bioihbjkbjnl/mcl2 huggingface dataset:
Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
Condition: Contour
Study type: Interventional
Phase: Phase 4

Summary: 
      This study has been designed to evaluate the safety and effectiveness of sequential treatment
      with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and
      VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the
      jawline.
    

Detailed description: 
      Participants may be treated with up to 6 treatments with Belkyra, followed by treatment with
      Voluma. Participants will have opportunity to participation in a skin biopsy sub-study.
    

Intervention name(s): BELKYRA®; Juvéderm® VOLUMA™ with Lidocaine
Intervention type(s): Drug; Device
Intervention description(s): BELKYRA® was injected into preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart).; Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lower Face Contouring
Why Are Fertility Preservation Patients Not Coming Back?
Condition: Fertility Issues; Cancer
MeSH terms: Infertility
Study type: Observational

Summary: 
      This is a single-center retrospective study carried out with a phone call follow-up to
      investigate women's decision not to return for criopreserved ovocytes use after cancer
      treatment. The study database includes all women who underwent fertility preservation cycles
      at a third-level university-affiliated center from January 2001 to December 2017.

      Patients were asked a set of standardized questions whose purpose was to investigate their
      present health conditions, cancer treatment and any potential relapses, their family projects
      and sentimental status, any spontaneous conception, and why they had not yet returned for
      embryo transfer.

      All data were recorded anonymously in our dataset.
    

Detailed description: 
      All women who underwent oocyte cryopreservation cycles for oncological purposes from January
      2001 to December 2017 at Fertility Center of Humanitas Research Hospital, Rozzano (Milano),
      Italy, were contacted.

      The survey's purpose was to investigate their present health conditions, cancer treatment and
      any potential relapses, their family projects and sentimental status, any spontaneous
      conception, and why they had not yet returned for oocytes use.
    

Intervention name(s): Follow up survey
Intervention type(s): Other
Intervention description(s): phone call follow-up to investigate women's decision not to return for embryo transfer after cancer treatment.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with an oncological diagnosis who underwent ovarian stimulation and oocytes retrivial
        and cryopreservation for fertility preservation
Confocal Laser Endomicroscopy for in Vivo Molecular Imaging of Gastric Cancer by Targeting MG7-Ag
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      The study aims to:

        1. Achieve molecular imaging of MG7 antigen in patients with gastric cancer in vivo using
           confocal laser endomicroscopy.

        2. Compare the results of in vivo MG7-specific molecular imaging with CLE and ex vivo
           immunohistochemistry .
    

Detailed description: 
      Gastric cancer remains the world's second leading cause of cancer-related death. Improved
      prognosis essentially depend on earlier diagnosis. Gastric monoclonal antibody MG7 has been
      validated as a specific antibody in gastric cancerous tissue. Conventional evaluation of MG7
      antigen expression is immunohistochemistry, which is time-consuming, and the immunoreactivity
      can be affected by storage and fixation of tissue. Confocal laser endomicrosopy enables
      visualization of the cellular and subcellular structures in vivo. Thus this study aims to
      achieve molecular imaging of MG7 antigen in gastric cancer in vivo using confocal laser
      endomicroscopy.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with endoscopically diagnosed gastric cancer
      
Biospecimen description: 
      Taken biopsies during endoscopy
Human Muscle Gene Expression Profiles in Young and Old Men
Condition: Elderly; Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      To reach the goals of living longer in better medical conditions, many countries reach the
      same conclusion: new strategies have to be developed to avoid, or at least limit, the effects
      of age; this requires a better knowledge of the mechanisms of aging. Our project focuses on
      the loss of muscle mass associated with aging, called sarcopenia. Sarcopenia unavoidably
      leads to impaired mobility and poor balance, which contributes to loss of functional autonomy
      and to increased prevalence for severe falls. Skeletal muscle also plays a central role as a
      reserve for energy and amino acids. Hence, sarcopenia further triggers severe side metabolic
      effects such as frailty among elderly persons. The precise mechanisms of muscle aging are
      still mostly unknown, although many theories have been proposed.

      The present study aims at better understanding the mechanisms of skeletal muscle loss
      associated with aging. Using muscle biopsies from young and old subjects, the differential
      expression profiles of mRNA will be obtained through chips that will evaluate more than 39000
      transcripts. On the same samples, proteomic analyses will involve two complementary
      approaches: (1) bidimensional electrophoresis (2DGE) coupled to mass spectrometry (MALDI-ToF)
      for dominant proteins; (2) Western-blot (more than 800 antibodies) targeting regulating
      proteins not detectable using 2DGE. Complementary histological studies
      (immunohisto-fluorescence, confocal microscopy) will specify the localisation of the major
      biomarkers in the muscle biopsies.

      The results of that research will have applications in the medium term and will lead to
      nutritional interventions to modulate specific metabolic pathways and improve the quality of
      life in the elderly.
    


Intervention name(s): Skeletal muscle aging
Intervention type(s): Other
Intervention description(s): W1 - Blood test
Maximal voluntary contraction of quadriceps
Hydrostatic weighing
W2 - Maximal metabolic test using a cycloergometer
W3 - Muscular biopsy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young : students of the Saint-Etienne's university. Old : men who participate in the PROOF
        study
      
Biospecimen description: 
      Serum, muscle
    
Keywords: Aging; Biopsy; Skeletal muscle; Molecular biology; Genetic markers; Gene expression regulation; Young and old men; Healthy volunteers
Comparing Remote Interpreter Modalities in the Pediatric Emergency Department
Condition: Limited English Proficient Patients and Families
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      Professional interpretation improves quality of care for patients with limited English
      proficiency (LEP). However, many health care settings lack access to professional
      interpreters, and even in locations with good access, logistical factors and perceived
      barriers have limited their widespread use. Remote methods of professional interpretation,
      including telephone and video, hold great promise for expanding access, but only limited data
      exist on the relative impacts of these modalities on patient care and provider uptake.
      Comparing how these modalities impact multiple aspects of health care quality, including
      family comprehension, provider communication, and consistency of provider interpreter use
      will inform dissemination of strategies for delivery of safe, efficient, and equitable care
      to LEP families.

      Aim 1: To determine whether randomly assigned remote interpreter modality (telephone versus
      video) impacts parent-reported quality of communication and interpretation, diagnosis
      comprehension, and length of stay (LOS) among LEP Spanish-speaking families seen in a
      pediatric Emergency Department (ED).

      Hypothesis 1: Parent-reported quality of communication and interpretation and parent
      diagnosis comprehension will be higher among families assigned to video interpretation
      compared to telephone interpretation.

      Hypothesis 2: LOS will not differ between families assigned to video and telephone
      interpretation.

      Aim 2: To determine whether assigned interpreter modality is associated with provider
      decision to communicate without professional interpretation.

      Hypothesis 3: Parent-reported provider communication without professional interpretation
      (e.g. using the patient or a family member to interpret for some part of the visit) will be
      lower for families assigned to video interpretation compared to telephone interpretation.
    


Intervention name(s): Telephone Interpretation; Video Interpretation
Intervention type(s): Other; Other
Intervention description(s): Professional interpretation provided over the phone by a national network of certified medical interpreters; Professional interpretation provided over video by a national network of certified medical interpreters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes
Condition: Insulin Hypoglycemia; Type 1 Diabetes Mellitus; Severe Hypoglycemia
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a non-inferiority, multi-center, randomized, controlled, single-blind, two-way
      crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study
      involves two daytime clinical research center (CRC) visits with random assignment to receive
      G-Pen™ glucagon 1 mg during one period and Lilly Glucagon 1 mg during the other. Each daytime
      visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study
      visit, the subject is brought into a state of hypoglycemia through IV administration of
      regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 50
      mg/dL is verified, the subject is administered a dose of G-Pen or Lilly Glucagon via
      subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes
      post-dosing, with a value of >70.0 mg/dL within 30 minutes of glucagon administration
      indicating a positive response. After 3 hours, the subject is given a meal and discharged
      when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC,
      and the procedure are repeated with each subject crossed over to the other treatment. A
      follow-up visit as a safety check is conducted 2-7 days following administration of the final
      dose of study drug.
    


Intervention name(s): G-Pen; Lilly Glucagon
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector; 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
Other intervention name(s): glucagon; GEK
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: glucagon; hypoglycemia
Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this clinical trial was to evaluate the
      pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at
      three therapeutically relevant doses in subjects with type 1 diabetes.

      The trial is designed as a four period, incomplete block cross-over trial where the trial
      participant will be randomised to a treatment sequence by which the subject will receive two
      matched dose levels of NN5401 and biphasic insulin aspart, respectively.
    


Intervention name(s): insulin degludec/insulin aspart; insulin degludec/insulin aspart; insulin degludec/insulin aspart; biphasic insulin aspart 30; biphasic insulin aspart 30; biphasic insulin aspart 30
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin); Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin); Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin); Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin); Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin); Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate the Effects of Psyllium on Blood Glucose
Condition: Healthy Men
Study type: Interventional

Summary: 
      This is an open label, single use, randomized, 4-period cross-over study. In each period,
      subjects will receive one of 4 test combinations. Blood will be drawn prior to study product
      consumption and following study product consumption for glucose measures.
    


Intervention name(s): 3.4 g psyllium; 6.8 g psyllium; 6.8 g psyllium; Meal
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 3.4 g psyllium served with meal; 6.8 g psyllium served with a meal; 6.8 g psyllium; meal
Intervention MeSH terms: Psyllium; Calcium polycarbophil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Resistance
Study type: Interventional

Summary: 
      This protocol will investigate physiological parameters including insulin sensitivity and
      counterregulatory function using a mixed meal test and induced hypoglycemia in subjects with
      type I diabetes.
    

Detailed description: 
      The principal idea of the proposed research is: in order to be successful, closed-loop
      control of glucose in diabetes must adapt to individual physiologic characteristics and to
      the behavioral profile of each person. We propose to build a system that will use observers
      of patients' behavior and metabolic state and control modules that are responsible for
      insulin delivery and hypoglycemia prevention. In this phase of the project, we will
      investigate relationships of insulin sensitivity and impaired counterregulation with blood
      glucose variability, aiming to develop algorithmic physiology observers, which will track
      specific parameters of glucose variability and recurrent hypoglycemia as markers of change in
      a person's insulin sensitivity and counterregulatory ability.
    

Intervention name(s): Mixed meal and insulin challenge
Intervention type(s): Dietary Supplement
Intervention description(s): The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus
Alternate Day Buprenorphine Administration, Phase IX - 14
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if four times a subjects' daily maintenance dose
      will hold for 120 hours without changes in agonist and antagonist effects.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway
Condition: Asthenozoospermia
MeSH terms: Asthenozoospermia
Study type: Observational

Summary: 
      The ability of spermatozoa to produce reactive oxygen species (ROS) has been respected since
      the 1940's. Oxidative stress limits the functional competence of mammalian spermatozoa via
      lipid peroxidation, the induction of oxidative DNA damage and the formation of protein
      adducts. Nitric oxide (NO) is a free radical generated from the oxidation of L-arginine to
      L-citrulline by reduced nicotinamide adenine dinucleotide phosphate (NADPH)-dependent NO
      synthases. Several studies suggest that the overproduction of this free radical and the
      subsequent excessive exposure to oxidative conditions have a potential pathogenetic
      implication, which due to the reduction of sperm motility. The present study was conducted to
      study the effect of Zn supplementation on the levels of NO synthase and arginase in semen of
      patients with asthenozoospmia.
    

Detailed description: 
      Previous studies suggest that high concentrations of NO play an injurious consequence on
      spermatozoa kinetic characteristics. These studies reported that NO may react with superoxide
      or hydrogen peroxide, resulting in the production of peroxinitrite, hydroxyl radical, or
      singlet oxygen, which cause oxidation of sperm membrane lipids and thiol proteins. NO also
      may inhibit cellular respiration by nitro-sylation of heme in mitochondrial enzymes,
      aconitase, and glyceraldehyde phosphate dehydrogenase, leading to a reduction of adenosine
      triphosphate and that is due to loss of motility of spermatozoa.
    

Intervention name(s): zinc sulfate
Intervention type(s): Dietary Supplement
Intervention description(s): every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
Intervention MeSH terms: Zinc Sulfate
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        this study includes 60 fertile male partners from couples who had consulted the infertility
        clinic of babil hospital of maternity (Hilla city/ IRAQ).
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess, in a controlled environment, the efficacy and safety
      of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.
    


Intervention name(s): NRP104; Adderall XR; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning; 10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg; Placebo capsule taken once daily in the morning
Other intervention name(s): lisdexamfetamine dimesylate; mixed salts of a single-entity amphetamine
Intervention MeSH terms: Amphetamine; Lisdexamfetamine Dimesylate; Adderall
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Gabapentin as Preanesthetic Medication to Fast Procedures in Pediatric´s Oncology
Condition: Pain, Postoperative; Agitation States as Acute Reaction to Exceptional Stress; Anesthesia; Vomiting
MeSH terms: Psychomotor Agitation; Vomiting; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a clinical trial, prospective, randomized and double-blinded. Placebo,
      Gabapentin syrup at 15 mg/kg, and Gabapentin syrup at 30 mg/kg were administered to reduce
      agitation before and after in children submitted procedures (myelogram or lumbar puncture)
      among 1 and 6 years.
    

Detailed description: 
      Gabapentin syrup at 15 mg/kg and at 30 mg/kg was administered to reduce the agitation before
      and after oncologic procedures (myelogram or lumbar puncture) in children among 1 and 6
      years. Three groups were compared: the control group received placebo, the other two groups
      received gabapentin at 15mg/kg or at 30mg/kg. All patients received the same protocols
      (anesthesia and analgesia). Anesthesia protocol used was induction with sevoflurane 8% plus
      N2O 50% and oxygen, maintenance with sevoflurane 4%. We provided local analgesia with 5%
      lidocaine creme before the procedure. If it was required, dipyrone 10mg/kg every 6 hours was
      given as rescue analgesia. To prevent post-operative vomit, ondasentron 0,1mg/kg was
      administered when intrathecal chemotherapy. The mYPAS scale was used to evaluate preoperative
      anxiety at several moments: at basal, at after 1-hour administration, at separation from
      parents, and at induction. The PAED scale was applied after 30 minutes of procedure to
      evaluate postoperative agitation. The CHIPPS scale was used to assess postoperative pain. The
      frequency of vomits was recorded for 8 hours after the procedure finished.
    

Intervention name(s): Placebo Group; GABA 15mg/kg Group; GABA 30mg/kg Group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive placebo concentrate.; Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 15mg/kg.; Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 30mg/kg.
Other intervention name(s): Lumbar puncture; Myelogram; Lumbar puncture; Myelogram; Lumbar puncture; Myelogram
Intervention MeSH terms: gamma-Aminobutyric Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; gabapentin; agitation; induction