bioihbjkbjnl/mcl2 huggingface dataset:
Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies
      Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration
      of human rabies immunoglobulins (Imovax® Rabies).

      Primary Objectives:

        -  To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of
           subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international
           units (IU)/mL at Day 14.

        -  To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5
           IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI)
           of at least 97%.

      Secondary Objectives:

        -  To assess the clinical safety of each vaccine after each vaccine injection when
           administered in a simulated post-exposure schedule.

        -  To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day
           14.
    

Detailed description: 
      All participants will receive five vaccine injections, i.e. one at Day 0, at Day 3, at Day 7,
      at Day 14 and at Day 28, respectively, (Essen regimen). In addition, human rabies
      immunoglobulins (HRIG) will be concomitantly administered to all subjects on Day 0.

      Safety will be assessed in all participants up to 28 days after vaccination, as applicable,
      in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse
      events of special interest (AESIs) up to 6 months post-vaccination 5.
    

Intervention name(s): Purified Vero Rabies Vaccine (VRVg); Imovax® Rabies: inactivated rabies vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 1.0 mL, Intramuscular
Other intervention name(s): Imovax® Rabies
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rabies; Purified Vero Rabies Vaccine - Serum Free; Human Diploid Cell Vaccine; Imovax® Rabies
rTMS in Spasmodic Dysphonia
Condition: Spasmodic Dysphonia; Laryngeal Dystonia
MeSH terms: Dysphonia; Hoarseness; Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      Focal dystonia is a neurological movement disorder characterized by excessive involuntary
      muscle contractions of any body part. Spasmodic dysphonia (SD) is a type of focal dystonia
      characterized by excessive contraction of intrinsic muscles in the larynx, leading to
      difficulty in speaking and affecting effective communication. The cause of SD is unknown and
      there are no treatments that produce long-term benefits. Previous studies have suggested that
      SD and other focal dystonias are associated with decreased inhibition in sensorimotor areas
      in the brain. However, no studies have investigated the effects of modulating excitability of
      the laryngeal motor cortex in healthy individuals or SD. The goal of this pilot project is to
      determine if brain excitability of the laryngeal motor cortex can be changed with
      low-frequency inhibitory repetitive transcranial magnetic stimulation (rTMS) in individuals
      with SD and healthy controls. Considering that rTMS at low frequencies (≤1 Hz) produces
      lasting inhibition in the brain, and that SD is associated with decreased cortical
      inhibition, the purpose of this pilot study is to determine safety, feasibility and response
      to 1Hz rTMS to the laryngeal motor cortex in individuals with SD and healthy people. The
      results will help understand changes associated with the disorder, as well as contribute to
      the development of future clinical interventions for SD.
    


Intervention name(s): 1Hz repetitive transcranial magnetic stimulation (rTMS)
Intervention type(s): Device
Intervention description(s): 1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Repetitive transcranial magnetic stimulation (rTMS); Spasmodic dysphonia; Dystonia
The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries
Condition: Bleeding; Hemorrhage; Hemodynamic Instability
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      Bleeding is one of the most important causes of mortality and morbidity in patients.

      Hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in
      the hemodynamic sense. Hemoglobin determination is studied at laboratories along with blood
      gasses or complete blood analysis. Recently, non-invasive techniques where measurement is
      made from the fingertips have been offered for use. One of these techniques is non-invasive
      hemoglobin (SpHb) measurement. SpHb is used as a trend monitor. Based on the severity of
      bleeding, the compensatory mechanisms of patients may be disrupted. This situation may lead
      to lower levels of toleration of anemia during bleeding. The relationship between blood
      transfusion and mortality is under debate.
    


Intervention name(s): non-invasive hemoglobin (SpHb)
Intervention type(s): Device
Intervention description(s): hemoglobin measuring device
Intervention MeSH terms: Chrysarobin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        General anesthesia undergoing hip surgery
      
Keywords: Perioperative Bleeding; Mortality; Hemoglobin; Non-invasive monitoring; Transfusion;; SpHb
Clinical and Radiographic of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.
Condition: Socket Preservation
Study type: Interventional

Summary: 
      After tooth extraction, the residual alveolar ridge generally provides limited bone volume
      because of ongoing, progressive bone resorption. Healing events within post-extraction
      sockets reduce the dimensions of the socket over time. Therefore, socket preservation became
      an indispensable procedure as well as fundamental to prevent bone loss following tooth
      extraction. Preservation, by the name, is the maintenance of the socket, which is essentially
      the height and width of the gap that is left after the tooth is removed. It is done by
      placing a graft material or scaffold immediately into the socket of an extracted tooth to
      presto preserve bone height, width and density
    

Detailed description: 
      Investigator evaluate the clinical and radio graphic effect of roll pedicle connective tissue
      graft as a barrier membrane together with bovine bone in alveolar ridge preservation in
      extraction sockets.
    

Intervention name(s): roll pedicle connective tissue graft with bovine bone
Intervention type(s): Procedure
Intervention description(s): rotated pedicle connective tissue graft together with bovine bone applied for socket preservation after tooth extraction
Other intervention name(s): vascularized interpositional connective tissue graft
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: socket preservation; vascularized interpositional connective tissue graft; alveolar ridge preservation techniques; bovine bone graft; roll pedicle graft
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
Condition: Diabetes Mellitus, Type II; Fatty Liver
MeSH terms: Fatty Liver; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus
      (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:

        -  The safety and tolerability of multiple doses of INT 747;

        -  The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and
           glucose homeostasis;

        -  Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes
           and biochemical markers of hepatic and metabolic function and inflammation, and;

        -  Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic
           acid (6-EDCA) and tauro 6-ECDCA.
    

Detailed description: 
      This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose,
      parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25
      mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.

      The primary objective of assessing changes in insulin resistance and glucose homeostasis will
      be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of
      6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse
      experiences; vital signs; clinical laboratory values; plasma drug and metabolite
      concentrations; and general health and well-being.
    

Intervention name(s): INT-747; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg by mouth once daily, 50 mg by mouth once daily; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Farnesoid X receptor agonist; Metabolic Disorder; Diabetes; NAFLD
Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years
Condition: Healthy Children
Study type: Interventional

Summary: 
      Evaluation of the learning and encouragement effect on six minutes walking test in children
      under 12 years
    


Intervention name(s): six minute walking test; six minute walking test
Intervention type(s): Other; Other
Intervention description(s): six minute walking test; six minute walking test with encouragement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Validity and Reproducibility of Dietary Assessment Against Objective Measures
Condition: Validation Study
Study type: Observational

Summary: 
      A cross-sectional study with repeated measurements among healthy Danish adults to assess the
      validity and reproducibility of a self-administered 7-day web-based dietary assessment tool,
      myfood24® tested against objective biomarkers.
    

Detailed description: 
      Healthy volunteers (age 35-70 yrs; BMI 22-32) will be recruited for the study. Informed
      consent will be obtained and participants will complete a self-administered web-based 7-day
      24-hour dietary recall tool (myfood24®).Validity of this dietary registration tool will be
      assessed by comparing the estimated intake of selected nutrients (protein, energy) and
      selected food groups (fruit and vegetables, whole grain, coffee, alcoholic beverages) against
      objective biomarkers obtained from a 24-hour urine sample, through a measurement of resting
      energy metabolic rate, and from a fasting blood sample, respectively. Reproducibility will be
      assessed by comparison of the results from two self-administered web-based 7-day 24-hour
      dietary recalls obtained 4 weeks (± 1 weeks) apart.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy Danish adults
      
Biospecimen description: 
      Urine and blood samples to measure biomarker excretion
Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of Single and Multiple-Doses of ATF936 and AXT914 Administered Orally in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study and is designed to evaluate the safety, tolerability,
      pharmacodynamic and pharmacokinetic effects of a single and multiple-doses of ATF936 and
      AXT914 administered orally in healthy subjects.
    


Intervention name(s): ATF936; AXT914
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ATF936, AXT914, healthy subjects, pharmacokinetics, parathyroid hormone, osteoporosis; Healthy male and female subjects
Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence
Condition: Alcohol Dependence; Depression
MeSH terms: Alcoholism; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy of mecamylamine (MEC, 10 mg/day)
      versus placebo in reducing depressive and alcohol symptoms in patients with depression and
      co-morbid alcohol dependence. The researchers hypothesize that MEC will significantly reduce
      depressive symptoms and decrease alcohol consumption compared to placebo in patients with
      depression and alcohol dependence who are on a stable dose of a selective serotonin reuptake
      inhibitor (SSRI).
    

Detailed description: 
      Depression with co-morbid alcohol dependence is very prevalent and it is very costly to
      treat. The co occurrence of the two disorders leads to greater severity and worse long-term
      outcome, including suicide. Although a number of treatment strategies have been implemented
      for depressed patients with alcohol dependence the controversy concerning best treatment
      options for those patients persists.

      The clinical relationship between depression and alcohol dependence suggests some common
      mechanism underlying both disorders. It has been hypothesized that medications that block
      presynaptic nAChR may be effective in the treatment of alcoholism and depression.
      Mecamylamine (Inversine ®) is a noncompetitive, high affinity nAChR antagonist with low
      selectivity for the alpha-7 receptor. Mecamylamine has never been investigated as an
      effective adjunct treatment for dually diagnosed patients with depression and alcohol
      dependence. Methods: Thirty participants with a current diagnosis of depression and alcohol
      dependence will be recruited for this 12-week treatment study. Fifteen participants will be
      randomized to mecamylamine and fifteen to placebo. Participants will be included in the study
      if: they meet current DSM-IV criteria for Major Depression and Alcohol Dependence and have
      been on a stable SSRI dose for 2 weeks. All participants will come weekly to take their
      medications and complete weekly assessments. Weekly assessments will consist of questioners
      that will assess depressive symptoms and alcohol consumption over the entire treatment
      period. Significance: This study is the first to evaluate the efficacy of mecamylamine as an
      augmenting agent for treatment of depression and alcohol dependence.
    

Intervention name(s): Mecamylamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): mecamylamine 10mg/day for 12 weeks; Placebo pill
Intervention MeSH terms: Mecamylamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: treatment; alcohol dependence; depression; mecamylamine
The Effect of Omega-3 Polyunsaturated Fatty Acids in the Treatment and Prevention of Relapse of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The whole study will be divided into two major parts: (A) A 12-week, double-blind, randomized
      controlled, parallel n-3 fatty acids adjunctive therapy study in 30 bipolar disorder patients
      with mild to moderate depression. (B) A double-blind, randomized controlled, parallel n-3
      fatty acid add-on prophylactic study in 31 patients with stable bipolar disorder.
    

Detailed description: 
      Part of the study will be a 12-week parallel-group placebo-controlled double-blind randomized
      n-3 fatty acids add-on combination therapy trial. A total of 30 patients in the acute
      depression stage of bipolar disorder will be collected from outpatient clinics and randomly
      assigned to receive n-3 fatty acids or placebo. T-test (or Mann-Whitney U-Test) will be used
      to evaluate the differences in the severity of depressive and manic symptoms between the two
      groups across the study points. The second part of the study will be a 6-month add-on
      prophylactic trial with parallel-group, double-blind random allocation to n-3 fatty acids or
      placebo groups. A total of 31 patients with stable bipolar disorder recruited by newspaper
      advertisements will be recruited and randomly assigned to receive n-3 fatty acids or a
      placebo. Kaplan-Meier Survival analysis will be used to evaluate the differences in the
      recurrence rate of bipolar depression between the two groups. Also, t-test (or Mann-Whitney
      U-Test) will be used to evaluate the differences in the severity of depressive and manic
      symptoms between the two groups across the study points. The 2 separate studies will be
      conducted after approval from the Human Trials Committee.
    

Intervention name(s): n-3 fatty acids; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): EPA 1680 mg/d + DHA 880 mg/d; Soybean oil
Other intervention name(s): control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Natural History Study of Patients With MPS IIIA
Condition: Mucopolysaccharidosis IIIA
MeSH terms: Mucopolysaccharidoses
Study type: Observational

Summary: 
      Evaluate the clinical progression in patients with MPS IIIA who are untreated with any
      investigational product and to obtain standardized assessments: neurocognitive, behavioral,
      sleep-wake habits and effect of MPS IIIA on the quality of life of patients and their
      families.
    

Detailed description: 
      This is a multicenter, multinational, longitudinal, observational study in children aged up
      to and including 9 years, who have been diagnosed with MPS IIIA. The study will detail the
      natural course of MPS IIIA via standardized clinical, biochemical, neurocognitive,
      developmental, behavioral and imaging measures. This information is anticipated to inform the
      design and interpretation of future interventional studies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects diagnosed with MPS IIIA
      
Biospecimen description: 
      Cerebral Spinal Fluid
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at
      11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a
      2 dose vaccination schedule of hepatitis A vaccine.
    

Detailed description: 
      This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after
      primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To
      evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years
      11, 12, 13, 14,15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary
      vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations If
      a subject has become seronegative for anti-HAV antibodies during any of the long-term blood
      sampling time point (i.e. Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years), he/ she
      will be offered an additional vaccine dose. A blood sample will be taken on the day of the
      additional vaccination, 14 days and one month after additional vaccination to evaluate the
      immune response following this vaccination.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
      and to include an extended follow up period up to Year 20 after primary vaccination.

      The study has 10 phases (100576, 100577, 100578, 100579, 100580, 111028, 111029, 111030,
      111031, 111032).
    

Intervention name(s): Havrix™
Intervention type(s): Biological
Intervention description(s): 2 doses at 6 months interval
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Havrix™; Hepatitis A
A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.
      Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can
      lead over time to cervical cancer in women . This study will evaluate the immune response
      induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      The protocol was primarily amended for the following reason:

      Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming
      commercially available in an increasing number of countries. Therefore, the study procedures
      were revised to include questions at every visit to determine if subjects have received an
      HPV vaccine outside of the study.
    

Intervention name(s): HPV-16/18 L1 VLP AS04
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Cervical neoplasia; Cervical cancer; Double-blind; HPV-16/18 L1 VLP AS04; HPV; AS04
Studying the Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature
Condition: To Assess Erectile Function in Patients Complaining of Congenital Penile Curvature
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      Patients complaining of congenital penile curvature were subject to Penile duplex study to
      assess their curvature. Their penile duplex data including Peak Systolic velocity, End
      Diastolic velocity and Resistivity index were recorded as well as their assessing the degree
      of curvature and the quality of their erection using the erection hardness grading scale.
    


Intervention name(s): Penile Duplex Study
Intervention type(s): Diagnostic Test
Intervention description(s): A penile duplex study will be done to assess PSV, EDV, RI, angle and degree of curvature and Erection quality using the erection hardness grading scale
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult males complaining of congenital penile curvature
      
Keywords: Congenital penile curvature, Erectile dysfunction