bioihbjkbjnl/mcl2 huggingface dataset:
EFFICACY AND TOLERABILITY OF BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to compare the efficacy and tolerability of the fixed combination
      beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with
      moderate to severe asthma
    

Detailed description: 
      Asthma is a chronic disease that is estimated to affect over 25 million people both in the
      U.S. and Europe (i.e. approximately 10% of the total population). Pharmacological therapy is
      used to treat reversible airway obstruction, inflammation and hyper-reactivity. Medications
      include preventive treatments in forms of antinflammatory/antiallergic agents (i.e.
      glucocorticosteroids, leukotriene antagonists, cromolyn sodium) and reliever treatments, in
      form of bronchodilators (i.e. β-adrenergic agonists, anticholinergics). In patients treated
      with inhaled glucocorticosteroids whose asthma is not fully controlled, national and
      international guidelines recommend a stepwise approach. Recent evidence-based clinical trials
      show that the addition of a LABA to inhaled glucocorticosteroids is more beneficial in terms
      of asthma control than increasing the dose of corticosteroids alone.

      Comparisons: CHF 1535 (BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg) pMDI VIA
      HFA-134a compared to FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI (SERETIDE®)
    

Intervention name(s): beclomethasone dipropionate plus formoterol fumarate combination; fluticasone propionate plus salmeterol xinafoate combination
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance; Beclomethasone; Formoterol Fumarate; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: asthma; combinations; inhaled therapy; corticosteroids; long acting bronchodilators; salmeterol; beclomethasone; formoterol; fluticasone
A Phase I Study of the Effects of APF530 Exposure, Granisetron and Moxifloxacin
Condition: Healthy
Study type: Observational

Summary: 
      This Phase I study will be performed in a double-blind, randomized, crossover design in
      healthy male and female subjects. The central ECG laboratory will be blinded to treatment.
      Every effort will be made to enroll equal numbers of males and females into the study.

      Eligible subjects will participate in a screening phase (within 28 days of the dosing day), a
      treatment phase and a final visit, which will be conducted on discharge from the study. Study
      duration will be 32 days with a total of approximately 12 days of confinement. During the
      resting ECG periods, 12-lead digital ECGs will be extracted from continuous telemetry at
      selected time points to assess potential ECG effects. Blood samples for PK evaluation will be
      collected in conjunction with the ECG time points.
    


Intervention name(s): Withdraw treatment
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Male and Female Subjects
      
Keywords: QTc Prolongation
Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Hydromorphone (HM) is a semi-synthetic derivative of morphine used for pain control. Like
      other opiates, due to its high potential of abuse HM is included on the World Anti-Doping
      Agency (WADA) list of prohibited substances.

      Hypothesis:

      The oral administration of hydromorphone hydrochloride in healthy subjects allows generating
      detectable concentrations of the drug in urine. Positive urine samples will enable to
      identify analytical strategies for doping control.

      Objectives:

      Primary objective: To measure the concentrations of hydromorphone in urine for anti-doping
      control samples.

      Secondary objective: To identify metabolites and precursors of hydromorphone in urine. To
      assess safety and tolerability of the drug used.

      Methods:

      Phase I, open, non-randomized clinical trial, with a treatment condition (hydromorphone)
      administered orally to 2 subjects.
    

Detailed description: 
      This study aims to characterize the patterns of urinary excretion of HM following the oral
      administration of 4 mg of hydromorphone hydrochloride (equivalent to 3.56 mg of
      hydromorphone). The detection of HM consumption can be done by urine immunoassay but several
      immunoassay tests are required to thoroughly detect synthetic, semi-synthetic and natural
      opioids due to the limited cross-reactivity of each assay. Therefore, superior test
      strategies are required to specifically identify low concentrations of opioids.
    

Intervention name(s): Hydromorphone Hydrochloride
Intervention type(s): Drug
Intervention description(s): 4 mg of hydromorphone hydrochloride (equivalent to 3.56 mg of hydromorphone) administered orally in a single dose.
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Intervention model description: There is one single treatment group (HM), and no control group.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hydromorphone; Opiates; Anti-doping control
PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau)
      pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®
      - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose.
      The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic
      and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau
      Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing
      plasma concentration of the drug and the reticulocyte count following a multiple intravenous
      administration during 4 weeks of 100 IU/kg in healthy subjects.
    


Intervention name(s): Epoetin Alfa
Intervention type(s): Drug
Intervention description(s): Intravenous administration for 4 weeks, three times a week (monday, wednesday, friday)
Other intervention name(s): Eprex
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising of BEA 2180 BR in Japanese Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese
      healthy volunteers
    


Intervention name(s): BEA 2180 BR - rising dose; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain
      associated with diabetic peripheral neuropathy.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study to assess the efficacy and
      safety of NYX-2925 in subjects with neuropathic pain associated with diabetic peripheral
      neuropathy.

      The study will be a 13- to 16-week study, including a 1- to 4-week Screening Period, followed
      by a 12- week double-blind, randomized, placebo-controlled Treatment Period.
    

Intervention name(s): NYX-2925 50 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NYX-2925 administered orally; Placebo administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive either placebo or NYX-2925.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Chemotherapy in Treating Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I/II trial to study the effectiveness of annamycin liposomal in treating
      patients who have locally advanced or metastatic breast cancer that has not responded to
      previous chemotherapy.
    

Detailed description: 
      OBJECTIVES: I. Determine the observed anti-tumor activity of annamycin liposomal in patients
      with anthracycline-resistant locally advanced or metastatic breast cancer. II. Determine the
      qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these
      patients. III. Determine the clinical pharmacology of this regimen in these patients. IV.
      Determine the rationale for the dose and chosen schedule of this regimen in these patients.

      OUTLINE: Patients receive annamycin liposomal IV over 60 minutes on day 1. Treatment
      continues every 3 weeks for at least 2 courses in the absence of disease progression or
      unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-30
      months.
    

Intervention name(s): liposomal annamycin
Intervention type(s): Drug
Intervention MeSH terms: Annamycin
Primary purpose: Treatment
Keywords: stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; male breast cancer
Regulation of Postprandial Nitric Oxide Bioavailability and Vascular Function By Dairy Milk
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is the leading cause of death in the United States. Short-term
      increases in blood sugar, or postprandial hyperglycemia (PPH), affect blood vessel function
      and increase the risk of CVD. Greater intakes of dairy foods have been associated with a
      lower risk of CVD, but whether these effects occur directly or indirectly by displacing foods
      in the diet that might increase CVD risk is unclear. The health benefits of dairy on heart
      health are at least partly attributed to its ability to limit PPH and resulting PPH-mediated
      responses leading to vascular dysfunction. This provides rationale to further investigate
      dairy as a dietary strategy to reduce PPH and risk for CVD. The objective of this study is to
      define the extent to which dairy milk, and its whey and casein protein fractions, protect
      against postprandial vascular dysfunction by reducing oxidative stress responses that limit
      nitric oxide bioavailability to the vascular endothelium in adults with prediabetes.
    

Detailed description: 
      This study consists of four, 3-hour postprandial trials in response to consuming the
      following dietary treatments: 1. oral glucose challenge, 2. oral glucose challenge in
      combination with non-fat milk, 3. oral glucose challenge in combination with whey protein
      isolate, and 4. oral glucose challenge in combination with sodium caseinate. For three days
      preceding each trial, participants will be provided all meals to standardize physiologic
      responses to test meals. On each trial day, vascular function will be assessed and blood
      samples collected prior to and at 30 minute intervals for 3 hours following test meal
      ingestion.
    

Intervention name(s): Glucose; Glucose with Non-fat Milk; Glucose with Whey Protein Isolate; Glucose with Sodium Caseinate
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.; Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.; Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.; Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes.
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dairy; Milk; Glucose; Postprandial; Hyperglycemia; Prediabetes; Blood glucose; Oxidative stress; Vascular health; Vascular function
A Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort
Condition: Healthy
Study type: Interventional

Summary: 
      A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the
      efficacy of Pain Bloc-R in healthy participants with non-pathological aches and discomfort.
      The study will have 3 study periods. During each study period, eligible participants will
      consume either Pain Bloc-R, comparator product, or placebo for 7 days during each study
      period (1 product per study period), with a 1-week washout period in between each period. The
      primary objective is the comparison of change in unresolved aches and discomfort from
      pre-supplement to Day 7 between the Pain Bloc-R, comparator, and placebo, as assessed by the
      Brief Pain Inventory (BPI) questionnaire.
    


Intervention name(s): Pain Bloc-R; Active Comparator - Acetaminophen; Placebo
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): Herbal Supplement containing Vit D3, Vit B6, Vit B12, White Willow Bark, Angelica Root, Acetyl L-carnitine HCl, Caffeine, L-Theanine, Benfotiamine, and L-Tetrahydropalmatine; DIN 02447479 Encapsulated for Blinding Purposes; No active ingredients
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, cross-over
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Aches; Discomfort; Healthy; Adults; Body aches
COVID-19: SARS-CoV-2 Detection in Saliva, Oropharyngeal and Nasopharyngeal Specimens
Condition: SARS-CoV Infection; Covid19; Coronavirus
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to compare the SARS-CoV-2 detection rate using either a Saliva,
      oropharyngeal swabs or nasopharyngeal swab method for specimen collection.
    

Detailed description: 
      The reference test to evaluate patients with suspected respiratory infection caused by virus
      is a real-time reverse transcription-polymerase chain reaction (RT-PCR) from a nasopharyngeal
      swab (NPS). However, other specimen collection methods like oropharyngeal swabs (OPS) and a
      saliva specimen collection have also been accepted by the Centers for Disease Control and
      Prevention for SARS-CoV-2 testing during the current coronavirus disease 19 (COVID-19)
      pandemic. It is unclear how much the SARS-CoV-2 detection rate differs when using different
      sampling methods and the aim of this study is to compare the expected COVID-19 detection rate
      using saliva, oropharyngeal swabs or nasopharyngeal swab in a public setting.

      We, therefore, aim to investigate the detection rate of SARS-CoV-2 in Saliva, oropharyngeal
      swab, and nasopharyngeal swab specimen samples collected in symptomatic and non-symptomatic
      individuals tested for COVID-19 in a public test center during the COVID-19 pandemic.

      Individuals referred for outpatient COVID-19 testing center will be invited to participate in
      a prospective clinical study. They will have saliva, OPS, and NPS specimen collection
      performed at the same time and analyzed separately for SARS-CoV-2. The rate for SARS-CoV-2
      detection in saliva, OPS, and NPS will be compared using a logistic regression mixed-effect
      analysis. A Sample Size Calculation estimated that a sample of 18,000 participants would be
      needed for the trial with 80% power at a significance level of 5%.
    

Intervention name(s): Sequence of testing.
Intervention type(s): Diagnostic Test
Intervention description(s): The participants will be tested in the following sequences of sampling technique: (1) nasopharyngeal swab, oropharyngeal swab, and salvia collection OR (2) oropharyngeal swab, salvia collection, and nasopharyngeal swab OR (3) salvia collection, nasopharyngeal swab, and oropharyngeal swab. Only the sequence is different in the different arm, while the sampling technique for each method is the same in all arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants will have Saliva collected and recieve nasopharyngeal swabs and oropharyngeal swabs for SARS-COV2. To avoid systematic bias we plan to randomize the sequence of testing.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea
Condition: Scleroderma, Localized; Morphea; Scleroderma, Circumscribed
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional

Summary: 
      This is a randomized, blinded, and controlled trial to assess the efficacy and safety of UVA1
      phototherapy in the treatment of active morphea in adults and children. Forty patients will
      be randomized to receive either medium dose (70 J/cm2) phototherapy (active UVA1
      phototherapy) with an ultraviolet translucent acrylic screen or "sham" UVA1 (0 J/cm2)
      phototherapy with an ultraviolet opaque acrylic screen 3 times per week for 10 weeks. The
      phototherapists, patients, and principal investigator will be blinded to whether the patients
      receive active or sham UVA1 phototherapy. Patients will only be allowed to apply emollients
      during the study.

      Patients completing the randomized placebo controlled trial (RPCT) will be followed during an
      open observation period for 3 months. During the open phase, all outcome measures from the
      RPCT (LoSSI, PGA-A) will be assessed every 5 weeks as well as adverse events. Patients who
      received sham UVA1 phototherapy will be invited to receive active UVA1 phototherapy using the
      same protocol as in the RPCT during the open observation. Adult patients enrolled in the RPCT
      will also be part of a nested translational study investigating the effect of UVA1
      phototherapy on gene expression from whole skin biopsies taken before (Study Visit 1) and
      after UVA1 phototherapy (Study Visit 3). Gene expression profiles will be compared in
      lesional skin before and after treatment as well as nonlesional skin.
    


Intervention name(s): UVA-1 Phototherapy; Placebo
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
CHRONOtype-adjusted DIET on Weight Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      BACKGROUND: Several reports have observed that the alteration of normal biological rhythms is
      associated with obesity development. In this regard, those subject with the preference for
      evening seems to be prone to develop obesity. However, the current treatment of obesity does
      not take into account these aspects OBJECTIVE: To evaluate whether a diet adjusted to
      patient's chronotype is more effective than the current dietary recommendations.

      SUBJECTS/METHODS: 209 subjects take part in a randomized, double-blind clinical trial. 104
      subjects followed a typical hypocaloric dietary treatment (CONTROL) and the other 105
      subjects undergone a diet with a daily caloric distribution adjusted to their chronotype
      (CHRONO).

      CONCLUSIONS: A chronotype-adjusted diet may be a promising alternative to the classical
      hypocaloric dietary treatment since the investigator's data indicate a higher effectiveness
      regarding weight loss when the diet was adjusted to the patient's chronotype.
    


Intervention name(s): CHRONOTYPE-ADJUSTED DIET
Intervention type(s): Procedure
Intervention description(s): Those patients followed a daily caloric distribution attending to their chronotype. In this regards, 'morning' subjects ate a higher quantity of calories at the first part of the day, while 'evening' subjects ate a higher amount of calories at the second half of the day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Appetite regulation; Chronotype; Diet