bioihbjkbjnl/mcl2 huggingface dataset:
Quality of Life in Patients With and Without a Parastomal Bulge
Condition: Quality of Life; Parastomal Hernia
MeSH terms: Hernia
Study type: Observational

Summary: 
      It is not well-established whether a parastomal bulge impacts stoma patients HRQoL or if
      HRQOL differs according to the underlying disease or type of stoma. In this large
      cross-sectinal study stoma patients with and without a parastomal bulge are asked about their
      health-related quality of life and stomarelated quality of life. Stoma patients are
      identified in the danish stoma database and contacted two times by email. Non-responders are
      sent a paper booklet.
    

Detailed description: 
      A cross-sectional study of patients registered in the Danish Stoma Database Capital Region
      (DSDCR), with permanent or temporary enterostoma after surgery performed between 2011 and
      2016. Via a unique personal identification number registered in DSDCR patients will be
      contacted by e-mail using the e-Boks system, an official electronic distribution system
      covering around 80% of the Danish adult population. The e-mail will contain information about
      the study and a personal link to SurveyXact, an online survey program allowing for direct
      electronic data entry by patients. First reminder will be sent after one week and a second
      reminder again one week later. If necessary, a third reminder additionally three weeks later
      will be sent to patients by post, including a paper booklet of the questionnaires as
      described below.

      For patients without e-Boks, DSDCR will be linked to the Danish Civil Registration System via
      the unique personal identification number, providing information on patient's addresses.
      Information on the study and a paper booklet of questionnaires will be sent to patients by
      post. A reminder will be sent by post after three weeks if necessary. Hereafter, no further
      attempts will be made to contact the patients. To include other relevant variables in the
      analysis of data, data from the Danish Anaesthesia Database (DAD) and the Danish Colorectal
      Cancer Database will be linked. Quality of life will be assessed using StomaQol and SF-36.
      Colostomy Impact score will also be obtained. Patients will self-report a parastomal bulge
      and information such as education, alcohol consumption, physical activity and civil status.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): No intervention only observational
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients registered in the Danish Stoma Database Capital Region, having undergone stoma
        surgery between 2011 till end of 2016.
      
Keywords: Quality of life; hernia; parastomal bulging; stoma; cross-sectional
Homeless Population and Mental Health: Impact of Primer la Llar Program
Condition: Mental Health Disorder
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      The main goal is to evaluate the impact of the Primer La Llar housing program for the
      homeless population on the mental health of the participants.

      The hypothesis is that the housing program, which follows Housing first model, for the
      homeless population has a positive impact on the mental health of the participants, compared
      to the group that does not receive the intervention -treatment as usual group (meaning the
      "positive impact" a lower score on the symptomatology scales and lower toxic intake in the
      group receiving the intervention).
    

Detailed description: 
      The specific objectives are:

      Identify the socio-demographic and clinical characteristics of the participants.

      Compare the severity of psychiatric symptoms and improvement among the participants in the
      intervention group and the control group (depressive, anxious, psychotic or manic
      symptomatology, depending on the case).

      Compare the consumption of alcohol and drugs among the participants of both groups.

      Compare the basic daily life skills among the participants in both groups, as well as the
      improvement of them in the experimental group.

      Compare the use of services and between the participants of the intervention group and the
      control group.

      Intervention group receives entry to the program (which means individual and permanent
      housing without previous requirements such as abstinence, compliance with treatment or
      sobriety.

      Control group receives treatment as usual, as they are users of homeless population network
      of Barcelona.
    

Intervention name(s): Primer la Llar program
Intervention type(s): Other
Intervention description(s): Housing First model: permanent housing without previous requirements such as abstinence, sobriety or compliance with treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group (housing first model program) and control group (treatment as usual).
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mental health; Housing First; homeless
Type 1 Diabetes and the Brain in Children
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The investigators have previously studied a group of young children with T1D using brain MRI,
      age-appropriate neurocognitive testing and continuous glucose monitoring, followed for 18
      months. The investigators observed significant differences in gray matter volumes and white
      matter microstructure in the children with diabetes as compared to controls. These
      differences appeared to increase over time, with slower rates of brain growth in the T1D
      group (Mazelli, et al, Diabetes 2014; Barnea-Goraly, et al, Diabetes Care 2014; Mauras, et
      al, Diabetes 2015). In this new protocol the investigators will include the same children
      with T1D and healthy controls previously studied and recruit new similar subjects to replace
      those lost by attrition. The investigators will be using structural and functional brain MRI,
      neurocognitive testing and measures of glycemic control, to determine if changes in the brain
      persist or worsen over longitudinal follow up, and whether these changes are associated with
      measures of glycemic control and neurocognitive metrics as these children grow and progress
      through puberty.
    

Detailed description: 
      Study participation will last about 2 to 2 1/12 years and will include a brain MRI without
      sedation, as well as a functional MRI and neurocognitive testing. The children with T1D will
      wear a continuous glucose monitor (CGM), will follow up every 3 months and will be asked to
      wear the CGM each time. The structural and functional MRI and neurocognitive testing will be
      repeated 2 yrs from baseline.

      The healthy controls will also undergo MRI and cognitive testing as well as have a blood
      sample at baseline and after 2 years.

      Parents of newly recruited subjects will also have abbreviated IQ testing.
    

Intervention name(s): Observational
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with Type 1 Diabetes or Healthy non-diabetic controls
      
Keywords: Brain Growth and Development; Cognition; Children; Continuous Glucose Monitoring; MRI; Functional MRI
Examining the Real-World Effectiveness of the Movr App
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this 8-week pilot pragmatic randomized controlled trial was to examine the
      real-world impact of movr on functional movement, flexibility, strength, and cardiovascular
      fitness.
    

Detailed description: 
      Thousands of mobile apps available for download are geared towards health and fitness, yet
      limited research has evaluated the real-world effectiveness of such apps. The movr app is an
      mHealth app designed to enhance physical functioning by prescribing functional movement
      training based on individualized movement assessments. movr's influence on functional
      movement and physical fitness (flexibility, strength, and cardiovascular fitness) has not yet
      been established empirically. Thus, the objective of this 8-week pilot pragmatic randomized
      controlled trial was to examine the real-world impact of movr on functional movement,
      flexibility, strength, and cardiovascular fitness.
    

Intervention name(s): movr mHealth App
Intervention type(s): Device
Intervention description(s): The exercises prescribed through the movr app were accompanied with videos, images, and detailed instructions on how to complete them. These exercises consisted of basic movement and mobility patterns and are designed to promote functional movement. Participants were instructed to complete a total of four 'Minis' and two workout 'Builder' sessions per week. Workout Builders are designed to be longer exercise sessions tailored to the user's desired exercise time (15, 30, 45 or 60 min), equipment available (TRX Band, kettlebell, chin-up bar, dumbbells, foam roller, or none), target body region (lower, upper, or whole body), and specific exercise goal ('get sweaty,' 'build strength,' or 'develop mobility'). Version 3.6 of the movr app was used at the start of data collection and was updated to Version 4.1 over the course of the trial. No significant changes were made to the app or to the exercise prescription functionality throughout those updates.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: mHealth; functional movement; flexibility; strength; cardiovascular fitness
A Novel Approach for Horizontal Augmentation: A Split Box
Condition: Alveolar Bone Loss; Alveolar Ridge Augmentation; Augmentation, Alveolar Ridge
MeSH terms: Alveolar Bone Loss
Study type: Observational

Summary: 
      The goal of this clinical study is to investigate the effectiveness of the split-box
      technique in systemically healthy, non-smoking, over 18 years of age, participants with
      narrow crests (<5mm bone width) and adequate bone height (>12mm). The main questions it aims
      to answer are:

        -  The primary objective of the present study is to investigate the effectiveness of the
           split-box technique by evaluating the change in width and height of the alveolar bone.

        -  The secondary objective is to evaluate the superiority of the split-box technique and
           its modifications in terms of the amount of bone gain.

      According to the 3D topography of the alveolar ridge of the patients before augmentation,
      split box or one of its modifications, reverse split box or sliding split box techniques were
      selected and applied. (split box was applied if the bone thickness was more than 3 mm at the
      top of the crest and did not increase towards the lower border at the alveolar bone, reverse
      split box technique was applied if the bone thickness was more than 3 mm at the top of the
      crest and increased towards the lower border at the alveolar bone, sliding split box was
      applied if the bone thickness was less than 3 mm at the top of the crest but the bone
      thickness increases towards the lower border at the alveolar bone.)
    


Intervention name(s): Splitting of bone and fixation of bone laminae differ between the 3 groups.
Intervention type(s): Procedure
Intervention description(s): In split-box technique, all osteotomies were made using with piezoelectric surgery. Horizontal and vertical osteotomies were performed 1.5 mm away from adjacent teeth. Lower border osteotomy of the vestibular cortical bone was performed. A chisel osteoma was used to separate completely and mobilize the segmented bone. This separated, corticocancellous block was stabilized on the distance to the native alveolar crest with micro screws. The space between the block and the alveolar crest was filled with allograft. In reverse split box technique, differs from the split-box technique as follows: it involves reversing the separated corticocancellous bone block before fixation. In sliding split box technique, differs from the split-box technique as follows: horizontal osteotomy is performed at the level where the bone thickness reaches at least 3 mm. Separated corticocancellous bone block is slid toward the coronal of alveolar crest and fixed in line with the native alveolar bone.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients whose thickness at the top of the alveolar crest is insufficient for implant
        placement and who require bone augmentation.
      
Keywords: Alveolar ridge augmentation; Horizontal augmentation; Bone block augmentation
Lipoprotein Apheresis in Refractory Angina Study
Condition: Refractory Angina; Raised Lipoprotein(a)>50mg/dL or >500mg/L
MeSH terms: Angina Pectoris
Study type: Interventional

Summary: 
      The goal of this study is to determine the impact of apheresis on clinical parameters and
      symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct
      a prospective, randomised controlled crossover study of 20 patients with refractory angina
      and raised Lp(a), randomised to undergoing lipoprotein apheresis weekly for three months or
      sham apheresis weekly for three months with assessment of myocardial perfusion, carotid
      atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina
      symptoms and quality of life at the beginning and end of treatment. Patients will then
      crossover to the opposite study arm with the protocol repeated. The hypothesis is that the
      above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and
      Refractory Angina. Investigators will also test for the genotypic presence of
      apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to
      be associated with an increased level of Lp(a) and an increased risk of coronary disease.
    

Detailed description: 
      Angina which is refractory to conventional medical therapy and revascularisation is
      challenging to manage. Lipoprotein(a) or Lp(a) is a genetically determined form of
      LDL-cholesterol, elevation of which is an independent risk factor and predictor of adverse
      cardiovascular events. Lp(a) is felt to increase cardiovascular risk via its prothrombotic
      effect and by enhancing intimal lipoprotein deposition. Lipoprotein apheresis is the most
      effective treatment for raised Lp(a). Lipid lowering agents such as statins have little to no
      effect on Lp(a) levels.
    

Intervention name(s): Lipoprotein Apheresis; Sham Apheresis
Intervention type(s): Other; Other
Intervention description(s): Weekly lipoprotein apheresis for 3 months; Weekly sham (placebo) apheresis for 3 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Refractory Angina; Lipoprotein
Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD Effects in Male Volunteers
Condition: IBD
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I
      study in healthy male subjects.
    

Detailed description: 
      Single oral doses of AKB-4924 will be investigated in up to 6 sequential cohorts of 8 healthy
      male subjects. Primarily 6 dose levels are planned; the proposed doses are 20 mg, 60 mg, 120
      mg, 240 mg, 360 mg, and 480 mg. Actual doses may be decreased or increased based on the
      safety and tolerability of the drug, as determined by the Investigator and Sponsor.
      Additional cohorts may be added as needed to test lower, higher, or repeat doses.
    

Intervention name(s): AKB-4924; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Comparison of different dosages of AKB-4924; Placebo comparator
Other intervention name(s): AKB-4924 Cohort 1-6; Placebo Cohort 1-5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Anticoagulation, Vitamins, and Endothelial Function
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Determine whether low or high dose B vitamin therapy will lower homocysteine and
      thrombomodulin in patients anticoagulated with warfarin.
    

Detailed description: 
      We hypothesize that 1) both high and low dose B vitamin therapy will lower homocysteine in
      patients anticoagulated with warfarin and 2) high dose B vitamin therapy will lower
      thrombomodulin in patients anticoagulated with warfarin. To accomplish these specific aims,
      we proposed a double- blind randomized controlled trial of 6 months duration comparing 2
      different multivitamin regimens differing only in the doses of the following 3 vitamins. The
      multivitamin for the control group has no folic acid, B2, B6, or B 12. The multivitamin for
      the intervention group has 5 ing folic acid, 1.7 mg B2, 100 mg B6, and I mg B12. Participants
      age 50 and older, 150 in each group, are being recruited from the Anticoagulation Clinics at
      the Baltimore VAMC and neighboring centers. Clinical and risk factor information is being
      obtained through a face-to-face interview. Blood is being drawn for analyses of homocysteine
      and vitamin levels (University of Colorado Health Science Center) and thrombomodulin
      (Baltimore VAMC Hemostasis and Thrombosis Laboratory). Data analysis will be conducted
      according to the "intention to treat" principle using ordinary least squares regression
      models.
    

Intervention name(s): Vitamin B
Intervention type(s): Drug
Intervention MeSH terms: Vitamins; Vitamin B Complex
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: geriatrics; vitamin B complex; thrombomodulin; anticoagulants
Study of A-101 for the Treatment of Seborrheic Keratosis
Condition: Seborrheic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of
      A-101 versus a vehicle control in the treatment of seborrheic keratosis.
    

Detailed description: 
      The main objective of this study is to evaluate the dose-response relationship of 2
      concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to
      seborrheic Keratosis (SK) target lesions on the face. A further objective is to evaluate the
      safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution
      Vehicle when applied topically up to 2 times to SK target lesions on the face.
    

Intervention name(s): A-101
Intervention type(s): Drug
Intervention description(s): Topical Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe
      hypertension
    


Intervention name(s): Aliskiren
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension, aliskiren, blood pressure, rennin
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
Condition: Chronic Idiopathic Urticaria; Chronic Idiopathic Pruritus; Lichen Planus; Lichen Simplex Chronicus; Plaque Psoriasis
MeSH terms: Psoriasis; Pruritus; Urticaria; Lichen Planus; Chronic Urticaria; Neurodermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Participants with diseases characterized by chronic pruritus experiencing moderate to severe
      pruritus will be enrolled in this pilot Phase 2 study.

      The diseases characterized by chronic pruritus investigated in this pilot study currently
      include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus
      (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).
    


Intervention name(s): KPL-716; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection.; Placebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection.
Other intervention name(s): vixarelimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pruritus, chronic pruritus, moderate to severe
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on
      percent change from baseline in lipoprotein(a) (Lp[a]).
    


Intervention name(s): Olpasiran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose 1 Dose 2 Dose 3 Dose 4; Dose 5
Other intervention name(s): AMG 890
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Olpasiran; AMG 890; siRNA; lipoprotein (a) Lp(a); Cardiovascular; Cardiovascular disease; Atherosclerotic cardiovascular disease; Cholesterol; Apolipoprotein (B); Hyperlipidemia; Dyslipidemia
Platelet-rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation
Condition: Patella-Dislocation
MeSH terms: Joint Dislocations; Patellar Dislocation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To check the influence of injected platelet-rich plasma (PRP) on the healing of medial
      retinaculum and the redaction in recurrent dislocation of the patella.
    

Detailed description: 
      Autologous platelet-rich matrices may aid in the healing of ligaments & tendons by promoting
      and accelerating tissue healing because of the release of growth factors including
      transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from
      platelet alpha-granules.
    

Intervention name(s): Plasma Rich in Growth Factors (PRGF); placebo
Intervention type(s): Biological; Drug
Intervention description(s): US guided IM injection 3-6mg; injection of 6 cc of saline into injured area
Other intervention name(s): platelet-derived preparation rich in growth factors; saline 0.9% NaCl
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: medial retinaculum tear s/p patella dislocation