bioihbjkbjnl/mcl2 huggingface dataset:
Teriflunomide Tecfidera LMCE
Condition: Tecfidera; Teriflunomide
Study type: Observational

Summary: 
      This study will investigate the effect of teriflunomide in reducing cortical gray matter
      (CGM) atrophy and leptomeningeal (LM) inflammation over 24 months compared to dimethyl
      fumarate (Tecfidera®)
    


Intervention name(s): Dimethyl Fumarate; Teriflunomide
Intervention type(s): Drug; Drug
Intervention description(s): Individuals with MS treated with dimethyl fumarate (Tecfidera); Individuals with MS treated with teriflunomide (Aubagio)
Other intervention name(s): Tecfidera; Aubagio
Intervention MeSH terms: Teriflunomide; Dimethyl Fumarate
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals diagnosed with MS who have used dimethyl fumarate or teriflunomide and had
        magnetic resonance imaging at baseline (before starting disease modifying therapy (DMT) in
        question), 12 months after starting DMT, and 24 months after starting DMT.
Project Daire: Derry/Londonderry as the Nexus City for Food, Education, Trust and Health
Condition: Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      Project Daire is a randomised-controlled factorial design trial working in partnership with
      primary schools and local food producers evaluating two interventions designed to improve
      primary school children's knowledge of and interest in food and where it comes from, with the
      ultimate aim of driving improvement in health, well-being and educational status.
    

Detailed description: 
      Project Daire is a randomised-controlled factorial design trial working in partnership with
      primary schools and local food producers evaluating two interventions designed to improve
      primary school children's knowledge of and interest in food and where it comes from, with the
      ultimate aim of driving improvement in health, well-being and educational status. Key Stage 1
      and 2 pupils will be recruited from 15 primary schools in the North West of Northern Ireland
      and will be randomised to one of four intervention arms: i) 'Engage', ii) 'Nourish', iii)
      'Engage' and 'Nourish' and iv) Delayed of duration up to 6 months. Study outcomes include
      food knowledge, attitudes, trust, diet, behaviour, health and wellbeing and will be collected
      at baseline and six months.
    

Intervention name(s): Engage; Nourish
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Engage intervention was developed with input from primary school teachers and includes a range of age-appropriate educational activities related to food. Activities include videos, lesson plans, worksheets, games, talks/visits from experts, visits to industrial partners and other local food-related centres of interest and practical activities such as experiments. All 'Engage' material is mapped to the Northern Ireland School Curriculum. The 'Engage' intervention is structured into three broad topics: Farm to Fork; Pleasure on a Plate and Food Futures. Engage resources were provided to schools electronically and in hard copy and teachers delivered most of the content, with the exception of several sessions which were delivered by visiting scientists.; The Nourish intervention is a school food environment intervention which included weekly healthy snack provision supplied by food industry partners, enhancement of canteen dining area (café style, tablecloths, centre pieces, bunting and menu boards, healthy eating posters), attendance at Tasting Days held in Higher Education Colleges (children were encouraged to try new foods provided by industry partners and received stamps on 'food passports' in return) and sensory educational and cookery activities.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Project Daire is a randomised-controlled, factorial design trial evaluating two interventions
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary School Children; Food Education; Food Knowledge; Childhood Health; Childhood Wellbeing
Endomina Post RYGB
Condition: Obesity
Study type: Interventional

Summary: 
      Surgery is the only effective treatment for morbid obesity and can be divided into
      restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary
      pancreatic deviation and duodenal switch) or a combination of both (RYGBP).

      This later technique is the most common and most effective surgical procedure performed
      worldwide and has been processed to be an effective treatment of morbid obesity and its
      complications, achieving excess weight loss of 65 to 80 % ; 1-2 years after surgery.1
      However, after the initial weight loss induced by RYGBP; 50 % of patients regain some weight
      2 and approximately 20 % of the patients will reach again a BMI of 35 at 10 years , defined
      as a failure rate.3 The reasons for weight regain are multiple but the most two potential
      contributing factors are related with the loss of the restrictive effect of the RYGBP by
      stretching of the gastric pouch and/or the gastrojejunal anastomosis (GJA), leading to
      increased satiety.

      Surgical options available for treating weight regain after RYGBP include placement of
      adjustable gastric band, Redo of the anastomosis or Reconstruction of the pouch.4 These
      procedures are technically difficult especially in patients who had previous single or
      multiple surgical interventions leading to a morbidity of around 15 % and a mortality of 1 %;
      Which is twice the one of the original surgery. This justifies the interest in less invasive,
      peroral revisions that include injection of sclerosant or suturing the anastomosis using
      Endoluminal gastroplication device (EndoCinch; Bard) 5,6 They have been however of marginal
      effectiveness compared to the medical treatment may be because their effect is limited to the
      anastomosis and doesn't reduce the size of the stretched gastric pouch. StomaphyX
      (Endogastric Solutions, Redmond, WA) is another systems aiming to reduce the gastric pouch
      has proved initial efficacy but are disappointing on the long term by a lack of persistence
      of the plicators. 7, 8 Endomina (Endo Tools Therapeutics, Nivelles, Belgium) is CE mark robot
      driven device that may be attached to an endoscope inside the body and allows remote
      manipulation of the arms of devices during a peroral intervention. It offers the
      possibilities of making transoral surgical full thickness sutures and may allow performing,
      via a transoral route, an intervention combining anastomoses reduction and gastric pouch
      reduction. It might be an effective treatment option for patients regaining weight after
      RYGBP and having a stretched pouch and or anastomosis.
    


Intervention name(s): Endomina
Intervention type(s): Device
Intervention description(s): Reduction of the gastro-jejunal anastomosis through sutures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Photobiomodulation in a Population Suffering From Fibromyalgia
Condition: Fibromyalgia; Chronic Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional

Summary: 
      The development of an integral and global treatment to improve the quality of life in those
      with fibromyalgia syndrome (FMS) is challenging, thus a whole body Photobiomodulation (PBM)
      therapy program is proposed as an effective option.
    

Detailed description: 
      This study is a randomized, placebo-controlled clinical trial. Participants will be recruited
      in a private care practice and randomized to receive either a whole body Photobiomodulation
      (PBM) therapy program or placebo. Primary outcomes will be pain (Numeric Pain Rating Scale;
      Widespread Pain Index; Symptom Severity Score), functionality (Fibromyalgia Impact
      Questionnaire; The Leisure Time Physical Activity Instrument), quality of soft tissue
      (elastography) and central sensitisation (pain pressure threshold and the Autonomic Symptom
      Profile). Secondary outcomes will be psychological factors (Pain Catastrophising scale, Tampa
      Scale, Self-Efficacy questionnaire). Assessments will be at baseline, after treatment 6,
      immediately following the last treatment (4 weeks), and then 2 weeks and at 3 monthly follow
      up intervals to 6 months after completion of treatment.
    

Intervention name(s): PBM; PLACEBO PBM
Intervention type(s): Device; Other
Intervention description(s): A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes; A placebo whole body red light will be carried out during 20 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this this study is to evaluate the lot-to-lot consistency of the liquid
      formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared
      to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered
      concomitantly with a combination childhood vaccine.
    


Intervention name(s): 2-dose oral live attenuated G1P[8] human rotavirus vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HRV vaccine; Diarrhoea; Rotavirus
A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in
      HCV positive patient volunteers
    


Intervention name(s): PF-00868554; PF-00868554; PF-00868554; PF-00868554; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300 mg BID; 450 mg BID; 100 mg BID; 300 mg TID; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison Across Multiple Types of Sleep Deprivation
Condition: Sleep Deprivation; Sleep Restriction
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      This study is designed to assess neurobehavioral performance, as well as genetic and other
      physiological changes associated with variations in timing and quantity of sleep.
    

Detailed description: 
      During a 1.5 week inpatient laboratory protocol, subjects will undergo one of four parallel
      sleep conditions. Subjects will be randomly assigned to each condition group. During their
      time in the laboratory, biological samples (e.g., blood) will be collected for genetic and
      other analyses, and sleep quantity and quality will be monitored. Additionally responses on
      neurobehavioral tests and surveys will be monitored for differences among the groups.
    

Intervention name(s): Controlled sleep
Intervention type(s): Behavioral
Intervention description(s): Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each participant will undergo one of four separate arms manipulating levels and timing of sleep in a controlled laboratory setting.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Neurobehavioral performance; Genetic
Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an
      open label post study follow-up, to assess the efficacy and safety of Movicol in the
      treatment of chronic constipation in children
    

Detailed description: 
      After a baseline period of 1 (one) week, subjects who had met the inclusion criteria were
      entered into the treatment phase of the study. Patients were randomised to receive either
      Movicol or matching Placebo for two (2) weeks. Following the treatment phase, patients
      underwent a two (2)-week placebo washout period prior to crossing over to receive the
      alternative treatment e.g. those patients who took Movicol were given the matching Placebo or
      vice versa on completion of the washout period for two (2) weeks.

      On completion of the double blind treatment phase, patients were given the option to
      participate in the eight (8) week open label post study follow-up. Patients who participated
      in the post study follow-up received Movicol.
    

Intervention name(s): Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)
Intervention type(s): Drug
Intervention MeSH terms: Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Effect of Monosodium Glutamate Supplementation on Gastric Emptying and Postprandial Nitrogen Kinetics
Condition: Healthy
Study type: Interventional

Summary: 
      There are receptors to free glutamate in the oral cavity and stomach that may mediate effects
      of this amino acid on gastrointestinal physiology. The investigators hypothesize that a
      chronic supplementation of monosodium glutamate (MSG) could modulate gastric emptying and the
      further metabolism of dietary protein in healthy subjects.
    


Intervention name(s): MSg supplementation; NaCl supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Basic Science
Keywords: Physiology
SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
Condition: Hypertension
MeSH terms: Renal Insufficiency; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in
      hypertensive patients with renal dysfunction
    


Intervention name(s): Aliskiren
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension, aliskiren, blood pressure, rennin
A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is determination of the event-free survival with and without
      Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific
      therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of
      death.
    

Detailed description: 
      This is a two-arm (group), open-label (all people know the identity of the intervention),
      prospective (a study in which the patients are identified and then followed forward in time
      for the outcome of the study) randomized (the study medication is assigned by chance),
      multi-center study. Approximately 385 patients will be enrolled in this study. Patients will
      be randomly assigned to treatment or observation group in a ratio of 1:1. The study duration
      from screening up to the study end is up to 27 weeks. Then the patients will be observed
      until the last included patient has completed a 30 month post observational phase. The
      patients in the treatment arm will receive 4 cycles of a therapy. Each cycle lasts for a 35
      days. Safety evaluations will include assessment of adverse events, vital signs, physical
      examination, electrocardiograms, and clinical laboratory tests.
    

Intervention name(s): Bortezomib; No intervention
Intervention type(s): Drug; Drug
Intervention description(s): Bortezomib will be administered as 1.6 mg/m2 per body surface area on the days 1, 8, 15, 22 for the duration of 4 therapy cycles.; Participants in the observation group will be observed and will not receive any consolidation therapy.
Intervention MeSH terms: Bortezomib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Bortezomib; PS341; Proteasome inhibitor; Consolidation therapy
Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis
Condition: Non-melanomatous Skin Cancer; Precancerous/Nonmalignant Condition
MeSH terms: Keratosis, Actinic; Skin Neoplasms; Precancerous Conditions; Keratosis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. Eflornithine with or without triamcinolone may be
      effective in preventing nonmelanoma skin cancer.

      PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or
      without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic
      keratosis.
    

Detailed description: 
      OBJECTIVES: I. Compare the safety and efficacy of eflornithine (DFMO) vs placebo as
      chemoprevention of non-melanoma skin cancer in patients with moderate to heavy actinic
      keratosis (AK). II. Determine whether this drug reverses AK in these patients. III. Determine
      whether triamcinolone reduces DFMO-induced skin irritation in these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
      randomized to 1 of 4 treatment arms. Arm I: Patients receive eflornithine (DFMO) topically
      and triamcinolone topically to forearms once daily. Arm II: Patients receive DFMO and placebo
      topically as in arm I. Arm III: Patients receive placebo and triamcinolone topically as in
      arm I. Arm IV: Patients receive 2 placebos topically as in arm I. Treatment continues for 6
      months in the absence of unacceptable toxicity. Patients are followed at 2 weeks.

      PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 1 year.
    

Intervention name(s): eflornithine; triamcinolone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Eflornithine; Triamcinolone
Primary purpose: Treatment
Keywords: basal cell carcinoma of the skin; squamous cell carcinoma of the skin; actinic keratosis
Efficacy and Safety Study of Stemchymal® in Polyglutamine Spinocerebellar Ataxia
Condition: Cerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the clinical trial is to study the therapeutic efficacy and safety of
      Stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized,
      double-blind, placebo-controlled study design. Eligible subjects will receive Stemchymal®
      through intravenous infusion.
    


Intervention name(s): Stemchymal®; Excipients
Intervention type(s): Biological; Procedure
Intervention description(s): Patients will receive Stemchymal® through intravenous infusion; Patients will receive excipients through intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Stem Cells; Adult Stem Cells; Spinocerebellar Ataxia; Steminent
Botox Injection in Treatment of Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as
      headaches for at least 15 days per month, of which 8 days have typical migraine features. In
      many cases, oral drug treatment has little effect.

      The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved
      in several primary headaches, including migraine, by facilitating release of inflammatory
      substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of
      acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.

      The purpose of the present study is to evaluate a new technique with injection of BTA using
      an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The
      goal is to relieve the migraine symptoms and develop an alternate treatment for cases where
      oral drug treatments fail.

      The main objective of the project is to determine the safety of this method of BTA injection
      in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives
      are to measure changes in headache attack parameters with this novel method.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Drug
Other intervention name(s): Botox; BTA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine with aura; Migraine without aura; Headache disorders; Botulinum Toxin Type A; Sphenopalatine Ganglion Block; Autonomic Nerve Block
Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic
      fibrosis transmembrane regulator protein. As a result mucus stagnation, obstruction and
      plugging take place in the respiratory and gastrointestinal tract, the biliary and pancreatic
      duct, and in the reproductive system. The objective of this study is to determine the safety
      and tolerability of 3 days of daily dosing of OligoG CF-5/20 versus placebo in healthy
      volunteers.
    


Intervention name(s): OligoG CF-5/20
Intervention type(s): Drug
Intervention description(s): Inhaled OligoG CF-5/20 will be given to healthy volunteers with different concentrations to test tolerability of the drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Digestive System Diseases; Genetic Diseases; Inborn; Respiratory Tract Diseases; Cystic Fibrosis; Lung Disease; Pancreatic Diseases