bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent
      influenza vaccine in healthy children aged 6-35 months.
    

Detailed description: 
      The study includes open-labelled phase I and randomized, double-blind, controlled phase III
      clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were
      administered with two doses of QIV (7.5μg/0.25ml). In the phase Ⅲ clinical trial, 2320
      children were assigned to QIV group, TIV (B/Victoria) group and TIV (B/Yamagata) group in a
      2:1:1 ratio. All vaccines were manufactured by Sinovac Biotech Co., Ltd.
    

Intervention name(s): Quadrivalent influenza vaccine; Quadrivalent influenza vaccine; Trivalent influenza vaccine (contains B/Victoria strain); Trivalent influenza vaccine (contains B/Yamagata strain)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.; One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.; One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5μg antigen.; One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5μg antigen.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The phase Ⅰ clinical trial was a single arm.The phase Ⅲ was 3 parallel arms.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza Vaccine; Quadrivalent; Trivalent; Children
Somatostatin Receptor Imaging in Patients With Suspected Cardiac Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional

Summary: 
      The purpose of this research study to find out if a drug called OctreoScan or DOTATATE can
      help doctors diagnose people with cardiac sarcoidosis better.

      OctreoScan and DOTATATE are both approved by the U.S. Food and Drug Administration (FDA) to
      diagnose certain tumors.
    


Intervention name(s): Indium-111 Pentreotide; Gallium-68 DOTATATE
Intervention type(s): Drug; Drug
Other intervention name(s): OctreoScan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Oxytocin on Stress in Marijuana Users
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate how people who frequently use marijuana respond to a
      stressful task, and if a medication (oxytocin) affects this response.
    

Detailed description: 
      Stress is commonly associated with drug craving and relapse in substance-dependent
      individuals. Several studies indicate that hypothalamic neuropeptides may mediate behavioral
      response to stress. For example, preclinical and clinical investigations have indicated that
      the neuropeptide oxytocin exerts anxiolytic effects in stress paradigms. Several studies have
      indicated that oxytocin promotes trust, social bonding, and calmness; however, little is
      known about the potential anxiolytic affects of oxytocin in marijuana-dependent individuals.
      A preclinical study investigating the effects and mechanism of lithium on cannabinoid
      withdrawal in rats had positive findings, with increasing oxytocin levels hypothesized to
      moderate this effect (Cui et al, 2001). Given the anxiolytic nature of oxytocin, it may have
      a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in
      marijuana-dependent individuals, as well as the anxiety associated with marijuana withdrawal.
      This pilot protocol will provide important preliminary data on the effect of oxytocin on
      stress in marijuana-dependent individuals.
    

Intervention name(s): Oxytocin; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 40 IUs; 40 IUs
Other intervention name(s): Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: marijuana; substance abuse; drug abuse; marijuana dependence; drug addiction
HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety of and immune response to a DNA HIV
      vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.
    

Detailed description: 
      The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and
      effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct,
      readily produced in large quantities, and stable for long periods of time. This study will
      evaluate the safety and immunogenicity of an experimental multiclade HIV vaccine,
      VRC-HIVDNA016-00-VP, followed by a similarly structured adenovirus-vectored vaccine boost,
      VRC-HIVADV014-00-VP, in HIV uninfected adults. The DNA plasmids in both the vaccines code for
      proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in
      the world. Participants in this study will be recruited in North America, South America, and
      Africa.

      Each volunteer will participate in the study for 36 months. Participants will be randomly
      assigned to one of two groups. Group 1 participants will receive the DNA HIV vaccine at study
      entry and at Months 1 and 2. At Month 6, Group 1 participants will receive an injection of
      the adenoviral vector HIV vaccine. Group 2 participants will receive placebo at study entry
      and Months 1, 2, and 6. There will be 17 study visits, which will occur at study entry and
      every 2 weeks thereafter until Day 70; at Month 6 and every 2 weeks thereafter until Day 210;
      and Months 9.5, 12, 18, 24, 30, and 36. A physical exam, adverse events reporting, HIV and
      pregnancy prevention counseling, and medication history will occur at each visit. Blood and
      urine collection will occur at selected visits.
    

Intervention name(s): VRC-HIVDNA016-00-VP; VRC-HIVADV014-00-VP; VRC-HIVDNA016-00-VP placebo; VRC-HIVADV014-00-VP placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 4 mg administered in deltoid; 1 x 10^10 PU administered in deltoid; 1 mL administered at study entry and Months 1 and 2; 1 mL administered at Month 6
Other intervention name(s): Multiclade HIV-1 DNA Plasmid Vaccine; rAD; DNA HIV placebo vaccine; Phosphate buffered saline; rAD placebo; VRC-DILUENT013-DIL-VP
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine
Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques
Condition: Endodontically Treated Teeth; Missing Teeth; Discoloration, Tooth; Prosthesis Failure, Dental; Open Margin on Tooth Restoration
MeSH terms: Tooth, Nonvital; Tooth Loss; Anodontia; Tooth Discoloration; Prosthesis Failure
Study type: Interventional

Summary: 
      This randomized controlled trial is to clinically assess and compare impression quality of
      polyvinylsiloxane impression material using one step (experimental) and two step (control)
      impression techniques and its effect on marginal fit of prosthesis and proximal contact of
      prosthesis.
    

Detailed description: 
      Study participants will be randomly allocated to either of the two groups (experimental or
      control) through software-generated random numbers.

      Indicated tooth will be prepared to receive a fixed prosthesis under local anesthesia as per
      standard guidelines.

      Polyvinylsiloxane (PVS) impressions will be recorded in stock tray after moisture control,
      according to the assigned group.

      In experimental group, light body and putty PVS will be mixed simultaneously and placed in
      stock tray to record impressions in single stage.

      In control group, a putty PVS impression will be recorded first in stock tray and allowed to
      set. After setting of putty PVS, light-bodied PVS material will be applied to recorded
      impression surface and reseated in mouth to record final impression in second stage.

      All impressions will be disinfected according to the recommended guidelines. All impressions
      will then be assessed by a senior clinician using 3.5 x magnification loupe and graded
      according to the selected criteria.

      Impressions will then be poured in dental stone and prosthesis will be manufactured in dental
      lab.

      Participants will be recalled for prosthesis trial and fit assessment of prosthesis margins
      using a dental explorer instrument and visual evaluation. Proximal contact of prosthesis will
      be graded according the criteria and assessed using dental floss.

      Satisfactory prostheses will be cemented after final adjustments.
    

Intervention name(s): Polyvinylsiloxane impression with different techniques
Intervention type(s): Device
Intervention description(s): One step impression technique will be compared with the standard two step technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polyvinylsiloxane impression; fixed prosthetics; impression techniques; single stage impression; two step putty wash impression; marginal fit; prosthesis fit; endodontically treated teeth
Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid
Condition: Bullous Pemphigoid
MeSH terms: Pemphigoid, Bullous
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine
      or mycophenolate mofetil for the treatment of bullous pemphigoid.
    

Detailed description: 
      This multicenter randomized, non-blinded clinical trial compared two parallel groups of
      patients with bullous pemphigoid treated with oral methylprednisolone in combination with
      either azathioprine or mycophenolate mofetil. Patients were randomly assigned, irrespective
      of severity of disease, to receive either 0.5 mg per kg body weight (BW) methylprednisolone
      (Urbason®, Aventis Pharma, Bad Soden, Germany) with 2 mg per kg BW azathioprine sodium
      (Imurek®, GlaxoSmithKline, Munich, Germany) once daily or 0.5 mg per kg BW methylprednisolone
      once daily and 1,000 mg mycophenolate mofetil (CellCept® provided by Hoffmann-La Roche AG,
      Grenzach-Wyhlen, Germany), given twice daily (2 g/d). The initial dose was maintained until
      blister formation ceased, crusts as well as erosions disappeared, and re-epithelialization of
      previous lesions started. The corticosteroid dose was then sequentially reduced by 10 mg
      every two weeks until a dose of 20 mg per day was reached followed by a reduction in 5
      mg-steps every two weeks until 10 mg per day. Afterwards, corticosteroid reduction was
      performed in 2.5 mg-steps every two weeks until zero. After discontinuation of
      corticosteroids azathioprine or mycophenolate mofetil doses were maintained at the initial
      dosage as monotherapy for an additional 4 weeks. Subsequently, azathioprine was reduced by
      0.5 mg per kg BW every four weeks to a dose of 100 mg per day. Thereafter, azathioprine was
      tapered in 25 mg-steps every four weeks until discontinuation of treatment. Mycophenolate
      mofetil was reduced in 500 mg/d-steps every four weeks to 1,000 mg per day. From then on the
      mycophenolate mofetil dosage was decreased in 250 mg-steps every four weeks until
      discontinuation of treatment.
    

Intervention name(s): Azathioprine or Mycophenolate mofetil
Intervention type(s): Drug
Intervention MeSH terms: Mycophenolic Acid; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bullous autoimmune disease; bullous pemphigoid; immunosuppressants; corticosteroids; mycophenolate mofetil
Study of SCY-635, Pegasys and Copegus in Hepatitis C
Condition: Hepatitis C Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the effectiveness of 28 days of triple combination therapy including
      SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An
      additional 20 weeks of treatment with the currently approved standard of care will be offered
      to all participants. The Week 24 visit will be the last on-study visit. After the Week 24
      visit, all subjects with undetectable HCV RNA will be given the option to continue treatment
      with standard of care for an additional 24 weeks (out to Week 48) under the care of their
      Principal Investigator.
    

Detailed description: 
      Objectives:

      The primary objective of this Phase 2a study was to assess the effect of treatment with
      SCY-635, used in combination with peginterferon alfa-2a (PegIFN α-2a) and ribavirin (RBV), on
      hepatitis C viral replication (as measured by quantitative serum HCV RNA) in treatment-naive
      subjects with chronic genotype 1 infection who have an IL28B genotype of C/T or T/T.

      The secondary objective of the study was to evaluate the safety and pharmacokinetics (PK) of
      SCY-635 when given in combination with PegIFN α-2a and RBV.

      Primary Endpoints:

      Proportion of subjects in each cohort with an undetectable serum HCV RNA level at Week 4 of
      treatment

      Secondary Endpoints:

      Adverse events and clinical laboratory assessments, including tests of liver function
      Proportion of subjects achieving complete early virologic response (cEVR, defined as an
      undetectable serum HCV RNA level at Week 12) Proportion of subjects achieving partial early
      virologic response (pEVR, defined as a detectable serum HCV RNA level with ≥ 2 log10
      reduction in serum HCV RNA from Baseline to Week 12) Proportion of subjects achieving an
      undetectable serum HCV RNA level at Week 24 Pharmacokinetic assessments of SCY-635 when given
      in combination with PegIFN α-2a and RBV; trough concentrations of PegIFN α-2a and RB
    

Intervention name(s): Placebo; SCY-635; Pegasys; Copegus
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral tablets given bid for 28 days; SCY-635 tablets, 300 mg bid for 28 days; 180 ug prefilled syringe given once per week for up to 48 weeks; tablets given bid for up to 48 weeks
Other intervention name(s): Batch # BMR/10/731
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; SCY-635; Ribavirin; Interferon
Influence of Plantago Major on Mineral Metabolism and Selected Biochemical Parameters in Obese Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Effect of oral supplementation with Plantago major on cardiometabolic risk factors and
      mineral content and lifestyle in obese women: double-blind, randomized clinical trial.
    

Detailed description: 
      The purpose of the study is to determine whether oral Plantago major supplementation affects
      cardiometabolic risk factors, mineral content, and lifestyle in obese women.

      In previous research it was found that the Plantago maxima extract counteracts the
      development of adipose tissue in rats on a high-fat diet. In addition, antioxidative,
      anti-inflammatory and antidiabetic action of Plantago has been demonstrated. Moreover, it has
      been shown that Plantago influences lipolysis in obese mice and ameliorates metabolic
      processess in obese rats.

      The project is due to evaluate the effect of oral supplementation with selected Plantago
      species - Plantago major in obese patients on:

        -  the content of minerals in blood, hair and urine

        -  total cholesterol, HDL and LDL cholesterol and triglycerides blood concentration,

        -  blood glucose and insulin concentration,

        -  blood pressure,

        -  anthropometric parameters: body mass, body height, waist and hip circumferences

        -  body content measured by bioimpedance: % of fat tissue and % of muscle tissue

        -  quality of life

           70 subjects will be randomized into two groups and receive oral Plantago major extract
           (the first group) or oral placebo (the second group) once daily for 12 weeks. At
           baseline and at completion (after 12 weeks) fasting blood, urine and hair samples will
           be collected and abovementioned parameters will be measured.
    

Intervention name(s): Plantago major; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Individuals receive Plantago major daily, for 12 weeks; Individuals receive placebo daily, for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Plantago major; obesity; mineral content; adipose tissue
The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery
Condition: Nerve Pain; Shoulder Pain
MeSH terms: Shoulder Pain; Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given
      either intravenously or as part of the interscalene nerve block solution, prolongs pain
      relief following shoulder surgery compared to local anesthetic solution alone.
    

Detailed description: 
      Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and
      Bankart procedure generally allow the patient to go home the same day. However, post-surgical
      pain is often severe and it is common to encounter a delay in discharge from the hospital due
      to difficulty in pain control.

      Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that
      included a significant reduction in acute pain and analgesic requirements, prolonged time to
      first analgesic request, decreased incidence of nausea, as well as earlier hospital
      discharge. Previous studies have attempted to prolong the duration of the analgesia of
      interscalene block by administering additional drugs to the local anesthetics but these
      studies have had varying degrees of success. Dexmedetomidine has recently been considered as
      a potentially useful drug in prolonging nerve block analgesia. Various modes of
      administration of Dexmedetomidine have demonstrated a consistent effect on the duration of
      analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and
      peripheral nerve blocks. When combined with local anesthetics in intravenous regional
      anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal
      studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable
      of prolonging the duration of analgesia of peripheral nerve blocks.

      The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This
      trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in
      interscalene brachial plexus block.
    

Intervention name(s): Dexmedetomidine; Ropivacaine; Normal Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction; 15 ml 0.5%; 1 mL 0.9%
Other intervention name(s): Precedex; Naropin
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: duration of analgesia
Post-partum Perineal Pain - Chirocaine®
Condition: Post-partum Perineal Pain; Episiotomy; Vaginal Tear
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local
      infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree
      tear. The pain intensity is measured in immediate postpartum period by using a numerical
      rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest,
      defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are
      also evaluated at each time.
    


Intervention name(s): Chirocaine; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Post-partum Perineal pain; Episiotomy; First-degree tear