bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a
      booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary
      vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and
      Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the
      long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.

      This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).
    


Intervention name(s): Meningococcal conjugate vaccine GSK134612
Intervention type(s): Biological
Intervention description(s): Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Booster; Healthy; Vaccine response; Safety; Neisseria meningiditis; Antibody persistence; Meningococcal conjugate vaccine
Intrathecal Fentanyle Versus Dexamethasone in Gynacological Laparoscopic Surgeries
Condition: Intraoperativ Pain
Study type: Interventional

Summary: 
      Laparoscopy was first introduced to the medical field of in the middle of the last century.
      It revolutionized the surgical interventions; it reduced the total medical expenditures and
      hastened postoperative recovery . General anaesthesia (GA) was considered the only anesthetic
      technique suitable for laparoscopic interventions, and several myths and facts prevented
      regional anaesthesia (RA) implementation. Respiratory and Cardiovascular impairment were the
      main aspects of concern which are thought to be best controlled by GA
    


Intervention name(s): intrathecal fentanyle; dexamethasone; saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mic fentanyle added to heavy bupivacaine for spinal anesthesia; 8 mg dexamethasone give intrathecally for spinal anaesthesia; normal saline will be mixed with bupivacaine intrathecally
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions
Condition: Healthy; Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker
      Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70
      -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in
      which the subject is moving. The end goal is to provide supporting documentation for the SpO2
      accuracy validation of the reprocessed sensors with motion indications.
    

Detailed description: 
      In this study, the level of oxygen within the blood will be reduced in a controlled manner by
      reducing the concentration of oxygen the study volunteer breathes. The accuracy of a
      noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation
      measurements from a laboratory blood gas analyzer.

      A machine will be used to induce motions of 20 mm during testing at a sine rate of 2Hz, 3Hz,
      and 4Hz. A third motion moves the arm a random distance of 0 to 30mm at a random speed up to
      5Hz.

      It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse
      oximetry sensors will meet a specification of +/-3% with a target of +/-3% or better in
      motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once
      with air breathing and then at three or six levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% or
      95%, 85% and 75% saturation for about 30-60 seconds or 60-90 seconds at each level), thereby
      demonstrating an acceptable SpO2 accuracy performance specification. This study should
      utilize a three level structure (95%, 85% and 75%).
    

Intervention name(s): Experimental Masimo RD SET SpO2 Adhesive Sensors
Intervention type(s): Device
Intervention description(s): Masimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult & Neonate (4003 Neo)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Kidney Function and Healthy Participants
Condition: Healthy; Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into
      the bloodstream and how long it takes the body to eliminate it in participants with impaired
      kidney function and healthy participants. The side effects and tolerability of pirtobrutinib
      will also be evaluated. Participation could last around 46 days.
    


Intervention name(s): Pirtobrutinib
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LOXO-305, LY3527727
Intervention MeSH terms: Pirtobrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Phase 1/2 Study to Evaluate MEDI4736
Condition: Advanced Solid Tumors
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multicenter, open-label, first-time-in-human study with a standard 3+3
      dose-escalation phase in participants with advanced solid tumors followed by an expansion
      phase in participants with advanced solid tumors. An exploration cohort has been added to
      determine the safety using every 4 weeks (Q4W) dosing.
    

Detailed description: 
      A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets
      programmed cell death ligand-1 (PD-L1)) will evaluate the safety, tolerability,
      pharmacokinetics (PK), immunogenicity (IM), and antitumor activity of MEDI4736 in adult
      participants with solid tumors. A dose exploration cohort will look at the safety profile of
      Q4W dosing of MEDI4736.
    

Intervention name(s): MEDI4736
Intervention type(s): Drug
Intervention description(s): Participants will receive IV infusion of MEDI4736 for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Other intervention name(s): Durvalumab
Intervention MeSH terms: Durvalumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced solid tumors
Evaluation of the Ulthera® System for Treatment of the Brachia
Condition: Brachial Ptosis
Study type: Interventional

Summary: 
      This study is an evaluation of the Ulthera® System used to treat the upper arms for
      improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm
      treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.
    

Detailed description: 
      This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study
      photographs of the upper arms will be taken prior to treatment, immediately post-treatment,
      and at each follow-up visit. Brachial volume and dermal thickness measurements will be
      obtained.
    

Intervention name(s): Ulthera® System
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin.
Other intervention name(s): Ultherapy™ treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ treatment; Ulthera, Inc.
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR
      with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how
      much of the drug is absorbed into the body.
    


Intervention name(s): Lisdexamfetamine Dimesylate; Adderall XR (mixed salts amphetamine)
Intervention type(s): Drug; Drug
Intervention description(s): 50mg capsule; 20mg capsule
Intervention MeSH terms: Amphetamine; Lisdexamfetamine Dimesylate; Adderall
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug; Interaction; Study
Epidural Waveforms: Pressure Transducer vs CompuFlo
Condition: Anesthesia
Study type: Interventional

Summary: 
      The purpose of this single arm, open label study will be to compare and evaluate the
      sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess
      the correct placement of the catheter in the epidural space when compared to the standard
      pressure transducer.
    

Detailed description: 
      40 patients who had an epidural functioning catheter previously positioned for anesthesia or
      analgesia will be enrolled. After removing the epidural filter and after having zeroed the
      instrument, the investigator will connect in a random fashion sequence, a standard pressure
      transducer attached to a standard invasive blood pressure monitor or to the CompuFlo
      CathCheck instrument to observe and record the occurrence of epidural pulsatile waveform.

      The investigator will also note and evaluate:

      The volume of saline priming necessary to obtain the waveform The effects of patient's
      position on the occurrence and amplitude of epidural pulsatile waveform
    

Intervention name(s): CompuFlo
Intervention type(s): Device
Intervention description(s): The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer
Other intervention name(s): Standard Pressure Transducer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Probing TBS-induced Neural Plasticity and Associated Effects on Learning
Condition: Healthy
Study type: Interventional

Summary: 
      Recent animal research indicates that excitatory brain stimulation opens a time window of
      increased neural plasticity that permits remodeling of neural representations. Repetitive
      transcranial magnetic stimulation (rTMS) may thus facilitate learning of new associations by
      reducing proactive interference but human research is missing. Therefore, it is the aim of
      this study to investigate the effects of intermittent theta-burst stimulation (iTBS), a
      potent form of excitatory brain stimulation, on associative memory. Twenty right handed
      healthy participants will receive 3 minutes of iTBS or sham stimulation of the left lateral
      parietal cortex after memorizing a set of 20 face-word associations. Recall capacity will be
      tested directly before and after stimulation. Participants will then learn a new combination
      of associations using the same set of stimuli, followed by an evaluation of their recall
      capacity. It is hypothesized that iTBS compared to sham stimulation will reduce recall
      capacity directly after the stimulation but increase recall capacity of the newly learned
      associations due to reduced proactive interference. This study may not only pave the way
      towards a new understanding of the mechanism of action of brain stimulation, but can also
      help in developing new treatment strategies for neuropsychiatric disorders.
    


Intervention name(s): Theta-burst stimulation
Intervention type(s): Device
Intervention description(s): iTBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz) as described previously (Huang, Edwards et al. 2005) and consists of 2-second trains with an inter-train-interval of 8 seconds. We will repeat trains (30 pulses; 10 bursts) for 20 times to reach a total number of 600 pulses per session (3x10x20)
Other intervention name(s): Transcranial Magnetic Stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: single-blind parallel-group crossover design
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
The Effect of Simvastatin With Guided Bone Regeneration in Ridge Splitting and Simultaneously Implantation
Condition: Ridge Splitting; Simvastatin; Immediate Implant
Study type: Interventional

Summary: 
      Ridge split augmentation technique, with immediate implant placement, reduces the time of the
      treatment and the time of the final prosthetic reconstruction. Furthermore, compression of
      the bone increases its density. SMV is also found to promote osteogenic differentiation of
      bone marrow stem cells, suppress osteoclastic differentiation in bone tissue, and promotes
      osseointegration around implants in animal studies. The aim of this study is to compare
      surgical outcomes of the application of the alveolar ridge splitting (ARS) in combination
      with guided bone regeneration (GBR) using bone grafting and a barrier membrane, associated
      with immediate implant placement versus ARS in combination with the use of SMV with GBR using
      bone grafting and a barrier membrane, associated with immediate implant placement in patients
      with horizontally atrophic jaw bones.
    


Intervention name(s): Immediate implant placement and ARS with GBR and SMV; Immediate implant placement and ARS with GBR
Intervention type(s): Procedure; Procedure
Intervention description(s): Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with SMV; Implant insertion and GBR for augmentation of the gap between buccal and lingual plate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Relative Potency of Inhaled Corticosteroids
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Asthma; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the validity of a clinical model to determine the relative potency of
      different preparations of inhaled corticosteroids used for the treatment of asthma or of
      eosinophilic bronchitis without asthma.
    


Intervention name(s): fluticasone 25, 50, 100, 200 mcg
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Eosinophilic bronchitis with asthma; Eosinophilic bronchitis without asthma
Motivationally-Enhanced Brief Interpersonal Psychotherapy for Depressed Mothers of Ill Children
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate the effectiveness of motivationally-enhanced brief interpersonal
      psychotherapy (MI-IPT-B) in treating depression in mothers who bring their children to a
      child mental health clinic for psychiatric treatment.
    

Detailed description: 
      Depression is a serious illness and is common in mothers who have children facing an illness.
      Research has shown that these mothers, in particular, need better coping skills and ways to
      relieve depressive symptoms. Helping mothers of ill children achieve better mental health may
      also be beneficial to their children. Studies have shown that psychotherapy is an effective
      treatment for depression, and often results in long-term improvements in depressive symptoms.
      This study will investigate the effectiveness of MI-IPT-B in treating depression in mothers
      who bring their children to a child mental health clinic for psychiatric treatment.

      Participants in this open label study will be randomly assigned to receive either MI-IPT-B or
      facilitated referral to treatment as usual (F-TAU). Participants in both groups will undergo
      the same screening procedures following assignment to an intervention. The MI-IPT-B group
      will also receive one session of motivational therapy at the time of the initial screening
      procedures. Participants assigned to receive MI-IPT-B will report to the study site once
      weekly for therapy. This type of therapy will focus on improving the participants'
      relationships with their peers and the way that they perceive themselves. The F-TAU group
      will receive a referral for standard mental health care within the community health system.
      Both treatments will last 8 weeks. All participants will return to the study site at Week 14
      and Month 6 for follow-up assessments of depressive symptoms.
    

Intervention name(s): Motivationally-Enhanced Interpersonal Psychotherapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depression
Psychoeducational Programme for PD Patients With STN-DBS
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to
      improve motor signs and reduce dopaminergic treatment and related motor complications in
      patients with severe forms of Parkinson's disease (PD). However, psychological disorders and
      socio-familial maladjustment are less clearly improved with subthalamic stimulation with an
      aggravation of the social adjustment described in about 1/3 of cases, with work disruption,
      divorce or familial conflict. The caregivers have also been reported to present negative
      well-being after surgery with an aggravation of the quality of life. In the present study,
      the investigators evaluate the effects of a perioperative psychoeducational programme to
      avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic
      stimulation, and their caregivers, in a randomized controlled study.
    

Detailed description: 
      After inclusion, patients (and their caregivers) are randomized into two groups stratified on
      their preoperative social adjustment scale couple domain score : usual treatment and
      psychoeducational programme or usual treatment alone (Figure). The psychoeducational
      programme focuses on 3 domains: 1) neurosurgical procedure and neurological outcome, 2)
      social life including work, social and familial relationship, 3) couple relationship. The
      programme consists of 7 sessions with 3 to 4 couples at the same session, except for the
      'couple relationship' domain. Each domain is tackled in a two-way manner with
      information/education proved by the investigator and discussion of the patients' and
      caregivers' expectations during one session. The following session started with a 'Questions
      and Answers' on the previous domain and then information on another domain. Four sessions
      were carried out prior to surgery and 3 after.
    

Intervention name(s): Psychoeducational programme
Intervention type(s): Behavioral
Intervention description(s): 4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Scintigraphic Assessment of I- Transport in Metastatic Breast Cancer and Evaluation of I31I Ablative Therapy: (Part I) Radioiodide Imaging Study
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to examine breast cancers that express the protein (NIS) that
      may be found in malignant breast tissues and to evaluate proteins found in blood and their
      relationship to NIS, to test whether iodide can be concentrated by breast cells to possibly
      treat some breast cancers with radioactive iodine, and to calculate the amount of radioactive
      iodine entering breast cancer cells, how long your cancer retains the agent as well as how
      much is taken up by other organs, particularly the thyroid gland.
    

Detailed description: 
      To demonstrate iodide uptake capacity of breast cancer metastases by imaging women with
      iodide radioisotope (123I) and calculating potential ablative dose of radioactive iodide
      (131I).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligibility criteria include histological proof of invasive breast cancer and current
        radiological evidence of metastatic disease.
      
Biospecimen description: 
      Archival tissue blocks and blood
Evaluation of University Students' Knowledge Levels and Perceptions of the Physiotherapist
Condition: Physical Therapist
Study type: Observational

Summary: 
      The aim of this study is to determine the knowledge, perceptions and perspectives of students
      about physiotherapy and rehabilitation profession, who are studying in different departments,
      especially in the health sector in Turkey.
    


Intervention name(s): College student
Intervention type(s): Other
Intervention description(s): Our research will be conducted by face-to-face interviews within the scope of questionnaires prepared by us for students studying in departments other than Physiotherapy and Rehabilitation at Acibadem Mehmet Ali Aydinlar University.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The current study will be conducted by face-to-face interviews within the scope of
        questionnaires prepared by us for students studying in departments other than Physiotherapy
        and Rehabilitation at Acibadem Mehmet Ali Aydinlar University