bioihbjkbjnl/mcl2 huggingface dataset:
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
Condition: Suicide; Suicide, Attempted
MeSH terms: Suicide; Suicide, Attempted
Study type: Interventional

Summary: 
      The investigators propose to test the efficacy of a brief, readily accessible, and
      personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown,
      2012).
    

Detailed description: 
      Background: Mental health related hospitalizations and suicide are both significant public
      health problems within the United States Department of Defense (DoD). There are limited
      evidence-based suicide prevention interventions that have been developed for military
      personnel and veterans who are experiencing suicide ideation or who have made a suicide
      attempt.

      Objectives: To evaluate the efficacy of the Safety Planning for Military (SAFE MIL) on
      suicide ideation, suicide-related coping, and attitudes toward help seeking for hospitalized
      military personnel at high suicide risk.

      Methodology: To test the efficacy of the adapted intervention, the investigators will
      randomize 186 patients to one of two conditions: Safety Planning for Military (SAFE MIL) or
      Enhanced Usual Care (E-CARE). The SAFE MIL condition (intervention) will consist of the
      Safety Planning Intervention to help the suicidal individual with a collaboratively generated
      personal plan to mitigate or prevent a future suicidal crisis. The E-Care will consist of the
      usual care patients receive at an inpatient facility during their hospitalization in addition
      to assessment services provided by independent evaluators who work directly with our research
      team. Primary outcomes include suicide ideation, suicide-related coping, and attitudes toward
      help-seeking [acceptability and initiation of services]. Patients in both conditions will be
      assessed on the dependent measures at the time of hospital admission (i.e., baseline), at the
      time discharge (Follow-Up Interval 1 [FU-1]), at 1-month (Follow-Up Interval 2 [FU-2]) and at
      6-month (Follow-Up Interval 3 [FU-3]).
    

Intervention name(s): Safety Planning - Military (SAFE MIL)
Intervention type(s): Behavioral
Intervention description(s): The Safety Planning Intervention (SPI) which is delivered in the SAFE MIL condition aims to help individuals lower their imminent suicide risk by having them collaborate with the study clinician to generate a detailed, hierarchically-arranged action plan for managing suicidal thoughts and urges.
Other intervention name(s): Safety Planning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Suicide Prevention; Suicide Attempt; Suicide Ideation; Randomized Controlled Trial; Safety Planning
Effects of Cocoa Procyanidins on Vascular Function
Condition: Healthy
Study type: Interventional

Summary: 
      There is a question regarding the role of higher flavanol oligomers (procyanidins) and of
      intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol
      intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are
      absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are
      not absorbed and are catabolized by the colonic microflora. The catabolites enter the
      circulation. Phenolic acids and valerolactones represent a significant proportion of these
      catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The vascular
      effects of these colonic microbiome-derived flavanol derivatives have not been studied so
      far. The purpose of the study is to determine the timecourse of endothelial function along
      with flavanol catabolites & metabolites during acute, sustained, and acute on sustained
      ingestion of procyanidins as compared to previously used flavanol interventions, and flavanol
      free control.
    


Intervention name(s): Flavanol and procyanidin supplement; Procyanidin-containing supplement; control supplement deprived of flavanols and procyanidins
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers); Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers); Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement
Intervention MeSH terms: Proanthocyanidin; Procyanidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: flavanols; cocoa procyanidins; vascular function; endothelial function
Digitalization of Neurofunctional Tests Via a Mobile Application DAMS for Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple Sclerosis (MS) is a chronic immune-mediated inflammatory disease with a broad
      diversity of symptoms and fluctuating progression patterns. Clinical assessments are
      challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care
      depends on early detection of disease progression. The Digital self-Assessment for Multiple
      sclerosis (DAM) mobile program was developed by Ad Scientiam in order to create a robust and
      clinically validated remote monitoring platform for MS patients and clinicians. The
      correlation between DAM version 0 (the first iteration of DAMS) and Multiple Sclerosis
      Functional Composite (MSFC) has been clinically evaluated in a preliminary study in 30
      subjects. DAM version 0 and MFSC global scores were correlated. However, the cognition test
      had a poor reproducibility and clinicians expressed the wish to measure a walking range
      rather than a walking speed. Even though vision is the main sense impacting all other tests,
      particularly when interacting with a mobile, visual tests are rarely performed in real life.
      A new version of DAM version 0, DAMS, was therefore developed with the addition of the Sloan
      Low Contrast Letter Acuity Test (SLCLAT), the replacement of the walking speed test with a
      walking distance test and the Paced Auditory Serial Addition Test (PASAT) by a new version of
      the cognitive test which resembles the Symbol Digit Modalities Test (SDMT).

      The hypothesis is that systematic and prospective multi-dimensional data collection of MS
      disabilities through the DAMS mobile application will refine the quality and accuracy of both
      clinicians and patients' knowledge of the disease progression and will ultimately improve the
      current care of patients.

      To test this assumption, the statistician will analyze:

        1. The global diagnostic performance of DAMS with (DAMS 4 tests) and without (DAMS 3 tests)
           the low contrast vision test versus standard MS scales

        2. The test-retest reliability of DAMS' scores at a 15 day interval
    


Intervention name(s): Digital Assessment on mobile
Intervention type(s): Other
Intervention description(s): The digital assessment is composed on 4 tests:
walking test
coordination test
attention test
vision test
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients will perform one or two visits at 15 days interval. Healthy volunteers will only perform one visit. Patients and healthy volunteers will be randomly assigned to either traditional/digital group (Group A) or digital/traditional group (Group B), followed by a crossover to the other group at day 15 for patients who will do two visits.
Masking: None (Open Label)
Primary purpose: Other
Keywords: DAM; multiple sclerosis; MSFC; application; mobile
A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in the United States of America (USA). The aim of this clinical
      trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian
      subjects, and to identify somatostatin-related adverse events.
    


Intervention name(s): somatropin; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional

Summary: 
      An multi-site, randomized, prospective study to compare the efficacy and safety of
      multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza
      therapy.
    

Detailed description: 
      Azathioprine (AZA) has been used for maintenance therapy of lupus nephritis for many years.
      We compare the efficacy and safety of multi-target therapy as continuous induction and
      maintenance treatment vs CTX-Aza.
    

Intervention name(s): Multi-target therapy; Azathioprine
Intervention type(s): Drug; Drug
Intervention description(s): Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d); 1.0-2.0mg/kg/d
Other intervention name(s): Tacrolimus+mycophenolate mofetil; Aza
Intervention MeSH terms: Mycophenolic Acid; Azathioprine; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Carbonated Soft Drinks on the Body Weight
Condition: Obesity; Metabolic; Complications; Dietary Habits
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation
      leading to obesity development. Although drinks sweetened with aspartame are available the
      anticipated positive effect of these drinks on obesity development has not been convincing.
      However, the mechanisms linking drinks intake to obesity are yet to be clarified.

      The investigators aim is to investigate the long-term effects of intake of soft drinks, milk
      and water. The study is a parallel, intervention trial with 80 overweight, healthy
      volunteers. They will be randomly selected to drink one liter a day of one of the four drinks
      for six months. The objectives are changes in numerous circulating metabolic risk factors,
      changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and
      MR-spectroscopy).

      The investigators expect to clarify the mechanisms linking drinking habits to obesity
      development and provide scientifically based nutritional guidelines.
    


Intervention name(s): Sugar-sweetened soft drink; Aspartame-sweetened soft drink; Semi-skimmed milk; Water
Intervention type(s): Other; Other; Other; Other
Intervention description(s): One litre a day for six months.; One litre a day for six months.; One litre a day for six months; One litre a day for six months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Diaphragmatic Echography in COVID-19 Pneumonia
Condition: Pneumonia, Viral; Covid19; Respiratory Failure
MeSH terms: COVID-19; Pneumonia; Pneumonia, Viral; Respiratory Insufficiency
Study type: Observational

Summary: 
      We hypothesized that diaphragm thickness is concerned in acute respiratory failure of COVID19
      patients and its ultrasound measure at the begining of hospitalisation is a good predictor of
      poor outcome.

      A prospective observational non intervention study is designed.
    

Detailed description: 
      To answer our hypothesis we will perform diaphragm ultrasound in the first 24hr hospitalized
      COVID19 patients.

      In the ultrasound exploration we will assess diaphragm movility and thickness. We will also
      assess other clinical, biochemistry and radiological variables. The main outcome we want to
      analyze is the destination on discharge: home, respiratory intermediate critical unit or
      exitus.
    

Intervention name(s): Diaphragmatic echography
Intervention type(s): Diagnostic Test
Intervention description(s): Diaphragmatic echography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People hospitalaised in pulmonology service
      
Keywords: COVID19 pneumonia; Diaphragm ultrasound
Safety, Pharmacokinetics (PK), And Hematological Activity Of AMD3100 (Plerixafor) In Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy
      control subjects (aged 35 to 78 years) will be enrolled in the study. Subjects with renal
      impairment will be enrolled and entered into three groups based on their renal function: Mild
      Impairment, Moderate Impairment, and Severe Impairment(not requiring dialysis). Control
      subjects will have normal renal function.

      The screening visits will occur within 14 days prior to plerixafor administration on study
      day one. Subjects will be monitored for 10 hours following administration of the study drug.
      In addition, subjects will return to the clinic at 24 and 48 hours after plerixafor
      administration for blood samples and safety assessments.
    

Detailed description: 
      This is a phase I, open label, multi-center study in which up to eighteen subjects with renal
      impairment and six healthy control subjects with normal renal function will receive a single
      dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.

      Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy
      control subjects (aged in the upper age range of the renal impairment subjects) will be
      enrolled in the study. Subjects with renal impairment will be enrolled and stratified into
      three cohorts using their Screening 24 hour urine collection to measured creatinine clearance
      (CLcr) values (an estimate of Glomerular Filtration Rate): Mild Impairment (CLcr = 51-80
      ml/min), Moderate Impairment (CLcr = 31-50 ml/min), and Severe Impairment (CLcr <31 ml/min,
      not requiring dialysis). Control subjects will have normal renal function (CLcr >90 ml/min),
      as determined by a Screening 24 hour urine collection.

      The screening visits will occur within 14 days prior to plerixafor administration on study
      day one. Subjects will be monitored for 10 hours following administration of the study drug.
      In addition, subjects will return to the clinic at 24 and 48 hours after plerixafor
      administration for blood samples and safety assessments.

      This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
      acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
    

Intervention name(s): plerixafor
Intervention type(s): Drug
Intervention description(s): Single dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection
Other intervention name(s): Mozobil; AMD3100
Intervention MeSH terms: Plerixafor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AMD3100
Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
Condition: Caries, Dental; Health Behavior
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This is a randomized clinical trial to test the efficacy of a parent-targeted text
      message-based intervention program on caries incidence and oral health behaviors (child and
      parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and
      Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman
      Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or
      TMs regarding child wellness. The study will enroll English and Spanish speaking parents and
      their youngest child who is < 7 years old, has at least one tooth showing, and attends the
      targeted pediatric clinic to receive primary care (n= 1700). Parents will complete
      self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and
      respond to TM assessments during the 4-month intervention; and will also receive TMs during a
      'booster' period of one month, which will occur 12-months post baseline. Parent's children
      will be assessed for caries by a clinical oral examination performed by licensed Clinical
      Examiners at baseline, 12-and-24-months post-baseline.
    


Intervention name(s): OHT Parent targeted text messages; CWT Parent targeted text messages
Intervention type(s): Other; Other
Intervention description(s): For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.; For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Child oral health behaviors; Text messages; Motivation; Self efficacy; Outcome Expectations; Sugar sweetened beverage consumption; Fluoride varnish; Healthy eating; Parent oral health behaviors; Parent oral health attitudes; Fluoride; early childhood caries
Analysis of Spread Level During Thoracic Erector Spinae Block
Condition: Pain; Radiculopathy, Cervical
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The primary purpose of this study was to identify the ESPB spread level in the craniocaudal
      direction when performed at the T2 level. The secondary purpose was to determine the
      incidence of spread into epidural, paravertebral, intercostal, and intravascular injections
      with ESPB
    

Detailed description: 
      The ESPB requires ultrasound guidance which enables visible local anesthetic spread
      underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis
      muscles comprise the ES muscles, which run vertically along both sides of the vertebral
      column from the sacrum up to the skull base. The ESPB can be performed in the cervical,
      thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more
      widely compared to cervical and lumbar regions. Previous cadaveric studies on the ESPB at the
      T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the
      extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral
      segments deep to the ES muscles and variable involvement of epidural, paravertebral, and
      intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an
      injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of
      an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral
      side. The exact mechanism of action of ESPB remains unclear. A recent study suggested that
      the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of
      the spinal nerves by passing through the costotransverse foramen. However, in clinical
      practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB.
      The study of the physical spread of the injected agent can be used to predict the clinical
      result and elucidate the possible mechanism of action of ESPB.
    

Intervention name(s): Erector spinae plane block
Intervention type(s): Procedure
Intervention description(s): fascial plane injection using ultrasound and fluoroscopic guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Cardiac Arrhythmia Pilot Study (CAPS)
Condition: Arrhythmia; Cardiovascular Diseases; Heart Diseases; Ventricular Arrhythmia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the effectiveness of various drugs and drug combinations in suppressing complex
      ventricular arrhythmias, and to evaluate their safety.
    

Detailed description: 
      BACKGROUND:

      Epidemiologic studies had indicated that complex ventricular premature beats made an
      independent contribution to risk of sudden death in survivors of a myocardial infarction
      (MI), and did not appear to be merely a reflection of their association with relatively
      severe myocardial damage. The potential for reduction in mortality by identification and
      administration of drugs capable of safely suppressing ventricular arrhythmias was tremendous.
      In 1982, there was incomplete knowledge regarding which types of ventricular arrhythmias
      responded to various kinds of drugs. A pilot study of antiarrhythmic agents helped clarify
      this issue.

      Numerous antiarrhythmic agents with differing pharmacologic properties and side effects had
      been shown to suppress ventricular arrhythmias. It had also been postulated that
      antiarrhythmics might raise an individual's threshold for experiencing ventricular
      fibrillation. There had been several published reports of large (at least l00 patients),
      long-term clinical trials of antiarrhythmic agents in post-MI patients. None of these had
      yielded statistically significant results using mortality as the response variable. This
      might have been due to incorrect drug selection, inadequate sample size, inappropriate choice
      of patients, or the lack of impact of arrhythmia treatment on mortality.

      Due to incomplete knowledge as to which drug(s) and combinations of drugs were most
      effective, it was considered to be premature to undertake a full scale trial in 1981-1982.
      However, the public health problem was of sufficient magnitude to warrant a pilot study to
      learn more about the efficacy and safety of various antiarrhythmic drugs singly or in
      combination.

      The protocol planning phase began in October l982. Patient recruitment started in July l983
      and ended in the summer of 1985. Each patient was followed for one year.

      DESIGN NARRATIVE:

      Randomized, double-blind, fixed sample. A total of 502 patients were randomly assigned to 5
      treatment groups consisting of encainide, ethmozine, flecainide, imipramine, and placebo.
    

Intervention name(s): encainide; moricizine; flecainide; imipramine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Flecainide; Moricizine; Encainide; Imipramine
Allocation: Randomized
Masking: Double
Primary purpose: Treatment