bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary immunogenicity objective is to assess and compare the immunogenicity of one dose
      of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured
      by the percentage of subjects with serum bactericidal titers directed against N. meningitidis
      serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).
    


Intervention name(s): MenACWY-CRM197 (two doses); MenC; PCV7; DTPa-IPV-HepB-Hib; MenACWY-CRM197 (one dose)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.; One 0.5mL dose of MenC vaccine was administered by intramuscular injection.; One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.; One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.; One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Toddlers; Infants; Concomitant Vaccination
Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy
      and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment
      of acute schizophrenic patients. The eligible patient will be assigned to study treatment
      with Quetiapine XR on Day 1.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine Fumarate XR
Intervention type(s): Drug
Intervention description(s): oral, once daily, flexible dose
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute schizophrenia; PANSS
Impact of Hypoglycaemia in Patients With Diabetes Mellitus Type 2 on Platelet Activation
Condition: Diabetes Mellitus With Hypoglycemia; Diabetes Mellitus, Type 2; Hypoglycemia; Hypoglycemic Episode
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Interventional

Summary: 
      This experimental study is planned to investigate the impact of hypoglycaemia on platelet
      activation parameters (PAP) during a hyperinsulinaemic hypoglycaemic clamp study. The
      hypothesis that hypoglycaemia in patients with Diabetes Mellitus, Type 2 (T2DM) leads to
      increased platelet activation will be tested.
    

Detailed description: 
      Increased platelet activation is significantly involved in the pathophysiology of micro- and
      macrovascular diabetic complications. Previously performed studies suggested platelet
      activation in both, hyper- and hypoglycaemic states, leading to a potentially increased risk
      for thromboembolic complications. Hypoglycaemia, in particular severe hypoglycaemic episodes,
      has been associated with increased cardiovascular or overall mortality in previous studies.
      Potential mechanisms include arrhythmias or increased risk for thromboembolism, based on
      platelet activation and/or hypercoagulability.

      The aim of this experimental study is to investigate the impact of hypoglycaemia on platelet
      activation parameters (PAP) during a hyperinsulinaemic hypoglycaemic clamp study. We
      hypothesize that Hypoglycaemia in patients with T2DM leads to increased platelet activation.

      The primary objective is to investigate platelet activation during different levels of
      hypoglycaemia induced by a stepwise hyperinsulinaemic, hypoglycemic clamp experiment in
      patients with T2DM.

      Active study duration will be 5 days for each study participant. 14 subjects with T2DM
      without history of cardiovascular events or manifest atherosclerosis will be enrolled. During
      this monocentric, single arm, open, mechanistic trial platelet activation and recovery at one
      week after the clamp experiment, changes of pro-atherothrombotic markers during the
      hypoglycaemic clamp as well as counter regulatory hormone response during the clamp will be
      investigated.
    

Intervention name(s): Euglycaemic Clamp; Hyperinsulinaemic/Hypoglycaemic Clamp
Intervention type(s): Other; Other
Intervention description(s): All 14 subjects will undergo an euglycaemic clamp at Visit 2 with a plasma Glucose target of 5.5 mmol/L +/- 10% (4 timepoints for platelet activity parameter blood sampling); All 14 subjects will undergo a hypoglycaemic/hyperinsulinaemic clamp at Visit 3 with 4 timepoints for platelet activity Parameter blood sampling 30 minutes after reaching certain plasma glucose plateaus (5.5 mmol/L; 3.5 mmol/L; 2.5 mmol/L; after recovery again at 5.5 mmol/L)
Intervention MeSH terms: Hypoglycemic Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hypoglycaemia; Platelet activity; Type 2 diabetes mellitus
Utility of Ultrasonography During Internal Jugular Vein Catheterisation in Pediatric Patients
Condition: Number of Trials; Complication Rate
Study type: Observational

Summary: 
      Central venous access may be essential in pediatric patients for fluid and a blood product
      administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic
      monitoring. Obtaining central venous access in pediatric patients can be challenging, failure
      rates in pediatric patients range from 5% to 19% with reported complication rates from 2,5%
      to 22% The landmark technique has been standard approach for many years. In comparison with
      landmark method in pediatric patients the use of ultrasound is associated with an increased
      success rate decreased operative time, reduced number of cannulation attempts , and a
      decreased number of carotid artery punctures. We wanted to evaluate our success rate using
      ultrasound as a guidance during central vein insertion.
    


Intervention name(s): internal jugular vein catheter placement
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric patients aged more than 1 month
Warm Patch Decrease Propofol Injection Pain
Condition: Pain Syndrome; Propofol Infusion Syndrome; Injection Site Irritation
MeSH terms: Syndrome; Propofol Infusion Syndrome
Study type: Interventional

Summary: 
      Propofol causes injection pain is still a common clinical unsolved problem. Mixing a small
      amount of lidocaine with propofol or injecting lidocaine in advance can reduce the pain
      caused by propofol injection. Using an air warmer to warm the arm can also reduce the pain
      caused by propofol injection. Investors suspect that treatment with a warming patch (covering
      the injection site) can also reduce the pain caused by propofol injection.
    

Detailed description: 
      This is a single-center randomized controlled clinical study. Purpose of this study is to
      explore whether the coverage of the warming patch (for 5min before injection) can reduce the
      pain induced by propofol injection.

      The patients included in the study were randomly divided into two groups. The group W used a
      warming patch to cover the injection site, and the group C used a cotton pad to cover the
      injection site. After 5 minutes of coverage, the propofol injection was induced, and the
      patient's complaint of pain (calling or arm withdrawal) during propofol injection was
      observed, and the patient's recall of the pain score during induction after the patient
      recovered. After the patients regained consciousness, the data of the two groups were
      compared to determine whether the use of the warming patch could reduce the pain caused by
      propofol injection.
    

Intervention name(s): Warming patch; Cotton patch
Intervention type(s): Device; Device
Intervention description(s): The warming patch can increase the temp of injection site, result in a blood vessels to dilate, which may have some contribute to decreasing injection pain.; The Cotton patch will cover the injection site as placebo. It dose not have the function of heating comparing to Warming patch.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group W : the injection site was covered with warm patch. Group C: the injection site was covered with Cotton patch.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: propofol,injection,pain
Sedation MRI - Propofol Versus Propofol-Ketamin in Children
Condition: Sedation
Study type: Interventional
Phase: Phase 3

Summary: 
      Children < 10 years of age often need deep sedation or anaesthesia to allow elective
      diagnostic magnetic resonance imaging; standard routine protocols are

        1. propofol induction without other sedative (Propofol much as needed) or hypnotic drugs
           and propofol infusion 10 mg/kg h

        2. propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed)
           and propofol infusion 5 mg / kg h

      both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI,
      cerebral perfusion/blood flow.

      Hypothesis:

        1. reduces recovery time compared to propofol mono sedation

        2. combination of ketamine-propofol increases incidence of Postoperative nausea and
           vomiting (PONV) compared to propofol mono sedation

        3. combination of ketamine-propofol increases global cerebral blood flow and changes
           regional distribution of cerebral perfusion compared to propofol mono sedation
    


Intervention name(s): Propofol; Ketamine-Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion; Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: deep sedation; propofol; ketamine; child; preschool child; infant; recovery and quality of sedation
Atopy Patch Test in Normal Population : Pilot Study
Condition: Normal
Study type: Interventional
Phase: Phase 1

Summary: 
      Atopy patch test in normal population
    

Detailed description: 
      The initial diagnostic work up of suspected food allergy includes patient's history, skin
      prick test (SPT), measurement of food specific immunoglobulin E (IgE) with serological
      assays, and more recently the atopy patch test. A positive SPT seems to reflect early
      reactions to food challenges, whereas the atopy patch test has a high diagnostic efficacy for
      late phase clinical reactions. The purpose of this study was to evaluate atopy patch test
      reaction in non-atopic population.
    

Intervention name(s): Atopy patch test with food allergen
Intervention type(s): Device
Intervention description(s): Atopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate reaction one day later(72 hrs after applying atopy patch test)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Atopy patch test
TD-6450 MAD Study in HCV Infected Subjects
Condition: Hepatitis C; HCV
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This proof of concept study is designed to evaluate the safety, tolerability,
      pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1,
      GT-2 or GT-3 chronic HCV.
    


Intervention name(s): TD-6450; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV
Preoperative Gabapentine for Carpal Tunnel
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the postoperative analgesic effect of preoperative
      gabapentine for carpal tunnel syndrome surgery.
    

Detailed description: 
      There was studied 40 patients. Group 1 patients received 600 mg of gabapentin 1 hour before
      surgery; G2 received placebo 1 hour before surgery.

      Anesthesia was regional intravenous block. Postoperative analgesia when needed was with
      acetaminophen. If needed was administered codeine. The evaluation of neuropathic pain was
      made by DN4 questionnaire. Pain intensity was assessed by numeric scale at block and after
      30min, 1h, 2h, 2wk, 4wk, 6m. It was noted the duration of analgesia, and the amount of
      acetaminophen and codeine.

      The statistical program used for analysis of the results was the Instat Graph
    

Intervention name(s): Gabapentine; Sugar pill
Intervention type(s): Drug; Other
Intervention description(s): Gabapentine 600 mg 01 dose; Sugar pill 01 dose
Other intervention name(s): Anticonvulsant
Intervention MeSH terms: Gabapentin; Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gabapentine; postoperative pain
Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis
Condition: Uncomplicated Diverticulitis
MeSH terms: Diverticulitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is to compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs.
      Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo in patients with acute uncomplicated
      diverticulitis.
    


Intervention name(s): Rifamycin SV-MMX® 400 mg b.i.d.; Rifamycin SV-MMX® 600 mg t.i.d.; Rifamycin SV-MMX® Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rifamycins; Rifamycin SV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the long-term safety of MTS in the symptomatic treatment of children
      aged 6-12 diagnosed with ADHD
    

Detailed description: 
      Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3
      main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the
      long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with
      ADHD
    

Intervention name(s): Methylphenidate Transdermal System
Intervention type(s): Drug
Intervention description(s): MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Other intervention name(s): MTS
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Condition: Idiopathic Hypersomnia
MeSH terms: Disorders of Excessive Somnolence; Idiopathic Hypersomnia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution
      being developed as a low sodium alternative product for Xyrem.
    


Intervention name(s): JZP-258; Placebo Oral Solution
Intervention type(s): Drug; Drug
Intervention description(s): Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period.; Participants randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to investigate the effect of addition of different doses of Ketamine
      locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the
      probability of developing chronic post-mastectomy pain.
    


Intervention name(s): group (A); group (B); group (c)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % ) and irrigated onto surgical field after hemostats and before skin closure.; patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.; patients will receive 3 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
Condition: Tobacco Use Disorder; Schizophrenia
MeSH terms: Tobacco Use Disorder; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to investigate the relative contributions of nicotine
      replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on
      abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms,
      cognitive task performance and 90-min ad libitum usual-brand smoking behavior in smokers with
      schizophrenia and non-psychiatric smokers.
    

Detailed description: 
      This study used a mixed between- and within-subjects design to investigate the separate and
      combined effects of sensorimotor replacement for smoking (very low nicotine content [VLNC]
      cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine [NIC] vs.
      placebo [PLA] patches) in smokers with schizophrenia and control smokers without psychiatric
      illness. Each session contained a 5-h controlled administration period in which participants
      underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no
      cigarettes + NIC, no cigarettes + PLA, Usual Brand cigarettes + no patches. Next,
      participants completed measures of cigarette craving, nicotine withdrawal, smoking habit
      withdrawal, cigarette subjective effects, psychiatric symptoms and cognitive task performance
      followed by a 90-min period of ad libitum usual-brand smoking.
    

Intervention name(s): sensorimotor replacement; 42 mg transdermal nicotine replacement; Placebo transdermal nicotine; usual brand smoking
Intervention type(s): Behavioral; Drug; Drug; Other
Intervention description(s): denicotinized cigarettes; 2 21-mg nicotine patches; 2 placebo patches matched to 21-mg nicotine patches; participant smokes usual brand of cigarette
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Within-subjects design study that investigated the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content [VLNC] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine [NIC] vs. placebo [PLA] patches). Participants were smokers with schizophrenia and equally-heavy smokers without psychiatric disorders. Each participant underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, usual-brand cigarettes + no patches.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: nicotine; craving; dual-diagnosis; comorbidity
A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study aims at investigating whether bilateral movement-based training with computer
      games could augment motor function of paretic upper limb and improve quality of life in
      sub-acute stroke patients.
    


Intervention name(s): Bilateral movement-based computer training; Video-directed conventional training
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: stratified, single-blinded, intervention and controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; upper limb; motor control; function; bilateral movement; virtual reality