bioihbjkbjnl/mcl2 huggingface dataset:
Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Condition: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
MeSH terms: Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether subcutaneous immunoglobulin given in small
      doses, is effective in maintaining the force, in patients with chronic inflammatory
      demyelinating polyradiculoneuropathy compared with placebo (saline infusions), and
      intravenous immunoglobulin.
    

Detailed description: 
      CIDP is an autoimmune disease of the peripheral nervous system, responding well to treatment
      with intravenous immunoglobulin (IVIg), steroids and plasmapheresis. IVIg is effective in
      treating patients with CIDP, but most of the patients need long time maintenance treatment,
      which is associated with decreased autonomy and regular hospital admissions. Furthermore many
      of the patients complain of infusion related side effects such as headache, chills and
      fatigue, and over time there is problems obtaining intravenous entry because of occlusion of
      the veins.

      There is therefore a critical need for alternative methods to IVIg treatment. The aim of this
      study is to evaluate the efficacy, tolerability and safety of small doses of immunoglobulin
      administered subcutaneously (SCIg), compared with placebo. At the same time we compare the
      efficacy of SCIg with the regular IVIg treatment.

      We therefore hypothesize, 1: SCIg is better than subcutaneous placebo infusions, and is as
      good as IVIg in maintaining muscle function in patients with CIDP. 2: SCIg home treatment is
      safe and tolerable. 3: SCIg home treatment is preferred to IVIg under hospital admission, by
      the patients.
    

Intervention name(s): Subcutaneous immunoglobulin
Intervention type(s): Drug
Intervention description(s): The subcutaneous immunoglobulin is infused in the subcutaneous tissue on the abdomen twice or thrice a week, with a maximal speed of 2 mL/h. Every time 20 mL is infused, the needle is removed to a new place.
Other intervention name(s): Subcuvia®
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Subcutaneous immunoglobulin
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
Condition: Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous
      evolocumab administered every 2 weeks and once a month, compared with placebo, on percent
      change from baseline in LDL-C when used in combination with statin therapy in adults with
      high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.
    

Detailed description: 
      After a screening and placebo run-in period, eligible patients were randomized in a 1:1 ratio
      to 1 of 2 open-label background statin treatments (atorvastatin 5 mg or 20 mg daily [QD]) and
      entered a 4-week lipid stabilization period. After the lipid stabilization period, eligible
      patients were randomized in a 1:1:1:1 ratio to investigational product (evolocumab or
      placebo) for the 12-week treatment period.

      Both randomizations were stratified by subject diagnosis and lipid-lowering therapy as
      follows:

        -  current or prior diagnosis of heterozygous familial hypercholesterolemia (HeFH)

        -  no diagnosis of HeFH and receiving intensive lipid-lowering therapy

        -  no diagnosis of HeFH and receiving non-intensive lipid-lowering therapy. A participant
           was considered randomized into the study after successfully completing the screening
           period, meeting all inclusion/exclusion criteria including meeting final laboratory
           safety criteria, and undergoing both randomization procedures.
    

Intervention name(s): Atorvastatin; Evolocumab; Placebo to Evolocumab
Intervention type(s): Drug; Biological; Other
Intervention description(s): Administered orally once a day; Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): Lipitor; AMG 145; Repatha
Intervention MeSH terms: Atorvastatin; Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Japanese, high cholesterol, LDL-C, High Cardiovascular Risk
Low Dose Aspirin Studied With the AggreGuide
Condition: Platelet Aggregation
Study type: Observational

Summary: 
      This study is to determine whether the AggreGuide platelet aggregometer can discern the
      effect of low dose aspirin on subjects platelet aggregation using arachidonic acid as the
      agonist.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      whole blood
    
Keywords: platelet; aggregation; aspirin; inhibition; reactivity
Effect of Mat Pilates Training on Women After Menopause
Condition: Physical Activity; Blood Pressure
Study type: Interventional

Summary: 
      This project aims to verify the chronic effect of Mat Pilates exercise on climacteric
      symptoms, ambulatory blood pressure responses, lipid and glucose profile and pro and
      anti-inflammatory and antioxidant markers in postmenopausal normotensive and hypertensive
      women. All volunteers received the same intervention.
    

Detailed description: 
      The Pilates program was performed three times a week for 12 weeks. Initially a
      familiarization was made regarding the principles of the method. All volunteers underwent
      24-hour blood pressure assessment using ambulatory blood pressure measurement (ABPM) and
      venous blood samples were collected from fasting, saliva and questionnaires before and after
      the Pilates training period.
    

Intervention name(s): Hypertensive group; Normotensive group
Intervention type(s): Other; Other
Intervention description(s): Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.; Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 - Hypertensive: Composed of hypertensive women who participated in a training program with Pilates exercises in the soil associated to the daily antihypertensive of each one.
Group 2 - Normotensives: Composed of normotensive women who participated in a training program with solo Pilates exercises without antihypertensive presence.
Both groups underwent 12 weeks of Pilates training.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pilates; Blood Pressure; Postmenopausal women
Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
Condition: Severe Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its
      metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of
      vortioxetine 5 mg in participants with severe hepatic impairment compared to healthy
      participants.
    

Detailed description: 
      The drug being tested in this study is called vortioxetine. Vortioxetine is being tested to
      assess how it moves throughout the body in people with severe hepatic impairment compared to
      people with normal hepatic function. This study looked at lab results in people who took
      vortioxetine.

      The study enrolled 12 participants. Participants were assigned to one of the two treatment
      groups based on their hepatic function (severe hepatic impairment vs. normal hepatic
      function). All participants in both groups will receive one vortioxetine 5-mg tablet.

      This single-center trial was conducted in the United States. The overall time to participate
      in this study was up to 58 days. Participants made 2 visits to the clinic, including one
      12-day period of confinement to the clinic, and were contacted by telephone 30 days after
      last dose of study drug for a follow-up assessment.
    

Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Vortioxetine tablets
Other intervention name(s): Lu AA21004; BRINTELLIX
Intervention MeSH terms: Vortioxetine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Motor Skill Proficiency After Equine-assisted Activities and Brain-building Tasks
Condition: Motor Delay; Motor Skills Disorders; Autism Spectrum Disorder; Attention Deficit Hyper Activity; Intellectual Disability; Sensory Disorders
MeSH terms: Intellectual Disability; Sensation Disorders; Autism Spectrum Disorder; Motor Skills Disorders
Study type: Interventional

Summary: 
      There is no current research to support the efficacy of a combination of equine-assisted
      activities (EAA) and brain building activities to influence motor skill competencies in youth
      with neurodevelopmental disorders (ND). The primary objective of this study was to quantify
      changes in motor skill proficiency before and after 8 weeks of EAA and brain-building
      activities in youth with ND. A secondary objective was to quantify changes in motor skill
      proficiency before and after 1 year of EAA and brain-building activities in youth with ND.
    

Detailed description: 
      Twenty-five youth completed the same 32-week protocol that was separated into 4, 8-week
      blocks, in the following order: a) control, b) EAA-only, c) washout, and d) GaitWay block
      (EAA and brain building activities). Before and after each block, motor skills were assessed
      using the Short Form of the Bruininks-Oseretsky Test of Motor Proficiency-Version 2 (BOT-2).
      Seven youth continued with the GaitWay intervention for one additional year, and the BOT-2
      Short Form was also administered following this intervention. A repeated-measures
      analysis-of-variance was performed to compare BOT-2 subtest and overall scores between
      interventions. A significance of .05 was used. Manual dexterity was higher at Post-Washout
      versus Pre-Control (p = .018) and Post-Control (p = .024), and at Post-GaitWay versus
      Pre-Control (p = .037). Upper-limb coordination was higher Post-GaitWay versus Post-Control
      (p = .050). When compared to Pre-Control, strength was higher at Post-EAA (p = .028) and at
      Post-GaitWay (p = .015). Overall scores were higher at Post-GaitWay when compared to
      Pre-Control (p = .003) and Post-Control (p = .009). Among the seven participants who
      participated in the 1-year follow-up GaitWay motor skills were maintained for one year
      following the Post-GaitWay testing session. A combination of EAA and brain building
      activities may be an effective therapeutic modality to improve and maintain motor skill
      proficiency in youth with ND.
    

Intervention name(s): Equine-assisted activities; GaitWay program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants performed riding-related activities on and off of a horse once per week for 8 weeks; Participants performed riding-related activities on and off of a horse, along with brain-building activities including balance tasks, swinging, spinning, music therapy, and sensory tasks, all once per week for 8 weeks
Other intervention name(s): EAA; GW
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This study were to compare the relative bioavailability of Duloxetine HCl delayed release
      capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed
      release capsule 60 mg) in healthy, adult, human subjects under fed conditions and to monitor
      safety of subjects
    

Detailed description: 
      Open label, randomized, two period, two treatment, two sequence, crossover, balanced, single
      dose comparative oral bioavailability study in healthy, adult, human subjects under fed
      conditions
    

Intervention name(s): Duloxetine; Cymbalta®
Intervention type(s): Drug; Drug
Intervention description(s): Duloxetine Delayed-Release Capsules 60 mg; 60 mg capsule of Eli Lilly and Company
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chronic Inflammation After Obesity Surgery
Condition: Obesity
MeSH terms: Obesity; Inflammation
Study type: Observational

Summary: 
      To evaluate the impact of obesity surgery on chronic inflammation.
    

Detailed description: 
      A retrospective study to compare the impact of laparoscopic sleeve gastrectomy (LSG),
      laparoscopic Roux-en Y- gastric bypass (LRYGB) and laparoscopic omega-loop gastric bypass
      (LOLGB) on chronic inflammation and metabolic syndrome.
    

Intervention name(s): Laboratory Examination
Intervention type(s): Other
Intervention description(s): Laboratory Examination before, 1 month, 3 month, 6 month and up to 12 month after LSK, LRNYGB, LOLGB
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent LSG, LRYGB, LOLGB due to obesity and/or metabolic syndrome
      
Keywords: chronic inflammation; fatty liver index
POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability
Condition: Intellectual Disability; Weight Loss; Motivational Interviewing; Telehealth
MeSH terms: Intellectual Disability; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      POWERSforID is a 24 week randomized control trial designed to assess the feasibility of a
      telehealth and coaching intervention for improving health outcomes of adults with
      intellectual disability. Recruitment is conducted through a disability health clinic located
      in Colorado Springs, CO.
    

Detailed description: 
      POWERS (Personalized Online Weight and Exercise Response System) platform is a novel,
      multifocal-centered tailored intervention utilizing an innovative online tool designed to
      facilitate improvements in physical activity and nutritional behaviors. Aim 1 of this
      protocol is to customize the POWERS platform, demonstrated effective in previous research,
      for adults with intellectual disability (ID) and their caregivers to be referred to as
      POWERSforID. The POWERSforID intervention is designed to achieve weight loss and improve
      specific health markers while respecting and supporting the needs of the participants with ID
      as well as their caregivers. Aim 2 of the project is to conduct a pilot study to assess the
      usability and feasibility of the POWERSforID system and intervention with 5 adults with ID
      and their caregiver and improve the system based on pilot data. Aim 3 of the protocol is to
      conduct a randomized controlled trial (RCT) to examine the effect of POWERSforID on educating
      and coaching caregivers about nutrition and exercise and thus improving health status and
      reducing body weight in obese adults with ID. The investigators hypothesize that the obese
      participants in the intervention group (POWERSforID) will evidence significantly greater
      weight loss and improved health status (i.e. lower waist circumference, blood pressure,
      decreased body fat percentage, and improved blood lipids) compared to a control group. The
      investigators also hypothesize that both adults with ID and their caregivers will demonstrate
      improved knowledge, attitudes, and self-efficacy related to diet and exercise.
    

Intervention name(s): POWERSforID
Intervention type(s): Behavioral
Intervention description(s): Feasibility and outcomes associated with use of the POWERSforID system and coaching phone calls over the course of 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Misoprostol Prior to Intrauterine Device Insertion
Condition: IUD
Study type: Interventional

Summary: 
      The intrauterine device (IUD) is a reliable, safe, long acting, and effective contraceptive
      method . In spite of that, the pain associated with IUD insertion can be a cause against its
      insertion. Many researches have been conducted aiming to decrease the degree of pain during
      IUD insertion; these studies included medical and also technical methods.

      The physicians usually prefer to insert the IUD during women's menses because the women are
      very unlikely to be pregnant and the insertion is easier and the pain is lower The easiness
      of IUD insertion is a very important issue that can increase women's satisfaction and
      decrease insertion pain.
    


Intervention name(s): Misoprostol; IUD
Intervention type(s): Drug; Device
Intervention description(s): will be used 3 h before IUD insertion; a copper T380A IUD
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Negative Valence Brain Targets and Predictors of Anxiety and Depression Treatment
Condition: Internalizing Psychopathologies (IPs) Depression and Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Internalizing psychopathologies (IPs) involving depression and anxiety are among the most
      prevalent, costly and disabling illnesses. Treatments for IPs are available but the extent to
      which individual patients respond is quite heterogeneous. Little information exists,
      particularly in the biological domain, which helps to explain individual differences in
      treatment response. IPs share similar patterns of dysfunction within the Fronto-Limbic Affect
      Regulation and Emotional Salience (FLARES) brain circuit, and two commonly used, 'gold
      standard' treatments - selective serotonin reuptake inhibitors (SSRIs) and cognitive
      behavioral therapies (CBTs) - are equally effective for both anxiety and depressive
      disorders, and appear to change brain activity in the same areas within the FLARES circuit.
      The overarching goal of the project is delineate what are common versus specific FLARE brain
      targets for SSRI and CBT and identify specific aspects of FLARE dysfunction that might better
      predict response to both and to a specific modality of treatment. This experiment integrates
      emotion and its interaction with cognition across several stages of emotional experience,
      encompassing studies that probe sensitivity to acute and potential threat and automatic and
      volitional forms of affect regulation in relation to the FLARES brain network.

      We will enroll 200 patients presenting to our Mood and Anxiety Disorders Program seeking
      treatment for disabling 'anxiety, worry, depressed mood' (IPs, including those characterized
      as Not Otherwise Specified) and randomize them to a 12-week course of SSRI or CBT.
      Dimensional, transdiagnostic negative valence systems (NVS) constructs, including FLARES
      function, will be measured before and after each treatment. Specifically, the project will
      examine 2 Specific Aims: 1) Where and how do SSRI and CBT treatments exert their effects on
      NVS constructs?; and 2) Which NVS construct can predict the likelihood of success from SSRI
      and CBT treatment? Such findings can be used to guide the right patients to the right
      treatments with the highest likelihood of success. They also elucidate a
      pathophysiologically-driven mechanistic model of where and how treatments work in the brain
      and thus hasten the development of new treatments that target the underlying pathophysiology
      across internalizing conditions.
    


Intervention name(s): SSRI; CBT
Intervention type(s): Drug; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Internalizing psychopathologies; Depression; Anxiety; MRI; medication treatment; psychotherapy; brain function
Nudging Provider Adoption of Clinical Decision Support
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional

Summary: 
      The central hypothesis of this proposal is that the addition of a theory-informed "nudge" to
      a clinical decision support (CDS) tool will address identified behavioral barriers to use and
      significantly improve adoption by providers. Nudges are applications of behavioral science,
      defined as positive reinforcement and indirect suggestions that have a non-forced effect on
      decision making. This study will use a behavioral theory-informed process to develop a new
      CDS tool that includes a nudge that addresses barriers to adoption.
    

Detailed description: 
      The research team developed and pilot tested two CDS tools for pulmonary embolism (PE) risk
      stratification in the Emergency Department (ED). One of the tools incorporated two behavioral
      theory-informed nudges in the user interface. The research team's objective was to pilot test
      the tools to demonstrate feasibility as well as examine preliminary efficacy of the nudges on
      provider adoption of the tool. This cluster non-randomized controlled trial took place
      between September 20th, 2021 and March 3rd, 2022 in two EDs that are a part of a large
      academic health system in the New York City metropolitan area. All ED providers (physicians,
      physician assistants and nurse practitioners) seeing patients for the evaluation of PE during
      this time were included in the trial. The EDs were chosen based on their comparable size and
      acuity levels.
    

Intervention name(s): Pulmonary Embolism Risk Kalculator (PERK)
Intervention type(s): Other
Intervention description(s): Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. Nudges will be to the PE CALC CDS tool to develop the new CDS tool, PERK.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Clinical Decision Support; Pulmonary Embolism; Behavioral Design; Health Informatics