bioihbjkbjnl/mcl2 huggingface dataset:
Study of a New Medical Device in Gel Formulation Versus Calgel® for the Topical Treatment of Teething in Infants
Condition: Pain Teeth
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, open label, parallel-groups, multicenter study. The study will be
      conducted in three clinical sites. Test Medical Device: 0.54% Hyaluronic Acid rose honey
      flavour gel medical device class IIa.
    

Detailed description: 
      Due to the potentially serious toxicity that can result from the use of topical anesthetics
      to relieving the symptoms associated with gingival inflammatory conditions or gums trauma in
      infant, recently, products containing Hyaluronic Acid have been marketed in Europe. In
      particular, Ricerfarma is developing several high molecular weight Hyaluronic Acid medical
      devices characterized by the absence of preservatives, alcohol and dyes; therefore, the
      administration of these products in infants is safe and can help creating a natural
      protective layer on the gingival tissue. In previous clinical trials with these high
      molecular weight Hyaluronic Acid medical devices it was noted a periodontal tissue/fluid
      balance with accelerated healing and repair properties that could be of interest either for
      accelerating the wound healing process or for treating the complex physical symptoms (i.e.
      soreness and swelling of gums, crying, sleeplessness) related to the teething in infants.
      These data were confirmed by a recent pilot study on 18 infants suffering by teething where
      the two formulation of the tested high molecular weight Hyaluronic Acid medical device
      evidenced, at the end of treatment period, for pain, swelling, gingival rush,
      hyper-salivation and redness a statistically significant reduction from baseline.
    

Intervention name(s): Hyaluronic Acid 0.54%; Calgel®
Intervention type(s): Device; Drug
Intervention description(s): Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day; Administration: application of the gel on the gingival tissue, massage it in gently, three/four times a day (away from meals). In any case the interval between gel applications must be at least 3 hours.
Other intervention name(s): Hyaluronic Acid gel 0.54%.; Lidocaine 0.33% and Cetylpyridinium Chloride 0.10%
Intervention MeSH terms: Cetylpyridinium; Lidocaine; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment of teething in infants
VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Condition: Status Epilepticus, Electrographic; Coma
MeSH terms: Status Epilepticus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status
      epilepticus.
    

Detailed description: 
      This pilot trial aims to demonstrate the feasibility of enteral administration of a single
      load of vigabatrin within targeted 48 hours of post-anoxic status epilepticus onset in
      unconscious survivors of cardiac arrest undergoing targeted temperature management. The load
      of VGB is in addition to the load of a commonly used intravenous second-line therapy given at
      the discretion of the treating neurologist. Serial blood tests will be obtained, including
      vigabatrin levels, taurine levels, neuron specific enolase, light chain neurofilament, and
      glial fibrillary acidic protein. In survivors that regain consciousness and survive to follow
      up, 6 months visual field perimetry will be obtained.
    

Intervention name(s): Vigabatrin Only Product
Intervention type(s): Drug
Intervention description(s): enteral medication administration, serial blood draws, and outcome assessment
Other intervention name(s): sabril, vigabatrone
Intervention MeSH terms: Vigabatrin
Intervention model: Single Group Assignment
Intervention model description: pilot feasibility trial of pharmacokinetics of drug absorption
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: post-anoxic status epilepticus, cardiac arrest, nonconvulsive status epilepticus, coma, vigabatrin
Cognitive and Motor Tasks in Cerebral Palsy
Condition: Cerebral Palsy; Gait Disorders, Neurologic; Cognitive Orientation; Motor Activity
MeSH terms: Paralysis; Cerebral Palsy; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      Various gait deviations are observed in children with cerebral palsy. Our aim was to
      determine the effect of cognitive task (CT) and motor task (MT) on gait in children with
      cerebral palsy (CP). 15 children with CP, between 9-15 years old, with Communication Function
      Classification System (CFSS) level I, with Gross Motor Function Classification System (GMFCS)
      and Manual Ability Classification System (MACS) level I-II were included in the study. The
      gait with four different conditions (single gait, CT, MT and CT&MT) was evaluated by Kinovea
      video analysis method on a 10-meter course.

      Results:
    

Detailed description: 
      All children with CP were instructed to walk on the track under four different conditions:

        -  Single: Walking without task at a self-selected speed

        -  Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes

        -  Motor Task (MT): Walking while carrying an empty box

        -  CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in
           threes

      The task was explained to individuals by a physiotherapist. The individuals were not allowed
      to use orthosis during walking performance. Running was not accepted. 30 seconds were given
      to take a break between tasks. The physiotherapist followed the individuals along the track
      in case of any falling. If the child was not able to complete the track (falling or need to
      rest), the evaluation was accepted uncomplete and was excluded from the database.

      The Kinovea-08.15 software program was used to assess all of the outputs (images and videos)
      from the camera
    

Intervention name(s): 2D Gait analysis
Intervention type(s): Diagnostic Test
Intervention description(s): The gait with four different conditions (single gait, Cognitive Task, Motor Task and Cognitive Task&Motor Task) was evaluated by Kinovea video analysis method on a 10-meter course.
Single: Walking without task at a self-selected speed
Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes
Motor Task (MT): Walking while carrying an empty box
CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in threes
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        15 children with Cerebral Palsy, between 9-15 years old
      
Keywords: Cerebral Palsy; Cognitive Task; Dual Task Paradigm; Motor Task; Gait
Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19
Condition: Covid19; Thrombosis
MeSH terms: COVID-19; Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      SINGLE CENTER PHASE III INTERVENTIONAL RANDOMIZED CONTROLLED TRIAL comparing efficacy and
      safety of enoxaparin at prophylactic dose (standard treatment) and enoxaparin at therapeutic
      dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory
      failure (PaO2/FiO2<250) and/or increased D-dimer levels enrolled in different Units
      (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology) of Azienda Socio
      Sanitaria Territoriale Fatebenefratelli Sacco (ASST-FBF-SACCO).
    

Detailed description: 
      Patients with COVID-19 are at high risk of developing a venous thromboembolism (VTE) and it
      is essential that effective thromboprophylaxis with parenteral drugs (LMWH, UFH) is
      considered for all patients admitted to hospital especially in case of severe pneumonia.

      The aim of the study is the evaluation of efficacy and safety of enoxaparin at prophylactic
      dose (standard treatment) as compared to enoxaparin at therapeutic dose (OFF-LABEL treatment)
      in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2<250)
      and/or increased D-dimer levels.

      After the admission to different Units (Infectious disease, Internal Medicine, Emergency
      Medicine, Pneumology), enoxaparin at prophylactic dose (standard of care) will be prescribed
      to all patients.

      The randomization of the single patient will be made when the the inclusion criteria
      (PaO2/FiO2 <250 and/or D-dimer >2000 ng/) will be satisfied. Patients with increased bleeding
      risk will be excluded (exclusion criteria).

      Patients will be divided into two arms:

        -  arm A: enoxaparin at prophylactic dose (standard 4.000 IU; 6000 UI if body weight>100
           kg)

        -  arm B: enoxaparin at therapeutic dose (70 U/Kg b.i.d. every 12 h)

      In both arms, enoxaparin treatment will be monitored clinically and with first and second
      line laboratory tests Venous compression ultrasound (CUS) will be performed at admission and
      after 7 days in case of a first negative exam and elevated D-Dimer levels, to rule out deep
      vein thrombosis.

      Enoxaparin at prophylactic dose (4000 IU) will be maintained in all patients for 4 weeks
      after discharge.
    

Intervention name(s): Enoxaparin
Intervention type(s): Drug
Intervention description(s): subcutaneous injections
Other intervention name(s): Clexane
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID.19; Thrombosis; Enoxaparin; Outcome; Respiratory failure; D-dimer; Venous compression ultrasound
Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients
      with major depressive disorder during pregnancy and breast-feeding.
    


Intervention name(s): Omega-3 fatty acids
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Omega-3 Fatty Acids; Major Depressive Disorder; Pregnancy; Women during pregnancy and after childbirth are more vulnerable to psychiatric disorders; Pharmacotherapy for depression during pregnancy is a clinical dilemma.; Omega-3 polyunsaturated fatty acids (PUFAs) might be a promising alternative of treatment for pregnant women with depression.
A Phase 1 Ascending Dose Study to Assess the Safety and Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines
Condition: Anthrax Infection
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the
      positive (vaccine) control as studied in normal healthy volunteers.
    

Detailed description: 
      A Phase 1, randomized, double-blind, positive controlled, increasing dose clinical trial in
      healthy adult subjects at multiple sites. The study will assess safety and immunogenicity of
      two adenovirus vaccine candidates against anthrax compared to the positive control, Anthrax
      Vaccine Adsorbed (AVA). The trial will enroll 108 subjects in the anthrax vector vaccine arms
      and 12 subjects in the AVA positive control subjects. The study will look at three different
      dose of oral dosages of Ad4-PA (protective antigen) and Ad4-PA-GPI (10^9, 10^10, 10^11
      vp/dose)as well as 3 vaccine administration schedules (1 and 15 days; 1 and 29 days; 1, 15,
      and 29 days); 2 of 3 schedules will include an intramuscular (IM) AVA booster immunization, 1
      schedule will include 3 vaccine administrations of Ad4-PA or Ad4-PA-GPI
      (glycosylphosphatidylinositol) alone, and 1 schedule will include 3 vaccine administrations
      of AVA alone.
    

Intervention name(s): AVA; Ad4-PA-1; Ad4-PA-GPI-1
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Anthrax Vaccine Adsorbed (0.5 mL) as the placebo control on Days 1, 15 and 29; Ad4-PA will be given at 10^9, 10^10 and 10^11 on Day, followed by an oral placebo on Day 15 and an AVA boost on Day 29; Given at 10^9, 10^10 and 10^11 viral particles
Ad4 PA-GPI at Day 1 + oral placebo on Day 29 + AVA boost at Day 15
Other intervention name(s): Anthrax vaccine adsorbed (BioThrax); Adenovirus serotype 4 vector vaccine against anthrax PA; Adenovirus anthrax vaccine serotype 4 against anthrax PA
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anthrax vaccine
RCT Comparing the DEXA Results of the HA-Omnifit Versus the Symax Uncemented Hip Stem
Condition: Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      Thr purpose of this study is to compare the clinical and radiological results, as well as the
      femur bone density measurements of two uncemented total hip prostheses during 5 years of
      follow up.
    

Detailed description: 
      It is of great importance for the function of uncemented total hip arthroplasty that the
      anchorage of the prosthesis in the bone of the femur is sufficient. This is of great
      importance in the prevention of stress shielding of the bone and to insure tranfer of forces
      from the prosthesis to the femur.

      The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical
      stability.

      In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used
      and long term evaluated uncemented hip prosthesis) During the fist two years of follow up
      DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient
      fuction score and radiological evaluation measurements are done during 5 years of follow up.

      Our primary objective is: comparison of the short term bone remodelling surrounding the Symax
      hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem measured by
      bone densitometry, clinical and radiographic evaluation.
    

Intervention name(s): uncemented total hip arthroplasty
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: uncemented hip; bone remodeling; DEXA; clinical evaluation
Sun Protection Factor Assay (344/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987521; SPF control
Intervention type(s): Drug; Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-106); Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of OSSIX® Bone in Sinus Elevation
Condition: Maxillary Sinus Floor Augmentation
Study type: Observational

Summary: 
      A post marketing observational study to evaluate clinical performance of OSSIX Bone in
      maxillary sinus elevation procedure.
    


Intervention name(s): OSSIX Bone
Intervention type(s): Device
Intervention description(s): subjects will be implanted with OSSIX Bone during sinus elevation surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that need sinus elevation
Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology
Condition: Tissular Lesion
Study type: Interventional

Summary: 
      The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the
      positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by
      comparing the path indicated by the ultrasound fusion (virtual line) and the path actually
      obtained on the control CT scan (real line).

      Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more
      accurate, saving time and irradiation (not evaluated here).
    


Intervention name(s): Ultrasound fusion guiding system - TUS A-500 (Aplio 500)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Diagnostic (Biopsy) or Therapeutic Procedure (Infiltration, Ablation)
Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease
Condition: Elevated Lipoprotein(a); Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Hyperlipoproteinemias; Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to
      evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of
      different doses and dosing regimens of ISIS 681257 for reduction of plasma Lipoprotein(a)
      [Lp(a)] levels in participants with hyperlipoproteinemia(a) and established cardiovascular
      disease (CVD).
    


Intervention name(s): ISIS 681257; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ISIS 681257 solution for SC injection.; Sterile normal saline (0.9% NaCl)
Other intervention name(s): AKCEA-APO(a)-LRx, IONIS-APO(a)-LRx, TQJ230 and Pelacarsen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IONIS-APO(a)-LRx; AKCEA-APO(a)-LRx; Dyslipidemia; Dyslipoproteinemia; Hyperlipidemia; Hyperlipoproteinemia; Hyperlipoproteinemia(a); Hyperlipoproteinemia a; Lipoprotein; Lipoprotein(a); Lipoprotein a; Lp(a); Lp a
The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study is being undertaken to understand how a gastric bypass can affect a subject's
      diabetes even prior to their losing significant amounts of weight. The hypothesis of this
      study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration
      in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.
    


Intervention name(s): Exendin 9,39; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Exendin 9,39 is a competitive antagonist of endogenous GLP-1.; A saline infusion will be given to match the study drug infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Gastric Bypass; bariatric surgery; glucose metabolism
Effects of Binaural Beat Music on Elderly Sleep
Condition: Sleep Quality
Study type: Interventional

Summary: 
      Background:

      Older people in long-term care institutions often have poor sleep quality and depression,
      which may negatively affect their health and welfare. Binaural beat music (BBM) has been
      proposed as a possible intervention. However, its effects on older people with poor sleep
      quality in long-term care institutions is still unclear.

      Objective:

      This study aimed to examine the effects of binaural beat music on sleep quality, heart rate
      variability, and depression in older people with poor sleep quality in a long-term care
      institution

      Methods:

      A single-blind randomized controlled trial design was employed and 64 older participants with
      poor sleep quality were recruited from a long-term care institution in Taiwan. Participants
      were randomized into the BBM group or control (sham) group (32 per group) and received 14
      days of intervention. During the intervention period, participants in the experimental group
      listened to 20 minutes of Taiwanese Hokkien oldies embedded with BBM once in the morning and
      afternoon thrice a week. Participants in the control group only listened to Taiwanese Hokkien
      oldies. Questionnaires and heart rate variability analysis were used to assess participants'
      sleep quality, heart rate variability, and depressive symptoms.
    


Intervention name(s): Binaural beat music group (BBM group); Control group
Intervention type(s): Other; Other
Intervention description(s): The participant sat on a chair with eyes closed and wore over-ear stereo headphones to listen to 15 minutes of Taiwanese Hokkien oldies (familiar music, can be selected by participant) with BBM embedded.; The participant sat on a chair with eyes closed and wore over-ear stereo headphones to listen to 15 minutes of Taiwanese Hokkien oldies (familiar music, can be selected by participant) without BBM embedded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Skeletal Muscle Atrophy and Dysfunction in Human Cancer
Condition: Nonsmall Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung; Muscular Atrophy; Atrophy
Study type: Interventional

Summary: 
      Cancer and its treatment can have profound effects on skeletal muscle, the most
      well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations
      negatively impact quality of life, treatment decisions and survival. Despite these
      consequences, the factors promoting these adaptations remain poorly defined and understudied
      in human patients. To address this gap in knowledge, our goal in this study is to examine the
      role of muscle disuse as a regulator of muscle size and function in human cancer patients
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Unilateral lower limb resistance exercise will be performed 3 times per week for 8 weeks in non-small cell lung cancer patients on only one leg, while the contralateral leg serves as a non-exercising control.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science