bioihbjkbjnl/mcl2 huggingface dataset:
Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences
Condition: Port Wine Stain
MeSH terms: Hemangioma, Capillary; Port-Wine Stain
Study type: Observational

Summary: 
      The purpose of the study is to improve the efficacy of pulsed dye laser treatment of port
      wine stain birthmarks. Involvement in the protocol will involve formal documentation of the
      level of treatment pain, duration of post-treatment purpura and incidence of side effects. In
      addition, measurements will be taken of blood substances that promote blood vessel
      formation/regrowth and non-invasive reflectance measurements and photographs will be taken
      before and after treatment.

      The objective of this study is to document the degree of port wine stain lightening, the
      incidence of side effects and the presence of angiogenic factors induced during treatment
      with the pulsed dye laser in association with cooling agent. This information ultimately lead
      to improved treatment.
    

Detailed description: 
      The flashlamp-pumped pulsed dye laser has offered the best results with the lowest incidence
      of side effects. The yellow light is preferentially absorbed by hemoglobin allowing more
      selective destruction of the ectatic capillaries in the dermis.

      The flashlamp-pumped pulsed dye laser has become the treatment of choice for port wine stain
      birthmarks; however, therapeutic challenges remain. The epidermis is not totally spared due
      to partial absorption of energy therein by melanin which presents an optical barrier through
      which the light must pass to reach the underlying blood vessels. Absorption of laser energy
      by melanin causes localized heating in the epidermis, which may, if not controlled, produce
      permanent complications such as hypertrophic scarring or dyspigmentation.

      Clinical studies have demonstrated the efficacy and safety of cryogen spray cooling during
      pulsed laser treatment of port wine stain birthmarks. This technology allows the use of
      higher incident laser light dosages and has been demonstrated to improve treatment results.
      cryogen spray cooling also decreases treatment pain and the duration of post-laser treatment
      purpura.
    

Intervention name(s): Port wine stain Birthmark
Intervention type(s): Other
Intervention description(s): Port wine stain Birthmark
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
      
Keywords: Port Wine Stain
Soluble Corn Fiber and Calcium Utilization in Adolescents
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effect of soluble corn fiber on calcium
      absorption and retention and gut microflora in adolescent boys and girls.
    

Detailed description: 
      In a previous study, soluble corn fiber (SCF) was found to greatly enhance calcium
      utilization and bone properties in a growing rat model. Because factors that enhance bone
      density and mineral content can potentially result in a skeleton that will resist fracture
      later in life, it is important to investigate this potential in adolescents. Therefore, the
      objective of this study was to determine the effect of SCF on calcium absorption and
      retention in adolescent boys and girls. A second objective of this study was to assess
      whether additional dietary fiber leads to changes in gut microflora which may influence
      calcium absorption. During this two-phase metabolic camp participants consumed packages of
      fruit snacks supplemented with either 0 or 6 grams of soluble corn fiber twice a day during
      the first phase of the study, and switch to the opposite treatment during the second phase,
      with a 2-week washout period in between. Subjects collected all excreta during both phases
      and calcium absorption, gut microbiota, height, weight, and bone density were evaluated
      throughout the 6-week period of the study.
    

Intervention name(s): No soluble corn fiber; 12 g soluble corn fiber
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times per day; Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times per day.
Other intervention name(s): soluble corn fiber; soluble corn fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bone; adolescents; fiber; healthy; boys; girls; camp; calcium
Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1%
      cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream
    


Intervention name(s): pimecrolimus 1% cream; hydrocortisonacetat 1% cream; betamethasonvalerat 0,1% cream; clobetasol-17-propionat 0,05% cream; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks; twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks; twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks; twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks; twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other intervention name(s): Elidel 1% cream; Hydrogalen cream; Betagalen cream; Clobegalen cream
Intervention MeSH terms: Clobetasol; Pimecrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: pimecrolimus; hydrocortison; betamethasone; clobetasol-17-Propionat; Optical Coherence Tomography; skin healthy probands
Hippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome
Condition: Cushing's Syndrome
MeSH terms: Cushing Syndrome; Syndrome
Study type: Observational

Summary: 
      OBJECTIVES: I. Evaluate whether chronic hypercortisolemia is specifically toxic to
      hippocampal cells and causes structural reduction of hippocampal volume in patients with
      Cushing's syndrome.

      II. Determine whether reduced hippocampal volume is associated with specific memory
      dysfunction.

      III. Examine the relationships of adrenal androgen to hippocampal volume and memory
      dysfunction.

      IV. Examine the reversibility of hippocampal structural changes and cognitive dysfunction
      after cortisol levels are normalized.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients undergo a psychiatric evaluation for mood and cognition during
      confirmation of diagnosis. Neuropsychologic exams include pencil and paper test and a
      cognitive assessment.

      Endocrine studies include dexamethasone and corticotropin-releasing hormone stimulation
      tests. The hippocampal complex volume is assessed with coronal magnetic resonance imaging.

      There is a follow-up 1 year after the initiation of treatment.
    

Keywords: Cushing's syndrome; endocrine disorders; rare disease
The Effect of Trendelenburg Position on CCA Blood Flow
Condition: Perfusion; Perioperative/Postoperative Complications
MeSH terms: Pneumoperitoneum; Postoperative Complications
Study type: Observational

Summary: 
      The investigators will evaluate the change of the common carotid artery blood flow according
      to patient's position and penumoperitoneum.
    

Detailed description: 
      The study will include 20 patients undergoing gynecological surgery. The common carotid
      artery blood flow will be measured using Doppler US during the following conditions; supine
      position before induction of anesthesia, supine position immediately after induction of
      anesthesia, supine position with penumoperitoneum, head-down position with or without
      pneumoperitoneum.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing gynecology surgery under trendelenburg position
      
Keywords: Common carotid artery; Trendelenburg; Pneumoperitoneum; Blood flow
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Condition: Active Polyarticular Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin)
      at Day 113 in children and adolescents with pJIA
    


Intervention name(s): Abatacept
Intervention type(s): Biological
Other intervention name(s): Orencia
Intervention MeSH terms: Abatacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Performance Of Lithium Disilicate Crowns Restoring Endodontically Treated Teeth With Two Occlusal Preparation Schemes
Condition: Fracture of Lithium Disilicate (e.Max) Crowns
MeSH terms: Tooth, Nonvital
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the clinical performance of lithium disilicate crowns
      restoring endodontically treated teeth with two occlusal preparation schemes.
    

Detailed description: 
      Statement of the problem:

      The endodontically treated teeth need to be restored back to form, function and aesthetics.
      The quality of the coronal restoration will directly impact on their survival and success.
      The aim of the coronal restoration of endodontically treated teeth is to provide the
      necessary strength for the restoration/tooth complex through tooth preparation in order to
      withstand functional stress and prevent crown and/or root fracture. The use of ceramic crowns
      has increased substantially in recent years because of their superior esthetics and high
      mechanical properties. Long term success of all ceramic crowns is affected by many factors
      and the failure patterns of these all ceramic crowns should be inspected closely to detect
      their clinical performance.

      Rationale for carrying out the trial:

      Endodontic treatment weakens posterior teeth and ought to be covered by crowns.The capability
      of these crowns to bear load relies on the preparation of an appropriate design and the
      selection of a crown material with adequate fracture strength and thickness. In vital teeth,
      the anatomic occlusal preparation design is followed such that the occlusal surface is
      reduced uniformly, maintaining the cusps and normal inclined planes but at a reduced height.
      This aids in minimizing the risk of pulp injury. In contrast, in non-vital teeth, this design
      can be modified such that the occlusal surface is prepared in two planes (buccal and lingual
      planes). A flat prepared occlusal surface provides less quantitative and better qualitative
      stresses when compared to an anatomically prepared surface
    

Intervention name(s): Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns
Intervention type(s): Procedure
Intervention description(s): Clinical trials lacks information about flat occlusal preparation design in case of endodontically treated teeth. Therefore, this is tested during preparation when compared to planer occlusal preparation while the final restoration in both arms is lithium disilicate (e.max) crowns.
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: e.max; occlusal scheme; endodontically treated teeth
Rosuvastatin Calcium Bioequivalence Study - Fast
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, two treatment, two sequences, two periods crossover study,
      using a crossover 2x2 design, where each subject will be randomly assigned to reference or
      test formulation, in order to evaluate if both formulations are bioequivalent.
    

Detailed description: 
      The objective of this study is to confirm if two formulations of rosuvastatin calcium 20 mg
      tablets are bioequivalent. Test formulation is rosuvastatin calcium 20 mg tablets -
      manufactured by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brazil Ltda.,
      administration of one single-dose tablet. Reference formulation is rosuvastatin calcium 20 mg
      tablets (Crestor® 20 mg - AstraZeneca do Brasil Ltda.), administration of one single-dose
      tablet. Sixty-four healthy volunteers, of both genders, with age ranging from 18 and 50 years
      old, will receive test or reference formulation under fasting conditions, according to the
      randomization list. In each period, after administration of medication, blood samples are
      collected at the following times: 0:00 (prior to administration), 0:30, 1:00, 1:30, 2:00,
      2:20, 2:40: 3:00, 3:20, 3:40, 4:00, 4:20, 4:40, 5:00, 5:30, 6:00, 7:00, 8:00, 10:00, 12:00,
      24:00, 36:00, 48:00 and 72:00 hours. The comparative bioavailability of formulations is
      evaluated based on relevant pharmacokinetic parameters for statistical comparison. Such
      parameters are obtained directly from the determination of the drug active principle
      plasmatic concentration, based on the application of a non-compartmental pattern for the
      evaluation of these concentrations after the drug oral administration.
    

Intervention name(s): Crestor®; rosuvastatin calcium tablets
Intervention type(s): Drug; Drug
Intervention description(s): Reference formulation is rosuvastatin calcium tablets, 20mg, currently commercialized by AstraZeneca do Brasil Ltda., under the trademark Crestor®; Test formulation is rosuvastatin calcium tablets, 20 mg, produced by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda.
Intervention MeSH terms: Rosuvastatin Calcium; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To investigate the 5-hour acute effect on energy expenditure, substrate oxidation and ad
      libitum food intake after intake of the Metobes-compound (green tea extract, capsaicin,
      tyrosine, caffeine). Furthermore, to investigate if the effect of the Metobes-compound can be
      inhibited by blocking the β-adrenergic receptors.

      The effect of the Metobes-compound will be investigated by:

        1. 5-hour energy expenditure and respiratory quotient (ventilated hood).

        2. 5-h change in blood pressure and heart rate

        3. 5-h change in sympathetic/parasympathetic ratio.

        4. Ad libitum energy intake.

        5. Self-reported postprandiel appetite sensations (VAS).
    

Detailed description: 
      Subjects 22 healthy Danish overweight to obese men (BMI between 25 and 35 kg/m2), 18 to 50
      years of age. All subjects must be weight stable (within  3-kg) 2 months prior to study
      inclusion, non-smoking, non-athletic and have no daily use of medication.

      Method

      The study is designed as a 4-way crossover, randomised, placebo controlled, double-blind
      study. Each treatment will be separated by >1-week washout period. The treatments will
      consist of:

        1. Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without
           calcium together with 5 mg propranolol.

        2. Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without
           calcium together with 10 mg propranolol.

        3. Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without
           calcium together with a placebo tablet for propranolol (microcrystalline cellulose).

        4. Placebo for the Metobes compound (microcrystalline cellulose) together with a placebo
           tablet for propranolol (microcrystalline cellulose).

      On each test day body weight and composition will be assessed. All subjects will undergo a
      5-h post dose assessment of energy expenditure by indirect calorimetry in a ventilated hood.
      Subjective appetite sensations, ECG and dual measures of blood pressure/heart rate will be
      assessed every 30 minutes. After completed respiratory measurements the subjects will be
      served an ad libitum lunch meal (pasta salad).

      All subjects shall collect all urine excreted during the respiratory measurements. Urine
      samples will be analyzed for nitrogen content and content of catecholamines.
    

Intervention name(s): Metobes-compound
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Green tea; capsaicin; tyrosine; caffeine; energy expenditure; catecholamines
Adaptive Treatment for Adolescent Cannabis Use Disorders
Condition: Mental Disorders; Addictive Behaviors; Cannabis Use Disorder
MeSH terms: Marijuana Abuse; Mental Disorders; Behavior, Addictive
Study type: Interventional

Summary: 
      The purpose of this study is to examine an Adaptive Treatment approach in order to improve
      outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.
    

Detailed description: 
      The study will address the current contrasts in youth response to treatment, the problem of
      poor response to treatment and the prevention of relapse. Results from the study may support
      Adaptive Treatment as an efficacious approach for youth with Cannabis Use Disorder who are
      poor responders to treatment.

      Poor responders fall into two categories, those who failed to achieve a negative drug
      urinalysis during the last session of the initial MET/CBT-7 treatment they attended, and
      those who either dropped out or were administratively discharged at any time during the
      initial MET/CBT-7 treatment.
    

Intervention name(s): ACRA; CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Ten weekly,60-minute therapy sessions including six individual, two parent/guardian and two joint (individual and parent/guardian).; 10 weekly, 60-minute sessions of augmented individualized CBT
Other intervention name(s): Adolescent Community Reinforcement Approach; Cogntive Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Substance Use Disorders
Study of Hydroxyurea to Treat Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      The aim of this single-center observational study was to evaluate quality of life, clinical
      effectiveness, and satisfaction in pediatric and young adult patients with sickle cell
      disease receiving hydroxyurea.
    

Detailed description: 
      In this study, 34 pediatric (HbSS: n= 5; HbSβ0: n= 29) and 16 (HbSS: n=5; HbSβ0: n= 11) young
      adult adult patients with sickle cell disease receiving hydroxyurea for at least a year were
      participated. Upon receipt of Informed Consent Form, Case Report Form, Demographic Data
      Collection Form, Child Health Questionnaire-Parent Form, Life Quality Survey Short Form-36,
      and Hydroxyurea Therapy Satisfaction Survey were used to obtain data for effectiveness of
      hydroxyurea therapy and parameters that may affect compliance to treatment and life quality
      of the participants.

      Regarding the normal ranges, ferritin, hemoglobin A, A2, F, and S, platelet, mean corpuscular
      volume, erythrocyte distribution width, basophil percentage, monocyte, monocyte percentage,
      total bilirubin, direct bilirubin, and C-reactive protein values were higher while
      hemoglobin, hematocrit, and erythrocyte values were lower in these patients. Our findings
      regarding quality of life and satisfaction with hydroxyurea therapy indicated that the
      patients with sickle cell disease had lower scores.

      Demographic, clinical, and therapeutic variables as well as comorbid diseases and concomitant
      drug use when considered together, these findings suggest that the health quality and
      compliance of the pediatric and young adult patients to therapy might be low due to not
      sufficiently effective hydroxyurea therapy in addition to comorbidities, concomitant drug
      use, and side effects.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric (7-17 years) and young adult (18-22 years) patients with sickle cell disease who
        received hydroxyurea
      
Keywords: Sickle cell disease; Hydroxyurea; Compliance