bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Depth and Duration of Anesthesia
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera
      topical patch (using sensory depth and pain depth evaluations), and to determine the duration
      (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing
      and thermal sensory testing evaluations), compared with a matching heated placebo patch.
    


Intervention name(s): Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine); Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): 30 minute applicable on antecubital fossa; placebo
Intervention MeSH terms: Lidocaine; Tetracaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Topical anesthesia; Analgesia
Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if cantharidin is a safe and effective treatment
      for molluscum contagiosum in kids
    

Detailed description: 
      This was a double-blind, placebo-controlled trial. Participants were recruited from the
      Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants
      were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with
      occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3
      (blinded phase). At week 6, all participants were treated with open-label, topical
      cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label
      phase).
    

Intervention name(s): Cantharidin; Placebo; Gauze occlusion bandage
Intervention type(s): Drug; Drug; Device
Intervention description(s): cantharidin 0.7% topical liquid; Placebo topical liquid; Gauze occlusion bandage with adhesive tape
Other intervention name(s): 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione; flexible collodion
Intervention MeSH terms: Cantharidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Corneal Endothelial Changes Following Pediatric Cataract Surgery With IOL Implantation
Condition: Congenital Cataract Surgery; IOL Implantation; Change in Corneal Endothelial Cell Morphology
MeSH terms: Cataract
Study type: Observational

Summary: 
      Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is
      reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs
      following cataract surgery. However, no data is available regarding endothelial changes after
      cataract surgery with IOL implantation in pediatric eyes.

      The aim of this study is to prospectively observe changes in endothelial cell density,
      coefficient of variation and hexagonality following cataract surgery with IOL implantation in
      pediatric eyes.
    


Intervention name(s): Congenital Cataract Surgery
Intervention type(s): Procedure
Intervention description(s): Congenital cataract surgery with IOL implantation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children older than 4 years undergoing cataract surgery with IOL implantation were
        included.
      
Keywords: corneal endothelium; congenital cataract surgery; IOL implantation
Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity
Condition: Melasma
MeSH terms: Melanosis
Study type: Observational

Summary: 
      The objective of the study was to compare the level of serum FT4 and TSH in patients with
      mild melasma and moderate-severe melasma. The determination of melasma lesion could also be
      known by using Janus II facial analysis UV light and polarization light to analyze the
      pattern of hyperpigmentation on melasma. This was a descriptive-analytic study used a
      cross-sectional method that was performed in 2019 at two different dermatology and venerology
      clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta and Gatot Subroto Army Hospital
      Jakarta. Forty-eight subjects with melasma, 50% diagnosed with mild melasma and 50% with
      moderate-severe melasma according to the modified melasma area and severity index (mMASI)
      score. The level of serum FT4 and TSH were then measured in both groups of the patients.
    

Detailed description: 
      Melasma has been suspected to be linked with thyroid hormone. There is no study that explains
      the association of thyroid hormone level with melasma severity.

      This study aims to find the difference in the levels of thyroid hormone in varying severity
      of melasma.

      This was a descriptive-analytic study used a cross-sectional method that was performed in
      2019 at two different dermatology and venerology clinics in Indonesia, Cipto Mangunkusumo
      Hospital Jakarta and Gatot Subroto Army Hospital Jakarta.

      Forty eight patients participated in this study, 50% diagnosed with mild melasma and 50% with
      moderate-severe melasma. Subjects are chosen consecutively based on mMASI and Janus II
      measurement. The level of serum FT4 and TSH were then measured in both groups of the
      patients. The data is tabulated and a comparative analysis of serum FT4 and TSH levels with
      mild and moderate-severe melasma is done. In addition, this study also analyzes the level of
      serum FT4 and TSH with the result of Janus II facial analysis system scoring. The same method
      of analysis was done to know the association between mMASI and examination by using Janus II
      facial analysis system.

      This study aims to find the difference in the levels of thyroid hormone in varying severity
      of melasma.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The target population is patients with melasma in Indonesia aged 20-50 years.

        Affordable population are patients with melasma who come to the Skin and Genital Clinic of
        RSCM aged 20-50 years in the study period.
      
Keywords: mMASI; Janus II facial analysis system; TSH; FT4
Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)
Condition: Cardiovascular Diseases; Cerebrovascular Disorders; Metabolic Disease; Neoplasms; Endocrine System Diseases; Neurologic Symptoms; Skeletal Anomalies; Diabetes Mellitus; Pregnancy Complications
MeSH terms: Cerebrovascular Disorders; Neurologic Manifestations; Pregnancy Complications; Cardiovascular Diseases; Metabolic Diseases; Endocrine System Diseases
Study type: Observational

Summary: 
      To study, prospectively, the association between dietary patterns and risk of health outcomes
      (cardiovascular, metabolic, endocrine, neurological, skeletal muscular, cancer) in cohort
      study of 116,671 women age 24 to 44 years at baseline in 1989 (the Nurses' Health Study II;
      NHS II).
    

Detailed description: 
      Health status and lifestyle information was self-reported on a questionnaire at baseline, and
      on questionnaires distributed to participants biennially thereafter. Dietary intake data was
      collected in form of a comprehensive, 131-item food frequency questionnaire (FFQ),
      distributed among participants every four years. The response rate remained over 90%. Dietary
      data was validated using biomarkers, health status data using medical records.

      Dietary pattern scores were derived from FFQs using cumulative average whenever possible from
      years preceding the outcomes.

      Multivariable Cox proportional hazards models were used to evaluate associations between
      dietary pattern scores and health outcomes, except in case of pregnancy complications (such
      as gestational diabetes mellitus/GDM and hypertensive disorders of pregnancy/HDPs) where
      multivariable logistic regression models with generalized estimating equations, with an
      exchangeable working correlation structure to account for correlated outcomes between
      pregnancies.
    

Intervention name(s): Dietary intake
Intervention type(s): Other
Intervention description(s): Dietary intake converted into dietary pattern scores.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Nurses' Health Study II (NHS II) is a prospective cohort established in 1989 that
        includes 116,671 female registered U.S. nurses, aged 24-44 at baseline. Mailed
        questionnaires were administered biennially to collect data on medical and lifestyle
        factors, with a follow-up rate exceeding 90% for each 2-year cycle. Comprehensive food
        frequency questionnaires (FFQs) were distributed every four years to collect data on
        dietary intake.
      
Biospecimen description: 
      Plasma and buffy coat
A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult
      subjects with cystic fibrosis.
    


Intervention name(s): SPX-101
Intervention type(s): Drug
Intervention description(s): Inhalation solution twice daily for 7 days.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines
Condition: Facial Wrinkles; Skin Aging
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of
      the cryo-touch II device for the treatment of forehead and/or glabellar lines
    


Intervention name(s): Cryo-Touch II
Intervention type(s): Device
Intervention description(s): Percutaneous treatment with the device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome; Impulsive Behavior
Study type: Interventional

Summary: 
      Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics.
      Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality
      and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source
      of these troubles. Its anatomical substrates is based on connections between frontal and
      striatal areas.

      Initially, a battery of behavioral tests measuring different types of impulsivity (motor,
      cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40
      patients treated and 40 untreated) and 40 healthy volunteers.

      Then, investigators will study the fronto-striatal connections in the TS group of 80 patients
      (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging
      techniques (3T MRI). The techniques used will be functional connectivity study of "resting
      state" MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion
      tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging
      data to highlight the functional anatomical substrates of impulsivity in patients with TS.

      Finally, investigators will look specifically using functional MRI activation, the anatomical
      and functional substrates of the three types of impulsivity (motor, cognitive and
      decision-making).

      Through this study, investigators hope to elucidate the anatomical and functional bases of
      cognitive impulsivity in patients with TS and thus lay the basis for more targeted
      treatments.
    


Intervention name(s): IRM and comportemental tasks
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cognitive impulsivity; IRM; Tourette Syndrome
Non Invasive Haemodynamics in Neuraxial Anaesthesia Hypotension
Condition: Hypotension, Controlled; Anaesthesia, Spinal; Caesarean Section
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Spinal (or neuraxial) anaesthesia is still considered the first choice technique for elective
      Caesarean section as simple, quick, reliable and cheap. However, this anaesthetic method can
      be burdened by maternal hypotension with significant maternal and foetal implications.
    

Detailed description: 
      Hypotension induced by neuraxial anaesthesia (NA-induced hypotension) is defined as systolic
      blood pressure (SBP) less than 100 mmHg or a decrease of 20-30% from baseline values. The
      incidence of hypotension could exceed 71% and can cause, if serious and prolonged, nausea,
      vomiting, lost of consciousness, placental hypoperfusion and foetal acidosis.

      There are two alternative hypotheses to explain why hypotension might be so commonly
      diagnosed after regional analgesia during labour: preload reduction theory and afterload
      reduction theory. A non-invasive continue haemodynamic monitoring could be useful in
      detecting pregnant women with a positive preoperative supine stress, at increased risk for
      clinically significant hypotension during Caesarean section under spinal anaesthesia. These
      women seem more likely to benefit from optimizing the administration of fluids and
      vasoconstrictors to maintain pressure and cardiac output at basal levels.

      Predictors of clinical need of therapy to counteract symptomatic hypotension (dependant
      variable) will be sought by using regression logistic analysis. Putative variable to include
      in the model will be selected through clinical and statistical criteria. Univariate screening
      will be performed assuming the usual cut-off of p<0,1 and taking into account the biological
      relevance. The final variable to challenge in the multivariate model will be selected
      according to the parsimony criteria in order to avoid overfitting and multicollinearity.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy pregnant women admitted in the enrolling Centre to undergo to elective Caesarean
        section under spinal anaesthesia
      
Keywords: Induced hypotension; Spinal Anaesthesia; Elective Caesarean section; non-invasive haemodynamic parameters
Exercise, Glucose Kinetics, and the Incretin Effect
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Human volunteers will be stratified by oral glucose tolerance status: normal glucose
      tolerant, impaired glucose tolerant, and type 2 diabetic. All subjects will undergo 4
      experimental trials: [1] an oral glucose tolerance test (OGTT) combined with infused and
      ingested stable isotopes of glucose to assess glucose kinetics. [2] a 1 hour bout of cycling
      exercise at 50% of maximum power output, immediately followed by the same OGTT combined with
      stable isotope glucose tracers used in trial 1. [3] an isoglycemic clamp to match the plasma
      glucose profile measured in trial 1. [4] a 1 hour bout of cycling exercise at 50% of maximum
      power output, immediately followed by an isoglycemic clamp to match the plasma glucose
      profile measured in trial 2.

      Exercise-induced changes in oral glucose tolerance, glucose kinetics, insulin and glucagon
      secretion, and the incretin effect will be examined. The exercise responses will be compared
      between the subjects groups of different glucose tolerance status.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): 1 hour of cycling at 50% of maximum power output
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise; Physical activity; Type 2 diabetes; Obesity; Incretin effect; GLP-1; GIP; Insulin secretion; Glucagon; Beta-cell function; Disposition Index
Intraobserver and Interobserver Reproducibility on Hip Clinical Assessment
Condition: Hip Joint
Study type: Observational

Summary: 
      The functional assessment of the hip joint is complex and challenging. Reproducible measures
      are necessary to identify changes in the structures and functionality of the hip joint over
      time and to evaluate the outcomes of treatments. A systematic evaluation process is critical
      to evidence-based practice. However, there are few studies investigating the reproducibility
      of these measures such as muscle strength, range of motion (ROM) and hip functionality in
      healthy subjects.
    

Detailed description: 
      Twenty subjects were randomized in two different days: (1) First evaluation of muscle
      strength, range of motion and single-leg squat performed by the evaluator 1; (2) Repeat the
      first evaluation with 3 different evaluators
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Male healthy subjects
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      compare the efficacy of insulin decludec with insulin glargine on glycaemic control using
      continuous glucose monitoring in patients with type 1 diabetes.
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) once daily.; Administered subcutaneously (s.c., under the skin) once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to demonstrate that macitentan and tadalafil
      administered as a fixed combination is bioequivalent to both compounds given as separate
      tablets given at the same doses as in the fixed combination (i.e. whether the amounts of
      macitentan and tadalfil which reach the blood are comparable).
    


Intervention name(s): Macitentan / tadalafil FDC; Macitentan (Opsumit®); Tadalafil (Adcirca®)
Intervention type(s): Combination Product; Drug; Drug
Intervention description(s): Tablets for oral administration containing 10 mg of macitentan and 40 mg of tadalafil; Film-coated tablets for oral administration formulated at a strength of 10 mg; Film-coated tablets for oral administration formulated at a strength of 20 mg
Other intervention name(s): ACT-064992
Intervention MeSH terms: Tadalafil; Macitentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence
The Effect of Coffee After Resection of Small Bowel
Condition: Postoperative Ileus
Study type: Interventional

Summary: 
      Post-operative ileus ("post-op ileus") is a condition which can occur after surgery. This
      means that the bowels stop working correctly and food and liquids will not pass through in
      the normal manner. Post-op ileus can be uncomfortable and require a longer hospital stay
      until the bowels begin to function correctly again. Currently there are no effective methods
      for preventing post-op ileus. Some studies suggest there is a benefit from drinking coffee
      following colon or gynecological cancer surgeries with very little risk. However, the effects
      of coffee following small bowel surgery have not been studied. This randomized, controlled
      trial will compare the outcomes of patients who receive coffee during their hospital stay
      after small bowel surgery to similar patients who receive warm water. About 60 patients will
      be in each group. The main outcomes are time until the nasogastric tube is removed and length
      of hospital stay.
    


Intervention name(s): Coffee; Water
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Brewed, caffeinated coffee, 100 cc's each dose; Tap water heated to same temperature as coffee
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, parallel-group, controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Safety Study of Dengushield in Healthy Adults
Condition: Phase 1; Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal
      antibody) in healthy adults.
    

Detailed description: 
      This Phase 1 study will evaluate the safety and tolerability of a single dose of Dengushield
      (dengue monoclonal antibody) in healthy adults in a dose-escalating study design. In
      addition, pharmacokinetics will also be studied.
    

Intervention name(s): Dengushield 1 mg/kg (Cohort 1) intravenous; Dengushield 3 mg/kg (Cohort 2) intravenous; Placebo 3 mg/kg (Cohort 2) intravenous; Dengushield 7 mg/kg (Cohort 3) intravenous; Placebo 7 mg/kg (Cohort 3) intravenous; Dengushield 12 mg/kg (Cohort 4) intravenous; Placebo 12 mg/kg (Cohort 4) intravenous
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.; Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.; Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.; Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.; Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.; Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.; Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Phase 1, randomized, partially-blind (observer-blind), placebo controlled, single dose ascending study in healthy adults. For the Cohort 1 (Initial Safety Cohort), no placebo control will be used and hence, blinding is not applicable.
There will be 4 dose levels. The proposed doses to be studied are; 1 mg/kg, 3 mg/kg, 12 mg/kg and 25 mg/kg. Total of 40 participants will be dosed and followed till Day 84 from dosing.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dengue