bioihbjkbjnl/mcl2 huggingface dataset:
Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Metabolic Diseases; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of docosahexaenoic fatty acid and
      eicosapentaenoic fatty acid supplementation for six months on the inflammation state as well
      as the process of muscular regeneration and the metabolic disorders like obesity and insulin
      resistance in patients with Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy
      (DMB) compared to those receiving placebo.
    

Detailed description: 
      DMD and DMB are X-linked diseases caused by mutations in the DMD gene, these mutations have
      important functional and structural consequences in skeletal muscle. In muscle fiber is
      observed inflammation and necrosis as a result of lost regenerative capacity. The muscle
      fibers can be replaced by connective and adipose tissue. In a previous study the
      investigators identified that 50% of Duchenne and Becker patients in the range of thirteen
      years old have obesity. In addition, these patients (N=66) have hyperinsulinemia (53.7%) and
      insulin resistance (48.5%). It is well known that obesity, hyperinsulinemia and insulin
      resistance have a inflammatory background.

      It has been demonstrated that eicosapentaenoic fatty acid (EPA) and docosahexaenoic fatty
      acid (DHA) exhibit anti-inflammatory properties and have beneficial effects on obesity,
      hyperinsulinemia and insulin resistance in children and adolescents.

      Objective: Determine the effect of EPA and DHA on inflammation, obesity and insulin
      resistance in patients with DMD/DMB compared to those receiving placebo.
    

Intervention name(s): EPA and DHA; Placebo Comparator
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.; Placebo capsules will contain gelatin and sunflower oil. Fatty acid composition is as follows: lauric (C12:0), 0.19%; myristic (C14:0), 0.29%; palmitic (C16:0), 7.59%; palmitoleic (C16:1), 0.25%; stearic (C18:0), 3.49%; oleic (C18:1), 31.08%; linolenic (C18:3), 1.13%; linoleic (C18:2), 55.64%; DHA 0.02%; arachidic (C20:0), 0.30% and arachidonic (C20:4), 0.01%.
Other intervention name(s): omega 3 fatty acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Muscular Dystrophy; Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Omega 3; Eicosapentaenoic fatty acid; Docosahexaenoic fatty acid
W0265-104: A Single-Center, Evaluator-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial Evaluating the Photoallergic Potential of Topically Applied Clindamycin Phosphate 1.0% and Tretinoin 0.025% (CT Gel) in Healthy Volunteers
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single-center, evaluator-blinded, randomized, placebo (vehicle) -controlled phase
      I study to evaluate the photoallergic potential of Clindamycin-Tretinoin Gel. The design
      consisted of the following periods: screening, induction, rest, challenge, and rechallenge
      (if indicated). Induction visit 1 was to occur within 5 days of screening visit 2. The study
      expected to enroll approximately 62 healthy adult volunteers. Subjects were to receive
      repeated 24-hour study patch applications; after patch removal, the sites were irradiated
      with ultraviolet B light (UVB) and visible light (VIS) during the induction period
      (consisting of 6 consecutive induction phases), and ultraviolet A light (UVA)/ UVB and VIS
      during the challenge and rechallenge periods. Each application site was observed
      approximately 1, 24, 48, and 72 hours later for signs of inflammation.
    

Detailed description: 
      This was a single-center, evaluator-blinded, randomized, placebo (vehicle) -controlled phase
      I study to evaluate the photoallergic potential of Clindamycin-Tretinoin Gel. The design
      consisted of the following periods: screening, induction, rest, challenge, and rechallenge
      (if indicated). Induction visit 1 was to occur within 5 days of screening visit 2. The study
      expected to enroll approximately 62 healthy adult volunteers. Subjects were to receive
      repeated 24-hour study patch applications; after patch removal, the sites were irradiated
      with ultraviolet B light (UVB) and visible light (VIS) during the induction period
      (consisting of 6 consecutive induction phases), and ultraviolet A light (UVA)/ UVB and VIS
      during the challenge and rechallenge periods. Each application site was observed
      approximately 1, 24, 48, and 72 hours later for signs of inflammation.
    

Intervention name(s): clindamycin1%/tretinoin 0.025% gel; vehicle gel
Intervention type(s): Drug; Drug
Intervention description(s): clindamycin1%/tretinoin 0.025% gel; vehicle gel
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Comparison of Two Different Videolaryngoscopes Regarding Hemodynamic Parameters in Open Heart Surgey
Condition: Intubation;Difficult; Coronary Bypass
Study type: Interventional

Summary: 
      Endotracheal intubation increased the heart rate and blood pressure in normal patients. Open
      heart surgery patients are more prone to hemodynamic variability. In addition, they have
      increased possibility for difficult intubation The heart rate and blood pressure increase
      impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly
      effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in
      normal and difficult airway. This study aimed to compare two laryngoscopes regarding
      hemodynamic parameters and intubation times in coronary bypass surgery.
    

Detailed description: 
      Aim: Endotracheal intubation increased the heart rate and blood pressure in normal patients.
      Open heart surgery patients are more prone to hemodynamic variability. In addition, they have
      increased possibility for difficult intubation The heart rate and blood pressure increase
      impaired the oxygen consumption. This was previously shown that Videolaryngoscopes minimaly
      effects the vital signs in normal patients. Videolaryngoscopy inreased the rate of success in
      normal and difficult airway. This study aimed to compare two laryngoscopes regarding
      hemodynamic parameters and intubation times in coronary bypass surgery.

      Material and methods: 50 patients undergoing coronary bypass surgery enrolled in this
      prospective.randomized study. Demogaphic variables and airway characteristics of patients
      were recorded. Glottic visulisation and intubation time were recorded. Systolic blood
      pressure, diastolic blood pressure, mean arterial pressure and heart rate were recorded 2
      minutes intervals before intubation, after intubation during 10 minutes.
    

Intervention name(s): airtraq; storz
Intervention type(s): Device; Device
Intervention description(s): airtraq videolaryngoscope; storz videolaryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: intubation; airtraq; open heart surgery; hemodynamic parameters
Oral Zinc Therapy for the Prevention of Mucositis
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional
Phase: Phase 4

Summary: 
      Zinc is an intracellular mineral with important enzymatic cofactor activities for cell
      membrane stability, DNA and RNA structure. Zinc deficiency is associated with delayed wound
      healing and immune dysfunction. In patietns with hematological malignancies an inverse
      correlation was found between disease stage and zinc level. Patients undergoing high dose
      chemotherapy for hematologic malignancies are predisposed to develop oral and
      gastrointestinal complications, in particular oral mucositis. These patients may have
      relative zinc deficiency, therefore oral zinc therapy may be benefical in the prevention of
      these complications.
    

Detailed description: 
      Patients candidate for High dose chemotherapy with stem cell support for the diagnosis of
      relapsed/resistant Hodgkins or NHL or MM will be screened for enrollment in the study.

      Patients will be randomized in a 1:1 ratio to therapy with either zincol 1 Tab TID or placebo
      1 Tab TID.

      Therapy will start on the morning before commencing chemotherapy and will continue untill the
      first of either discharge day or day 21.

      Response assesment will include:

        1. Mucositis assesment using NCI-CTC and OMAS scores- to be done eod from baseline and
           untill day 21/discharge day if before day 21

        2. Evaluation of zinc levels in the serum, PBMC and saliva- to be done at baseline, day 6/7
           and day 21/discharge day if before day 21.

        3. Collection of clinical outcome data regarding infectious complications including-
           presence and length of febrile neutropenia,use of antibacterial and antifungal
           medications,
    

Intervention name(s): Zinc; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Zincol 1 Tab TID from day -6/-7 until discharge; Oral placebo 1 Tab TID from day -6/-7 until discharge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Stem cell transplantation; Mucositis; Zinc
Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix
Condition: Keloid; Scleroderma, Localized; Acne Keloidalis; Scars; Granuloma Annulare
MeSH terms: Granuloma; Scleroderma, Systemic; Scleroderma, Diffuse; Keloid; Skin Diseases; Granuloma Annulare; Acne Keloid; Scleroderma, Localized
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research study will evaluate the effectiveness of high dose UVB light therapy in the
      treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn
      scars, granuloma annulare or related conditions.
    

Detailed description: 
      Keloid, scleroderma, acne keloidalis nuchae, and burn scars are all characterized by
      collagenous thickening of the skin resulting in superficial and deep cutaneous sclerosis.
      Treatments for these disabling conditions are inadequate at present. Recently, in
      non-controlled studies, UVA1 was shown to induce improvement in patients with scleroderma,
      granuloma annulare and urticaria pigmentosa.

      However, UVA1 is unable to penetrate pigmented skin at an effective level to activate matrix
      metalloproteinases (MMPs). The investigators' preliminary data show that high dose UVB (160
      mJ/cm2) will penetrate pigmented skin and activate the cellular pathways necessary to
      stimulate MMPs. They postulate, therefore, that in pigmented skin, higher than usual UVB
      doses can improve these fibrosing skin conditions safely through collagenase-mediated removal
      of excess dermal collagen via activation of MMP pathways.

      The purpose of this research project is to study the effectiveness of high dose UVB
      (290-320nm at up to 320mJ/cm2) irradiation for the treatment of skin conditions with altered
      dermal matrix in patients with increased skin pigmentation. These disorders include but are
      not limited to keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn
      scars, and granuloma annulare. Up to fifty patients with one of these diagnoses or related
      conditions will receive UVB irradiation up to 5 times per week, for 16 weeks.
    

Intervention name(s): UVB Irradiation
Intervention type(s): Procedure
Intervention description(s): A dose of up to 320 mJ/cm2 from a UVB irradiation device will be administered at maximum 5 times per week for 16 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: UVB; keloid; scleroderma; acne keloidalis nuchae; scars; granuloma annulare
Stroke Prevention in Sickle Cell Anemia (STOP 2)
Condition: Blood Disease; Cerebrovascular Accident; Anemia, Sickle Cell
MeSH terms: Stroke; Anemia; Anemia, Sickle Cell; Hematologic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine how long blood transfusions are needed for primary stroke prevention. Also, to
      determine the duration of risk associated with abnormal transcranial Doppler ultrasound (TCD)
      and to determine the specificity of the stroke risk model developed in STOP 1 in patients
      with abnormal TCD measurements.
    

Detailed description: 
      BACKGROUND:

      Without intervention, 11 percent of children with sickle cell anemia will sustain a stroke
      before the age of 20. The STOP 2 follows on the recently completed NHLBI trial, Stroke
      Prevention Trial in Sickle Cell Anemia (STOP 1), which found that patients at high risk for
      stroke could be identified using transcranial Doppler (TCD) ultrasound, and that the
      incidence of stroke could be reduced by 90 percent in those children by periodic blood
      transfusion for at least 36 months. However, chronic intermittent blood transfusions are
      cumbersome, expensive and associated with morbidity from iron overload. Thus, this study to
      determine if transfusion can be safely halted after 30 months of treatment is critically
      important to the continued clinical care of patients with sickle cell disease at risk for
      stroke.

      DESIGN NARRATIVE:

      In this multicenter, randomized clinical trial, 100 children will be randomized to continue
      to receive periodic transfusion therapy and 50 to discontinue receiving periodic transfusion
      therapy. The primary endpoint will be the reversion of the transcranial Doppler velocity
      levels to greater than 200 cm/second, indicating return of increased risk for overt stroke.
      Recruitment will be in two phases. Phase I will include those patients who began transfusions
      before April 1, 1999. These will come mainly from the STOP 1 cohort. Those who begin
      transfusions after April 1, 1999 but before April 1, 2001 will be eligible for Phase II of
      recruitment. All patients will receive quarterly TCD examinations. Patients who revert to
      high risk will be offered return to transfusion. The overall design includes a three month
      start-up, the two phases of recruitment (established STOP patients and new patients) for a
      total of 36 months, 18 months of observations after recruitment ends and then 3 months of
      wrap-up.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): Blood Transfusion
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Prevention
Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer
Condition: Cervical Cancer; Nasopharyngeal Cancer; Chemotherapy-induced Nausea and Vomiting; Radiation-Induced Nausea and Vomiting; Antiemetic
MeSH terms: Uterine Cervical Neoplasms; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to evaluate the antiemetic effect of adding fosaprepitant to biplet regimen of
      tropisetron and dexamethasone for patients with cervical cancer or nasopharyngeal cancer
      treated with radiotherapy and concomitant weekly cisplatin chemotherapy in a south Chinese
      cohort.
    

Detailed description: 
      The study was designed as a prospective,randomized, single-blind control clinical trial
      aiming to assess the efficacy and safety of fosaprepitant combined with tropisetron and
      dexamethasone in preventing nausea and vomiting during 5 weeks of fractionated radiotherapy
      and concomitant weekly low-dose cisplatin chemotherapy in patients with cervical cancer or
      nasopharyngeal cancer.
    

Intervention name(s): Fosaprepitant; tropisetron; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In fosaprepitant group, patients would receive fosaprepitant combined with tropisetron plus dexamethasone to prevent chemoradiotherapy-induced nausea and vomitting while the control group would only be given tropisetron and dexamethasone .; All patients received tropisetron 5mg on day 1.; .All patients received dexamethasone 5mg infusion on day 1 and oral dexamethasone 3.75 mg once a day on day 2-3.
Other intervention name(s): shanqi; luoting; xiluoan
Intervention MeSH terms: Dexamethasone; Fosaprepitant; Aprepitant; Tropisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the present study is to assess the influence of the administration of low dose
      hCG on the endometrium. The study is a randomised trial where 2 groups of patients,
      undergoing a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization,
      are studied. In addition to the histological findings, by analysing the correlation of the
      morphological pattern and gene expression profile of human endometrium on the day of oocyte
      retrieval in patients of both treatment groups, the investigators want to study the
      implantation potential.
    


Intervention name(s): human menopausal gonadotropin
Intervention type(s): Drug
Intervention description(s): 200 IU per day in the late follicular phase
Intervention MeSH terms: Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: infertility; ICSI; hCG; infertility treatment
Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions
Condition: Cervical Lesions
MeSH terms: Uterine Cervical Diseases
Study type: Interventional

Summary: 
      The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA
      approved and marketed universal dental adhesive formulation in adult noncarious cervical
      lesions using self-etch and selective etch approaches.

      The hypothesis is that using a selective enamel etch with this universal adhesive will
      enhance the restoration margin performance.
    

Detailed description: 
      The purpose of this prospective clinical trial will be to evaluate the efficacy of a newly
      formulated universal dental adhesive formulation in adult noncarious cervical lesions using
      self-etch and selective etch approaches.

      Thirty-three patients with at least two non-carious cervical lesions will receive one
      restoration utilizing the self-etch universal adhesive with no separate enamel etching and
      another restoration utilizing the universal adhesive and a a selective etch protocol in which
      in which enamel is etched with 37% phosphoric acid.

      After a screening/baseline visit at which the restorative procedures listed above will
      conducted, the patient will be seen at recall visits after approximately 6, 12 and 24 months
      to observe sensitivity, retention, marginal discoloration and marginal adaptation.
    

Intervention name(s): Self etch enamel etching; selective etch protocol; Adhese Universal
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel.; Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group.; the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions
Other intervention name(s): Adhese Universal; Ivoclar Vivadent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: noncarious cervical lesions; dental adhesive; retention; enamel margin discoloration; self etch; selective etch procedures
Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects
Condition: Human Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      Several studies have shown poor immune response to conventional influenza vaccines in
      HIV-infected individuals. This study was conducted expecting the more potent immunogenicity
      of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected
      adults.
    

Detailed description: 
      During the 2011/2012 pre-influenza season, three vaccines were used in HIV-infected adults
      (18 to 60 years): inactivated intramuscular vaccine (Agripal), reduced-content intradermal
      vaccine (IDflu9μg) and standard-content intradermal vaccine (IDflu15μg). Serum
      hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time
      of vaccination and 1 month after vaccination. Adverse events were recorded for 7 days.
    

Intervention name(s): Agripal; IDflu9μg; IDflu15μg
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose; 2011/2012 influenza season reduced-content intradermal split vaccine, single dose; 2011/2012 influenza season standard-content intradermal split vaccine, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention