bioihbjkbjnl/mcl2 huggingface dataset:
Injection of an Autologous A2M Concentrate Alleviates Back Pain in FAC-positive Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      A cartilage degradation product, the Fibronectin-Aggrecan complex (FAC), has been identified
      in patients with degenerative disc disease (DDD). Alpha-2-macroglobulin (A2M) can prevent the
      formation of the G3 domain of aggrecan, reducing the fibronectin-aggrecan G3 complex and
      therefore may be an efficacious treatment. The present study was designed to determine 1) the
      ability of autologous concentrated A2M to relieve back pain in patients with LBP from DDD and
      2) the ability of FAC to predict the response to this biologic therapy.

      24 patients with low back pain and MRI-concordant DDD had prospective evaluation. Oswestry
      disability index (ODI) and visual analog scores (VAS) were noted at baseline and at 3- and
      6-month follow-up. Primary outcome of clinical improvement was defined as patients with both
      a decrease in VAS of at least 3 points and ODI >20 points. Molecular discography and delayed
      FAC analysis and injection of platelet poor plasma at the time of the procedure. Patients
      with FACT-positive assays were significantly more likely to show improvement in their VAS and
      ODI at follow-up.
    

Detailed description: 
      Objectives: A cartilage degradation product, the Fibronectin-Aggrecan complex (FAC), has been
      identified in patients with degenerative disc disease (DDD). Alpha-2-macroglobulin (A2M) can
      prevent the formation of the G3 domain of aggrecan, reducing the fibronectin-aggrecan G3
      complex and therefore may be an efficacious treatment. The present study was designed to
      determine 1) the ability of autologous platelet poor plasma (PPP) with concentrated A2M to
      relieve back pain in patients with low back pain (LBP) from DDD and 2) the ability of FAC to
      predict the response to this biologic therapy.

      Study design/setting: Prospective cohort

      Patients: 24 patients with low back pain and MRI-concordant DDD

      Methods: All patients underwent lavage for molecular discography and delayed FAC analysis and
      injection of autologous platelet poor plasma (PPP) rich in A2M (Cytonics Autologous Protease
      Inhibitor Concentrate, APIC) at the time of the procedure. ANOVA with Bonferonni correction
      for multiple comparisons was performed.
    

Intervention name(s): autologous PPP injection
Intervention type(s): Other
Intervention description(s): autologous platelet poor plasma (PPP) injection taken from the participants own blood is injected in to all patients.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with LBP
      
Biospecimen description: 
      lavage sample of the disc for FAC analysis is taken prior to autologous PPP injection. It was
      discarded after the analysis was complete.
    
Keywords: biologic,; Alpha 2 Macroglobulin; A2M; back pain; APIC; FAC; FACT
Self-selection Study of the Toothwave Toothbrush
Condition: Gingivitis; Plaque; Calculus; Tooth Discoloration
MeSH terms: Gingivitis; Tooth Discoloration; Calculi
Study type: Interventional

Summary: 
      This study objective is to test the Silk'n Toothwave self-selection, by potential end users.
      Additionally, this study will evaluate if contraindicated subjects will self-exclude from use
      of the device and the ability to understand accurately the labeling content (box and user
      manual).
    

Detailed description: 
      The Silk'n Toothwave Device, in its original packaging, along with the user manual will be
      provided to the patient in a simulated home use environment. The patient labeling will be in
      the format intended for distribution.

      All subjects will sign an informed consent before any study activity. Five (5) potential end
      users and Additional five (5) contraindicated subjects will be screened for this
      self-selection study. Subjects will be provided with the device in its original packaging and
      will be evaluated for their ability to decide if they are eligible or they should
      self-exclude themselves from use of the device based solely on reading the device labeling
      (box and user manual).

      Once the subjects complete reviewing the labeling materials (box and user manual) they will
      be requested to perform a labeling comprehension exam for testing the ability to correctly
      understand the labeling content.

      The study will not include treatment.
    

Intervention name(s): Toothwave toothbrush
Intervention type(s): Device
Intervention description(s): Subjects get the device's box with the user manual and the device. However, they don't use the device, but only read the user manual and fill questionnaires.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 5 participants are suppose to exclude themselves from the use of the device, while the 5 others should claim they can use it.
Masking: Single (Participant)
Primary purpose: Screening
Correlation Between Dental Caries Prevalence in Primary Teeth and First Permanent Moilar of Children in Mixed Dentition Stage
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      to find the clinical relation between caries experience in primary teeth and first permanent
      molar in mixed dentition stage using def index for primary teeth , DMF index for first
      permanent molars and to find the clinical relation between caries prevalence in the selected
      children in relation with other associated factors such as age, sex tooth brushing frequency,
      dietary habits and mother's attitude toward child's oral health.
    

Detailed description: 
      the problem for which the study held is lacking of data about relation between prevalence of
      dental caries in primary teeth and first permanent molar of the same child in mixed dentition
      stage, incidence of dental caries is influenced by number of risk factors such as age, sex
      dietary and oral hygiene habits identifying high risk individuals helps development of
      systemic approaches for preventive oral care programs world wide Dental caries is the major
      public health problem in most high income countries, affecting 60-90%of school children and
      the vast majority of adults. it also the most prevalent oral disease in several Asian and
      Latin American countries Although for the moment it appears to be less common and less severe
      in the greater part of Africa, the WHO report 2003 anticipates that in light of changing
      living conditions and dietary habits, the incidence of dental caries will increase in many of
      that continent's low income countries(WHO,2006)
    

Intervention name(s): caries prevalence def ,DMF
Intervention type(s): Diagnostic Test
Intervention description(s): the examination will carried out on dental chair using diagnostic set
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        children are selected from from children attending the diagnosis clinic of Department of
        pediatric dentistry and Dental public health
      
Keywords: risk factors, caries prediction
Neuromuscular Blockade in Patients With Severe Renal Impairment
Condition: Neuromuscular Blockade; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to be a single-site, prospective, randomized, double-blinded study
      that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery
      with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to
      receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of
      rocuronium). A standardized anesthetic protocol that is usual and customary for the type of
      operation the patient is having will be provided to the anesthesia teams of enrolled
      subjects. The remainder of the anesthetic care of the subject will not deviate from the
      standard of care. All patients will be monitored with continuous pulse oximetry
      postoperatively for 24 hours.
    

Detailed description: 
      This will be a prospective, randomized, double-blinded study of surgical patients with severe
      renal impairment that seeks to address the following:

      Specific Aim:

      To determine whether rocuronium-induced moderate neuromuscular blockade and reversal with
      sugammadex achieves recovery of neuromuscular function (TOF ≥ 0.9) faster than reversal of
      cisatracurium-induced moderate neuromuscular blockade and reversal with neostigmine in
      patients with severe renal impairment.

      Primary Hypothesis:

      Patients with severe renal impairment who are reversed with sugammadex after rocuronium will
      achieve a TOF ≥0.9 within a time frame that is one-third of the time it takes for reversal
      with neostigmine after cisatracurium.
    

Intervention name(s): Cisatracurium + Neostigmine; Rocuronium + Sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate; Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex
Intervention MeSH terms: Rocuronium; Cisatracurium; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single site, randomized, controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of Food on LY2216684
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of food on LY2216684. There will be 2 study periods each
      lasting up to 5 days. There will be at least 7 days between the two doses and a follow up
      will occur at least 7 days after the last dose. Screening is required within 30 days prior to
      the start of the study.
    


Intervention name(s): LY2216684
Intervention type(s): Drug
Intervention description(s): Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after
      vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune
      response to the challenge dose of Engerix™-B.
    

Detailed description: 
      Subjects who participated in the primary study 217744/031 (NCT01457495) will be invited at
      the age of 11-12 years to participate in this follow-up study.
    

Intervention name(s): Engerix™-B
Intervention type(s): Biological
Intervention description(s): Intramuscular, single dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Persistence; challenge dose; Engerix-B; immune response
Sentinel Surveillance of Malnutrition, Niger
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Malnutrition is a critical public health problem in developing countries. Malnutrition may be
      linked to more than one half of the deaths in children under 5 years old. In July 2001, after
      an intervention related to a measles epidemic, Medecins sans Frontieres-France opened a
      nutritional program in Maradi, in the South of Niger. The introduction of ready to use
      therapeutic foods (RUTF), in particular Plumpy'Nut (Nutriset, France) allowed for the
      treatment of the majority of children at their homes using ambulatory treatment. Children
      with complicated cases were cared for in an inpatient center. With ambulatory treatment the
      number of children cared for in the MSF program reached close to 70000 in 2006.

      This study aimed to assess the effect of a 3-month distribution of RUTF in the context of a
      preventative supplementary feeding program. The primary hypotheses were that short-term RUTF
      supplementation at the village-level would prevent declines in weight-for-height and reduce
      the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. Because RUTF
      may have additional health effects, the intervention effect on height-for-age, stunting,
      mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.
    


Intervention name(s): PlumpyNut; PlumpyDoz
Intervention type(s): Dietary Supplement; Dietary Supplement
Primary purpose: Prevention
Keywords: malnutrition; ready to use food; Niger
Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.
Condition: Rheumatoid Arthritis; Polymyalgia Rheumatica; Giant Cell Arteritis; Polymyositis; Wegener's Granulomatosis
MeSH terms: Osteoporosis; Rheumatic Diseases; Polymyalgia Rheumatica; Polymyositis; Granulomatosis with Polyangiitis; Giant Cell Arteritis; Arteritis; Collagen Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine wich treatment is the most effective in prevention
      of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a
      randomized placebo controlled trial with alendronate versus alfacalcidol.
    

Detailed description: 
      Treatment with glucocorticoids (GCs) is associated with bone loss initiated already early in
      therapy, causing increased (vertebral) fracture risk. Bone loss is caused by inhibition of
      bone formation by GCs. Active vitamin D analogues like alfacalcidol directly stimulate
      osteoblasts leading to an increase in bone formation. Bisphosphonates like alendronate induce
      apoptosis of osteoclasts leading to inhibition of bone resorption.

      We performed a randomized, double-placebo, double-blind clinical trial of 18 months duration
      in patients with a rheumatic disease, starting GCs in a dosage of 7.5 mg prednisone
      equivalent daily or higher. Two hundred one patients were allocated to receive either
      alendronate 10 mg and alfacalcidol-placebo daily or alfacalcidol 1 microgram and
      alendronate-placebo daily. Primary outcome was change in bone mineral density of the lumbar
      spine in 18 months, secondary outcome incidence of (symptomatic) morphometric vertebral
      deformities.
    

Intervention name(s): Alendronate versus alfacalcidol (1-alpha OH vitamin D)
Intervention type(s): Drug
Intervention MeSH terms: Vitamin D; Alendronate; Alfacalcidol; Hydroxycholecalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: glucocorticoid-induced osteoporosis; rheumatic diseases; prevention; randomized double-blind, double placebo controlled trial; alendronate versus alfacalcidol
Vitamin D and Sleep Disorders in Pregnancy
Condition: Sleep Disorder; Pregnancy Related; Vitamin D Deficiency
MeSH terms: Sleep Wake Disorders; Parasomnias; Vitamin D Deficiency
Study type: Observational [Patient Registry]

Summary: 
      Lack of sleep and poor sleep quality in pregnant women are associated with maternal
      depression and cognitive-sensual irregularities. These irregularities were reported worsening
      women's life quality and even increasing suicide ideation. It is also associated with
      obstetrical complications such as fetal growth deficiency, preterm birth, prolonged labor,
      preeclampsia and increased abdominal delivery frequency.Vitamin D also may affect the sleep
      indirectly through the cases with nonspecific pains. It was reported that vitamin D levels
      are correlated with sleep disorders such as obstructive sleep apnea and restless legs
      syndrome. The primary purpose of this study is to examine sleep disorders and vitamin D
      levels in pregnant women, and also, secondarily, vitamin D - anxiety and sleep disorders -
      anxiety relations were assessed.
    


Intervention name(s): Behavioral scales were used
Intervention type(s): Behavioral
Intervention description(s): Women's Health Initiative Sleeplessness Scale (WHISS) and State Anxiety Scale (SAS), were applied.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        225 pregnant women who are in second or third trimester of pregnancy
      
Keywords: anxiety; Pregnancy,; Sleep Wake Disorders; Vitamin D
Optimized 2D-RT for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate cancer (CAP) is one of the most common malignancies in men, both in Western
      countries and developing countries. Radiation therapy (RT) is an important therapeutic
      option. New technologies (3D, IMRT, IGRT, VMAT) have been introduced in the last decades,
      with a progressive improvement of clinical outcome. However, in many countries the only
      treatment option is the traditional 2D technique based on standard simulation. The
      indications for field definition in this treatment are still based on expert's opinions. The
      aim of this analysis is to propose new indications for 2D fields definition based on
      three-dimensional simulation in a population of patients with CAP. Twenty patients with CAP
      consecutively treated with RT in our center were identified. Patients underwent CT-simulation
      in supine position. Pelvic MRI images were fused with CT-simulation images. In this way,
      delineation of the prostate and seminal vesicles was performed on MRI images. Clinical Target
      Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different
      categories: low-risk CAP, intermediate-risk CAP, high-risk CAP without involvement of the
      seminal vesicles, and high-risk CAP with involvement of seminal vesicles. The Planning Target
      Volume (PTV) was defined by adding a margin of 10 mm to the CTV in all directions. For each
      patient, 8 treatment plans were calculated. In particular, for each of the 4 categories of
      risk, 2 treatment plans were calculated by using a cobalt source or 10 MV photons. Treatment
      plans were calculated using the box technique. Progressive optimization was realized with an
      iterative procedure by evaluating the three-dimensional dose distribution. Once the final
      plan was achieved (respecting the PTV constraint: D98 > 95%), distances of the fields edges
      from a set of reference points were measured.
    


Intervention name(s): 2D radiotherapy
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 2D; prostate neoplasms; radiotherapy; simulation
Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts
Condition: Gastrointestinal Dysfunction; Physiological Stress; Cognition - Other
Study type: Interventional

Summary: 
      This study aims to test the central hypothesis that adding to the diet daily yogurt provides
      beneficial effects on digestive health and subjective mood in healthy adults.
    

Detailed description: 
      This clinical trial will include a 4-week lead-in period and a 2-week treatment period. The
      lead-in period will be devoid of all supplemental and dietary probiotics, fermented dairy
      products, and fermented foods. Participants will be asked to refrain from consuming all
      supplemental and dietary probiotics, fermented dairy products, and fermented foods throughout
      the entire study. During the treatment period, participants will be given yogurt with sugar.
      This trial will serve as a continuation of the NECTAR Study (NCT04187950).
    

Intervention name(s): Yogurt with B. lactis and added cane sugar
Intervention type(s): Dietary Supplement
Intervention description(s): The intervention condition will utilize a commercially available yogurt (Activia) that contains Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of yogurt with cane sugar twice daily for 14 days.
Intervention model: Single Group Assignment
Intervention model description: Controlled single-group trial with a 4-week lead-in period and a 2-week treatment period. The treatment will consist of yogurt with sugar.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: gastrointestinal transit time; mood; emotion