bioihbjkbjnl/mcl2 huggingface dataset:
"Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults
Condition: Intubation; Difficult
Study type: Interventional

Summary: 
      The purpose of this study is to investigate two different patient's head and neck
      positions(neutral head position and head-lift position) for the effectiveness of orotracheal
      intubation with using the "Clarus Video System (Trachway®)" intubating stylet.
    

Detailed description: 
      The sniffing position has traditionally been considered the optimal head position for direct
      laryngoscopy, However, it may aggravate cervical spine injury. The Trachway® video stylet is
      an intubating device that may avoid cervical movement during intubation. Nonetheless, the
      effectiveness of limited neck movement in patients with neutral head or head-lift position
      using the Trachway® video stylet remains unclear. The purpose of this study was to compare
      the intubation time of the two positions with the Trachway® video stylet.
    

Intervention name(s): Head-lift position; 7cm high pillow
Intervention type(s): Procedure; Device
Intervention description(s): A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.; A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: intubating stylet; head and neck position
Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      Determine if the addition of a specific acupuncture protocol to a standard of care prescribed
      exercise program is more effective at improving pain and function in adult patients with
      plantar fasciosis.
    

Detailed description: 
      This is a randomized, controlled, multi-site trial investigating whether a specific
      acupuncture protocol can improve pain and function in adults with plantar fasciosis when
      added to standard of care treatment. The investigators hypothesize that there will be a
      significant improvement in both pain and functional outcomes, both acutely and over time, in
      the experimental group compared to the control group.
    

Intervention name(s): Intervention + Standard of care; Standard of care
Intervention type(s): Device; Other
Intervention description(s): Acupuncture with electrostimulation plus standard of care prescribed home exercise program for treatment of plantar fasciosis.; Standard of care prescribed home exercise program for treatment of plantar fasciosis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plantar fasciosis; acupuncture; electrostimulation; primary care
VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC
Condition: Renal Failure Chronic Requiring Hemodialysis; Chronic Renal Insufficiency
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled
      dialysis catheters.
    

Detailed description: 
      The VectorFlow tunneled dialysis catheter is a novel symmetrical tip design tunneled dialysis
      catheter which in pre-clinical testing and retrospective review has improved flow and patency
      compared to other dialysis catheter designs. This study will compare 90 day patency rates of
      newly inserted VF catheters to the Palindrome catheter both of which are FDA approved devices
      and will inserted as standard of care. The Palindrome catheter has been selected as the
      comparison device because it is also a symmetrical tip catheter design and prior studies by
      the manufacturer of this device suggests it has a lower occlusion rate and better flow
      compared to other catheter designs.
    

Intervention name(s): VectorFlow TDC; Palindrome TDC
Intervention type(s): Device; Device
Intervention description(s): TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.; TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.
Other intervention name(s): ARROW-Clark™ VectorFlow™ Hemodialysis Catheter; Palindrome™ Dialysis Catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation
Condition: Parkinson's Disease; Constipation
MeSH terms: Parkinson Disease; Constipation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of an orally-administered medication to relieve symptoms of constipation
      associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be
      studied over an 8-12 week period. Forty patients will be enrolled in Phase 2, and will be
      studied over an 8-10 week period. All subjects will receive the study drug during one of the
      observational periods of the study.
    

Detailed description: 
      Phase 1 will enroll 10 patients to assess the safety, tolerability, and pharmacokinetics of
      single escalating doses over a 30-60 day period. The dose-escalation period will be preceded
      by a 2-week run in period and followed by a 2-week wash-out period.

      Phase 2 follow the safe completion of Phase 1. It will enroll 40 patients and is composed of
      4 periods of study: 1) a 2-week run-in period, 2) a 3-5 week escalating dose period to
      identify a prokinetic dose in the initial set of 10 patients, 3) a 1-week period of
      randomized dosing (placebo versus the previously identified pro-kinetic dose), and 4) a
      2-week wash-out period. Pharmacodynamics will be assessed along with safety and tolerability.
      Relative outcomes will be compared within each patient and across groups for the randomized
      dosing period.

      Frequency of bowel movements and other non-motor symptoms of Parkinson's Disease will be
      collected over the course of both phases.
    

Intervention name(s): ENT-01; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Daily dosing with ENT-01. ENT-01 is an orally administered proprietary substance formulated as a small 25mg coated tablet. Dosing will range from 25-200mg, and the dose will be taken upon awakening on an empty stomach with 8oz water simultaneous to dopamine.; Daily dosing with a placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Phase 1 is a single group; Phase 2 will begin subsequent to the safe completion of Phase 1. Phase 2 patients will undergo randomization for parallel study during one period of observation of the course of the study phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: non-motor symptoms
Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome
Condition: Down Syndrome With and Without Auto Immune Abnormalities
MeSH terms: Down Syndrome; Congenital Abnormalities; Syndrome
Study type: Observational

Summary: 
      The purpose of the study is to identify biological data linked to auto immune abnormalities
      associated with Down Syndrome.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Down syndrome patients followed in a specialized clinic devoted to healthcare of mentally
        retarded children and adults
      
Biospecimen description: 
      whole blood and white cells
    
Keywords: Down syndrome, Humans,Clinical study,Immunity, Autoimmunity,
Assessment of Deep Gray Matter Anatomic Changes in RRMS Patients Treated With Gilenya® With and Without Cognitive Impairment Over a 2 Year Period Using NeuroQuant, NeuroQuarc and ANAM
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of the research study is to investigate whether the extent and severity of
      lesions in the brain as measured by special MRI techniques can distinguish between Multiple
      Sclerosis (MS) patients with or without memory impairment and also between MS patients and
      age matched healthy controls.
    

Detailed description: 
      Impairment in thinking or memory is frequently present in multiple sclerosis but there are
      difficulties finding changes on the Brain MRI that correlate with impairment in thinking and
      memory. This occurs because standard MRI is good for detecting some but not all abnormalities
      in the brain. Those lesions that we do see in the brain on standard MRI do not correlate with
      memory impairment or the source of disability in most RRMS patients. This occurs because RRMS
      symptoms mainly result from parts of the brain which have been hard to evaluate with MRI
      until now.

      To gain more insight into the source of memory impairment, we plan to explore differences in
      brain volume that may be present in RRMS patients without thinking or memory problems
      compared with those who are impaired. A secondary objective will be to compare RRMS patients
      in general with healthy controls.

      A new MRI technique called NeuroQuant which reliably defines the volume of those parts of the
      brain that are important for memory and thinking will be used. Neuropsychological testing
      will also be offered, at no cost, to those patients being treated with Gilenya® in order to
      help define the presence and extent of their memory impairment. Automated Neuropsychological
      Assessment Matrices (ANAM)looks at all functional brain systems and will be administered by a
      psychometrist over a period of 90 minutes.
    

Intervention name(s): NeuroQuant; Automated Neuropsychological Assessment Matrices; EDSS; Physical Examination
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Reliably defines the volume of those parts of the brain that are important for memory and thinking.; This is like an IQ test.; Extended Disability Status Score; Physical Examination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Relapsing Remitting Multiple Sclerosis; RRMS; Gilenya; Fingolimod; MRI; NeuroQuant; NeuroQuarc; Automated Neuropsychological Assessment Matrices; ANAM
Protein Nutrition for Muscle Hypertrophy in Older Adults
Condition: Healthy Elderly Muscle; Anabolically Resistant Elderly Muscle
Study type: Interventional

Summary: 
      The primary objective is to determine the effect of reduced activity on the stimulation of
      myofibrillar FSR with protein feeding in the elderly.
    

Detailed description: 
      The primary objective is to determine the effect of reduced activity on the stimulation of
      myofibrillar FSR with protein feeding in the elderly
    

Intervention name(s): isolated whey protein; micellar whey protein; glycine; citrulline
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): isolated whey protein; micellar whey protein; glycine; citrulline
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study comparing the pharmacokinetics of prolonged-release melatonin versus standard,
      immediate-release melatonin. Multiple blood draws over a 10-hour period will be analysed to
      determine the area under the curve, time to peak concentration, peak concentration,
      absorption rate constant, elimination rate constant, absorption half-life, and elimination
      half-life. Vital signs, hematology parameters, clinical chemistry parameters, and incidence
      of adverse events are also analysed.
    


Intervention name(s): Prolonged-Release Melatonin; Immediate-Release Melatonin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4.47 mg melatonin in a bi-layer prolonged-release capsule; 4.47 mg melatonin in a standard release bi-layer capsule
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Healthy; Adult; Melatonin; Pharmacokinetic; Absorption; prolonged-release; immediate-release
Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The main purpose of this study is to learn about the influence of two different behavioral
      interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the
      mechanisms involved. There is research evidence that healthy sleep promotes heart-health and
      may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be
      influenced by sex. This research will compare two interventions that are each designed to
      improve sleep health, and will investigate sex differences in response. The project includes
      3 in-hospital stays with biological measurements to evaluate the underlying mechanisms
      associated with the effectiveness of two different blood pressure lowering behavioral
      interventions.
    

Detailed description: 
      The study involves home-based sleep-wake data collection before and during behavioral
      intervention, and 3 overnight stays in the hospital. For each hospital stay participants will
      be asked to arrive in the afternoon, and stay until the next evening. They will be provided
      dinner on the first day and breakfast, lunch and dinner on the second day. If they are taking
      any blood pressure medication they will continue to take it through the study. During the
      in-hospital stays, blood pressure will be measured continuously using two small finger cuffs.
      In order to monitor and record brain waves to determine sleep and wakefulness, small
      gold-coated disks called electrodes will be placed on the head and body. Heart rate, blood
      pressure and brain activity will be recorded for a little over 24 hours on each in-hospital
      stay. Before as well as during the in-hospital stays questions will be asked about sleep
      times, subjective sleepiness and other indices relating to well-being.
    

Intervention name(s): Sleep Extension; Sleep Timing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Lengthen the duration of sleep time.; Regularize the timing of the sleep period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Clazosentan in Preventing the Occurrence of Cerebral Vasospasm Following an Aneurysmal Subarachnoid Hemorrhage (aSAH)
Condition: Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to measure how effective and safe three different doses of the
      drug clazosentan are in preventing vasospasm after subarachnoid hemorrhage.
    


Intervention name(s): Clazosentan 1 mg/h; Clazosentan 5 mg/h; Clazosentan 15 mg/h; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects receive intravenous clazosentan at a rate of 1 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture; Subjects receive intravenous clazosentan at a rate of 5 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture; Subjects receive intravenous clazosentan at a rate of 15 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture; Subjects receive intravenous placebo starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
Other intervention name(s): ACT-108475; ACT-108475; ACT-108475
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: delayed ischemic neurological deficits (DIND); vasospasm; clazosentan; cerebral vasospasm; computer tomography scan (CT scan); digital subtraction angiography (DSA); endothelin A receptor; aneurysmal subarachnoid hemorrhage (aSAH)
Assessment of Duration of Metabolic Effect of a Single Bolus of sc Injected Lantus Compared to NPH Insulin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the duration of the metabolic effect of a sc injected single dose of either insulin
      glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type
      2 diabetes
    


Intervention name(s): Insulin glargine
Intervention type(s): Drug
Intervention description(s): Lantus (commercial formulation, Reference):
10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)
NPH-insulin (Protaphan) (Test):
10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Intervention Study of Oral Health Education Programs Directed to Adolescents
Condition: Gingivitis; Periodontal Infection
MeSH terms: Infections; Gingivitis; Periodontitis
Study type: Interventional

Summary: 
      This study evaluates behavioral interventions to increase adolescent's motivation for self
      performed periodontal infection control, by means of adequate oral hygiene. Study subjects
      will be allocated to test and control group where the test will be subjected to an
      individually tailored oral health education program, based on cognitive- behavioral theory
      and principles, and the control to standard educational intervention.
    

Detailed description: 
      The prevalence of chronic periodontitis is about 40% among the Swedish adult population. The
      key-factor for the prevention of periodontal disease progression is the establishment of
      periodontal infection control, by means of adequate daily oral hygiene. Hence, a main task
      for dental professionals is to educate and motivate the patient to such beneficial behavior.
      A hypothesis for the current study is that patient centered health promotion programs based
      on cognitive behavioral theory and principles and with a directive communicative approach,
      i.e. motivational interviewing techniques, add positive and lasting effects to standard
      educational interventions on self-performed periodontal infection control.

      This randomized clinical field study involves 30 professionals (dental hygienists) and about
      350 adolescent patients at 16 dental clinics in the Västra Götaland Region, Sweden. The
      approach in the evaluation is on patient-centered outcomes and health economics.
    

Intervention name(s): Patient centered oral health education; Standard educational intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Procedure: The theory-based educational intervention follows a specific structure. The initial phase contain 3 treatment sessions (45-60 min each) during a period of 12 weeks (baseline, 2-3 weeks and 10-12 weeks). Follow up are performed at 6- and 18-months.; Procedure: The initial phase contain educational intervention in accordance with conventional routines (oral health information and oral hygiene instruction at one or several occasions). Follow up are performed at 6- and 18-months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gingivitis; Adolescents; Oral hygiene; Oral health behavior; Periodontal infection control
OPALINE : A Study Of Morbidity And Mortality At 2 Years
Condition: Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
MeSH terms: Neuroendocrine Tumors; Adenoma, Islet Cell
Study type: Observational

Summary: 
      A descriptive, prospective (partly retrospective), multisite, observational study conducted
      in France in adult patients treated for a well differentiated, unresectable or metastatic,
      pancreatic neuroendocrine tumor with disease progression.
    

Detailed description: 
      prospective and retrospective Analyses will be performed using SAS® software
    

Intervention name(s): sunitinib; everolimus; chemotherapies recommended in france
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sunitinib 37.5mg/d orally; everolimus 10mg/d orally; depends on the chemotherapy prescribed (IV)
Intervention MeSH terms: Everolimus; Sunitinib
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients with progressive, metastatic or unresectable, and well differentiated pancreatic
        neuroendocrine tumors