bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia
Condition: Anemia, Iron Deficiency; Delivery Complication
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will be a comparative pragmatic open label feasibility randomized controlled trial
      of oral daily versus IV iron in anemic postpartum patients.

      Two randomly assigned groups will be compared during the postpartum period:

        1. Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6
           weeks TID.

           IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home
           over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.

        2. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9%
           500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron
           dextran infusion in 100mL 0.9% sodium chloride.

      2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.
    


Intervention name(s): Ferrous sulfate; Iron dextran
Intervention type(s): Drug; Drug
Intervention description(s): one tablet 325 milligrams three times a day; 1000 mg intravenous infusion
Intervention MeSH terms: Dextrans; Iron-Dextran Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postpartum, iron deficiency anemia, intravenous iron
Study to Evaluate the Safety of a New Oxime, MMB4 DIMETHANESULFONATE (DMS)
Condition: Treatment Against the Lethal Effects of Nerve Agent Intoxication
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when
      delivered intramuscularly (i.m.) to the anterior thigh.
    

Detailed description: 
      The goal of this study is to assess safety, tolerability, and PK of MMB4 DMS EF at up to six
      cohorts chosen to provide the range required for PK analyses, including assessment of dose
      proportionality.
    

Intervention name(s): MMB4 DMS; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be administered the drug product formulation at the assigned dosage of MMB4 DMS or placebo i.m. to the anterior thigh using a 5 mL syringe.; Subjects will be administered the drug product formulation at the assigned dosage of placebo i.m. to the anterior thigh using a 5 mL syringe. The placebo group in each cohort will receive the same injection volume and number of injections as the dose group in that cohort.
Other intervention name(s): 1,1'-methylenebis[4-[(hydroxyimino)methyl]-pyridinium] dimethanesulfonate; Benzyl alcohol USP/NF and methanesulfonic acid adjusted to a pH 2.3
Intervention MeSH terms: Benzyl Alcohol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Effect of Aging & Obesity With Exercise Intervention
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity leads to a vicious circle that increases intramuscular fat, insulin resistance,
      promotes muscular dysfunction resulting in increased muscle fat accumulation. The study of
      muscle function and intramyocellular lipids is insufficient for obesity. Particularly, the
      study of mechanisms in muscle function and intramyocellular lipids is few nationally and
      internationally.
    

Detailed description: 
      This study is prospective study. The goal of this study is

        1. To examine the distribution and contractile properties (cross-sectional area, maximal
           force, specific force, maximal shortening velocity) of single muscle fiber sex/Myosin
           heavy chain (MHC) type-related differences, by extracting a single muscle fiber from the
           vastus lateralis in young men and women.

        2. To examine the effects of intramyocellular lipids on physical activity ability, muscle
           dysfunction, and metabolic disorders in relation to aging and obesity.

        3. To examine the effects of intramyocellular lipids on physical activity ability, muscular
           dysfunction, and metabolic disorders after 12 weeks resistance exercise intervention.
    

Intervention name(s): Resistance exercise with a gym stick
Intervention type(s): Other
Intervention description(s): Exercise intervention: The resistance exercise intervention is performed with a gym stick for 3 times a week for 12 weeks. Exercise load is gradually increased by the number of times the band is wound and the speed of motion by dividing into three stages in 1-4 weeks (1st stage), 5-8 weeks (2nd stage) and 9-12 weeks (3rd stage).
Other intervention name(s): Exercise training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Aging; Obesity; Single muscle fiber contractile properties; Intramyocellular lipids; Resistance exercise
Study to Assess the Efficacy of Cognitex
Condition: Elderly; Memory Impairment
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      A Single-Center, Open Label Study to Assess the Efficacy of Cognitex in Elderly Subjects with
      Memory Impairment
    


Intervention name(s): Cognitex
Intervention type(s): Dietary Supplement
Intervention description(s): Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitex; subjects
The Gratitude Gallery - A Positive Psychology Intervention
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study will assess the feasibility and acceptability of a positive psychology
      intervention, The Gratitude Gallery, for increasing gratitude in adults.

      The study hypothesizes that participants will find the activity feasible and acceptable and
      complete the intervention as directed. The project also hypothesizes that those that complete
      the intervention will show an increase in self-reported gratitude, as well as a decrease in
      symptoms of anxiety and depression.
    


Intervention name(s): taking photographs
Intervention type(s): Behavioral
Intervention description(s): Participants will photograph images (using a cell phone) that invoke a feeling of gratitude. At least 1 photograph (at any time of the day) should be taken for a period of three weeks.
Once the photo images are captured, the participant should spend a moment looking at the image and reflecting on why they are grateful for the subject of the photograph.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Photos; Photography; Gratitude
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Condition: Partial Epilepsies
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine whether lacosamide is safe and effective for
      long-term use in patients with partial-seizures from epilepsy
    


Intervention name(s): lacosamide
Intervention type(s): Drug
Intervention description(s): 50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adjunctive treatment in epilepsy; add-on treatment for epilepsy; partial seizures; AEDs; antiepileptic drugs; seizures
Myocardial Infarction Prediction
Condition: Myocardial Infarction; Artificial Neural Network
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      prediction of MI in patients with chest pain and nondiagnostic ECG was done in 2 weeks
    

Detailed description: 
      Myocardial infarction remains one the leading causes of mortality and morbidity and involves
      a high cost of care. Early prediction can be helpful in preventing the development of
      myocardial infarction with appropriate diagnosis and treatment. Artificial neural networks
      have opened new horizons in learning about the natural history of diseases and predicting
      cardiac disease.

      Methods: A total of 935 cardiac patients with chest pain and nondiagnostic electrocardiogram
      (ECG) were enrolled and followed for 2 weeks in two groups based on the appearance of
      myocardial infarction. Two types of data were used for all patients: nominal (clinical data)
      and quantitative (ECG findings). Two different artificial neural networks - radial basis
      function (RBF) and multi-layer perceptron (MLP) - were used.
    

Intervention name(s): ANN prediction of myocardial infarction
Intervention type(s): Other
Other intervention name(s): sofware detected risk of new myocardial infraction
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Myocardial infarction; artificial neural networks; Electrocardiography
Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:
Condition: Parkinson's Disease; Mpulse Control Disorders
MeSH terms: Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Noradrenergic system is involved in impulsivity in the general population and is altered in
      Parkinson's disease (PD) in the early stages of the disease. Thus, targeting this system
      could be of interest in impulse control disorder (ICD). Acting on the noradrenergic system is
      possible using clonidine, an α2 adrenergic agonist largely used in hypertension treatment and
      that induces a decrease of NADR release. Thus, our aim is to conduct a proof of concept study
      evaluating the efficacy and safety of clonidine on ICD in PD. This study is a multicenter,
      randomized, double-blind, placebo-controlled in parallel group clinical trial.
    


Intervention name(s): placebo; Clonidine
Intervention type(s): Drug; Drug
Intervention description(s): Treatment (placebo) will be taken during 8 weeks with one visit at 2, 4 and 8 weeks.
Medication: placebo twice a day (in the morning and evening).; Treatment will be taken during 8 weeks with one visit at 2, 4 and 8 weeks. Medication: 75 μg of clonidine twice a day (in the morning and evening).
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; Impulse control disorder; Clonidine; Noradrenergic system
Evaluation of Triathlon - A New Total Knee Prosthesis System - Roentgen Stereophotogrammetric Analysis (RSA) Triathlon CR vs. PS
Condition: Arthroplasty, Replacement, Knee
Study type: Interventional

Summary: 
      The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric
      behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective
      randomized clinical trial.
    

Detailed description: 
      The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric
      behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective
      randomized clinical trial.

      The evaluation is carried out by a prospective randomised RSA-study with Triathlon CR vs.
      Triathlon PS.
    

Intervention name(s): Triathlon CR; Triathlon PS
Intervention type(s): Device; Device
Intervention description(s): Implantation of Knee Prosthesis; Implantation of Knee Prosthesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; Arthroplasty; Implant
Short Intervention for Medication Overuse Headache (MOH) - Pilot
Condition: Medication Overuse Headache
MeSH terms: Headache Disorders, Secondary; Headache
Study type: Interventional

Summary: 
      The purpose of the study is together with the BIMOH (NCT01314768) RCT study to evaluate
      whether training of GPs in the detection and treatment of medication overuse headache leads
      to improved care for these patients as compared to "business as usual".
    

Detailed description: 
      The present pilot study focuses on testing the logistics and the methodology of short
      intervention on a pilot group of GPs and their patients.

      Due to low recruitment and the pilot study focus on logistics and methodology, the study was
      changed to not include a control (business as usual) arm. The outcomes were evaluated as
      "before - after" data and qualitative comments on acceptability and utility of the method.
      Primary outcomes were changed to be the acceptability and utility (previously listed as
      secondary outcomes) while secondary outcomes were headache days and medication days
      (previously listed as primary).
    

Intervention name(s): Trained counselling
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Observational

Summary: 
      Pain assessments in non-verbal, critically ill infants represent an important clinical
      challenge. Older children or adults can easily express their pain, but infants lack that
      capability. They frequently experience repetitive acute pain during routine ICU care, but
      their analgesic management flounders on the horns of a dilemma: (a) failure to treat infant
      pain leads to immediate clinical instability and potentially long-term physical, behavioral,
      and cognitive sequelae, vs. (b) strong analgesics may increase risks for medical
      complications and/or impaired brain growth. Bedside nurses currently assess pain using pain
      scores, before taking action to ameliorate pain. Pain scores increase nursing workload and
      provide subjective assessments, rather than objective data for evaluating infant pain.
      Consequently, infants exposed to skin-breaking procedures, surgery, or other painful
      conditions often receive variable and inconsistent pain management in the ICU. The
      investigators aim to develop a multimodal pain assessment system, using sensor fusion and
      novel machine learning algorithms to provide an objective measure of pain that is
      context-dependent and rater-independent. This will enhance the quality of pain management in
      ICUs and allow continuous pain monitoring in real-time.
    


Intervention name(s): Pain Measurement
Intervention type(s): Other
Intervention description(s): Measurement of infant responses (behavioral and physiological) during a painful procedure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will collect data from 30 study subjects in each of the following age groups:

          -  Preterm infants (34-37 weeks, postnatal age 3-30 days)

          -  Term newborns (37-42 weeks gestation, less than 1 month of age)

          -  Infants from 1-3 months age, and

          -  Older infants from 3-6 months age. A total of 120 subjects will be recruited before
             study closure.
      
Keywords: infant-newborn; infant-premature; pain; acute pain
Long-Term Experience and Health Effects of COVID-19
Condition: Covid19; Corona Virus Infection; Quality of Life; Risk Reduction
MeSH terms: COVID-19; Coronavirus Infections
Study type: Observational

Summary: 
      The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action
      locally and nationally in order to mitigate transmission. Data will be deidentified and
      consolidated to create a large national longitudinal database.
    

Detailed description: 
      Ths is a longitudinal, observational, descriptive study to gather data needed to support a
      better understanding of COVID-19 from the perspective of a diverse national population.

      This multi-phase study will use an action research approach to identify specific ways that
      physician groups, federally qualified health centers (FQHCs), public health departments, and
      other health and social services systems in the United States can address healthcare needs
      and mitigate the transmission of COVID-19. Email surveys will be used to assess the
      historical and current status of participants by medical condition, geography, and
      demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever,
      loss of sense of taste or smell, etc.) and their current psychosocial needs.

      The study will provide the structure for an iterative exploration of trends over time (up to
      24 months). The opt-in survey will be posted and available to individuals 18 and older who
      choose to participate. Survey frequency will be every two weeks.

      To analyze broader trends, all survey responses will be de-identified and aggregated. Overall
      general findings will not be linked to individuals or physician groups when reporting and
      publishing study results.
    

Intervention name(s): none - observational
Intervention type(s): Other
Intervention description(s): online survey
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Anyone in the USA can participate in this study that meets inclusion criteria. To ensure
        diversity urban, suburban and rural areas of the country will be included.
      
Keywords: covid-19; corona virus; covid19; coronavirus; SARS-CoV-2; infection; household; transmission; vaccine; clinical trials; online; Altura; outpatient; telemedicine
The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease
Condition: Behcet's Disease
MeSH terms: Behcet Syndrome
Study type: Interventional

Summary: 
      Behçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes
      of vessels. Statins display numerous effects often independent of the well-established
      lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and
      ischaemic vascular events. The aim of the present study was to determine the efficacy of
      rosuvastatin in improving vascular dysfunction and vascular inflammation and to assess the
      effect of rosuvastatin on vascular involvement in BD patients. Fifty-six BD patients (51
      males and 5 females) mean age 33.4 years, mean disease duration 5.8 years), all fulfilling
      the classification criteria of the International Study Group for Behçet's disease were
      recruited.Patients were randomised into 2 groups.

      The first group (n=27: 20 active and 7 inactive) were assigned to receive 40 mg of
      rosuvastatin and the second group(n=29: 21 active and 8 inactive) received placebo for 12
      months. Inflammatory and endothelial dysregulation markers were measured at baseline and
      after 12 months. All patients were examined for vascular involvement. Venous or arterial
      system involvement was defined as present when confirmed by Doppler ultrasonography, magnetic
      resonance angiography, conventional angiography or CT.
    


Intervention name(s): Rosuvastatin calcium 40mg; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Active drug -Rosuvastatin; 40 mg placebo for 12 months
Other intervention name(s): Experimental active drug; Placebo comparator
Intervention MeSH terms: Rosuvastatin Calcium; Calcium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Behcet's Disease; Rosuvastatin; Vascular Markers; Improvement in vascular involvement in Behcet's Disease
Comparison of I-FFQ and Two Reference Methods
Condition: Iodine Deficiency
Study type: Observational

Summary: 
      Mild-to-moderate iodine deficiency remains a problem in many parts of the world, including
      Norway. Of particular concern are fertile, pregnant, and lactating women. The Norwegian Dairy
      Council developed a digital iodine-specific food frequency questionnaire (I-FFQ) for the
      assessment of iodine intake levels, but it has yet to be validated. The main objective was
      thus to investigate the relative validity of the I-FFQ by comparing estimates of iodine
      intake obtained from the I-FFQ against a single 24-hour recall (24HR) and urinary iodine
      concentration (UIC) in fertile women.
    


Intervention name(s): spot urine samples
Intervention type(s): Biological
Intervention description(s): No intervention, but measurement of urinary iodine concentration by 6 repeated spot urine samples
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy women aged 18-40 years
      
Keywords: validation; food frequency questionnaire
A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate
      safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous
      administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.
    


Intervention name(s): Placebo; KHK4827
Intervention type(s): Drug; Drug
Intervention MeSH terms: Brodalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Psoriasis