bioihbjkbjnl/mcl2 huggingface dataset:
Drawing as a Measurement of Dental Anxiety
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational [Patient Registry]

Summary: 
      In the present study, we aimed to assess children's anxiety levels by using different dental
      anxiety scales and children's drawings evaluated according to two different scoring systems:
      Child Drawing: Hospital (CD: H) and Emotional indicators of Human Figure Drawings (HFD).
    

Detailed description: 
      Background: Drawings can be used as a method of communication that represents an individual's
      self-concept, anxiety, attitude, or conflict.

      Aim: The purpose of this study was to evaluate children's drawing as a measure of dental
      anxiety in a dental setting.

      Design: Seventy- eight children, aged 6-12 years, were enrolled in this study. Pulp therapy
      and/or restorative treatment was performed during the first therapeutic session for all
      participants. Sound, Eye, and Motor (SEM) and Frankl scales were used as an objective
      assessment of dental anxiety during treatment. After the treatment session, the children were
      instructed to draw a picture of a person at a dental clinic. Children's drawings were scored
      by a paediatric dentist and a psychologist using Child Drawing: Hospital (CD: H) scale and
      emotional indicators of Human Figure Drawings (HFD). The findings were compared with Frankl
      and SEM scores.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Number of patients required was calculated on the basis of a micro-sample at an accepted
        level of significance(p<0.05) and a maximum permissible error α<0.05 and β<0.2. A total of
        78 children were enrolled in this study. The participants of this study included children
        referred to, Paediatric Dentistry Department for their dental treatment on primary teeth.
        Once admitted to the Paediatric Dental Clinic children are examined by a paediatric dentist
        and each child is appointed for their dental therapeutic session. Comprehensive treatment
        plans of 571 children were examined and eligible 78 subjects who matched the inclusion
        criteria were randomly selected from children who were appointed for their first dental
        treatment session.
      
Keywords: Drawing; Children; Dental Anxiety
Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to compare an individually optimized dose of the lisuride TTS
      patch against placebo and against an individually optimized dose of oral ropinirole (active-
      and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy,
      safety, and quality of life.
    

Detailed description: 
      Approximately 300 patients will be randomized to receive either lisuride, ropinirole or
      placebo in a 2:1:1 fashion. After completion of 12 weeks of double-blind treatment, eligible
      patients will have the option to continue treatment with the lisuride patch for further 36
      weeks in an open-label extension of the study.

      Primary outcome: Changes in the total score of the International Restless Legs Severity Scale
      (IRLS) from baseline to end of double-blind treatment (12 weeks) will be used as primary
      efficacy outcome measure.

      Secondary objectives are to evaluate quality of life, safety and tolerability. After the
      double-blind period, long-term efficacy of lisuride will be assessed for further 36 weeks in
      an open-label extension of the study.
    

Intervention name(s): Lisuride; Ropinirole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ropinirole; Lisuride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Restless Legs Syndrome; dopamine agonist; lisuride; ropinirole
Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy and safety of topical tranexamic acid versus placebo in patients
      diagnosed with severe knee osteoarthritis who will undergo prosthetic knee surgery in terms
      of saving blood loss (estimated blood loss, decreased hemoglobin and Decrease in hematocrit).
    

Detailed description: 
      Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the
      fibrinolytic properties of plasmin. Tranexamic acid binds to plasminogen when it is
      transformed into plasmin. The activity of the tranexamic acid-plasmin complex on fibrin
      activity is less than the activity of free plasmin alone.

      There are two methods of presentation: one, as an injectable solution; Two as a clear,
      colorless aqueous solution.

      Tranexamic acid in Spain is approved for use in the prevention and treatment of bleeding due
      to general fibrinolysis. As for its specific indications the investigators find that it is
      used for the treatment of metrorrhagia, menorrhagia, gastrointestinal hemorrhage, urinary
      hemorrhagic disorders after prostate surgery, surgery of ears, nose, throat, gynecological,
      thoracic, abdominal or cardiovascular or to counter associated hemorrhages To the
      administration of a fibrinolytic drug.
    

Intervention name(s): Amchafibrin; Saline Solution
Intervention type(s): Drug; Other
Intervention description(s): Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.; Placebo
Other intervention name(s): Placebo
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Tranexamic acid
A Phase 1 Study of CNTO 3157 in Healthy Volunteers and Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.
    

Detailed description: 
      A phase 1, randomized (study drug assigned by chance), double blind (neither physician nor
      patient knows if CNTO 3157 or placebo has been assigned), placebo controlled, single,
      ascending-dose study of CNTO 3157 in healthy volunteers and multiple dose study in patients
      with asthma. This study will compare the effects (both good and bad) of CNTO 3157 to those of
      placebo. The purpose of this study is to evaluate the safety and potential side effects of
      CNTO 3157 given to healthy volunteers and patients with asthma. In addition, the
      investigators will measure how much study drug is in the blood following a dose of CNTO 3157,
      and determine if the body makes antibodies to it. (An antibody is a protein made by the body
      in response to a foreign substance). Safety assessments will be performed throughout the
      study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood
      pressure), and the occurrence and severity of adverse events. There will be 2 parts to this
      study. The first part of this study will involve healthy volunteers, and the second part of
      the study will involve patients with asthma. About 56 healthy volunteers and 16 asthmatic
      patients will take part. Volunteers will be required to stay at the research center after
      study agent administration for an inpatient portion of the study and then return for required
      out-patient visits. Up to approximately 8 different dose levels will be studied. CNTO 3157
      will be administered by IV infusion. The duration of volunteer participation will be up to 21
      weeks in Part 1 and up to 24 weeks in Part 2.
    

Intervention name(s): CNTO 3157 or placebo; CNTO 3157 or placebo; CNTO 3157 or placebo; CNTO 3157 or placebo; CNTO 3157 or placebo; CNTO 3157 or placebo; CNTO 3157 or placebo; CNTO 3157 or placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.003 mg/kg CNTO 3157 or placebo infusion; 0.03 mg/kg CNTO 3157 or placebo infusion; 10 mg/kg CNTO 3157 or placebo infusion; 0.01 mg/kg CNTO 3157 or placebo infusion; 1 mg/kg CNTO 3157 or placebo infusion; 3 mg/kg CNTO 3157 or placebo infusion; 0.3 mg/kg CNTO 3157 or placebo infusion; 0.1 mg/kg CNTO 3157 or placebo infusion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CNTO 3157; healthy volunteers; asthma
Chlorhexidine Mouthrinses and Plaque Control
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      The aim of the present study was to compare antiplaque effectiveness of two commercial
      mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine
      non-alcohol base with 0.1% of Formaldehyde (CLX-F).
    

Detailed description: 
      Chlorhexidine (CLX) mouthrinse has been the gold standard as antiplaque solution.However, if
      its efficiency seems to be preserved even if the chlorhexidine concentration is bellow 0.10%,
      the formulation of the final product may affect the effectiveness. Thus, it can be concluded
      from this study that 0.12% CLX alcohol base mouthrinse is significantly more effective in
      inhibiting plaque than the diluted 0.1% CLX non-alcohol base containing formaldehyde
      mouthrinse.
    

Intervention name(s): Synthodont; Soludent
Intervention type(s): Drug; Drug
Intervention description(s): 15 ml, tree times/day for 07 days
Arm: Chlorhexidine alcohol-base mouthrinse; 15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days
Arm: Experimental: non alcohol chlorhexidine mouthrinse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Chlorhexidine mouthrinse; Plaque control
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1
      (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different
      vaccination schedules.

      Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21
      on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody
      response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in
      vaccine delivery. This study compares these two delivery schedules using the unadjuvanted
      vaccine formulation rsgp120/HIV-1 with or without addition of alum.
    

Detailed description: 
      Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21
      on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody
      response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in
      vaccine delivery. This study compares these two delivery schedules using the unadjuvanted
      vaccine formulation rsgp120/HIV-1 with or without addition of alum.

      Healthy volunteers (20 per group) receive MN rsgp120/HIV-1 (300 or 0 mcg) in combination with
      QS21 (100 mcg), either with or without alum, at 0, 1, and 2 months or 0, 1, and 6 months. For
      both vaccination schedules, an additional five volunteers receive only vehicle with alum. The
      0 mcg antigen groups are included primarily as negative controls. Subjects may be contacted
      for follow-up on health status once or twice yearly for at least 5 years.
    

Intervention name(s): Aluminum hydroxide; QS-21; rgp120/HIV-1MN
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Drug Therapy, Combination; Adjuvants, Immunologic; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 894416 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect of rifampicin on the
      pharmacokinetics of BI 894416.
    


Intervention name(s): BI 894416; Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): tablet; tablet
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This project focuses on embedding the participants' own diabetes data into state-of-the-art
      technology platforms to constitute a novel educational simulation interface for
      decision-support in Type 1 Diabetes (T1D) - the Web-based Simulation Tool (WST).
    

Detailed description: 
      The Web-based Simulation Tool (WST) allows patients with Type 1 Diabetes (T1D) to not only
      visualize their data, but also to explore changes to their meals and insulin parameters, and
      easily estimate their potential clinical impact. WST is an educational tool, and as such, it
      does not have prescriptive power. This platform collects glucose, insulin and meal data from
      the participants' insulin pump, and generates personalized models of their glucose
      metabolism. Both data collection and model personalization are backend processes, that is,
      without user intervention.

      Participants can interact with WST through a user interface (UI) that is equipped with a
      dashboard page, where they can:

      (i) select a particular date range using a calendar to visualize their historical glucose
      control, such as glucose traces, and time in range;

      (ii) control the amount of information on the screen - users can show/hide more details, such
      as glucose variability;

      (iii) select different insulin therapy parameters: basal rate, insulin sensitivity factor,
      and carbohydrate ratio;

      (iv) change their values by moving a slider;

      (v) select informed meals within the selected date range, and modify their time and size by
      moving a slider;

      (vi) run a simulation with the modified insulin therapy parameters and meals by tapping a
      button;

      (vii) save the insulin and meal settings of the simulations to compare multiple
      configurations; and

      (viii) generate a report from the selected simulation, comparing both original and simulated
      or replay data.
    

Intervention name(s): Web-based Simulation Tool
Intervention type(s): Other
Intervention description(s): Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations.
Intervention model: Single Group Assignment
Intervention model description: Single-arm, single center, non-randomized, uncontrolled pilot clinical trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: Web-based Simulation Tool (WST); Continuous Glucose Monitoring (CGM); Glucose Metabolism Model; Insulin Pump
Inflammatory Markers in Patients With Active Migraine Headaches
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in
      patients with active migraine headaches. Secondary goal is to determine whether other
      inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal
      Polypeptide (VIP) or Substance P (SP) are elevated in patients having a migraine headache.
    

Detailed description: 
      A random selection of patients both male and female from a primary care practice with a
      diagnosis of having migraine headaches will be enrolled. Thirty (30) patients will be
      recruited mainly from the primary care practice. Recruitment will include males and females
      aged 21-65. The patients who meet the inclusion criteria will be enrolled. The patients who
      do not have migraine headaches will also be enrolled and function as controls. Non-migraine
      patients will meet inclusion criteria 1, 2 and 3 and all of the exclusion criteria.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Migraine
      
Keywords: Inflammatory Markers; Migraine
Crossover Feasibility Study of Portable AP Device With Zone-MPC and HMS and Adapted I:C and Basal Insulin
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device
      using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1
      diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to
      compare closed-loop control with or without optimization of initialization parameters related
      to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals and
      snacks.
    

Detailed description: 
      The study consists of an evaluation of the Artificial Pancreas device system during two
      24-27.5-hour closed-loop phases in an outpatient/hotel environment. Prior to the closed-loop
      phases, each subject will undergo a 7-day data collection period consisting of his or her
      usual free-living conditions along with 3 meals of known carbohydrate content. Data from the
      insulin pump, a continuous glucose monitoring sensor (CGM), diet and exercise records will be
      collected during this period. These data from this 7-day period will be analyzed in order to
      come up with adapted basal insulin infusion rates and bolus insulin to carbohydrate (I:C)
      ratios.
    

Intervention name(s): portable Artificial Pancreas
Intervention type(s): Device
Intervention description(s): The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on measured glucose levels.
Intervention MeSH terms: Pancrelipase
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: artificial pancreas
ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor
      cells and slow the growth of kidney cancer.

      PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have
      recurrent or stage IV kidney cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate in patients with progressive stage IV or recurrent renal
           cell cancer treated with ZD 1839.

        -  Determine the median time to objective progression in these patients receiving this
           drug.

        -  Determine the toxic effects of this drug in this patient population.

        -  Determine if epidermal growth factor receptor expression in tumor tissue correlates with
           response and survival of these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral ZD 1839 daily. Courses repeat every 28 days in the absence of disease
      progression or unacceptable toxicity.

      Patients are followed every 8 weeks.

      PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 11-23
      months.
    

Intervention name(s): gefitinib
Intervention type(s): Drug
Intervention MeSH terms: Gefitinib
Primary purpose: Treatment
Keywords: stage IV renal cell cancer; recurrent renal cell cancer
Evaluation of Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
Condition: Stress Urinary Incontinence in Women
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This study will evaluate the safety, tolerability and efficacy of duloxetine and pelvic floor
      muscle training in women who suffer from stress urinary incontinence
    

Detailed description: 
      This is a randomized-intervention, parallel, multicentric study which will evaluate the
      safety, tolerability and efficacy of oral duloxetine and innovative pelvic floor muscle
      training to woman suffering from stress urinary incontinence
    

Intervention name(s): Pelvic floor muscle training (PFMT) with lumbopelvic stabilization
Intervention type(s): Behavioral
Intervention description(s): Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.
Educating of probands about anatomy, physiology, and pelvic floor muscles functions
Training of pelvic floor muscles in different position
Training of pelvic floor muscles with lumbopelvic stabilization
Exercise 5 times a week for 20-30 minutes a day, after initial training with a physiotherapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress urinary incontinence; Pelvic floor muscle training
An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen
      Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute
      ischemic stroke
    


Intervention name(s): alteplase
Intervention type(s): Drug
Other intervention name(s): Actilyse®
Intervention MeSH terms: Tissue Plasminogen Activator
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Acute ischemic stroke within three hours after symptom onset treated at stroke centers