bioihbjkbjnl/mcl2 huggingface dataset:
Trekking Poles to Aid Multiple Sclerosis Gait Impairment
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      In this study, the investigators will examine a sample of persons with multiple sclerosis
      (MS) to determine whether their walking function and ability is different depending on which
      walking assistive device is used.
    

Detailed description: 
      In this study, the investigators will examine a sample of persons with multiple sclerosis
      (MS) to determine whether their walking function and ability is different depending on which
      walking assistive device is used. In addition, the investigators will examine the
      psychosocial impact and amount of fatigue induced by each assistive device. Data collection
      will consist of a series of assessments via survey and physical performance. The analyses
      will consist of appropriate comparisons of means to determine if the use of different
      assistive devices alters any of the outcomes.
    

Intervention name(s): No device; Single-point cane (SPC); Four-point cane (FPC); Trekking pole (TP).
Intervention type(s): Other; Device; Device; Device
Intervention description(s): Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).; Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).; Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).; Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Multiple Sclerosis; Walking; Gait
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in
      patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to
      undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer
      surgery.
    

Detailed description: 
      The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light
      to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by
      palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled
      to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer
      surgery
    

Intervention name(s): OTL38; near infrared camera imaging system; laparotomy
Intervention type(s): Drug; Device; Procedure
Intervention description(s): 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes; Infrared imaging used to excite OTL38 for fluorescence; primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Other intervention name(s): OTL38 for Injection; Near IR imaging
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE
      products by measurement of Plasma concentrations of Amlodipine ,Losartan, Carboxylic acid
      losartan metabolite & Hydrochlorothiazide in plasma and calculation of the bioequivalence
      parameters from those measurements followed by ANOVA and 90% confidence interval statistical
      evaluation.
    


Intervention name(s): Amlodipin, losartan, HCTZ
Intervention type(s): Drug
Other intervention name(s): LOSANET AM PLUS
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bio-equivalence, crossover
Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study investigating the effect of MEDI7352 on chronic pain in patients with painful
      diabetic neuropathy.

      The study incudes a screening period of up to 45 days and a 12-week treatment period during
      which MEDI7352 or placebo will be administered intravenously (IV) on 6 occasions, with each
      dose separated by 14 days. There will be a 6-week follow-up period.

      Subjects will randomly be assigned to double-blind treatment with one of 4 dose levels of
      MEDI7352 or placebo
    


Intervention name(s): MEDI7352; Placebo
Intervention type(s): Biological; Other
Intervention description(s): MEDI7352; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Integrative Intervention for Loss of Control Eating Among Adolescent Girls
Condition: Binge Eating/Loss of Control Eating
MeSH terms: Bulimia; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This study aims to develop a manualized and culturally sensitive intervention for adolescent
      girls targeting binge and loss of control (LOC) eating. The investigators will evaluate the
      feasibility and acceptability of the intervention in a controlled pilot trial. The
      investigators hypothesize that this intervention will serve to reduce binge and LOC eating,
      as well as improve psychosocial functioning as evidenced by decreased depression, anxiety,
      eating disorder cognitions, and impulsivity, and improved quality of life.
    


Intervention name(s): Linking Individuals Being Emotionally Real (LIBER8); Weight Management Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will attend a 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques.; Participants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: binge eating; loss of control eating; eating in the absence of hunger; emotional eating
Drug Utilization Study for Pirinase Hayfever Relief
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Observational

Summary: 
      The purpose is to obtain real-world information on how consumers are complying with the
      product labelling This study will coincide with the launch of Pirinase Hayfever Relief for
      Adults 0.05% Nasal Spray in the United Kingdom (UK).
    


Intervention name(s): Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
Intervention type(s): Drug
Intervention description(s): Aqueous suspension of 0.05% micronised fluticasone propionate.Each actuation contains 50 micrograms of fluticasone propionate
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        An all comers population (consumers who opt in at their own discretion) of approximately
        1,537 consumers, will be included in this study. Age, gender, and social backgrounds will
        be allowed to fall out naturally.
Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.
Condition: Prostate Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Laparoscopic prostatectomy (LP) is characterized by substantial tissue trauma, despite its
      minimally -invasive approach. Although postoperative pain intensity is lower when compared to
      open procedures, the use of opioids is common. Retrospective review of available LP cases
      revealed that although analgesic demand varied, nearly all of our LP patients required
      opioids postoperatively. Bilateral Quadratus Lumborum Block (QLB), being one of relatively
      new features of regional anesthesia, offers good analgesia of abdominal wall, with the
      potential for control of visceral pain. This study was established to evaluate its
      effectiveness in alleviating pain after radical prostatectomy in a double - blind, placebo -
      controlled manner.
    


Intervention name(s): Qadratus Lumborum Block; 30 milliliters of 0.375% Ropivacaine; 30 milliliters of 0.9% NaCl
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Bilateral, ultrasound - guided Quadratus Lumborum Block; 30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block; 30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, placebo-controlled, randomised
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: regional anesthesia; quadratus lumborum block; patient controlled anesthesia; laparoscopic prostatectomy
Long-term Release of Fluoride Formed on Enamel by Fluoride Gel or Varnish to Biofilm Fluid
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The anticaries effect of professional fluoride application has been associated with the
      formation of calcium fluoride-like products ("CaF2") on dental surface, which may function as
      a slow release fluoride reservoir. Among professional fluoride products, fluoride gel and
      varnish are the most important, and have different soluble fluoride concentrations, pHs and
      vehicles. Although the concentration of fluoride formed on enamel after the use of both is
      similar, the retention of these reaction products is unknown. Also, it is unknown the
      capacity of these reservoirs to enhance dental biofilm fluid with fluoride. Moreover, the
      effect of the varnish application time on these parameters is unknown. Therefore, the aim of
      this study is to compare the capacity of fluoride gel and varnish to form fluoride reservoirs
      on enamel and increase dental biofilm fluid fluoride concentration with time. Rapid
      biofilm-forming individuals will be selected to participate and divided into 4 experimental
      groups: 1. Negative control: no treatment; 2. Varnish 4 hours: fluoride varnish will be
      applied and kept on teeth for 4 hours; 3. Varnish 24 h: fluoride varnish will be applied on
      teeth and kept for 24 h; and 4. Gel: Fluoride gel will be applied on teeth. Microbiopsies of
      enamel will be obtained by a microbiospy technique to assess fluoride concentration before, 7
      and 28 days after the treatments. Dental biofilm will be collected before and 3, 7, 14 and 28
      days after treatments. Fluoride concentration on enamel and in the biofilm fluid will be
      determined by an ion-specific electrode. Data will be analyzed statistically comparing the
      groups and collection times.
    


Intervention name(s): 5% sodium fluoride varnish; 1.23% sodium fluoride acidic gel
Intervention type(s): Drug; Drug
Intervention description(s): Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base; Fluoride gel containing 12,300 ppm F (as NaF) in an acidic pH (by addition of phosphoric acid)
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Fluoride; Biofilm fluid; Calcium fluoride; Topical
Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan
Condition: Breast Milk Collection; Infant Development
Study type: Interventional

Summary: 
      Breastmilk is considered optimal for infant growth and development. However, evidence
      suggests that breastmilk composition can vary according to maternal nutritional status. Among
      women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies.
      As well, the prevalence of early stunting among Pakistani infants is high. Using a
      hypothesized pathway model, this study will assess pathways between maternal nutritional
      status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari
      emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier:
      NCT03287882).
    


Intervention name(s): Multiple micronutrients (UNIMMAP composition)
Intervention type(s): Dietary Supplement
Intervention description(s): The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.
Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Aurolab Hydrophobic Foldable Intraocular Lens Study
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured
      by aurolab are safe and effective in the surgical treatment of cataract.
    

Detailed description: 
      Hydrophobic as the name suggests is fear for water. Hydrophobic foldable IOLs are made from
      acrylic material. Aurolab has developed its own hydrophobic acrylic material. This material
      has been subjected to several biocompatibility studies and it has proved itself to be
      biocompatible.
    

Intervention name(s): Intraocular Lens
Intervention type(s): Device
Intervention description(s): Phacoemulsification with in the bag implantation of the IOL
Other intervention name(s): Aurovue, Model HP757SQ
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lenses, Intraocular; Prospective Studies; Visual acuity; Clinical Trial
Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      To demonstrate that in patients with persistent poorly controlled diabetes,
      short/intermittent use of continuous glucose monitoring can driver better longer-term
      glycaemic control and HbA1c.
    

Detailed description: 
      Study Overview This is a multi-centre pilot study across 6 study sites, recruiting 50
      subjects. Each subject will use a FreeStyle Navigator Continuous Glucose Monitor for a period
      of 20 days at the start of the study, after which their Healthcare Professionals (HCPs) may
      recommend changes to their glucose management based on the continuous glucose monitoring(CGM)
      data. Subjects will then return to self-managing their diabetes with a blood glucose meter.
      After 2 months, subjects will use the FreeStyle Navigator for a further 5 days and review
      their results and glucose management with their HCPs. Subjects will again return to
      self-managing their diabetes with a blood glucose meter until the end of the study, when the
      last FreeStyle Navigator 5 day wear is completed and HbA1c and measures of glycaemic
      variability are recorded.
    

Intervention name(s): FreeStyle Navigator Continuous Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Six x 5 day wears of the continuous glucose monitoring device. Two of the 6 wears will be using a masked device (1 at the start and 1 at the end of the study).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Continuous Glucose Monitoring
A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Observational

Summary: 
      The purpose of this prospective, multi-centre, PMS cohort study was to monitor the safety of
      Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical
      cancer caused by HPV types 16 and 18. The vaccine was approved by National Drug
      Administration of China (CNDA), in July 2016.

      As per the CNDA commitment, this study collected data regarding the safety of the vaccine,
      related information on potential immune-mediated diseases (pIMDs); which are diseases that
      could affect the immune system, and the effect on pregnancy outcomes (POs) including birth
      defects in the newborn.

      Cervarix was approved for use in females between 9-25 years of age, for the prevention of
      cervical cancer, cervical intraepithelial neoplasia grade 1 (CIN1), cervical intraepithelial
      neoplasia grade 2, grade 3 (CIN 2/3) and adenocarcinoma in situ caused by high-risk human
      papillomavirus (HR-HPV) types 16 and 18.

      In May 2018, Cervarix was also approved for use in women of age up to 45 years.

      The exposed set (ES) comprised 3013 subjects, who were vaccinated with Cervarix, on a
      voluntary basis, as per standard practice. The study collected information on any adverse
      event following immunisation, pIMDs, POs and congenital anomalies.
    


Intervention name(s): Safety data collection (following routine vaccination)
Intervention type(s): Other
Intervention description(s): This study assessed the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine when administered routinely according to the Prescribing Information in female Chinese subjects aged between 9 and 45 years.
The intervention consisted in the active surveillance of adverse events following immunization and pregnancy outcomes if the vaccine was administered inadvertently during pregnancy. Information of potential adverse events and pregnancy outcomes were collected at immunisation visits, telephone contacts and through spontaneous reporting by the patient/LAR/physician.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy female Chinese subjects aged between 9 and 45 years, vaccinated on a voluntary
        basis as per standard practice.
      
Keywords: Safety; Human Papillomavirus Vaccine; Adverse Event Following Immunization
High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective
      procedure.
    

Detailed description: 
      Atrial fibrillation (AF) ablation is the most commonly performed radiofrequency (RF) ablation
      and is usually associated with a long procedural time and sensation of pain in conscious
      patients. Prolonged radiation exposure during the procedure puts the patient and the operator
      at risk of malignancy and genetic abnormalities. Complications such as asymptomatic cerebral
      lesions, tamponade, perforation, and also arrhythmia recurrence were associated with longer
      ablation time.

      High-power, shorter-duration radiofrequency ablation (HPSDRFA) appears to be a novel concept
      for atrial fibrillation (AF) but there are scarce data in conscious patients. The lesion side
      index (LSI) value has been associated with durability of pulmonary vein isolation (PVI)
      lesions.

      We hypothesised that HPSDRFA applications based on the lesion side index (LSI; its has been
      associated with durability of pulmonary vein isolation (PVI) lesions) which were not inferior
      to standard approach regarding safety and effectiveness with shorten procedure time and being
      less painful for a patient.
    

Intervention name(s): RF ablation of atrial fibrillation
Intervention type(s): Other
Intervention description(s): Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with atrial fibrillation
      
Keywords: atrial fibrillation ablation; high power radiofrequency ablation
TD-1473 for Active Ulcerative Colitis (UC)
Condition: Ulcerative Colitis, Active Moderate; Ulcerative Colitis, Active Severe
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28
      days. This exploratory study will also serve as a signal seeking endeavor to demonstrate
      biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic,
      and histologic assessments.
    


Intervention name(s): TD-1473; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis, Active Moderate and Severe