bioihbjkbjnl/mcl2 huggingface dataset:
Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled
      glucocorticosteroid improves disease control in persistent asthma. This observation has
      supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination
      preparations for the management of asthma. Currently, salmeterol/fluticasone and
      formoterol/budesonide are available for clinical use. The long-term beneficial clinical
      effects of the two drug classes seem to be synergistic, and several mechanisms of
      glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been
      invoked to explain this phenomenon.This study, wish to address the question whether
      glucocorticoids can acutely potentiate the bronchodilator response to a long-acting
      beta-adrenergic agonist.We expect that in patients with asthma, the short-term bronchodilator
      effect of salmeterol is enhanced by the addition of fluticasone, which by itself has no
      short-term bronchodilator effect. To test this premise, we will assess the respective
      short-term effects of salmeterol (50 µg), fluticasone (250 µg), salmeterol/fluticasone
      (50/250 µg), and placebo/placebo on spirometric parameters. Airway Blood flow will also be
      measured to ensure that vasoconstriction does not occur.
    

Detailed description: 
      Fourteen lifetime nonsmokers with a physician diagnosis of asthma will be recruited for the
      study. All subjects will be allowed to use short-acting beta-adrenergic agonists as rescue
      medication.

      Inclusion criteria:

        1. Males and females, 18 to 65 years of age.

        2. FEV1 60-85% of predicted on the screening day.

      Exclusion criteria:

        1. Women of childbearing potential who do not use accepted birth control measures; pregnant
           and breast feeding women.

        2. Cardiovascular disease and/or use of cardiovascular medications

      2. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute
      respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to
      the study, of any anti-asthma medication not mentioned above
    

Intervention name(s): fluticasone; placebo inhalation; Salmeterol; fluticasone/salmeterol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 220- mcg once; placebo inhalation once; 50 mcg salmeterol once; inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol
Other intervention name(s): flovent; sugar pill; serevent; advair
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: asthma, corticosteroids, bronchodilator, airway blood flow
Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women
Condition: Overactive Bladder; Postmenopausal Disorder; Urination Disorders
MeSH terms: Urinary Bladder, Overactive; Urination Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a multi-site, randomized, opened and parallel-controlled clinical study.

      The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate
      Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks.
      Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and
      various indices are evaluated.
    


Intervention name(s): Solifenacin Succinate Tablets; Estrogen
Intervention type(s): Drug; Drug
Intervention MeSH terms: Solifenacin Succinate; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive Bladder; Solifenacin Succinate Tablets; Estrogen
Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma
Condition: HCC
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and
      receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients
      wiht advanced hepatocellular carcinoma (HCC) .
    

Detailed description: 
      Eligibility Criteria:

        -  18 -70 years old;

        -  Patients with measurable, histologically proven, inoperable HCC;

        -  Child-Pugh (CP) score of A;

        -  Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.

        -  Patients received prior systemic treatments for HCC before 4 weeks;

        -  Patients received operate before 3 months;

        -  Patients received TACE before 4 weeks;

        -  Life expectancy at least 3 months;

        -  Adequate hepatic and renal function;

        -  Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per
           deciliter);

        -  Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or
           APTT≤43s;or TT≤21s.

      Exclusion Criteria:

        -  Patients had prior treatment with sorafenib;

        -  CNS involvement.

      Method:

        -  open-label,randomized,multiceters study;

        -  2 dose cohorts: 200mg bid and 300mg bid;

        -  Patients with advanced HCC(inoperable) and Child-Pugh (CP) A , randomized,receive
           continuous donafenib either 200mg bid or 300mg bid in 4 weeks cycles;

        -  Sample size:106 patients(53 patients in each dose cohort).

      Endpoints:

        -  Safety: toxicities are assessed according to CTCAE 3.0;

        -  TTP:Tumor response is assessed every two cycles using RECISIT1.1 criteria;

        -  Donafenib pharmacokinetics is measured in plasma samples.
    

Intervention name(s): Donafenib(200mg); Donafenib(300mg)
Intervention type(s): Drug; Drug
Intervention description(s): Donafenib 200mg,bid,po; Donafenib 300mg,bid,po
Other intervention name(s): A Group; B Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Donafenib; HCC; Advanced; inoperable; Phase 1B
Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
Condition: Child Development Disorders, Pervasive
MeSH terms: Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if the known differences in genes influence drug
      metabolizing enzymes and receptors that are involved in risperidone drug action. The study
      will determine if differences in these genes will change the concentration of risperidone in
      the blood over time in children in relation to side effects and clinical response to
      risperidone.
    

Detailed description: 
      To the knowledge of the investigators there are no studies documenting the pharmacokinetics
      and pharmacogenetics of risperidone in children with PDD. Currently the PPRU network is
      conducting a PK study whose aim is to establish a new enantio-selective micro-assay
      methodology and to generate preliminary population PK data of risperidone and its metabolites
      in PDD. This study focuses on pharmacogenetic evaluation of PDD patients having little or no
      effect, those that are unusually sensitive and those experiencing drug toxicity/adverse
      events at standard risperidone dosages.

      In this study two 5 ml blood samples will be drawn at a regulary scheduled PK visit.
      Alternatively pooled waste blood samples or a buccal swab can be obtained.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Primary purpose: Treatment
Keywords: Risperidone; Autism; Pervasive Developmental Disorder (PDD)
Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone Height.
Condition: Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional

Summary: 
      Sinus floor elevation (SFA) and GBR have been applied in the placement of dental implants in
      longstanding edentate posterior maxilla region. However, the number of study on the efficacy
      of these procedure on areas with 0mm bone height is limited. This case study aims to compare
      two cases of 0mm bone height in the posterior maxillae region with different handling
      procedure. In this article, two female patients in their 40s underwent maxillary sinus
      augmentation (sinus lifting) due to longstanding missing posterior maxillary molars with the
      bone of which area had resorbed entirely, leaving 0mm bone height. One patient went through
      conventional sinus augmentation while the other had a two-stage - sinus - lift procedure.
      Researchers compared the bone - volume induced between the two procedures.
    


Intervention name(s): Conventional sinus lift surgery; Two-stage-sinus-lift procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): After graft reflection, sinus membrane is separated from bone or oral mucosa and then bone graft is inserted in between the two structures.; Procedure is performed in two stages with the purpose of stage one to separate the oral mucosa from the sinus membrane using a small amount of bone graft and stage two as actual sinus augmentation, which is performed similar to that of conventional sinus lift procedure.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery
Condition: Anesthesia
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of sub anesthetic dose of ketamine on
      vasopressor (Ephedrine) requirement to prevent maternal hypotension after spinal anesthesia
      in caesarean section.
    


Intervention name(s): Ketamine; isotonic saline
Intervention type(s): Drug; Drug
Intervention description(s): patients will receive sub- anesthetic dose of ketamine 0.5 mg/kg in 3 ml of isotonic saline after spinal anesthesia; patients will receive 3 ml of isotonic saline after spinal anesthesia
Other intervention name(s): general anesthetic
Intervention MeSH terms: Ketamine; Anesthetics; Anesthetics, General
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age
Condition: Diarrhoea;Acute; Diarrhea, Infantile
MeSH terms: Diarrhea; Diarrhea, Infantile
Study type: Interventional

Summary: 
      This study evaluates the effect of zinc over the duration, severity and relapse of acute
      diarrheic disease, in children between 6 and 59 months of age. One study group will receive a
      tablet that contains 20 mg of zinc, and the other study group will receive a tablet,that does
      not contain zinc, it is a tablet that investigators will use as control.
    

Detailed description: 
      In Mexico acute diarrheal diseases mortality in children continues to be a public health
      issue, being between the main causes of morbidity and mortality, with an important load for
      the health systems. Consequently, there exists a necessity for the implementation of
      alternate strategies for this condition, nutrition being one of the pillars to strengthen.

      Zinc administration during the diarrhea episode is a simple intervention for clinical picture
      reduction and relapse. The recommendation of including zinc in the treatment of ADD is not
      part of the Mexican normativity. The evaluation of the efficacy of zinc administration in
      Mexican children is insufficient and a program or national strategy for zinc treatment does
      not exist.

      The objective of this study is evaluates the efficacy of oral zinc sulfate administration,
      during the diarrhea clinic picture in children of Mexico City.
    

Intervention name(s): zinc sulfate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): zinc 20mg tablets; Sugar pill manufactured to mimic zinc 20mg tablet
Other intervention name(s): Placebo (for zinc)
Intervention MeSH terms: Zinc; Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: zinc sulfate; Children; acute diarrheal diseases
The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition
Condition: Cognitive Ability, General; Dietary Modification
Study type: Interventional

Summary: 
      The aim of this study is to investigate the acute effects of ingestion of carbohydrates -
      with different glycemic profiles - on cognitive function among preadolescent children (i.e.,
      9-10 years).
    

Detailed description: 
      Regular breakfast consumption is linked to improved cognitive performance in school-aged
      children. However, the acute benefits of defined nutrient consumption on brain and cognitive
      health are not well understood, particularly in preadolescent children. One factor that may
      relate to brain health and learning in children is the contribution of carbohydrates to the
      digestion rate of a meal (and associated effects on post-prandial glycemia).

      The effects of differentially absorbed carbohydrates on brain and cognition are unknown,
      especially when ingested via a fortified nutritional beverage providing a balanced array of
      nutrients. The aim of this study is to investigate the acute, transient effect of nutrient
      supplementation with varied carbohydrate systems in preadolescent children (i.e., 9-10
      years).

      Participants will be randomized to receive one of three treatment nutritional formulations
      containing carbohydrates with varying absorption rates along with a non-caloric placebo.
      Participants will perform a cognitive battery in the fasted condition, shortly after
      treatment ingestion, and an hour after ingestion. Group differences in performance will be
      contrasted to assess the effects of different carbohydrate types on children's cognitive
      function following an overnight fast.

      Findings from this study will inform our understanding of the macronutrient profile of
      breakfast that may potentially improve children's cognitive performance in the morning.
    

Intervention name(s): SLOW Carbohydrate; MEDIUM Carbohydrate; FAST Carbohydrate
Intervention type(s): Other; Other; Other
Intervention description(s): Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response; Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response; Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
3 Fixation Devices in Laparoscopic Ventral Herniotomy
Condition: Ventral Hernia
MeSH terms: Hernia, Ventral
Study type: Interventional

Summary: 
      Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7
      cm, laparoscopic surgery with intraperitoneal onlay mesh.

      Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with
      either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd
      postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1,
      6, 12, 24, 36, 48 and 60 months postoperative.
    

Detailed description: 
      see brief summary
    

Intervention name(s): laparoscopic ventral herniotomy; Protack; Securestrap; Glubran
Intervention type(s): Procedure; Device; Device; Device
Intervention description(s): Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices; fixation of mesh with protack; fixation of mesh with Securestrap; fixation of mesh with Glubran
Other intervention name(s): no other names
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
B. Lactis HN019 for Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will investigate the effects of 4-week probiotic supplementation on whole gut
      transit time and gastrointestinal symptoms in adults with functional constipation.
    

Detailed description: 
      This prospective, double-blind, randomized, placebo-controlled clinical trial will
      investigate the effects of 4-week B. lactis HN019 supplementation on whole gut transit time
      and gastrointestinal symptoms in adults with functional constipation. Participants who meet
      all study entry criteria will enter a 2-week run-in period. Following successful completion
      of the run-in period, subjects will be randomized to 4-week supplementation with B. lactis
      HN019 (10 billion cfu), B. lactis HN019 (1 billion cfu), or placebo. The primary outcome of
      whole gut transit time will be evaluated with abdominal x-rays on days 0 and 28. Secondary
      outcomes include IBS-specific questionnaires (administered on days 0 and 28); abdominal pain
      severity, bowel movement frequency, stool consistency, and adverse events (evaluated daily
      throughout the study); and overall product satisfaction (evaluated at day 28). Physical
      activity questionnaires and 24-hour food recalls will be completed periodically during the
      trial.
    

Intervention name(s): B. lactis HN019; B. lactis HN019; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Capsule containing 10 billion cfu B. lactis HN019 once a day; Capsule containing 1 billion cfu B. lactis HN019 once a day; Capsule containing no probiotic once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: constipation; probiotic; functional constipation; IBS-C
Validation of the Sickle Cell Disease Pain Burden Interview
Condition: Sickle Cell Disease; Pain
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      The purpose of this study is to validate a brief survey tool, the SCD Pain Burden Interview
      (SCPBI), which can be used in the clinical and/or research settings to assess the impact of
      pain on children with sickle cell disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents diagnosed with sickle cell disease.
A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to evaluate the safety profile and tolerability of
      single oral doses of BMS-791325 in subjects with chronic hepatitis C infection
    


Intervention name(s): BMS-791325; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, Oral, Once Daily, Single Dose; Capsules, Oral, Once Daily, Single Dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Responses to E-Cigarette Advertising
Condition: E-Cig Use
Study type: Interventional
Phase: Early Phase 1

Summary: 
      While conventional cigarette use continues to decline among youth and young adults,
      e-cigarette (EC) use is on the rise. The use of ECs during young adulthood, particularly 18
      years of age, is especially alarming because it is not only a critical period in development
      but also a time when tobacco use is established. Additionally, the tobacco industry targets
      individuals of this age with the hope that they will one day progress to using combustible
      cigarettes. Advertising may be one of the reasons leading young people to use ECs, and the
      Food and Drug Administration (FDA) now has the authority to regulate EC advertisement
      features. The goal of the study is to determine which EC ad features most strongly influence
      young adults' attitudes, susceptibility, and intentions to use ECs. Fifteen ads from the most
      popular EC brands that employ a brand, product descriptions, and modeling features were
      selected. Young adults who are susceptible to EC use will come into the lab and view these
      ads. During exposure, they will be assessed for real-time visual attention using
      eye-tracking, orienting responses using heart rate, and arousal using skin conductance as
      well as pre- and post-ad self-report measures of attitudes, susceptibility, and behavioral
      intentions. These factors will help determine the most high impact features, which will be
      associated with the greatest visual attention, orienting responses, and arousal levels and
      changes in attitudes. Findings from this study will provide public health officials important
      and urgently needed information as to what advertising features are contributing to the sharp
      rise in the use of ECs among young adults.
    


Intervention name(s): Viewing e-cigarette ads
Intervention type(s): Other
Intervention description(s): All participants will see the same e-cigarette ads presented in a random order.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research