bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RO4989991 in Patients With Allergic Rhinitis
Condition: Asthma
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the
      safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis
      who are otherwise healthy. The anticipated time on study treatment is 2 weeks.
    


Intervention name(s): Placebo; RO4989991
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous repeated dose; Subcutaneous repeated dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
KOmparison Study KOmparison Study
Condition: Healthy
Study type: Interventional

Summary: 
      In this double blind, placebo controlled, parallel group study, the relative uptake of 1g/d
      krill oil in comparison to 1g/d fish oil in healthy female and male adults will be assessed.

      Primary objective is to determine if a 12 week supplementation with krill oil increases
      tissue levels in erythrocytes (omega-3 index) significantly more than fish oil after dose
      adjustments to EPA and DHA levels.
    


Intervention name(s): Krill oil or Fish oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Retrospective Examination of Initial Care of Severe Bacterial Infections of the Child
Condition: Bacterial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional

Summary: 
      The aim of the study is to determine the frequency of sub-optimal care in the initial care
      (before arrival at the intensive care unit) of children from "West France regions" suffering
      of severe bacterial infections.The characteristic "optimal or not" of the initial medical
      care will be determined by 2 independent experts, blinded from each other and blinded from
      the issue of the care. In case of a discordance between the two experts, a third expert will
      be demanded. Three possibilities of conclusion will be proposed to the experts: "sure
      sub-optimal medical care", "possible suboptimal care" and "optimal care".
    


Intervention name(s): Retrospective examination by experts whether care given fo child admitted at the ICU for suspicion of bacterial infection (not nosocomial) was optimal or not
Intervention type(s): Other
Intervention description(s): When child is admitted at Intensive Care Unit (ICU) for suspicion of bacterial infection that is not nosocomial, data on child's infection and cares received, is completed on an electronic Case Report Form (e-CRF) by Doctor of ICU. Characteristic "optimal or not" of initial medical care is then determined by the independent experts blinded from issue of the care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: severe bacterial infection
Mylan Insulin Aspart Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy
      profile between MYL-1601D and NovoLog® in patients with T1DM.
    

Detailed description: 
      This is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with
      T1DM comparing the safety and efficacy of MYL-1601D with NovoLog®.

      After up to 3-week screening period, all subjects will be titrated on NovoLog® during a
      4-week run-in period, and will be shifted from their current basal insulin to study insulin
      Lantus®. After run-in period, subjects will be randomized; one group will receive MYL-1601D,
      while the other group will receive NovoLog® for 24 weeks. A follow-up visit, via telephone
      call, will be scheduled 4 weeks after last dose of MYL-1601D.
    

Intervention name(s): MYL-1601D Product; FlexPen NovoLog®
Intervention type(s): Drug; Drug
Intervention description(s): (100 U/mL); (100 U/mL)
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity (PSMF)
Condition: Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity; Obesity, Morbid
Study type: Observational

Summary: 
      This is a 12 month prospective observational cohort study of the outpatient protein-sparing
      modified fast diet for children with severe obesity and serious comorbid condition(s). The
      study will enroll 30 Center for Healthy Weight and Nutrition patients aged 11-19 years who
      have been placed on a protein sparing modified fast as part of their treatment plan. The
      study-specific procedures consist of questionnaires/interviews on diet and PA behaviors,
      adherence and self-efficacy measures, data abstraction from the chart and tracking of
      activity using a Fitbit.
    

Detailed description: 
      Aggressive dietary interventions may provide an accessible treatment option for children and
      adolescents with severe obesity who are not successful with traditional lifestyle behavioral
      interventions or do not want or qualify for weight loss surgery. One such intensive dietary
      option is the protein sparing modified fast (PSMF). The PSMF involves minimal carbohydrate
      intake to induce ketosis, while maintaining adequate or high protein intake to minimize
      catabolism. The PSMF, under medical supervision, can be an effective and safe intervention
      for children and adolescents, yet the PSMF diet is not regularly used in the treatment of
      pediatric severe obesity. This pilot study will employ a prospective cohort study design.
      Thirty children, 11-19 years-old, with severe obesity, who have been prescribed the rPSMF as
      part of their treatment in a tertiary care pediatric weight management clinic (PWMC), will be
      recruited along with their attending parent to participate in the study. The primary aim of
      the study is to evaluate the acceptability of the rPSMF as assessed by adherence,
      satisfaction with the intervention, and participation rate using quantitative and qualitative
      methods. The secondary aim is to investigate the effectiveness of the rPSMF on improving a)
      anthropometric measures (weight, body mass index [BMI] and BMI z-score); b) metabolic
      measures (lipid profile, glycosylated hemoglobin, liver function tests); and c) quality of
      life. Results of this study will provide guidance for the standardization of a pediatric
      rPSMF protocol in a clinic setting, delineate which factors improve or hinder adherence and
      weight loss and provide preliminary data for a multicenter randomized controlled trial.
    

Intervention name(s): protein-sparing modified fast diet
Intervention type(s): Other
Intervention description(s): a PSMF diet follow the usual care format in the Center
Other intervention name(s): The PSMF diet
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents seen by Center for Healthy Weight and Nutrition at Nationwide
        Children's Hospital
Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new
      anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV
      drugs in the past. Genetic response will be studied.
    

Detailed description: 
      Prior to study entry patients are stratified according to HIV-1 RNA level, CD4 cell count,
      and number of antiretroviral drugs. PMPA Prodrug or placebo is added to current
      antiretroviral regimens, and is administered in one of three dosing regimens. Patients
      randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the
      remainder of the 48-week study period after at least 24 weeks post randomization.
    

Intervention name(s): Tenofovir disoproxil fumarate
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir
Masking: Double
Primary purpose: Treatment
Keywords: Drug Therapy, Combination; Prodrugs; Anti-HIV Agents
Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and
      ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent
      antiplatelet effects compared with clopidogrel and are associated with an improved net
      clinical benefit. However, to date there are limited head-to-head comparisons of these two
      new agents.
    

Detailed description: 
      Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of
      treatment for prevention of thrombotic events in patients with coronary artery disease (CAD)
      undergoing percutaneous coronary intervention (PCI). However, there are a considerable number
      of patients who continue to have recurrent ischemic events despite this treatment regimen.
      These observations underscore the need for more potent antiplatelet therapies. Recently, two
      P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor. Both
      prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects
      compared with clopidogrel. These more favorable pharmacodynamic effects translate into
      reduced ischemic event rates, at the expense of an increased risk of bleeding in patients
      with acute coronary syndromes. Overall, these drugs are associated with an improved net
      clinical benefit. These findings from large-scale clinical investigations have led to
      approval of prasugrel and ticagrelor. However, to date there are limited head-to-head
      comparisons of these two new agents.
    

Intervention name(s): Prasugrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 60mg loading dose and 10mg maintenance dose; Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Other intervention name(s): Effient; Brillinta
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary artery disease; Dual antiplatelet therapy; prasugrel; ticagrelor
Postprandial Glycemic Response in Adults With Type 2 Diabetes
Condition: Glycemic Control
Study type: Interventional

Summary: 
      This is a randomized, controlled, crossover study to compare the effects of two treatments on
      postprandial glucose in adults with type 2 diabetes.
    


Intervention name(s): Experimental Formula; Test Meal
Intervention type(s): Other; Other
Intervention description(s): Diabetes-specific study formula; Instant oatmeal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Assess the Efficacy, Safety and Tolerability of DFD-04
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this exploratory study is to assess the efficacy, safety and tolerability of
      DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.
    

Detailed description: 
      Subjects with mild to moderate papulopustular rosacea (Investigator's Global Assessment [IGA]
      grade 2-3), a Clinician's Erythema Assessment (CEA) score of 2-3 and 6-30 inflammatory
      lesions (papules and pustules) were randomized to treatment with DFD-04 ointment or Vehicle
      ointment in a ratio of 2:1.

      During the 12-week treatment period subjects used the IMP twice daily with approximately 12
      hours between applications. Subjects were instructed to treat affected skin in a defined
      treatment area on the face.

      The investigator assessed efficacy by using an IGA 5-point scale and CEA 4-point scale and by
      counting the number of inflammatory lesions on the face at Baseline (Day 1) and Weeks 4, 8
      and 12 (End of Treatment [EoT], defined as complete clearance of inflammatory lesions or Week
      12, whichever was earlier). Furthermore, a non-invasive biomarker assessment was done by
      using a Transdermal Analysis Patch (TAP) at Baseline (Day 1) and Weeks 4 and 12.

      Safety assessments included investigator's assessment of application site reactions at
      Baseline (Day 1) and Weeks 4, 8, and 12 for all treated areas.

      Other safety assessments included vital signs (blood pressure [BP] and pulse rate) and urine
      pregnancy tests (UPTs) (only for females), clinical laboratory parameters (serum and urine),
      extent of exposure, and Adverse Events.

      In addition, pharmacokinetic (PK) analysis was performed to evaluate the systemic exposures
      of itraconazole and its active metabolite, hydroxyl-itraconazole, with blood samples drawn
      from the first 12 subjects at various pre-specified timepoints.
    

Intervention name(s): DFD-04 Ointment; Placebo Ointment
Intervention type(s): Drug; Other
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Haloperidol for the Treatment of Nausea and Vomiting in the ED
Condition: Vomiting; Nausea; Abdominal Pain; Cannabis Use
MeSH terms: Nausea; Vomiting; Abdominal Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Single center, double-blind, randomized, controlled trial in patients who present to the
      emergency department (ED) with a chief complaint of nausea or vomiting. A total of 300
      patients age 18-55 presenting to the emergency department with chief complaint of nausea or
      vomiting will be enrolled from February 2021 - February 2022. Patients will be randomized and
      symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by
      telephone at 24 hours.
    


Intervention name(s): Haloperidol; Ondansetron
Intervention type(s): Drug; Drug
Intervention description(s): 2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP; Ondansetron
Other intervention name(s): Haldol
Intervention MeSH terms: Haloperidol; Ondansetron; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single-center prospective randomized double-blinded non-inferiority trial with potential assessment of superiority comparing haloperidol to ondansetron for the treatment of nausea and vomiting.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension
Condition: Resistant Hypertension
MeSH terms: Hypertension; Hyperaldosteronism
Study type: Interventional

Summary: 
      Primary aldosteronism(PA) is the most common endocrine cause of resistant hypertension.
      Surgery and medicine are the main treatment for PA by the current guidelines. However,only a
      small part of patients with PA meet the surgical criteria, and most of them have to take
      spironolactone or other antihypertensive drugs for long time. On the other side, long-term
      inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other
      adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which
      cause extensive cerebrovascular damages even though blood pressure and blood potassium had
      been normalized.

      With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and
      treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with
      significant decrease of blood aldosterone and blood pressure in patients with PA, which made
      it promissing that primary aldosteronism with resistant hypertension could be relieved by
      adrenal artery ablation.
    


Intervention name(s): Adrenal Artery Ablation
Intervention type(s): Procedure
Intervention description(s): Intervention with adrenal artery ablation is performed in PA patients with resistant hypertension.
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: resistant hypertension; aldosteronism
Study of the Vaginal Microbiota in Women Under Fertile Age
Condition: Vaginal Disease
MeSH terms: Vaginal Diseases
Study type: Observational

Summary: 
      Characterization of the vaginal microbiota of women under fertile age and study of
      correlations with gynecological disorders
    

Detailed description: 
      The study aimed to characterize, in women under fertile age, the composition and dynamics of
      the vaginal microbiota as well as to in-depth study correlations among microbiota and
      gynecological disorders
    

Intervention name(s): Probiotics; No intervention
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Assumption of commercial probiotics; No assumption of probiotics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy volunteers with vaginal microbiota imbalance
      
Biospecimen description: 
      vaginal discharge
RF Rejuvenation for Pelvic Floor and Vagina
Condition: Symptoms Associated With Pelvic Floor Weakness
Study type: Interventional

Summary: 
      Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for
      vaginal treatments.
    

Detailed description: 
      This study will evaluate the effects of radiofrequency on pelvic floor strength and the
      change in associated symptoms through direct measurement and patient reporting. The patients
      will undergo two separate evaluation appointments then receive two treatments. One group will
      receive a sham treatment and the other will receive the treatment. The sham group will be
      offered treatment at the end of the study.
    

Intervention name(s): Votiva
Intervention type(s): Device
Intervention description(s): The applicator uses radio-frequency energy to treat the vaginal canal
Intervention model: Single Group Assignment
Intervention model description: Subjects will receive the treatment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Training Intensity on Health Outcomes in Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The project will investigate high intensity interval training on the glucose regulation in
      type 2 diabetic subjects compared to moderate continuous exercise.
    


Intervention name(s): Training
Intervention type(s): Behavioral
Intervention description(s): The duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise
Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim: To evaluate the effects of Valsartan versus Amlodipine on LV deformation in relation to
      plasma adiponectin and leptin levels in hypertensive individuals.

      Methods: LV strain measured by 2 dimensional speckle tracking echocardiography, plasma levels
      of adiponectin and leptin was determined in 30 healthy individuals served as control group
      and in 200 hypertensive patients before and after treatment for three months with either
      Valsartan 160 mg or amlodipine 10 mg.
    

Detailed description: 
      Patients and methods Thirty control healthy individuals and 200 patients with uncomplicated,
      essential hypertension were enrolled and followed up for 3 months in a controlled randomized
      study. All subjects' health status was evaluated by a complete medical examination. All BP
      measurements were made with calibrated mercury manometers (Korotkoff I and V). Three separate
      measurements were taken at least 2 min apart and the average of these values was calculated.
      Subjects' height and weight were recorded in the fasting state with the subjects wearing only
      light clothes and without shoes and BMI was calculated using the equation (BMI = weight
      (kg)/height (m)2). Patients, of both sexes with mild to moderate essential hypertension
      (diastolic blood pressure [DBP] >80 and ≤100 mmHg after a 2-week wash-out period, SBP
      systolic blood pressure>120 and 160 mmHg). Patients were randomly assigned into two groups
      using a computer-generated random number: Group I treated with valsartan (160 mg/d, n = 100),
      Group II amlodipine (10 mg/d, n = 100). Another 30 healthy subjects are enrolled as control
      group (Group III). Subjects in group I and II were asked to maintain their usual dietary and
      physical activity habits throughout the study. Treatment tolerability was assessed at each
      follow-up visit.
    

Intervention name(s): valsartan (160 mg/d); amlodipine (10 mg/d).
Intervention type(s): Drug; Drug
Intervention description(s): Group I treated with valsartan (160 mg/d, n = 100); Group II amlodipine (10 mg/d, n = 100).
Other intervention name(s): Tareg 160 mg; Norvasc 10 mg
Intervention MeSH terms: Amlodipine; Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Thirty control healthy individuals and 200 patients with uncomplicated, essential hypertension were enrolled and followed up for 3 months in a controlled randomized study.
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the effect of medical food on reducing asthma symptoms in asthmatic children.
    


Intervention name(s): medical food with EPA and GLA, vitamins and minerals; medical food minus EPA and GLA, antioxidant vitamins/minerals
Intervention type(s): Other; Other
Intervention description(s): 1 8oz serving per day for 12 weeks; 1 8oz serving a day for 12 weeks
Intervention MeSH terms: Vitamins; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment