bioihbjkbjnl/mcl2 huggingface dataset:
The Relationship Between Serum Levels of Angiogenin, bFGF, VEGF and Ocular Involvement in Patients With Behçet's Disease
Condition: Behçet's Disease
MeSH terms: Behcet Syndrome
Study type: Observational

Summary: 
      Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial
      dysfunction plays a prominent role in the pathogenesis of the disease, we considered
      angiogenic cytokines as an interesting target for investigation in BD. The aim of this study
      was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF)
      and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.

      Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included
      in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in
      vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.
    


Intervention name(s): serum levels of angiogenin, bFGF, VEGF
Intervention type(s): Other
Intervention description(s): Behçet's patients
Intervention MeSH terms: Angiogenin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Turkish patients fulfilling the international diagnostic criteria for Behçet's disease
      
Biospecimen description: 
      serum
    
Keywords: Angiogenin, Behçet's disease, bFGF, VEGF
Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Genistein may help gemcitabine and erlotinib kill more tumor cells by making tumor
      cells more sensitive to the drugs.

      PURPOSE: This phase II trial is studying how well giving genistein together with gemcitabine
      and erlotinib works in treating patients with locally advanced or metastatic pancreatic
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the 6-month survival rate of patients with locally advanced or metastatic
           pancreatic cancer treated with genistein, gemcitabine hydrochloride, and erlotinib
           hydrochloride.

      Secondary

        -  Determine the frequency of objective tumor response rate in these patients.

        -  Determine the time to treatment failure in these patients.

        -  Determine the effect of baseline expression of pAKT and activation of NF-kappaB on
           survival of patients treated with this regimen.

        -  Determine the overall time to disease progression in these patients.

        -  Estimate the quantitative and qualitative toxicities of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral genistein twice daily on days -7 to 28 in course 1 and on days 1-28 in
      all other courses. Patients also receive gemcitabine hydrochloride IV over 30 minutes on days
      1, 8, and 15 and oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every
      28 days in the absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
    

Intervention name(s): genistein; erlotinib hydrochloride; gemcitabine hydrochloride
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride; Genistein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; stage III pancreatic cancer; stage IV pancreatic cancer; recurrent pancreatic cancer
Bacterial Reduction and Post Operative Endodontic-pain Using Different Kinematics
Condition: Root Canal Infection
Study type: Interventional

Summary: 
      This study was conducted to compare the antibacterial effect and degree of postoperative pain
      of single rotary and reciprocating file systems during endodontic therapy
    

Detailed description: 
      Introduction: Instrumentation kinematic is one of the many aspects of shaping files that
      underwent heavy development through the last decade. The impact of the type of motion used to
      drive shaping instruments was heavily studied but mostly in-vitro. More randomized clinical
      trials are needed to achieve a reliable body of data concerning the issue.

      Aim: This study aimed to evaluate the effect of varying shaping files' kinematics on
      bacterial reduction, post-operative pain and the incidence of flare-ups. Methods: Necrotic,
      asymptomatic, single-rooted mandibular premolars with single canals were used in the study,
      where 46 patients were randomly allocated to two groups. In the first group, WaveOne Gold was
      used for mechanical preparation while One Shape was used in the second group. Samples were
      taken preoperatively (S1) and after chemomechanical preparation (S2). Bacterial reduction was
      evaluated and compared between both groups via culturing technique and quantitative analysis
      by real-time polymerase chain reaction (qPCR). Post-operative pain and the incidence of
      flare-ups were also evaluated using the visual analog scale (VAS) method.
    

Intervention name(s): root canal shaping
Intervention type(s): Other
Intervention description(s): root canal treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The trial design is a prospective, parallel, randomized with an allocation ratio (1:1), double-blinded, single-center clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Reciprocation; Kinematics; Bacterial reduction; post-operative pain; endodontic flare-ups
Increasing Mitochondrial Function on Skeletal Muscle Performance in Older Men
Condition: Impaired Mitochondrial Function, Muscle Performance
Study type: Interventional

Summary: 
      As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced
      mobility and quality of life. To understand and reverse this negative process investigators
      need to find new ways of improving the ability of muscle to perform physical activity. There
      is some evidence that supplements may improve how the mitochondria work, and investigators
      want to explore this idea in more detail, by measuring how the muscles work and respond to
      exercise before and after taking the supplement. This will give us the basic information
      investigators would need to see if this is a useful idea.
    

Detailed description: 
      A defining feature of ageing is loss of muscle mass ('sarcopenia') and associated functional
      weakness ('dynapenia'). A common characteristic of dynapenia is lowered mitochondrial content
      and metabolic function, causing reduced aerobic capacity, increased sensations of effort and
      impaired lipid oxidation (with resultant glucose intolerance). Exercise training improves
      mitochondrial and muscle function in ageing populations, however such adaptations remain
      below that of young counterparts, suggesting alternative approaches are required.
      Pre-clinical studies show that dietary supplementation with precursors of nicotinamide
      adenine dinucleotide (NAD+) restore mitochondrial biogenesis and oxidative capacity in ageing
      rodents and diabetic humans. However, whether NAD+ precursors rejuvenate mitochondrial
      capacity and, ultimately, muscle function in older humans is unknown. This pilot project will
      therefore investigate the efficacy of NAD+ precursor supplementation for increasing muscle
      performance in normally active older men, combined with examination of the molecular and
      metabolic mechanisms regulating physiological responses.
    

Intervention name(s): Acipimox; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral supplement containing Acipimox 250mgs as the active ingredient in blinded label tablet form.; The placebo supplement will contain only cellulose microcrystalline. This is an inert substance widely used in many pill and tablet formulations. It is an insoluble fibre and is not absorbed into the blood stream therefore is unlikely to cause toxicity when taken orally.
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Caffeic Acid Tablets as a Second-line Therapy for ITP
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators are undertaking a multicentre, randomised controlled trial of 120 adults
      with newly diagnosed ITP from 5 medical centers in China. Part of the participants are
      randomly selected to receive caffeic acid tablets combining dexamethasone and the other part
      are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other
      symptoms were evaluated before and after treatment. Adverse events are also recorded
      throughout the study.
    

Detailed description: 
      All participants' platelet count will be monitored weekly. Response will be evaluated after
      3, 6 and 12 months after treatment. If the participant did not get complete response or
      response after 3 months, he would quit the trail.
    

Intervention name(s): Caffeic acid; Dexamethasone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration of caffeic acid tablet 0.3g three times per day for 1 year; Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.; Sugar pills manufactured to mimic caffeic acid tablet. Oral administration of placebo tablet 0.3g three times per day for 1 year.
Other intervention name(s): Caffeic acid tablet; Placebo tablet
Intervention MeSH terms: Dexamethasone; Caffeic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ophthalmologic Examinations After Infusion of ZK200775
Condition: Visual Acuity
Study type: Interventional
Phase: Phase 1

Summary: 
      ZK 200775 is an antagonist at the α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA)
      receptor and had earned attention a possible neuroprotective agent in cerebral ischemia.
      Probands receiving the agent within a stroke therapy related Phase I trial reported on an
      alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system
      will be analyzed in detail.

      In a randomised, placebo-controlled, double-blind study eyes and vision will be examined
      before and after the intravenous administration of ZK 200775. The following methods will be
      applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute
      threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and
      full-field electroretinogram (ERG).
    


Intervention name(s): ZK200775; ZK200775; Sodium Chloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.; Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.; Intravenous infusion of sodium chloride over a period of 4 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ZK200775 is tested for its effects on vision on healthy probands.
Evaluation of Five Selected Markers in Skin Biopsies of Patients With Postherpetic Neuralgia and Healthy Controls
Condition: Postherpetic Neuralgia; Healthy Age/Gender Matched Volunteers
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional

Summary: 
      Postherpetic Neuralgia is a painful nerve condition that can occur when nerve fibers are
      damaged following an outbreak of shingles.

      The purpose of this study is to identify and study abnormalities in the nerves and cells in
      the of patients with postherpetic Neuralgia (PHN) and characterize changes that could be
      responsible for causing nerve pain. This data will be compared to the tissue of healthy
      volunteers. Our goal is that this information will lead to the development of better
      treatment options for people with painful nerve conditions.
    


Intervention name(s): skin biopsy
Intervention type(s): Other
Intervention description(s): Using a punch biopsy, the study doctor will take a small sample of skin (3mm diameter) from a pre-defined site of the subject. For PHN patients, 4 biopsies will be obtained: 2 in an area of PHN and 2 in a contralateral control site. Biopsy sites for each PHN control subject will be matched anatomically to the corresponding PHN patient with two biopsies each from symmetrical sites in a left and right dermatome. One biopsy from each site in each subject will be fixed in a left and right dermatome. One biopsy from each site in each subject will fixed yb immersion in 4% paraformaldehyde for immunocytochemical analysis, and the second biopsy form each site will be flash frozen for assessments of mRNA expression.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section
Condition: Perfusion Index Predicts Post-spinal Hypotension
MeSH terms: Hypotension
Study type: Observational [Patient Registry]

Summary: 
      Hypotension is a common adverse effect of spinal anesthesia during caesarean section
      especially in obese patients.

      The aim of this study is to find out the correlation between baseline PI and post spinal
      hypotension in obese parturient.
    

Detailed description: 
      Abstract Background Hypotension is a common adverse effect of spinal anesthesia during
      caesarean section especially in obese patients.

      The aim of this study is to find out the correlation between baseline PI and post spinal
      hypotension in obese parturient.

      Methods After approval of ethical committee and written informed consent, fifty Parturients
      aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25
      &40 admitted for cesarean section under spinal anesthesia were recruited in this prospective,
      observational study. The primary outcome is the correlation between baseline perfusion index
      and post spinal hypotension. The secondary outcome is the correlation between BMI and the
      incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index
      before and after spinal induction using Masimo device, level of sensory block, dose of
      ephedrine required to correct hypotension, dose of atropine required to correct bradycardia,
      incidence of nausea, vomiting and shivering were recorded.
    

Intervention name(s): correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction
Intervention type(s): Procedure
Intervention description(s): correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        After approval of ethical committee and written informed consent, fifty Parturients aged
        between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 &40
        admitted for cesarean section under spinal anesthesia were recruited in this prospective,
        observational study. The primary outcome is the correlation between baseline perfusion
        index and post spinal hypotension. The secondary outcome is the correlation between BMI and
        the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion
        index before and after spinal induction using Masimo device, level of sensory block, dose
        of ephedrine required to correct hypotension, dose of atropine required to correct
        bradycardia, incidence of nausea, vomiting and shivering were recorded.
Infant Sleep Hygiene Counseling Trial
Condition: Sleep
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of an intervention to improve quality and duration of
      self-regulated nighttime sleep (the amount of time the child maintains a combination of
      uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental
      intervention).
    

Detailed description: 
      The development of adequate sleep patterns is paramount to the optimal neurodevelopment, as
      well as to promote proper learning, develop memory and preserve cerebral plasticity. Factors
      that hinder sleep patterns can negatively influence the child's growth, neurological and
      motor development.

      The investigators will conduct a randomized controlled trial within the 2015 Pelotas Birth
      Cohort. At the 3-month follow-up, children who sleep less than 13 hours per 24 hours
      (nighttime sleep and daytime naps) will be eligible for the study. The sample size was
      estimated at 276 children per arm. Nighttime self-regulated sleep duration will be evaluated
      at baseline (age 3 months) and at 6, 12 and 24 months using actigraphy and via a sleep diary
      completed by the mother. Following block randomization, mothers from the intervention group
      will be visited by a trained fieldworker who will deliver counseling on age-appropriate
      normal sleep behaviors, how to facilitate sleep onset and how to manage night awakenings.
    

Intervention name(s): Sleep hygiene counseling
Intervention type(s): Behavioral
Intervention description(s): The mothers of the eligible infants will be visited at home and will be invited to participate at the study. To those who sign the Consent Form (CF) a following visit will be scheduled to within 5 days. Between CF signature and the 5-day visit, the enrolled children will use an actigraph-device in the leg and the mothers will fill out a sleep diary registering the times of the day the child is asleep, awake, napping, and feeding. At the 5-day visit the child allocation in the trial (intervention or control group) will be uncovered and the sleep recommendations will be delivered to mothers in the intervention group. Phone calls on days 6 and 7 and a home visit on day 8 will be paid to support mothers for possible difficulties in implementing the recommendations.
Other intervention name(s): Child sleep trial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy
      volunteers.
    

Detailed description: 
      This "first-in-human" Phase I, single-center, dose escalation study (using 3 dose levels) is
      proposed to assess the safety of infusing reconstituted lyophilized human plasma (LyP). The
      study design incorporates plasmapheresis-derived autologous plasma (FFP) for infusion(s) to
      eliminate variables and events known to be related to allogenic transfusion. Subjects will be
      enrolled at a blood center and provide autologous FFP that will be shipped to the sponsor
      site and used as the starting material to manufacture LyP. Once manufacturing is complete,
      the LyP (autologous) will be returned to the blood center for reconstitution and infusion
      into subjects. Maximum dosage within this study will approach "massive transfusion" (1 liter
      in Cohort 3) to obtain a preliminary assessment of safety. One half of the FFP obtained from
      subjects in Cohort 3 (only) will be shipped to the sponsor and returned to the site (but not
      manufactured into LyP) to serve as the control (autologous FFP).
    

Intervention name(s): Lyophilized Plasma; Fresh Frozen Plasma
Intervention type(s): Biological; Other
Intervention description(s): Lyophilized Plasma is serves as a source of plasma proteins for subjects who are deficient in plasma proteins. The donor and recipient are the same person, therefore the process is autologous. HemCon's lyophilized plasma originates from FFP from screened individual donors to significantly reduce the risk of bloodborne disease transmission and undesired transfusion-associated reactions. Each single-donor unit is tested (per required of the blood supply) to reduce the risk of transmission of infectious agents and hence, maximize subject safety.; The fluid portion of one unit of human blood that has been centrifuged, separated, and frozen solid at -18 °C (-0.4 °F) (or colder) within 6 hours of collection.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Lyophilized Plasma; Fresh Frozen Plasma; Hemorrhage; Coagulopathy; Autologous; HemCon; Plasmapheresis; Freeze Drying; Transfusion; Resuscitation; Safety of Lyophilized Plasma in Normal, Healthy Volunteers
Comparison of Different Methods of Controlling Pain During Debonding of Orthodontic Brackets
Condition: Analgesia; Orthodontic Appliance Complication
Study type: Interventional

Summary: 
      Purpose of this study was to evaluate different methods of controlling pain during debonding
    

Detailed description: 
      Patients data was obtained from the Department of Orthodontics, Armed Forces Institute of
      Dentistry, Rawalpindi. One Hundred and ten patients were included in the study, which were
      divided into two groups, 55 patients in each group, based on method of controlling pain
      during debonding. To control pain during debonding in one group , teeth were stabilized with
      finger pressure with cotton between finger and teeth and then debonding using open mouth
      technique was done. In second group teeth were stabilized using a plastic wafer between
      maxillary and mandibular teeth and then debonding was done using closed mouth technique. In
      order to reduce biasness, all of the patients were debonded with same plier and with wires
      still ligated to brackets. With the help of VAS, pain score was measured after debonding. A
      single operator performed complete procedure of debonding and pain recording.
    

Intervention name(s): Stabilization of teeth during debonding using fingure pressure and elastic wafer
Intervention type(s): Other
Intervention description(s): To control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Orthodontic pain