bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
Condition: Quadrivalent HPV Vaccine; Human Papillomavirus Vaccine
Study type: Interventional

Summary: 
      The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine
      among males 18-24 years old, comparing an on-time administration of the third dose with
      delayed administration of the third dose. All participants would receive the first and second
      doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3
      at 12 months.

      Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the
      usual timing control group (C):

      H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified
      non-inferiority margin
    

Detailed description: 
      1. Specific Aims and Overview: The investigators propose a randomized, open label trial of
      HPV vaccine among males 18-24 years old, comparing an on-time administration of the third
      dose with delayed administration of the third dose. All participants would receive the first
      and second doses according to schedule. They would be randomized to either Dose 3 at 6 months
      or Dose 3 at 12 months.

      Blood would be drawn for titers at twice from all participants: pre-dose 1 and one month post
      Dose 3.

      No cytology studies or DNA studies will be conducted.

      1.1 Aims:

        1. Determine if delay in the third dose is immunologically non-inferior to the standard
           administration schedule (1 month post-dose 3).

        2. Determine the side effect profile of a delayed third dose, in comparison to the standard
           schedule.

        3. Determine the preference and compliance of the men for the timing of the third dose.

      1.2 Hypothesis for non- inferiority:

      The GMTs in the test group (T) are non-inferior to the usual timing control group (C):

      H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified
      non-inferiority margin.
    

Intervention name(s): quadrivalent human papillomavirus vaccine; quadrivalent human papillomavirus vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months; 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
Other intervention name(s): Gardasil; Gardasil
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: human papillomavirus vaccine L1, type 6,11,16,18; HPV Vaccines; HPV L1 vaccine, quadrivalent 6,11,16,18
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987516)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation number - SR15-61-Z15-034).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hydroxychloroquine for the Prevention of Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial
Condition: Myocardial Infarction; Acute Coronary Syndrome; Inflammation; Hydroxychloroquine; Antirheumatic Agents; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Acute Coronary Syndrome; Inflammation; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      This safety pilot study evaluates the effect of hydroxychloroquine on preventing recurrent
      cardiovascular events among myocardial infarction patients. Half of the participants will
      receive hydroxychloroquine, whereas the other half will receive placebo during six months.
    

Detailed description: 
      Anti-rheumatic medications decrease cardiovascular mortality in rheumatoid arthritis
      patients, based mainly on their anti-inflammatory effect. No studies have addressed their
      effect on preventing recurrent cardiovascular events among non-rheumatic patients.

      In the pilot phase 200 myocardial infarction patients will be recruited during their index
      visit to the study hospitals. Patients will be randomized after initial coronary angiography
      to receive either hydroxychloroquine 300 mg a day or placebo during six months. Patients will
      be followed up until 12 months at four visits. Visit one is at doctor´s office at 3 to 5
      weeks from the day of recruitment. Visit two is at study nurse´s office at 5.5 to 6 months.
      Visit three is a phone interview by the study nurse at 8.5 to 9.5 months. Visit four at 11.5
      to 12.5 months is at doctor´s office.

      This study evaluates the safety of hydroxychloroquine in the setting of myocardial
      infarction, and whether hydroxychloroquine treatment could reduce the incidence of recurrent
      cardiovascular events among myocardial infarction patients. Furthermore, the effect of
      hydroxychloroquine on cardiovascular risk factors and systemic inflammation parameters will
      be studied. In a subgroup of 40 patients, the effect of hydroxychloroquine on aortic
      inflammation will be assessed by PET/CT scan.

      If this safety pilot study with 200 patients proves successful (i.e. no major complications),
      2500 patients will be recruited in additional centers in Finland and the Nordic Countries.

      Orion Pharma provides the active hydroxychloroquine tablet (Oxiklorin) but provides no other
      assistance or funding for the study.
    

Intervention name(s): Hydroxychloroquine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Oxiklorin
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hydroxychloroquine; anti-inflammatory; Myocardial infarction; cardiovascular diseases
Open Label Ketamine Treatment for Major Depressive Disorder in Veterans
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Medically healthy Veterans ages 21-75 that have been diagnosed with Depression will get up to
      6 treatments of Ketamine infusions, weekly. After treatment is completed, follow up will
      occur at 1 month, 3 months, and 6 months after completion of infusions to evaluate the longer
      term effects of ketamine.
    

Detailed description: 
      A total of 25 depressed subjects between the ages of 21-75 who have current major depressive
      disorder without psychotic features by DSM-5 will be recruited. Subjects will be accepted
      into the protocol after an opportunity to review and provide voluntary written informed
      consent and completion of a comprehensive medical and psychiatric history, physical
      examination, mental status examination, and routine laboratory assessments. Patients will be
      recruited in outpatient settings to the Refractory Depression Clinic. Providers or Refractory
      Depression consult team will be informed if the patient may be eligible for participation in
      the ketamine protocol. Subjects must have established care in the VA Connecticut Healthcare
      System. If the Veteran is interested, a screening visit for further evaluation for the
      ketamine protocol will be scheduled. Veterans will receive up to 6 infusions for ketamine
      weekly, per PI discretion. The primary goal of this proposal is to test the effectiveness of
      repeated ketamine treatment (0.5 mg/kg; once or twice a week for up to 6 weeks; up to a total
      of 6 ketamine infusions). An open-label trial will be conducted that will include up to 25
      Veterans with MDD with a follow-up of 6 months. This open-label trial will allow us to
      examine the safety and tolerability of the ketamine treatment in this population and the
      long-term effects. All patients will receive usual standard care during this trial.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): 0.5mg/kg ketamine in normal saline. Infusion will be delivered during a 40 minute interval
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ketamine; Major Depressive Disorder
Vitamin D Supplementation in TB Prevention
Condition: Latent Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial is to determine whether vitamin D supplementation reduces
      risk of acquiring latent tuberculosis infection (LTBI) in school age children in Mongolia.
      The investigators hypothesize that (1) vitamin D supplementation will reduce risk of
      acquisition of LTBI, (2) vitamin D supplementation will safely reduce risk of developing
      active TB and improve other secondary efficacy outcomes, and (3) children with the lowest
      vitamin D status at baseline will gain most from the intervention.
    


Intervention name(s): Cholecalciferol (vitamin D3); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 14000 IU vitamin D3 weekly Experimental group will receive vitamin D supplement (Tishcon, USA).; Placebo group will receive placebo (Tishcon, USA) weekly.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Influence of Consecutive Strength- and Endurance Regimes on the Myonuclear Domain and Satellite Cell in the M. Vastus Lateralis of Old Healthy Men
Condition: Regeneration Potential of Healthy Old Men in Terms of Satellite Cell Activation
Study type: Interventional

Summary: 
      Randomised training intervention.

      Influence of consecutive training regime on the impact of the myonuclear domain and satellite
      cell

      Sarcopenia

      Despite that the muscle mass can be positively influenced by training, the loading with high
      weights and/or to the total exhaustion is for many old persons not possible.

      Therefore we aim to enhance the myonuclei in the muscle fiber of old male subjects in a first
      phase by endurance training, in order to promote a more effective muscle growth in a second
      phase by resistance exercise.
    


Intervention name(s): Training
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Development of 'Emma'--a Pediatric IBD Quiz
Condition: Ulcerative Colitis; Crohn's Disease; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma';
      to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps
      can be used to improve patient education.
    


Intervention name(s): playing the ipad quiz game
Intervention type(s): Other
Intervention description(s): Individualized education to the patient via the quiz game, with optional additional education provided by medical providers.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Objectives: To analyze the number of sessions needed to achieve a positive impact after
      combining interferential current therapy and therapeutic exercise, compared with therapeutic
      exercise alone, on self-reported pain, disability and range of motion in subjects with
      chronic neck pain.

      Design: A randomized, single-blind, controlled trial. Subjects: Patients between 18 and 65
      years old, with idiopathic chronic neck pain.

      Methods: The experimental group who will perform a combined treatment using Interferential
      current therapy and therapeutic exercise for two weeks. The control group will receive the
      same program of therapeutic exercise during the same period of time.
    


Intervention name(s): Interferential Current and Therapeutic Exercise Program; Therapeutic Exercise Program
Intervention type(s): Other; Other
Intervention description(s): The Interferential Current Program will be based on a bipolar application using the Sonopuls 692 device (Enraf Nonius, Rotterdam, The Netherlands). The current parameters will be: a) 4000Hz carrier frequency; and b) 60 Hz AMF with a modulation frequency of 90 Hz. The intensity of the current will be adapted to the sensitivity of each patient.
The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:
Ergonomic advices on reducing repetitive movements and/or maintained positions
A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises; The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:
Ergonomic advices on reducing repetitive movements and/or maintained positions
A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Neck Pain; Interferential Current Electrotherapy; Therapeutic Exercise; Physical Therapy
Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to
      determine the effect of ranolazine when given as monotherapy on glycemic control in subjects
      with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise
      alone and who are treatment naive to antihyperglycemic therapy or have not received
      antihyperglycemic therapy in the 90 days (or thiazolidinediones [TZDs] for at least 24 weeks)
      prior to screening, and to characterize the relationship between HbA1c reduction and other
      glycemic parameters in subjects with T2DM.
    


Intervention name(s): Ranolazine; Placebo; Diet; Exercise
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): Ranolazine tablets administered orally twice daily.; Placebo to match ranolazine administered orally twice daily.; Participants are instructed to continue the diet regimen prescribed by their physician.; Participants are instructed to continue the exercise regimen prescribed by their physician.
Other intervention name(s): Ranexa®
Intervention MeSH terms: Ranolazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus
Leuprolide in Determining the Cause of Gonadotropin Deficiency
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional

Summary: 
      RATIONALE: The body's response to one injection of leuprolide may provide more information
      than the standard test for gonadotropin deficiency in determining whether the cause of
      gonadotropin deficiency is related to the hypothalamus or the pituitary gland.

      PURPOSE: Randomized double-blinded clinical trial to study the effectiveness of leuprolide in
      determining the cause of gonadotropin deficiency.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to
      receive leuprolide acetate or gonadotropin releasing hormone (GnRH) first, then cross over to
      receive the other test.

      Patients receive one subcutaneous injection of leuprolide acetate or GnRH, then have blood
      samples drawn periodically. One month later, patients receive the other test.

      Another cohort of patients are randomized to receive leuprolide acetate once daily on days 0,
      4, and 8, or days 0, 5, and 10.

      Patients are followed for up to 2 years.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): gonadotropin releasing hormone; leuprolide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leuprolide; Hormones
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: endocrine disorders; hypogonadism; rare disease
Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment
Condition: Human Gastrointestinal Physiology Data
Study type: Interventional

Summary: 
      In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The
      purpose of this clinical study was to evaluate the in vivo drug dissolution and systemic
      absorption of the BCS Class IIa drug ibuprofen under fed and fasted conditions by direct
      sampling of stomach and small intestinal luminal content. Expanding current knowledge of drug
      dissolution in vivo will help to establish physiologically relevant in vitro models
      predictive of drug dissolution.
    

Detailed description: 
      This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data from
      healthy subjects under fasting and fed conditions which are necessary for mechanistic
      absorption model development. Each subject will be asked to complete two GI tube insertion
      procedures. Subjects will complete this study twice under the same conditions of the GI
      tract, either fasting state or fed state, in order to provide intra-subject variability. A
      minimum of 7 days will separate each GI tube insertion procedure. The objectives of this
      study are, as follows: Objective #1: To acquire human GI physiology data including GI
      motility, pH of GI fluids, and GI fluid volume under fasting and fed conditions; Objective
      #2: To measure drug concentration and calculate drug dissolution in the GI tract in vivo
      under fasting and fed conditions; Objective #3: To monitor plasma drug concentration and
      evaluate pharmacokinetics of administered drug during GI tube insertion studies under fasting
      and fed conditions. These in vivo results will be used to validate in vitro dissolution
      methods and to support computational and mathematical modeling efforts, in order to develop
      an oral drug product optimization process that may be applied to future drugs to maximize
      oral drug safety and efficacy.
    

Intervention name(s): Single dose of ibuprofen (800 mg tablet); Pulmocare, two 8.0 oz (236.6 mL) cans
Intervention type(s): Drug; Dietary Supplement
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a parallel study design that allocated subjects into a fasted or fed group. Subject were asked to complete the same study procedures on two occasions.
Subjects assigned to the fasted or fed group were not crossed-over from one group to the other.
Masking: None (Open Label)
Primary purpose: Basic Science
A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK)
      after administration of SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.
    


Intervention name(s): SID1903; SID1903-R1/SID1903-R2
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of SID1903 after an overnight fast; Single oral administration of SID1903-R1 and SID1903-R2 after an overnight fast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DIALOOG: Crestor in Patients With Diabetes Mellitus Type 2: Lowering of LDL-C Levels to New European Guidelines
Condition: Diabetes Mellitus Type 2; Crestor, Rosuvastatin; LDL Cholesterol; Observational
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to determine in DM II patients the efficacy of Crestor in
      obtaining the new European LDL cholesterol guidelines.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Diabetes Mellitus Type 2
Effects of a Single Dose of Amisulpride on Functional Brain Changes
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate effects of a single dose of amisulpride on functional
      brain changes during reward- and motivation-related processing and at rest in healthy
      volunteers (HV) and in patients with Major Depressive Disorder (MDD).
    

Detailed description: 
      Double blind, placebo-controlled, randomized, single dose, parallel-group design The study is
      designed to investigate effects of a single dose of amisulpride on functional brain changes
      during reward- and motivation-related processing and at rest. Measurement of functional brain
      changes will occur after a single dose of amisulpride or placebo in HV and patients with MDD.
      It is hypothesized that functional brain changes previously linked to reward- and
      motivation-related processing require dopaminergic signaling and are diminished in MDD
      compared to HV. In MDD, but not in HV, treatment with a single low dose (100 mg) amisulpride
      should increase brain activation associated with reward- and motivation-related processing.
      To test these hypotheses, we will implement a randomized, placebo-controlled, parallel- group
      design with 4 treatment arms (MDD/placebo, MDD/amisulpride, HV/placebo and HV/ amisulpride).
      All subjects will undergo MRI scanning sessions at Visit 3 and Visit 4. Treatment with
      amisulpride or matching placebo will occur 3.5 to 4 hours before the start of each scanning
      session. Time of treatment will be standardized across subjects.

      At Visit 3 and Visit 4, blood samples will be taken 30 minutes pre-dose, and 1 hour, 3.5 to 4
      hours, and 4.5 to 5 hours after oral drug administration to determine target plasma levels of
      amisulpride.

      The study is composed of 4 outpatient visits: Screening, baseline and 2 scanning sessions.
    

Intervention name(s): Amisulpride Pill; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two single low doses amisulpride (100 mg); orally; two doses, orally
Intervention MeSH terms: Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Amisulpride; Functional Brain Changes; BOLD responses