bioihbjkbjnl/mcl2 huggingface dataset:
Study of Wellness Behaviors as a Function of Oxytocin vs Placebo
Condition: Sustained Positive Emotions; Sustained Positive Behavior Change
Study type: Interventional
Phase: Phase 1

Summary: 
      The specific aim of this study is to test whether oxytocin (OT) boosts the positive emotion
      yield of a new wellness behavior (Lovingkindness meditation or Mindfulness meditation) and
      thereby increases nonconscious motives that shape daily behavioral decisions to repeat it,
      which in turn foster positive emotions that further augment nonconscious motives in an upward
      spiral dynamic.

      The proposed research targets three hypotheses: (1) Oxytocin manipulation magnifies (i.e.,
      moderates) the positive emotion yield of Lovingkindness meditation; (2) The positive emotion
      yield of meditation, which varies by experimental condition, increases the nonconscious
      incentive salience of Wellness Behavior-related cues; and (3) Behavioral decisions predict
      positive emotions, sparking the relationships among OT manipulation, positive emotion yield,
      and nonconscious incentive salience of Wellness Behavior-related cues.
    


Intervention name(s): Oxytocin; Placebo (for oxytocin); Lovingkindness Meditation; Mindfulness Meditation
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): 24 International Units; intranasal spray manufactured to mimic oxytocin nasal spray
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: positive emotions; meditation; oxytocin
Short- and Long-term HRV Measurements After Osteopathic Myofascial Thoracic Manipulations
Condition: Heart Rate Variability
Study type: Interventional

Summary: 
      The adaptation of the heart to react to any stimulus is called heart rate variability (HRV).
      Moreover, HRV is now used as a health index. In fact, among the pathologies affecting HRV the
      most, there are the cardiovascular diseases and depressive disorders that take a predominant
      part in the investigator's actual societies, According to a recent literature overview, many
      factors influence HRV and they need to be determined in order to plan efficient research
      protocols. Moreover, the control of these factors can improve the HRV and therefore help the
      heart to have maximum capacity to fulfill its physiological functions. Valorizing a good HRV
      seems, according to the effects reported by several studies, to be a good opportunity to take
      into consideration and to apply.

      Visceral osteopathy, even if it goes back to the founder of Osteopathy himself, Andrew Taylor
      Still, is at its debuts in terms of acknowledgement from a scientific point of view. The
      evidence of efficacy of osteopathy is not to be done anymore. However, it is now necessary to
      define the action mechanisms of the osteopathic techniques, particularly by using
      physiological variables, and starting from a biomechanical angle. In fact, Jean-Pierre Barral
      and others has developed visceral manipulation techniques based on the viscera anatomy.

      The originality of this research can be found in the technical protocol, not used yet, the
      use of witness group, the measurements over four weeks to evaluate the effect of this
      protocol with time on chosen dependant variables, its reproducibility but also its
      inter-therapist variance. This objective if this study is to reinforce the proof level of the
      osteopathic approach on the cardiac physiology. HRV is a solid tool recognized for research,
      the variable is well isolated and the control group ensures an isolation of some confounding
      variables.
    


Intervention name(s): Osteopathic manipulative treatment; Sham therapy
Intervention type(s): Other; Other
Intervention description(s): Specific protocol including 4 osteopathic techniques targeting the pericardium; Sham therapy mimicking the osteopathic techniques applied to experimental group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: heart rate variability; autonomous nervous system; osteopathy; osteopathy manipulative treatment; visceral; pericardium
A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of four different lazertinib oral
      tablet formulations in healthy adult participants under fasted condition.
    


Intervention name(s): Lazertinib
Intervention type(s): Drug
Intervention description(s): Lazertinib will be administered orally.
Other intervention name(s): JNJ-73841937
Intervention MeSH terms: Lazertinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Factors Affecting Atopic Dermatitis in Children Age 1-3
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      This study evaluates the influence of different triggers on atopic dermatitis manifestation
      in children under 3 years old.
    

Detailed description: 
      In this study investigators evaluate the influence of atopic dermatitis triggers before
      labour, right after labour, in firsts weeks after labour, in first year. Investigators want
      to find the most popular and most important factors witch provoke atopic dermatitis
      manifestation and comparison the results with children without atopic dermatitis but with
      genetic predisposition to it.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients A Medclinic
      
Keywords: atopic dermatitis
A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine the safety and efficacy of this antibody in
      participants with rheumatoid arthritis.

      Part A of the study is an initial dose escalation phase

      Part B of the study is a randomized allocation of the entire dosing group to parallel
      treatment assignments
    


Intervention name(s): LY2189102; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Effectiveness of the PiQo4 System for Reduction of Infra-orbital Pigmentation
Condition: POH
Study type: Interventional

Summary: 
      A total of 10 healthy subjects at a single site, aged 18-65 years old and Fitzpatrick skin
      type I-IV with mild to moderate infra-orbital hyperpigmentation on the background of
      epidermal and/or dermal pigmentation that wish to improve their POH
    


Intervention name(s): PiQo4 Laser System
Intervention type(s): Device
Intervention description(s): PiQo4 Laser System for treatment of POH
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"Core Stabilization Exercises in Hearing Impaired Children"
Condition: Hearing Disorders in Children; Core Stabilization; Respiratory Muscle Strength; Respiratory Functions; Postural Control
MeSH terms: Deafness; Hearing Loss; Hearing Disorders
Study type: Interventional

Summary: 
      In this study the investigators will examine the effects of core stabilization exercises on
      respiratory muscle strength, respiratory functions and postural control in hearing-impaired
      children.
    

Detailed description: 
      Hearing organs develop together with the vestibular system and work with close cooperation.
      Because of this close neuro-anatomic relationship; cochlear, semicircular canal, or both may
      cause damage to the vestibular dysfunction, resulting in imbalance. Sensory impairment in
      children with hearing loss may lead to decreased muscle strength and respiratory function
      with balance and coordination disorders. Core stabilization is provided anatomically with
      abdominal muscles at the front, spinal and gluteal muscles at the back, diaphragm at the top
      and pelvic floor and hip muscles at the bottom. Core stabilization training is a training to
      increase the strength, endurance and neuromuscular control of the aforementioned muscles.

      When the literature is checked, the invetigators find that postural control is being
      evaluated in children with hearing impairment, but there are few studies evaluating
      respiratory functions. However, they did not encounter a study in which respiratory muscle
      strength was assessed in these children. In this study the investigators will examine the
      effects of core stabilization exercises on respiratory muscle strength, respiratory functions
      and postural control in hearing-impaired children.
    

Intervention name(s): Core Stabilization Exercises; No Intervention
Intervention type(s): Other; Other
Intervention description(s): Jeffrey's core stabilization exercise training protocol will be performed to the training group. This protocol includes exercises progressing gradually from level 1 to level 3. Level 1; static contraction training on a stable surface, level 2; dynamic training on a stable surface, level 3; dynamic and resistant training on an unstable surface.; Since no training is given to the control group during the study period, it is ethically necessary to give the same training to the control group if the benefit is achieved when the study is completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Pyridorin in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the safety, tolerability and efficacy of
      Pyridorin (pyridoxamine dihydrochloride) up to 250 mg given orally twice daily in patients
      with diabetic kidney disease.
    


Intervention name(s): Pyridorin (pyridoxamine dihydrochloride)
Intervention type(s): Drug
Intervention MeSH terms: Pyridoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetic nephropathy; Advanced Glycation Endproduct Inhibitor; Pyridorin; Pyridoxamine
Computer Modelling of the Cervical Spine Movements in Cervical Dystonia
Condition: Cervical Dystonia, Primary
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Observational

Summary: 
      Cervical dystonia (CD) is a syndrome characterized by sustained and/or phasic involuntary
      neck muscle activity causing abnormal head postures and movements. It is the most frequent
      form of adult focal dystonia. The distribution of dystonic muscles is unique for each
      patient, explaining the variety of patterns encountered.

      The therapeutic management of CD is essentially local and symptomatic: Botulinum Neurotoxin
      injections and/or specific retraining therapy programmes. Therefore, analyzing the
      characteristics of abnormal head movements and identifying the dystonic muscles are the key
      points of these treatments.

      To a better understanding of the posture and movement disorders of head and neck, we wish to
      establish a three-dimensional (3-D) computer model of cervical spine movements of ten healthy
      subjects built from images obtained with the "Cone Beam " system. Then we will compare the
      cervical posture and movements for each of ten CD patients matched in age and genre to the
      computer model. Comparison with patients' images in the axial plane reconstructed by computer
      with the 3-D computer model will lead to the description of various patterns of CD. Analysis
      of the musculoskeletal disturbances in CD should be a help to improve the localization of
      Botulinum Neurotoxin injection sites as well as retraining programmes.
    


Intervention name(s): cone beam imagery of cervical spine
Intervention type(s): Device
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        10 CD patients without Botulinum neurotoxin injection in the preceding 3 months and 10
        control subjects, age and gender matched.

        All subjetcts included in the study will undergo cervical spine imagery with the cone beam
        device (static and cervical rotation).
      
Keywords: Cervical spine; Musculoskeletal imagery; computer modelling of cervical spine; ConeBeam.
Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate change in weight as a result of switching
      from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder
      who have failed to achieve a satisfactory clinical response to quetiapine due to lack of
      efficacy or poor tolerability.
    


Intervention name(s): ziprasidone
Intervention type(s): Drug
Intervention description(s): Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
Other intervention name(s): Geodon, Zeldox
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder
Radiological vs Clinical Outcome in DRF
Condition: Distal Radius Fracture
MeSH terms: Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      Background: Several studies have investigated the degree of final displacement and its
      association with clinical outcome. There is still no consensus on the importance of
      radiological outcome and published studies do not use the same criteria for an acceptable
      alignment. Previous reports have used a linear or a dichotomized exposure in the statistical
      analysis, but no study has investigated a nonlinear association.

      Methods: We included 438 patients treated for a distal radius fracture (DRF) with either
      reduction and cast immobilization or surgery. Radiographic outcomes were determined by
      radiographs 3 months after the injury. Clinical outcome was determined by QuickDASH (qDASH),
      ROM and grip strength at 1-year after the injury. Nonlinear correlations were analysed with
      cubic splines.
    


Intervention name(s): Surgery of distal radius fracture; Reduction and cast treatment of distal radius fracture
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgery of distal radius fracture for displaced fractures; Reduction and cast treatment of distal radius fracture for minimally displaced fractures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome
Condition: Obesity; Type 2 Diabetes; Cardiovascular Diseases; Acute Exercise
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine the ability of acute exercise to regulate fat
      metabolism in muscle of overweight and obese people compared to lean people.
    

Detailed description: 
      After being informed about the study details and possible risks and benefits, 15
      overweight/obese and 15 lean participants gave written informed consent and were then
      screened and enrolled in the study. All participants then gave a muscle sample and ate a
      calorically controlled breakfast. Participants completed ~1 hour of cycling exercise on a
      stationary bike and gave a second muscle sample 4 hours after eating breakfast.
    

Intervention name(s): Acute exercise
Intervention type(s): Behavioral
Intervention description(s): All participants consumed a standardized, high carbohydrate meal (7 kcal/kg; 60% carbohydrate, 25% fat, 15% protein) and completed an exercise testing trial, expending a total of 650 kcal upon completion 4h later.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants underwent the same exact study protocol on random days throughout the study period.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Clinical Trial on Treatment of Intraventricular Hemorrhage
Condition: Intraventricular Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The specific objective of this trial is to determine the lowest dose and dose frequency
      possible with the best pharmacokinetic and safety profile and it's ability to remove a blood
      clot from the ventricular system.
    

Detailed description: 
      The purpose of this trial is to determine the efficacy and pharmacokinetics of
      intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already
      randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12
      hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most
      effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the
      optimal frequency of dosing. We propose to test if this intervention facilitates more rapid
      clot resolution, complete recovery function and decreased mortality from this condition.
    

Intervention name(s): tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)
Intervention type(s): Drug
Intervention description(s): 0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.
Other intervention name(s): rt-PA; Cathflo; Activase
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator; Fibrinolytic Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intraventricular hemorrhage (IVH); rt-PA
Antidepressant Incomplete Response Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      Observational, non-interventional, longitudinal, prospective,multicenter, open label (No
      treatment is involved). 3 assessment will be carried out . The 1st one will be on baseline,
      the 2sd one after a significant change in pharmacological treatment and 3rd one after a
      second significant change in pharmacological treatment. If there isn´t any significant change
      in therapeutic plan a control assessment will be carry out in week 10th and 24th. A
      significant treatment change is defined as a change in SSRI/SNRI, to add another SSRI/SNRI or
      a augmentation treatment added to SSRI/SNRI. The primary objective is to describe
      therapeutical strategies (antidepressant change, association with another antidepressant or
      association with another treatment) in the management of patients with MDD with incomplete
      response or intolerance to an antidepressant after a first or a second failure; and when the
      psychiatrist decide a change of strategy. Secondary objectives include: 1 - To describe the
      clinic profile of depressive patients with incomplete response or intolerance to an
      antidepressant after a first or a second failure; 2- To describe the profile of patients
      based on therapeutic strategies used and number of therapeutic strategies; 4- Evaluate the
      use of health resource due to lack of fast onset of action, and social cost (productivity,
      care givers…); 5 - To associate clinical variable with therapeutic action by psychiatrist.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatient with major depressive disorder, who has a change in pharmacological therapeutic
        plan after an incomplete response or intolerance to a treatment with an adecuate dosage of
        an antidepresant (SSRI/NSRI) (20-40 mg fluoxetine, 75-225 mg venlafaxine or equivalent) for
        at least 6 weeks.
      
Keywords: Depression; Major Depressive Disorder; SSRI resistant depression; strategies in depression
Effects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI
Condition: Spinal Cord Injuries; Obesity; Insulin Resistance
MeSH terms: Spinal Cord Injuries; Overweight; Insulin Resistance; Hypoxia
Study type: Interventional

Summary: 
      The purpose of this research is to examine changes in blood glucose control and metabolism in
      individuals with SCI and non injured controls at rest and during exercise after five days of
      exposure to IH. This response will be compared with breathing normal room air (a SHAM
      control).
    


Intervention name(s): Intermittent Hypoxia (IH); SHAM
Intervention type(s): Device; Device
Intervention description(s): Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.; Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).
Other intervention name(s): Hypoxico
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Spinal Cord Injuries; Obesity; Insulin Resistance; Intermittent hypoxia