bioihbjkbjnl/mcl2 huggingface dataset:
Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects
      aged 12 through less than 18 years with plaque psoriasis in order to check the safety, the
      potential to suppress the adrenal glands and the degree to which the drug is absorbed into
      the bloodstream.
    

Detailed description: 
      This is a Phase 4 (for US site only, Phase 2 for non-US sites), open label, multicenter study
      of halobetasol propionate (HBP) Foam, 0.05% in male and female subjects who are 12 to less
      than 18 years of age with stable plaque psoriasis. Twenty-four subjects with stable plaque
      psoriasis on at least 10% of their body surface area (BSA) (excluding the face, scalp, groin,
      axillae, and other intertriginous areas), who fulfill the inclusion/exclusion criteria will
      be enrolled at multiple study sites in the US and Europe. All subjects are to have a
      Cosyntropin Stimulation Test (CST) to assess their (hypothalmic pituitary adrenal) HPA axis
      response at Visit 1/Screening initiated between 7 and 9 AM. Enrollment into the treatment
      phase of the study will be timed such that the Screening CST is performed a minimum of 20
      days before Visit 2/Baseline. At Visit 2/Baseline, eligible subjects with normal adrenal
      function will be eligible to participate in the study.

      The primary objective of the study is to assess safety, not efficacy. Safety will be
      determined by assessing the adrenal suppression potential and the PK properties of HBP Foam,
      0.05% applied twice daily in male and female subjects who were 12 to less than 18 years of
      age with stable plaque psoriasis.

      Other safety endpoints include plasma levels of HBP. Trough HBP concentrations in plasma on
      day 8 and 15 will be calculated and summarized. Efficacy will also be noted utilizing the
      Investigator's Global Assessment (IGA) scale and percent BSA treated and affected with
      disease to assess and document any changes observed with regard to IGA and percent BSA.
    

Intervention name(s): Halobetasol Topical Foam
Intervention type(s): Drug
Intervention description(s): Foam
Other intervention name(s): HBP Foam
Intervention MeSH terms: Halobetasol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Depression, Epinephrine, and Platelet Function
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Men and women who have suffered sexual and/or physical abuse before the age of 12 are at
      increased risk for anxiety and mood disorders, other serious psychiatric disorders, and
      likely medical illnesses. What is not known is whether adult survivors of childhood adversity
      experience heightened negative emotions and increased physical responses due to altered
      norepinephrine or serotonin systems in their brains and bodies. The investigators expect to
      see that survivors of childhood adversity experience heightened negative emotions and
      increased physical responses to stress.
    


Intervention name(s): Escitalopram; Desipramine
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention; 25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
Other intervention name(s): Lexapro; Norpramin
Intervention MeSH terms: Desipramine; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: platelet function; childhood abuse; depression; antidepressants; immune function; stress response
Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Condition: Infertility
MeSH terms: Infertility; Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral
      Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women
      underwent intracytoplasmic sperm injection (ICSI).
    

Detailed description: 
      Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles
      will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1
      cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 21 days; while in
      group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG
      injection and for 8 days.
    

Intervention name(s): Calcium Dobesilate; Cabergoline
Intervention type(s): Drug; Drug
Intervention description(s): 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days; 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days
Other intervention name(s): doxium; Dostinex
Intervention MeSH terms: Cabergoline; Calcium Dobesilate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: infertility ICSI OHSS Calcium Dobesilate Cabergoline
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone
           when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males

        -  Cohort 2: To evaluate the pharmacokinetics, safety, and tolerability of oral edaravone
           in healthy Japanese and Caucasian adult males
    


Intervention name(s): MT-1186; Rosuvastatin; Sildenafil; Furosemide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Suspension; Tablets; Tablets; Tablets
Other intervention name(s): Edaravone; Crestor; Viagra; Lasix
Intervention MeSH terms: Furosemide; Sildenafil Citrate; Edaravone; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Cohort 1 is open-label, non-randomized, sequential, and add-on study. Cohort 2 is single-dose, open-label, randomized, and cross-over study.
Masking: None (Open Label)
Primary purpose: Other
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to show that addition of device use to a routine breast cancer
      tumor excision procedure is beneficial and assists the surgeon in correctly determining the
      extent of excision.
    

Detailed description: 
      The study is a prospective, multi-center, randomized, double arm study demonstrating the
      effectiveness of the device in adjunctive use for locating the tissue for additional excision
      following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and
      the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the
      MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon
      will use the results derived from the device and other routine assessments to decide if it is
      necessary to remove some additional breast tissue.
    

Intervention name(s): MarginProbe; Lumpectomy
Intervention type(s): Device; Procedure
Intervention description(s): Device use to assess margin status of the excised specimen surface.; Standard of care lumpectomy procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: IDC, DCIS, ILC
A First In Human Study Of PF-00184562 In Healthy Volunteers
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are:

        -  To determine the safety, tolerability and pharmacokinetics of single doses of
           PF-00184562; and

        -  To explore the exposure-response relationship of neuropsychometric and tolerability
           measures of PF-00184562 compared to olanzapine.
    


Intervention name(s): PF-00184562; Olanzapine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Bioavailability Study With Alternate Methods of Administration of Naloxegol Tablets, and Solution
Condition: Bioavailability; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study is an open-label, randomized, 4-period, 4-treatment, crossover,
      single-center, single-dose bioavailability study with alternate methods of administration of
      crushed naloxegol tablets, 25 mg and of a naloxegol solution formulation, 25 mg, compared to
      whole naloxegol tablets, 25 mg, in healthy subjects.

      The main objective of this study is to determine the bioavailability of each of three
      alternative methods of naloxegol administration compared to whole naloxegol tablets given
      orally by assessment of the primary pharmacokinetic (PK) parameters of naloxegol
    

Detailed description: 
      This is an open-label, randomized, 4-period, 4-treatment, crossover, single-center,
      single-dose bioavailability study with alternate methods of administration of naloxegol:
      crushed and suspended in water and administered orally (Treatment A),crushed and suspended in
      water administered via nasogastric tube (Treatment B), solution administered orally
      (Treatment C) and tablet swallowed as a whole (Treatment D).

      Alternative ways of administering a tablet may be useful to help patients who, for different
      reasons, have difficulties with swallowing a whole tablet. Administration of dispersed
      (crushed) tablets suspended in water is a common way of administering drugs to these
      patients. A useful method in patients whose condition prevents swallowing is administration
      of dispersed tablets through nasogastric tubes. Additionally a solution formulation may be an
      attractive option for some patients including the pediatric population. The main aim in this
      clinical study is to investigate whether the blood concentrations of naloxegol
      (pharmacokinetic) after each treatment A, B and C is comparable to that after treatment D.
      Additionally, the safety and tolerability shall be assessed.
    

Intervention name(s): Naloxegol 25 mg tablet, crushed, suspended in water, given orally; Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube; Naloxegol 25 mg (10 mL oral solution); Naloxegol 25 mg tablet, given orally
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): naloxegol 25 mg (1 tablet) crushed, suspended in water, given orally; naloxegol 25 mg (1 tablet) crushed, suspended in water, given via nasogastric tube; naloxegol 25 mg (10 mL oral solution); naloxegol 25 mg (1 tablet) whole tablet, given orally
Other intervention name(s): Treatment A; (Test product); Treatment B; (Test product); Treatment C; (Test product); Treatment D; (Reference product)
Intervention MeSH terms: Naloxegol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: naloxegol tablet crushed; naloxegol oral solution; naloxegol whole tablet; relative bioavailability; Phase I; healthy subjects
GOS and Microbial Fermentation in Aging
Condition: Healthy Young Adults; Prefrail Elderly
Study type: Interventional

Summary: 
      The population is aging worldwide, concomitant frailty is increased in older age groups.
      Frailty has a strong impact on outcomes of multi-morbidity and daily living, thereby
      negatively influencing quality of life and health care costs. Prevention or delay of onset of
      frailty associated with aging is needed. Dietary intake of galacto-oligosaccharides (GOS) may
      have beneficial effects on microbiota composition and health outcome parameters. As
      microbiota composition and function may be altered in elderly compared to younger adults, it
      will investigated whether the effects of GOS on selected parameters of microbiota and gut
      health differ between elderly versus younger adults. The primary objective of this study is
      to compare the effects of four weeks GOS supplementation on intestinal microbiota composition
      and activity in elderly versus younger adults. Further, this study has four secondary
      objectives. The study conforms to a randomized double-blind placebo-controlled cross-over
      design per age-group. Study populations are human volunteers (male and female), healthy young
      adults of 25-50 years and prefail older adults of 70-85 years old, BMI 20-30 kg/m2. One
      intervention period subjects will receive 7.2 grams of Vivinal® GOS Powder three times daily
      for four weeks. The other intervention period subjects will receive isocaloric placebo
      supplements (5.7 grams maltodextrin) three times daily for four weeks. At the start and end
      of each intervention period, several measurements will take place. There will be a washout
      period of four to five weeks between intervention periods. The main study parameter is the
      change in microbial composition and activity induced by GOS intervention, in younger adults
      and elderly.
    


Intervention name(s): Galacto-oligosacchride; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): During this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks; During this period subjects will receive 7.24 grams of maltodextrin supplements three times daily for four weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Response Guided Treatment With Direct Acting Anti-Viral Medications for Chronic HCV Infection
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional

Summary: 
      To evaluate the efficacy and safety of direct acting anti-viral agents (DAA) therapy in
      chronically infected Hepatitis C Virus (HCV) patients using an individualized response guided
      therapy (RGT) model.
    

Detailed description: 
      Treatment of HCV infection is directed at achieving sustained virological response (SVR),
      defined as the continued absence of detectable HCV RNA for 12 or more weeks after completion
      of therapy Given the limited resources available for the costly DAA treatment, implementation
      of a response-guided treatment (RGT) model to individualize length of DAA therapy in a
      prospective setting could result in substantial cost saving on HCV drug expenditure in
      addition to improving patients' compliance to treatment. Furthermore, if adopted at a larger
      scale, incorporation of such model into clinical practice may enable expansion of access to
      DAA therapy for patients who are currently not included in the various treatment programs,
      especially in resource-limited countries.
    

Intervention name(s): Direct acting anti-viral agents
Intervention type(s): Drug
Intervention description(s): Standard of care for Hepatitis C treatment
Other intervention name(s): Treatment
Intervention MeSH terms: Antiviral Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Interleukin-6 and Procalcitonin as Novel Inflammatory Biomarkers in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta
Condition: Covid19 Positive Patients
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Serum Interleukin-6 and Procalcitonin of 100 consenting COVID 19 positive patients from April
      2020 - May 2021 were assessed at Pathology department CMH Quetta and the results were
      correlated with severity of lung involvement on HRCT Chest
    

Detailed description: 
      Objective: To explore the relation between Interleukin-6 and Procalcitonin with COVID
      severity on HRCT Chest Study Design: Randomized Control Trial (Clinical Trials. gov
      Identifier: NCT04798391) Place and duration of study: Pathology, Radiology & ENT Department
      CMH Quetta from April 2020 - May 2021 Methodology: Serum Interleukin-6 and Procalcitonin of
      100 consenting COVID 19 positive patients from April 2020 - May 2021 were assessed at
      Pathology department CMH Quetta and the results were correlated with severity of lung
      involvement on HRCT Chest Results: Serum Interlukin-6 levels were raised in 97 (97%) patients
      with mean levels of 20.43 + 19.66 (pg/ml). Serum procalcitonin levels were raised in 95 (95%)
      patients with mean levels of 0.4331 + 0.24 (ng/ml). A P value of <0.001 was calculated on
      Independent Sample T-test for both serum interlukin-6 and serum procalcitonin as correlated
      with severity of lung involvement on HRCT Chest.

      Conclusion: Interlukin-6 and procalcitonin are excellent biomarkers for diagnosis and
      predicting severity of COVID19 pneumonia.

      Keywords: Covid19 pneumonia, Interlukin-6, procalcitonin.
    

Intervention name(s): Interlukein 6 and procalcitonin serum levels
Intervention type(s): Diagnostic Test
Intervention description(s): Blood tests
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Predictive Value of Cardiovascular Magnetic Resonance Related Parameters in STEMI Patients After Primary PCI for Adverse Left Ventricular Remodeling and Major Adverse Cardiovascular Events
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Ventricular Remodeling
Study type: Observational [Patient Registry]

Summary: 
      This study aim to investigate the predictive value of CMR parameters: infarct size (IS),
      intramyocardial hemorrhage, microvascular obstruction, area at risk and CMR derived strain
      parameters with the Major Adverse Cardiovascular Events (MACEs) and myocardial remodeling
      afterinfarction.
    

Detailed description: 
      Investigators will enroll 500 patients with STEMI after PCI who were admitted to the Chinese
      PLA General Hospital and other eight hospitals across China: Wuhan Asia Heart Hospital; the
      First People's Hospital of Yunlin; Chaoyang Hospital, Capital Medical University; Hainan
      Hospital of PLA General Hospital; the Second Affiliated Hospital of Nanchang University; the
      Second Hospital of Hebei Medical University; Guizhou Provincial People's Hospital; Affiliated
      Hospital of Zunyi Medical College between January 2014 and December 2019. CMR was performed
      at 7 days and 6 months after primary PCI to assess the final infarction size(IS),
      microvascular obstruction (MVO), intramyocardial hemorrhage(IMH), area at risk (AAR) and
      related strain parameters. All patients will be followed up by 5 years after adimission.
      Cardiovascular events concluded stroke, repeat revascularization, rehospitalization for acute
      heart failure, nonfatal myocardial infarction, and all cause death. All adverse clinical
      events as well as study end points were monitored and adjudicated by the independent event
      committee.
    

Intervention name(s): cardiovascular magnetic resonance (CMR)
Intervention type(s): Diagnostic Test
Intervention description(s): Testing CMR on patients of 7 days and 6 months after myocardial infarction
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Investigators will enroll 500 patients with STEMI after PCI who were admitted to the
        Chinese PLA General Hospital and other eight hospitals across China between January 2016
        and January 2019. CMR was performed at 7 days and 6 months after primary PCI to assess the
        final infarction size, microvascular obstruction (MVO), area at risk (AAR) and related
        strain parameters. All patients will be followed up by 5 years after addimission index.
      
Keywords: Intramyocardial Hemorrhage(IMH); Microvascular Obstruction(MVO); Area at Risk(AAR); CMR Related Strain; ST-segment elevation myocardial
Non-invasive Substrate Evaluation in Atrial Fibrillation
Condition: C14.280.067.198
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The study aims to assess the right and left atrial electrophysiological substrate in atrial
      fibrillation patients using the invasive electroanatomic map (basal and with extraestimulus)
      as well as its correlation with cardiac magnetic resonance and electrocardiographic imaging.
      The results will also be compared when the patient is in sinus rhythm and atrial
      fibrillation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with persistent or paroxysmal atrial fibrillation, without cardiomyopathy (LVEF>
        40%) or significant valvulopathy who will undergo first AF ablation.
      
Keywords: Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation