bioihbjkbjnl/mcl2 huggingface dataset:
Pain Perception of Needle-free System
Condition: Pain; Needle Phobia; Anxiety; Dental Fear; Local Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the pain perception associated with a
      needle-free injection system( Comfort-In) and dental injection method in filling and
      pulpotomy treatments
    

Detailed description: 
      Needle-free injection system(Comfort-In) and dental injection method was applied on the teeth
      of children who need dental treatment.70 patients were included in the study. Patients were
      randomized into two grups according to the injection technique.

      Group1: Needle-free injection system(Comofrt-In) 2:Dental injection method. The pain
      intensity was assessed during anesthesia, during treatment and at the end of thetreatment by
      the Wong Baker Faces Pain Scale.

      The datas were analyzed with a three-way variance method in repeated.
    

Intervention name(s): Needle-free injection
Intervention type(s): Behavioral
Intervention description(s): This study was performed among children aged 4-11 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 70 patients were evaluated in accordance with the exclusion criteria and 56 children (31 girls and 25 boys) were included in this study. Children who needed dental treatment were randomly divided into two groups. All dental injections were administered by the same operator (MB), a pediatric dentist with two years of experience in using the Comfort-In system.
In both groups, the children were asked to rate their pain intensity by choosing the closest statement on the Wong-Baker Pain Scale at three time points: immediately after injection (Pain 1), during treatment (Pain 2), and at the end of the treatment (Pain 3).
Other intervention name(s): Dental injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Dental injection; Needle-free injection system; Pain; Pulpotomy
Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors
Condition: Vestibular Schwannoma; Neurofibromatosis Type 2
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neurilemmoma; Neuroma, Acoustic; Neurofibromatosis 2
Study type: Interventional
Phase: Phase 2

Summary: 
      1)Preliminarily evaluate the treatment effect of continuous vein injection of recombinant
      human endostatin on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of
      the treatment of endostatin; 3)Provide an objective basis for an enlarged randomized
      double-blind trial.
    

Detailed description: 
      Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by
      mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to
      develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas.
      The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients
      experience complete hearing loss either from tumor progression or after treatment of the
      tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients
      with progressive hearing loss because hearing loss is associated with impairment in social,
      emotional,and communication function and with increased depression.

      Previous studies of NF2 patients treated with bevacizumab suggested that inhibition of
      vascular endothelial growth factor (VEGF) could result in hearing improvement and reduction
      in tumor size.Recombinant human endostatin can inhibit the formation of blood vessels by
      inhibiting the migration of vascular endothelial cells .In this way, endostatin can inhibit
      the nutrition of the tumor and decrease the tumor's growth and metastasis. In vitro tests,
      endostatin can inhibit the cell migration and Tube formation of the microvascular endothelial
      cell line HHEC. Besides, it can inhibit blood vessels' formation of the chicken embryo sac
      membrane. Based on these studies, we perform this clinical trial to known the treatment
      effect and tolerability of endostatin on NF2.
    

Intervention name(s): Endostatin
Intervention type(s): Drug
Intervention description(s): Method of drug administration:continuous intravenous pumping; Dosage: 7.5mg/m2/d; Course of treatment: 3 months;Total three treatment courses.
Other intervention name(s): Recombinant Human Endostatin
Intervention MeSH terms: Endostatins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurofibromatosis Type 2; Vestibular Schwannoma; Other NF2-related tumors
Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy
Condition: Epiretinal Membranectomy
MeSH terms: Epiretinal Membrane; Aniseikonia
Study type: Observational

Summary: 
      Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old
      population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and
      epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but
      nowadays with technical improvement and surgical instrument renovation, it seems to have been
      changed the surgical indication. Therefore, we plan to evaluate the changes of binocular
      visual acuity, aniseikonia in patients with epiretinal membrane.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with epiretinal membrane who had metamorphopsia or had imparied vision, therefore
        planned to undergo vitrectomy
      
Keywords: epiretinal membrane, stereopsis, aniseikonia
Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an extension of previous rAvPAL-PEG studies. Administration of rAvPAL-PEG will
      be continued to assess whether long-term dosing of rAvPAL-PEG is safe and can maintain
      reduced blood Phe concentrations in PKU subjects.
    

Detailed description: 
      PAL-003 is designed to evaluate long-term treatment of subjects who are continuing to take
      rAvPAL-PEG. Subjects'previous rAvPAL-PEG dosing will continue in PAL-003. In PAL-003, each
      subject's dose will be adjusted as needed to attain or maintain blood Phe concentrations of
      60-600 µmol/L. rAvPAL-PEG dose will be based on either a subject's weight or will be a fixed
      dose (subjects who have maintained blood Phe levels to 60-600 µmol/L for at least 2
      consecutive weeks and who have maintained a stable rAvPAL-PEG dose for at least 2 consecutive
      weeks). Doses will be evaluated on an individual basis.
    

Intervention name(s): rAvPAL-PEG
Intervention type(s): Drug
Intervention description(s): The doses are planned to be in the same range as those tested in PAL-002 or PAL-004 and then modified either by increasing or decreasing the dose, adhering to an upper limit up to 5.0 mg/kg per week or 375 mg/week, considering each subject's individual responses related to safety and efficacy.
Other intervention name(s): Pegvaliase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether raltegravir is effective in preventing
      progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced
      MRI.
    

Detailed description: 
      There is accumulating research evidence that Human Endogenous Retrovirus (HERV) and herpes
      viruses (in particular Epstein-Barr Virus) are involved in the pathogenesis of multiple
      sclerosis. People with active MS have higher levels of HERVs than people either without MS or
      who have other neurological conditions. It has been shown that HERVs may produce neurotoxic
      proteins/antigens associated with MS activity and disease progression. This is the first
      clinical trial investigating the hypothesis that the antiretroviral drug raltegravir may
      suppress HERV activity and ameliorate progression of relapsing remitting MS. Raltegravir is
      an integrase inhibitor which blocks retroviral replication. A recent experimental study
      suggests that raltegravir may also be active against herpes viruses.

      Eligible participants (see Inclusion/Exclusion Criteria) will be observed for 3 months having
      monthly brain Gadolinium enhanced MRIs and blood/urine/saliva sampling (baseline). Then they
      will be treated with raltegravir (one 400mg pill taken twice a day) for 3 months. During
      treatment period participants will continue to have monthly MRIs and blood/saliva/urine
      sampling. Participants will have monthly clinical and neurological examinations and they will
      complete questionnaires assessing response to treatment. Participants will have screening and
      study visits at The Royal London Hospital, Whitechapel. Monthly MRIs will be performed at the
      Institute of Neurology at Queens Square, London.
    

Intervention name(s): Raltegravir
Intervention type(s): Drug
Intervention description(s): 400mg twice daily for 3 months
Other intervention name(s): Isentress
Intervention MeSH terms: Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: raltegravir; MS; RRMS; Charcot Project
Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases
Condition: Autoimmune Diseases; Infertility
MeSH terms: Infertility; Autoimmune Diseases
Study type: Observational

Summary: 
      This study evaluates the immunomodulatory effects of subcutaneous progesterone in patients
      undergoing IVF by determination of anti-nuclear antibodies (ANA),extractable nuclear antigen
      antibodies (ENA),anti- neutrophil cytoplasmic antibodies(ANCA),anti-DNA antibodies,
      anti-cardiolipin antibodies (ACA),Lupus anticoagulant antibodies (LAC) and C3 and C4
      fractions of complement on the day of beta hCG dosage and during the eigth week of gestation.
    

Detailed description: 
      The aqueous progesterone preparation for s.c. injection is the first systemic progesterone of
      its kind for the provision of luteal phase support (LPS) in patients undergoing IVF.

      The the high solubility and rapid absorption of the new preparation are enhanced using
      cyclodextrins that are starch residues with no therapeutic activity and with a particular
      molecular structure that closely resembles a 'cap'.

      Once absorbed after injection, the progesterone molecule is immediately dissociated from its
      cyclodextrin 'cap', remaining free in the circulation as if produced endogenously by the
      ovaries.

      In comparison to progesterone-in-oil preparation, the new aqueous solution administered by
      s.c.route resulted in a 3 fold higher and more rapid progesterone peak serum concentrations.

      The immunomodulating effects of progesterone are mediated outside of the pelvic cavity, on
      the peripheral cell of the immune system. For this reason only the injection procedure has
      this advantage Furthermore, the faster absorption rate and the higher peak serum
      concentration should increas the systemic immunomodulatory effect of subcutaneous
      progesterone compared to the vaginal and intramuscular administration
    

Intervention name(s): aqueous subcutaneous progesterone
Intervention type(s): Drug
Intervention description(s): 25 mg/die of aqueous subcutaneous progesterone from the day of oocytes retrieval for two weeks.
Intervention MeSH terms: Progesterone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile patients affected by autoimmune diseases undergoing IVF
      
Keywords: autoimmune diseases and infertility; luteal supplementation with subcutaneous progesterone; Systemic effect of progesterone
An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single center, prospective, randomized, placebo -controlled, parallel design and
      double blind study to evaluate oxidative stress, inflammation and hypertension markers and
      mediators before and after treatment with dapagliflozin.
    

Detailed description: 
      Two groups of 26 patients each (total 52 patients) with type 2 diabetes on oral agents will
      be included in the study. One group will be randomized to dapagliflozin (a dose of 5 mg daily
      will be titrated to 10 mg daily during the first week) while the other will be placebo. The
      patients will be treated for 12 weeks. Only half the patients (equal numbers in both groups)
      will be tested for the secondary endpoints related to postprandial and single dose induced
      changes. The primary endpoint of the study is to detect a significant difference in the
      percent change in fasting Nuclear factor-k B (NFκB) activation (DNA binding activity) in
      mononuclear cells (MNC) before and after dapagliflozin use (0 week vs. 12 weeks) as compared
      to placebo.
    

Intervention name(s): dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SGLT-2 inhibitor for the treatment of type 2 diabetes
Other intervention name(s): Farxiga
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Vitamin D and soy extract may be effective in lowering prostate-specific antigen
      (PSA) levels in patients with recurrent prostate cancer that has not responded to previous
      treatment.

      PURPOSE: This phase II trial is studying how well giving vitamin D together with soy
      supplements works in treating patients with recurrent prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Test the response of biochemically recurrent prostate cancer to a combination of
           cholecalciferol (i.e., vitamin D) and soy isoflavones (i.e., soy extract) after failed
           definitive local therapy as determined by PSA response.

      OUTLINE: Patients receive oral cholecalciferol twice daily and a soy supplement (i.e., soy
      bar or shake) once daily. Treatment continues for 3-12 months in the absence of disease
      progression or unacceptable toxicity.

      Blood samples are obtained at baseline and periodically during study to measure serum PSA,
      serum calcium, plasma cholecalciferol, and plasma soy isoflavone levels. Blood samples are
      also analyzed for expression of cholecalciferol receptor, p21, and p27 in peripheral blood
      lymphocytes as surrogate markers of the actions of cholecalciferol and genistein. Protein
      expression is assessed by immunoblot analysis of cell lysates as well as quantitative
      polymerase chain reaction.

      Patients complete a toxicity questionnaire once each month to assess for cholecalciferol and
      soy supplementation toxicities and symptoms of hypercalcemia.

      After completion of study therapy, patients are followed every 3 months for 1 year.
    

Intervention name(s): Vitamin D; soy
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol); Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).
Other intervention name(s): cholecalciferol; isoflavones
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer
Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The overall aim of the present research project is to examine whether consumption of high
      daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a
      study population of men and women with metabolic syndrome risk factors.

      It will be explored whether high-fat and/or low-fat cheese consumption can be regarded
      healthy to consume for at-risk populations (assessed by within-group comparisons from
      baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue to
      be recommended (assessed by between-group comparisons).

      In addition, it will be assessed if cheese consumption affects women and men differently as
      suggested by observational data. The present research project will examine the health effects
      of cheese as a food product per se and not as a sum of single nutrients, knowing that the
      single components of cheese cannot be adequately placebo-matched. A relatively high daily
      intake of high-fat cheese will be compared to a similar intake of low-fat cheese and with a
      carbohydrate control.
    


Intervention name(s): High-fat cheese; Low-fat cheese; No-cheese/carbohydrate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cheese; Dairy; Saturated fat; Blood lipid concentrations; Lipoprotein particle size; Metabolic Syndrome; Insulin sensitivity; Blood glucose concentrations
A Pilot Study of Pulmonary Function in Dysphagic Infants
Condition: Chronic Lung Disease
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      Infants less than 2 years old who have been newly diagnosed with problems swallowing will
      have pulmonary function tests performed to try to detect the presence of chronic lung
      disease. Six months later after the infants have received appropriate therapy for their
      swallowing problems, pulmonary function tests will be performed again to see if there has
      been any change in their chronic lung disease.
    

Detailed description: 
      Twenty-five infants between the ages of 1 month and 24 months who have just been diagnosed
      with dysphagia via a modified barium feeding study will be recruited into the study. The
      infants will be sedated with chloral hydrate and have pulmonary functions measured (pre- and
      post-bronchodilator spirometry and lung volume) using the infant pulmonary laboratory.
      Treatment for the infants' dysphagia/chronic aspiration will be treated as determined by the
      primary care physicians. Six months later the infants will again be sedated and have
      pulmonary functions measured. Results of the two sets of tests will be compared
      statistically.
    

Intervention name(s): Infant Pulmonary Function Tests
Intervention type(s): Procedure
Intervention description(s): Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pulmonary function tests; infants; chronic lung disease; dysphagia; chronic aspiration
The BMI Project (Body, Mind, Inflammation)
Condition: Overweight and Obesity; Chronic Inflammation
MeSH terms: Obesity; Overweight; Inflammation
Study type: Interventional

Summary: 
      Obesity and chronic inflammation influence the development and progression of many types of
      cancer. These conditions share several of the same causes, including physical inactivity,
      poor nutrition, stress, and insufficient sleep. Emerging adulthood (ages 18-25) represents an
      important developmental period in which to address behaviors and psychological variables that
      affect both weight status and inflammation. At least 40% of emerging adults have
      overweight/obesity, and this transition from adolescence to early adulthood is associated
      with significant increases in fast food consumption, decreases in physical activity,
      unpredictable sleep schedules, and alarmingly high rates of depression and perceived stress.

      Despite this high risk for obesity, very few weight loss interventions are designed
      specifically for emerging adults. Preliminary findings from weight loss interventions
      targeting this population have shown some promise, but generally produce modest outcomes with
      less consistent effects than programs in older adults. Depression and stress have been found
      to interfere with weight loss among emerging adults, and may be in part responsible for
      poorer outcomes. This proposal will develop and test an Integrated Lifestyle Intervention
      (ILI) that comprehensively addresses both psychological distress and traditional weight
      management targets. This novel approach has not been tested before and has the potential not
      only to enhance weight loss outcomes in this high risk population, but also to produce
      reductions in markers of inflammation beyond those achievable by weight loss alone.
    


Intervention name(s): Integrated Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): This program is grounded in data demonstrating the dysregulation across multiple domains and considerable life stressors experienced by this population. The central hypothesis is that by simultaneously ameliorating psychological dysregulation and directly targeting proinflammatory behaviors, ILI operates on multiple proposed mediators of poor treatment outcomes in this population, thereby enhancing treatment outcomes. As such, the overall framework emphasizes integration of self-regulation as it applies to both psychological functioning and weight control. Content will highlight the interconnectedness of mood, stress, eating and exercise behaviors, and risk for inflammation and disease. Each treatment session will present a combination of behavioral and psychological content, representing a truly integrated approach. Participants will meet for 75-minute group sessions weekly for months 1-2, followed by bi-weekly groups in months 3-4, for a total of 12 groups.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an initial proof of concept, phase to study to assess the safety and efficacy
      tofimilast for the chronic maintenance treatment of adults with persistent asthma
    


Intervention name(s): Tofimilast
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment