bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Clinical Study of Metatinib Tromethamine Tablet
Condition: Advanced or Metastatic Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of
      daily oral administration of metatinib tromethamine in subjects with solid tumors;
      Investigate the influence of food on pharmacokinetic parameters.

      Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral
      administration of metatinib tromethamine in subjects with solid tumors; To observe
      preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive
      biomarkers at MTD.
    


Intervention name(s): Metatinib Tromethamine
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Latin American Real-world Study in Acute Leukemia
Condition: Acute Myeloid Leukemia; Acute Lymphoid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Observational

Summary: 
      The objective of the study is to describe the current epidemiology, treatment patterns,
      outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory
      (R/R) B-cell ALL and de novo AML in 4 Latin American countries.
    

Detailed description: 
      This is a retrospective multicenter non-interventional study using real-world data collected
      from medical records of newly diagnosed AML or with relapsed/refractory B-cell ALL diagnosed
      between 01 January 2015 and 31 December 2019 in 4 Latin American countries: Argentina,
      Brazil, Chile, and Colombia. In addition, as secondary objectives, the study will also
      describe molecular profile, cytogenetic risk, clinical outcomes, and healthcare resource
      utilization of treated B-cell ALL R/R and AML patients.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients ≥18 years old at diagnosis, with de novo AML or R/R B-cell ALL diagnosed between
        01 January 2015 and 31 December 2019, as documented in the medical chart and according to
        the physician's notes, and with at least 1 line of treatment for AML or R/R ALL within the
        study period.
      
Keywords: Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Relapsed Refractory B-cell Acute Lymphoblastic Leukemia; Acute Leukemia in Latin America; LOYAL study
Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED
Condition: Pain; Renal Colic
MeSH terms: Colic; Renal Colic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Hypothesis: Intravenous administration of Ketorolac 10 mg and 20 mg is as effective as 30 mg
      in treating renal colic pain in patients presenting to the emergency department
    

Detailed description: 
      Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the
      Emergency Department (ED). Because of the Ketorolac significant analgesic potency, it is
      usually used for moderate-to-severe pain. However, ketorolac has several side effects, of
      which gastrointestinal hemorrhage is most concerning. "Analgesic ceiling" is defined as the
      dose beyond which no additional analgesia can be achieved and on the other hand, more side
      effects might be encountered. Several studies suggested 10 mg as analgesic ceiling. Despite
      this, many recommendations are still advocating several folds higher doses (e.g. 30, 60 mg).
    

Intervention name(s): Ketorolac
Intervention type(s): Drug
Intervention description(s): Subject will receive 10, 20, and 30mg of Ketorolac.
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the safety, tolerability, pharmacokinetics and
      antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus
      (HCV)-infected participants.
    

Detailed description: 
      This was a Phase 2a, blinded, randomized, placebo-controlled clinical trial in hepatitis C
      virus (HCV)-infected adults with 2 planned sequential evaluations, Part 1 and Part 2. The
      study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-333
      or placebo monotherapy, followed by 26 days of ABT-333 or placebo with pegylated interferon
      a-2a (pegIFN) and ribavirin (RBV) combination therapy. Review of safety and efficacy in Part
      1 of the study showed similar response rates across ABT-333 doses so Part 2 of the study was
      not performed. The study also assessed emergence of resistant HCV in conjunction with
      kinetics of viral load decay and rebound in treatment-naïve, HCV-infected participants.
    

Intervention name(s): ABT-333; Placebo for ABT-333; Pegylated interferon; Ribavirin
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): 50 mg capsules; Capsule; Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly; 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Other intervention name(s): dasabuvir
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
GW406381 In Patients With Peripheral Nerve Injury
Condition: Hyperalgesia; Neurodynia; Pain; Trauma
MeSH terms: Hyperalgesia; Peripheral Nerve Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The findings from preclinical animal models confirm the peripheral
      anti-inflammatory/analgesic activity of GW406381 and also suggest contribution of a central
      site of action to the anti-hyperalgesic efficacy that may not be shared by other COX-2
      inhibitors. A central action is consistent with distribution of GW406381 into the CNS in
      animals. Furthermore, preliminary data from a positron emission tomography study in which 6
      healthy male volunteers received a tracer dose of 11C labelled GW406381 indicate that
      GW406381 is rapidly absorbed into the central nervous system in man.
    


Intervention name(s): GW406381
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GW406381; peripheral nerve injury; patients; allodynia; hyperalgesia; randomised; placebo-controlled
Effect of Hibiscus and Lippia Extract on Blood Pressure
Condition: Blood Pressure
Study type: Interventional

Summary: 
      Determine if a double-blind, randomized, placebo-controlled clinical intervention, based on a
      dietetic intervention and physical exercise, supplemented with a polyphenolic extract,
      decreases blood pressure in hypertensive volunteers.
    

Detailed description: 
      Slightly hypertensive individuals, before diagnosed with type 1 hypertension, are generally
      monitored by their physician and given dietetic and physical activity guidelines. The
      objective of this intervention is to prevent onset of a hypertensive pathologic condition.
      However, in many cases, this intervention is unsuccessful, and therefore the patient must
      follow-up with anti-hypertensive drugs.

      Here, in the current study, the objective is to include a nutritional supplement in the
      intervention in order to increase the probability of success of the diet/exercise
      intervention. Previous studies with the supplement Metabolaid has shown the product to
      significantly decrease the blood pressure of slightly hypertensive individuals. It is
      estimated, based on the results of previous clinical studies, that the polyphenolic content
      of the nutritional supplement will reduce at least an additional 10% of the blood pressure of
      the patients undergoing a diet and exercise intervention.
    

Intervention name(s): Metabolaid®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mg per day, in fasting conditions.; 500 mg per day, in fasting conditions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Alternate Day Buprenorphine Administration, Phase XI - 16
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate open buprenorphine dosing with dose choice after
      open exposure.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Intervention model: Crossover Assignment
Primary purpose: Treatment
Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris
Condition: Acne
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study
      to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel,
      0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide)
      gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris
    

Detailed description: 
      Up to 1000 patients 12 to 40 years of age inclusive will be enrolled to have 870 patients in
      the modified intent-to-treat (mITT) population and 579 patients in the per-protocol (PP)
      population. The primary inclusion criteria are the presence of ≥ 20 inflammatory lesions
      (papules and pustules) and ≥ 25 non-inflammatory lesions (opened and closed comedones) and ≤
      2 nodulocystic lesions (i.e., nodules and cysts) on the face and an Investigator's Global
      Assessment (IGA) score of 3 or 4.

      Eligible patients will be randomized in a 1:1:1 ratio to one of the three treatments (Test,
      Reference or Placebo) on Visit 1. Patients will be instructed to apply the first treatment on
      the evening of enrollment into the study and then continue to apply once daily for the next
      83 days (for a total 84 days). Patients will attend the following scheduled clinic visits:

        -  Visit 1 - Screening/Baseline: Day 1

        -  Visit 2 - Interim Visit: Day 28 ± 4

        -  Visit 3 - Interim Visit: Day 56 ± 4

        -  Visit 4 - End of Study: Day 85 ± 4 Efficacy evaluations will be based on dermatological
           assessments in the clinic. The primary statistical analyses of interest are (1) the
           percent change from baseline to Week 12 in the number of inflamed (papules/pustules)
           lesions and non-inflamed (open and closed comedones) lesions. In addition, patients will
           also be evaluated by the Investigator to determine "Clinical Success" or "Clinical
           Failure" at Week 12
    

Intervention name(s): Epiduo® Forte Gel; Adapalene and Benzoyl Peroxide Gel; placebo gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w; Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w; vehicle used as placebo
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging
      (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of
      developing cardiac events.
    

Detailed description: 
      The purpose of this clinical research study is to determine how well CARDIOLITE® rest and
      stress myocardial (heart) imaging can define the pediatric Kawasaki disease (KD) population
      into high and low risk categories of developing cardiac (heart) events (complications) from 1
      year through 3 years after image completion. The safety of CARDIOLITE® rest and stress heart
      imaging will also be studied.
    

Intervention name(s): Sestamibi
Intervention type(s): Drug
Intervention description(s): Sestamibi
Other intervention name(s): Cardiolite
Intervention MeSH terms: Technetium Tc 99m Sestamibi
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to compare safety and efficacy of sitagliptin and placebo therapy when added to
      stable sulfonylurea alone or in combination with metformin in participants with type 2
      diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the
      addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C
      (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.
    


Intervention name(s): Sitagliptin; Placebo; Gliclazide; Glimepiride; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sitagliptin 100 mg oral tablet once daily for 24 weeks; Matching placebo to sitagliptin oral tablet once daily for 24 weeks; Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.; Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.; Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.
Other intervention name(s): Januvia®; MK-0431
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state concentrations of
      odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA)
      ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and
      ethinylestradiol in healthy female participants.
    


Intervention name(s): Drospirenone/ethinylestradiol; AL-335; Odalasvir (ODV); Simeprevir (SMV)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol to be taken orally on Days 1, 6, 25, and 32.; AL-335 (800 mg) tablet once daily on Days 5-7 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.; ODV 25 mg tablet once daily on Days 12-25 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.; SMV 75 mg capsule as a component of 3-DAA combination to be taken orally on Days 26-32.
Other intervention name(s): Yaz®
Intervention MeSH terms: Simeprevir; Odalasvir; Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Cognitive Dysfunction in COPD Patients : Role in the Performance of Cognitive-motor Dual Task Situation?
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cognitive Dysfunction
Study type: Observational

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease starting point
      characterized by multiple systemic effects as cognitive dysfunction. This one seems to have
      an impact in activity daily living, considered mainly as a cognitive-motor dual task
      situations. Yet to date, no study has specifically focused in the cognitive-motor performance
      in patients with COPD or on the effects during a rehabilitation program. The main objective
      of this work was to evaluate the impact of cognitive dysfunction in COPD, comparing
      performance between COPD patients and healthy subjects in a single and dual task
      cognitive-motor situation. The secondary objective was to assess the impact of a
      rehabilitation program on these performances.
    


Intervention name(s): Cognitive and motor performances
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        COPD patients, entered in a rehabilitation program in Clinique du Souffle were included
      
Keywords: cognitive dysfunction; Activity of Daily Living; interference; rehabilitation; cognitive-motor dual task
Quality of Life Assessment in Greek asthmatIc Patients Treated With the Fixed Dose Combination of Budesonide / Formoterol in Clinical Practice
Condition: Asthma; Quality of Life; Satisfaction
Study type: Observational

Summary: 
      The greater efficacy of combination therapy led to the development of fixed combination
      devices which simultaneously carry both glucocorticosteroid and a LABA (eg stable
      combinations of fluticasone-salmeterol, budesonide-formoterol).

      Fixed combinations are easier to use for patients, potentially increasing compliance, and
      ensure that the LABA always accompanied by glycocorticosteroeides1. From the available
      combinations of the combination of budesonide-formoterol can be used both in maintenance
      therapy and for the relief of symptoms due to the rapid onset of action of formoterol
      compared with salmeterol. Both components of budesonide-formoterol combination when
      administered on demand contribute to strengthening protection from severe exacerbations in
      patients receiving combination therapy for maintenance, and enable improvement of asthma
      control at relatively low doses of ICS.
    

Detailed description: 
      This prospective observational study of the Greek population to approximately 2,500 patients
      suffering from asthma, aims to collect the characteristics of patients that were selected to
      obtain an inhaled combination of budesonide and formoterol fumarate dihydrate in any of
      portions 100 / 6mcg, 200 / 6mcg, 400/12 mcg (Pulmoton®), and to collect data on the quality
      of life to such an inhaled combination through Elpenhaler® device.

      Data will be collected for a period of three months from patients diagnosed with asthma not
      adequately controlled with inhaled corticosteroids and 'as needed' inhaled beta2-agonists
      short-acting or patients already adequately controlled on both inhaled corticosteroids and
      long-acting beta2-agonists.

      Data will be collected during the period of one (1) to three (3) months (± 2 weeks) from the
      initiation of treatment with inhaled combination include ACQ checklist questionnaire mini
      AQLQ, questionnaire FSI 10, and data any existing comorbidities.
    

Intervention name(s): budesonide formoterol fixed combination
Intervention type(s): Other
Intervention description(s): Asthmatic patients who will be on budesonide formoterol fixed combination treatment administered by Elpenhaler device.
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asthmatic patients
Effectiveness of Vancomycin Loading Therapy
Condition: Infection
Study type: Interventional

Summary: 
      The goal of tish clinical research study is to identify that loading of vancomycin can
      facilitate rapid attainment of target trough serum vancomycin concentration.
    

Detailed description: 
      The Study drug

        -  Vancomycin : a glycopeptide antibiotic, is the first line agent in the treatment of
           methicillin resistant staphylococcus aureus

      Study design : Randomized controlled trials

      Study Drug Administration

        -  If your doctor believes you are eligible, and you agree to take part in this study, you
           will be randomized to two treatment groups.
    

Intervention name(s): Vancomycin HCL
Intervention type(s): Drug
Intervention description(s): Loading dose of 30mg/kg via central or peripheral intravenous infusion during 2 or 3 hours.
Maintenance dose of vancomycin is 15mg/kg twice a day or 1g twice a day.
Other intervention name(s): The brand name is the Vancomycin hydrochloride.; It is made by Lilly.
Intervention MeSH terms: Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the
      tumor without affecting the surrounding tissue.

      PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating
      patients who have prostate cancer that has not spread beyond the prostate.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the ability of Sonablate to focus ultrasonic waves for the purpose of
           selectively destroying prostate cancer tissue, with resultant drop in PSA levels to
           below 0.5 ng/mL and negative biopsy for cancer cells, in patients with organ-confined
           prostate cancer.

      OUTLINE: This is a multicenter study.

      A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using
      the Sonablate system is delivered to the prostate tissue over approximately 2-3 hours.
      Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing
      PSA levels taken at least 2 months apart, visible prostate tissue on ultrasound, and no local
      or distant metastases after day 90 undergo retreatment with HIFU.

      Patients are followed at 2, 14, 30, 90, and 180 days.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): high-intensity focused ultrasound ablation
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer