bioihbjkbjnl/mcl2 huggingface dataset:
Personalized Feedback for Smokers With Elevated Anxiety Sensitivity
Condition: Anxiety Disorders; Anxiety; Tobacco Dependence; Smoking, Cigarette; Smoking, Tobacco
MeSH terms: Hypersensitivity; Tobacco Use Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This project will develop and refine a computer-delivered integrated Personalized Feedback
      Intervention (PFI) that directly addresses smoking and anxiety sensitivity (AS). The PFI will
      focus on feedback about smoking behavior, AS, and adaptive coping strategies.
    

Detailed description: 
      The primary goal of the research study is to investigate the efficacy of a brief,
      personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and
      anxiety sensitivity (AS) to reduce smoking, increase quit attempts, reduce perceived barriers
      to cessation, reduce AS and negative affective symptoms, and increase adaptive coping skills
      compared to a smoking information only control. To address this aim, we will implement a
      randomized controlled trial that will employ a longitudinal experimental design and involve
      three stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a
      pre-intervention assessment (eligibility), random assignment to a one-session
      computer-delivered intervention (PFI versus smoking information control with no personalized
      feedback), and a post-intervention assessment; (c) 1-month follow-up. Assessments will
      include a multi-method approach, including biological, behavioral, and self-report methods.
    

Intervention name(s): Personalized Feedback Intervention; Smoking Information Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Personalized Feedback Intervention for smoking and anxiety.; Smoking Information with no personalized feedback.
Other intervention name(s): PFI; Control; Clearing the Air Pamphlet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: If participant meets eligibility criteria, the participant will be randomly assigned to complete a computer-delivered intervention: either the (a) Personalized Feedback Intervention or (b) smoking information control.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anxiety Sensitivity; Tobacco; Smoking; Anxiety; Feedback; Stress
Effectiveness of Dry Needling and Stretching in People With Fibromyalgia.
Condition: Dry Needling; Stretch; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Effectiveness of dry needling and stretching on joint range and myofascial pain at the
      cervical level in people with fibromyalgia
    

Detailed description: 
      A randomised clinical trial will be conducted in which there will be 3 groups. One control
      group and 2 experimental groups; one of them will undergo dry needling of the upper trapezius
      fibres and the other will undergo passive stretching of the upper trapezius fibres. Both
      groups will have the joint range of cervical lateral tilt, pain measurement by algometer and
      visual analogue scale (VAS) measured. All these measurements will be taken before and after
      treatment. The participants of the study will be people who have been diagnosed with
      fibromyalgia at least 6 months before the start of the study, who are members of the
      FIBROFAMUR association. Association of Fibromyalgia, Chronic Fatigue, Rheumatic and
      Musculoskeletal Diseases of Murcia. The data collected will be: socio-demographic data, age,
      sex, measurement of cervical joint range using a goniometer and measurement of pain using an
      algometer and visual analogue scale (VAS). As undesirable effects, in exceptional cases, the
      dry needling technique may produce residual discomfort in the puncture area that may last
      between 1 and 3 days.
    

Intervention name(s): Dry needling on cervical trigger point
Intervention type(s): Other
Intervention description(s): One experimental group will receive dry needling treatment on the upper trapezius fibres using the Hong technique and the other experimental group will receive passive muscle stretching treatment on the upper trapezius fibres.
Other intervention name(s): Trapezius muscle stretch
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry needling; Stretch; Fibromyalgia; Physical Therapy
Effects of Orotic Acid Derivatives With or Without Glutathione on Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      The purpose of this study is to learn if two nutritional supplements, Orotic Acid and
      Glutathione will have any effect on the immune system response and if there will be any
      effect on the symptoms of seasonal allergies. It is our thinking that they will have an
      positive effect.
    

Detailed description: 
      Current therapy for most immune-based diseases center around the use of anti inflammatory
      agents, many of which have unpleasant or dangerous side effects. Allergic rhinitis affects
      over 40 million Americans and its morbidity results from a combination of physical and
      psychological symptoms. The primary immunopathology has been defined as an imbalance of
      TH1/TH2 cytokines production resulting in increased allergen-specific IgE production, mast
      cell activation and eosinophil recruitment/activity. Metallic salts of orotic acid (OR), a
      natural intermediate in pyrimidine nucleic acid synthesis have been utilized to improve the
      signs and symptoms of a variety of maladies including the common cold, allergies and as
      preventatives for cancer and heart disease. Recent studies have reported that moderate doses
      of OR can mitigate or prevent endocrine and subjective psychological stresses in an acute
      laboratory stress model. All these findings lead us to hypothesize that OR salts
      administration will alleviate or eliminate the signs and symptoms associated with seasonal AR
      through a protective effect that involves direct anti-inflammatory immune effects and/or
      immunomodulation that include leukocyte trafficking, immunoregulatory cytokine balance and/or
      decrease inflammatory cell activity.
    

Intervention name(s): Orotic acid and Glutathione-(Nutritional Supplements)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: allergic rhinitis
Effects of Genistein in Postmenopausal Women With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The 15-25% of the population of developed countries suffers for metabolic syndrome. It is
      associated with a 2-4 fold increase in cardiovascular morbility and mortality and with a 5- 9
      fold increase in developing type II diabetes. MS prevalence increases after the onset of
      menopause, because of estrogen deficiency. It is still not clear if menopause itself
      increases the risk of cardiovascular diseases in al women or only in those that develop MS.
      Many MS patients that show slight modification in cardiovascular and metabolic parameters are
      not generally pharmacologically treated since diabetes or alteration in the lipid profile are
      not evidenced. In this respect it is of importance to develop new therapeutic strategies to
      prevent and treat MS. Genistein (4,5,7-trihydroxyisoflavone), shown a potentially preventive
      role on the cardiovascular apparatus in post-menopausal women, may be termed as selective ER
      modulator (SERM), since it reveals both ER-alpha full agonist and ER-beta partial agonist
      activity.
    

Detailed description: 
      The investigators studied whether genistein may represent an efficacious and safe alternative
      for reducing vascular risk in postmenopausal women with metabolic syndrome. The clinical
      study was a randomized, double-blind, placebo-controlled study involving 150 patients with
      metabolic syndrome. After a 4-week stabilization on a standard fat-reduced diet, participants
      were randomly assigned to receive either phytoestrogen genistein (54 mg/day) or placebo for 6
      months. At baseline and following treatment fasting plasma glucose, insulin, insulin
      resistance (HOMA-IR), lipid concentrations, plasma total homocysteine, leptin, adiponectin
      and visfatin were measured. Bioimpedentiometric and nutritional analysis, as well as a safety
      assessment of the endometrium and vagina were also performed.
    

Intervention name(s): Genistein; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Genistein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: menopause; pre-diabetes
Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
Condition: Pandemic Influenza; Influenza A Virus Infection; Orthomyxoviridae Infections
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose
      schedule in immunologically naïve adults against one vaccine formulation without adjuvant in
      terms of tolerance and immunogenicity

      Primary Objective:

      To describe the safety profile and immunogenicity following each injection.
    


Intervention name(s): A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant; A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant; A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant; A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant; A/H5N1 inactivated, split-virion influenza vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pandemic influenza; Avian influenza; Orthomyxoviridae Infections; A/H5N1
Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Mechanism-based choice of therapy for pain:

      Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?
    


Intervention name(s): Amitriptyline; Topiramate
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks; For the first 5 days of treatment 25mg is prescribed and should be ingested in one evening dose. For another 5 days, 25g dose should be taken twice a day (morning and evening). For the next 5 days, morning dose will be 25mg; evening dose will be 50mg. For the remaining 6 weeks of treatment, a dose of 50mg twice a day will be advised
Intervention MeSH terms: Topiramate; Amitriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: migraine patients
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, the concentration of antibody to the vaccine one year, three and five years
      after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine
      GSK134612 in a previous study (whose objectives & outcome measures are presented in a
      separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune
      response of a booster dose of vaccine GSK134612 administered at 5 years post-primary
      vaccination will also be evaluated. In addition, the immune response to a dose of vaccine
      GSK134612 administered to age-matched controls not previously given a meningococcal vaccine
      will be evaluated.

      This protocol posting has been updated further to protocol amendment 2, dated 28 october
      2010. The sections impacted are summary, study design, outcome measures, intervention, and
      eligibility criteria.
    

Detailed description: 
      GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate
      vaccine has been shown to be well tolerated and immunogenic in toddlers.

      The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3
      years and 5 years post-administration of one dose or two doses of GlaxoSmithKline (GSK)
      Biologicals' meningococcal vaccine GSK134612 when given to healthy toddlers 9-12 months of
      age. To evaluate, the safety and immunogenicity of a booster dose of GSK134612 administered
      to all eligible subjects at 5 years after the primary vaccination. To evaluate the safety and
      immunogenicity in a new group of subjects aged 5-6 years (naive control group) who will
      receive a single dose of vaccine GSK134612.
    

Intervention name(s): Meningococcal vaccine GSK134612
Intervention type(s): Biological
Intervention description(s): One dose, as intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Safety; Vaccines, conjugate; Immunogenicity; Meningococcal vaccine; Booster vaccination; Primary vaccination; Neisseria meningitides; Toddlers; Humans; Meningococcal disease
Effects of an Oxymizer on Endurance Time in Patients With Chronic Lung Diseases
Condition: COPD; Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long
      term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir,
      the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.

      The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to
      the blood oxygenation during exercise testing. Given that the "endurance time" is very
      sensitive for little changes in exercise capacity, this test will be used to show the
      difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration
      at 70% of peak Watt and oxygenation.

      The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and
      heart rate.
    


Intervention name(s): Oxymizer; conventional nasal cannula
Intervention type(s): Device; Device
Intervention description(s): Using first the Oxymizer and 24 h later the conventional nasal cannula.; Using first the conventional nasal cannula and 24h later the Oxymizer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxymizer; endurance time; exercise test; nasal cannula; COPD; ILD; oxygenation
Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate whether armodafinil treatment is more
      effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the
      negative symptoms of schizophrenia
    

Detailed description: 
      This study was designed and was powered to evaluate the efficacy and safety of armodafinil
      treatment at dosages of 150, 200, and 250 mg/day compared with placebo over 24 weeks as an
      adjunctive therapy to antipsychotic medication (olanzapine, oral risperidone, or
      paliperidone) in adults with schizophrenia who were clinically stable at study entry.
      Specifically, the effects of armodafinil treatment on the negative symptoms of schizophrenia
      were the primary assessment in this study.
    

Intervention name(s): armodafinil; placebo; armodafinil; armodafinil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 150 mg/day armodafinil; placebo; 200 mg/day armodafinil; 250 mg/day armodafinil
Other intervention name(s): R-modafinil; CEP-10953; R-modafinil; CEP-10953; R-modafinil; CEP-10953
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone
      supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated
      with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of
      patients with Multiple Sclerosis have Vitamin D deficiency.

      Rebif® is known to be an effective treatment for slowing down the progression of MS. The
      purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any
      benefit on the progression of MS compared to Rebif® and placebo.

      Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging
      (MRI). The planned study treatment duration for each study participant is 48 weeks, and the
      study consists of a total of 8 visits. Study participants who are already passed Week 48 at
      the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a
      total of 12 visits.

      During the study, the participant will undergo physical examination, neurological
      assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).
    


Intervention name(s): VigantOL oil plus interferon beta-1a (Rebif); Placebo plus interferon beta-1a (Rebif); Interferon beta-1a (Rebif®) alone
Intervention type(s): Drug; Drug; Biological
Intervention description(s): VigantOL oil 6,670 International Units per day (IU/d) (167 microgram per day [mcg/day]), was administered orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) administered orally for 44 weeks on top of Rebif 44mcg three times per week (tiw) administered subcutaneously.; Matching placebo daily, orally administered matched placebo for 48 weeks on top of Rebif 44 mcg tiw.; Rebif® 44 mcg tiw, sub-cutaneously alone.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Rebif; VigantOL® oil; Vitamin D; Add-on treatment
Intra-articular Dexmedetomidine Versus Neostigmine After Knee Arthroscopy (a Comparative Study)
Condition: Knee Injuries
MeSH terms: Knee Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Knee arthroscopy is a minimally invasive day case procedure which may be done for diagnosis,
      meniscectomy or debridement. Arthroscopic surgery is associated with a variable degree of
      postoperative pain, which is caused by an irritation of free nerve endings of the synovial
      tissue, anterior fat pad, and joint capsule due to surgical excision and resection
    

Detailed description: 
      Many studies were done using different intra-articular agents as local anesthetics, opioids,
      ketamine and alfa2- adrenergic agonists for prevention and treatment of pain after knee
      surgeries.

      Dexmedetomidine is a potent and highly selective alfa2-adrenoreceptor agonist. It has
      sedative-hypnotic, anxiolytic, analgesic, anesthetic and sympatholytic effects.
      Intra-articular dexmedetomidine was used in several studies to enhance postoperative
      analgesia after knee arthroscopy with an increased time to first analgesic request and a
      decreased need for postoperative analgesia Neostigmine is an anticholinesterase and also has
      antinociceptive effects when administered intrathecally or peripherally.
    

Intervention name(s): dexamedetomidine; neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): intraarticular injection of 1µg/kg dexametomidine +18ml 0.25%bubivacaine in a total volume of 20 ml.; intraarticular injection of 0.5mg/dose neostigmine +18ml 0.25%bubivacaine in a total volume of 20 ml.
Other intervention name(s): precedex; dexamedetomidine Hcl injection; prostigmine
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly allocated to one of two groups each including 50 patients; the group received either intraarticular dexametomidine or neostigmine .
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: knee arthroscopy; dexmedetomidine; neostigmine
Intracutaneous Delivery of Varied Dose Volumes of Saline
Condition: Influenza
Study type: Interventional

Summary: 
      This study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of
      saline from the FLUGEN 101.2 investigational microneedle-based device.
    

Detailed description: 
      An intracutaneous delivery device will be evaluated for ability to inject various volumes of
      saline into subjects skin.
    

Intervention name(s): FLUGEN 101.2 device
Intervention type(s): Device
Other intervention name(s): FLUGEN 101.2
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: microneedle-based delivery; hollow microneedle; intracutaneous; drug delivery