bioihbjkbjnl/mcl2 huggingface dataset:
Triple Combination Therapy in High Risk Crohn's Disease (CD)
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of triple combination therapy with an
      anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist
      (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic
      remission in participants with newly-diagnosed CD stratified at higher risk for
      complications.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
      treat people who have CD. This study will look at the endoscopic remission and mucosal
      healing of gastrointestinal tract of people who take vedolizumab as triple combination
      therapy with adalimumab and methotrexate.

      The study will enroll approximately 60 participants. Participants will receive triple
      combination therapy which includes:

        -  Vedolizumab 300 mg (intravenous)

        -  Adalimumab 160/80/40 mg (subcutaneous)

        -  Methotrexate 15 mg (oral)

      All participants will receive vedolizumab intravenous infusion on Weeks 0, 2, 6, 14 and 22
      along with adalimumab 160 mg, subcutaneous injection at Week 0, 80 mg at Week 2, then 40 mg
      once at Week 4 and every 2 weeks thereafter until Week 26 along with methotrexate tablets
      orally, once weekly from Weeks 0 up to Week 34. In monotherapy phase, all participants will
      receive vedolizumab intravenous infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and
      102.

      This multi-center trial will be conducted in the United States and Canada. The overall time
      to participate in this study is 128 weeks. Participants will make multiple visits to the
      clinic, plus a final visit 18 weeks after last dose of study drug for a safety follow-up
      assessment. Participants will also participate in a long-term safety questionnaire, by phone,
      at 26 weeks (6 months) from the last dose of study drug.
    

Intervention name(s): Vedolizumab; Adalimumab; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vedolizumab intravenous infusion.; Adalimumab injection for subcutaneous use.; Methotrexate oral tablets.
Other intervention name(s): Entyvio; MLN0002 IV; Humira
Intervention MeSH terms: Adalimumab; Methotrexate; Vedolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
Condition: Cataract; Aphakia
MeSH terms: Cataract; Aphakia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos TL (thin
      lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.
    


Intervention name(s): The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
Intervention type(s): Device
Intervention description(s): Surgery to implant the Bausch & Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Affect of Multiple Health Education on Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients
Condition: Ischemic Stroke; Medication Persistence
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The study aimed to demonstrate the relationship between secondary prevention medication
      persistence and clinical prognosis of ischemic stroke patients at 3,6,12 months
    

Detailed description: 
      The study is a prospective, multicenter, hospital-based study on secondary prevention for
      patients with ischemic cerebrovascular diseases between May 2014 and June 2015. Physicians
      from 24 hospitals in Beijing underwent a standard secondary prevention training of ischemic
      cerebrovascular diseases by professional training, instruction manuals, stratification
      management software. In order to improve the persistence of taking preventive secondary
      medicine, IS patients from these 24 hospitals received healthy education through manuals and
      Digital Video Disc about health education during hospitalization and acquired secondary
      preventive knowledge of ischemic cerebrovascular diseases through regular health education
      messages during 6 months after discharge. Patients with IS from other 6 hospitals were used
      as a control, and no such intervention was given to them.

      Telephone follow-up was performed at 3 months, 6 months, and 1 year after the onset of
      cerebral infarction, during which the use of antiplatelet and statins drugs and recurrence of
      IS were recorded. Patients who took antiplatelet drugs or statins at three follow-ups were
      regarded as persistent antiplatelet drugs or statins taking within one year after the onset
      of the disease. The main prognostic indicator was the recurrence of IS and persistence of
      antiplatelet and statins medication within 1 year, and the main purpose was to explore the
      impact of persistent statins and antiplatelet medication use on IS recurrence.
    

Intervention name(s): multiple health education interventions
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ischemic stroke; Medication Persistence; outcome
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
Condition: Primary Hypogonadism; Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      Bioequivalence study comparing the rate and extent of testosterone absorption for a test
      formulation versus the reference product.
    

Detailed description: 
      To compare the rate and extent of testosterone absorption for a test formulation of
      Testosterone Topical Gel, 1.62% Metered Pump, manufactured with that of AndroGel®
      (testosterone gel) 1.62% Metered-Dose Pump, in normal, healthy, adult, testosterone-deficient
      (hypogonadal) human male subjects under fasting conditions.
    

Intervention name(s): Testosterone Topical Gel, 1.62% Metered Pump; AndroGel (testosterone gel) 1.62% Metered-Dose Pump
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional

Summary: 
      To determine the percentage of patients and number of cycles in which a packed red blood cell
      transfusion was administered due to anemia and in which antibiotics were administered due to
      neutropenic fever.
    

Detailed description: 
      The use of hematopoietic growth factors have been shown to reduce neutropenic complications
      and red cell transfusion requirements associated with chemotherapy. This trial will study the
      combination of pegfilgrastim and darbepoetin alfa administered once per cycle of
      chemotherapy. Prior experience with growth factors in this setting provides historical data
      for comparison of safety and activity of these newer longer acting growth factors in reducing
      the incidence of febrile neutropenia requiring antibiotics and anemia requiring transfusions.
      The once dosing per cycle would simplify the patient management and would improve patient
      convenience and compliance.
    

Intervention name(s): Aranesp (darbepoetin alfa); Neulasta (pegfilgrastim); Adriamycin; Ifosfamide
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Doxorubicin Hydrocholoride; Adriamycin PFS; Adriamycin RDF; Ifex
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Ifosfamide; Darbepoetin alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Aranesp; Darbepoetin Alfa; Pegfilgrastim; Neulasta; Sarcoma; Adriamycin; Doxorubicin Hydrocholoride; Adriamycin PFS; Adriamycin RDF; Ifosfamide
A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers
Condition: Depressive Disorder and Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in healthy volunteers to investigate the effect of single dose
      GSK561679 on the changes of brain activation, as it compares to an active comparator,
      lorazepam.
    


Intervention name(s): single dose
Intervention type(s): Drug
Intervention description(s): Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: GSK561679,; single,; dose,; lorazepam,; fMRI,; BOLD,; healthy volunteers
The Effects of Active Warming on Temperature on Core Body and Thermal Comfort
Condition: Postoperative Hypothermia; Thermal Comfort; Body Temperature Changes
MeSH terms: Hypothermia; Body Temperature Changes
Study type: Interventional

Summary: 
      Purpose: This study was conducted to examine the effect of warmed intravenous fluids (WIVF)
      on the core body temperature and the patients' thermal comforts during the postoperative
      period in patients undergoing transurethral resection of the prostate (TURP).

      Design: This was a prospective, randomized controlled experimental study. Methods: A total of
      105 male patients undergoing TURP surgery and bladder irrigation were randomized to one of
      either room temperature (n=51) or warmed intravenous fluids (n=54) groups in postanesthesia
      care unit. The fluids in the experimental group were warmed until the body temperature was
      reached 36.0°C.
    

Detailed description: 
      Purpose: This study was conducted to examine the effect of warmed intravenous fluids (WIVF)
      on the core body temperature and the patients' thermal comforts during the postoperative
      period in patients undergoing transurethral resection of the prostate (TURP).

      Design: This was a prospective, randomized controlled experimental study. Methods: A total of
      105 male patients undergoing TURP surgery and bladder irrigation were randomized to one of
      either room temperature (n=51) or warmed intravenous fluids (n=54) groups in postanesthesia
      care unit. The fluids in the experimental group were warmed until the body temperature was
      reached 36.0°C. The intravenous (IV) fluid given to the two groups was 1000 ml of 0.9%
      isotonic sodium chloride solution.
    

Intervention name(s): Warmed Fluids
Intervention type(s): Other
Intervention description(s): The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a prospective, randomized controlled experimental study.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fluid infusion; postoperative hypothermia; nursing; active warming
Clinical Trial on Performance and Safety of Disposable Powered Articulating Linear Cutter Stapler and Reloads in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)
Condition: Lung Cancer
Study type: Interventional

Summary: 
      To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes
      is not inferior to the similar products produced by Johnson & Johnson when the Fengh
      Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Thoracoscopic
      Anatomic Lobectomy (segmentectomy)
    

Detailed description: 
      By comparing the effectiveness and safety of the disposable electric-endoscopic linear cutter
      stapler and cartridge (the subject product) produced by Jiangsu Fengh Medical Co., Ltd. and
      the similar product (electric-endoscopic linear cutter stapler with articulating head)
      produced by Johnson & Johnson in total-thoracoscopic anatomic lobectomy (segmentectomy), to
      prove that the subject product can be used for pulmonary tissue resection and anastomosis,
      and that the clinical trial meets the requirements of Good Clinical Practice for Medical
      Devices, Guidelines for Clinical Trial Design of Medical Devices and Guidelines for Technical
      Review of Endoscopic Stapler Registration, which can be used for product registration
      application.
    

Intervention name(s): Lung cancer surgery
Intervention type(s): Device
Intervention description(s): Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod
      versus interferon β-1a to reduce the frequency of relapses in patients with
      relapsing-remitting multiple sclerosis.
    


Intervention name(s): Fingolimod 1.25 mg; Fingolimod 0.5 mg; Interferon β-1a 30 µg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.; Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily.; Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
Other intervention name(s): FTY720; FTY720
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FTY720; Interferon; RRMS; Multiple Sclerosis; Efficacy
A Phase 1/2 Study of a Intramuscular Injection of TAK-850 in Healthy Adult Subjects
Condition: Influenza
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in
      healthy Japanese adult participants
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and immunogenicity of a single
      intramuscular injection of TAK-850 for 22 days in healthy Japanese adults
    

Intervention name(s): TAK-850
Intervention type(s): Drug
Intervention description(s): TAK-850 injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
First-line Chemotherapy for Recurrent Cervical Cancer
Condition: Recurrent Cervical Carcinoma; Persistent Advanced Cervical Carcinoma; Chemotherapy; Vascular Endothelial Growth Factor 2 Inhibitor; Apatinib; Targeted Therapy
MeSH terms: Carcinoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The response rate of traditional first-line chemotherapy for recurrent or persistent advanced
      cervical cancer was low. This single arm, open, phase II trial would recruit 37 eligible
      patients. A combination of cisplatin, paclitaxel and apatinib would be given for first 23
      patients. If at least 13 patients achieved complete or partial remission, the same regimen
      would be given for rest patients. The primary end is overall response rate (ORR). The second
      ends include progression-free survival, overall survival, disease control rate, remission
      duration, and adverse events. A molecular testing, mainly consisting of genomic analysis,
      will be carried in the oncologic tissues.
    


Intervention name(s): Chemotherapy plus apatinib
Intervention type(s): Drug
Intervention description(s): A combination of cisplatin, paclitaxel and apatinib would be given for all patients:
Cisplatin: 50 mg/m2 body surface area, on the first day, every 3 weeks. If the creatinine clearance rate was less than 40 ml/min, the cisplatin would be replace by carboplatin (area under ther curve = 5)
Paclitaxel: 50 mg/m2 body surface area, on the first day, every 3 weeks
Apatinib: 250 mg every day The total courses of cisplatin and paclitaxel would be no more than 6.
Other intervention name(s): First line chemotherapy plus apatinib
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Intervention model description: A combination of cisplatin, paclitaxel and apatinib would be given for all patients
Masking: None (Open Label)
Primary purpose: Treatment
Research on Individualized Treatment for Alcoholism
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to compare the effects of two psychosocial treatments that
      differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement
      Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking
      behaviors in alcohol dependent patients.
    


Intervention name(s): naltrexone; naltrexone; Broad Spectrum Treatment; Motivational Enhancement Treatment
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): 50 mg naltrexone daily for 3 months; 50 mg of naltrexone daily for 6 months; 8-14, one hour sessions over 6 months; 4, 20 minute sessions over 3 months
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcoholism; naltrexone; motivational enhancement therapy
Effectiveness of Nature Walks in Depressed Adults
Condition: Experimental
Study type: Interventional

Summary: 
      Over the past few years, a growing number of campaigns from around the world, including
      Canada, are highlighting the positive impact of spending time in nature on well-¬being.
      Indeed, mounting evidence suggests that spending time with nature is associated with a myriad
      of affective and cognitive benefits. Surprisingly few studies to date have tested the
      assumption that walking in nature versus in urban settings could alleviate stress and
      depressive symptoms in clinically depressed adults.

      The main purpose of this study is to investigate the effectiveness of walking in nature
      versus in urban settings to improve depression related symptoms and reduce stress. The trial
      initially included 2 primary outcomes: patients stress levels (salivary cortisol) and
      depression-related symptoms (eg, affect, rumination, executive functioning).

      However, due to hygienic concerns in light of the COVID-19 pandemic in 2020, the collection
      of saliva samples (and in turn, the measurement of stress levels via salivary cortisol) was
      removed from the study's procedure. The main outcome was changed to effects on positive and
      negative affect.
    


Intervention name(s): Walking in Urban setting; Walking in nature setting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Walking for 60 minutes as described above; Walking for 60 minutes as described above
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Clinical depression; Stress; Group-walking; Walking condition (nature vs urban)
Phase II Pharmacokinetics Study of CAM2038
Condition: Opioid Use Disorder; Chronic Pain
MeSH terms: Chronic Pain; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II, open label, partially randomized, three treatment group study designed to evaluate
      the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated
      subcutaneous administrations of CAM2038.
    

Detailed description: 
      This is a phase II, open label, partially randomized, three treatment group study designed to
      evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following
      repeated subcutaneous administrations of CAM2038 weekly and monthly at different injection
      sites and to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine
      after repeated subcutaneous administration of CAM2038 monthly in opioid dependent subjects
      with a history of chronic non cancer pain. The study will involve three phases: Screening,
      Treatment, and Follow up.
    

Intervention name(s): CAM2038
Intervention type(s): Drug
Intervention description(s): Long-Acting Subcutaneous Injectable Depot of Buprenorphine
Other intervention name(s): Buprenorphine
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Sestrin Levels in Patients With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Serum sestrin levels of endometriosis patients are compared with a group of healthy
      volunteers of the same age.
    

Detailed description: 
      Serum sestrin levels are compared with 45 endometriosis patients and 45 healthy volunteers of
      the same age. The energy metabolism of the endometriosis group and its possible relationship
      with the endometriosis stage will be compared since sestrin gives information about the
      energy metabolism of the people.
    

Intervention name(s): sestrin
Intervention type(s): Other
Intervention description(s): Serum sestrin levels involved in inflammation and energy metabolism are compared between endometriosis and healthy control group.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The serum sestrin level of women between the ages of 18-45 who have been diagnosed with
        endometriosis by surgery or ultrasound will be compared with the level of women of the same
        age.
      
Keywords: sestrin