bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Physostigmine on Patient-Controlled Analgesia (PCA) in Postoperative Intensive Care Patients
Condition: Pain
Study type: Observational

Summary: 
      The study is to evaluate the influence of physostigmine in the postoperative period in
      intensive care patients considering pain quality, opioid consumption, hemodynamics and
      mobilisation.
    

Detailed description: 
      Pain management is of major concern in the postoperative period, mostly based on opioids. In
      numerous experimental and clinical trials cholinergic mechanisms have been demonstrated to
      play an important antinociceptive role. Physostigmine, a central cholineresterase inhibitor,
      has been shown to produce analgesia and enhance opiate analgesia after systemic injection.
      This action is not based on µ-receptor (opioid) activity, but can be mostly explained by
      stimulation of serotonine (5-HT-3) receptors. The major withdrawal of utilizating
      physostigmine in postoperative care, is due to its short duration of action.

      In the present study, we examined the effect of a continuous intavenous physostigmine
      application during a patient-controlled analgesia with piritramide for 48 hours compared to a
      placebo infusion with NaCl.

      Major concern was set for consumption of analgesics, VAS-pain scale, hemodynamics,
      mobilisation and side effects.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Elective major surgery, postoperative ICU patients
      
Keywords: physostigmine; postoperative analgesia; pain; patient-controlled analgesia; Opioid consumption; Pain quality (VAS Score); Hemodynamics; Mobilisation; Side effects
Immediate Dental Implant Placed in the Presence of Chronic Inflammatory Periapical Lesions
Condition: Immediate Dental Implant; Tooth Exratction; Periapical; Infection
Study type: Interventional

Summary: 
      Compromised teeth with periapical pathologies are removed before dental implant placement and
      sockets are left to heal.

      Some clinicians began to immediately place dental implants in fresh extraction sockets
      associated with chronic inflammatory periapical lesions and these studies revealed high
      success rates
    

Detailed description: 
      12 implants will be immediately placed in sockets associated with chronic periapical
      granuloma. Clinical (Wound healing, Pain, swelling, implant stability) and radiographic
      parameters (Peri-implant radiolucency) will be evaluated
    

Intervention name(s): Immediate dental implants
Intervention type(s): Procedure
Intervention description(s): Implants will be immediately placed in sockets associated with chronic periapical granuloma Extraction of non-restorable Teeth with periapical granuloma and socket debridement will be done then implants will be placed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, randomized, double-blind, single ascending dose,
      placebo-controlled study, in subjects aged 45-80 years with stable mild to moderate heart
      failure due to left ventricular systolic dysfunction, to evaluate the safety, tolerability,
      and pharmacokinetics of escalating single intravenous infusion doses of Bendavia™ (MTP-131).
    


Intervention name(s): MTP-131; MTP-131; MTP-131; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): MTP-131 (low dose) administered as single intravenous infusion over 4 hours; MTP-131 (intermediate dose) administered as single intravenous infusion over 4 hours; MTP-131 (high dose) administered as single intravenous infusion over 4 hours; Placebo Comparator (at each dose cohort) administered as single intravenous infusion over 4 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Congestive Heart Failure; Bendavia™; MTP-131
Changes in Motor Cortex Following Exercises for Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The motor cortex of the brain changes following chronic pain and injury, and this is linked
      to pain-associated changes in motor behaviour. This study aimed to investigate whether
      therapeutic exercises in patients with chronic pain can induce reorganisation of the motor
      cortex and restore normal motor behaviour. The investigators hypothesised that motor training
      can induce reorganisation of the motor cortex and that these changes are related to improved
      motor behaviour.
    

Detailed description: 
      The sensory and motor systems can reorganize following injury and learning of new motor
      skills. Recently we observed adaptive changes in motor cortical organization in patients with
      chronic back pain, which are closely linked to changes in motor behavior. Although
      pain-related alterations in behavior can be trained and are associated with improved
      symptoms, it remains unclear whether these meaningful functional outcomes are related to
      motor cortical reorganization. Here we investigate the effects of two interventions in people
      with chronic back pain: skilled motor training and a control intervention of self-paced
      walking exercise. We measured motor cortical excitability (motor threshold (MT)) and
      organization (center of gravity (CoG) and map volume) of the deep abdominal muscle,
      transversus abdominis (TrA), using transcranial magnetic stimulation (TMS). In addition,
      motor behavior of TrA was assessed during single rapid arm movements. The study helps to
      elucidate the mechanisms of specific motor exercises in chronic back pain management.
    

Intervention name(s): Skilled motor training; Walking exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This involves training subjects to independently and cognitively activate the deep abdominal muscles, transversus abdominis, with minimal or no activity in other trunk muscles. The contraction is held for 10 seconds and subjects complete three blocks of ten contractions, twice per day for two weeks. This training protocol is commonly used clinically for people with chronic back pain.; The control intervention involves walking exercises for ten minutes, twice per day. Subjects are advised to walk at their own pace with no instructions on activation of specific trunk muscles. The exercise is performed over two weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: low back pain; motor training; motor cortex; brain plasticity
Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
Condition: Chronic Refractory Low Back and Leg Pain
Study type: Observational [Patient Registry]

Summary: 
      The main purpose of this study is to establish the extent that chronic pain patients
      implanted with surgical, laminectomy-type, leads experience position-related variation in
      spinal cord stimulation therapy and to investigate the effects of manual versus automatic
      position-adaptive spinal cord stimulation on clinical outcome.
    

Detailed description: 
      A single-center, prospective, randomized study with a two-arm crossover design. The primary
      objective of this study is to establish threshold and therapeutic stimulation parameters for
      the RestoreSensor neurostimulator in response to postural changes. The secondary objective is
      to compare the effectiveness of spinal cord stimulation with manual versus automatic
      position-adaptive settings for chronic refractory low back and/or extremity pain.
    

Intervention name(s): RestoreSensor Neurostimulation
Intervention type(s): Device
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with chronic refractory back and leg pain associated with failed back
        surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy
        refractory to conservative and surgical interventions.
Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the therapeutic equivalence and safety of
      Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).
    

Detailed description: 
      The objectives of this study are to evaluate the therapeutic equivalence and safety of
      Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%) in the treatment of acne vulgaris and
      to demonstrate the superiority of the efficacy of the test and reference products over the
      placebo.
    

Intervention name(s): Adapalene Gel 0.3%; Differin®; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Adapalene Gel 0.3% applied to the entire face once daily for 84 consecutive days; Differin® applied to the entire face once daily for 84 consecutive days; Placebo (vehicle of the test product) applied to the entire face once daily for 84 consecutive days
Other intervention name(s): Adapalene; Adapalene; Vehicle
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Genetic Factors on Outcomes of Kidney Transplant Patients With Tacrolimus-based Therapy
Condition: Kidney Transplantation
Study type: Observational

Summary: 
      The purpose of this study is to identify the influence of genetic and clinical factors on the
      clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression
      in Taiwan.
    

Detailed description: 
      Tacrolimus (TAC) is the most important immunosuppressants for maintenance therapy after
      kidney transplantation. Many genetic and clinical factors had been found to have effect on
      TAC pharmacokinetics (PK). Whether these factors affect clinical outcomes is still
      controversial.

      In this retrospective study, investigators will review records of kidney transplant patients
      with TAC based immunosuppression recruited from a previous study (IRB approval number:
      201512005RINC) to understand the influence of clinical and genetic factors on their 3-years
      clinical outcomes, including biopsy-proven acute rejection, patient survival, graft survival
      and safety issues of kidney transplant patients.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Kidney transplant recipients who underwent transplantation at National Taiwan University
        Hospital, and received tacrolimus based immunosupression
      
Keywords: tacrolimus; clinical outcomes; genetic polymorphism; clinical factors
miRNA-155 Assay Before and After Immunotherapy and Probiotics
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aimed to explore miRNA-155 change in response to sublingual immunotherapy
      (SLIT), probiotics and combined treatment with SLIT and probiotics in AR children.
    

Detailed description: 
      Allergic rhinitis (AR) is an inflammatory state characterized by a disturbance of
      immunoregulatory mechanisms that leads to an amplified T helper "Th-2" response. Micro-RNAs
      (miRNAs) are short single-stranded RNA molecules that post transcriptionally control gene
      expression and can mediate allergic process. The aim of this study was to explore miRNA-155
      change in response to sublingual immunotherapy (SLIT), probiotics and combined treatment with
      SLIT and probiotics in AR children.
    

Intervention name(s): Lacteol fort; Standardized Timothy Grass Pollen; Lacteol fort and Standardized Timothy Grass Pollen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lacteol fort is a drug containing lactobacilli; SLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) .; Lacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases.
Intervention MeSH terms: Calcium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group I included 15 cases who received probiotics only. Group II included 15 children who received SLIT. Group III included 15 children who received probiotics and SLIT.
Masking: None (Open Label)
Primary purpose: Other
ExerCube Training on Executive Functions in Young Athletes
Condition: Effects of Exergaming on Cognitive Functions in Young Athleten
Study type: Interventional

Summary: 
      Competitive game sports require the existence of several sport-specific skills. In
      particular, game sport athletes need a good set of skills in order to perform well on the
      field. Therefore, it is important for athletes, especially young athletes, not only perform
      their sport, but also perform variable trainings, which differently train/trigger
      sport-specific skills. One skill set that is important in competitive game sports are
      so-called executive functions. Executive functions are needed for action planning and
      adaptation to the individual environmental situation, e.g. inhibition, flexibility and
      divided attention. A form of training that is very promising in this respect is exergaming as
      nowadays coaches are using virtual reality simulations to create realistic training
      environments. An exergame that combines this cognitive stimulation with whole-body movements
      in a motivating training environment is the ExerCube. Until now, however, evidence is lacking
      how an additional holistic exergame training can influence executive functioning in young
      athletes. Therefore, this study aims to get preliminary insight into the effects of the
      ExerCube performance on the executive function in young athletes (primary objective). The
      participants will be allocated into either the intervention group (ExerCube training) or the
      control group (no additional ExerCube training). The intervention group will train 2 times
      per week for about 30 minutes over a time frame of 10 weeks. Additionally, to consider the
      effects of the training environment, the secondary objectives include training motivation,
      enjoyment and flow as well as mental well-being.
    


Intervention name(s): Exergame Training
Intervention type(s): Other
Intervention description(s): An exergame combines exercise and gaming in a holistic approach.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Exergaming; Cognitive Functions; Young athletes; Training
Mobile Sleep and Growth Study
Condition: Childhood Sleep Promotion
Study type: Interventional

Summary: 
      The purpose of this research study is to see if we can help parents to get their children to
      go to bed earlier. This may help children to improve their sleep. The study will use a
      web-based study platform and an activity monitor.
    


Intervention name(s): Mobile Sleep and Growth Study
Intervention type(s): Behavioral
Intervention description(s): The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State
Condition: Severe Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Design studies of nebulization in COPD does not respond adequately to the clinically relevant
      question: the intervention of administering nebulized bronchodilators at home it is likely to
      make a profit, compared to the standard optimized treatment as defined by the recommendations
      of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical
      value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of
      profit in this context is based on criteria of dyspnea, quality of life, use of health system
      (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).
    


Intervention name(s): Atrovent + Bricanyl or Atrovent + Ventoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks; 1 capsule lactose during 48 weeks
Intervention MeSH terms: Terbutaline; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: weaned tobacco; Has not submitted an exacerbation in the past 3 months
Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis; Inflammation
Study type: Interventional

Summary: 
      The main objective of this study is to show that there is a concordance between lung disease
      at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis
      asymptomatically.

      This will identify at the first examination at 8 weeks, newborns who have the most impaired
      lung function at 13 months. To meet this objective an assessment of their lung function at 9
      weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.
    


Intervention name(s): assessment of lung function
Intervention type(s): Other
Intervention description(s): measurement of lung volumes and flow rates of bronchial
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were
      considered to benefit from vaccination to prevent invasive disease caused by Neisseria
      meningitides serogroup C.
    

Detailed description: 
      At the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against
      meningitis. All patients received a challenge at the month 6 visit with a low dose of meningo
      polysaccharide vaccine. A control group of healthy subjects (not suffering from atopic
      dermatitis) received only the vaccination and the challenge dose.
    

Intervention name(s): tacrolimus ointment 0.03%; hydrocortisone acetate ointment 1%; hydrocortisone butyrate ointment 0.1%; Meningitec; AC VAX
Intervention type(s): Drug; Drug; Drug; Biological; Biological
Intervention description(s): topical application; topical application; topical application; im injection; im injection
Other intervention name(s): Protopic 0.03%; ATC code H02AB09; ATC code H02AB09
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Hydrocortisone-17-butyrate; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atopic dermatitis; meningitis; vaccination; tacrolimus; steroids; equivalence response; meningococcal vaccine
Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis
Condition: Insomnia; Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid; Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia
      related to rheumatoid arthritis (RA).
    

Detailed description: 
      A multicenter, randomized, double-blind, placebo controlled, parallel group study of
      eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis. This study was
      previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon
      Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion
      Pharmaceuticals Inc.
    

Intervention name(s): Eszopiclone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): eszopiclone 3 mg; placebo tablet
Other intervention name(s): Lunesta; S-zopiclone
Intervention MeSH terms: Eszopiclone; Zopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia related to rheumatoid arthritis (RA)
Effects of Aerobic Exercise Detraining
Condition: Motor Activity; Body Weight; Obesity
MeSH terms: Body Weight
Study type: Observational

Summary: 
      The proposed study seeks to better understand the role of body weight, energy expenditure,
      and energy intake as mechanisms of body weight gain during detraining following aerobic
      exercise. It is hypothesized that participants in the higher dose exercise group will have
      greater body weight gain compared to the lower exercise dose and control group from wk 24 to
      wk 76 follow-up.
    

Detailed description: 
      Eligibility criteria include having successfully completed the main E-Mechanic study, be
      willing to archive blood samples and not being currently enrolled in another study that may
      effect body, energy intake or energy expenditure. The investigators will measure body weight,
      waist/hip circumference, blood pressure, body composition, physical activity, questionnaire
      about appetite/food intake and physical fitness.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants that successfully enrolled and completed the E-Mechanic study and are not past
        88 weeks study randomization.
      
Biospecimen description: 
      serum, plasma
    
Keywords: Physical Inactivity; Aerobic Exercise Detraining; Body Weight; Energy Expenditure; Metabolic Syndrome