bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of an Online Problem-solving Intervention for Aggression
Condition: Aggression
MeSH terms: Aggression
Study type: Interventional

Summary: 
      Aggressive behaviour among adolescents is a social problem that can be reduced by social
      problem-solving interventions. However, these interventions usually include more than one
      technique, and the specific techniques that are effective in reducing and preventing
      aggression remain to be identified. Therefore, the main aim of this study is to test whether
      the instruction and practice of problem-solving on their own are effective in changing
      aggressive behaviour among adolescents.

      As the intervention in this trial is aimed at the general population, it will be delivered
      online. The rapid growth in the use of the Internet among young people provides an
      opportunity to deliver interventions universally in a cheap and efficient way.

      Problem-solving skills are fundamental to effective behaviour change. Therefore,
      problem-solving skills will be measured to assess whether they mediate the effect of the
      intervention on aggressive behaviour.

      Finally, young people with callous-unemotional traits are less likely to change their
      problematic behaviour such as aggression after an intervention. Therefore,
      Callous-Unemotional traits will be measured to assess if they act as a moderator of
      effectiveness.

      It is expected that participants randomised to the intervention improve their problem-solving
      skills and consequentially, reduce their aggressive behaviours. In addition, participants
      with lower callous-unemotional traits are expected to have a greater change.
    


Intervention name(s): Problem-solving
Intervention type(s): Behavioral
Intervention description(s): The steps of problem-solving are explained to the participants. Then, they are presented two conflictive situations and they are asked to apply the problem-solving steps to find a solution. Once they finish, they are asked to apply the steps in a conflictive situation they have experience in the last month. In the end, they are reminded of the steps and encouraged to practice them in their daily conflicts.
Other intervention name(s): social problem-solving
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention and control group. Participants are randomised to one of them.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: problem-solving; youth; brief intervention; online intervention; young people; aggressive behaviour
Prandial Insulin Dosing in Hospitalized Patients
Condition: Diabetes; Admitting Hospital; Non-critically Ill
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether mealtime insulin results in better control
      of blood sugar than a fixed meal dose in hospitalized patients.
    

Detailed description: 
      The purpose of this study is to determine whether mealtime insulin, dosed to match the intake
      of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed
      meal dose in hospitalized patients.
    

Intervention name(s): Aspart fixed dose; Aspart flexible dose
Intervention type(s): Drug; Drug
Intervention description(s): fixed dose; dose based upon carbohydrate intake and total daily requirements
Other intervention name(s): Novolog; Novolog
Intervention MeSH terms: Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; glucose; hospital
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Observational

Summary: 
      The aim of this study is to explore the microRNA profile in serum of women with Polycystic
      Ovary Syndrome and investigate the correlation between the microRNA profile and markers of
      metabolic syndrome.
    

Detailed description: 
      The study consist of 2 parts:

        1. A cross-sectional study of a cohort of women with PCOS with analysis of materials from
           the established biobank. (the PICOLO cohort) Data and blood samples from 266 women with
           PCOS was collected from January 2010 - February 2013 as a part of the PICOLO
           collaboration: "PCOS, infertility, Cardiovascular and Obstetric risk markers and
           Long-term Outcome" at Holbaek Fertility Clinic and at Herlev Hospital.

           Serum samples will be analysed with Reverse Transcript polymerase chain Reaction
           (RT-qPCR) for selected microRNAs.

        2. A follow-up study of local participants from the PICOLO study. 90 of the participants
           were recruited at Holbaek Fertility Clinic.

      Following tests will be performed at reexamination, in order to describe the clinical
      phenotype: Health interview, anthropometrics, acne score, Ferriman-Gallway score, blood
      pressure, Transvaginal ultrasound of uterus and ovaries, insulin Resistance (IR) assessed
      with Oral glucose Tolerance test (OGTT), Venous blood for hormone analysis and lipid status.

      MicroRNA analysis with Taqman microRNA array will be performed on serum samples.

      Detection and treatment of women with PCOS is a challenge due to the variability of the
      syndrome. If MiRNA could serve as marker of metabolic syndrome, it would be possible to
      detect and follow the women of greater risk at an earlier stage, and thereby preventing
      morbidity.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Local Participants from the PICOLO study, performed at Holbæk Hospital between 2010 and
        2013
      
Biospecimen description: 
      Serum Buffy Coat
A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate
      Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major
      Depressive Disorder (MDD).
    


Intervention name(s): DVS SR
Intervention type(s): Drug
Intervention description(s): Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Depression
Pre-Shave Gel and Brush in Pseudofolliculitis Barbae
Condition: Pseudofolliculitis Barbae
MeSH terms: Hair Diseases
Study type: Interventional

Summary: 
      This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with
      symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be
      divided into two groups: the Control group of 20 subjects and the Experimental group of 20
      Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.

      All subjects will use their normal razors and shave products during the six week study. The
      Experimental group of subjects will also be given the study product Pre-Shave Gel and
      Cleansing Brush.
    

Detailed description: 
      This will be a randomized investigator blinded study of up to 40 men age 20-60 (inclusive)
      with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects
      will be divided into two groups: the Control group of 20 subjects and the Experimental group
      of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.

      All subjects will use their normal razors and shave products during the six week study. The
      Experimental group of subjects will also be given the study product Pre-Shave Gel and
      Cleansing Brush. The study gel and brush will be used prior to their normal shave
      routine.Quantitative lesion counts will be done by trained clinicians at each visit. Efficacy
      assessments include Investigator Global Assessment (IGA) scoring
    

Intervention name(s): shave gel; Brush
Intervention type(s): Other; Other
Intervention description(s): Non marketed pre-shave gel with the following INCI list of ingredients:
WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE; All subjects randomized to brush will use the brush with each shave
Other intervention name(s): Oil of Olay cleansing brush
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Role of Oral Steroids in Reducing Recurrence of Urethral Stricture After Direct Vision Internal Urethrotomy
Condition: Recurrence
MeSH terms: Urethral Stricture; Recurrence
Study type: Interventional

Summary: 
      It was a randomized controlled trial conducted at department of Urology, Armed Forces
      Institute of Urology, Rawalpindi from 1st January, 2018 July 2019 to 31st March 2021 to
      determine the role of oral steroids after Direct Vision Internal Urethrotomy to reduce the
      recurrence rate of urethral strictures.
    


Intervention name(s): Steroid Drug; No steroid
Intervention type(s): Drug; Drug
Intervention description(s): In this group Oral steroid medication after Direct Vision Internal Urethrotomy; In this group no Oral steroid medication (palcebo medication) after Direct Vision Internal Urethrotomy
Other intervention name(s): Oral steroid medication; Placebo Medication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized , double-blind, placebo-controlled study of approximately 70 patients
      with ulcerative colitis.
    


Intervention name(s): placebo; rhuMAb Beta7
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous and subcutaneous escalating doses; Intravenous and subcutaneous escalating doses
Intervention MeSH terms: Etrolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: UC; Ulcerative Colitis
A Study to Compare Two Formulations of LY3819469 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess two formulations of LY3819469 based on the amount
      that gets into the blood stream and how long it takes the body to get rid of it, when given
      to healthy participants. The information about any adverse effects experienced will be
      collected and the tolerability of LY3819469 will also be evaluated.

      Screening is required within 28 days prior to the enrolment. For each participant, the total
      duration of the clinical trial will be about 17 weeks including screening and follow-up
      periods.
    


Intervention name(s): LY3819469
Intervention type(s): Drug
Intervention description(s): Administered SC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Electroacupuncture is Effective in Cardiac Deconditioning Induced by Head-down Bed Rest
Condition: Cardiovascular Abnormalities; Weightlessness
MeSH terms: Cardiovascular Abnormalities
Study type: Interventional

Summary: 
      To investigate the changes of cardiovascular function during short-term simulated
      weightlessness after electroacupuncture (EA) treatment．
    

Detailed description: 
      Spaceflight is associated with cardiovascular deregulation. However, the influence of
      microgravity on the cardiovascular system and the underlying mechanisms and countermeasures
      remain largely unknown. Our previous studies have demonstrated that electroacupuncture (EA)
      is effective at improving orthostatic tolerance (OT). The purpose of this study was to
      determine if EA treatment can attenuate cardiovascular deconditioning induced by a 4-day -6°
      head-down bed rest (HDBR). Fourteen healthy male subjects were randomly allocated into a
      control group (Con, n=6, 4 days HDBR without countermeasure) and an EA treatment group (EA,
      n=8, 4 days HDBR with EA at Neiguan [PC-6] for 30 min daily for 4 consecutive days during
      HDBR). OT was estimated with a combination of +75°/20 min head-up tilt and lower body
      negative pressure test before and after HDBR. Plasma hormones and heart rate variability were
      assessed before and after HDBR. Cardiac systolic functions and cerebral blood flow were
      measured before, during, and after HDBR. The data showed that EA treatment applied daily for
      30 min during a 4-day HDBR prevented OT and cardiac systolic function from decrease,
      prevented autonomic dysfunction (a decrease in the activity of the parasympathetic nervous
      system), and increased the concentrations of plasma angiotensin II (Ang II) and aldosterone
      (Ald). These results indicate that 30 min of daily EA treatment at PC-6 is highly effective
      in partially maintaining OT and cardiac systolic function. Activation of the peripheral
      sympathetic nervous system and increased plasma hormones is largely responsible for
      maintaining OT after a 4-day HDBR. Therefore, EA treatment appears to be an effective
      countermeasure against cardiovascular deconditioning induced by HDBR.
    

Intervention name(s): electronic acupuncture treatment instrument
Intervention type(s): Device
Intervention description(s): Electroacupuncture was performed using small-sized (1.5 cm) cutaneous electrode pads placed bilaterally at the PC-6 points of the forearms (Supplementary Figure 1). The intensity of the electrical stimulation was adjusted to produce the most intense tolerable electrical sensation without muscle contractions or uncomfortable feelings at a frequency of 50 Hz using the Hwato electronic acupuncture treatment instrument (Model No. SDZ-II; Suzhou Medical Appliances Co, Ltd, Suzhou, China).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Electroacupuncture; Cardiovascular function; Orthostatic tolerance; Head-down bed rest
Fibroids in Women of Reproductive Age and Women Pregnancy
Condition: Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 4

Summary: 
      Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and
      women pregnancy to lost the size fibroids.
    

Detailed description: 
      Uterine fibroids are a very common finding in women of reproductive age. But may fibroids
      grow in the first trimester pregnancy.

      Clinically has shown that:

      Uterine fibroids are associated with an Heavy or prolonged menstrual periods. Abnormal
      bleeding between menstrual periods.

      Uterine fibroids are associated with an increased rate of spontaneous miscarriage, preterm
      labor, placenta abruption, malpresentation, labor dystocia, cesarean delivery, and postpartum
      hemorrhage, pain is the most common complication of fibroids during pregnancy. Can usually be
      controlled by conservative treatment on Dydrogesterone Multivitamin nature.
    

Intervention name(s): Dydrogesterone M ( case 1 ); Dydrogesterone M ( case 2 )
Intervention type(s): Drug; Drug
Intervention description(s): Dydrogesterone Multivitamin nature
Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature.
1tablet/24 hours/day (to 4 weeks after postpartum); Dydrogesterone Multivitamin nature
Fibroids/ Women of Reproductive age ( discovered fibroids )
1tablet/24 hours/day ( from discovered fibroids through 6 months)
Other intervention name(s): Dydrogesterone M; Dydrogesterone M
Intervention MeSH terms: Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibroids
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The effects of food additives on body weight in humans are largely unknown. This is a
      before-and-after feasibility study in 5 obese adults who will be followed for 5 months.
      Eligible participants will meet with the study team and will be taught how to limit the
      exposure to the studied food additives in their diet. Participants will also be asked to
      limit eating out to a maximum of 2 days per week. Primary outcomes in this study are
      recruitment rate, retention rate and adherence to the proposed dietary intervention.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dietary modification
Spinal Cord Compression Re-Treat Study
Condition: Pain; Radiation Toxicity; Spinal Cord Compression; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Spinal Cord Compression
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy
      may be effective in treating malignant spinal cord compression in patients who have received
      previous radiation therapy to the spine.

      PURPOSE: This phase II trial is studying radiation therapy in treating patients with
      malignant spinal cord compression.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the efficacy of a biologically effective dose-based re-irradiation
           strategy, in terms of the response rate (based on the mobility score using the Tomita
           scale where improvement in mobility or stable mobility score will be regarded as a
           response) in patients with malignant spinal cord compression.

      Secondary

        -  To determine quality of life as assessed by the EORTC QLQ-C15 PAL version 1.0
           questionnaire.

        -  To determine the non-spinal radiation-induced toxicity using standard RTOG criteria.

        -  To determine the rate of long-term spinal toxicity and radiation-induced myelopathy
           using the RTOG SOMA morbidity grading system.

      OUTLINE: Patients are divided into 2 groups according to the interval since their most recent
      radiotherapy to the involved area of the spinal cord.

        -  Group 1 (< 6 months since prior radiotherapy): Patients undergo radiotherapy for a
           cumulative biologically effective dose (BED) ≤ 100 Gy_2 in addition to receiving other
           current treatment.

        -  Group 2 (≥ 6 months since prior radiotherapy): Patients undergo radiotherapy for a
           cumulative BED ≤ 130 Gy_2 in addition to receiving other current treatment.

      Mobility score is assessed and patients complete a quality-of-life assessment at baseline and
      at each follow-up visit starting at week 5.

      After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months,
      and then every 3 months thereafter.
    

Intervention name(s): Cumulative BED ≤ 100; Cumulative BED ≤ 130 Gy2
Intervention type(s): Radiation; Radiation
Intervention description(s): Radiation; Radiation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; radiation toxicity; spinal cord compression; unspecified adult solid tumor, protocol specific
Southend Imaging Study
Condition: Cognition Disorders
MeSH terms: Cognition Disorders
Study type: Observational

Summary: 
      The study objective is to correlate global cognition and episodic memory performance to
      resting state fMRI functional connectivity. This is a non-treatment, prospective, natural
      history data collection study in a cross-sectional cohort of patients with cognitive
      impairment.
    

Detailed description: 
      At present, Magnetic Resonance Imaging (MRI) is widely used along with other tests to help
      diagnose dementia, however diagnosis still remains challenging. There is currently a focus on
      the usefulness of resting state functionalMRI (RS fMRI) as a way of establishing differences
      in functional connectivity between healthy subjects and those with various neurodegenerative
      disorders. Although the potential for RS fMRI to be used as a biomarker for neurological
      diseases looks promising, further research is needed, especially regarding validation of
      normal values and seed-based functional connectivity. Further research into this area will
      help to improve the ability to appropriately classify new subjects and ultimately allow use
      of RS functional connectivity as a biomarker. This is a nontreatment, prospective, natural
      history data collection that aims to analyse functional connectivity in a cohort of patients
      with suspected cognitive impairment. Correlation of global cognition and episodic memory
      performance to resting state fMRI functional connectivity will be evaluated. Patient
      population will include patients over the age of 18 with cognitive impairment and age and
      gender matched controls. Eligible patients will have to complete neuropsychological and
      clinical assessments and complete an fMRI scan prior to enrolment.Study duration is estimated
      at 4 years.
    

Intervention name(s): fMRI; Neuropsychological tests
Intervention type(s): Other; Other
Intervention description(s): Functional MRI scan to be performed; Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with suspected cognitive impairment, mild cognitive impairment, autosomal dominant
        Alzheimer's disease, late onset Alzheimer's disease, Vascular dementia, Parkinson's
        dementia and age and gender matched controls.