bioihbjkbjnl/mcl2 huggingface dataset:
Random Assignment of Intervention Messages for Developing Personalized Decision Rules to Promote Physical Activity
Condition: Cardiovascular Risk Factor
Study type: Interventional
Phase: Phase 1

Summary: 
      Our goal is to develop personalized decision rules for selecting the frequency, timing, and
      content of messages to promote physical activity. The objective of this project is to develop
      personalized dynamical models of physical activity (PA) under different weather and temporal
      conditions as well as in response to different types of intervention messages. This approach
      relies on having extensive observations within the person under varying conditions to develop
      a dynamical model of how different conditions interact with each other to predict how
      behavior changes in response to text messages. Complementary sub-models will be estimated for
      each participant to describe their behavioral responses under different weather conditions.
      Healthy but insufficiently active young adults (n=80) will wear an activity monitor and
      receive a variety of randomly-timed and randomly-selected notifications via smartphone. GPS
      coordinates at the time of messages delivery and receipt are recorded and used to look up
      weather indices at that location at that time. The work is exploratory/descriptive as we will
      be developing models to describe participants' responses to messages under different weather
      conditions. This work is needed to develop the decision rules for a subsequent behavioral
      intervention that will be developed and tested in a future project.
    


Intervention name(s): Short Message with Text and Optional Image
Intervention type(s): Behavioral
Intervention description(s): Messages can be up to 256 characters of text and with or without an image. "Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting
      injectable formulation of risperidone (an antipsychotic medication) and its influence on
      quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of
      emotional instability, detachment from reality, often with delusions and hallucinations, and
      withdrawal into the self).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention) single-arm, and
      prospective study (study following participants forward in time) of risperidone microspheres
      in participants with schizophrenia. Participants will be treated with intramuscular (into a
      muscle) injections of either 25 milligram (mg) or 37.5 mg or 50 mg of risperidone twice
      weekly, every 2 weeks for 2 years. The total duration of study will be 2 years. The efficacy
      of participants will primarily be evaluated by total Positive and Negative Syndrome Scale
      (PANSS) score. Participants' quality of life and safety will be monitored throughout the
      study.
    

Intervention name(s): Risperidone Long-Acting Injectable (RLAI)
Intervention type(s): Drug
Intervention description(s): The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
Intervention MeSH terms: Risperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Risperidone; Risperidal Consta
A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma
Condition: Allergy; Asthma; Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as
      change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with
      ALK HDM tablets given once daily over 60 days.
    

Detailed description: 
      To demonstrate superiority of ALK HDM tablets versus placebo in the immune response, measured
      as change of D. Farinae specific IgG4 from baseline to end of treatment with ALK HDM tablets
      given once daily over 60 days

      To evaluate the immune response, measured as change of D. pteronyssinus, D. farinae specific
      immunoglobulin E (IgE) and D. pteronyssinus specific IgG4 from baseline to end of treatment
      with ALK HDM tablets given once daily over 60 days, compared to placebo

      To evaluate in patients with HDM-allergic respiratory disease the safety and tolerability of
      60-day treatment with ALK HDM tablets compared to placebo
    

Intervention name(s): Mitizax; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Allergen extract; Placebo tablet
Other intervention name(s): ALK HDM tablet; allergen extract; Placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: House Dust Mite
Effects of the Pressure and Traction Technique on the Plantar Footprint and Balance
Condition: Healthy; Foot; Manual Therapy
Study type: Interventional

Summary: 
      The aim of this clinical trial is to check the effects of manual pressure and traction
      technique on balance and plantar footprint variables comparing with Laser placebo.
    

Detailed description: 
      Forty healthy subjects wil be recruited for a simple blind study. Participants will be from 1
      to 40 years old, not obese. Participants will be randomized into two groups. Experimental
      group performed a bilateral plantar fascia manual pressure and traction technique. Control
      group performed a laser placebo. The time duration (5 minutes), position, and therapist were
      the same for both treatments. The investigators will measure stabilometry variables and
      static footprint. The footprint variables will be divided in bilateral rear foot, bilateral
      midfoot, bilateral fore foot.

      Measures. Stabilometry will be measured by displacement of the center of pressures in X and Y
      with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with
      eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with
      eyes open and closed, and COP speed. Two trials will be recorded for each condition and the
      order of the conditions will be randomized across subjects, eyes open and eyes closed. Foot
      plantar pressure and surface area of two static footprints will be measured during bipedal
      standing. Static plantar pressure will be evaluated by means of maximum pressure, medium
      pressure and surface area of each aspect of the foot (rearfoot, midfoot, and fore foot).
    

Intervention name(s): Laser; pressure and traction tecnique
Intervention type(s): Other; Other
Intervention description(s): laser with no emision will applied; pressure and traction in plantar fascia with hands will be applied
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two arms parallel ( intervention and control) will be randomized asigned to compare pressure and traction tecnique versus laser placebo
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: fascia; myofascial; plantar fascia; postural balance; stabilometry; platform
Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the
      efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to
      lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among
      postmenopausal women.
    


Intervention name(s): Lactulose, Vitamin D, Calcium
Intervention type(s): Drug
Intervention MeSH terms: Vitamin D; Lactulose; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: lactulose; randomised clinical trial; osteopenia; postmenopause
Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients
Condition: Nephrotoxicity
Study type: Interventional
Phase: Phase 4

Summary: 
      Kidney damage is a major complication of current antirejection medicines used in
      transplantation. An increasing number of brittle diabetics are successfully receiving a
      pancreas transplant. One of the challenges following pancreas transplant is that a patient
      can develop kidney damage from one of their antirejection medicines, tacrolimus. The
      objective of this study is to substitute a new antirejection medicine which does not cause
      kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus
      related kidney damage to slow the progression of kidney disease.
    

Detailed description: 
      Nephrotoxicity is a major complication of current immunosuppression regimens used in
      transplantation. Pancreas transplantation has been increasedly performed to manage labile
      diabetes mellitus during the last few decades and survival rates of pancreatic grafts are
      improving. One of the challenges that is faced following pancreas transplantation alone are
      pathologic changes from diabetes frequently seen in native kidneys in the pancreas transplant
      recipients. High levels of calcineurin inhibitors (CNI) have been identified as risk factors
      for decline in kidney function and progression to end-stage renal disease. The objective of
      this trial is to take subjects who have biopsy proven CNI toxicity off of their CNI and begin
      belatacept, which is not a CNI.

      The hypothesis is by switching the pancreas transplant subject with documented CNI kidney
      toxicity to belatacept will slow the progression of chronic kidney disease.
    

Intervention name(s): Belatacept
Intervention type(s): Drug
Other intervention name(s): Nulojix
Intervention MeSH terms: Abatacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreas transplantation; immunosuppression; belatacept
Evaluation of a MRI-based Prostate Cancer Screening Program
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effort and resources (incl. costs) required to
      detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of
      the prostate.
    

Detailed description: 
      Informed men at risk for prostate cancer will be included into the study to undergo prostate
      cancer screening. According to European guidelines we will include men > 50 years of age and
      men >45 years of age and a family history of PCA as well as African-Americans >45 years of
      age. In this study, bpMRI will be used for opportunistic prostate cancer screening.

      The indication for prostate biopsy is based solely on the results of bpMRI. In case of
      detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion
      biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA (
      PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for
      PCA.
    

Intervention name(s): Screening
Intervention type(s): Other
Intervention description(s): Use of bpMRI for opportunistic prostate cancer screening.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion Epidurals?
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Ultrasound scanning of the back has been shown to increase success when used to guide
      epidural catheter insertion. However, this technique is not applied widely in clinical
      practice. Stronger evidence is required to prove that it will improve the clinical experience
      of labour epidurals.

      The study hypothesis is that anesthesiologists (both residents and fellows), will have an
      increased rate of success and ease of insertion of labour epidural catheters, and that there
      will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done
      prior to the procedure.
    

Detailed description: 
      Studies have shown that ultrasound scanning of the lumbar spine is beneficial in certain
      circumstances (eg. predicted difficult epidurals). However, no large scale studies with
      multiple anesthesiologists performing the technique have been done to show that ultrasound
      scanning may be of benefit in their everyday clinical practice.

      This study will involve residents and fellows, each performing epidural insertions with and
      without the use of ultrasound scanning of the lumbar spine prior to the procedure. If the
      hypothesis is correct, then the use of this technique may become widespread, resulting in
      less complications and increased patients satisfaction.
    

Intervention name(s): Portable ultrasound machine; Portable ultrasound machine
Intervention type(s): Device; Device
Intervention description(s): Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.; Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidural Analgesia; Ultrasound; Training, Inservice
The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      There will be formed of groups for application of vibration methods on the lungs: the method
      of vibroacoustic lung massage using the "BARK VibroLUNG" device; the method of oscillating
      PEP therapy using Acapella DH Green; the method of hardware stimulation of cough with a
      mechanical insufflator-aspirator Comfort Cough Plus (Comfortable cough Plus). As a control
      group, classical manual chest massage with percussion and verbal stimulation of cough against
      the background of chest compressions with a total duration of 15 minutes will be used
    

Detailed description: 
      The patient signs an informed consent to participate in the study after 10-12 hours tracheal
      extubation and transfer of the patient to spontaneous respiration. The application of one or
      another method of influence is carried out by the method of random sampling (the envelope
      method). Next, a session is conducted using one of the methods of vibrational respiratory
      therapy. We are exploring the gas composition of arterial blood is examined, spirometry, and
      the respiratory rate is measured after 20 minutes of the procedure. Further, respiratory
      therapy sessions are repeated 3 times a day for three days
    

Intervention name(s): prevention of respiratory failure
Intervention type(s): Procedure
Intervention description(s): Positive dynamics during CT or X-ray examinations in the form of reduction of hypoventilation zones, straightening of lung tissue
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medical rehabilitation; oxygenation
Reinforcement Learning in Diabetes Mellitus Trial
Condition: Diabetes Mellitus, Type 2; Medication Adherence
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Reinforcement learning is an advanced analytic method that discovers each individual's
      pattern of responsiveness by observing their actions and then implements a personalized
      strategy to optimize individuals' behaviors using trial and error. The goal of this pilot
      study is to develop and test a novel reinforcement learning-enhanced text messaging program
      to support medication adherence in patients with type 2 diabetes. Type 2 diabetes is an
      optimal condition in which to test this program, as it is one of the most prevalent chronic
      conditions in the US adult population and requires most patients to be on daily or twice
      daily doses of medications. This pilot study will be a parallel randomized pragmatic trial
      comparing medication adherence and clinical outcomes for adults aged 18-84 with type 2
      diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be
      randomized to one of two arms for the duration of the study period: (1) a reinforcement
      learning intervention arm with up to daily, tailored text messages based on time-varying
      treatment-response patterns; or (2) a control arm with up to daily, un-tailored text
      messages. Our outcomes of interest will be medication adherence, as measured by electronic
      pill bottles, and HbA1c levels.
    

Detailed description: 
      The goal of this pilot study is to develop and test a novel reinforcement learning-enhanced
      text messaging program to support medication adherence in patients with type 2 diabetes. This
      pilot study will be a parallel randomized pragmatic trial comparing medication adherence and
      clinical outcomes for adults aged 18-84 with type 2 diabetes who are prescribed 1-3 daily
      oral medications for this disease. Participants will be randomized to one of two arms for the
      duration of the study period: 1) a reinforcement learning intervention arm with up to daily,
      tailored text messages based on time-varying treatment response patterns, or 2) a control arm
      with up to daily, untailored text messages. Our outcomes of interest will be medication
      adherence, as measured by electronic pill bottles, and HbA1c levels.
    

Intervention name(s): Reinforcement Learning
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention arm will receive up to daily, tailored text messages based on their electronic pill bottle-measured adherence. Given the participants' baseline characteristics and time-varying responses to the messages, a reinforcement learning algorithm will deliver different text messages and adapt over time to determine which type of messaging works best for each individual participant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Condition: Lateral Canthal Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate
      to severe lateral canthal lines in adults and duration of effect.
    

Detailed description: 
      This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center
      study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single,
      bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will be
      randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and
      efficacy of two different doses of RT001, compared to placebo, will be evaluated.

      At least 180 adult volunteers who have provided informed consent and have met the study
      eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential
      cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2 will
      consist of 108 subjects; 36 subjects per treatment group. In order to confirm the safety of
      the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have reached Day
      14 or later with no Study Pause Criteria being observed.
    

Intervention name(s): RT001; RT001; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Dose A RT001; Dose B RT001; Dose C Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
Magnesium Treatment on Vitamin D Metabolism in Participants Completed Personalized Prevention of Colorectal Cancer Trial
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      One striking observation is that a large portion of the inter-person variation in serum
      25-hydroxyvitamin D (25(OH)D) levels is unexplained. In vitro and in vivo studies indicate
      vitamin D synthesizing and metabolizing enzymes are Mg-dependent. Magnesium (Mg)
      supplementation substantially reversed the resistance to vitamin D treatment in patients with
      magnesium-dependent vitamin-D-resistant rickets. The investigators reported in 2013 from
      observational studies conducted in the general US population that Mg intake significantly
      interacted with vitamin D intake in affecting vitamin D status as well as interacted with
      serum 25(OH)D in risk of cardiovascular disease mortality and, maybe, colorectal cancer
      mortality. The potential interaction between Mg and vitamin D was supported by two subsequent
      studies, including a Finnish cohort study and a mouse study.

      In the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT01105169), the
      investigators proposed to measure blood concentration of total 25(OH)D as a secondary aim
      using Elisa approach. However, following the novel finding of Mg-vitamin D interaction
      published by the investigators in 2013, they submitted a separate grant application to NCI
      which was funded in 2014. In the new study, the investigators proposed to use a LC-MS
      approach, which is more accurate and specific than an Elisa method, to measure 5 vitamin D
      metabolites. This new ancillary study allows the investigators to evaluate whether Mg
      supplementation differentially affects vitamin D synthesis and metabolism dependent on
      baseline serum 25(OH)D levels using existing biospecimens collected in our double-blind
      placebo-controlled randomized chemoprevention trial.
    


Intervention name(s): Magnesium glycinate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral administration of magnesium glycinate daily for 12 weeks; Oral administration of identical-appearing placebo daily for 12 weeks
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Personalized prevention trial; Magnesium; Vitamin D metabolism and synthesis; Magnesium-vitamin D interaction