bioihbjkbjnl/mcl2 huggingface dataset:
Gene Therapy for Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of injecting VM202 in the
      leg muscle in patients with painful diabetic neuropathy (DPN). The study will also assess the
      potential of VM202 to reduce the pain associated with DPN.
    

Detailed description: 
      Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries
      a high risk of pain, trophic changes and autonomic dysfunction.

      Currently, there are no approved drugs or interventional strategies known to halt or reverse
      the progression of DPN. Treatments target pain reduction, physical function improvement,
      reduction of psychological distress, and quality of life improvements.

      There is currently no effective treatment for diabetic neuropathy, and good glycemic control
      is the only way to minimize the risk of occurrence. Clearly, it would be desirable to
      prevent, impede, or reverse the disrupting and often life-threatening manifestations of
      peripheral neuropathy by stimulating growth or regeneration of peripheral nerve axons.
    

Intervention name(s): VM202
Intervention type(s): Biological
Intervention description(s): Intramuscular injections in the calf on Day 0 and Day 14.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic; Neuropathy; peripheral; diabetes
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals'
      pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib
      and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of
      age.

      The study has 2 groups.

        -  One group of subjects will receive a 3-dose primary vaccination with the GSK
           Biologicals' pneumococcal conjugate vaccine (three different lots will be used and
           randomly allocated).

        -  The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.

      All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol
      posting deals with objectives & outcome measures of the primary study. The objectives &
      outcome measures of the Booster study are presented in a separate protocol posting (NCT
      number =00547248).
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
    

Intervention name(s): Pneumococcal conjugate vaccine GSK1024850A; Prevenar; Tritanrix-HepB; Hiberix; Polio Sabin.; Poliorix.
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3 Intramuscular injections.; 3 Intramuscular injections; 3 Intramuscular injections; Reconstituted with Tritanrix before injection; 3 oral doses.; 3 intramuscular injections
Other intervention name(s): DTPw-HBV; Hib; OPV; IPV
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immunogenicity; Safety; Pneumococcal vaccine; Pneumococcal disease
The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The aim of this study is to explore premeal protein-enriched bar effect in postprandial
      glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1)
      and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with
      type 2 diabetes.
    

Detailed description: 
      Fifteen healthy subjects and fifteen subjects with type 2 diabetes treated by diet and/or
      metformin, SU, DPP4 inhibitors will be recruited. Every subject will studied on 2 separate
      days in random order with 1-2 week intervals. These participants will consume protein
      enriched bar followed by a standardized high-glycemic-index breakfast in a hospital setting
      or breakfast followed protein enriched bar in a cross-over fashion. Blood sampling will be
      done at the moment of start of breakfast (0 min) and then 10, 20, 30, 60, 90, 120, 150, 180
      min. Plasma glucose levels, total/active GLP-1, GIP, insulin, C-peptide, glucagon will be
      measured. Incremental area under the curve (iAUC) of glucose level and hormone from 0 min to
      180 min will be calculated.
    

Intervention name(s): premeal protein-enriched bar intake; breakfast follows by protein bar
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Premeal protein bar is provided 30 minutes before breakfast. Participants have to eat protein bar with in 5 minutes with 150ml of water.; Participants have to eat provided breakfast within 30 minutes. It is recommended for participants to eat protein bar shortly after finishing breakfast within 5 minutes.
Other intervention name(s): premeal protein bar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: diabetes mellitus; incretin hormone; glucose level; GLP-1; GIP; premeal protein
Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      The objective of the present study was to compare the effects of a commercially available
      dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base, versus
      a control dentifrice, containing exactly the same ingredients apart from strontium chloride
      and potassium nitrate, on the instant and lasting relief of DH.
    

Detailed description: 
      Dentin hypersensitivity (DH) is a very common complaint that occurs in the general
      population. The intensity of the pain can be minor to very serious, which may prevent one
      from eating or performing ordinary oral hygiene practices. The most accepted mechanism by
      which DH occurs is hydrodynamic theory, which suggests that pain-producing stimuli cause
      rapid movement of fluid within the dentin tubules, as a result the free nerve endings, at the
      inner ends of the tubules or the periphery of the pulp, are excited and DH occurs. According
      to this theory, one approach to treat DH is reducing dentin tubule fluid movement through
      occluding open tubules. Strontium chloride was the first tubule-blocking ingredient used in
      dentifrice about fifty years ago and since that time a paucity of clinical studies have been
      carried out to test its effectiveness on DH. The other approach is to reduce the pulp nerve
      excitability by depolarizing the nerve endings, in which the most widely used material is
      potassium salts. Although there is limited clinical evidence that dentifrices containing
      strontium chloride or potassium nitrate alone, as the major desensitizing agent, has an
      effect on reducing DH, no clinical studies have shown the effectiveness of a dentifrice
      containing both strontium chloride and potassium nitrate in a silica base on alleviating DH.
    

Intervention name(s): control dentifrice; strontium chloride/potassium nitrate dentifrice
Intervention type(s): Other; Other
Intervention description(s): use the dentifrice to brush teeth twice a day for one minute for 3 days; use the dentifrice to brush teeth twice daily for 3 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dentifrice; potassium nitrate; strontium chloride
The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
Condition: Brief Description of Focus of Study Instead
MeSH terms: Vitiligo
Study type: Interventional

Summary: 
      Vitiligo is a relatively common acquired disorder of pigmentation characterized by the
      development of well-defined white macules on the skin. Biopsies of lesional skin reveal a
      loss of epidermal melanocytes. Lesions may occur in a localized or generalized distribution
      and may coalesce into large, depigmented areas. Given the contrast between the white areas
      and normal skin, the disease is most disfiguring in darker skin types and has a profound
      impact on the quality of life of both children and adults . Patients with vitiligo often
      experience stigmatization, social isolation, and low self-esteem. The therapys include
      topical steroids, topical immunosuppresant, systemic steroids, phototherapy, and surgery.

      The aim of this study is to investigate the effect of phototherpy and accupuncture combined
      therapy for vitiligo patients.
    


Intervention name(s): Surrounding needling+ phototherapy; phototherapy
Intervention type(s): Device; Device
Intervention description(s): Surrounding needling+ phototherapy; phototherapy
Other intervention name(s): phototherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment
Condition: Post Operative Pain; Total Knee Replacement
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Total knee arthroplasty is amongst the most painful procedures postoperatively, and pain
      management can be a challenge. Different measures have been introduced to manage severe
      postoperative pain int hese patients. Previous studies have investigated gabapentin in acute
      postoperative pain and demonstrated reducted pain, postoperative morphine consumption,
      morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct
      has yet to be investigated in total joint arthroplasty patients.
    

Detailed description: 
      The study was submitted to Health Canada and received the letter of no objection. A
      randomized, double-blind, placebo-controlled study. The randomization scheme will be prepared
      and will be done by the pharmacy department at McMaster University. Ninety patients
      undergoing primary knee arthroplasty will be recruited from the preoperative clinic.
      Forty-five patients in each population will be allocated to a gabapentin group and the other
      forty-five to a placebo group.
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days; Placebo will match the the gabapentin pill and will be given orally.
Other intervention name(s): Neurontin; Sugar pill
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee; arthroplasty; postoperative pain; gabapentin
Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects
Condition: Peanut Allergy; Immunotherapy; Pharmacokinetics
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract
      in healthy adults and children
    

Detailed description: 
      In this study, 15 non-peanut allergic children and adults will be enrolled. At three visits,
      each at least a day apart, the study product (dissolving film) containing approximately 60
      mcg of the major peanut allergen (Ara h 2), equivalent to approximately 1000 mcg of peanut
      protein, will be placed in one of three areas: the sublingual space, affixed to the buccal
      mucosa, and in the vestibular space. Concentrations of Ara h2 in saliva collected at several
      locations over several time points in the mouth will be analyzed by ELISA.
    

Intervention name(s): sublingual film with peanut extract
Intervention type(s): Biological
Intervention model: Single Group Assignment
Intervention model description: Open label, crossover, local pharmacokinetics study
Masking: None (Open Label)
Primary purpose: Other
Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms
Condition: Post-menopausal Vasomotor Symptoms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose
      study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will
      be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be
      dosed for 14 days.
    


Intervention name(s): BAY3427080; Placebo (for BAY3427080)
Intervention type(s): Drug; Drug
Other intervention name(s): NT-814
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hot flashes; Post-menopausal
Mitochondria in HIV and Aging (MITO+)
Condition: Human Immunodeficiency Virus (HIV); Mitochondrial Diseases
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Mitochondrial Diseases
Study type: Observational

Summary: 
      Older adults with human immunodeficiency virus (HIV) and a long history of antiretroviral
      therapy have more mitochondrial dysfunction- the cells that help them make energy. This
      dysfunction in mitochondria may lead to symptoms of muscle fatigue, physical function
      impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar
      age and body mass index (BMI). Furthermore, the investigators hypothesize that the older
      antiretroviral therapy (ART) of tenofovir disoproxil fumarate (TDF) is associated with
      greater impairment in mitochondrial function than the newer agent, tenofovir alafenamide
      (TAF).
    


Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected participants will be those living with HIV, between the ages of 50-75 years,
        recruited from the University of Colorado Infectious Diseases Group Practice HIV-uninfected
        participants were previous enrolled and completed an IRB approved protocol (historical
        database).
Clinical Assessment of Spinal Muscular Atrophy Type II and III (SMA Europe)
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Spinal Muscular Atrophies of Childhood; Atrophy
Study type: Interventional

Summary: 
      The aim of this project is to establish a network of clinical teams including the major
      neuromuscular centers in Europe.

      We plan to work together to find the best common outcome measures for the following
      multicenter therapeutic trials.
    

Detailed description: 
      16 patients (6 ambulant and 10 non ambulant), affected by type II and type III SMA will be
      enrolled and assessed at baseline and 6 and 12 months later. Non ambulant patients will be
      assessed using the modified version of the Hammersmith Motor Functional Scale while ambulant
      patients will be assessed using the extended module of the Hammersmith Motor Functional Scale
      and timed items, the 6 minute walk and a step activity monitor. All patients will also be
      assessed using the Motor Function Measure (MFM), that covers the whole range of activities
      for both ambulant and non ambulant patients. All measures will undergo a process of
      validation including inter observer reliability. This information will be most valuable for
      any future trial and will make the groups involved ready to participate to future
      collaborative studies saving a lot of time on the preliminary aspects (validation,
      reliability, training) that will be fulfilled by the present study. The study will also
      provide natural history data for a 12 month period on patients with SMA II and III.
    

Intervention name(s): Functional tests; Functional tests
Intervention type(s): Other; Other
Intervention description(s): The ambulant patients will perform
MFM (20 items)
Hammersmith modified module - MHMFS
Timed tests (time to rise from the floor,...)
6 minute walk test
PedsQL - neuromuscular module; The non-ambulant patients will perform:
MFM (20 items)
Hammersmith modified module - MHMFS
Upper Limb Functional Items
Egen Klassifikation 2 questionnaire - EK2
PedsQL questionnaire - neuromuscular module
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: outcome measures; spinal muscular atrophy
Vilazodone for Separation Anxiety Disorder
Condition: Separation Anxiety Disorder
MeSH terms: Anxiety Disorders; Anxiety, Separation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a
      receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week
      treatment course.
    

Detailed description: 
      In this randomized clinical trial, 40 adults with a principal diagnosis of Adult Separation
      Anxiety Disorder (ASAD) and no major depression or substance abuse disorders will be
      randomized to 12 weeks of treatment with vilazodone (flexibly dosed) or matched pill placebo.
      Outcome will be assessed in respect to symptomatic improvement, quality of life, adverse
      events and safety.
    

Intervention name(s): Vilazodone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg to 40mg per day for 12 weeks; One to two pills per day for 12 weeks
Other intervention name(s): Viibryd (brand name)
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adult separation anxiety disorder; ASAD
A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine
Condition: Menstrual Migraine
MeSH terms: Migraine Disorders; Premenstrual Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this phase 2 Proof.of Concept study is to evaluate the efficacy and safety
      of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine
      occurring between Day -2 and Day 5 of the menstrual cycle. Patients will be taking
      Sepranolone or Placebo (blinded to patient and study doctor) during the two week preceding
      the menstruation for three menstrual cycles. Effect (change from baseline) will be assessed
      by comparison of symptoms recorded daily by the patients using an electronic diary using
      validated scales for assessment of menstual migraine symptoms.

      Sepranolone is identical to an endogenous steroid.
    

Detailed description: 
      The objective of this phase 2 Proof-of-Concept study is to evaluate the effect and safety of
      two doses of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women
      with migraine occurring between Day -2 and Day 5 of the menstrual cycle in comparison to
      placebo. Study treatment will be self-administrated as subcutaneous injections during the
      luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of
      symptoms recorded daily by the patients using an electronic migraine diary and a validated
      rating scale for assessment the physical and functional impact of menstrual migraine symptoms
      (MPFID). Preceding the treatment period, the diagnosis of Menstrual Migraine will be
      established by verifying menstrual migraine in at least two out of three menstrual cycles of
      daily symptom ratings by the patients. This period will also constitute the baseline data.
      The effect of study medication will be assessed as the change in symptoms from baseline to
      during treatment. The reduction in average number of menstrual migraine days per menstrual
      cycle during the treatment period cycles vs. the three menstrual cycles of baseline will
      constitute the primary endpoint.

      The study will also include a follow-up (no treatment) cycle before patients final visit.

      The study is conducted in three European countries (Sweden, Finland and Denmark) and will
      randomize 84 patients.
    

Intervention name(s): Sepranolone injection low dose; Sepranolone injection high dose; Placebo injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous (SC) administration; Subcutaneous (SC) administration; Subcutaneous (SC) administration
Other intervention name(s): UC1010; UC1010
Intervention MeSH terms: Pregnanolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention