bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Pneumococcal Vaccine Formulations in Young Adults
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of
      pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of
      two months.
    

Detailed description: 
      This amendment was due to

        -  The addition of secondary endpoints for safety. The collection of data related to these
           secondary safety endpoints was already planned and the corresponding statistical
           analyses were described in the statistical section.

        -  The addition of an exclusion criterion regarding the administration of immunoglobulins
           and blood products. It is already included in the elimination criteria section. It
           impacts only immunogenicity.
    

Intervention name(s): Pneumococcal vaccine GSK2189242A; Pneumo 23™
Intervention type(s): Biological; Biological
Intervention description(s): Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested; One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Young adults; Pneumococcal vaccine,; Streptococcus pneumoniae,
Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction
Condition: Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD
      assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years
      undergoing hip surgery under spinal anaesthesia.
    

Detailed description: 
      Postoperative cognitive dysfunction (POCD) is a common postoperative neurological
      complication in elderly. POCD is a subtle impairment of memory, concentration and information
      processing with clinical manifestations of delirium, anxiety, personality changes and
      impaired memory, which is associated with prolonged hospitalization, a reduced quality of
      life and an increase in morbidity and mortality. Dexmedetomidine is a highly selective α-2
      adrenergic receptor agonist with a dose-dependent sedative hypnotic effect. It has also been
      reported that dexmedetomidine has a potential role in preventing POCD due to its
      neuroprotective effects both in vitro and in vivo.

      Till date very few studies have analysed the impact of dexmedetomidine on early POCD. Even in
      the few available studies compared assessment of POCD using the Mini-Mental State Examination
      (MMSE) scores and found that MMSE have lower sensitivity for identifying Cognitive
      Dysfunction as compared to Montreal Cognitive Assessment (MoCA). The study would analyze the
      impact of Intraoperative Dexmedetomidine infusion on early Postoperative Cognitive
      Dysfunction (POCD) in geriatric patients above 60 years undergoing hip surgery under spinal
      anesthesia.

      So this study will aim to identify the impact of Intraoperative dexmedetomidine infusion on
      POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60
      years undergoing hip surgery under spinal anaesthesia.
    

Intervention name(s): Dexmedetomidine Injection
Intervention type(s): Drug
Intervention description(s): Dexmedetomidine Injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
Other intervention name(s): Normal Saline as placebo
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Desflurane and Anesthesia Recovery Period in Endonasal Endoscopic Pituitary Adenoma Resection
Condition: Pituitary Neoplasms
MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases
Study type: Interventional

Summary: 
      Nasal packing is required after endoscopic pituitary adenoma resection. The patient can only
      breathe through the mouth. The blood and secretion in the nasal cavity may be inhaled into
      the trachea after the operation. GH-secreting pituitary adenoma causes pharyngeal soft tissue
      and tongue hypertrophy. These conditions increase the risk of respiratory obstruction and
      hypoxemia during anesthesia recovery. Propofol total intravenous anesthesia has a rapid
      effect and a low incidence of nausea and vomiting. Patients anesthetized with desflurane
      recover quickly is conducive to early recovery of respiratory function and orientation. This
      study intends to compare the effects of desflurane and propofol on the quality of anesthesia
      recovery period in patients undergoing endonasal endoscopic pituitary adenoma resection and
      to provide clinical evidence for the use of desflurane in neurosurgical anesthesia.
    


Intervention name(s): Desflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): After induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and 0.05-0.3 μg/kg/min remifentanil.; After induction, anesthesia will be maintained with 4-6mg/kg/h propofol and 0.05- 0.3 μg/kg/min remifentanil.
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Bioequivalence Study of an Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil 2% Oral Solution
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover
      design study in adult male and female healthy participants. Eligible participants will
      receive either treatment A (reference): Fluimucil® Acetylcysteine 2% oral solution, 200 mg N-
      acetylcysteine (NAC) in 10 mL dose, or treatment B (test): Acetylcysteine 2% oral solution,
      200 mg NAC in 10 mL dose. Blood sampling will be collected pre-dose and up to 48 hours in
      each period. After completion of the second study period (i.e. last pharmacokinetic (PK)
      sample on Day 3 of Period 2) participants will be discharged from the clinic.
    


Intervention name(s): Fluimucil® 2% solution; Acetylcysteine 2% solution
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference).; Participants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test)
Intervention MeSH terms: Acetylcysteine; Pharmaceutical Solutions; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension
Condition: Fracture, Closed, Comminuted, Healing
MeSH terms: Fractures, Bone; Fractures, Closed
Study type: Observational

Summary: 
      Treatment of lateral fractures of the clavicle is challenging and has been controversially
      discussed for a long time due to high non-union rates in non-operative treatment and high
      complication rates in surgical treatment. A recently developed implant was proven to ensure a
      biomechanically sufficient fixation of fractures leading to bony union and promising
      functional outcome in a small collective of patients.
    

Detailed description: 
      Treatment of lateral fractures of the clavicle is challenging and has been controversially
      discussed for a long time due to high non-union rates in non-operative treatment and high
      complication rates in surgical treatment. A recently developed implant was proven to ensure a
      biomechanically sufficient fixation of fractures leading to bony union and promising
      functional outcome in a small collective of patients.

      In this prospective study patients with dislocated fractures of the lateral clavicle
      (Jäger&Breitner I-III, Neer I-III) are enrolled. All patients are surgically treated using
      the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional
      outcome is recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative
      self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the
      Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint
      stability is evaluated using the Taft-Score.
    

Intervention name(s): Plate osteosynthesis
Intervention type(s): Procedure
Intervention description(s): Plate osteosynthesis using LCP plate (Synthes)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from a dislocated fracture of the lateral clavicle presenting at our
        emergency department.
A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
Condition: Dyslipidemias; Hypertension
MeSH terms: Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
    

Detailed description: 
      An open-label, randomized, multiple-dose crossover study to investigate drug interaction
      between D326, D337, and D013 in healthy male subjects
    

Intervention name(s): D013, D326 and D337; D013; D326 and D337
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days; Daily oral administration of 1 tablet under fasting conditions for 7 days; Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
Other intervention name(s): CKD-386 Test; CKD-386 Reference1; CKD-386 Reference2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyslipidemia; Hypertension; CKD-386; Drug-Drug Interaction
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy
Condition: Ovarian Cancer Stage IV; Lymph Node Metastases
MeSH terms: Neoplasm Metastasis; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Lymphatic Metastasis
Study type: Observational

Summary: 
      To evaluate the survival impact of extensive lymphadenectomy as part of debulking surgery in
      stage IVB ovarian cancer with supradiaphragmatic lymph node metastasis.
    


Intervention name(s): debulking surgery
Intervention type(s): Procedure
Intervention description(s): debulking surgery as primary debulking surgery or interval debulking surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients underwent treatment at University Hospital.
      
Keywords: internal mammary lymph node; supraclavicular lymph node; cardiophrenic lymph node
Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee
Condition: Articular Cartilage Defect
MeSH terms: Cartilage Diseases; Fractures, Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to demonstrate superior efficacy and safety of MACI compared
      with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with
      symptomatic articular cartilage defects of the knee.
    

Detailed description: 
      This is a prospective, randomized, open-label, parallel-group, multicenter study designed to
      investigate the outcome of MACI implant versus arthroscopic microfracture in the treatment of
      articular cartilage defects in the knee in patients between ages of 18 and 55 years.

      All patients who meet the eligibility criteria and are considered suitable for inclusion will
      have a cartilage biopsy taken prior to randomization to study treatment. Eligible patients
      will then be randomized during the index arthroscopy procedure to receive either MACI implant
      or microfracture treatment.

      Patients randomized to treatment with MACI implant will return within approximately 4 to 8
      weeks of the index arthroscopy to undergo the chondrocyte implantation procedure via
      arthrotomy. Patients randomized to microfracture will undergo the procedure during the index
      arthroscopy.

      Patients will be assessed post-arthroscopy and post-arthrotomy at intervals during 2 years
      follow-up. Evaluations include adverse events, functional and pain outcomes, arthroscopic and
      histologic evaluation and magnetic resonance imaging (MRI).
    

Intervention name(s): autologous cultured chondrocytes on porcine collagen membrane; Microfracture
Intervention type(s): Biological; Procedure
Intervention description(s): Implantation via mini-arthrotomy; Microfracture performed by arthroscopic surgery
Other intervention name(s): MACI; matrix-applied characterized autologous cultured chondrocytes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cartilage legions; symptomatic focal cartilage defects; microfracture; MACI; autologous chondrocyte
Predicting Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients
Condition: Heart Failures
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The ultimate goal is to improve our understanding of the pathophysiology and resistance to
      effective treatment of sleep disordered breathing in patients with heart failure, with a
      focus on selecting patients that will benefit specifically from acetazolamide treatment.

      The study addresses three primary hypotheses: 1) Acetazolamide treatment will reduce the
      apnea-hypopnea index and improve markers of heart-failure severity in heart-failure patients
      with sleep apnea. 2) Acetazolamide will provide the greatest improvement in patients with the
      most severe ventilatory control instability (strongest chemoreflex response to carbon
      dioxide; highest loop gain). 3) Acetazolamide will act primarily via stabilizing ventilatory
      control (reducing loop gain), rather than via improvement to upper airway anatomy, pulmonary
      congestion, and cardiac function.
    


Intervention name(s): Acetazolamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg/kg, once daily before bed, for 7 days; 4 mg/kg, once daily before bed, for 7 days
Other intervention name(s): Diamox
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia
Condition: Adverse Effect
MeSH terms: Pre-Eclampsia; Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy and safety of norepinephrine for
      prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia
      undergoing cesarean section.
    

Detailed description: 
      Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and
      neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with
      exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia
      are apparently higher than healthy parturients, placental hypoperfusion is more common.
      Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia
      for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous
      blood flow (provided that hypotension is avoided) which contribute to increase placental
      perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia
      hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a
      potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction
      for use in parturients undergoing cesarean section. But the efficacy and safety in
      parturients with preeclampsia is still unknown. The purpose of this study is to investigate
      the efficacy and safety of norepinephrine for prophylaxis against post-spinal anesthesia
      hypotension in parturients with preeclampsia undergoing cesarean section.
    

Intervention name(s): Phenylephrine; Norepinephrine
Intervention type(s): Drug; Drug
Intervention description(s): A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block; A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block
Other intervention name(s): Vasopressors; Vasopressors
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine; Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Norepinephrine; Postspinal anesthesia hypotension; Preeclampsia; Cesarean section
Telehealth BPT in DBP Practice
Condition: ADHD
Study type: Interventional

Summary: 
      Access to evidence-based psychosocial interventions, particularly Behavioral Parent Training
      (BPT), for youth with Attention Deficit/Hyperactivity Disorder (ADHD) is limited. An approach
      to increasing such access is to utilize trained paraprofessionals (Family Peer Advocates;
      FPAs) in the delivery of BPT, particularly through modalities, like telehealth, that further
      improve access and availability. This approach, FPA-delivered BPT via telehealth has yet to
      be studied. This study will evaluate the benefits of a FPA-delivered BPT for parents of
      children identified with ADHD in Developmental Behavioral Pediatric (DBPs).
    

Detailed description: 
      There are two aims of the study: Specific Aim 1: To determine the benefits of a FPA-delivered
      telehealth BPT model on children's ADHD symptoms, oppositional behavior, functional outcomes,
      parenting behavior and parental stress. Specific Aim 2: Understand the shared decision making
      process between the parent, physician, and FPA within the Pediatric- Family Peer Advocate
      (PEDS-FPA) model through qualitative interviews.
    

Intervention name(s): Behavioral Parent Training (BPT)
Intervention type(s): Behavioral
Intervention description(s): BPT is an evidence-based psychosocial intervention that is directed exclusively to parent of children with ADHD and related disorders. BPT focuses on instructing parents to use approaches to enhance the parent-child relationship (e.g., quality time, praise) and proactive discipline strategies (e.g., time out, reward systems) to reduce challenging child behavior.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol): ReSTIM
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Previous research that utilises single sessions of transcranial direct current stimulation
      (tDCS) have demonstrated functional improvements. However these improvements are usually
      short-lived, lasting less than one hour before the patient's performance returns to baseline.
      In these studies, tDCS is typically applied with the goal of adaptively enhancing functional
      activation of pathologically under-active tissue or suppressing pathologically over-active
      tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can
      improve learning/memory functions in healthy controls. The goal of this study is to test if
      the application of tDCS could enhance learning and/or memory for physiotherapy
      rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients
      at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions
      of tDCS.

      This research has important implications; previous studies suggest that such an approach has
      the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a
      clinically viable rehabilitative tool. Recovery of motor skills may take many months to
      acquire and therefore strategies that have the potential to enhance acquisition of skill are
      of practical and scientific interest.
    


Intervention name(s): anodal tDCS (device) Eldith DC-Stimulator; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): tDCS applied to the motor cortex every day of two consecutive weeks (10 sessions) at 1 mA during 20 minutes. Conductive rubber covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased over 100 seconds.; Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).
Other intervention name(s): Eldith DC-Stimulator (CE certified)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; transcranial direct current stimulation (tDCS); motor function