bioihbjkbjnl/mcl2 huggingface dataset:
Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study
Condition: Generalized Anxiety Disorder; Separation Anxiety Disorder; Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social; Anxiety, Separation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate neurobehavioral, affective, and social processes
      that may influence and predict treatment response in pediatric anxiety disorders.
    

Detailed description: 
      This protocol proposes to study neurobehavioral and social correlates of treatment response
      in 200 youth (ages 9-13) with general anxiety disorder (GAD), separation anxiety disorder
      (SAD), and social phobia (SP). All youth with an anxiety disorder will receive 14 weeks of
      Cognitive Behavioral Therapy (CBT) or Client Centered Therapy (CCT) for child anxiety
      disorders. The study combines state-of-the-art measures from affective neuroscience,
      ecologically valid (EMA) measures of mood and behavior in natural environments, and measures
      of family and social context within a developmentally framed treatment study. The study
      design focuses on predictors and mechanisms of treatment response. This protocol will test
      key features of a "vigilance-avoidance" model focusing on hypotheses that pretreatment neural
      correlates of affective reactivity will predict treatment response and early changes in
      emotional processing will correlate with clinical response during treatment. In addition, the
      protocol examines how affective experiences within the family and social context are
      associated with treatment response and change across treatment, and how these are associated
      with and interact with neurobehavioral changes in affective functioning. Taken together these
      aspects of the study will advance understanding of the neurobehavioral, affective, and social
      processes that underpin treatment response in ways that will inform the design, refinement,
      and optimal developmental timing of cognitive behavioral treatments, and thus, decrease the
      morbidity, mortality, and lifetime impairments from these common disorders in youth.
    

Intervention name(s): Cognitive Behavioral Therapy; Client Centered Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 16 sessions of CBT; 16 sessions of CCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neural correlates of pediatric anxiety disorder; Social correlates of pediatric anxiety disorder; Generalized Anxiety Disorder in pediatric populations; Separation Anxiety Disorder in pediatric populations; Social Phobia in pediatric populations
Sarcopenia in Axial and Peripheral Spondyloarthropathies
Condition: Spondylarthropathy; Sarcopenia
MeSH terms: Spondylitis; Spondylarthropathies; Spondylarthritis; Sarcopenia
Study type: Interventional

Summary: 
      Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in
      adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much
      documented in the literature, and not yet studied in France. In addition, sarcopenia is
      associated with decreased physical activity and increased risk of falls and fractures. A
      better characterization of the determinants of this muscular loss will allow to better detect
      and take care of it.

      The aim is to conduct the first French study on the prevalence and severity of sarcopenia in
      patients with spondyloarthropathies and to study the variables that may be associated with
      it. Finally, we propose to evaluate obesity related to sarcopenia in these patients and
      compare them to cases matched for age and sex (from OFELY / STRAMBO cohorts, Lyon, FRANCE).

      This is a prospective interventional and monocentric study with minimal risks and
      constraints: patients will be included for one day for an evaluation of their sarcopenia by
      measuring their muscle strength, physical performance and body composition and recording of
      their socio-demographic and disease characteristics.
    


Intervention name(s): Dynamometry exam; Walking test; DXA measurement; SARQOL questionnaire; Life habits Questionnaire
Intervention type(s): Other; Other; Radiation; Other; Behavioral
Intervention description(s): Prehension strength of the main hand will be assessed thanks to dynamometry, in order to evaluate patient's muscular strength; A 4 metres walking test will be performed to assess patient's walking speed; DXA measurement will be performed to assess patient's body composition; Patient's quality of life will be assessed thanks to the SARQOL questionnaire; Life habits Questionnaire
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Spondylarthropathy; Sarcopenia; lean mass; fat mass
Pulp Revascularization Versus MTA Apexification
Condition: Necrotic Pulp
MeSH terms: Dental Pulp Necrosis; Necrosis
Study type: Interventional

Summary: 
      This study compared the efficiency of pulp revascularization and MTA apexification in the
      treatment of patients with necrotic immature anterior teeth.
    

Detailed description: 
      the participants with 66 anterior necrotic immature teeth were randomly assigned into two
      equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the
      first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as
      intra-appointment intracanal medication. At the second visit, after removal of the medication
      with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the
      orifice in the regeneration group. While in the Apexification group, the MTA was packed
      apically and all teeth were finally restored with resin composite restorations. The patients
      were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.
    

Intervention name(s): revascularization; Apexification
Intervention type(s): Procedure; Procedure
Intervention description(s): a sterile sharp needle was used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process; a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.
Other intervention name(s): regeneration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants are allocated at random to receive one of two interventions according to the research plan. In RCT the outcomes are measured, so it is considered a quantitative study . This trial conforms to the Consolidated Standard of Reporting Trials (CONSORT)statement.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: regeneration, MTA apexification and TAP; revascularization
Efficacy of Erenumab on Functional Impact of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of erenumab on functional impact due to
      Migraine in adults.
    

Detailed description: 
      This is a single group, multicenter, open-label study with a study population of patients who
      meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for
      migraine with or without aura and have 4 to 20 migraine days per month. This is a
      single-group supportive care study with one arm and no masking. A maximum of 54 participants
      will be enrolled to study intervention. All participants in this single-group study will
      complete a 4-week run-in period. After the run-in period, eligible participants will be
      enrolled to study intervention and enter a 12-week treatment period.
    

Intervention name(s): Erenumab-Aooe 140 MG/ML [Aimovig]
Intervention type(s): Drug
Intervention description(s): 140 mg/mL administered subcutaneously
Other intervention name(s): Erenumab; Aimovig
Intervention MeSH terms: Erenumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System
Condition: Adenoma Colon
MeSH terms: Adenoma; Colonic Polyps
Study type: Interventional

Summary: 
      This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe)
      system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese
      population. In addition, this study will evaluate the effect of CADe system on adenoma
      detection of endoscopists under fatigue.
    


Intervention name(s): AI-assisted colonoscopy
Intervention type(s): Device
Intervention description(s): AI can not only detect suspicious lesions timely, and label them in the field of view of the colonoscopy, but also monitor withdrawal speed and calculate the clean withdrawal time automatically.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching
      Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human
      Insulin and Metformin: a Randomized, Open, Parallel trial.
    

Detailed description: 
      This is a multicentre, open-label, randomized and parallel trial that will compare the
      efficacy and safety of basal insulin glargine combination with Exenatide bid vs. switching
      premix human insulin to aspart30 in type 2 diabetic patients with inadequate glycaemic
      control on premixed human insulin and metformin. Approximately 248 patients will be enrolled
      in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms:
      once-daily insulin glargine + twice-daily exenatide + metformin; or twice-daily aspart 30 +
      metformin.

      Study treatment will continue for 24 weeks. The primary efficacy measure is the change in
      HbA1c at 24 weeks. The study consists of 3 periods: a 1-week screening (period A), a 12-week
      run-in period (period B) and a 24-week treatment period (period C).
    

Intervention name(s): glargine + exenatide; aspart 30
Intervention type(s): Drug; Drug
Intervention description(s): glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily); aspart 30 ( subcutaneous injection, twice daily)
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exenatide; glargine; aspart 30
Physical Therapy for Hypertensive Elderly
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Physical therapy for hipertensive elderly: effects in the physical activity and exercise
      adherence.

      Introduction: The arterial hypertension (AH) is a clinical syndrome characterized by blood
      pressure ≥ 140/90mmHg. Practical of physical activity (PA) and/or physical exercise (PE) is
      one of the modalities of not farmacological treatment. Hypertensive aged not adhere to this
      recommendation for presenting factors that make it difficult this practical. Objective: to
      verify if physical therapy (PT) treatment can improve the AF and EF adhesion of hypertensive
      aged. Methods: The sample was composed by 43 hypertensive aged of Arterial Hypertensive
      League of the Federal University of Goiás. Of these, 30 had remained in the study and had
      been randomized in study group (SG) (16 patients) and control group (CG) (14 patients). SG
      was submitted of the PT treatment and participated of educative meetings, the CG only
      participated of the meetings. To evaluate adhesion to the AF was used the pedometer and EF
      was used a questionnaire of open and closed questions, six minute walk test (6'WT) and
      ergometric test (ET).
    


Intervention name(s): Physical Therapy and education meetings; education meetings
Intervention type(s): Other; Other
Intervention description(s): Physical therapy was realized three two times per week and education meeting every fifteen days; This group only participed of education meeting (every fifteen days)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical therapy; hypertension; aged; exercise; Physical exercise; Physical activity
A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The aim of study is to compare skin-to-delivery time and postoperative morbidity between
      extraperitoneal cesarean and transpirational cesarean.
    


Intervention name(s): Transperitoneal cesarean technique; Extraperitoneal cesarean technique
Intervention type(s): Other; Other
Intervention description(s): Pfannenstiel-Kerr technique for laparatomy and uterine entry; Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extra-peritoneal cesarean; Intra-peritoneal cesarean
Pharmacokinetic Study Protocol of ANAWIDOW Lyophilized Powder for Solution for Intravenous Use in Fasting Conditions
Condition: Latrodectism
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-dose, open-label, single-treatment, single-period pharmacokinetic study under
      fasting conditions, in 12 healthy adult. To evaluate the single dose pharmacokinetic profile
      ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for
      solution 10 mL (dose: 3x10 mL vials) for intravenous use.
    

Detailed description: 
      To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black
      widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for
      intravenous use of Laboratorios Silanes, S.A. de C.V. in healthy adult human male and female
      subjects under fasting conditions. To assess the safety of single dose of ANAWIDOW [antivenin
      latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL (dose:
      3x10 mL vials) for intravenous use in healthy adult human male and female subjects under
      fasting conditions. In a minimum of 12 healthy adult. In this study, all subjects will be
      required to fast overnight for at least 10.00 hours prior to dosing at least 04.00 hours
      post-dose.

      In this study, 3 ANAWIDOW 10 mL vials (3x10 mL) will be administered after diluting with
      normal saline solution up to 50 mL as intravenous infusion over 30 minutes. The solution will
      be infused through a 20-gauge catheter placed in the subject's left or right hand antecubital
      fossa at room temperature under fasting conditions.
    

Intervention name(s): ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL
Intervention type(s): Drug
Intervention description(s): Antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL for intravenous use [parenteral formulation]; hence, a single-dose fasting pharmacokinetic study is planned.
Other intervention name(s): ANAWIDOW
Intervention MeSH terms: Antivenins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Latrodectus envenomation; Black Widow; Equine immune; F(ab´)2
Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the effects of VX-770 on Midazolam and
      Rosiglitazone, and the effect of Fluconazole on VX-770.
    


Intervention name(s): VX-770; VX-770
Intervention type(s): Drug; Drug
Intervention description(s): In period 1, subjects will receive a single oral dose of midazolam (2 mg) and on Day 1 and Day 8. Subjects will receive single oral dose of rosiglitazone 4 mg and on Day2 and Day 9. Subjects will receive multiple doses of VX-770 150 mg q12h Day 3-10.; In period 2, subjects will receive 150 mg VX-770 q12h orally from Day 1 through the morning of Day 8. On the morning of Period 2 Day 1, subjects will receive a 400 mg loading dose of fluconazole. Thereafter, subjects will receive 200 mg fluconazole qd orally from Day 2 through Day 9.
Intervention MeSH terms: Ivacaftor
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to compare the pharmacokinetics of two different lots of tablets.
    


Intervention name(s): Treatment A; Treatment B
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R3 lot; 150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R4 lot
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: formulation comparison
Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      The purpose of this study is to determine the prevalence of positive antiphospholipid
      antibodies among women with preeclampsia and to determine the effect of antiphospholipid
      antibodies on the severity of preeclampsia and the obstetric outcomes
    

Detailed description: 
      For all women included in the study, blood samples will be tested for anticardiolipin
      antibodies and lupus anticoagulant. The clinical details of all women will be collected by
      reviewing their hospital and prenatal records. The following clinical characteristics will be
      evaluated: maternal age, previous gestations, parity, past or family history of preeclampsia,
      gestational age at the onset of preeclampsia, gestational age at delivery and birth weight.
      The following pregnancy and delivery complications will be assessed: placental insufficiency,
      intrauterine growth restriction, fetal loss (stillbirth) and early neonatal death.
    

Intervention name(s): Testing for antiphospholipid antibodies
Intervention type(s): Other
Intervention description(s): Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant
Intervention MeSH terms: Antibodies; Antibodies, Antiphospholipid
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Attendants of Tertiary Hospital Obstetric Outpateint Clinics and Emergency Department
      
Biospecimen description: 
      Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant
    
Keywords: Preeclampsia; Antiphospholipid Antibodies
Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
Condition: Forearm Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      It is believed, that Non Steroidal Antiinflammatory Drug (NSAID) drugs slows bone healing,
      but the knowledge is based only on animal studies, and the results are automatically raised
      for the people.

      Many patients with bone fracture must therefore avoid the formerly so popular and good
      painkillers, although no clinical trial evidence is, that this medicine is really harmful for
      patients with fractures.

      The purpose of this study is to investigate whether these drugs slows bone healing, and what
      the relationship is between various bone studies - DEXA scanning, biochemical bone marker
      tests, radiographic controls and tissue examination of newly formed bone under a microscope.
      How sensitive and specific, each of the above study methods? If they are just as sensitive,
      the cheapest of them recommended as a routine investigation on suspicion of bone effects.
      Furthermore, to compare the benefit (pain-relieving effect, influence on rehabilitation) of
      these drugs and their possible harmful side effects (affected and delayed bone healing).

      The expectation is that the study may contribute to increased knowledge about NSAIDs effect
      do pain management, rehabilitation and the entire treatment process significantly easier and
      safer, so that patients recover faster and return to usual activities.
    


Intervention name(s): Ibuprofen; Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis; Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture; Only placebo treatment instead of NSAID painkillers
Other intervention name(s): M01AE01 7 days; M01AE01 3 days; M01AE01 0 days
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSAID; bone fracture; heal
The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters
Condition: Minimal Erythema Dose; Skin Viscoelasticity; Dermis Density
MeSH terms: Erythema
Study type: Interventional

Summary: 
      The double-center, randomized, placebo-controlled, one-period effectiveness study will
      include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III).
      Subjects will be divided in two groups, 15 in each. One group (test group) will receive
      investigational product - lutein syrup (4 mg/mL; daily dose 20 mg) and the other (placebo
      group) placebo syrup. Participants will test continuous administration of placebo or
      investigational product for 12 weeks in order to demonstrate and assess multiple-dose
      effects. The primary objective is to assess the photoprotective potential of the
      investigational product in relation to placebo product. The secondary objectives are to
      assess effects of investigational product on dermis density and skin viscoelasticity after 12
      weeks of dietary supplementation.
    


Intervention name(s): Lutein syrup; Placebo syrup
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 12- week dietary supplementation with lutein syrup (20 mg lutein/day); 12- week dietary supplementation with placebo syrup (0 mg lutein/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment