bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Motor Interference Rehabilitation in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study examines the effect of balance and walking exercise on cognition and mobility in
      people with Multiple Sclerosis.
    

Detailed description: 
      Walking and cognitive impairments are common in persons with multiple sclerosis (MS).
      Approximately 85% of persons with MS report walking as a major limitation, whereas 65%
      experience cognitive dysfunction. Traditionally, walking and cognition have been viewed as
      unrelated, but there is evidence of cognitive-motor interference (CMI). CMI is believed to
      stem from damage to common neural tracts. Recent evidence supports cognitive-motor
      interference in persons with MS. For example, there is evidence that walking performance
      declines when performed in conjunction with a simultaneous cognitive task (i.e., dual task
      cost [DTC] of walking) and this decline in walking performance is greater in persons with MS
      compared to healthy controls. This elevated cognitive-motor interference during walking is
      mainly associated with walking performance in persons with MS although cognitive function
      does play a role. Cognitive-motor interference during mobility tasks is of practical and
      clinical importance because it has been linked to decreased community mobility and a greater
      risk of falls in other clinical populations. Despite the adverse consequences of elevated CMI
      there is ambiguity concerning prevention and rehabilitation strategies for cognitive-motor
      interference in individuals with MS.

      This study seeks to examine whether single and/or targeted dual task rehabilitation has a
      beneficial effect on CMI in individuals with MS. The results of this investigation will
      provide the foundation for future rehabilitation-based randomized control trials seeking to
      improve walking and cognitive function in persons with MS.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Balance and gait exercise twice a week for an hour
Other intervention name(s): Physical Rehabilitation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects
Condition: Alcohol Related Disorders; Alcoholism; Alcohol Abuse
MeSH terms: Alcoholism; Alcohol-Related Disorders
Study type: Interventional

Summary: 
      To monitor the inhibition of 5a-reductase (5AR) enzyme activity at 1, 3, 7, 14, 21, 28 and 42
      days following administration of a single dose of dutasteride (2, 3, or 4 mg) by measuring
      the change in blood levels of 3a-androstanediol glucuronide (3a-diolG) and the ratio of
      dihydrotestosterone (DHT) to testosterone. To accomplish this aim, an open-label,
      between-subjects dose comparison study design will be employed with subjects receiving a 2,
      3, or 4 mg dosage. Subjects (up to n=40 enrolled to allow a minimum of 24 completers) will be
      randomly assigned to one of the 3 dose levels. Results of this study will inform the dose
      selection for a subsequent placebo-controlled, within-subject, crossover study of dutasteride
      on the effects of alcohol.

      A secondary aim of this study is to examine the correlation of a genetic variation in the
      type I 5AR gene and baseline DHT/T ratio and effect of dutasteride at day 3. A variation in
      this gene which is one of the targets of dutasteride has been reported to be associated with
      higher baseline levels of DHT.
    

Detailed description: 
      Alcohol abuse and dependence remain important public health problems. The chemical mechanisms
      by which alcohol affects the nervous system are not well understood. Recent theories suggest
      that alcohol stimulates release of "neuroactive" steroid hormones which are important
      mediators of alcohol effects. This proposal seeks to identify the most appropriate dosage of
      an FDA approved medication, dutasteride, which blocks the metabolism of steroid hormones, so
      that we can use dutasteride as a pharmacologic probe of the biochemistry of alcohol effects
      in human subjects in a subsequent study.
    

Intervention name(s): Dutasteride
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single dose of 2, 3 or 4 mg of dutasteride based on random assignment.
Other intervention name(s): Avodart
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Keywords: steroid 5AReductase; genetic polymorphism; GABA receptor
Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This trial will assess the feasibility of reduction gastroplasty with standard suture in
      bariatric patients who are candidates for surgical weight loss intervention.
    

Detailed description: 
      The overall plan for all subjects consists of the following elements:

        -  Subject will be informed about the nature of the research, given the Informed Consent
           Document (ICD) to read, and if the subject understands and agrees to the procedure will
           be asked to sign a written informed consent (the ICD).

        -  Subjects will undergo reduction gastroplasty by gastric plication in which a section of
           the stomach will be infolded by multiple rows of sutures.

        -  Subjects are followed for 12 months to evaluate outcomes and potential complications.
    

Intervention name(s): Reduction Gastroplasty
Intervention type(s): Procedure
Intervention description(s): Subjects will undergo reduction gastroplasty by gastric plication
Subjects are followed for 12 months to evaluate outcomes and potential complications.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intraumbilical Misoprostol in Retained Placenta
Condition: Retained Placenta
MeSH terms: Placenta, Retained
Study type: Interventional
Phase: Phase 1

Summary: 
      Administration of intraumbilical misoprostol to women with retained placenta despite active
      management of third stage of labour reduces the need for manual removal of placenta and the
      amount of blood loss vaginally.
    

Detailed description: 
      Retained placenta (RP)is one of the complications of third stage of labour; it should be
      managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality
      .The current standard management of RP word wide, by manual removal aims to prevent these
      problems, but it is unsatisfactory method because it requires general anaesthesia in
      hospital, It is an invasive procedure with its own serious complications of bleeding,
      infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe
      method and could be performed at the place of delivery .
    

Intervention name(s): Misoprostol; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.; It is a placebo group
Other intervention name(s): (Misotac)® tablet; Normal saline 0.9%
Intervention MeSH terms: Misoprostol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intraumbilical misoprostol; Retained placenta; Active management of third stage of labour
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment
      of anemia in patients with chronic kidney disease not on dialysis
    

Detailed description: 
      This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in anemic
      patients with Stage 3, 4 or 5 chronic kidney disease (CKD) who are not on dialysis.
    

Intervention name(s): Roxadustat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.; The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Renal,; CKD,; Roxadustat,; anemia,; non-dialysis
Comparing Imaginal Exposure and Imagery Rescripting in Treatment of Posttraumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The outcome of trauma treatment (Posttraumatic Stress Disorder - PTSD) may be influenced by
      which emotions that are predominant among current symptoms, e.g. fear, anger, guilt, shame.
      Different treatment procedures for processing traumatic memories may resolve different
      emotions. This study compares two different treatment procedures of working with trauma
      memories in PTSD treatment (namely, Imaginal Exposure and Imagery Rescripting) in order to
      test this.
    

Detailed description: 
      The main objectives of this study are:

        1. To assess the relative efficacy of the two procedures in inpatient treatment for PTSD

        2. To assess whether the predominant emotions in the traumatic memories moderate the
           outcome of the different procedures

        3. To assess whether theory-derived constructs mediate outcome and whether the mediating
           relationships are different in the two treatments

        4. To provide a theoretical account of the two models

        5. To psychometrically evaluate 3 new measures
    

Intervention name(s): Imaginal exposure; Imagery rescripting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 7 individual sessions of imaginal exposure of trauma memories according to the prolonged exposure treatment manual; 7 individual sessions of imagery rescripting of trauma memories according to the imagery rescripting and reprocessing therapy manual
Other intervention name(s): prolonged exposure; pe; rescripting; irrt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Estimation of Muscle Area and Thickness of Deep Cervical Muscle Contraction During Cervical and Limb Movements
Condition: Multifidus
Study type: Observational

Summary: 
      The purpose of this study is to investigate the validity and reliability of measurement for
      cervical multifidus using ultrasonography, and to investigate cervical multifidus muscle
      function by the change pattern of multifidus thickness, and to compare the changes in muscle
      thickness among different resistance levels (rest, 25%, 50%, 75% and 100%) and different
      cervical levels (C4, C5 and C6).
    

Detailed description: 
      Cervical multifidus has specific sensory and motion function. However, it was unclear about
      muscle architectural change of cervical multifidus during head retraction manoeuvre with
      progressive resistance. The validity and reliability of measuring cervical multifidus using
      ultrasonography hasn't been proven.

      In the pilot study, thickness, width and area of multifidus were measured at C4, C5 and C6
      were measured using MRI and ultrasonography. The limit of agreement and the regression
      analysis were used to compare the results of two modalities. Besides, muscle thickness was
      repeatedly measured during the static and head retraction manoeuvre using ultrasonography by
      the same rater on the same day; the CVw and CVb were used to investigate reliability. In the
      main study, multifidus architecture measured in twenty asymptomatic subjects (24.3±4.7 yo, 5
      women and 15 men) during head retraction manoeuvre with progressive resistance and during
      relaxation using ultrasonography apparatus with 10MHz linear transducer. ANOVA with repeated
      measurement and post-hoc analysis were to investigate the difference among different cervical
      levels and resistance force levels.

      The results of the pilot study showed that the limit of agreement was ±0.20 cm and the
      moderate level of correlation (R2 ranged in 0.42~0.64) for muscle thickness measured between
      MRI and ultrasonography. For muscle thickness, the CVw values under static and under head
      retraction against maximum resistance were lower than 10%. In the main study, there was a
      curvilinear relationship between muscle thickness change and resistance, and the quadratic
      equations were the proper curves for estimation. There was significant difference of muscle
      thickness change within 50% of maximum retraction against resistance; and there was no
      significant difference among three cervical levels. It was suggested that muscle at C6
      relaxed more slowly during the period from the beginning of relaxation.

      In conclusion, the present study built a valid and reliable method for measuring continuous
      and dynamic changes of muscle thickness using ultrasonography. The results supported muscle
      function of cervical multifidus for segmental stability but not for force production.
    

Observational model: Defined Population
Time perspective: Other
Keywords: Ultrasonography; Cervical Multifidus
The Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary aim of this study is to investigate the effects of exogenously administered
      nicotinamide riboside (NR) on brain NAD+/NADH ratio and bioenergetics functions in healthy
      individuals using phosphorus magnetic resonance spectroscopy (31P MRS) imaging.

      The secondary aims are to investigate the change in brain PCr/ATP and creatine kinase enzyme
      rate after NR use. In addition, NAD+/NADH ratio, PCr/ATP and CK enzyme rate will be measured
      in the calf muscle, as secondary outcome measures.
    


Intervention name(s): Nicotinamide Riboside
Intervention type(s): Drug
Intervention description(s): Nicotinamide riboside 2g/day for a 2 week duration
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Postoperative Atrial Fibrillation
Condition: Postoperative Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The primary aim of this study is to determine the safest and most effective therapeutic
      strategy to decrease the incidence of postoperative atrial fibrillation following cardiac
      surgery in an era with shorter ICU and hospital length of stay. A secondary goal is to
      evaluate the length of hospital stay associated with each treatment strategy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult patients undergoing open heart surgery
Analgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether multiple ports improve the analgesic
      efficacy of flexible catheters used for the provision of epidural analgesia during the entire
      continuum of labor and delivery
    

Detailed description: 
      Multiport catheters, when compared to uniport catheters, have been associated with better
      analgesic quality during labor epidural analgesia because the presence of more than one port
      may enhance the distribution of epidural medication

      Flexible catheters, when compared to rigid catheters, have been associated with better
      analgesic quality during labor epidural analgesia because greater flexibility may minimize
      catheter deviation in the epidural space, facilitate more optimal catheter placement in the
      epidural space, and result in better distribution of epidural medication

      It is unknown whether multiple ports, which promote better distribution of epidural
      medication, provide added analgesic benefit to flexible catheters, which also facilitate
      better distribution of epidural medication, when used for the provision of epidural analgesia
      during labor and delivery
    

Intervention name(s): Multiport flexible catheter; Uniport flexible catheter
Intervention type(s): Device; Device
Intervention description(s): Multiport flexible catheter has three ports for the delivery of epidural medication; Uniport flexible catheter has one port for the delivery of epidural medication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epidural catheter; Epidural analgesia; Labor epidural analgesia; Analgesic efficacy; Multiport epidural catheter; Uniport epidural catheter; Flexible epidural catheter
Influence of Pioglitazone for Renal Transplant Function in Diabetics
Condition: Diabetes Mellitus; Kidney Transplantation; Proteinuria
MeSH terms: Proteinuria; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test whether pioglitazone is able to prevent the progression
      of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.
    

Detailed description: 
      About 30 % of kidney transplant recipients will develop diabetes mellitus. This condition is
      a risk factor for graft dysfunction, graft loss and increased mortality of patients.
      Inflammatory reactions within the graft and proteinuria are considered as pathogenetic
      mechanisms.

      Recent studies indicated that pioglitazone might have beneficial effects on the urinary
      protein excretion of type 2 diabetic patients with diabetic nephropathy and was able to
      reduce systemic inflammation.

      This lead to the hypothesis that pioglitazone could improve proteinuria of kidney transplant
      patients with diabetes.

      Comparison: Effects of pioglitazone vs. placebo on proteinuria and renal function of kidney
      transplant recipients in a cross over study.
    

Intervention name(s): pioglitazone
Intervention type(s): Drug
Intervention description(s): Pioglitazone 30 mg o.d. tablet for 12 weeks or placebo o.d. tablet for 12 weeks in random order. After 12 wk treatment there is a 4 wk washout out which is followed by switch of study medication in a cross over fashion and a further 12 wk treatment.
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: posttransplant diabetes mellitus; kidney transplantation; filtration fraction; proteinuria
The Healthy Heroes Study
Condition: Shift Workers' Health; Time Restricted Eating; Fasting
Study type: Interventional

Summary: 
      This is the first study of its kind to assess and test an intervention to improve biological
      rhythms and general health of shift workers, specifically first responders with San Diego
      Fire and Rescue. In a randomized control trial, investigators intend to measure the health
      impact of Time Restricted Eating in emergency responders who work a 24-hour shift schedule.
    

Detailed description: 
      Participants will be randomly assigned to a control group of behavioral nutrition counseling
      (standard of care) or the intervention group of standard of care with the addition of
      adopting a 10 hour eating window for one year (TRE). For the first 3 months of intervention,
      participants will be monitored closely by the research team. For the following 9 months,
      participants will be in a self-monitored intervention period. Investigators will evaluate the
      impact of TRE on blood glucose levels, biomarkers, sleep/mood, and weight loss. These
      assessments will be made at baseline, at the end of the 12-week monitored intervention
      period, and every 3 months (months 6, 9, and 12) during the self-monitored intervention
      period for one year. Food/drink intake, activity, and sleep will be monitored with the
      smartphone myCircadianClock application ("mCC app") throughout the study. A continuous
      glucose monitor, a wrist-worn actigraphy device, and questionnaires will also be used during
      the study.
    

Intervention name(s): Time Restricted Eating + Standard of Care; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in this arm will adhere to a daily, consistent 10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietician.; Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 10-hr eating window.
Other intervention name(s): Time Restricted Eating
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Firefighters; San Diego Fire and Rescue; Cardiometabolic Health; First Responder; Shift Workers; Time-Restricted Eating; Fasting
A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.
    


Intervention name(s): ALN-PCSSC; Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Single or multiple doses of ALN-PCSSC by subcutaneous (sc) injection; calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: LDL-C; RNAi therapeutic