bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Insomnia in Patients With Low Back Pain
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether insomnia due to chronic low back pain can
      improve with use of eszopiclone.
    

Detailed description: 
      There is a great need to develop effective treatments for insomnia in patients with chronic
      low-back pain. Chronic low-back pain is among the most prevalent of all health complaints, is
      associated with enormous health-care and productivity costs, reduced quality of life, and
      limitation of function and is almost universally associated with insomnia (Rives and Douglas,
      2004). While it had long been believed that insomnia was a symptom of pain conditions and of
      little consequence in its' own right, a growing literature suggests that insomnia has
      important effects on the clinical course of pain syndromes (Smith and Haythornthwaite, 2004).
      While pain may disrupt sleep, it appears that problems with sleep increase pain and are
      associated with impairments in daytime function. The emerging point of view is that specific
      treatment for both pain and insomnia is needed for optimal clinical management (Smith and
      Haythornthwaite, 2004). Surprisingly, despite the fact that chronic low-back pain is the most
      common pain condition, the treatment of insomnia in this disease has never been studied. As a
      result, we propose to carry out the first double-blind placebo-controlled study of the
      treatment insomnia in patients with chronic low back pain.

      Comparison(s): We will test the hypothesis that treating the insomnia with eszopiclone 3 mg
      (ESZ) along with management of pain with naproxen 500 mg bid (NAP) will result in
      statistically significantly improved sleep compared with placebo. We also propose to test as
      a secondary hypothesis that treatment with ESZ will lead to significant improvement in pain
      and daytime function vs. placebo.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eszopiclone 3 mg po nightly for duration of study blind phase.; Placebo nightly over duration of double blind study phase
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Low Back Pain; Hypnotics; Eszopiclone; Pain; Disability
Immunogenicity and Safety of Fractional Booster Dose of COVID-19 Vaccines Available for Use in Pakistan/Brazil: A Phase 4 Dose-optimizing Trial
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      Since the emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
      pathogen in late 2019, millions of people around the world have fallen ill and died from
      coronavirus disease 2019 (COVID-19), with variant-fueled case spikes causing repeated cycles
      of morbidity and mortality. The rapid development and emergency use authorization of vaccines
      against SARS-CoV-2 presents an enormous opportunity to protect populations, but bottlenecks
      in production have led to demand for vaccines that far outpaces supply. This project will
      investigate the immunogenicity of fractional doses of SARS-CoV-2 vaccines given a minimum of
      six months following an initial two-dose schedule or following natural immunity via
      documented infection. The consortium of research partners from the Sabin Vaccine Institute,
      Aga Khan University, Fundação Oswaldo Cruz (Fiocruz), and Stanford University will recruit
      volunteers to receive a full or fractional booster dose of BNT162b2, AZD1222 or Sinovac
      following receipt of their primary vaccination series or PCR-confirmed natural infection in
      Pakistan. The research team will follow participants for six months from boosting, with blood
      draws at baseline, 28 days, 3 months and 6 months, and measure sero-response rate (SRR) by
      anti-Spike immunoglobulin G (IgG) binding enzyme-linked immunosorbent assay (ELISA) with the
      ultimate aim of identifying whether fractional doses provide a similar immune response
      compared to full doses of vaccine.
    


Intervention name(s): Sinovac; AZD1222; BNT162b2
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Sinovac inactivated COVID-19 vaccine:
● Full dose (0.5 ml); AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine:
Full dose (0.5 ml)
Half dose (0.25 ml); Pfizer/BioNTech BNT162b2 mRNA vaccine:
Full dose (30 micrograms)
Half dose (15 micrograms)
One-third dose (10 micrograms)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fractional dose; COVID-19
Action of Amantadine on Post-Stroke Aphasic Patients
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of the study is to test the action of the amantadine, as DOPA-agonist, in a
      double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post
      stroke aphasic patients.
    

Detailed description: 
      In France, there are around 30000 aphasic patients. The actual taking care of these patients
      after stroke includes the treatment of acute stage in stroke unit, followed by rehabilitation
      program. However, most non fluent aphasic patients remain chronically handicapped despite of
      intensive logopedic training.

      The objective of this clinical project is to test the action of pharmacologic agents on
      verbal fluency of aphasic patients victims of cerebral infarctions. Only a few studies have
      been done with various pharmacologic agents, and although the results were not clearly
      conclusive, they were sufficiently positive for suggesting to launch a well controlled
      randomized cross-over study.

      Then the objective of study is to test the action of the amantadine, as DOPA-agonist, in a
      double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post
      stroke aphasic patients.
    

Intervention name(s): Amantadin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Amantadin caps; Placebo caps
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cerebral infarction
The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer
Condition: Photosensitivity
MeSH terms: Photophobia; Photosensitivity Disorders
Study type: Interventional

Summary: 
      This is a 6-visit, single-center, non-dispensing, randomized, single-masked, 5×5 crossover
      study. Subjects will participate in 6 scheduled over the duration of approximately 10.5
      months.
    


Intervention name(s): 419 nm Spectacle Filter; 437 nm Spectacle Filter; 456 nm Spectacle Filter; 476 nm Spectacle Filter; 373 nm Spectacle Filter
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): TEST; TEST; TEST; TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Soy Protein in Preventing Recurrent Cancer in Patients Who Have Undergone Surgery for Stage II Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Soy protein may help prevent prostate cancer recurrence in patients who have
      undergone surgery for prostate cancer.

      PURPOSE: This randomized phase II/III trial is studying how well soy protein works and
      compares it to a placebo in preventing recurrent cancer in patients who have undergone
      surgery for stage II prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether soy protein isolate reduces the PSA failure rate and time to PSA
           failure within 2 years following radical prostatectomy in patients who are at high risk
           for prostate cancer recurrence.

        -  Determine the effects of soy protein isolate on intermediate biomarkers of steroid
           hormone axis (testosterone, estradiol, and SHBG) and thyroid activity (T3 and T4).

        -  Determine the effects of soy protein isolate on intermediate biomarkers of apoptosis
           (soluble Fas and Fas-ligand), angiogenesis (VEGF and bFGF), antioxidant activity
           (8-isoprostanes), and IGF axis (IGF-1 and IGFBP-3).

        -  Compare patients who are equol producers to those who are non-producers.

      OUTLINE: This is a multicenter study. Patients are stratified according to hospital/clinic
      site (NYU vs UIC or Jesse Brown VA Medical Center vs other sites), number of high-risk
      characteristics (1 vs > 1), and race (African American vs non-African American [i.e.,
      non-Hispanic White, Hispanic, Asian, and other]). Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients receive an oral soy protein isolate beverage once daily.

        -  Arm II: Patients receive an oral casein placebo beverage once daily. Treatment in both
           arms continues for up to 2 years in the absence of disease progression or unacceptable
           toxicity.

      Blood samples are collected periodically for biomarker laboratory studies. Samples are
      analyzed to measure PSA levels by Tosoh PSA assay; cholesterol levels; isoflavone and equol
      concentrations by HPLC and ESA; and indicators of steroid hormone axis (testosterone,
      estradiol, and SHBG), indicators of thyroid activity (T3 and T4), indicators of apoptosis
      (soluble Fas and Fas-ligand), indicators of angiogenesis (VEGF and bFGF), indicators of
      oxidative stress (8-isoprostanes), and indicators of IGF axis (IGF-1 and IGFBP-3) by ELISA.
    

Intervention name(s): soy protein isolate; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Given orally; Given orally
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: stage IIB prostate cancer; stage IIA prostate cancer
Brown Seaweed Extract on Glycemic Control and Body Weight
Condition: PreDiabetes; Insulin Resistance
MeSH terms: Insulin Resistance; Body Weight
Study type: Interventional

Summary: 
      The overall goal of this study is to investigate the effects of a daily dietary supplement of
      brown seaweed (2 capsules of InSea2®) on body weight, glycemic control and insulin secretion
      in overweight prediabetic men and women in association with a moderate weight loss
      intervention.
    

Detailed description: 
      Diets that produce lower glucose and insulin responses may reduce diabetes and cardiovascular
      risk. They may also facilitate weight control by promoting satiety, insulin sensitivity and
      optimal insulin secretion after a meal. Food ingredients may indeed reduce postprandial
      glucose and insulin response through an inhibition of α-amylase and α-glucosidase activity
      that may slow down the absorption of carbohydrates. InSea2® is a unique combination of
      polyphenolic extracts of brown algae (Ascophyllum nodosum and Fucus vesiculosus) which has
      been shown to inhibit the action of α-amylase and α-glucosidase. Preliminary data in healthy
      men and women have demonstrated a reducing effect on plasma insulin of a single intake of
      InSea2® consumed with a high-carbohydrate meal.

      The main objective is to evaluate the effects of a daily dietary supplement of 500 mg (2
      capsules) of brown algae extract powder (InSea2®) on body weight and blood glucose
      homeostasis (glucose, insulin, c-peptide) measured in the fasting state and during a 2-hour
      oral glucose tolerance test (OGTT) in overweight prediabetic men and women.

      The secondary objectives are to assess the contribution of a daily consumption of this
      supplement (InSea2®) on weight loss when associated with a daily caloric restriction of 500
      kcal due to individualized nutritional intervention on markers of lipid profile, blood
      pressure, inflammation, oxidative stress and gut barrier integrity.

      The investigators expect that InSea2® lowers body weight and blood glucose homeostasis
      (glucose, insulin or C-peptide, as marker of insulin secretion, in the fasting state or
      during a 2-hour oral glucose tolerance test) in association with metabolic and inflammatory
      markers in the context of moderate weight loss in overweight prediabetic human subjects.
    

Intervention name(s): InSea2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily supplement: 2 capsules of InSea2; Daily supplement: 2 capsules of Placebo
Other intervention name(s): Brown seaweed extract supplement; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease
Condition: Subjective Cognitive Decline; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive
      training of working memory leads to performance improvement in individuals with prodromal
      Alzheimer's disease.
    

Detailed description: 
      The goal of the present study is to assess behavioral (primary) effects of a multi-session
      cognitive training combined with transcranial direct current stimulation (tDCS). Many studies
      to date have found tDCS to be an efficient method to enhance various cognitive functions by
      modulating cortical excitability in young adults, but its behavioral impact and underlying
      mechanisms in pathological aging still need to be elucidated. Individuals with prodromal
      Alzheimer's disease, will participate in a three-week cognitive training with concurrent
      online tDCS application. Cognitive performance (primary) will be examined before, during and
      after the intervention, in order to draw conclusions about the effect of tDCS. In addition to
      cognitive training, a control group, receiving sham stimulation during training, will be
      assessed. Follow-up sessions to assess long-term effects are planned four weeks and seven
      months after the post assessment. Furthermore, to assess potential predictors of tDCS
      effects, functional and structural parameters will be measured with MRI. The results of the
      study will offer valuable insights into efficacy of combined tDCS and cognitive training, as
      compared to training alone, in individuals with prodromal stages of Alzheimer's disease.
      Moreover, improved understanding of tDCS effects on cognitive training performance and
      underlying neural correlates may help to develop novel approaches for modulating cognitive
      decline in healthy and pathological aging.
    

Intervention name(s): anodal tDCS; Intensive cognitive training
Intervention type(s): Device; Behavioral
Intervention description(s): Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA); Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: memory; brain stimulation
Pharmacokinetics of Tacrolimus in Children
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      the present study was conducted to assess the population pharmacokinetics of tacrolimus in
      children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen
      of tacrolimus for use in these patients.
    


Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): Tacrolimus was administered orally at a dose of 0.05 mg/kg/dose twice daily (bid) for children with nephrotic syndrome.
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Investigator-initiated, Explorative Trial Evaluating the Effect of SAT-008 in Healthy Adults
Condition: Allergy and Immunology
Study type: Interventional

Summary: 
      The purpose of this exploratory study is to evaluate the efficacy, safety, and feasibility of
      a novel digital device called SAT-008 in healthy adults.
    

Detailed description: 
      This clinical study was designed as a single institution, open, controlled, and
      investigator-led clinical trial to evaluate the efficacy, safety, and feasibility of a novel
      digital device called SAT-008 in healthy adults.
    

Intervention name(s): SAT-008
Intervention type(s): Device
Intervention description(s): SAT-008 is a digital device containing several types of activities related to the immune function of adults.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of two study arms. One group (treatment) will receive an experimental digital device for 13 weeks while the other group (control) will maintain daily activity as usual.
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Gefapixant (MK-7264/AF-219) on Cough Reflex Sensitivity in Healthy and Chronic Cough Participants (MK-7264-014)
Condition: Refractory Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to assess the effect of a single dose of gefapixant
      100 mg on cough reflex sensitivity to various challenge agents (capsaicin, citric acid,
      adenosine triphosphate [ATP], and distilled water) in healthy and chronic cough participants.
    

Detailed description: 
      The study had a Screening period to determine participant inclusion, two Baseline Visits, and
      two treatment periods with a minimum 48-hour washout between the treatment periods. At
      Baseline and during each treatment period, cough sensitivity was measured by standard
      clinical methodology incorporating four cough challenges. Daytime cough monitoring was
      performed at Baseline and during each of the two treatment periods (chronic cough
      participants only).
    

Intervention name(s): Gefapixant 100 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gefapixant 100 mg (2 x 50 mg tablets), administered orally as a single dose in treatment Period 1 or treatment Period 2; Placebo (two tablets matching gefapixant 50 mg), administered orally as a single dose in treatment Period 1 or treatment Period 2
Other intervention name(s): MK-7264; AF-219
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Chronic cough and healthy participants were randomly assigned to receive gefapixant and placebo in one of two treatment sequences: Sequence A (placebo in treatment period 1, then gefapixant in treatment period 2) or Sequence B (gefapixant in treatment period 1, then placebo in treatment period 2). There was at least a 48-hour washout between the treatment periods. Daytime cough monitoring was performed in chronic cough participants only.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preventive Osteopathic Treatment of Plagiocephaly
Condition: Positilonal Deformation of the Skull; Head Turn Preference; Axial Hypertony
MeSH terms: Plagiocephaly
Study type: Interventional

Summary: 
      Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for
      pediatric consultation, which has increased significantly since the recommendation to lay
      babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern
      for parents about their impact on psychomotor development and the aesthetic risk of
      deformity. The High Authority for Health (HAS) will soon put in place recommendations with a
      fact sheet for health professionals and the public. The aim of this research is to study
      whether early treatment of rotation disorders and hypertonia in newborns by manual
      osteopathic techniques would prevent the occurrence of positional deformities of the skull.

      The main objective is to evaluate the effectiveness of an early osteopathic treatment on the
      rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk.

      the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment
      on the quality of life of the child at 4 months.

      Methodology: Controlled, randomized monocentric two-arm parallel study between (1)
      osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18
      months and the follow-up period is 4 months.

      Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group
      will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of
      3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and
      stimulation advice.

      The perspectives are:

        -  the decrease in the prevalence of CPP after early osteopathic treatment.

        -  Defining a decision algorithm for early osteopathic treatment.

        -  Subject to recommendations on the indication of early osteopathic treatment in neonates
           at risk.
    


Intervention name(s): manual therapy/osteopathy
Intervention type(s): Procedure
Intervention description(s): In this group, children will benefit from early osteopathic treatment over a period ranging from the third day to 4 months. The number of sessions will not be fixed, on average, 3 sessions will be carried out during this period at the University Hospital of Montpellier.
The duration of the session will be between 20 minutes to 30 or even 40 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Gene Regulation by Thiazolidinediones
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of rosiglitazone on the genes of the
      colon
    

Detailed description: 
      The primary aim of the study is to examine the effect of rosiglitazone (Avandia) on gene
      regulation in colonic epithelium in the absence of pathologic acute and chronic intestinal
      inflammation. The secondary aims are to determine the effect of rosiglitazone (Avandia)
      therapy on T cell activation and cytokine expression in the absence of pathologic acute and
      chronic intestinal inflammation.
    

Intervention name(s): Rosiglitazone
Intervention type(s): Drug
Intervention description(s): 8mg tablet once a day for 14 days
Other intervention name(s): Avandia
Intervention MeSH terms: Rosiglitazone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science