bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the
      spine in which lateral flexion and axial rotation are seen in vertebrae with a Cobb (method
      for measuring spinal curvature) angle of 10° and above. AIS is the most common type of
      scoliosis and it occurs in the period from the onset of puberty (up to 10 years) until the
      closure of growth plates.

      Children with AIS have cosmetic effects, decrease in functional capacity, muscle weakness in
      certain parts of the body, decrease in quality of life and posture disorders. Lack of core
      stability might be causing these problems.

      Core stability training may have a positive effect for these problems experienced by children
      with AIS.

      Pathologies that cause the disease may originate from the nervous system and musculoskeletal
      system. In this study, the investigators will evaluate these systems objectively with EMG
      biofeedback and Isokinetic Testing.

      The aim of this study is to show the effect of core stability training on various problems
      (as we mentioned before) caused by the disease. In addition, the investigators of this study
      hope to contribute to the literature(with objective evaluations) about the pathological
      background and treatment of this challenging disease which the cause is unknown.
    


Intervention name(s): Home Based Traditional Scoliosis Exercises; Core Stability Training
Intervention type(s): Other; Other
Intervention description(s): Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.; Patients in this group will receive traditional scoliosis exercises. In addition, the training group will receive core stabilization exercises for multifidus, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, iliopsoas, gluteus maximus, and pelvic floor muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Isokinetic Testing; EMG Biofeedback; Core Stability
Therapeutic Cocaine Vaccine: Human Laboratory Study
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces
      selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct
      effects is unknown. The objective of this human laboratory study was to measure the
      relationship between antibody titers and the effects of smoked cocaine on ratings of
      intoxication, craving and cardiovascular effects.

      Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks
      inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and
      at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.
    

Detailed description: 
      I do not desire to provide a more extensive description.
    

Intervention name(s): Cocaine vaccine (TA-CD)
Intervention type(s): Biological
Intervention description(s): TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.
Intervention MeSH terms: Cocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine; immunotherapy; vaccination; antibody; addiction; dependence
Effect of Vitamin d and Omega 3 on Osteocalcin
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin
      levels
    

Detailed description: 
      The data about effect of vitamin D3 (VD3) and omega-3 fatty acids(omega-3FA) on plasma levels
      of osteocalcin (OCN) are scarce and conflicting and nothing is published in the literature
      about the effect of the combination of VD3 and omega-3FA on the OCN levels.

      This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other
      on PLASMA OCN levels in females and males with vitamin D deficiency (VDD).

      This randomized, controlled clinical trial was designed to test effects of 50,000 IU VD3
      weekly and 300 mg omega-3FA daily for eight weeks,separately and with each other, on the
      plasma levels of OCN and 25-hydroxy vitamin D (25OHD).

      This study was conducted during winter in 86 healthy Jordanian females and males with VDD
      with a mean age of (40± 10) years.

      Fasting serum levels for 25OHD,OCN, PTH (parathyroid hormone),calcium, phosphate, ALT
      (alanine aminotransferase), and urea were assessed at baseline and the end of the trial .
    

Intervention name(s): vitamin D3; omega-3 fatty acid; vitamin D3 and omega-3 fatty acid; control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 50,000 IU VD3 / week for 8 weeks; 300 mg of omega 3-FA once daily for 8 weeks; 50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks; no intervention
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vitamin D Deficiency; plama osteocalcin; omega-3 fatty acids
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study which will evaluate the PK, safety, and tolerability of a single
      1500 milligram (mg) oral dose of gepotidacin in subjects with normal hepatic function and in
      subjects with mild, moderate, and severe hepatic impairment. In Part 1, subjects with
      moderate hepatic impairment and subjects with normal hepatic function will be enrolled.
      Matching subjects with normal hepatic function in Part 1 (Group D), will be enrolled
      following the completion of all Day 3 assessments of the respective matched, hepatically
      impaired subject. In Part 2, subjects with mild (optional) and severe hepatic impairment and
      subjects with normal hepatic function will be enrolled concurrently based on the PK, safety,
      and tolerability data of Part 1. Subjects with mild hepatic impairment, may be studied if
      there is a significant difference in PK between subjects with moderate hepatic impairment and
      subjects with normal hepatic function. Subjects with severe hepatic impairment, will be
      studied in Part 2, provided that, the PK objectives are achieved in Part 1. A totals of 48
      subjects, are planned to be enrolled in the study. The study duration is approximately of 44
      days from Screening to Follow-up visit. The results from this study will enable the
      development of appropriate dosing recommendations in subjects with impaired hepatic function.
    


Intervention name(s): Gepotidacin
Intervention type(s): Drug
Intervention description(s): It is an immediate-release tablet (1500 mg (2 x 750 mg), containing gepotidacin (free base) an inactive formulation excipients.
Intervention MeSH terms: Gepotidacin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child-Pugh classification; Open label; Hepatic Impairment; Gepotidacin
Protein Digestibility in Older and Younger Adults
Condition: Ageing
Study type: Interventional

Summary: 
      The main goal of this study is to determine the difference in amino acid digestibility of
      milk, sorghum and black beans between older (65-80 years) and younger (20-35 years) adults
      using the dual tracer method.
    

Detailed description: 
      Older adults should meet their amino acid requirements to prevent development of sarcopenia.
      Dietary protein quality is of importance, as determined by amino acid composition and
      digestibility of the consumed protein. There is a need to investigate the impact of ageing on
      amino acid digestibility and thus quality in vivo. The dual tracer method is an indirect,
      minimal-invasive method to determine amino acid digestibility in humans. It is expected that
      amino acid digestibility decreases with age and that the effect between age groups is greater
      for poorly digestible protein sources. In this randomized, cross-over study, the researchers
      will determine the difference in amino acid digestibility of milk, sorghum and black beans
      between older (65-80 years) and younger (20-35 years) adults using the dual tracer method.
      Secondary objectives concern the difference in amino acid kinetics between older and younger
      adults and the association between gut health plasma markers and amino acid digestibility.
    

Intervention name(s): Milk; Sorghum; Black beans
Intervention type(s): Other; Other; Other
Intervention description(s): Twenty grams of the deuterium (2H) - labelled skimmed milk powder mixed with water will be consumed on one of the three different test days. The meal will be divided in 10 portions, consumed every hour. The 2H-labelled protein source is mixed with free 13C-labelled amino acids as reference. Protein free cookies are served alongside to equal macronutrient composition with the other two protein sources.; Twenty grams of the deuterium (2H) - labelled whole grain sorghum cooked with water will be consumed on one of the three different test days. The meal will be divided in 10 portions, consumed every hour. The 2H-labelled protein source is mixed with free 13C-labelled amino acids as reference.; Twenty grams of the deuterium (2H) - labelled black beans cooked with water and mashed into a puree, will be consumed on one of the three different test days. The meal will be divided in 10 portions, consumed every hour. The 2H-labelled protein source is mixed with free 13C-labelled amino acids as reference. A carbohydrate drink is served alongside to equal macronutrient composition with the other two protein sources.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will have three test days, each separated by two weeks. The participants will randomly consume one of the three protein sources on each test day respectively.
Masking: Single (Investigator)
Primary purpose: Prevention
Bilateral DLPC tDCS in Drug-resistant Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The goal of this clinical trial is to study and describe the effects of bilateral tDCS
      applied to dorso-lateral-prefrontal cortex (DLPC) in patients with drug-resistant migraine in
      terms of reduction in frequency of pain, impact of pain in daily life, quality of sleep and
      psychological measures. We finally planned to include high frequency and chronic migraine
      patients.

      The main questions it aims to answer are:

        -  Will bilateral DLPC tDCS be feasible, well tolerated and safe in drug resistant migraine
           patients?

        -  Will bilateral DLPC tDCS be effective in reducing pain frequency, intensity and its
           impact in daily life activities?

        -  Will bilateral DLPC tDCS be effective in ameliorating sleep and psychological associated
           symptoms?

        -  Will bilateral DLPC tDCS be such effective in reducing pain frequency, intensity and its
           impact in daily life activities as anti-CGRP treatments?

      Participants will undergo 2 tDCS sessions daily for 2 consecutive weeks. Patients will be
      blinded to treatment and will be divided in two groups (real vs placebo). A third group of
      patients, age-matched to the other two, will undergo anti-CGRP treatment. Patients will be
      asked to complete Patient-Reported Outcomes (PROMs) scales at baseline, one week after the
      end of the treatment and at 6 months after the end of the treatment.

      Researchers (blinded to the treatment) will compare the group that underwent real tDCS
      treatment vs the one that underwent placebo tDCS vs the one that underwent anti-CGRP drugs to
      see if bilateral DLPC tDCS is effective in reducing migraine frequency, intensity and impact
      and if bilateral DLPC tDCS is such effective as anti-CGRP treatment.
    


Intervention name(s): Transcranial direct current stimulation (tDCS); anti-CGRP-mAbs
Intervention type(s): Device; Drug
Intervention description(s): TDCS was delivered by a DC-Stimulator (Newronika, Italy) over both DLPC. The electrodes (35 cm2) were soaked in 0.9% NaCl. The anode was positioned on the left dorsolateral prefrontal cortex and the cathode on the right dorsolateral prefrontal cortex.; CGRP-mAbs have been the first target-driven treatment to be approved for migraine prevention. Their efficacy and safety have been demonstrated in randomized controlled trials (RCT) as well as, in real-world evidence (RWE) studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine; drug-resistant; tDCS; DLPC; Neuromodulation; anti CGRP
The HEADWIND Study - Part 3
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      To analyse driving behavior of individuals with type 1 diabetes in eu- and mild hypoglycaemia
      using a validated research driving simulator. Based on the driving variables provided by the
      simulator the investigators aim at establishing algorithms capable of discriminating eu- and
      hypoglycemic driving patterns using machine learning classifiers.
    

Detailed description: 
      Hypoglycaemia is among the most relevant acute complications of diabetes mellitus. During
      hypoglycaemia physical, psychomotor, executive and cognitive function significantly
      deteriorate. These are important prerequisites for safe driving. Accordingly, hypoglycaemia
      has consistently been shown to be associated with an increased risk of driving accidents and
      is, therefore, regarded as one of the relevant factors in traffic safety. Therefore, this
      study aims at evaluating a machine-learning based approach using in-vehicle data to detect
      hypoglycemia during driving at an early stage.

      During controlled eu- and hypoglycemia, participants with type 1 diabetes mellitus drive in a
      validated driving simulator while in-vehicle data are recorded. Based on this data, the
      investigators aim at building machine learning classifiers to detect hypoglycemia during
      driving.
    

Intervention name(s): Controlled hypoglycaemic state while driving with a driving simulator
Intervention type(s): Other
Intervention description(s): Participants arrive in the morning after an overnight fast. During the controlled hypoglycaemic state, participants drive on a designated circuit using a driving simulator. Initially, a euglycaemic state (5.0-8.0 mmol/L) is kept stable and blood glucose is then progressively declined targeting at a level between 3.0-3.5 mmol/L by administering insulin. Blood glucose is kept stable in the hypoglycaemic range for 30 minutes. Thereafter, blood glucose is raised again and kept stable for another 30 minutes at an euglycaemic level between 5.0-8.0mmol/L. During the procedure, the investigators analyse counterregulatory hormones. Heart rate, skin conductance, CGM values, eye movement and facial expression are recorded by a smart-watch, a CGM device, an eye-tracker and an onboard camera, respectively. Participants are blinded to the blood glucose values during the procedure and have to rate their symptoms and their driving performance on a 0-6 scale every 15 minutes.
Intervention MeSH terms: Hypoglycemic Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Automotive Technology; Hypoglycemia; Hypoglycaemia; Driving; Driving simulator
FDG Uptake in Vaginal Tampons is Due to Urine
Condition: Cancer
Study type: Interventional

Summary: 
      The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and
      can potentially impair image interpretation.

      The aim of this study is to determine the etiology of this artefact and identify potential
      means how to prevent it.
    

Detailed description: 
      In this prospective, Institutional Review board approved study we included 44 women referred
      to FDG PET/CT for staging or follow-up in an oncology setting. All women were provided a
      normal commercial or modified vaginal tampon with a silicon coated base to be used during
      examination. Images were analyzed to determine the localization and the FDG uptake in the
      tampons. Between the uptake phase and imaging, all patients were asked to void. After image
      acquisition, tampons were individually analyzed for creatinine concentration, blood traces,
      position relative to the pubococcygeal line, and FDG activity. Statistical significance was
      determined by means of the Mann-Whitney U test.
    

Intervention name(s): modified vaginal tampon
Intervention type(s): Device
Intervention description(s): modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination
Other intervention name(s): Ob® Regular; Johnson & Johnson, with silicon seal
Intervention MeSH terms: Silicon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: FDG PET/CT, vaginal tampon, urinary contamination, pitfall
A Study of Japanese Rheumatoid Arthritis Participants
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety and tolerability of 48 weeks
      subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior
      LY2127399 clinical study. At the end of the 48-week treatment period, participants will
      participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to
      assess B-cell recovery.
    


Intervention name(s): LY2127399
Intervention type(s): Drug
Intervention description(s): Administered subcutaneously every 4 weeks for 48 weeks
Other intervention name(s): tabalumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
Condition: Keratoconus; Corneal Opacity
MeSH terms: Keratoconus; Corneal Opacity
Study type: Interventional

Summary: 
      The purpose of the study is evaluating safety and clinical efficiency of full femtosecond
      laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus
      and corneal opacities
    

Detailed description: 
      Keratoplasty is the most widely spread tissue transplantation procedure. Although penetrating
      keratoplasty (PKP) is still commonly used for curing corneal dystrophy and opacities of
      different genesis, lamellar techniques provide significant advantages in terms of safety and
      predictability.

      Al in all 13 FS-ALK procedures were performed for 11 eyes with advanced keratoconus and 2
      eyes with superficial corneal scattering Before and after surgery uncorrected visual acuity
      (UCVA), best spectacle-corrected visual acuity (BSCVA), postoperative astigmatism,
      endothelial cell loss, central cornea thickness, residual recipient's tissue thickness,
      corneal hysteresis (CH) and corneal resistance factor (CFR) were evaluated . At 1-year
      follow-up Confoscan investigation of donor-recipient interface was performed.

      All FS-ALK procedures were performed with Intralase FS 60kHz femtosecond laser in a following
      way. At first a 80% thickness corneal graft was prepared. Then maximum thickness recipients
      corneal dissection was performed according to OCT (optical coherence tomography) data and
      superficial tissue was removed. Transplant was fixed in a resulted bed by continuous suture.
    

Intervention name(s): FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
Intervention type(s): Procedure
Intervention description(s): The procedure was a non-penetrating transplantation of 80% thickness corneal graft
Other intervention name(s): Femto-ALK
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: femtosecond laser; anterior lamellar keratoplasty; atomic-force microscopy
Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol
Condition: Pain After Knee Arthroscop
Study type: Interventional

Summary: 
      Comparison between preemptive and postoperative intraarticular injection of tramadol on pain
      sensation after arthroscopy
    

Detailed description: 
      220 patients assigned for therapeutic knee arthroscopy were divided into four equal groups in
      this prospective comparative study. All patients received IAI of 20 ml (0.5%) levopubivacaine
      alone in Group C; with 100 mg tramadol as PE (Group PE), at end of surgery (Group PO) or
      divided as 50 mg tramadol + 20 ml 0.25 % levobupivacaine as PE and 50 mg trmadol + 20 ml 0.25
      % levobupivacaine as PO (Group PE/PO). Numeric rating scale (NRS) was used to assess pain
      sensation. Duration till request of rescue analgesia and number of requests were recorded.
      Patients' satisfaction concerning efficacy of PO analgesia was assessed using Iowa
      Satisfaction with Anesthesia Scale.
    

Intervention name(s): Levobupivacaine Hydrochloride 2.5 MG/ML
Intervention type(s): Drug
Intervention description(s): Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative
Other intervention name(s): Tramadol 50 MG/ML; Tramadol 100 MG/ML; Levobupivacaine Hydrochloride 5MG/ML
Intervention MeSH terms: Tramadol; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Tramadol; Intra-articular injection; Preemptive; post-arthroscopy pain; Levobupivacaine