bioihbjkbjnl/mcl2 huggingface dataset:
The Effectiveness of Robotic Gait Training in Children With Neurological Impairment
Condition: Acquired Brain Injury; Cerebral Palsy
MeSH terms: Brain Injuries; Cerebral Palsy
Study type: Observational

Summary: 
      The recovery of walking ability is one of the primary rehabilitation goals for children with
      neurological impairment. The aim of the study is to investigate the clinical effectiveness of
      rehabilitation treatments based of Robotic-Assisted Gait Training (RAGT). Additional goals of
      the research are to identify the specific effects of RAGT in children with different
      etiologies (acquired brain injury and cerebral palsy) and with different levels of function
      (according to the Gross Motor Function Classification System).
    


Intervention name(s): Robotic Assisted Gait Training (Lokomat); Physiotherapy
Intervention type(s): Device; Procedure
Intervention description(s): The RAGT treatment consisted of sessions lasting 45 minutes each performed with the commercially available Lokomat device. The same exercises were offered to the children with preset duration, speed, and difficulty. For all patients, the initial body-weight support was set at 50%, and was then gradually decreased according to the individual functional capacity. The guidance force was initially set to 100% for all children, and then gradually reduced.; The physiotherapic sessions aimed at strengthening the gluteus and quadriceps muscles, stretching the hip flexor and hamstrings muscles, increasing static balance, increasing dynamic balance, increasing functional abilities, improving ground gait and climbing stairs.
Other intervention name(s): RAGT
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Neurophysiatric care unit
      
Keywords: Robotic-Assisted Gait Training; Gait Rehabilitation
Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and
      consolidation. Standard chemotherapy combination for induction treatment associates
      cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About
      60-70% of patients achieved complete remission after this standard chemotherapy. As
      cytarabine competes with endogenous nucleotides to exert its activity, the aim of this
      protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of
      the induction treatment. Thus, intracellular nucleotides levels will be determined in
      peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment,
      and results will be compared with the efficacy of the treatment. This parameter will be
      assessed by the achievement of complete remission.
    


Intervention name(s): Biological analyses
Intervention type(s): Biological
Intervention description(s): Biological analyses will be realized on samples collected before induction treatment and at the end of bone marrow aplasia i.e. about day 30 to determine the nucleotide pools in peripheral blood mononuclear cells.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients or healthy volunteers over 18 years with acute myeloid leukemia (except acute
        myeloid leukemia3)
Non-oxidative Metabolite Profiles After Increasing Doses of Ethanol
Condition: Alcohol Consumption; Healthy
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to study the profile of ethanol and non-oxidative biomarkers (ethyl
      glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental administration of
      increasing doses of alcohol in adult subjects.
    

Detailed description: 
      The abuse of alcohol causes serious health and social problems. Alcohol consumption can be
      monitored by detecting biomarkers. In current practice indirect biomarkers (mean corpuscular
      volume, transaminases, gammaglutamyl or carbohydrate-deficient transferrin) are used,
      although direct biomarkers of alcohol, including alcohol itself and metabolites also exist.

      Biomarkers of alcohol consumption are used as tools to prevent health and social problems
      related with alcohol, allowing the identification of subjects at risk of abuse, dependence or
      withdrawal and to assess the efficacy of treatments for alcohol dependence.

      Non-oxidative metabolites (ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters)
      have longer biological half-life than ethanol and accumulate in tissues after consumption.

      The objective of the study is to study the profile of ethanol and non-oxidative biomarkers
      (ethyl glucuronide, ethyl sulphate and fatty acid ethyl esters) after experimental
      administration of increasing doses of alcohol in adult subjects.

      Subjects will be genotyped for genetic polymorphisms of proteins related to ethanol
      metabolism and effects (as alcohol dehydrogenase and aldehyde dehydrogenase), and the
      genotypes will be used to evaluate their influence in the results.
    

Intervention name(s): 10 g ethanol; 20 g ethanol; 40 g ethanol; 60 g ethanol; 80 g ethanol
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Alcohol single oral dose; Alcohol single oral dose; Alcohol single oral dose; Alcohol single oral dose; Alcohol single oral dose
Other intervention name(s): Vodka Absolut®; Vodka Absolut®; Vodka Absolut®; Vodka Absolut®; Vodka Absolut®
Intervention MeSH terms: Ethanol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Ethanol; Fatty acid ethyl esters; Ethyl glucoronide; Ethyl sulphate; Pharmacokinetics
Limitations of Using a Sheimpflug Image-Based Device for Measuring Anterior Chamber Depth in Pseudophakic Eyes
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      There have been numerous studies comparing various ACD measurements in phakic eyes,while
      researches comparing ACD in pseudophakic eyes are less extensive. With the recent popularity
      of presbyopia correction, measuring the ACD will facilitate differentiating pseudophakic
      accommodation from pseudoaccommodation. It is thus mandatory to verify the accuracy of ACD
      measurement of these devices since the innovation of various IOLs in the recent decade makes
      this task more complicated. In this study, we will assess the limitations of using Pentacam
      for ACD measurement in pseudophakic eyes and compare Pentacam measurement with IOLMaster and
      A-scan measurements.
    

Detailed description: 
      In this prospective study, ACD was measured in 90 phakic and 94 pseudophakic eyes by
      Pentacam, IOLMaster and A-scan. Correlations and differences between the three measurements
      were investigated. The accuracy in detecting the anterior lens surface in pseudophakic eyes
      was also assessed.Differences in ACD-Pen, ACD-IOLM, and ACD-A were analyzed using one-way
      analysis of variance (ANOVA). When an overall significance of P< 0.05 was obtained, pair-wise
      comparisons were made using Tukey's multiple comparison t tests. The association between
      ACD-Pen, ACD-IOLM, and ACD-A was assessed using Pearson's correlation test. The distribution
      of erroneous ACD-Pen measurement for the three IOLs was analyzed with the chi-square test. In
      all analyses, P <0.05 was considered statistically significant.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Ninety phakic eyes were randomly selected for study from the outpatient clinic. Ninety-four
        pseudophakic eyes that had a standard clear cornea phacoemulsification with one of three
        acrylic IOLs (MA60BM, SA60AT, SN60AT) implanted into the capsular bag by the same surgeon
        were also studied.
      
Biospecimen description: 
      no specimen
    
Keywords: pseudophakic; anterior chamber depth; Pentacam
Multilevel Intervention Based on Colorectal Cancer (CRC) and Cervical Cancer Self-screening in Rural, Segregated Areas
Condition: Colorectal Cancer Screening; Cervical Cancer Screening
MeSH terms: Colorectal Neoplasms; Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests
      and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational
      materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer
      screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated
      counties of Pennsylvania.

      The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted
      educational materials, to women in rural, segregated areas could help increase cancer
      screening, reduce geographic cancer disparities, and improve public health.
    

Detailed description: 
      In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests
      and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational
      materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer
      screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated
      counties of Pennsylvania. A control group of 110 women, also recruited through FQHCs in
      rural, segregated counties of Pennsylvania, will be used for comparison; these women will
      receive standard-of-care reminders for cancer screening and complete the baseline and
      follow-up surveys.

      The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted
      educational materials, to women in rural, segregated areas could help increase cancer
      screening, reduce geographic cancer disparities, and improve public health.
    

Intervention name(s): Self-sampling HPV test; Fecal occult blood test
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Tests for human papillomavirus from cervical cell sample; Tests for human hemoglobin from blood in fecal samples
Other intervention name(s): Evalyn® Brush; InSure® test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Environmental barriers to cancer screening; Person-level barriers to cancer screening
Ulimorelin Study of Efficacy and Safety (ULISES 007)
Condition: Gastrointestinal Dysmotility
Study type: Interventional
Phase: Phase 3

Summary: 
      Post-operative administration of ulimorelin is expected to reduce time to recovery of
      Gastrointestinal (GI) function in patients who have undergone partial large bowel resection.
    


Intervention name(s): Ulimorelin Intravenously (IV); Ulimorelin Intravenously (IV); 5% dextrose in water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 480 microg/kg daily (QD); 160 microg/kg daily (QD); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bedside Ultrasound Assessment of Gastric Content and Volume
Condition: Gastroscopy
Study type: Interventional

Summary: 
      Patients undergoing gastroscopy will undergo two pre-procedure ultrasound scans of the
      stomach, once on arrival in the unit and on an empty stomach and a second time after
      consumption of a randomized amount of apple juice (0, 50, 100, 200, 300 or 400 mL).
      Immediately after ingestion and the second ultrasound scan, subjects will have their
      gastroscopy which will start by suctioning out the apple juice. Measurements of stomach fluid
      volume conducted by ultrasound will be compared to the actual volume removed during the
      gastroscopy procedure.
    


Intervention name(s): Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.
Intervention type(s): Other
Intervention description(s): Ultrasound scan of the stomach followed by ingestion of 0, 50, 100, 200, 300, or 400 mL of apple juice, followed by second ultrasound scan of the stomach, followed by gastroscopic suctioning of stomach content.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Keywords: gastroscopy; ultrasound; stomach volume; patients having gastroscopy
Treatment of Prepubertal Labial Adhesions
Condition: Prepubertal Labial Adhesions
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      First-line treatment for labial adhesions in prepubertal girls has been topical estrogen.
      This study aims to evaluate an alternative and less costly option of treatment with
      potentially less side effects.

      Primary Hypothesis:

      There will be a difference in complete resolution of labial adhesions with topical estrogen
      with lateral traction as compared to an emollient with lateral traction.
    

Detailed description: 
      The etiology of labial adhesions is unclear but appears to be related to hypoestrogenism in
      combination with vulvar irritation. For many years, first-line treatment for labial adhesions
      in prepubertal girls has been topical estrogen. With the use of topical estrogen, 50% of
      labial adhesions resolve in 2 to 3 weeks and most labial adhesions resolve with 6 weeks of
      treatment. However, because topical estrogen is systemically absorbed, its use is associated
      with side effects such as breast budding, vulvar hyperpigmentation, vaginal bleeding. There
      is a high risk of recurrence of labial adhesions of up to 35% after treatment with topical
      estrogen. In addition, topical estrogen is costly. Therefore, there continues to be
      controversy over the optimal treatment of labial adhesions in prepubertal girls.

      Generally, for medical treatment of labial adhesions, topical estrogen is applied to the
      adhesion whist applying gentle lateral traction to promote separation of the labia. It is,
      therefore, plausible that the lateral traction applied to the adhesion site is what
      ultimately results in the separation of the labial fusion, while the use of estrogen improves
      healing after mechanical separation.

      This is a single site, prospective, randomized, double-blinded study evaluating the
      comparative effectiveness of topical estrogen with lateral traction versus topical emollient
      with lateral traction for the treatment of labial adhesions in prepubertal girls.
    

Intervention name(s): Estradiol cream 0.01%; Cetaphil
Intervention type(s): Drug; Drug
Intervention description(s): Apply a pea-sized amount to the labial adhesion with lateral traction twice daily; Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
Other intervention name(s): Estrace Vaginal
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vulvar disease, adhesions, topical therapy; Labial adhesions prepubertal girls; Labial agglutination; Labial fusion
Effect of Oxytocin on Craving and Therapy Response
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of this study is to examine the impact of a medication called oxytocin on
      marijuana use and therapy response in people who frequently use marijuana.
    

Detailed description: 
      Oxytocin has been shown to promote trust, social bonding, and calmness; however, its
      potential additive effects with a therapy intervention have not been explored in
      marijuana-dependent individuals. In the proposed study, the impact of intranasal oxytocin on
      therapy effectiveness and marijuana use outcomes following a brief therapy intervention will
      be investigated. It is hypothesized that oxytocin administration (vs. placebo) will improve
      treatment satisfaction and decrease marijuana use.
    

Intervention name(s): Oxytocin; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.; Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.
Other intervention name(s): Pitocin; Placebo
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: marijuana; substance abuse; drug abuse; marijuana dependence; drug addiction
Olopatadine Eye Drops and Allergy Skin Testing
Condition: Allergic Rhinitis; Allergic Conjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional

Summary: 
      Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test
      reactivity.
    


Intervention name(s): olopatadine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day; placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day
Intervention MeSH terms: Olopatadine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: allergy; skin testing; eye drops; antihistamines
Alcohol and Breast Cancer (ABC) Trial
Condition: ER+ Breast Cancer; Breast Cancer; Aromatase Inhibitors
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research study is a pilot study, which is the first time investigators are examining the
      effect of light alcohol consumption on sex hormones among postmenopausal women with estrogen
      receptor-positive (ER+) breast cancer taking an aromatase inhibitor

      The names of the study exposures involved in this study are:

        -  White wine

        -  White grape juice
    

Detailed description: 
      This research study is trying to to help understand whether light alcohol consumption causes
      short-term changes in the levels of estrogen, progesterone and testosterone, called sex
      hormones, among postmenopausal women with estrogen and/or progesterone receptor positive
      breast cancer taking estrogen-blocking medications called aromatase inhibitors.

      The research study procedures include one screening visit to obtain informed consent, four
      study visits with blood draws, and ten weekly phone calls and online questionnaires over the
      ten weeks of the study.

      This research study involves 10 weeks of participation, including 3 weeks consuming one
      serving of white wine daily, 3 weeks consuming one serving of white grape juice daily, and 2
      weeks of drinking neither alcohol nor grape juice before each of these 3-week drinking
      periods.

      In this experimental study, participants will be asked to drink white wine and white grape
      juice, which are not consumed as the standard of care. The U.S. Food and Drug Administration
      (FDA) has not approved alcohol as a treatment for any disease.

      It is expected that about 20 women will take part in this research study.
    

Intervention name(s): White Wine; Grape Juice
Intervention type(s): Other; Other
Intervention description(s): One serving (5 ounces) of white wine daily for 3 weeks; One serving (6 ounces) of white grape juice daily for 3 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: ER+ Breast Cancer; Breast Cancer; Aromatase Inhibitors; Anastrozole; Letrozole; Exemestane
Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence
Condition: Urinary Incontinence, Stress; Urge Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge; Urinary Incontinence, Stress
Study type: Observational

Summary: 
      Aims: To assess pelvic floor muscle (PFM) strength in women with stress urinary incontinence
      (SUI) and urgency urinary incontinence (UUI).

      Methods: 51 women were prospectively divided into two groups, according to the symptoms as
      SUI (G1 = 22) or UUI (G2 = 29). Demographic data, such as number of Pads/ 24 hours, number of
      micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for
      which an urgent void could be voluntarily postponed), number of parity and vaginal deliveries
      were obtained using a clinical questionnaire. Objective urine loss was evaluated by 60-min
      Pad Test. Subjective [urine stream interruption test (UST), visual survey of perineal
      contraction and transvaginal digital palpation] and objective (vaginal manometry) evaluations
      of PFM were performed in all patients.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The sample size was established considering a significance level of 5%, the test power of
        80%, and the estimated error of 10%. According to these results and considering the range
        between percentages of answers as the casual error, each group was established with
        approximately 20 participants.
      
Keywords: pelvic floor evaluation,; women,; stress urinary incontinence;; urgency urinary incontinence.