bioihbjkbjnl/mcl2 huggingface dataset:
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate response to influenza vaccines in monozygotic and dizygotic twins
      of different ages.
    

Detailed description: 
      The investigators plan to study the response to influenza vaccines much more broadly and
      deeply across different age groups and with different vaccine formulations and to probe the
      influence of genetics on these responses using monozygotic and dizygotic twins. On an
      investigational basis, investigators plan to compare various immunological responses,
      identify age-specific biomarkers or clusters of markers, quantify the frequency of
      influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of
      T-cell repertoire to an influenza vaccine within an individual as a function of age and to
      what degree this is genetically determined.

      Twin Groups A-E will receive a single administration of the 2010-2011 formulation of seasonal
      trivalent inactivated influenza vaccine (TIV). Group F, elderly monozygotic twin
      participants, will be randomly assigned to receive a single dose of inactivated vaccine,
      either the usual dose or the High-Dose TIV. Blood samples to conduct the assays described
      will be taken at pre-immunization, Days 7-10 and 28 post-immunization. Each twin is counted
      as a single participant. All reporting numbers reflect the number of participants, not the
      number of twin pairs.
    

Intervention name(s): High Dose Fluzone® (intramuscular); Fluzone® (intramuscular)
Intervention type(s): Biological; Biological
Intervention description(s): Licensed seasonal High dose trivalent inactivated influenza; Licensed seasonal trivalent inactivated influenza
Other intervention name(s): High Dose TIV; TIV
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inactivated influenza vaccine; Identical twins; Fraternal twins; High-Dose influenza vaccine; Elderly twins; Child twins; Inactivated influenza vaccine, high-dose
A Study of the Pharmacokinetics of ASC09F in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the pharmacokinetic parameters of ASC09F in
      healthy subjects after multiple oral dosing.
    

Detailed description: 
      This study will evaluate the safety and the pharmacokinetics of ASC09F tablets in healthy
      volunteers. Subjects will receive 7 days multiple oral doses of ASC09F tablets.
    

Intervention name(s): ASC09F
Intervention type(s): Drug
Intervention description(s): ASC09F (300 mg ASC09 and 100 mg Ritonavir) one tablet at a time, once per day, up to 7 days.
Intervention MeSH terms: TMC-310911
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimization of IV Ketamine for Treatment Resistant Depression
Condition: Major Depressive Disorder (MDD); Treatment Resistant Depression (TRD)
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      Existing treatments for major depressive disorder (MDD) generally take weeks to months to
      exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for
      MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has
      been used as a standard intravenous (IV) anesthetic agent for many years in both pediatric
      and adult patients. Beyond its well-established role in anesthesia and pain management, there
      is emerging evidence that ketamine may have rapid antidepressant properties for patients with
      severe mood disorders.

      In this study we are investigating whether ketamine can have an antidepressant effect
      compared to midazolam. Midazolam has similar anesthetic effects compared to ketamine but has
      not been shown to be an antidepressant, and is therefore acting as an active control in this
      study.

      The study period can last up to 8 weeks, depending on your response to the study medication.
      There are two required overnight stays in our Research Commons as part of this study.
    


Intervention name(s): Ketamine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Single dose .5 mg/kg IV (in the vein) infused over 40 minutes; single dose 0.045 mg/kg IV infused over 40 minutes
Other intervention name(s): Racemic ketamine hydrochloride
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a Phase II, dose-ranging, multicenter, randomized, double-blind,
      placebo-controlled, parallel-group study of the efficacy and safety of a single
      subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent
      and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic
      despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll
      approximately 76 patients at approximately 45 study centers in the United States and Germany.
    


Intervention name(s): omalizumab; placebo; H1 antihistamines; Diphenhydramine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Participants received a single subcutaneous placebo injection on Day 0 of the study.; Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD; Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab; Diphenhydramine; Promethazine; Histamine H1 Antagonists; Histamine Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Xolair; CIU
Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
Condition: Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with
      placebo in prophylactic monotherapy treatment of migraine headache.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with
      placebo in prophylactic monotherapy treatment of migraine headache.

      Four weeks baseline, following with 12 weeks treatment phase. Subjects migraine are recorded
      by diary cards and re-evaluated by the investigator.

      Subject will have visit every 4-week (+/- 7 days).
    

Intervention name(s): Laxymig ER (drug)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Migraine; Migraine prophylaxis
TMC207 +/- Rifabutin/Rifampin
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of effect of rifampin or rifabutin on single dose PK of TMC207 in healthy
      volunteers
    

Detailed description: 
      32 (16 per treatment group) healthy male or female subjects, 18 - 45 years old will be
      enrolled.Subjects will receive two single oral doses of 400mg TMC207, first on Study Day 1
      followed by a 28-day wash-out, the second on Study Day 29. On Study Day 28, any abnormal
      safety labs will be reviewed by study physician and be determined not to meet the exclusion
      criteria before administration of the second dose of TMC207. Rifabutin 300mg (Group 1) or
      rifampin 600mg (Group 2) will be administered once daily during Period 2 from Study Day 20
      through Study Day 41. The primary endpoint for the study (pharmacokinetics, safety and
      tolerability of TMC207 (and its M2 metabolite) will be determined on the final study visit,
      Day 57 (28 days after the last TMC207 dose in Period 2).
    

Intervention name(s): Rifabutin; Rifampin; TMC207
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rifabutin 300 mg orally on days 20-41; Rifampin 600 mg orally on days 20-41; TMC207 400 mg orally on days 1 and 29
Intervention MeSH terms: Rifampin; Rifabutin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rifabutin; rifampin; TMC207; tuberculosis
Postamputation Pain: Peripheral Mechanisms
Condition: Neuropathic Pain; Amputation, Traumatic; Nerve Block; Phantom Limb Pain; Stump Pain
MeSH terms: Neuralgia; Phantom Limb; Amputation, Traumatic
Study type: Interventional

Summary: 
      Stump and phantom pain after amputation are common, but the responsible mechanisms are still
      not clarified. It has been suggested that phantom limb pain can be reduced by regional
      anaesthesia and in several recent studies, pain was reduced following intrathecal and
      intraforaminal blocks. In this study, the investigators want to investigate if spontaneous
      and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged
      nerves.
    


Intervention name(s): Lidocaine; Placebo
Intervention type(s): Device; Drug
Intervention description(s): Intervention is a nerve block with Lidocaine 2% with Adrenaline.; Intervention is a "placebo" nerve block with isotonic saline
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Foam Rolling and Tissue Flossing of the Cuff Muscles
Condition: Ankle Injuries; Ankle Sprains
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      The hypothesis is that self-myofascial release (SMR) intervention on the cuff muscles would
      affect positively sprint performance and jump height, as well as, decrease Achilles tendon
      stiffness. The second hypothesis is that tissue flossing would be more effective than foam
      rolling.

      The participants will be randomly assigned to foam rolling, tissue flossing, and control
      group (without any intervention). After the intervention, repeated measures will be performed
      (15m sprint, countermovement jump (CMJ) and Achilles tendon stiffness). This will aim to
      improve sprint time, jump height and decrease tendon stiffness.
    

Detailed description: 
      Foam rolling provides beneficial results in ankle range of motion, muscle flexibility or
      muscle sourness. Tissue flossing is popular in athletic training and physical therapy, as an
      effective strategy for ankle range of motion or performance. However, there is a lack of
      knowledge about the use of foam rolling and tissue flossing during a 60 minutes
      post-intervention examination on the performance and soft tissue stiffness.

      The main aim of this study is to investigate the effect of foam rolling and tissue flossing
      of the cuff on sprint performance, jump height and Achilles tendon stiffness at different
      time points. The second aim is to assess the effectiveness of those self-myofascial release
      methods (SMR).

      This study will include healthy, recreational active subjects aged between 20 and 25 years
      old.
    

Intervention name(s): Foam rolling; Tissue flossing
Intervention type(s): Other; Other
Intervention description(s): Foam rolling performed on cuff muscles in 3 sets of 30 seconds per each muscle part in duration with a 15-second rest between sets. The first sets on the central part of the cuff muscles, the second on the medial and third on the lateral side of the cuff.; A standard cuff muscle bandaging technique on cuff muscle. After the application, each participant is asked to perform a 2 min ankle-exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: self myofascial release; injury prevention; performance; athletic training
Magnetic Resonance Imaging of Human Supraclavicular Brown Adipose Tissue - MIBAT Study
Condition: Healthy
Study type: Observational

Summary: 
      Brown adipose tissue (BAT) is unique in its capability to convert chemical energy directly
      into heat. Active BAT increases energy expenditure and can thereby counteract obesity and
      insulin resistance. Currently, the imaging method of choice to assess BAT morphology and
      function is 18F-FDG-PET/CT which is expensive and exposes patients or healthy volunteers to
      ionizing radiation, thus impeding larger prospective studies.

      Magnetic resonance imaging (MRI) could constitute a suitable alternative and preliminary
      small-scale studies are promising.

      The overall aim of this research proposal is to develop reliable magnetic resonance imaging
      techniques to facilitate the study of brown adipose tissue in human adults, specifically in
      the context of endocrine disease.

      Specifically, investigators want to

        1. Develop a reliable MR imaging protocol for human BAT and compare BAT volume to cold
           induced nonshivering thermogenesis as a measure of BAT activity.

        2. Assess the intra-individual variance of BAT volume measured by MRI.

        3. Evaluate direct measurement of BAT temperature by functional MRI.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Biospecimen description: 
      plasma
    
Keywords: brown adipose tissue; magnetic resonance imaging; energy expenditure; non-shivering thermogenesis
Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets
      under fed conditions
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): 1000 mg tablet
Other intervention name(s): KEPPRA
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis
Condition: Ulcerative Colitis; Phosphatidylcholine
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate if retarded release phosphatidylcholine is an
      effective alternative to steroid dependent or -refractory course in chronic active ulcerative
      colitis.

      The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus
      layer. The background of the study is the finding, that the phosophatidylcholine content of
      the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls
      and patients with Crohn´s disease. The content was measured in non-inflamed areas of the
      colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method
      for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.
    

Detailed description: 
      Design: Prospective, randomized, placebo-controlled, double-blinded study.

      Population: 60 patients with chronic active ulcerative colitis and steroid dependency

      Inclusion: Chronic active ulcerative colitis, clinical index 5 or more, endoscopic Index 5 or
      more, steroid dependent course since at least 4 months.

      Main criteria: complete steroid reduction
    

Intervention name(s): Retarded Release Phosphatidylcholine (rPC)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: retarded phosphatidylcholine; chronic active; steroid
GARDASIL Reexamination Study (V501-059)
Condition: Human Papillomavirus (HPV) Infection
Study type: Observational

Summary: 
      This survey is conducted for preparing application materials for re-examination under the
      Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the
      clinical usefulness of Gardasil through collecting the safety information according to the
      Re-examination Regulation for New Drugs.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Females and males 9-26 Years Of Age who are vaccinated with GARDASIL in usual practice
The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression
Condition: Gingival Displacement
Study type: Interventional

Summary: 
      This study aims to evaluate and compare the efficacy of four methods in achieving vertical
      and horizontal gingival tissue displacement to be captured by optical digital impression.
      Moreover, the effect of the gingival displacement methods on the periodontal tissues around
      the final restoration will be assessed.
    


Intervention name(s): Laser troughing; Retraction cord and astringent; Cordless retraction paste with astringent; Cordless retraction paste without astringent
Intervention type(s): Device; Other; Other; Other
Intervention description(s): Laser troughing will be carried out by passing laser optic fiber in contact mode along the gingival sulcus. Laser energy will be delivered with a wavelength of 980nm and power of 0.8W, in continuous mode. Laser tip will be inserted 1mm into the gingival sulcus, to facilitate an accurate recording of finish line; Partial isolation of the tooth with cotton rolls and saliva ejector will be performed. Appropriate size of retraction cord will be soaked in astringent for 5 mins. Then packing of the cord will be started from the mesial interproximal area by gently packing into the sulcus with the gingival cord packer instrument using the single cord technique. Retraction cord will be kept in place for 5 minutes. Cord will be removed immediately before the start of the intraoral scan; The cordless paste with astringent will be injected gently into the sulcus, leaning on the tooth at the point of the cervical limit and not on the gingiva, the cannula will remain parallel to the axis of the tooth to exert optimal pressure. Then it will removed after 5 mins with copiously irrigated water until no traces of the materials left.; The cordless paste without astringent 10 will be injected into the sulcus of the gingiva. The suitable size of Comprecap will be held on the abutment to push the material deep into the sulcus of the gingiva, and the participants will be informed to bite over it for a period of 3 to 5 minutes. After 5 minutes, the comprecap with the set retraction material attached to it, will be removed from the patient mouth.
Intervention MeSH terms: Astringents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Image Content Analysis of Dural-axis Rotational Versus Standard Coronary Angiography
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The investigators hypothesized that dual-axis rotational coronary angiography was
      non-inferior to standard coronary angiography with respect to diagnosis of coronary artery
      disease.
    

Detailed description: 
      The prior studies have demonstrated that dual-axis rotational coronary angiography (DARCA) is
      associated with lower contrast usage and radiation exposure compared with standard coronary
      angiography (SA). Single-axis rotational coronary angiography (RA) has been proved by
      previous studies without any reduction in diagnostic accuracy compared to SA. However, the
      rotational protocol is obvious different between DARCA and single-axis RA. A recent study has
      assessed the diagnostic accuracy of DARCA, but this study was not designed for image content
      analysis and the number of patients included did not provide sufficient statistical power to
      allow a valid comparison of DARCA with SA. The diagnostic accuracy of DARCA aroused our
      attention.
    

Intervention name(s): Coronary Angiography
Intervention type(s): Procedure
Intervention description(s): Coronary angiography include standard coronary angiography (SA) and dual-axis rotational coronary angiography (DARCA). Patient first undergo SA of either left or right coronary system followed by DARCA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Coronary Angiography; Rotational Coronary Angiography; Contrast Media; Radiation; Quantitative Coronary Angiography
High-fiber Diet on the Body and the Brain
Condition: Diet Modification; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The central research question aims to understand what drives individuals to make and maintain
      a vegan / vegetarian dietary decision, to investigate whether there are possible predictors
      that might influence such a decision and whether personality differences already exist or can
      only be measured after the change in diet. The investigators will examine the effects of a
      high-fiber diet on food wanting on a neural and on a behavioral level. The microbiome is
      suggested to mediate the expected changes in food wanting.
    


Intervention name(s): inulin; maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): prebiotic supplement; placebo supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Arm 1: inulin; minimum of 14 days wash-out; 14 days placebo Arm 2: 14 days placebo; minimum of 14 days wash-out; 14 days placebo
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: microbiome; food wanting; memory; fiber