bioihbjkbjnl/mcl2 huggingface dataset:
Environmental Control as Add-on Therapy in Childhood Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effects of adding on an environmental home intervention to standard
      asthma medication management on controller medication requirements among children and
      adolescents with asthma. The investigators hypothesize that the addition of an
      individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based
      controller medication will result in less controller medication requirement and allergic
      inflammation than controller medication alone among urban asthmatic children.
    

Detailed description: 
      The study is a parallel arm study of an individually tailored, multi-faceted ECS plus
      controller medication titration versus controller medication titration alone. After a 4-week
      run-in period to stabilize the asthma, the investigators will randomize 200 Baltimore
      children with persistent asthma and a recent exacerbation in a 1:1 ratio to the two arms and
      follow the children for six months. There will be five clinic visits and three home visits
      over this time period for clinical and home assessments, respectively. There will be up to
      four environmental intervention visits for participants randomized to the environmental
      control plus controller medication group. The environmental modules include mouse, cockroach,
      furry pets, dust mites, and smoking. Air purifiers and laundered bedding are also included in
      this arm. Participants randomized to the controller medication group have the option of
      having one home visit after completing the study at which the participants will receive home
      intervention services that the environmental control plus controller medication group
      received. Participants will have repeated assessment of: controller medication requirements;
      secondary clinical, physiologic, and inflammatory outcomes; and particulate matter (PM), air
      nicotine, and allergen levels.
    

Intervention name(s): Flovent Diskus; Home Environmental Intervention; Advair Diskus
Intervention type(s): Drug; Other; Drug
Intervention description(s): Inhaled corticosteroids; Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding; inhaled corticosteroids + long-acting beta agonist
Other intervention name(s): Flovent Diskus, 50 mcg, 100mcg, 250 mcg
Intervention MeSH terms: Fluticasone; Xhance; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and
      immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult
      HIV-uninfected volunteers.
    

Detailed description: 
      This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and
      immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult
      HIV-uninfected volunteers. BG505 SOSIP.664 gp140 is a stable, soluble, cleaved HIV envelope
      trimer formulated in 0.55mL at 2mg/mL in 20 mM Tris, 100 mM NaCl, pH 7.5 and will be
      administered IM.
    

Intervention name(s): BG505 SOSIP.664 gp140, adjuvanted; BG505 SOSIP.664 gp140, adjuvanted; BG505 SOSIP.664 gp140, adjuvanted; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Dosage of 30ug, Intramuscular administration; Dosage of 100ug, Intramuscular administration; Dosage of 300ug, Intramuscular administration; Tris-NaCl Diluent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy
      Adult Subjects
    


Intervention name(s): Bemnifosbuvir (BEM); Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of BEM will be administered.; A single dose of matching placebo will be administered.; A single dose of Moxifloxacin will be administered.
Other intervention name(s): AT-527
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-masked, randomized-controlled, dispensing clinical trial. A total of
      approximately 60 eligible myopic subjects will be targeted to complete the study.
    


Intervention name(s): senofilcon A Multifocal; senofilcon A Sphere; etafilcon A Multifocal; etafilcon A Sphere
Intervention type(s): Device; Device; Device; Device
Intervention description(s): JJVC Investigational Multifocal Contact Lens; ACUVUE OASYS 2-WEEK with HYDRACLEAR PLUS; 1-Day Acuvue Moist Brand Multifocal Contact Lens; 1-Day Acuvue Moist Brand Contact Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I
Condition: Addison's Disease; Adrenal Insufficiency; Diabetes Mellitus Type I
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Adrenal Insufficiency; Addison Disease
Study type: Observational

Summary: 
      Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore,
      patients who suffer from both, adrenal insufficiency and type I diabetes more frequently
      report hypoglycemia, particularly after strenuous activities. The study investigates the
      counter regulatory hormonal response to physical stress and the impact on cognitive function
      in subjects with and without Addison's disease, type I diabetes and healthy subjects.
    

Detailed description: 
      As patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction and
      patients who suffer from both, adrenal insufficiency and type I diabetes more frequently
      report hypoglycemia, particularly after strenuous activities this study investigates the
      counter-regulatory hormonal response to physical stress and the impact on cognitive function
      in subjects with and without Addison's disease, type I diabetes and healthy subjects.
      Patients will perform ergometer training with an individualized intensity and fulfill
      cognitive function testing (stroop test and fatigue inventories) before and after strenuous
      activity.
    

Intervention name(s): Spiroergometry
Intervention type(s): Procedure
Intervention description(s): At visit 1 determination of the individual VO2max (maximal oxygen uptake) by spiroergometry after first testing of cognitive function.
At visit 2: Spiroergometry with 3 min warm up followed by 5 min 50% VO2max and 15 min at the individual respiratory compensation point (RCP).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Four groups:

        Patients with Addison's disease alone patients with diabetes mellitus type I alone patients
        with both, Addison's disease and Diabetes mellitus type I healthy controls
      
Biospecimen description: 
      blood samples for hormonal analysis
Uterocervical Angle in Patients With Preterm Premature Rupture of the Membranes
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature; Rupture
Study type: Interventional

Summary: 
      To evaluate the performance of uterocervical angle (UCA) in the prediction of labor timing in
      patients with preterm premature rupture of the membranes
    


Intervention name(s): uterocervical angle
Intervention type(s): Diagnostic Test
Intervention description(s): uterocervical angle is the angle between lower segment of uterus and cervix
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Pilot)
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      The purpose of the study is to evaluate of the relationships between fractionated exhaled
      nitric oxide, disease activity, and symptom severity in patients with eosinophilic
      esophagitis compared to those without eosinophilic esophagitis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients will be recruited from the outpatient clinic of the Pediatric Gastroenterology
        Division of The University of Texas Health and Science Center at Houston.
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicentric phase III study is designed to assess the efficacy and safety of
      recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of
      children with de novo ALL
    


Intervention name(s): asparaginase; recombinant asparaginase
Intervention type(s): Drug; Drug
Intervention description(s): 5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33; 5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
Intervention MeSH terms: Asparaginase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children with previously untreated acute lymphoblastic leukemia
Comparison of Effect of Repeated Exposure, Flavor-Flavor and Flavor-Nutrient Learning on Vegetable Acceptance in Infants
Condition: Development of Eating Behavior
Study type: Interventional

Summary: 
      This study aims at comparing learning mechanisms to increase vegetable acceptance in infants
      at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and
      flavor-nutrient learning (FNL); measuring the stability of the learning effect; and examining
      the impact of infants' feeding history on vegetable acceptance.
    


Intervention name(s): Repeated consumption of basic artichoke purée.; Repeated consumption of sweet artichoke purée.; Repeated exposure to fat artichoke purée.
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M).; In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M).; In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Children; Eating behaviour; Intake; Liking; Conditioned liking; Flavour; Nutrient; Vegetable
SAM: Discharge Based on the Use of a MUAC-based Criterion to
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Observational

Summary: 
      Retrospective analysis of routine program data of children aged 6 to 59 months admitted to
      the MSF therapeutic feeding program with MUAC ≤ 118 mm in Yako and Titao districts of Burkina
      Faso from 2007-2011.
    

Detailed description: 
      Comparison of patient characteristics and treatment outcomes was conducted between two
      groups: 1) children discharged as recovered from September 2007 to March 2009 with at least
      15% of their weight at admission (Period A); and 2) children discharged as recovered from
      April 2009 to December 2011 with MUAC ≥ 124 mm (Period B).

      A total of 50,841 children were admitted with MUAC ≤ 118 mm to the MSF therapeutic feeding
      program and were included in this analysis: 24,792 children in Period A (2007-2009) and
      26,049 children in Period B (2009-2011).

      Overall, 89% of admissions were directly into outpatient care and the majority (53%) entered
      with a MUAC 116-118mm; 48% of children were male and 80% of children < 2 years of age (Table
      1).

      Compared to children admitted in Period A, children admitted in Period B were statistically
      more likely to be female, younger, and of better anthropometric status (e.g. higher mean
      MUAC, WHZ and HAZ).

      There was a greater proportion of children admitted directly to inpatient care in Period B
      than in Period A (10.6% vs 8.0%).
    

Intervention name(s): Discharge from community-based management
Intervention type(s): Other
Intervention description(s): Comparison of patient characteristics and treatment outcomes between two groups
Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All children admitted to the MSF therapeutic feeding program in Yako and Titao districts
        from September 2007 to December 2011
Betamethasone to Control Postoperative Pain in Emergency Endodontic Care
Condition: Pain
MeSH terms: Emergencies; Pain, Postoperative
Study type: Interventional

Summary: 
      The objective of this randomized double-blind study was to evaluate the effect of
      betamethasone in the control of postoperative pain in patients undergoing endodontic
      treatment.
    

Detailed description: 
      To prevent post endodontic treatment pain, systemic administration of corticosteroids may
      have their effect maximized if the infiltration is performed in the oral mucosa, near the
      periapex of the tooth, which concentrates the inflammatory process. The administration of
      corticosteroids at this moment, taking advantage of the anesthetic effect still present,
      ensures continuous comfort during the postoperative period.

      The objective of this randomized double-blind clinical trial was to evaluate the effect of
      the systemic administration of betamethasone - through infiltration in the oral mucosa - to
      control pain and edemas in patients undergoing emergency endodontic treatment.
    

Intervention name(s): Bethametasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.; The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.
Other intervention name(s): Group 1; Group 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Steroids; Pain measurement
Study to Gather Information on the Influence of BAY1817080 on the Electrical Activity of the Heart Recorded by an Electrocardiogram in Healthy Male and Female Participants
Condition: Cough; Endometriosis; Overactive Bladder
MeSH terms: Endometriosis; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, researchers want to find whether the study drug BAY1817080 has an effect on
      the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65
      years will be enrolled into this study. The ECG of the participants will be monitored closely
      by the researchers to detect any change after intake of the study medication.
    


Intervention name(s): BAY1817080; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet; Matched placebo as film-coated tablet
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Orange Juice Consumption in Patients With Hepatitis C
Condition: Chronic Infection
MeSH terms: Hepatitis C; Persistent Infection; Hepatitis
Study type: Interventional

Summary: 
      This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C,
      may contribute to the treatment of patients with chronic hepatitis C.
    

Detailed description: 
      Forty-three patients with chronic hepatitis C who were being treated with pegylated
      interferon combined with ribavirin, according to the Clinical Protocol and Therapeutic
      Guidelines for Viral Hepatitis C and Co-infections of the Brazilian Health Ministry were
      randomly divided into two parallel groups: (1) orange juice (n = 23), which were supplemented
      with orange juice (500 mL/d) for 8 weeks; (2) control group (n = 20) composed of patients
      that were not drinking orange juice regularly. The recruitment process began in February
      2012, the intervention was carried out from May 2012 to July 2012, and the data analysis
      started in September 2012. The sample number took into account variances on total cholesterol
      with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Dourado et al., 2015).
      The minimum sample size should have 20 individuals per group (n = 40), considering an
      approximately 15% dropout rate. Primary and secondary endpoints were the reduction of total
      cholesterol and modification of biochemical markers, respectively. Kolmogorov Smirnov and
      Levene test assessed normality and homogeneity of data, respectively. Assessment of the data
      was performed in all participants on the first and last day of the experiment. All the
      parameters were compared between the juice group and the control group using General Linear
      Model of Repeated Measures Analysis. Differences in baseline patients' characteristics
      between the two groups were analyzed by One-way analysis of variance (ANOVA). The LSD signed
      rank post-test was used to assess significant changes in parameters after the start of
      treatment in each group, and the differences were considered statistically significant at p <
      0.05.
    

Intervention name(s): Orange juice (500 mL/d)
Intervention type(s): Other
Intervention description(s): The patients were instructed to drink orange juice in two daily portions during eight consecutive weeks. Patients from both groups were asked to maintain their usual lifestyle, diet, and physical activity, and they were checked weekly by the researcher's team. Assessments of anthropometric data, dietary intake, as well as blood sample collection for biochemical analysis were performed in all participants on the first and last day of the experiment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: orange juice; chronic hepatitis C; biochemical markers; oxidative stress; nutritional status; antioxidants
Study to Establish Whether the Use of T-Tube in Bile Duct Anastomosis in Liver Transplantation Decreases Morbidity
Condition: Evidence of Liver Transplantation
Study type: Interventional

Summary: 
      The purpose of this study was to compare the incidence and severity of biliary complications
      due to liver transplantation after choledochocholedochostomy with or without a T-tube. A
      per-protocol analysis was designed for recipients of orthotopic liver transplantation in a
      single center, who were randomly assigned to choledochocholedochostomy with or without a
      T-tube. It is a prospective and randomized study.
    


Intervention name(s): Choledocho-choledochostomy with T-tube; Choledocho-choledochostomy without T-tube
Intervention type(s): Device; Device
Intervention description(s): In the anastomosis between the common bile duct of the graft and the common bile duct of the recipient, a tutorial T-tube is inserted in the bile duct lumen and will be removed from the patient on third month postoperatively.; The termino-terminal anastomosis between common bile duct of the graft and common bile duct of the recipient is performed without any T-tube.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bile duct anastomosis; Biliary complications
Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)
Condition: Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective was to assess in subjects with CKD: Safety and tolerability of molidustat
      (BAY 85-3934), effects of molidustat on non-invasive hemodynamics Secondary objectives were
      to assess: Effects on pharmacodynamic parameters of erythropoiesis (erythropoietin,
      reticulocytes, erythrocytes, hemoglobin, hematocrit), pharmacokinetics of molidustat,
      exploratory biomarkers, ie, midregional pro-atrial natriuretic peptide, midregional
      pro-adrenomedullin, plasma renin activity, and optionally B-type natriuretic peptide,
      vascular endothelial growth factor, cyclic guanosine monophosphate, cyclic adenosine
      monophosphate, and noradrenaline
    


Intervention name(s): Molidustat (BAY85-3934); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg molidustat as a single tablet; Single oral dose of matching placebo will be given in each treatment arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)