bioihbjkbjnl/mcl2 huggingface dataset:
Validation of the Arabic Version of the Caries Questionnaire
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      Arabic is one of the most spoken languages in the world; however, the CARIES-QC questionnaire
      which evaluate the effect of oral diseases and disorders on children's oral health-related
      quality of life has not yet been validated in Arabic speaking children. So the purpose of
      this study was to translate the CARIES-QC into Arabic and test the measurement properties of
      the Arabic version of the CARIES-QC for use in children with dental caries who speaks Arabic
      .
    

Detailed description: 
      Dental caries is a major public health problem. It has been estimated that 621 million
      children in the world have untreated dental caries . Dental caries always manifests with
      significant pain, affecting oral health-related quality of life (OHRQoL) and well-being.
      Several measures were widely used to comprehensively evaluate the effect of oral diseases and
      disorders on children's OHRQoL. However, most of these measures were 'generic' measures, and
      they may fail to detect small, clinically important changes related to specific oral
      diseases. Gilchrist et al recently developed the Caries Impacts and Experiences Questionnaire
      for Children (CARIES-QC) in order to address this issue. Preliminary findings have confirmed
      that Caries Impacts and Experiences Questionnaire for Children measure had good reliability,
      validity, and responsiveness. However, The original CARIES-QC was an English measure; so
      appropriate translation and cultural adaptation should be done in order to be used in other
      culture and language.

      Arabic is one of the most spoken languages in the world; however, the CARIES-QC has not yet
      been validated in Arabic speaking children. So the purpose of this study was to translate the
      CARIES-QC into Arabic and test the measurement properties of the Arabic version of the
      CARIES-QC for use in children with dental caries who speaks Arabic .
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy children with active dental caries ranging in age from 5-16 year
      
Keywords: CARIES-QC ,validity ,reliability, Arabic, dental caries
Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening
Condition: Labor Onset and Length Abnormalities
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Mechanical methods used for induction of labor received a great attention nowadays due to the
      serious side effects of the pharmacological methods. Hygroscopic dilators are considered
      important subtype of these mechanical methods. One of them is Laminaria which is a synthetic
      type of sea algae that induces cervical dilation by absorbing water from the cervix and
      gradually increasing in thickness. The current study will compare the effectiveness and
      safety of laminiria and vaginal prostaglandins in induction of labor in women with
      unfavorable cervix.
    

Detailed description: 
      A new method for induction of labor to be studied
    

Intervention name(s): Laminaria; Vaginal prostaglandin
Intervention type(s): Device; Drug
Intervention description(s): mechanical method for induction of labor; Vaginal prostaglandin for ripening
Other intervention name(s): Vagiprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
Condition: Aphakia; Cataract
MeSH terms: Cataract; Aphakia
Study type: Interventional

Summary: 
      The objective of this study is to evaluate, for the visual correction of aphakia, whether the
      RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve
      visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory
      study. No primary effectiveness endpoints will be identified.
    


Intervention name(s): Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Intervention type(s): Device
Intervention description(s): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Light Adjustable Lens; Intraocular lens; LAL
Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage
Condition: Gastrointestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      This study aimed to Assess the validity of the Rockall score for the prediction of rebleeding
      and death in patients with upper gastrointestinal bleeding.
    

Detailed description: 
      This present study aimed to evaluate:

      Assess the validity of the Rockall score for the prediction of rebleeding and death in
      patients with upper gastrointestinal bleeding.

      1- Technical Design: The technical design included research design, setting, subject and
      tools for data collection.

      Research design:

      A descriptive exploratory design was followed to achieve the aim of the study. Study setting:
      This study was conducted between Tropical department in AinShams university and
      Gastroenterology and Hepatology department in TheodorBilharz Research Institute.

      Sample size: EPI - INFO program version 6 was used for sample size calculation guided by
      power of the test = 80% - confidence level =95% and accepted margin of error = 5% and risk
      ratio = 5.5 - total sample minimum accepted = 50 This study included 50 recipients and done
      Tropical department in Ain Shams university and Gastroenterology and Hepatology department in
      .

      Theodore Bilharz Research Institute
    

Intervention name(s): Upper gastrointestinal endoscopy
Intervention type(s): Other
Intervention description(s): Upper gastrointestinal endoscopy, if stigmata of recent hemorrhage are seen, varices are either injected with ethanolamine or banded, depending on the clinical setting and availability .
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult Egyptian patients with acute upper gastrointestinal bleeding
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and safety of a single intratracheal
      administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk
      premature infants by comparing Pneumostem-treated group with a control group.
    


Intervention name(s): Pneumostem®; Normal Saline
Intervention type(s): Biological; Other
Other intervention name(s): Human umbilical cord blood-derived mesenchymal stem cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human Umbilical Cord Blood Derived Mesenchymal Stem Cells; Bronchopulmonary dysplasia; Premature infants
A Phase 1 Study Assessing Local Cutaneous Effects of SB204
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, color (erythema) and pH will be measured on 3 consecutive days after
      application of 2 doses of SB204 to the cheeks of healthy volunteers.
    

Detailed description: 
      This study is to evaluate local cutaneous effects, including intensity and duration of
      erythema and changes in pH following 5 applications (twice daily for two days and once daily
      on the third day) of SB204 2% and SB204 4% twice daily to the face for 3 days.
    

Intervention name(s): SB204
Intervention type(s): Drug
Intervention description(s): Applied topically twice a day on days 1, 2 and 3 to left and right cheeks
Other intervention name(s): NVN1000
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acne
Testing of a Mobile Web App to Decrease Posttraumatic Stress Symptoms in Women After Sexual Assault
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Interventions are available to all adult women sexual assault survivors to reduce the risk of
      pregnancy and sexually transmitted infection, yet no interventions are provided to reduce
      posttraumatic stress. This pilot study tests the ability of a smartphone-based web app to
      prevent and reduce posttraumatic stress in women sexual assault survivors.
    


Intervention name(s): Mobile Web App
Intervention type(s): Behavioral
Intervention description(s): App for preventing development of posttraumatic stress based on cognitive behavioral techniques.
Intervention model: Single Group Assignment
Intervention model description: In this pilot study, all participants will receive the active web app intervention.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Posttraumatic Stress Disorder; Anxiety Sensitivity; Chronic Pain; Sexual Assault
Product Performance of a Daily Disposable Contact Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this one week, single group, bilateral, open-label study is to evaluate the
      product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test)
      when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted
      soft contact lens.
    


Intervention name(s): Daily disposable cosmetic tint lens
Intervention type(s): Device
Intervention description(s): Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: contact lens
Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment
Condition: Bone Degenerative Changes; Osteoarthritis; Degenerative Disorder of Bone
MeSH terms: Osteoarthritis; Bone Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional
      ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local
      application of BMP results in an increase of osseous tissue regardless of the location of the
      growth factor.

      5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and
      improve clinical results when autologous bone graft is reduced or removed.

      The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace
      autologous bone graft in order to stimulating ossification during transplantation of osseous
      tissue.
    


Intervention name(s): Bone Morphogenetic Protein 2; Autologous bone graft
Intervention type(s): Drug; Procedure
Intervention description(s): 12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.; Autologous bone graft in connection with bone docking operation.
Other intervention name(s): No other names.; No other names.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bone; Morphogenetic; Protein; Ilizarow; Autologous; Osteoarthritis
A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3
      phases:screening (up to 2 weeks [Day -15 to Day -2]), In-Clinic Treatment (Day -1 to Day 2;
      including double-blind treatment [Day 1]), and post-treatment follow-up (7 and 14 days after
      infusion on Days 8 and 15, respectively). A total of 93 adult subjects with TRD will be
      randomly allocated in equal cohorts of 31 subjects/arm to the 3 arms of the study in a
      blinded manner.
    


Intervention name(s): PCN-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Concentrate for solution for infusion; Concentrate for solution for infusion
Other intervention name(s): R-ketamine
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCN-101; R-ketamine
Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers
Condition: Cystic Fibrosis (CF)
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be performed to assess the safety, tolerability and PK of escalating inhaled
      AIR-DNase doses administered as a single dose followed by multiple doses for 5 consecutive
      days in healthy subjects.

      A thorough review of safety data will be conducted after completion of each dose level per
      subject and prior to both, moving to the next dose level in Part 1 and commencement of the
      multiple dose Part 2.
    

Detailed description: 
      This is a Phase I study to evaluate the safety, tolerability and pharmacokinetics of inhaled
      AIR DNase in healthy volunteers. Up to 18 healthy males subjects (age 18 -55 inclusive) will
      be randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving AIR DNase
      doses equivalent to 1.25 mg, 2.5mg or 5 mg or placebo in accordance. Subjects randomized to
      one of the cohorts will receive either active of placebo as single dose, in continuation,
      following safety assessments, will receive multiple doses, once daily for 5 consecutive days.
      Subjects will remain at the clinical center for 8 hours after the single administration of
      AIR DNase/placebo including PK sampling. During the multiple dosing subjects will arrive at
      the clinical center daily for AIR DNase/placebo administrations and study procedures and
      remain at the site for 4 hours post dosing.

      Follow up visits will be performed 7±2 days following single administration and 7±2 days
      following the last administration of the multiple phase.
    

Intervention name(s): AIR DNase; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine the maximum tolerated dose (MTD) based on
      the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of
      ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients
      with advanced solid tumors.

      Secondary Objectives:

        -  To assess the overall safety profiles of the combination therapy

        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR
           258063, paclitaxel, and carboplatin when used in combination

        -  To document the objective tumor response
    

Detailed description: 
      The duration of the study for each patient will include an up to 4-week screening phase,
      21-day study treatment cycles, an end of treatment visit and a follow-up period.
    

Intervention name(s): Ombrabulin (AVE8062); Paclitaxel; Carboplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution
Route of administration: intravenous; Pharmaceutical form:solution
Route of administration: intravenous; Pharmaceutical form:solution
Route of administration: intravenous
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glycemic Response of Co-ingesting Carbohydrate and Amino Acids
Condition: Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The study will investigate if consumption of amino acid mixtures results a change in glycemic
      response of carbohydrate (white rice) and insulinemic response at different doses and timing
      (before consumption of carbohydrate).
    

Detailed description: 
      Healthy male subjects will be served with amino acid mixtures in combinations of two doses
      and three time points along with white rice as control. The combinations were either low or
      high levels of amino acid mixtures. This was consumed together or 15 min, 30 min before
      consumption of white rice. Postprandial blood glucose and plasma insulin concentrations were
      measured at fasting and every 15 min after consumption of treatment meal until 60 min after
      the consumption of white rice. Subsequent blood sample were taken at 30 min interval until
      210min. The glucose and insulin in the blood will be analysed.
    

Intervention name(s): Rice and Amino Acid mixtures
Intervention type(s): Other
Intervention description(s): Rice and amino acid mixture
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effect of Testosterone Replacement on Insulin Resistance
Condition: Metabolic Syndrome; Hypogonadism
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypogonadism; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to determine whether testosterone replacement improves insulin sensitivity in
      non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome
      includes three of the following five conditions, 1) an elevated blood pressure (greater than
      130/85), 2) a triglyceride level greater than 150 mg/dl, 3) an HDL-cholesterol less than 40
      mg/dl, 4) glucose levels greater than 100 mg/dl, and 5) a waist measurement greater than 40
      inches.
    

Detailed description: 
      In this proposal, we will examine the relationship between hypogonadism and insulin
      sensitivity. The strongest relationship between hypogonadism and insulin resistance appears
      to reside in men with the metabolic syndrome who have a normal BMI. The causal relationship
      between these two conditions is unknown. Therefore, we propose to determine if testosterone
      replacement in hypogonadal non-obese men with metabolic syndrome will improve insulin
      sensitivity. Data obtained from this preliminary investigation, will hopefully result in a
      hypothesis that can be tested in a larger, more rigorous trial in the future.
    

Intervention name(s): Testosterone gel; Placebo for testosterone gel
Intervention type(s): Radiation; Drug
Intervention description(s): testosterone gel, applied daily. Dosed to achieve testosterone level <500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.; Placebo gel, 2.5g for each gel packet
Other intervention name(s): Androgel
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; Hypogonadism; Insulin Resistance
To Compare the Pharmacokinetics of Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to assess and compare the pharmacokinetics (PK) of
      Tiotropium delivered via Breath Actuated Inhaler (BAI) (4.5 mcg/day or 9.0 mcg/day),
      SPIRIVA®, HandiHaler®, (18 mcg/day) and Respimat® Soft Mist™ Inhaler (SMI) (5.0 mcg/day)
      following repeat dosing for 7 days in subjects with COPD.
    

Detailed description: 
      This multicenter study consists of a Screening Visit (3 to 14 days prior to randomization); 4
      multiple-dose (7-day) Treatment Periods, each consisting of a 2-night/3-day inpatient stay
      (Day 6 to Day 8); and a Final Visit. A washout period of at least 21 days will occur between
      each Treatment Period. The Final/ Early Termination Visit will occur 6-8 days following the
      last Treatment Period or upon early discharge from the study.
    

Intervention name(s): Tiotropium HFA BAI 4.5 mcg; Tiotropium HFA BAI 9.0 mcg; SPIRIVA® HandiHaler® 18 mcg/day; Spiriva® Respimat® 5 mcg/day
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD, pharmacokinetics, tiotropium
Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in
      healthy volunteers.
    

Detailed description: 
      The study is carried out in 2 parts. In part I, safety and tolerability is assessed in three
      groups (12 subjects per group) for single and multiple instillations (1 drop, 3 drops and 3+3
      drops). In each group, 9 subjects is randomized to receive Chloroprocaine 3% Gel and 3
      subjects receive vehicle as control in the right eye. After part I is completed, an internal
      independent board review safety endpoints of data collected from these first subjects and
      advise to go on with further enrollment.

      If no safety concerns arise, in part II efficacy, safety and tolerability is assessed in 60
      healthy subjects for the 3 drops dose regimen. 40 subjects receive Chloroprocaine 3% Gel and
      20 receive vehicle (2:1 randomization) in the right eye.
    

Intervention name(s): Ocular gel
Intervention type(s): Drug
Intervention description(s): Instillation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment