quality of life and survival. At the time of a diagnosis of CF,
      severe protein deficits can already be present. It is important to get CF children fed
      adequately to prevent that their condition becomes worse or that recovery takes longer. Oral
      supplementation trials showed that gains in lean body mass are difficult to achieve in CF
      unless specific metabolic abnormalities are targeted. However, the specific needs for certain
      food components are not clear yet in children that are ill. Therefore, more information is
      necessary on the need for protein and certain amino acids in children with CF. Previous
      studies support the concept of essential amino acids (EAA) as an anabolic stimulus in the
      young and elderly and in insulin resistant states. Until yet no information is present on the
      anabolic effects of EAA in CF.

      It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically
      designed to stimulate protein anabolism will target the metabolic alterations of pediatric
      subjects with CF. In the present proposal, the acute metabolic effects of this high leucine
      essential amino acids mixture will be examined in pediatric subjects with CF and compared to
      that of a regular balanced total mixture of essential and non-essential amino acids. The
      principal endpoints will be the extent of stimulation of whole body protein synthesis as this
      is the principal mechanism by which either amino acid or protein intake causes muscle
      anabolism, and the reduction in endogenous protein breakdown. Both endpoints will be assessed
      by isotope methodology which is thought to be the reference method.
    

Detailed description: 
      In this study, we will test the following hypothesis: A high-leucine essential amino acid
      mixture (dose of 6.7 g) will stimulate protein anabolism to a greater extent than a standard
      balanced mixture of total (essential and non-essential) amino acids in CF pediatric subjects.
      The principal endpoints will be the extent of stimulation of protein synthesis rate and the
      reduction in endogenous protein breakdown. The current project will provide information that
      will enable us to better understand the underlying metabolic mechanisms that regulate protein
      metabolism in pediatric subjects with CF.
    

Intervention name(s): Essential amino acid intake + Leucine vs total AA supplement
Intervention type(s): Dietary Supplement
Intervention description(s): 7 g as bolus
Other intervention name(s): 7 g EAA + 40% LEU
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: CF; protein metabolism; essential amino acid intake
Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1, open-label, multi-center, dose-escalation study to investigate the
      safety, pharmacokinetics and pharmacodynamics of ISU304/CB2679d in previously treated
      hemophilia B patients.
    

Detailed description: 
      This study is a phase 1, open-label, multi-center, dose-escalation study to investigate the
      safety, pharmacokinetics, and pharmacodynamics of ISU304/CB2679d/Dalcinonacog alfa in
      previously treated Hemophilia B patients.

      This study is comprised of 5 cohorts. Each cohort may receive an intravenous administration
      of 75 IU/kg, with subcutaneous administrations from 75 IU/kg to 150 IU/kg.

      During the study period, a subject may be hospitalized to facilitate the collection of blood
      samples for pharmacokinetic (PK)/pharmacodynamic (PD) analysis. The Data Safety Monitoring
      Board (DSMB) and Data Monitoring Committee (DMC) will be operated after the end of Cohorts 1
      to 4. These committees will monitor the PK/PD and safety data from each cohort to determine
      the continuation of next cohort (Cohorts 2 to 5), target dose, and blood sampling period for
      PK/PD (including timing of collection). Additional subjects may be enrolled in all cohorts or
      cohorts may be canceled depending on the results of PK/PD analysis. A cohort of subcutaneous
      dosing at 300 IU/kg was cancelled as single-dose PK is uninformative.
    

Intervention name(s): ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg; BeneFIX
Intervention type(s): Biological; Biological
Intervention description(s): ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg by intravenous or subcutaneous; BeneFIX 75 IU/kg, intravenous administration
Other intervention name(s): Dalcinonacog alfa
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ISU304; previously treated Hemophilia B patients; FIX; Factor IX; CB2679d; Dalcinonacog alfa
Implementation of Physical Exercise at the Workplace (IRMA08) - Healthcare Workers
Condition: Musculoskeletal Disorders
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The prevalence and consequences of musculoskeletal pain is considerable among healthcare
      workers, allegedly due to high physical work demands of healthcare work. Previous studies
      have shown promising results of physical exercise for relieving pain among different
      occupational groups, but the question remains whether such physical exercise should be
      performed at the workplace or in the private sphere at home. Performing physical exercise at
      the workplace together with colleagues may be more motivating for some employees and thus
      increase compliance. On the other hand, physical exercise at the workplace may be costly for
      the employers in terms of time spend. Thus, relevant ground exists to compare the efficacy of
      workplace- versus home-based training on musculoskeletal pain. This study investigates the
      effect of workplace-based versus home-based physical exercise on musculoskeletal pain among
      healthcare workers.

      The main hypothesis is that physical exercise at the workplace for 10 weeks compared with
      physical exercise at home results in reduced musculoskeletal pain among healthcare workers.
    


Intervention name(s): Workplace physical exercise; Home physical exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.
Condition: HER2 Expressing Breast or Gastric/Stomach Cancers
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is designed to evaluate an experimental drug, MEDI4276, in treating
      breast and stomach (gastric) cancer.
    


Intervention name(s): MEDI4276
Intervention type(s): Biological
Intervention description(s): MEDI4276 is an investigational product
Intervention MeSH terms: MEDI4276
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to:

        -  Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.
    


Intervention name(s): Voriconazole
Intervention type(s): Drug
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer
Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After CABG
Condition: Coronary Bypass Graft Surgery; Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Postoperative Atrial Fibrillation (POAF) is one of the most common complications following
      coronary artery bypass grafting (CABG) occurring to 20% - 40% of patients. It is associated
      with prolonged hospitalization, increased hospital costs, increased complications and
      mortality rate.

      Despite the use of Beta Blockers, approximately 20% of patients develop atrial fibrillation
      following CABG surgery, suggesting a role for polymorphism in the genes The aim of the
      present study is to determine the minor allele frequency of some of the genes that affect the
      beta blockers' response and to determine the association between polymorphism in these genes
      and the occurrence of postoperative atrial fibrillation after coronary artery bypass grafting
      in Egyptian patients receiving perioperative beta blockers.
    


Intervention name(s): Beta blocker
Intervention type(s): Drug
Intervention description(s): perioperative beta blockers
Intervention MeSH terms: Adrenergic beta-Antagonists
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Egyptian patients undergoing Coronary Artery Bypass grafting Surgery
A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the
      antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71
      years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously
      exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a
      0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received
      saline placebo controls will also be included in this follow-up study to make comparisons
      with the investigational vaccines. No vaccinations will be administered in this trial.
    


Intervention name(s): Blood sampling; GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.; GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.; Placebo
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.; 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity
The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)
Condition: Levels of DHA in the Blood
Study type: Interventional

Summary: 
      The clinical trial will provide a milk-based drink with constant amounts of nutrients but
      differing amount of Docosahexaenoic Acid (DHA).
    


Intervention name(s): Nutritional beverage
Intervention type(s): Other
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 44370 TA Tablets in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of safety, tolerability and pharmacokinetics of multiple rising oral doses of BI
      44370 TA in healthy male and female volunteers
    


Intervention name(s): BI 44370 TA; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Inulin,SCFA Production and Metabolic Response
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this placebo controlled, double-blind, randomized crossover study the investigators will
      investigate in overweight/obese healthy male volunteers whether inulin administration will
      increase intestinal SCFA production, thereby investigating whether this will lead to acute
      metabolic effects.
    

Detailed description: 
      Gut microbiota is being increasingly recognized as an important factor in fat distribution,
      insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota
      could play an important role in the development of obesity and type 2 diabetes mellitus. The
      role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by
      microbial fermentation of fibre, is still controversial. At the present time, our
      understanding of the effects of SCFA on human metabolism (in gut or systemically) is still
      limited. The investigators hypothesize that the ingested prebiotic inulin is fermented into
      SCFA and these SCFA have metabolic effects.
    

Intervention name(s): 13C inulin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Oral 13C inulin; Oral maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
Condition: Chronic Hepatitis C Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and
      antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir)
      administered as two-day monotherapy followed by ABT-267 in combination therapy with other
      direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also
      known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV)
      infection without cirrhosis.
    

Detailed description: 
      An open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and
      antiviral activity of ABT-267 as monotherapy for 2 days, followed by ABT-267, ABT-450 with
      ritonavir (ABT-450/r) and ABT-333 plus ribavirin (RBV) combination therapy for 12 weeks in
      treatment-naïve, non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. The
      study included post-treatment follow-up for 48 weeks.
    

Intervention name(s): ABT-267; ABT-450; ABT-333; Ritonavir; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet; Capsule; Tablet
Other intervention name(s): ombitasvir; dasabuvir
Intervention MeSH terms: Ritonavir; Ribavirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C,Genotype 1
Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg
      twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in
      healthy adults.

      The secondary objective is to assess the safety and tolerability of a single oral dose of
      metoprolol 50 mg when administered alone and in combination with repeated oral doses of
      eliglustat 150 mg BID in healthy adults.
    


Intervention name(s): Eliglustat; Metoprolol
Intervention type(s): Drug; Drug
Intervention description(s): Capsules for oral administration; Tablets for oral administration
Other intervention name(s): Genz-112638; Lopressor
Intervention MeSH terms: Metoprolol; Eliglustat
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug interaction
EPO906 Therapy in Patients With Advanced Colorectal Cancer
Condition: Colorectal Neoplasms; Colonic Neoplasms
MeSH terms: Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine whether the new investigational drug EPO906, given by intravenous
      infusion (IV directly into the vein), is effective in shrinking tumors and preventing the
      growth of cells that cause colorectal cancer.
    


Intervention name(s): epothilone b
Intervention type(s): Drug
Intervention MeSH terms: Epothilones; Epothilone B
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colon; rectum; colorectal; rectal; cancer; tumor; tumour; neoplasm; carcinoma; intravenous; epothilone
Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in
      intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for
      posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.
    


Intervention name(s): Dexmedetomidine; Oxycodone
Intervention type(s): Drug; Drug
Other intervention name(s): Dexdor; Oxanest
Intervention MeSH terms: Dexmedetomidine; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment