bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Cervical Spine Manipulation
Condition: Cervical Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      To determine the immediate effects of cervical spine manipulation on pressure pain
      sensitivity on upper trapezius trigger point. it was a randomized control trial including 66
      patients at physiotherapy OPD of railway rehabilitation center from August 2019 to December
      2019, Railway General Hospital Pakistan and Max Rehab and decompression center Max health
      Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and
      experimental) by free envelope method.
    

Detailed description: 
      To determine the immediate effects of cervical spine manipulation on pressure pain
      sensitivity on upper trapezius trigger point and neck ranges of motion. A randomized control
      trial of 66 patients was conducted from August 2019 to December 2019 at physiotherapy OPD of
      railway rehabilitation center, Railway General Hospital Pakistan and Max Rehab and
      decompression center Maxhealth Hospital G8 Islamabad. The subjects were randomly divided into
      two groups (group control and experimental) by free envelope method. Control was treated with
      Manual Pressure release followed by stretching while in experimental received cervical spine
      manipulation (chin hold) kaltenborn followed by stretching. Structural questionnaire was used
      for pre and post assessment. Outcomes were measured by algometry and inclinometer before and
      after the application of respective techniques. The data was analyzed at baseline and
      immediately after the intervention on IBM SPSS-21.
    

Intervention name(s): Cervical spine manipulation; traction
Intervention type(s): Other; Other
Intervention description(s): hot pack for 10 minutes will be applied followed by cervical manipulation (chin hold kaltenborn) once and then stretching; Hot pack will be applied followed by sustained pressure or MPR for 90 sec and then stretching.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching.
Masking: Single (Participant)
Primary purpose: Treatment
Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the long-term protection offered by GSK Biologicals'
      meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at
      15 to 19 years of age. This extension phase starts 18 months after vaccination and part of
      the subjects who were vaccinated in the primary study will be enrolled in this extension
      phase. No new subjects will be enrolled. This protocol posting deals with objectives &
      outcome measures of the extension phase 18, 30 and 42 months after vaccination. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, September 2007.
    

Detailed description: 
      Subjects were previously vaccinated at 15 to 19 years of age with GSK Biologicals'
      meningococcal vaccine 134612 or with Mencevax™ ACWY. This extension phase starts 18 months
      after vaccination and part of the subjects will be enrolled in this extension phase. No
      additional vaccines will be administered during this study and no new subjects will be
      enrolled. The subjects will have three blood samples taken: at 18, 30 and 42 months after
      vaccination.
    

Intervention name(s): Meningococcal vaccine 134612; Mencevax™ ACWY
Intervention type(s): Biological; Biological
Intervention description(s): One intramuscular dose during the primary study; One subcutaneous dose during the primary study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Meningococcal vaccine; Conjugate vaccine; Persistence
Dexmedetomidine PKPD Modeling and the Influence of Auditory Stimulation on Dexmedetomidine Effect
Condition: Anesthesia; Sedation
Study type: Interventional

Summary: 
      Dexmedetomidine is an α2-adrenoceptor agonist that has only recently been registered for
      human use in Europe. It has sedative, analgesic and anxiolytic properties, but patients
      remain arousable. This makes it an ideal drug for procedures which require the patient to
      perform tasks, or for light sedation during procedures or in the Intensive Care Unit.
      Pharmacokinetic models of (anaesthetic) drugs can be used in target controlled infusions
      (TCI), to deliver stable plasma concentrations of drug during anaesthesia or sedation. There
      are several models available for dexmedetomidine at this time, but the most often used models
      (Dyck and Talke) underpredict the plasma concentration at higher concentrations. Also, plasma
      concentrations aren't what the clinician is interested in, but in the effect. Therefore,
      pharmacokinetic/pharmacodynamic (PKPD) models can be developed to titrate the drug to effect
      instead of plasma concentration, using TCI. This has been done for many anaesthetic drugs,
      but not for dexmedetomidine. Additionally, we want to investigate the effect of stimulation
      on the pharmacodynamic effect of dexmedetomidine. The reason for this is that patients under
      dexmedetomidine sedation are arousable by noises or touch. An operating room or ICU is never
      quiet, and there are always sounds of monitors, alarms, and talking between team members or
      activity around another patient in the same room, therefore the stimulation of the patient in
      such an environment may have a profound effect on the sedative effect of dexmedetomidine.
    


Intervention name(s): Non-stimulation; Stimulation
Intervention type(s): Other; Other
Intervention description(s): The volunteers will be wearing noise-cancelling headphones (silent) and will be stimulated as little as possible. The volunteer will be instructed to keep his/her eyes closed.; The volunteers will be wearing noise-cancelling headphones, through which they will hear a continuous loop of recorded operating room noise (monitor beeps, talking), to simulate operating room conditions. The volunteer will be instructed to keep his/her eyes closed.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PKPD; Dexmedetomidine; Auditory Stimulation; Cardiac Output
Adrecizumab Phase 1 Trial
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first clinical trial with ADRECIZUMAB. The purpose of this clinical trial to
      identify safety and tolerability of different doses of ADRECIZUMAB in healthy volunteers.
    

Detailed description: 
      Adrenomedullin (ADM) is a natural occurring 52 amino acid peptide which is mainly expressed
      in endothelial and smooth muscle cells. ADM plasma levels are increased in patients with
      sepsis and related with severity of disease. ADM is a key regulator of vasotonus and of
      endothelial integrity in sepsis.

      ADRECIZUMAB is an antibody against the N-terminus of ADM which only partially inhibits the
      bioactivity of ADM. Several septic animal studies have shown that administration of
      ADRECIZUMAB leads to reduced catecholamine demand, improved renal function, improved fluid
      balance and improved survival.

      The administration of ADRECIZUMAB to rodents and non-human primates (NHP) has been tolerated
      very well. Single dose and repeated administrations over 14 days to rats and NHP in the GLP
      toxicology and safety study have not shown any clinical side-effects or histopathological
      findings.

      Based on these data the starting dose for human beings should be 0.5 mg/kg ADRECIZUMAB as
      single infusion over 1 hour and should be increased up to 8 mg/kg.
    

Intervention name(s): Placebo; Adrecizumab
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adrecizumab; Phase 1 clinical trial; Adrenomedullin; Healthy volunteers; Monoclonal recombinant antibody
A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to assess the pharmacokinetic (PK) profile of natalizumab (Tysabri)
      at steady state.

      The secondary objective is to assess the pharmacodynamics (PD) profile (α4 integrin
      saturation) of Tysabri at steady state.
    


Intervention name(s): Natalizumab
Intervention type(s): Drug
Intervention description(s): Participants continue to receive regularly-scheduled doses of Tysabri (300 mg infusion every 28±7 days) through the Tysabri Outreach: United Commitment to Health Prescribing Program (TOUCH) throughout the screening and assessment periods. Participants must continue to be dosed every 28±7 days in order to maintain steady-state pharmacokinetics.
Other intervention name(s): Tysabri; BG00002
Intervention MeSH terms: Natalizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: MS; Multiple Sclerosis
Pharmacokinetics and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 in Healthy Male Volunteers
Condition: Erectile Dysfunction; Prostatic Hyperplasia
MeSH terms: Erectile Dysfunction; Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetic properties and safety after administration of HCP1303 and
      co-administration of HGP1201, HIP1402 in healthy male volunteers
    

Detailed description: 
      The purpose of this study is to investigate the pharmacokinetic properties and safety after
      administration of HCP1303 and co-administration of HGP1201, HIP1402 in healthy male
      volunteers
    

Intervention name(s): HCP1303; HGP1201; HIP1402
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain
Condition: Mechanical Low Back Pain; Paraspinal Muscles; Muscle Stretching Exercises
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is one the leading cause of disability and affecting many individuals. Chronic
      low back pain is associated with restriction in daily physical activities that ultimately
      leads to disuse atrophy of muscles. The objective of the study is to find out the effects of
      Back Muscles Endurance Training on pain, disability, endurance and Lumbar flexibility in
      patients with chronic mechanical low back pain.
    

Detailed description: 
      Low back pain is the leading worldwide cause of years lost to disability and its burden is
      growing alongside the increasing and ageing population. Mechanical low back pain refers to
      back pain that arises intrinsically from the spine, intervertebral disks, or surrounding soft
      tissues. Repetitive trauma and overuse are common causes of chronic mechanical low back pain,
      which is often secondary to workplace injury. Most patients who experience activity-limiting
      low back pain go on to have recurrent episodes. Low back pain is a common condition affecting
      many individuals at some point in their lives. Chronic low back pain prevalence increases
      linearly from the third decade of life on, until the 60 years of age, being more prevalent in
      women.
    

Intervention name(s): Muscle endurance training (MET); Conventional Treatment
Intervention type(s): Other; Other
Intervention description(s): Experimental group will be given MET Program, stretching & strengthening exercises and Hot packs (for 15 minutes). MET program will include warm up, endurance and cool down exercises. The warm up and cool down period will be consisted of 5-minute walking, and 10 repetitions of stretching exercises. Endurance exercises will consist of 4 levels.; Conventional treatment group will be given hot packs (for 15 minutes) and Strengthening & stretching exercise program including:
STRETCHING EXERCISES (lumbar extensor muscles, iliopsoas muscles, hamstring muscles, gastrocnemius muscles and pectoral muscles).
STRENGTHENING EXERCISES (rectus abdominus crunch, oblique crunch, pelvic elevation, single leg pelvic elevation, lumbal spine extension, on hands and knees position with the raise of one leg, on hands and knees position with the raise of opposite arm and leg). Each exercise will be repeated 10 times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Sodium Nitrite in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Reperfusion Injury; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the intravenous infusion of sodium nitrite
      safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction
      resulting in improved left ventricular function.
    

Detailed description: 
      Despite reperfusion therapies, significant myocardial injury continues to occur from
      ischemic-reperfusion injury. Studies in animal models of acute myocardial infarction suggest
      that an infusion of sodium nitrite, which is nonenzymatically converted to nitric oxide in
      the setting of ischemia, significantly reduces ischemia-reperfusion injury resulting in
      smaller infarcts and improved left ventricular function. The objectives of this phase 2 trial
      are to determine the tolerability and safety of a 48-hour infusion of sodium nitrite in
      patients with an acute ST-segment elevation myocardial infarction receiving percutaneous
      coronary intervention. The efficacy of a 48-hour infusion of sodium nitrite will be
      determined by noninvasive imaging to determine infarct size and left ventricular function.
    

Intervention name(s): Sodium Nitrite
Intervention type(s): Drug
Intervention description(s): Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; Reperfusion injury; Nitric oxide
Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive; COPD; Lung Diseases, Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study is designed to obtain safety and efficacy data on three dose levels of indacaterol
      when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of
      treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg,
      indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a
      washout-period of 1 week.
    


Intervention name(s): indacaterol maleate
Intervention type(s): Drug
Intervention MeSH terms: Maleic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: indacaterol; long acting beta agonist
Efficacy and Safety of BG00012 in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine the efficacy, safety, and tolerability of BG00012 in MS patients.
    

Detailed description: 
      The study will be divided into two parts: Part 1 will be a 24-week, blinded,
      placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension
      phase in which all subjects will receive BG00012.
    

Intervention name(s): BG00012
Intervention type(s): Drug
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; MRI
Myofascial Stretch With And Without Functional Massage In Children With Cerebral Palsy
Condition: Cerebral Palsy, Functional Massage, Myofacial Stretch
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy is one of the most common childhood disabilities, and it occurs with an
      incidence of 2-2.5 per 1000 living births. Children with CP have various impairments
      including neuromuscular and musculoskeletal problems such as spasticity, dyscoordination,
      loss of selective motor control, and weakness. CP can be classified according to the severity
      of motor deficits as mild, moderate, or severe. Several other classification systems exist
      based on the pathophysiology, etiology, and distribution of motor deficits. The aim of the
      study to evaluate the effects of functional massage and myofascial stretch on spasticity and
      motor function of CP Children. Study will be conducted in 22 patients in experimental and
      control group. Pre and Post values will be evaluated. The tools used will be Modified
      Ashworth Scale (MAS) and Gross Motor Function Measure (GMFM). The significance of this study
      is that it will define for us that to how much extent we can improve the Spastic and painful
      condition of lower limb of CP child. Data will be analyzed using SPSS 22.0 mean and standard
      deviation will be calculated. Appropriate the statistical test will be used after checking
      normality of data.
    


Intervention name(s): Myofascial stretch; Functional massage along with myofacial stretch
Intervention type(s): Other; Other
Intervention description(s): Myofascial stretch will be applied at hip adductors, hamstrings and calf muscles for 10 -15 repetitions on each muscle. 2-3 sessions will be performed in a week for 8 weeks.; In this group during the first 20 minutes, ten minutes FM will be applied to each lower extremity of the subject. The muscle groups to which FM would be applied were hip adductors, hamstrings and calf muscles. During the remaining period traditional physiotherapy involving myofascial strecth will be given. 2-3 session will be performed in a week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Acute Effect of Egg-Based High Protein Meal on Hypertensive Response to Exercise
Condition: Blood Pressure; Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      The primary purpose of this study is to explore the effect of high versus normal egg-based
      protein meals on acute exercise-induced elevated blood pressure.
    

Detailed description: 
      This study is designed to assess BP changes during and post- exercise after consumption of a
      test breakfast. The design consists of three visits. The first visit will assess each
      participants aerobic exercise capacity (VO2 max). Visit 2 and 3 will be clinical testing days
      where the subject will consume either the 13g or 30g protein breakfast in a randomized
      cross-over manner and perform the exercise intervention. BP changes will be monitored before
      and after breakfast consumption, during the exercise intervention,
    

Intervention name(s): Normal Protein; HIgh Protein
Intervention type(s): Other; Other
Intervention description(s): Consumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl; Consumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: subject will consume either the 13g or 30g protein breakfast in a randomized cross-over manner
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Adjunctive Atropine During Ketamine Sedation
Condition: Conscious Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      -  Ketamine seems an obvious choice in the setting of an emergency department

        -  Ketamine leads to increased production of salivary and tracheal secretions

        -  Antisialagogues(atropine)therefore have been recommended as a routine adjunct

        -  We compare atropine with placebo as an adjunct to ketamine sedation in children
           undergoing primary closure of lacerated wound
    

Detailed description: 
      The degree of secretion was significantly less in the atropine group compared with the
      control group at the end of the procedure (VAS score: 16.5 ± 9.9 vs. 27.0 ± 15.9, atropine
      vs. control, p = 0.00). The change in the degree of secretion between the start and end of
      the procedure was significantly greater in the atropine group than in the control group (p =
      0.00) (Fig. 2). However, the frequency of hypersalivation as predefined (VAS score ≥50) did
      not differ between the groups (p = 0.06).

      The only complication that differed significantly between the two groups was tachycardia (p >
      0.05). Complications such as aspiration, laryngospasm, and apnea were not documented in the
      hospital. There were fewer interventions for hypersalivation in the atropine group, but the
      difference was not significant (p > 0.05). As interventions, O2 administration and
      endotracheal intubation were not needed. After discharge, the control patients tended to have
      more complaints of nausea, vomiting, and ataxia, although the difference was not significant
      (p > 0.05) Heart rate was increased significantly in the atropine group (p = 0.00). The
      frequency of tachycardia according to patient age was also significantly higher in the
      atropine group than in the control group (p = 0.00)
    

Intervention name(s): Atropine
Intervention type(s): Drug
Intervention description(s): Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment