bioihbjkbjnl/mcl2 huggingface dataset:
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The main objective of this study is:

      • To evaluate the immediate hypoalgesic effect of an aerobic exercise session of different
      intensities in patients with chronic low back pain;

      The secondary objective is:

      • To explore whether pain intensity, level of physical activity, functionality,
      catastrophizing, kinesiophobia, anxiety and depression interfere with the immediate
      hypoalgesic effect of exercise.
    

Detailed description: 
      There will be 3 groups of participants, an asymptomatic control group that will not perform
      any exercise and two groups of individuals with low back pain. One group will perform
      exercise at 90% VO2máx and the other at 60% VO2máx.

      All the three groups will be assessed at baseline for pressure pain threshold, pain
      intensity, pain phenotype, disability, kinesiophobia, catastrophizing, anxiety and
      depression, physical activity, and aerobic capacity. In addition, pressure pain threshold and
      pain intensity will also be assessed at post-intervention.
    

Intervention name(s): Exercise at 60% vo2; Exercise at 90% vo2
Intervention type(s): Other; Other
Intervention description(s): 15 minutes of exercise at 60% VO2 max.; 15 minutes of exercise at 90% VO2 max.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Participatory Research to Promote Physical Activity
Condition: Health Behavior
Study type: Interventional

Summary: 
      Secondary schoolgirls have the most unhealthy profile regarding physical activity and
      sedentary behaviour of all age groups. Since both behaviours independently contribute to
      various health outcomes, an effective intervention to promote physical activity and to reduce
      sedentary behaviour needs to be developed.

      Many interventions fail to induce changes in health behaviour, as they often use a top-down
      approach with limited input from the end-users (i.e. the secondary schoolgirls) of the
      intervention programmes. This project uses a participatory health research approach by
      actively involving the girls in the entire research process. A co-creation group was set up
      per intervention school (n=3), including girls and a researcher which co-created a
      school-specific intervention, tailored to the needs and interests of those girls.

      The effect of participatory process were evaluated via a clustered randomized controlled
      trial using an intervention and control condition and a pre- and post-test design. Effects on
      physical activity and related determinants (e.g. self-efficacy, attitude, etcetera) were
      evaluated. The hypothesis was that girls from the intervention condition would improve their
      physical activity levels and related determinants compared to no changes among girls from the
      control schools. The process was evaluated as well using focus group research and the
      hypothesis was that girls who participate in the co-creation groups would be positive about
      the process and will feel empowered.
    


Intervention name(s): Co-created intervention to promote physical activity
Intervention type(s): Behavioral
Intervention description(s): A working group of girls and researcher co-created a school-specific intervention to promote physical activity
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: One intervention and one control condition
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical activity
Monotherapy Study of MP-513 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in
      patients with type 2 Diabetes for 12 weeks administration.
    


Intervention name(s): Teneligliptin 20 mg; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): MP-513
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin resistance
Relationship Between Aortic Parietal Inflammation on 18F-FDG PET Scan and Arterial Stiffness as a Function of Age
Condition: Arterial Stiffness
MeSH terms: Inflammation
Study type: Observational [Patient Registry]

Summary: 
      Show that there is a relationship between arterial stiffness and aortic parietal inflammation
      and that this relationship is different in the three age groups with aortic parietal
      inflammation occurring earlier than arterial stiffness.
    

Detailed description: 
      In the literature, a relationship has been demonstrated between local inflammation in the
      aortic wall and increased arterial stiffness. Arterial stiffness is commonly represented by
      pulse wave velocity (PWV) measured using an applanation tonometer. It would seem that this
      parietal inflammation precedes arterial stiffness and consequently, arterial hypertension .
      Arterial stiffness is an important factor of cardiovascular morbidity and mortality and
      therefore represents a major public health interest in prevention in the face of the
      continuous aging of our population . This study will consist in studying on a population
      divided into three age groups, less than 40 years old, 40 to 60 years old and more than 60
      years old, the relationship between thoracic aortic parietal inflammation evaluated using the
      Standard Uptake Value parameters (SUV) and Hounsfield units (HU) measured on 18F-FDG PET/CT
      scans performed between 09/04/2018 and 11/06/2020 and arterial stiffness parameters. We will
      seek to show that there is a relationship between arterial stiffness and aortic parietal
      inflammation and that this relationship is different in the three age groups with aortic
      parietal inflammation occurring earlier than arterial stiffness.
    

Intervention name(s): Measure of aortic inflammation
Intervention type(s): Diagnostic Test
Intervention description(s): Standard Uptake Value (SUV) measures of aortic wall
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Patients who underwent whole-body 18F-FDG PET/CT included in the PACTEP study and in this
        context, who had an assessment of arterial stiffness by applanation tonometer
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, single-center, randomized, 2-way crossover study to evaluate the
      bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference
      product administered as two 500 mg tablets, under fasting conditions, in 24 healthy adult
      subjects. Each subject will receive two treatments (Treatment A and Treatment B). In Period
      1, subjects will be dosed with either one OXEMET™ 1000 mg tablet (Treatment A, Test) or two
      500 mg tablets of reference product (GLAFORNIL™ 500 mg) (Treatment B, Reference). Following a
      washout of at least 7 days, subjects will be crossed over in Period 2 to receive the
      treatment that they did not receive in Period 1.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Oral antidiabetic agent
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Metformin; Bioequivalence
Comparative Effectiveness of Unilateral vs. Bilateral Pulmonary Collapse in Cardiac De-airing
Condition: Brain Ischemia; Reduction of Cerebral Air Emboli
MeSH terms: Pulmonary Atelectasis; Brain Ischemia; Embolism; Embolism, Air; Ischemia
Study type: Interventional

Summary: 
      To compare the effectiveness of unilateral pulmonary collapse (right lung) to bilateral
      pulmonary collapse for cardiac de-airing in open left-sided heart surgery.
    

Detailed description: 
      Effective removal of air from the heart before termination of cardiopulmonary bypass (CPB) is
      vital in open left heart surgery. Bilateral collapse of the lungs during cardiopulmonary
      bypass decreases the duration of the de-airing procedure, decreases residual air emboli
      monitored on Trans-esophageal Echocardiography (TEE) and decreases gaseous cerebral
      microemboli (MES) monitored by Trans-cranial Echo-Doppler (TCD) when compared to expanded
      lungs during (CPB). Induced pulmonary collapse by opening of the pleura and disconnection of
      the patient from the ventilator during CPB decreases the amount of air that can enter the
      pulmonary veins. Not all surgeons wish to induce lung collapse from fraught that it might
      lead to pulmonary ischemia or infection. It is unknown whether collapse of only the right
      lung is as effective as collapse of both lungs.
    

Intervention name(s): Bilateral Open Pleurae; Right Pleura Open
Intervention type(s): Procedure; Procedure
Intervention description(s): Both pleurae are opened Right pulmonary vein drainage; Right pleura open Left ventricular apical drainage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cerebral air emboli, heart surgery
A Study to Assess the Cardiac Safety of Oritavancin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study was to generate cardiac safety data using a supratherapeutic
      oritavancin dose of 1600 milligrams (mg).
    

Detailed description: 
      This study was a single-center, double-blind, randomized, placebo-controlled, parallel-design
      study with an open-label, positive-control moxifloxacin arm to evaluate the effect of
      supratherapeutic dose of oritavancin on the QT and QT corrected for pulse rate (QTc)
      intervals.
    

Intervention name(s): Single-Dose IV Oritavancin Diphosphate; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous oritavancin was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.; Intravenous placebo was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.; Participants randomized to the open-label moxifloxacin treatment arm only received a 400-mg moxifloxacin tablet and did not receive a placebo infusion.
Other intervention name(s): Oritavancin Diphosphate; Avelox
Intervention MeSH terms: Moxifloxacin; Oritavancin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of
      infectious novel coronaviruses in a population of medical workers
    

Detailed description: 
      This is a single-center, open-ended, single-arm clinical study to evaluate the effectiveness
      of daily ursodeoxycholic acid plus routine protective measures for the prevention of novel
      coronavirus infection. The target sample size is 130 medical workers and each healthy
      volunteer will be followed weekly for nucleic acid/antigen testing or disease progression
      over an 8-week period for new crown infections.
    

Intervention name(s): Ursodeoxycholic acid
Intervention type(s): Drug
Intervention description(s): 250 mg/capsule, 2 capsules per day, for 4 weeks
Intervention MeSH terms: Ursodeoxycholic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ursodeoxycholic acid; COVID-19; prevention
Emdogain Minimally Invasive Surgical Technique
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The aim of this controlled study is to assess the clinical outcomes and patient reported
      outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct
      (test treatment) or without Straumann Emdogain (control treatment).
    

Detailed description: 
      The aim of the study will be achieved through the following primary and secondary objectives.
      The primary objective is to evaluate the regenerative potential of Straumann Emdogain by
      comparing the change in clinical attachment level from baseline to 12 months between the test
      and control arms. The regenerative potential of Straumann Emdogain will also be assessed by
      comparing the changes in gingival margins, changes in average probing pocket depth, changes
      in full mouth plaque score, changes in bleeding on probing, and changes in root dentin
      hypersensitivity from baseline to 12 months between the test and control arms.
    

Intervention name(s): Scaling and root planing; Scaling and root planing without Emdogain; Emdogain application
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.; Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.; Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
Condition: Postmenopausal; Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to assess the safety, tolerability, and
      immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations
      in healthy men and postmenopausal women with low bone mass.
    


Intervention name(s): Romosozumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 785; EVENITY™
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Performance of Resin-modified Glass Ionomer and Composite Restorations in Permanent Teeth
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this randomised controlled double-blinded, split mouth, single-center clinical
      trial was to evaluate the 18-month clinical performance of nano-filled resin-modified glass
      ionomer and sub-micron hybrid resin composite restorations in lower first permanent teeth of
      pediatric patients.
    

Detailed description: 
      Occlusal carious lesions on the left and right mandibular first molar teeth of 96 pediatric
      patients (54 female, 42 male) were restored in a split-mouth study design. Nano-filled
      resin-modified glass ionomer (Nano-RMGIC) (Ketac N 100, 3M/ESPE, USA) was used to restore the
      carious lesions for patients in the treatment group while a sub-micron hybrid resin composite
      (SpectrumTPH3, Dentsply, USA) was used for patients in the control group. Clinical evaluation
      of restorations were performed at the 1st week, 6th, 12th and 18th month recalls by two
      calibrated examiners according to the Modified-USPHS criteria.
    

Intervention name(s): Dental restoration
Intervention type(s): Other
Intervention description(s): Restoration of carious mandibular first molar teeth are restored either with nano-filled resin modified glass ionomer or sub-micron resin composite restorative material
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One of the Nano-filled glass ionomer or sub-micron hybrid resin composite restorative materials were applied to carious mandibular first molar teeth
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nano-filled resin-modified glass ionomer; sub-micron hybrid resin composite; permanent molar teeth
Swiss Childhood Health and Nutrition Survey
Condition: Overweight and Obesity in Schoolchildren
MeSH terms: Overweight
Study type: Observational

Summary: 
      The aim of the present study is to assess the prevalence of overweight and obesity in 6 to 12
      year old children in Switzerland. This data will be used to investigate trends in the
      development of overweight and obesity in Switzerland. In addition, a questionnaire will be
      used to assess data on physical activity, nutrition, health and socioeconomic background and
      waist circumference as well as skin fold thicknesses will be measured.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All children at the selected schools and in the defined age range are eligible.
A Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Paxceed™ is being developed by Angiotech Pharmaceuticals, Inc. for the treatment of
      Rheumatoid Arthritis (RA). The main objective of this study is to determine the effectiveness
      of treatment with Paxceed™ in patients with RA. In RA, there is an increase in cell growth
      and changes in cell function. The active substance in Paxceed™, paclitaxel, has undergone
      clinical studies as a cancer chemotherapeutic agent and has demonstrated its usefulness as an
      agent that stops growth of cells and blocks certain types of cell function associated with
      RA. Because of these effects, it is thought that Paxceed™ might alter the destructive course
      of RA.
    


Intervention name(s): Micellar Paclitaxel for Injection
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; Paxceed; Micellar Paclitaxel
Oronasopharyngeal Suction Versus Simple Nose and Mouth Wiping in Term Newborns
Condition: Pregnancy, Childbirth and the Puerperium; Resuscitation
Study type: Interventional

Summary: 
      Until recently, bulb or catheter oronasopharyngeal suctioning (ONPS) of all the infants,
      including vigorous infants in the delivery room, has been featured as a standard of newborn
      care. The 5th edition of the Newborn Resuscitation Program (NRP) has minimized the
      recommendation for routine suctioning of infants following delivery, provided they are not
      depressed or in need of immediate resuscitation. However, this new alternative recommendation
      was based on a small randomized trial and other lower level evidence rather than evidence
      from larger trials. The NRP Textbook cautions against vigorous suctioning because of the
      resultant apnea or bradycardia. Furthermore, suctioning may delay other more important steps
      of resuscitation. Thus, it is necessary to compare the alternative recommended practice, i.e.
      simple wiping of the mouth, to determine if it has equivalent efficacy and a favorable side
      effect profile compared to suctioning.
    


Intervention name(s): Bulb Suctioning; Wiping
Intervention type(s): Procedure; Procedure
Intervention description(s): Bulb suctioning of the mouth then the nose immediately following delivery; Gentle wiping of mouth then nose with a soft cloth immediately following delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Suctioning; Wiping; Neonate; Resuscitation
Neuronal Correlates of Altered States of Consciousness
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the present study is to assess the neuronal correlates of alterations in waking
      consciousness pharmacologically induced by a 5-hydroxytryptamine (HT)2A receptor agonist in
      healthy subjects using functional magnetic resonance imaging (fMRI).
    

Detailed description: 
      Functional neuroimaging may be useful in the diagnosis and characterization of early
      schizophrenia. However, little is known about how the subjectively experienced alterations in
      consciousness and perception are related with objective neuroimaging measures. The present
      study explores the association of subjective alterations and objective imaging findings and
      will inform us on the neuronal correlates of psychotic states and whether subjective
      alterations in perception translate into neuronal activation patterns that can be objectively
      measured in a brain scanner. Therefore, alterations in consciousness will be assessed in 20
      healthy subjects using a random order 2-period (normal and altered state of consciousness)
      cross-over design. Alterations in consciousness will be induced by the hallucinogenic
      5-hydroxytryptamine (HT)2A receptor agonist (5-HT2A) receptor agonist lysergic acid
      diethylamide (LSD).
    

Intervention name(s): LSD; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100ug per os, single dose; Capsules containing mannitol looking identical to LSD
Other intervention name(s): Lysergic Acid Diethylamide
Intervention MeSH terms: Lysergic Acid Diethylamide
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: altered state of consciousness; functional magnetic resonance imaging (fMRI); hallucination; model psychosis; serotonin receptor; LSD