bioihbjkbjnl/mcl2 huggingface dataset:
A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The study compares two semaglutide medicines and looks at how well they control blood sugar
      levels, in participants with type 2 diabetes (T2D). Participants will either get the
      currently available semaglutide or the semaglutide which is produced through a new
      manufacturing process. Participants need to take one injection of semaglutide once a week, on
      the same day of every week. Participants will have a total of 11 clinic visits and the study
      will last for about 35 weeks (approximately 8 months).
    


Intervention name(s): Semaglutide J; Semaglutide B
Intervention type(s): Drug; Drug
Intervention description(s): Participants will initially receive 0.25 mg subcutaneous injections of semaglutide J OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).; Participants will initially receive 0.25 mg subcutaneous injections of semaglutide B OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
      evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants
      with asthma whose disease remains uncontrolled despite daily treatment with inhaled
      corticosteroids (ICS) therapy and at least one second controller medication. Participants
      will be randomized in a 1:1:1 ratio to receive double-blind treatment with either
      lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks
      (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by
      an optional 52-week double-blind active-treatment extension. The anticipated time on study
      treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue
      prematurely or decide not to take part in the optional active-treatment extension will
      transition to the 20-week safety follow-up period.
    


Intervention name(s): Lebrikizumab; Placebo; Standard of Care
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lebrikizumab will be administered as SC injection at high or low dose Q4W.; Lebrikizumab matching placebo will be administered as SC injection Q4W.; Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists [LABAs], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the
      treatment of inflammatory airways diseases. This is the first study using a new formulation
      of GSK2269557 in healthy subjects and will evaluate the safety, tolerability and PK of a
      single dose of GSK2269557. Data derived from this study will inform on the PK profile and
      systemic exposure expected during Phase 2b. Approximately twelve healthy subjects will be
      randomized to receive a single dose of GSK2269557 750 micrograms (µg) or a single dose of
      GSK2269557 500 µg via the ELLIPTA® dry powder inhaler (DPI) formulated in a blend containing
      0.4 percent magnesium stearate (MgSt) in 1:1 ratio. This randomized, parallel group study
      will be carried out in 3 phases, including screening phase, treatment phase and follow-up
      phase. The total study duration for each subject will be up to 6 weeks. ELLIPTA is a
      registered trademark of GlaxoSmithKline group of companies.
    


Intervention name(s): GSK2269557 500 µg; GSK2269557 750 µg
Intervention type(s): Drug; Drug
Intervention description(s): GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 500 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI.; GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 750 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI.
Intervention MeSH terms: Nemiralisib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy subjects will be randomized to receive GSK2269557 750 µg or GSK2269557 500 µg.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Healthy; ELLIPTA; Safety; GSK2269557; Inhalation; Tolerability
Brief Group Intervention Using EFT (Emotional Freedom Techniques) for Depression in College Students
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Depression is an important mental health concern in college students. This study will recruit
      students who test positive for moderate to severe depression on the Beck Depression Inventory
      (BDI). Subjects will be randomly assigned to either a treatment or a control condition. Those
      in the treatment group will receive four 90 minute group classes using EFT (Emotional Freedom
      Techniques) to address traumatic memories and other self-identified causes of depression. It
      will compare them to a no treatment control group.
    


Intervention name(s): EFT (Emotional Freedom Techniques)
Intervention type(s): Behavioral
Intervention description(s): Four 90 minute group therapy classes of this behavioral intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: students,; depression,; group therapy,; EFT (Emotional Freedom Techniques),; energy psychology
Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines
Condition: Prophylaxis Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive
      subjects, the humoral and cellular immune response of herpes simplex candidate vaccines
      containing gD from two different cell lines and using gD-Alum as control.
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham.
    

Intervention name(s): Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141; Herpes simplex virus containing gD-Alum
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses, 2 different formulations; Intramuscular injection, 3 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Herpes simplex; Herpes simplex candidate vaccine
Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device
Condition: Wrinkles; Fine Lines; Crepey Skin; Acne Scars; Active Acne; Enlarged Pores; Loose Skin
MeSH terms: Cutis Laxa; Acne Vulgaris
Study type: Interventional

Summary: 
      The intended use of the Potenza™ device is to collect clinical data for brow lifting and/or
      treatment of dermatologic conditions in which electrocoagulation and hemostasis is a viable
      mechanism for means of improvement.
    


Intervention name(s): RF Device (Potenza™)
Intervention type(s): Device
Intervention description(s): Test spots may be performed prior to the first treatment. Following test spots, for the treatment, the tip will be placed in contact with the skin. Parameters may be adjusted throughout the treatment and will determined by the Clinician.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This proposal seeks to gather continuous blood glucose and physical activity data from
      individuals with and without diabetes.
    

Detailed description: 
      This proposal seeks to gather continuous blood glucose and physical activity data from
      individuals with and without diabetes who are physically active and exercising for health
      benefits. The investigators hypothesize that insulin requirements will be inversely related
      to intensity of activity and an algorithm will be able to detect physical activity and
      automatically adjust insulin doses. Once such an algorithm has been determined for an
      individual, it can be applied to future similar situations, but ideally the algorithm will be
      dynamically refined based on closed-loop feedback information.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): Sprinting, walking on a treadmill, and stationary bicycle riding
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        individuals without diabetes and those with type 1 and type 2 diabetes
Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus
Condition: Sarcoma
MeSH terms: Sarcoma; Carcinosarcoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. It is not yet known whether radiation therapy is more effective than combination
      chemotherapy in treating patients with cancer of the uterus.

      PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it
      works compared to combination chemotherapy in treating patients with cancer of the uterus.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the survival, progression-free interval, and failure patterns in patients with
           optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal
           radiotherapy vs ifosfamide and cisplatin.

        -  Compare the incidence and type of acute and late adverse events observed with these
           treatment regimens in this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
      treatment arms.

        -  Arm I: Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks, followed
           by radiotherapy boost to the pelvis 5 days a week for 2.2 weeks.

        -  Arm II: Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4.
           Treatment continues every 3 weeks for 3 courses.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 6 years.
    

Intervention name(s): cisplatin; ifosfamide; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Ifosfamide
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage I uterine sarcoma; stage II uterine sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; uterine carcinosarcoma
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
Condition: Chronic Hepatitis C; Liver Fibrosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no
      treatment for the prevention of fibrosis progression in adult participants with moderate to
      severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol
      treatment in protocol P02370 (NCT00039871).
    


Intervention name(s): peginterferon alfa-2b (SCH 54031)
Intervention type(s): Biological
Intervention description(s): 0.5 µg/kg Weekly QW SC for 36 months
Intervention MeSH terms: Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery
Condition: Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      In patients undergoing coronary artery bypass surgery, the relationship between
      neurocognitive changes seen in the early period and brain-induced neurotrophic factor serum
      levels will be investigated.
    

Detailed description: 
      Although postoperative cognitive dysfunction (POKD) is the most common neurological
      complication in patients undergoing coronary artery bypass grafting (CABG) surgery, its
      pathophysiology is still not fully understood. However, the quality of this dysfunction has
      not been properly measured. In addition to clinical tests, biomarkers are often used to
      detect the presence of POKD. In this study, it was aimed to evaluate the relationship between
      intraoperative and postoperative brain-derived neurotrophic factor serum levels and POKD in
      patients undergoing CABG surgery.

      This prospective observational study is planned to include 30 adult patients aged 40-90
      years. Patients with stroke history, neurodegenerative disease, seizure history, alcohol use,
      general anxiety, hearing deficit, unilateral carotid artery stenosis greater than 70%, and
      carotid artery bilateral stenosis greater than 50% will be excluded from the study.

      This study aimed to determine perioperative changes in serum brain-derived neurotrophic
      factor levels in patients undergoing CABG surgery.
    

Intervention name(s): Patients with cognitive dysfunction
Intervention type(s): Diagnostic Test
Intervention description(s): Mini Mental Test Those with a score below 21 points
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Volunteer patients to be included in the study: 30 adult patients who will undergo coronary
        artery bypass grafting (CABG) surgery
Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia
Condition: Acute Myeloid Leukemia; Myelodysplasia; Acute Lymphoblastic Leukemia; Chronic Lymphocytic Leukemia; Follicular Lymphoma; Multiple Myeloma; NHL; Myeloproliferative Diseases; Chronic Myeloid Leukemia; Renal Cell Carcinoma; Aplastic Anemia
MeSH terms: Carcinoma; Leukemia; Leukemia, Myeloid; Multiple Myeloma; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Carcinoma, Renal Cell; Hematologic Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Anemia; Anemia, Aplastic; Myeloproliferative Disorders
Study type: Observational

Summary: 
      The primary objective of this study is to examine transplant related mortality (TRM) at 100
      days <30%. A TRM of >50% is considered unacceptable. This study also seeks a TRM at 12 months
      that is <50%, engraftment >90% (defined as donor cells >80% at 6 months), and 1 year overall
      survival >50%.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia
      
Keywords: Allogeneic SCT; Matched unrelated donors; hematologic malignancies; renal cell carcinoma; aplastic anemia
Virtual Chromoendoscopy for Distal Polyps
Condition: Colorectal Polyps
MeSH terms: Polyps
Study type: Observational

Summary: 
      To assess the accuracy of predicting histology with virtual chromoendoscopy for distal
      colorectal polyps according to the ASGE PIVI statement.
    


Intervention name(s): Prediction of histology
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing screeining or surveillance colonoscopy
Drug Use Evaluation of Clindamycin in Critical Care Units in Alexandria Main University Hospital
Condition: Infection, Bacterial
MeSH terms: Bacterial Infections
Study type: Observational

Summary: 
      Irrational use of antibiotics is a one of the main health system problems,it leads to
      antibiotic resistance,increasing antibiotics side effects and the total cost. This study is a
      medication use evaluation study aims to evaluate intravenous clindamycin prescribing practice
      in critical care units in Alexandria Main University Hospital.
    


Intervention name(s): Clindamycin Injection
Intervention type(s): Drug
Intervention description(s): it is a clindamycin use evaluation study
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All adult patients admitted to critical care units and on clindamycin emperical therapy .
Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well nilotinib works in treating patients with
      newly diagnosed chronic phase chronic myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To establish the complete cytogenetic response rate at 6 months in patients with newly
           diagnosed Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia
           treated with nilotinib.

      Secondary

        -  To establish the complete cytogenetic response rate at 3, 9, 12, 18, and 24 months in
           these patients.

        -  To establish the molecular response rate at 3, 6, 9, 12, 18, and 24 months in these
           patients.

        -  To establish the safety of this drug in these patients.

        -  To correlate pharmacokinetic data with response rate and toxicity.

        -  To correlate Bcr-Abl results using GeneXpert with Bcr-Abl results using international
           standardized quantitative PCR.

        -  To estimate the prevalence of Bcr-Abl mutations prior to and during treatment.

      OUTLINE: This is a multicenter study.

      Patients receive oral nilotinib twice daily on days 1-28. Treatment repeats every 28 days for
      up to 24 courses in the absence of disease progression or unacceptable toxicity.

      Peripheral blood and bone marrow samples are collected periodically for mutation analysis,
      Bcr-Abl analysis by quantitative PCR, metaphase cytogenetics, and pharmacokinetic analysis.

      After completion of study therapy, patients are followed every 3 months for 2 years.
    

Intervention name(s): nilotinib; cytogenetic analysis; mutation analysis; polymerase chain reaction; pharmacological study
Intervention type(s): Drug; Genetic; Genetic; Genetic; Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic myelogenous leukemia, BCR-ABL1 positive; chronic phase chronic myelogenous leukemia
A Study to Compare the Pharmacokinetic Characteristics of CJ-12420
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics after administration of different formulation of CJ-12420
    

Detailed description: 
      The purpose of this study is to compare the pharmacokinetics after a single dose
      administration of CJ-12420 formulation 1 and formulation 2.
    

Intervention name(s): CJ-12420 formulation 2; CJ-12420 formulation 1
Intervention type(s): Drug; Drug
Intervention description(s): CJ-12420 formulation 2; CJ-12420 formulation 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intensity Modulated Radiation Therapy for Head and Neck Cancer
Condition: Nasopharyngeal Neoplasms
MeSH terms: Nasopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in
      the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of
      these normal tissues. Standard radiation treatment techniques using three or four radiation
      beams cannot avoid delivering some dose of radiation to these normal tissues that do not need
      to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of
      computer-controlled radiation beams aimed at your cancer to try to lower the amount of
      radiation that normal tissues receive, while still delivering the desired amount of radiation
      to your cancer and to areas that your doctor thinks may have cancer cells.

      The doctors at Princess Margaret Hospital are conducting this study in order to test whether
      the use of IMRT techniques can improve the chance of controlling your cancer in the head and
      neck region.
    


Intervention name(s): intensity modulated radiation therapy; cisplatinium and fluorouracil - standard treatment
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Fluorouracil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment