bioihbjkbjnl/mcl2 huggingface dataset:
Progesterone & Postpartum Relapse to Smoking
Condition: Tobacco Use Cessation; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The primary goal of this project is to investigate the potential efficacy of exogenous
      progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new
      mothers. Also to determine the feasibility of enhanced compliance monitoring and
      identification of collateral factors effecting outcomes.
    

Detailed description: 
      Pregnant women will be recruited at gestational weeks 33-36 who have quit smoking during
      pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery,
      women will be randomly assigned to receive 4 weeks of active or placebo exogenous
      progesterone starting on the 4th day postpartum. Participants will be in contact with study
      staff either by phone or clinic visits until 12 weeks postpartum to collect data on smoking
      status and protocol compliance, measure serum progesterone levels and receive behavioral
      counseling.
    

Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.; Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Other intervention name(s): Prometrium
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: pregnant; smoker; cigarette; tobacco
Persistence of Protection by Shingrix
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 1

Summary: 
      The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully
      prevents shingles in older people. Two vaccines are currently approved by the Food and Drug
      Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been
      available since 2006 and prevents shingles about 50% of the time, though it is less effective
      the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017,
      is not a live virus, but has an additive in the vaccine to boost immune response. It is about
      97% effective at preventing shingles regardless of a person's age and so far has been
      effective for at least 4 years after vaccination. Because Zostavax has live virus in it,
      giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have
      received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn
      more about how the body works to prevent shingles and how any shingles vaccination helps
      protect against shingles.
    


Intervention name(s): Zostavax; Shingrix
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal injection of Zostavax; Given to subjects in Arm 4 who've never had a herpes zoster vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: immunology
A Phase I Study of Oral UE2343 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomised, double-blind, placebo-controlled, phase I study in healthy subjects. Safety,
      pharmacokinetic and pharmacodynamic data will be collected.
    


Intervention name(s): UE2343; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Safety
Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection
Condition: Filarial; Infestation
MeSH terms: Parasitic Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Diethylcarbamazine (DEC) essentially a micro-filaricidal drug is given for 12 days as
      standard treatment for the clearance of W. bancrofti infection. It takes about one year for
      the individuals to completely clear the microfilaria from the blood. It takes another two to
      four years to clear the antigen. The aim of the present study is to shorten the time taken
      for clearing the Mf and antigen from the blood either by co-administration or sequential
      administration of a macrofilaricidal drug, Albendazole or doxycycline. This study is a
      randomized, double blind, controlled clinical trial to study the efficacy of these drug
      combinations in complete clearance the Mf and antigen from the blood in shorter span of 180
      days and 365 days respectively.
    

Detailed description: 
      Purpose:

      Lymphatic dwelling parasite W. bancrofti is the most common cause of secondary lymphoedema.
      Till today, there is no effective treatment protocol for the complete clearance of W.
      bancrofti infection, in a short duration of time.

      Methods:

      The investigators conducted a double blind RCT under field conditions recruiting 146
      asymptomatic W. bancrofti infected individuals. Participants were randomly assigned one of
      the four regimens for 12 days, DEC 300 mg + Doxycycline 100 mg co-administration or DEC 300
      mg + Albendazole 400 mg co-administration or DEC 300 mg + Albendazole 400 mg sequential
      administration or control regimen DEC 300 mg. Participants were followed up at 13, 26 and 52
      weeks post-treatment for the clearance of infection.
    

Intervention name(s): Diethylcarbamazine; Albendazole; Doxycycline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Diethylcarbamazine 300 mg tablet as single dose per day for 12 days; Experimental; Experimental
Other intervention name(s): DEC; Alb; Doxy
Intervention MeSH terms: Doxycycline; Albendazole; Diethylcarbamazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lymphatic filariasis; W. bancrofti; DEC; Albendazole; Doxycycline
Eating Disorders Genetics Initiative
Condition: Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder
MeSH terms: Anorexia; Bulimia; Feeding and Eating Disorders; Anorexia Nervosa; Binge-Eating Disorder; Bulimia Nervosa
Study type: Observational

Summary: 
      The overarching intention of the Eating Disorder Genetics Initiative (EDGI) is to lay the
      foundation for all future genomic discovery in eating disorders--anorexia nervosa (AN),
      bulimia nervosa (BN), and binge-eating disorder (BED)--by exploring both genetic and
      behavioral factors. To do this, information will be collected from 4000 people who have
      provided DNA samples for the Anorexia Nervosa Genetics Initiative (ANGI) and the same
      information and DNA will be collected from an additional 16,000 people. The goal is to better
      understand eating disorders and how they relate to each other so that better treatments can
      be developed.
    


Intervention name(s): Eating disorder diagnosis group
Intervention type(s): Other
Intervention description(s): This is an observational study, no active intervention is applied. Participants are assigned to an eating disorder diagnosis group based on their lifetime history of disordered eating behaviors and symptoms.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Interested individuals from the United States, Australia, and New Zealand who meet criteria
        may participate within their respective country.
      
Biospecimen description: 
      Participants from the United States, Australia, and New Zealand will be asked to submit a
      saliva sample using standard industry collection tubes. DNA will be isolated from these
      samples.

      DNA will be isolated from blood spots obtained at birth from participants in Denmark.
    
Keywords: Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder
Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine the safety of using a combination of minimally
      invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES
      arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE
      intention to treat subjects represent the hypothesized test group. The ICES cohort is to be
      analyzed separately.
    

Detailed description: 
      The purpose of this trial is to determine the safety of using a combination of minimally
      invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The
      procedure is to use image-based surgery (MRI or CT) to provide catheter access to ICH for the
      intervention, which is a one-time clot aspiration followed by instillation of rt-PA over 72
      hours.

      The Intraoperative stereotactic CT-guided Endoscopic Surgery (ICES) arm of the trial will
      determine the safety, feasibility and effectiveness of endoscopic surgery to remove ICH. This
      tests the first step of the MISTIE surgical procedure with an endoscope, not a rigid cannula.

      We propose to test if these interventions facilitate more rapid and complete recovery of
      function and decreased mortality from this condition compared to conventional medical
      management without subjecting the patient to craniotomy. The specific objective of this trial
      is to test the safety of these interventions and assess their ability to remove blood clot
      from brain tissue.
    

Intervention name(s): MIS+Cathflo Activase (drug); Intraoperative stereotactic CT-Guided Endoscopic Surgery
Intervention type(s): Drug; Procedure
Intervention description(s): MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.; Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting arm as MISTIE arm. No rt-PA administered, and in addition to best medical care.
Other intervention name(s): rtPA
Intervention MeSH terms: Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity
      disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be
      randomized to one of two groups: stimulant medication administered on the day of surgery or
      stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology
      will be at the discretion of the attending anesthesiologist, but the endpoint will be a
      bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia.
      Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and
      the incidence of hypotension, bradycardia, or administration of medications will be compared
      between the two groups.
    


Intervention name(s): Amphetamine and/or methylphenidate; Hold stimulant medication
Intervention type(s): Drug; Other
Intervention description(s): Patients who took their stimulant medication the day of surgery.; Patients who held their stimulant medication the day of surgery.
Intervention MeSH terms: Methylphenidate; Amphetamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in
      different dose regimens for the treatment of patients with plaque psoriasis
    


Intervention name(s): IBI112 dose 2; IBI112 dose 4; IBI112 dose 1; IBI112 dose 3; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive placebo or dose 2 IBI112 SC; Participants will receive placebo or dose 4 IBI112 SC; Participants will receive placebo or dose 1 IBI112 SC; Participants will receive placebo or dose 3 IBI112 SC; Participants will receive placebo SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Brain Stimulation for Traumatic Brain Injury
Condition: Traumatic Brain Injury; Diffuse Axonal Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Diffuse Axonal Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether repetitive Transcranial Magnetic
      Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse
      axonal injury(DAI) after Traumatic Brain Injury(TBI).
    


Intervention name(s): Active Coil; Sham
Intervention type(s): Other; Other
Intervention description(s): The patients will undergo 10 sessions (2,000 pulses each, lasting 20 minutes) of repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex with the following parameters: 10Hz, 50 trains (40 pulses on each train), biphasic wave, 25 seconds between the trains.; The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: traumatic brain injury; diffuse axonal injury; repetitive transcranial magnetic stimulation; neuromodulation; cognitive rehabilitation
LIraglutide and Beta-cell RepAir (LIBRA) Study
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive
      deterioration in the function of the pancreatic beta-cells, which are the cells that produce
      and secrete insulin (the hormone primarily responsible for the handling of glucose in the
      body). We propose a double-blind, randomized controlled study comparing the effect of
      liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo,
      on the preservation of beta-cell function over one year in patients with T2DM. This study may
      demonstrate an important beta-cell protective capacity of liraglutide.
    

Detailed description: 
      In this study, patients with type 2 diabetes who meet randomization criteria will be
      randomized to either liraglutide or placebo, with serial assessment of beta-cell function
      over 48 weeks follow-up. The hypothesis under study is whether liraglutide can preserve
      beta-cell function.
    

Intervention name(s): Liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide administered as once daily sc injection; placebo administered as once daily sc injection
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: beta-cell function; GLP-1 analogue; diabetes
An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra
      (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who
      completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical
      response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra
      8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
    


Intervention name(s): tocilizumab [RoActemra/Actemra]
Intervention type(s): Drug
Intervention description(s): 8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks
Masking: None (Open Label)
Primary purpose: Treatment
For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better?
Condition: Intubation; Video Rigid Stylet
MeSH terms: Muscle Rigidity
Study type: Interventional

Summary: 
      To determine which nostril is more suitable for nasotracheal intubation with video rigid
      stylet.
    

Detailed description: 
      Head and neck surgeries usually require nasal intubation, which allows leeway for operative
      maneuvering in the mouth, pharynx, larynx, and neck. Previous studies have found that the
      right nostril is more appropriate for nasal intubation using direct laryngoscope or
      videolaryngoscope. It has been shown that the optical rigid stylet was also an appropriate
      tool for nasal intubation. However, nasal intubation with rigid optical stylet is technically
      different from that with laryngoscope. It is unknown whether the choice of nostril could
      affect the intubation using rigid optical stylet. The main aim is to determine which nostril
      is more suitable for nasal intubation with video rigid stylet.
    

Intervention name(s): Video rigid stylet
Intervention type(s): Device
Intervention description(s): Nasal intubation was performed using the video rigid stylet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Nasotracheal intubation; Nostril; Video rigid laryngoscope
A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find biological response patterns of patients with rheumatoid
      arthritis to drugs with different biologic modes of action. This study should help to predict
      therapeutic responses and to find the right therapy for the right patient.
    

Detailed description: 
      The investigators propose a randomised, multi-centre strategic biomarker trial of rheumatoid
      arthritis (RA) patients with failure to methotrexate or leflunomide to one of the four
      current biological modes of action: targeting TNF (infliximab); co-stimulation (abatacept);
      IL-6R (tocilizumab); and B cells (rituximab); all agents are licensed for RA and have
      evidence for efficacy in this indication. Predictors of response to therapy after 24 weeks
      will be analysed, and include baseline and follow up assessments of clinical, functional,
      structural, laboratory tests (routine, autoantibodies, cytokines, gene expression, and
      susceptibility genes). In a second phase, patients not achieving LDA/REM will be randomised
      to one of the remaining MoA. Two hundred patients, who are started on a new biological
      therapy will be enrolled over an estimated period of 5 years; 50 patients per group will be
      included, and studied for a period of 12 months.
    

Intervention name(s): Remicade; Orencia; Ro-Actemra; Mabthera
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): - Infliximab (Remicade®) will be administered i.v. at a dose of 3 mg/kg at 0 and 2 weeks, and 5 mg/kg at weeks 6, 14, and 22, 30, 38, and 46.; - Abatacept (Orencia®) will be given i.v. at weeks 0, 2, 4, and then every 4 weeks until week 48 at a weight adjusted dose: <60 kg Body weight (BW): 500 mg; >60-100 kg BW: 750 mg; alternatively, based on preference and shared decision between patient and physician, patients randomized to the abatacept arm may receive s.c. application at a dose of 125mg weekly.; - Tocilizumab (Ro-Actemra®) will be administered every 4 weeks at a dose of 8 mg/kg BW (maximum dose of 800 mg); The employed dosage will be calculated using manufacturer guidelines; alternatively, based on preference and shared decision between patient and physician, patients randomized to the tocilizumab arm may receive s.c. application at a dose of 162mg every week.; - Rituximab (Mabthera®) will be given as 1000mg at weeks 0 and 2, and then repeated at weeks 24 and 26.
Patients will receive 100 mg methylprednisolon i.v. before each infusion, as well as 1000mg paracetamol, as well as 50mg diphenhydramine hydrochloride (Dibondrin©).
Intervention MeSH terms: Infliximab; Rituximab; Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Biologic therapies; Biomarker; Mode of Action
Determination of Grass Pollen Allergen Concentration Inducing Rhinoconjunctivitis Symptoms in Subjects Allergic to Grass Pollen in ALYATEC Allergen Exposure Chamber
Condition: Allergic Rhinitis Due to Grass Pollen
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The aim of this study is to determine the optimal concentration of grass pollen allergens
      inducing rhinoconjunctivitis in subjects allergic to grass pollen in ALYATEC allergen
      exposure chamber.

      Four concentrations of grass pollen allergen (Phl p 5) are tested during 3-hour exposures: 0,
      30, 60 and 90 ng/m3.
    


Intervention name(s): Grass Pollen Allergen Exposure
Intervention type(s): Other
Intervention description(s): After the screening visit, subjects are randomized into 3 groups presenting a sequence of allergen concentrations with randomly defined concentrations of Ph l p 5 (0, 30, 60 and 90 ng/m3).
Each participant undergo four different 3-hour exposure sessions to grass pollen allergen corresponding to the four different allergen concentrations.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, randomized, crossover, double-blind, controlled study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Allergy; Rhinitis; Pollen