bioihbjkbjnl/mcl2 huggingface dataset:
A Nutrition Intervention for Arthritis -3 (WCCR-ARTH3)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a
      low-fat, vegan diet improves pain and other subjective symptoms more effectively than a
      control supplement or a placebo. The principal measure is pain as measured by Visual Analog
      Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,
      respectively. The study duration is 36 weeks.

      This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified
      as triggers improves mood, using the Center for Epidemiologic Studies Depression
      Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
    

Detailed description: 
      Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional
      supplements can help reduce pain and also reduce the need for pain medications for some
      people. The investigators will ask about 100 people to participate. All of them will get a
      low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a
      placebo), although some will get the diet first, and others will get the supplement first.
      This order in which they will get the diet and the supplement will be determined randomly,
      that is, by chance (like the toss of a coin). The principal measure is pain as measured by
      Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and
      tender joints, respectively. The Beck Depression Inventory II (BDI-II)will be used to measure
      changes in mood. The study duration is 36 weeks.
    

Intervention name(s): Plant-based diet; Supplement
Intervention type(s): Other; Other
Intervention description(s): Weekly instructions will be given to the participants in the intervention group about following vegan diet.; unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
Other intervention name(s): Vitamin E
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rheumatoid Arthritis, Diet, Fat-Restricted, Diet, Vegetarian
DTaP and Apnea/Bradycardia in Preterm Infants
Condition: Prolonged Apnea; Prolonged Bradycardia
MeSH terms: Apnea; Bradycardia
Study type: Interventional

Summary: 
      The purpose of this study is to examine the relationship between receipt of DTaP and the
      occurrence of prolonged episodes of apnea and bradycardia in preterm infants, while employing
      a random control study design and an objective assessment of cardiorespiratory events.
    

Detailed description: 
      The American Academy of Pediatrics (AAP) recommends the immunization of preterm infants at
      two months chronological age with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine,
      regardless of birth weight and gestational age. However, several investigators, employing
      historical controls and subjective observations, have reported an increased incidence in
      prolonged apnea and bradycardia in preterm infants following immunization. Consequently, many
      primary care providers do not adhere to recommended AAP guidelines. The purpose of this study
      is to reexamine the relationship between receipt of DTaP and the occurrence of prolonged
      episodes of apnea and bradycardia in preterm infants, while employing a random control study
      design and an objective assessment of cardiorespiratory events.

      Ten participating hospitals will enroll infants < 37 completed weeks gestational age into the
      study when they are 56-60 days chronological age. Infants are randomly assigned into one of
      two groups: One group receives DTaP immunization and the control group does not (until study
      is completed). Physiological event recording monitors are used continuously during the next 2
      days to document the incidence of prolonged apnea (respiratory pause of ≥20 sec in duration
      or >15 sec in duration if associated with bradycardia for ≥5 sec) and prolonged bradycardia
      (heart rate <80 bpm that lasted ≥10 sec) in all infants. The presence and number of episodes
      during the 48-hour period will be compared between the 2 groups.
    

Intervention name(s): Infanrix; Pediatrix
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Apnea; Bradycardia; Preterm Infant; Immunization; DTaP
Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers
      participating in an endotoxin challenge.
    

Detailed description: 
      The LPS human endotoxemia model results in a well characterized, transient acute inflammatory
      response. The model has been widely used for decades as a system to study new therapeutic
      agents for inflammation before wider clinical studies are undertaken. This study will
      evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in
      an endotoxin challenge.
    

Intervention name(s): TT301; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single iv dose of TT301; Single iv dose of 0.9% sodium chloride for injection USP
Other intervention name(s): TT301 iv; 0.9% sodium chloride for injection USP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hemodilution Validation of INVSENSOR00026
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the concentration of hemoglobin within the subject's blood will be reduced in
      a controlled manner by administering fluids intravenously. The accuracy of a noninvasive
      hemoglobin sensor will be assessed by comparison to hemoglobin measurements from a laboratory
      analyzer.
    


Intervention name(s): INVSENSOR00026
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
App Teaches Doctors to Diagnose Skin Cancer
Condition: Melanoma (Skin); Carcinoma
MeSH terms: Melanoma; Skin Neoplasms
Study type: Interventional

Summary: 
      This study aimed to examine if self-paced learning with a novel digital patient-case-based
      educational platform can increase primary care physicians' diagnostic accuracy of malignant
      and benign skin lesions on both the level of benign/malignant and the diagnosis level.
      Secondarily the study aimed to investigate the time spent in reaching this change in
      proficiency.
    

Detailed description: 
      Participants were given a questionnaire and an initial Skin Cancer Multiple
      Choice-Questionnaire (MCQ) to test their diagnostic skills regardining skin and mole cancer
      and the most common differential diagnoses.

      Participants in the Intervention group was then given access to an educational mobile
      application (App) for 8 days and asked to diagnose 500 patient cases. The participants did so
      at their own leisure and time.

      After 8 days they were asked to abstain from using the App for another 8 days (wash out
      period) and were then given a Final Skin Cancer Multiple Choice-Questionnaire (MCQ).

      Participants of the control group received no intervention nor education during the 16 days
      of waiting before they took the final Skin Cancer Multiple Choice-Questionnaire.
    

Intervention name(s): Dermloop Learn
Intervention type(s): Other
Intervention description(s): Educational Mobile Application with a library of digital patient-cases and written learning modules the user can access on 36 common skin lesions, both benign and malignant.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention and Controlgroup parallel design using sequential continues block randomization.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Digital Learning; e-learning; Melanoma; Carcinoma; Dermoscopy; Dermloop
Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The purpose of this study is to determine the relative performance of a new toric soft
      contact lens against a toric contact lens currently available in market, specifically with
      regards to the comfort and vision after two weeks of use.
    

Detailed description: 
      Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks
      duration.
    

Intervention name(s): senofilcon A toric; alphafilcon A toric
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Other intervention name(s): SofLens66 Toric
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Astigmatism; vision; comfort; satisfaction; contact lenses
Open, Non-Comparative Study To Evaluate The Performance Of The Medical Device JANESSE®
Condition: Wrinkle
Study type: Interventional

Summary: 
      The hypothesis of this clinical investigation is that in a population of men and women
      affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will
      cross-linked hyaluronic acid (Janesse) significantly decrease the appearance of facial
      wrinkles, results observed after 4, 8 and 12 weeks.
    

Detailed description: 
      Janesse®'s action is to increase the volume of dermal-epidermal tissue based on the natural
      ability of hydrophilic hyaluronic acid molecules to bind to an amount of water many times
      greater than their weight. This allow to fill the intradermal spaces and integrate the
      intercellular matrix, conferring turgidity to the tissues. The cross-linking of the
      hyaluronic acid contained in the product has the effect of more stable and durable filling
      over time.

      The Research Question of the present study is the following: in a population of men and women
      affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will
      cross-linked hyaluronic acid (Janesse®) significantly decrease the appearance of nasolabial
      wrinkles, results observed after 12 weeks?
    

Intervention name(s): Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.
Intervention type(s): Device
Intervention description(s): The subjects will receive at baseline the first IMD by the Investigator in accordance with the CIP
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Intervention model description: This is a multi-center, open-label, non-randomized, single group clinical investigation
Masking: None (Open Label)
Primary purpose: Treatment
All on Four Versus All on Three Implant Treatment Concepts
Condition: Prosthesis Durability
MeSH terms: Prosthesis Failure
Study type: Interventional

Summary: 
      the evaluation of patient satisfaction of All on-4 versus All on-3 implant treatment concepts
      rehabilitation of atrophied mandibular ridge.
    

Detailed description: 
      Patients will be classified into 2 groups according to the implant treatment concept they
      received:

        -  Group 1 (control group); included patients who received All on 4 implant-supported fixed
           restoration. The patients received 2 inclined implants anterior to the mental foramina
           and 2 vertical implants in the lateral incisor/canine areas.

        -  Group 2 (test group); included patients who received All on 3 implant-supported fixed
           restoration. The patients received 2 inclined implants anterior to the mental foramina
           and 1 vertical implant in the midline of the mandible.
    

Intervention name(s): implant supported fixed full arch prosthesis
Intervention type(s): Device
Intervention description(s): the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be classified into 2 groups according to the implant treatment concept they received:
Group 1 (control group); included 3 patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
Group 2 (test group); included 3 patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
Masking: Single (Participant)
Primary purpose: Treatment
Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition
Condition: Wasting; Moderate Acute Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a
      new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of
      moderate acute malnutrition in children.
    

Detailed description: 
      Assuming the availability of some food in the household, the caregivers were instructed on
      how best to use the food they have and the quantity of supplementary food distributed was
      calculated to provide about 50% of child energy requirement.
    

Intervention name(s): A daily ration of 40 kcal/kg of body weight during 56 days
Intervention type(s): Dietary Supplement
Intervention description(s): On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Brain Imaging in PTSD
Condition: Post-traumatic Stress Disorder (PTSD); Trauma
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      Patients with post-traumatic stress disorder (PTSD) have abnormalities in the function of the
      amygdala and medial prefrontal cortex (particularly anterior cingulate), in addition to
      abnormalities of hippocampal volume. In this pilot study we propose to use the combined
      positron emission tomography/magnetic resonance (PET/MR) scanner and F-18-fluorodeoxyglucose
      (FDG, an analog of glucose, the most commonly used PET ligand) to examine brain function and
      directly correlate the data with the intrinsic functional connectivity of brain circuits that
      are responsible for social, emotional and cognitive processing in both individuals with PTSD
      and group-matched trauma controls (TC) and healthy controls (HC). Once the machine is
      validated, we will then use a more specific biomarker to better understand the neurochemical
      factors that contribute to individual differences in PTSD. Thus, the data obtained from this
      pilot study will guide our future molecular imaging studies. The link between general brain
      function, specific molecular target and the intrinsic functional connectivity of brain
      circuits that are responsible for social, emotional and cognitive processing in PTSD, TC and
      HC will be explored.
    


Intervention name(s): Positron emission tomography/magnetic resonance imaging
Intervention type(s): Procedure
Intervention description(s): Positron emission tomography/magnetic resonance (PET/MR) imaging using 18-F-fluorodeoxyglucose (FDG) as radio tracer
Other intervention name(s): PET Imaging
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects are between the age range of 18 to 65, are medically healthy and currently not
        taking any medications to treat any medical illness, and either have no history of
        post-traumatic stress disorder (PTSD) or have been diagnosed with PTSD.
      
Keywords: Trauma; Post-traumatic stress disorder (PTSD); Imaging; Neuroimaging; F-18-fluorodeoxyglucose (FDG)
Study to Evaluate an Influenza Vaccine Candidate
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      In order to find the formulation leading to a maximal increase of the immune response while
      maintaining an acceptable safety profile, this study is designed to evaluate the
      immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals'
      influenza vaccine administered in adults aged 18-64 years.
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Influenza Vaccine GSK1247446A - 4 different formulations; Fluarix™
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, Intramuscular injection; Single dose, Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; Influenza Vaccine
Safety of IFNa Kinoid in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus
      (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be
      an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a
      polyclonal antibody response.

      This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will
      also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE
      disease.
    


Intervention name(s): IFN-K
Intervention type(s): Biological
Intervention description(s): 3 to 4 IM injections over 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: SLE
The Impact of Infectious Disease on QT Segment
Condition: Sepsis; Pneumonia; Cardiomyopathy, Secondary
MeSH terms: Communicable Diseases; Infections; Cardiomyopathies
Study type: Observational

Summary: 
      Sepsis related to the development of cardiac complications. However, the investigators
      understanding regarding this condition remains incomplete. Possible explanations raised
      include coronary perfusion decrease, activation of the coagulation system and release of
      inflammatory mediators, including endotoxins, cytokines and others.

      In this study the investigators wanted to examine the impact of any infectious disease, (not
      necessarily Pneumonia), on the QT interval in patients hospitalized for acute infectious
      disease.
    


Intervention name(s): ekocardiogram test
Intervention type(s): Device
Intervention description(s): ekocardiogram test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients admitted to an internal medicine department due to an infectious disease.
The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)
Condition: Knee Arthroplasty, Total
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a perspective, randomized, blinded study with a parallel design and an allocation
      ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK
      (injection between the popliteal artery and the capsule of the knee) in addition to the
      adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).
    


Intervention name(s): ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)
Intervention type(s): Drug
Intervention description(s): nerve block for posterior knee pain after a TKA.
Other intervention name(s): iPACK
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants
Condition: Premature Infants
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total
      oral feeding cycle in premature infants
    

Detailed description: 
      In order to improve the feeding of premature infants <32 weeks of gestation, a complete oral
      feeding intervention program is provided for premature infants, which combined the evaluation
      of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional
      sucking intervention and progressive feeding program. Premature infants will be assessed 12
      times a day before feedings using the Feeding Preparation Scale.

      Assess the premature infants by using the Feeding Preparation Scale. If the premature infant
      does not meet the oral feeding standard, let the premature infant use the non-nutritive
      sucking for 3 minutes before the nasal feeding; if the premature infant meets the oral
      feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding
      schedule for the premature infant. The whole intervention stops until the premature infant
      achieves the full oral feeding. Length of time required for complete oral feeding of
      premature infants is compared between the intervention group and the control group to
      evaluate the effect of the complete oral feeding intervention program on improving the
      feeding of premature infants <32 weeks of gestation.
    

Intervention name(s): Complete oral feeding intervention; Routine nursing care group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale by trained nurses. Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding. If the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant.; Pre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: premature infants; oral feeding