bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK
      Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and
      Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in
      infants and toddlers.
    


Intervention name(s): Hib-MenCY-TT (MenHibrix®); Pediarix®; Rotarix®; Prevnar 13®; PedvaxHIB®; Havrix®
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 4 doses administered intramuscularly (IM) in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 in the HibCY Group.; 3 doses administered IM in the left upper anterolateral thigh at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper anterolateral thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper anterolateral thigh at Month 4 in the PedHIB Group.; 2 doses administered orally at Day 0 and Month 2 each in the HibCY Group and PedHIB Group.; 4 doses administered IM in the left lower anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 each in the HibCY Group and PedHIB Group.; 3 doses administered IM in the right upper anterolateral thigh at Day 0, Month 2 and Month 10-13 in the PedHIB Group.; 2 doses administered IM in the left upper anterolateral thigh at Month 10-13 and Month 16-19 each in the HibCY Group and PedHIB Group.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Conjugate; Immunogenicity; Hib-MenCY-TT vaccine; Haemophilus type b; Safety; Reactogenicity
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of Brivaracetam to support the submission
      file in the indication of adjunctive treatment in adolescents and adults with partial onset
      seizures.
    


Intervention name(s): Placebo; Brivaracetam 2.5 mg; Brivaracetam 10 mg; Brivaracetam 25 mg
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): Active Substance: Placebo
Pharmaceutical Form: Film-coated tablet
Concentration: 2.5 mg, 10 mg and 25 mg
Route of Administration: Oral use; Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 2.5 mg
Route of Administration: Oral use; Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 10 mg
Route of Administration: Oral use; Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 25 mg
Route of Administration: Oral use
Intervention MeSH terms: Brivaracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures, Adolescents & Adults
A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, open-label study of a total of approximately 560 subjects with active
      rheumatoid arthritis (RA) who have had an inadequate response to one or more
      disease-modifying anti-rheumatic drugs (DMARDs). Enrollment in the study was conducted in two
      stages. In Stage I of the study, approximately 400 subjects receiving non-biological DMARDs
      (with the exception of methotrexate [MTX] monotherapy or MTX and leflunomide combination
      therapy) were enrolled. In Stage II of the study, approximately 160 subjects receiving a
      Federal Drug Administration-approved biological DMARD at the time of screening were enrolled.
    


Intervention name(s): Rituximab; Anti-inflammatory drugs
Intervention type(s): Drug; Drug
Intervention description(s): Rituximab was supplied as a concentrate for IV administration at a concentration of 10 mg/mL in 500 mg (50 mL) single-use vials.; Each rituximab infusion was preceded by methylprednisolone 100 mg IV. Use of stable doses of oral corticosteroids was permitted (≤ 10 mg of prednisone or equivalent per day) as were stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs).
Intervention MeSH terms: Anti-Inflammatory Agents; Rituximab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituxan; RA; DMARD; Active Rheumatoid Arthritis
Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness
Condition: Dizziness; Equilibrium; Disorder, Labyrinth; Inner Ear Injury
MeSH terms: Dizziness
Study type: Interventional

Summary: 
      People that have difficulty with balance, such as those with damage to their inner ear, have
      a higher risk of falling, which may lead to anxiety and reduced quality of life. Some
      individuals that have lost part of their sense of balance can learn to compensate using
      information from their vision, their sense of where their limbs are in space, and from other
      balance organs that are still intact. Our study aims to determine if virtual reality used
      together with information from footplate sensors can be used to train people with balance
      problems to compensate for their inner ear deficits.
    


Intervention name(s): Vestibular rehabilitation with dynamic posturography
Intervention type(s): Device
Intervention description(s): Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
Intervention model: Single Group Assignment
Intervention model description: Longitudinal cohort; single group assignment; interventional
Masking: None (Open Label)
Primary purpose: Treatment
Nitrous Oxyde Misuse Among Teenagers Consulting in an Addictology Center Dedicated to Young Drug Users in Montpellier
Condition: Nitrous Oxide; Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      Nitrous oxide gas is used in several application areas : medical as an anesthetic drug ; in
      food industry as a foaming and a mixing agent ; industrial to speed combustion. It is also
      misused for its hilarant, euphoric and hallucinogenic effect. For this purpose the gas is
      transfered in a balloon to be inhaled.

      As its effects are briefs, its consumption is often perseived as safe. However, some risks
      exist and are majorated by the way of use and for some groups of people.

      Since 2016, the French observatory of drug and substances addiction (OFDT) describes an
      increasing misuse of nitrous oxide amoung teenagers and young adults. In november 2019, a
      french press release alerts on the recent increasing of neurologic side effects related to
      the misuse of nitrous oxide.

      That's why, it seems to be interesting to improve the screening of nitrous oxide abuse, in
      particular amoung adolescents and young adults.

      In our study, the investigators would like to determine the characteristics (social, medical,
      any drug abuse) of teenagers and young adults who misuse nitrous oxide. Through a
      questionnaire, the investigators plan to select teenagers and young adults who consult in an
      addictology center dedicated to young drug consumers in Montpellier. This questionnaire is
      anonymous. The data will be collected only after obtaining the patient's agreement.

      The final goal is to create a tool to help general practitioners in screening young people at
      risk of nitrous oxyde misuse.
    


Intervention name(s): assessing the nitrous oxide misuse
Intervention type(s): Other
Intervention description(s): assessing the nitrous oxide misuse among teenagers consulting in an addioctology center dedicated to young drug users in montpellier
Intervention MeSH terms: Nitrous Oxide
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        teenagers and young adults consulting in an addictology center dedicated to young drug
        abusers in Montpellier
      
Keywords: screening; spotting
A Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
      immunogenicity, pharmacodynamics (PD) and the preliminary efficacy of AK101，an
      anti-IL-12/23p40 monoclonal antibody, when administered subcutaneously in subjects with
      moderate-to-severe plaque psoriasis.
    

Detailed description: 
      This was a single-center, randomized, double-blind, placebo-controlled trial which consisted
      of a dose escalation phase (Phase I) and a dose expansion phase (Phase II)..
    

Intervention name(s): AK101; placebo
Intervention type(s): Biological; Biological
Intervention description(s): AK101 is an anti-IL-12/23p40 monoclonal antibody.; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IL12/23
The Effect of Dark Chocolate Consumption on Blood Parameters in Healthy Adult Individuals
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      In healthy individuals, the effect of regular dark chocolate consumption for 4 weeks on blood
      lipid parameters such as; total cholesterol, LDL cholesterol, HDL cholesterol and
      triglyceride levels, in addition to fasting blood glucose, HbA1c, CRP levels and blood
      pressure was investigated.
    

Detailed description: 
      Recent studies have shown that dark chocolate consumption may have a positive effect on
      cardiovascular risk markers.The aim of this study is to investigate the effect of regular
      consumption of dark chocolate (36 g/day) on biochemical blood parameters in healthy
      individuals. A total of 37 healthy individuals completed the study conducted in this
      direction. Participants were randomly divided into two groups as dark chocolate group (n=17)
      and control group (n=20). While the dark chocolate group consumed 36 g/day (400 mg/day
      flavanol) dark chocolate for 4 weeks, the control group did not receive any intervention. At
      the end of the study, the anthropometric measurements of the individuals were evaluated.
      Blood lipid profile, fasting blood glucose, HbA1c, CRP levels, systolic blood pressure and
      diastolic blood pressure measurements were investigated.
    

Intervention name(s): Dark Chocolate
Intervention type(s): Other
Intervention description(s): A daily consumption of 36 g dark chocolate (400 mg/day flavanol) was made. No Cocoa/chocolate product was consumed other than the intervention product.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chocolate; Cacao; Cholesterol; Blood Glucose; Blood Pressure
Effect of Ultra-low Dose Naloxone During Supraclavicular Brachial Plexus Block on Post-operative Opioi
Condition: Upper Extremity Trauma
Study type: Interventional

Summary: 
      Effective post-operative pain control can reduce patient morbidity and affect the patient
      outcome. Brachial plexus block is one of them, a popular and widely employed regional nerve
      block technique for perioperative anesthesia and analgesia for surgery of the upper
      extremity.

      Different drugs have been used as adjuvants with local anesthetics in brachial plexus block
      to achieve quick, dense and prolonged block like Morphine, Pethidine, Clonidine,
      Dexmedetomidine.

      Naloxone is opioid antagonists which could selectively block the excitatory effects of
      opioids. it release endorphins and also displace endorphins from receptor site .it also
      reduce the opioid induced side effects, such as vomiting, nausea, pruritus, and respiratory
      depression.
    

Detailed description: 
      The aim of this study is to evaluate the effect of ultra-low dose of naloxone when added to
      bupivacaine %.05 in supraclavicular brachial plexus block in orthopedic upper limb surgery
      and if it enhances the anti-nociceptive effect of post-operative opioid

      Effect of naloxone on anti-nociceptive criteria of post -operative opioid will be estimated
      by detecting the interval between each analgesic dose of post-operative opioid.
    

Intervention name(s): Bupivacaine plus naloxone; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Patients received 20 mL bupivacaine 0.5% plus 100 ng naloxone (1ml) in 2ml saline.(naloxone ampoule 0.4mg will dilute in 400ml of saline then 1ml of it will dilute in 10 ml saline, so each ml will have 100ng naloxone); Patients will be injected ultrasound guided in their brachial plexus by 20 mL bupivacaine 0.5% plus 3 ml of saline
Intervention MeSH terms: Bupivacaine; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
An Evaluation of Immunogenicity and Safety of Two Doses of MVA-nef vs. MVA-BN in HIV-1 Infected Patients
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to compare two doses of MVA-nef vs. MVA-BN to induce
      Nef-specific cellular immune response in HIV-1 infected patients
    


Intervention name(s): MVA-nef; IMVAMUNE
Intervention type(s): Biological; Biological
Intervention description(s): 3 imm.: 5E8_TCID50 MVA-nef, 1E8_TCID50 MVA-nef in non-dominant upper arm; 3 immunizations: 1E8_TCID50 IMVAMUNE
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment Experienced
Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)
Condition: Pain
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.
    


Intervention name(s): MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days
Intervention type(s): Drug
Intervention MeSH terms: Etoricoxib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks),
      placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and
      Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001),
      and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.
    


Intervention name(s): GFF MDI (PT003); GP MDI (PT001); FF MDI (PT005); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GFF MDI administered as two puffs BID; GP MDI administered as two puffs BID; FF MDI administered as two puffs BID
Other intervention name(s): glycopyrrolate/formoterol fumarate metered-dose inhaler; (GFF MDI); glycopyrrolate metered dose inhaler (GP MDI); formoterol fumarate metered dose inhaler (FF MDI)
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Combinations of Pharmacologic Smoking Cessation Treatments
Condition: Smoking
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the effectiveness of a combination of the drugs
      bupropion and mecamylamine along with a nicotine patch as a therapy for smoking cessation.
    


Intervention name(s): Bupropion; Mecamylamine; Nicotine Patch
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Mecamylamine; Bupropion; Nicotine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking cessation; bupropion; mecamylamine; nicotine
A Study to Evaluate the Effects of Sharpened Romberg Testing (SRT) in Healthy Subjects
Condition: Hypocapnia; Balance; Distorted
MeSH terms: Hypocapnia
Study type: Interventional

Summary: 
      This research study is being done to evaluate the effectiveness of using the sharpened
      Romberg test to screen for impaired postural control in patients with impaired or altered
      breathing patterns.
    

Detailed description: 
      The effects of hypocapnia on the postural system have not previously been adequately
      investigated. The specific aim of this study is to evaluate the effects of hypocapnia on
      postural standing balance using the sharpened Romberg test (SRT). There is very little
      research in this area, even though there is significant clinical relevance, ranging from
      individuals with conditions affecting ventilation (respiratory conditions, cardiac
      conditions, concussions, medications, post-surgical states requiring ventilatory support
      etc). The design of the experiment consists of testing healthy subjects and measuring their
      standing balance with SRT before and after they deliberately lower their carbon dioxide
      levels by increased ventilation over 2min. End-tidal CO2 (ETCO2) will be used to estimate the
      blood carbon dioxide level during the experimental procedures. ETCO2 will be measured using
      the Masimo, Emma Capnometer device. The device is a measurement tool that reads the end tidal
      carbon dioxide level on its display. The results will then be compared to the normal
      pre-hypocapnic SRT to assess how hypocapnia affects standing balance.
    

Intervention name(s): Increased breathing; sharpened Romberg test (SRT)
Intervention type(s): Behavioral; Other
Intervention description(s): hyperventilation to lower ETCO2; Balance test conducted by standing with feet in front of each other, heel-to-toe in line while the right hand is on the left shoulder and the left hand is on the right shoulder.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: hypocapnia; balance
Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 [monthly
      TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3
      months] compared with placebo for preventive treatment in Chronic Migraine patients
    


Intervention name(s): TEV-48125; TEV-48125 or placebo; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TEV-48125 will be subcutaneously administered once monthly for 3 months.; TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.; Placebo will be subcutaneously administered once monthly for 3 months.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Mailers Promoting Mammogram Screening
Condition: Breast Cancer
Study type: Interventional

Summary: 
      In this evaluation, 3 different versions of mailers promoting annual mammograms are being
      sent to women on the month of their 50th and 64th birthdays. The researchers hypothesize that
      the use of behavioral nudges in the mailers should lead to increased uptake in mammogram
      screening.
    

Detailed description: 
      Mammogram screening for women, starting at age 50, can significantly reduce the risk of
      complications due to breast cancer. As part of an existing outreach campaign, the health
      system mails a postcard and small gift (pink socks) to women on the month of their 50th and
      64th birthdays to promote annual mammogram screening.

      The researchers are evaluating two new versions of the mailers against a standard mailer to
      see which version leads to greater uptake in mammograms. The new mailers have content that
      applies behavioral nudge theory - specifically, loss frames and fear appeals - to encourage
      taking action. One of the two new versions does not include the small gift, to test whether
      its inclusion or exclusion has any effect on mammogram screening.
    

Intervention name(s): Postcard; Small Gift; Loss Frame and Fear Appeals
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.; Pink socks are included in the mailer. The gift increases salience of the mailer and it potentially promotes reciprocation from the recipient in the form of ordering a mammogram.; The postcard is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by stating the risks of breast cancer, while also stating that a mammogram screening is an accessible way to address those risks.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 1 x 3 design
Masking: Double (Participant, Care Provider)
Primary purpose: Screening
Keywords: Mass Screening; Communication; Mammography; Risk Reduction Behavior; Economics, Behavioral; Psychology; Loss Frame; Fear Appeals; Reciprocity