bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled
      study will evaluate the efficacy and safety of RO4602522 in participants with moderate
      severity Alzheimer's disease. Participants who are taking background therapy of
      acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4
      months before screening will be randomized to receive either one of two doses of RO4602522 or
      placebo for 12 months.
    


Intervention name(s): RO4602522; Placebo; Donepezil; Memantine; Rivastigmine; Galantamine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive RO4602522 orally once daily for 12 months.; Participants will receive placebo for RO4602522 orally once daily for 12 months.; Stable dose as background medication; Stable dose as background medication in combination with AChEIs; Stable dose as background medication; Stable dose as background medication
Intervention MeSH terms: Memantine; Rivastigmine; Donepezil; Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalency Study of Levetiracetam 1g Under Fasted 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 fasted 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
Age-Specific Strategies for Immunization Reminders and Recalls
Condition: Childhood Vaccination
Study type: Interventional

Summary: 
      The objective of this study was to assess the relative effectiveness of reminder/recall
      strategies among children who live in an urban area targeting alternative age-specific
      milestones.
    


Intervention name(s): Childhood vaccination reminder / recall notification
Intervention type(s): Behavioral
Other intervention name(s): Reminder / recall notifications sent by postal mail
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: immunization; vaccination; immunization information system; immunization registry; reminder / recall
Intranasal Steroids and the Nasal Ocular Response
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      Eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis
      or hayfever. The purpose of this study is to learn whether placing allergen (the substance
      that causes allergies) in the nose several days in a row will cause an increase in eye
      symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.
    


Intervention name(s): fluticasone furoate
Intervention type(s): Drug
Intervention description(s): corticosteroid nasal spray
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses
Condition: Skin Wrinkling
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the fields of anhydrotic effect (FAE) of
      abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units),
      comparing both sweat gland and muscle activity.
    

Detailed description: 
      This is a prospective, single-center, randomized, double-blind study. All participants were
      recruited from a research center in Porto Alegre, Brazil, and provided written informed
      consent. The purpose of this study is to assess the fields of anhydrotic effect (FAE) of
      abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units),
      comparing both sweat gland and muscle activities. Nineteen patients were enrolled and
      evaluations were performed at baseline and 28 days after treatment.
    

Intervention name(s): AbobotulinumtoxinA (ABO); OnabotulinumtoxinA (ONA)
Intervention type(s): Drug; Drug
Intervention description(s): Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.; Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.
Other intervention name(s): Dysport®; Botox®
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: wrinkles; botulinum toxin; abobotulinumtoxinA; onabotulinumtoxinA; field of anhydrotic effects
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114
      and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal
      disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when
      administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for
      pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits
      such as smoking or alcohol use, or 3) living in a community/environment with increased risk
      of disease transmission.
    


Intervention name(s): V114; Prevnar 13™; PNEUMOVAX™23
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose; 23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Other intervention name(s): PCV13; PPV23
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Active Management for Low Back Pain for 6 to 8 Year Old Schoolchildren
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The objective is to assess the effectiveness of a prevention campaign promoting active
      management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from
      a random sample of schools in Majorca, Spain: private, public and concerted. A 10 item
      questionnaire will be given to all children in that age group, to be answered in class on
      days 1, 14 and 97. Schools will be randomly assigned to the study and control groups. In the
      study group the students will get a Back Comic-Book (promotes active management) after the
      first assessment. The control group will have no other intervention than the questionnaire.
    


Intervention name(s): Education (Back Comic-Book)
Intervention type(s): Behavioral
Intervention description(s): Through the Back Comic-Book the schoolchildren are taught prevention methods for low back pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: low back pain; prevention; schoolchildren; education campaign
Predictability of Gestational Diabetes Mellitus in First and Second Trimester
Condition: Pregnancy; Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      The objective of the study is, if an early oral glucose tolerance test combined with maternal
      history, condition and multiple biomarker analysis can be used to detect gestational diabetes
      mellitus in the first trimester (12-14 weeks of gestation).
    

Detailed description: 
      It is the investigators' aim to prospectively examine an extended form of the current 1st
      trimester screening test for the detection of foetal aneuploidy, in order to ascertain
      whether this can also be used for the detection of patients at-risk for gestational diabetes
      mellitus. For this purpose the investigators will include a combination of new markers in a
      multiplex bio-array manner in conjunction with an early oral glucose tolerance test. A nested
      case-control proteomic analysis will be performed in a retrospective manner at the completion
      of this study in order to develop more specific biomarker panels.

      The primary outcome will be development of gestational diabetes mellitus in the second or
      third trimester.

      The secondary endpoints are the delivery outcome, neonatal morbidity, neonatal mortality,
      maternal morbidity and costs.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant Women
      
Biospecimen description: 
      Blood Saliva
    
Keywords: Oral Glucose Tolerance Test; Fibronectin; Adiponectin; Copeptin; Cortisol
Painful Procedures in the Emergency Department: A Distraction Intervention
Condition: Pediatric Pain and Anxiety
MeSH terms: Emergencies; Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the effectiveness of the video-based intervention over and
      above current standard practice for pain control in the pediatric emergency department (ED).
      This is a single-center trial based at the IWK Health Centre. The primary outcome will be
      based on the CAMPIS coding of the video-taped pain response of the research participants.
    

Detailed description: 
      The purpose of this study is to determine if the pain and anxiety that children experience
      when they have venipuncture procedures performed can be reduced by a video-based distraction
      and coping strategy intervention. An instructional video has been designed to educate parents
      and children about what is going to happen during the venipuncture procedure; to teach coping
      skills that can be used before and during the painful procedure; and to provide distraction
      during the procedure by using an entertaining video segment.

      Approximately 168 children (6-12 years of age)who are seen in the IWK ED requiring
      venipunctures for blood collection or IV starts will be randomized. PArent and child training
      in distraction and coping strategies will be provided by means of a self-administered
      video-delivery via a portable DVD player. Fifty percent of the eligible participants will
      receive the distraction and coping strategies intervention and 50% will receive the standard
      medical care provided by the IWK ED. Those receiving standard care will be evaluated for
      outcome results and then be compared to the intervention group. It is expected that children
      who receive the intervention will report less pain and anxiety associated with venipunctures
      than those who receive standard care.
    

Intervention name(s): PAT
Intervention type(s): Behavioral
Intervention description(s): Coping and Distraction Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric pain; Pediatric anxiety; Painful procedures
ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus (HCV)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and
      treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.
    


Intervention name(s): ombitasvir/paritaprevir/ritonavir and dasabuvir; Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet; Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
Other intervention name(s): Viekira Pak; paritaprevir also known as ABT-450; ombitasvir also known as ABT-267; dasabuvir also known as ABT-333
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HCV Infection; Chronic Hepatitis C Virus; Hepatitis C Virus (HCV) Genotype 1b
Infantile - Postoperative Residual Curarization - Study
Condition: Postoperative Residual Curarization; Neuromuscular Blockade; Neuromuscular Monitoring
MeSH terms: Delayed Emergence from Anesthesia
Study type: Observational [Patient Registry]

Summary: 
      The primary object of this study is, to investigate the current procedure of neuromuscular
      monitoring at a tertiary academic university medical center.
    

Detailed description: 
      Residual neuromuscular block is known to be a significant but frequently overlooked
      complication after the use of neuromuscular blocking agents. Aim of this prospective,
      observational study is to detect the incidence and severity of residual paralysis at a
      tertiary academic german university medical center.

      Methods:

      All infantile patients recieving neuromuscular blocking agents are included over a 12 week
      observational period. At the end of the operation procedure, directly prior to tracheal
      extubation a train-of-four ratio was assessed quantitatively by an independet observer using
      the TOF Watch SX monitor. Data related to patient postoperative outcome were collected in the
      operating theatre, during the way to the postoperative care unit (PACU) and during the stay
      in the PACU:

        -  incidence of residual paralysis

        -  incidence of aspiration, bronchospasm, laryngospasm, oxygen desaturation, airway
           obstruction,
    

Intervention name(s): Acceleromyography
Intervention type(s): Diagnostic Test
Intervention description(s): At the End of Surgery, shortly before Extubation, the TOF-Ratio is measured by an independent investigator using Acceleromyography.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children/youths between 1 Month to 18 years who are undergoing general anaesthesia with
        muscle relaxation due to surgical or diagnostical procedures.
The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration
Condition: Percutaneous Nephrolithotomy
Study type: Interventional
Phase: Phase 4

Summary: 
      Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the
      standard treatment for large and complex renal stones. Although it has lower complication and
      morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can
      cause distress for patients.

      Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation,
      which defeat the purpose of this minimally invasive procedure.

      Skin infiltration with bupivacaine around the nephrostomy tube is not effective. Infiltration
      of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting
      the role of renal capsule in pain management.

      Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy
      tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block
      offers the option of providing extendable perioperative pain relief without the above side
      effects or the physiologic derangement associated with local anesthetics in the central
      neuraxial space.

      The aim of this study is to determine whether ultrasound guided low thoracic paravertebral
      block effective post-operative analgesia as compared to peritubal infiltration analgesia in
      patients undergoing percutaneous nephrolithotomy.

      Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary
      endpoints are visual analogue pain scores, opioid related side effects.
    


Intervention name(s): Bupivacaine; Ultrasound
Intervention type(s): Drug; Device
Intervention description(s): 20 ml %0,25 bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Analgesia; Peritubal infiltration; Ultrasound guided low thoracic paravertebral block; Percutaneous Nephrolithotomy pain
Revaccination With Pollinex® Quattro
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex®
      Quattro as a short-term revaccination in patients who have already been successfully
      desensitized at least five years ago against grass-pollen but developed a recurrent allergy.
    

Detailed description: 
      The increasing prevalence of allergies represents a major problem for the health care system.
      Approximately 500 million people are suffering worldwide from allergic rhinitis (AR).
      Allergic rhinitis is a Type 1 hypersensitive disorder, initiated by IgE antibodies. Whereas
      seasonal allergic rhinitis (SAR) is caused by different allergens found outdoors such as
      grass, tree and weed pollen, perennial allergic rhinitis (PAR) is caused by allergens that
      are mainly found indoors such as dust mites, mould or animal hair.

      Specific immunotherapy (SIT) presently constitutes the only causal therapy available and is
      common practice. SIT is indicated in cases of IgE-mediated allergic diseases and includes two
      forms of treatment options: subcutaneous (SCIT) and sublingual immunotherapy (SLIT). Both
      therapies aim to train the immune system not react to supposed pathological allergens, but
      instead to develop tolerance to them.

      Even though allergy vaccinations have been applied for a century, the commonly used SCIT
      requires up to 90 injections over three to five years. Pollinex® Quattro is currently the
      only ultra-short term medicinal product which requires only four preseasonal injections. The
      immunological effect associated with Pollinex® Quattro shows an increase of allergen-specific
      IgG antibodies and a decrease of allergen-specific IgE antibodies as well as a shift from a
      Th2 to a more Th1 type-immune reaction. Previous studies on the therapeutic efficacy of
      Pollinex® Quattro have come to a positive conclusion in regards to tolerability and decrease
      of allergic symptoms. As an ultra-short course SCIT, Pollinex® Quattro might decrease the
      number of noncompliance and withdrawal for revaccination in patients that have already
      undergone an intensive immunisation therapy.

      In this non-interventional study, patients who were treated with Pollinex® Quattro and
      patients who decided to use anti-allergic drugs for the treatment of their grass pollen
      allergy were compared due to their allergic symptoms in the grass pollen season from May to
      July. For this purpose, the rhinoconjunctivitis and asthmatic symptoms as well as the use of
      concomitant medication were documented in a dia
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal
        allergic rhinitis (SAR) caused by grass pollen.
      
Keywords: Recurrent Grass Pollen Allergy; Pollinex® Quattro
Sarcosine or D-Serine Add-on Treatment for Chronic Schizophrenia
Condition: Schizophrenias; Psychoses; Psychotic Disorders; Schizophrenic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Both GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial
      for chronic schizophrenia patients.

      The purpose of this study is to compare efficacy and safety of add-on treatment of sarcosine,
      a GlyT-1 inhibitor, and D-serine, an NMDA-glycine site agonist, in chronically stable
      schizophrenia patients who have been stabilized with antipsychotics.
    

Detailed description: 
      The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive
      symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system
      hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the
      pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission has
      been regarded as a novel treatment approach. To date, there have been several reported trials
      on NMDA enhancers. Both sarcosine (N-methylglycine, a glycine transporter I inhibitor) and
      D-serine (a potent NMDA-glycine site agonist) showed therapeutic effects in chronically
      stable patients. Interestingly, sarcosine appeared more efficacious than D-serine in acutely
      exacerbated ones when added-on to antipsychotics. Both sarcosine and D-serine yielded
      excellent safety profiles.

      It remains unclear whether sarcosine can be also more efficacious than D-serine in the
      treatment for chronically stable schizophrenia. The aim of this project is to examine the
      efficacy and safety of add-on treatment of sarcosine vs. D-serine in chronically stable
      schizophrenia patients who have been stabilized with antipsychotics.

      In the study, 60-75 schizophrenic patients are recruited into the 6-week trial and randomly
      assigned into the three groups (2 gm/d sarcosine, 2 gm/d D-serine, or placebo) with a
      double-blind manner. Clinical manifestation (Positive and Negative Syndrome Scale [PANSS],
      side effects and quality of life (QOL) are evaluated every two weeks during the trial.. The
      efficacies of three groups are compared.
    

Intervention name(s): Sarcosine and D-serine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; sarcosine; D-serine; NMDA