bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion
Condition: Dental Erosion; Acid Wear
MeSH terms: Tooth Erosion
Study type: Interventional

Summary: 
      The purpose of this study is to compare and evaluate the ability of two European Union (EU)
      regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a
      modified in-situ model of dental erosion and remineralization. A positive control i.e
      fluoride containing toothpaste marketed in EU will also be compared to non-fluoride
      toothpaste.
    

Detailed description: 
      The aim of this study is to assess the remineralization effects of two EU gel to foam
      toothpaste formulations with 1450 parts per million (ppm) of fluoride as sodium fluoride
      (NaF) and 5% potassium nitrate (KNO3) versus a non-fluoride (0 ppm F)/KNO3 toothpaste as a
      negative control. The two experimental gel to foam toothpaste formulations differ in their
      relative dentine abrasivity (RDA) values which is an in-vitro measure of a toothpaste
      abrasivity to the dentinal tissues. A marketed toothpaste containing NaF and KNO3 will serve
      as a positive control.
    

Intervention name(s): Sodium Fluoride; Potassium nitrate
Intervention type(s): Drug; Drug
Intervention description(s): Toothpaste containing 1450 ppm F - EU level as NaF.; All study treatments contain 5% w/w KNO3.
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
the Efficacy and Safety of Fermented Soybean(Doenjang Powder) on Intestinal Microflora and Immune Enhancement.
Condition: Immunity
Study type: Interventional

Summary: 
      This study was conducted to investigate the efficacy and safety of Fermented soybean(Doenjang
      powder) on intestinal microflora and immune enhancement.
    

Detailed description: 
      This study was a 4 weeks, randomized, double-blind human trial to evaluate the efficacy and
      safety of Fermented soybean(Doenjang powder) on intestinal microflora and immune enhancement.
    

Intervention name(s): TMD21-16 group; TCD21-55 group; TFD21-1 group
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks; 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks; 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Fermented Soybean(Doenjang); Immunity
Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
Condition: Phosphorus and Calcium Disorders; Parathyroid Diseases; Hyperparathyroidism; Hypoparathyroidism
MeSH terms: Metabolic Diseases; Hyperparathyroidism; Hypoparathyroidism; Parathyroid Diseases
Study type: Observational

Summary: 
      Primary hyperparathyroidism (PHPT) and Hypoparathyroidism (HP) are two of the most frequent
      disorder of Calcium-Phosphorus (Ca-P) metabolism. The Ca/P ratio is an accurate tool to
      differentiate patients with PHPT from healthy subjects, according to a previous single-centre
      study. The reliability of this index is based on the fact that serum Ca and P are inversely
      related together either in healthy subjects or in patients with PHPT and HP.
    

Detailed description: 
      The aim of this study is to investigate the accuracy and diagnostic value of Ca/P ratio in
      the diagnosis of primary hyperparathyroidism and hypoparathyroidism. The definition of a
      valid cut-off of serum Ca/P ratio for patients with these disorders will be of help
      especially in those patients with apparently normal biochemical profile, but suggestive for
      primary hyperparathyroidism and hypoparathyroidism.
    

Intervention name(s): No intervention is provided
Intervention type(s): Other
Intervention description(s): No intervention is provided
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Serum Calcium to Phosphorus ratio will be compared among patients with different disorders
        of calcium-phosphorus metabolism (primary hyperparathyroidism and hypoparathyroidism) and
        controls.
Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
Condition: Supraventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Supraventricular
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the additional use of non-fluoroscopic
      imaging modalities can decrease the use of radiation exposure during standard ablation
      procedures for supraventricular tachycardia (SVT) in children.
    

Detailed description: 
      The standard of care for children undergoing SVT ablation is radiation (fluoroscopy) to see
      the heart. Non fluoroscopic imaging tools have been utilized for adult atrial fibrillation
      procedures. These tools utilize magnetic fields to visualize the heart without using
      radiation. The purpose of this study was to determine if these 3D mapping tools could reduce
      radiation exposure during SVT ablation procedures could be performed using these 3D tools.
    

Intervention name(s): Intracardiac echocardiography and 3D navigational system
Intervention type(s): Device
Intervention description(s): Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.
Other intervention name(s): AcuNav Intracardiac Echocardiography; NavX 3D navigational system; CARTO 3D navigational system
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intent to treat use of non fluoroscopic mapping system with traditional fluoroscopic mapping system during elective catheter ablation in children 8-17 with normal cardiac anatomy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Electrophysiology; Ablation; Radiation; Devices; SVT
Epidemiological Analysis of Vitamin D and Breast Cancer Risk in Saudi Arabian Women
Condition: Breast Cancer; Vitamin D Deficiency
MeSH terms: Breast Neoplasms; Vitamin D Deficiency
Study type: Observational

Summary: 
      This is an analysis of de-identified data collected from 240 Saudi Arabian women, 120 with
      breast cancer and 120 control women, to evalyate if vitamin D status is associated with
      breast cancer risk.
    

Detailed description: 
      Background: The role of vitamin D in breast cancer prevention is equivocal. Saudi Arabian
      women are thought to be at greater risk for vitamin D deficiency due to darker skin type and
      greater likelihood for reduced UVB radiation exposure. However, there is a lack of data
      regarding the vitamin D status of Saudi Arabian women and how this may relate to breast
      cancer risk.

      Objective: The purpose of this research was to evaluate the association between circulating
      concentrations of 25(OH)D and breast cancer risk in Saudi Arabian women.

      Design: A case-control study was conducted among 120 breast cancer cases and 120 controls.
      The study population was drawn from patients admitted to King Fahd Hospital in Jeddah, Saudi
      Arabia from June to August 2009. Participants completed questionnaires on diet and medical
      history and serum samples were collected from all women to measure circulating 25(OH)D
      concentrations.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Saudi Arabian women receiving care at King Fahd Women's clinic in Saudi Arabia during the
        summer of 2009.
      
Biospecimen description: 
      serum for vitamin D levels
    
Keywords: breast cancer; vitamin D; 25 OH vitamin D
Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Integrative approaches to promote wellness and reduce the distress associated with cancer are
      considered as essential components of cancer care. In case, exercise training has been shown
      to produce many positive physiological and psychological benefits. Mindfulness-based stress
      reduction program shows similar beneficial effects, and especially in emotional distress
      management. The aim of the study is to examine the cumulative effect of an 8
      week-exercise-training program combined with an MBSR program on cardio-respiratory fitness
      and quality of life in women with breast cancer. These effects are thought to be mediated in
      part through changes in underlying brain processes, that investigators will be put in light.
      Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine
      level measurements, investigators could expect to better understand the effect of these
      combined training in breast cancer.
    


Intervention name(s): Endurance exercise training; Mindfulness-based-stress-reduction; Both interventions together; Vo2max measurements; Telomerase activity on a blood sample; Quality of life (questionnaires); Cerebral IRMf
Intervention type(s): Other; Other; Other; Other; Genetic; Other; Other
Intervention description(s): In each group, there will be a comparison of aerobic capacity, quality of life (with questionnaires), functional cerebral measurements (fRMI), and telomerase activity between before and after the 8 weeks program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise capacity; Mindfulness; Quality of life
iParent2Parent Program for Parents of Children With Juvenile Idiopathic Arthritis
Condition: JIA
MeSH terms: Arthritis, Juvenile
Study type: Interventional

Summary: 
      The iParent2Parent program matches parents of children living with arthritis with a trained
      parent mentor who will provide parents of children newly diagnosed with arthritis: practical
      coping advice and social support through shared lived experiences. This study will compare
      two groups of parents: those who are in the iParent2Parent program and those in the control
      group (no mentor).
    

Detailed description: 
      Parents/primary caregiver of children with JIA are an often overlooked but essential member
      of their child's health care team. They are responsible for managing their child's treatment
      program, and act as advocates for their child to support positive adaptation to JIA and to
      learn self-management skills for the disease. This is in the context of managing the
      financial, logistical, emotional, and social demands of parenting in general. Within
      pediatric tertiary care centres, peer-support programs for parents of children with JIA are
      often limited or difficult to access. The iParent2Parent Program aims to fill this gap in
      services by offering a program of trained parent peer mentors who can provide practical
      coping advice, foster adaptive problem solving, and provide social support via shared lived
      experience.
    

Intervention name(s): iParent2Parent Program; Waitlist Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to standard care, parents in the experimental group will receive the iParent2Parent program. The iParent2Parent program is a tailored peer mentorship program that provides modeling and reinforcement by peers (trained parents of children with JIA) to parents of children diagnosed with JIA.; The control group will receive standard care but without the iParent2Parent program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      IBI306 is a fully human monoclonal antibody that binds proprotein convertase
      substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density
      lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and
      low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate
      the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high
      or high cardiovascular risk. This study will see if IBI306 will reduce low density
      lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of
      lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side
      effects
    

Detailed description: 
      This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of IBI306
      in Chinese non-familial hypercholesterolemia Subjects with very high or high cardiovascular
      risk. A total of around 600 subjects who meet admission criteria will be randomized and
      receive one of the two dose levels of IBI306 or matching placebo: 450mg Q4W, or 600mg Q6W.
      The double blind period for both groups will be 48 weeks. The study will last 52 weeks
    

Intervention name(s): IBI306 450mg SC Q4W; Placebo SC Q4W; IBI306 600mg SC Q6W; Placebo SC Q6W
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Subjects will receive IBI306 450mg every 4 weeks subcutaneously.; Subjects will receive placebo every 4 weeks subcutaneously.; Subjects will receive IBI306 600mg every 6 weeks subcutaneously.; Subjects will receive placebo every 6 weeks subcutaneously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Chemotherapy for Patients With Locally Advanced Pancreatic Cancer (LAPC) With Additional Chemo-radiotherapy (CRT) for Patients With Borderline Resectable Tumours
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Treating patients with initial local non-resectable pancreatic cancer with a combination of
      oxaliplatin, irinotecan & 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in
      potentially resectable patients, will result in a high rate of tumor shrinkage allowing
      subsequent resection in patients with initial borderline resectable tumors and improved
      overall survival for all patients.
    

Detailed description: 
      Pancreatic cancer (PC) is the third most common gastrointestinal malignancy and one of the
      top ten leading causes of cancer deaths in the Western world. Patients with PC can be divided
      into three subgroups; resectable (rPC), locally advanced (LAPC) and metastatic (mPC). For
      patients with rPC surgery offers the best chance for long term survival. However it is
      estimated that only 20% of patients have rPC at the time of diagnosis. For patients with
      LACP, invasion of local large vessels is most often the cause for non-resectability. The
      median survival of these patients is between 6 to 12 months and long term survival in is
      extremely rare. The optimal treatment of LAPC is controversial. Treatment strategies vary
      between attempts to "downstage" the tumour to rPC, or treat the patients in a palliative
      setting only. Phase II studies and retrospective series have evaluated various treatments
      regimens and strategies including chemotherapy and radiotherapy (RT) alone or in combination
      - chemoradiotherapy (CRT). Results from these trials give no clear answer regarding the best
      treatment strategy. However, data from several studies shows that treatment of LAPC may
      result in shrinkage of the tumour, and thus potentially lead to a resection; also data
      suggests that CRT after chemotherapy improves treatment efficacy. Recent data from patients
      with mPC has show a combination of oxaliplatin, irinotecan and 5-FU (FOLFIRINOX) increases
      response rates from 10% to 30% and median survival to 11.1 months. The promising efficacy
      makes it natural to attempt this treatment in patients with LAPC.
    

Intervention name(s): Oxaliplatin, irinotecan, 5-FU & leucovorin
Intervention type(s): Drug
Intervention description(s): FOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors
Intervention MeSH terms: Leucovorin; Oxaliplatin; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Chemotherapy; Chemoradiotherapy
Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian
      virus. Prevention and control of a pandemic will depend on the rapid production and worldwide
      distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be
      developed and tested in clinical trials to determine the most optimal formulation and the
      best vaccination schedule.This study is designed to test in healthy adults aged between 18-60
      years the reactogenicity and immunogenicity of one and two administrations of a candidate
      pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen
      doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to
      detect the optimal formulation for immunization against the H5N1 influenza strain.
    


Intervention name(s): Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine; Influenza Monovalent Whole virus (H5N1)
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21; 2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: prophylaxis of pandemic influenza
Cholera Anti-Secretory Treatment Trial
Condition: Cholera
MeSH terms: Cholera
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial was designed to assess safety and preliminary efficacy of oral doses of iOWH032 on
      diarrhea output and clinical symptoms after a cholera challenge in healthy adult
      participants.
    

Detailed description: 
      The study consists of a screening phase, an inpatient containment period with challenge with
      Vibrio cholerae on Day 1 followed by treatment with iOWH032 or placebo and a post-challenge
      observation period until discharge, an outpatient follow-up period of at least 28 days, and a
      final follow-up (by telephone) 6 months post-challenge (Day 180) for the collection of
      serious adverse events.

      Participants will be randomized 1:1 to receive either iOWH032 500 mg every 8 hours for three
      days or matching placebo. Blinded therapeutic dosing will start at the onset of diarrhea or
      by 48 hours after ingesting the challenge inoculum of V. cholerae. The observation and
      management of cholera diarrhea and symptomatology will occur on an inpatient isolation
      research ward over a duration of approximately 11 days, including a three-day course of
      antibiotics to treat all participants prior to discharge from the inpatient unit.
    

Intervention name(s): iOWH032; Placebo; V. cholerae Challenge; Antibiotics
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): Anti-secretory synthetically manufactured small molecule designed to inhibit the cystic fibrosis transmembrane conductance regulator chloride channel.; Oral tablets matching iOWH032 on taste, appearance, dissolution time with the same excipients but no active ingredients.; Freshly-harvested, wild-type Vibrio (V.) cholerae El Tor Inaba strain N16961,10^6 cfu suspended in 30 mL of sodium bicarbonate solution ingested orally.; Antibiotic therapy may include:
Ciprofloxacin 500 mg, twice daily;
Azithromycin 500 mg, once daily (for those persons who are allergic to fluoroquinolones);
Doxycycline 300 mg, once daily (for those persons who are allergic to fluoroquinolones)
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll.
      Patients will be randomized to one of two groups - a group implanted with a device that
      allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no
      implant). Patients have two baseline evaluations, one evaluation after implant but before
      initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS,
      followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of
      treatment. The intent is to assess safety and provide preliminary effectiveness information
      for VNS for upper limb functional improvement after stroke. Implanted patients may receive
      longer-term treatment and follow-up after the acute study.
    


Intervention name(s): Vivistim System; Rehab Only
Intervention type(s): Device; Other
Intervention description(s): The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.; Rehabilitation without device implant and VNS
Other intervention name(s): VNS, vagus nerve stimulation, paired VNS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Upper; Limb; Deficits; Rehabilitation; VNS