bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous
      (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment
      period.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
      treat people who have ulcerative colitis. This study will look at the stool frequency, rectal
      bleeding and findings on endoscopy of people who take vedolizumab compared to those who take
      adalimumab.

      The study will enroll approximately 658 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the two treatment groups-which will remain
      undisclosed to the patient and study doctor during the study (unless there is an urgent
      medical need):

        -  Vedolizumab 300 mg IV

        -  Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC

      All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38,
      and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each
      on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every
      2 weeks for up to Week 50. All participants will be asked to record the symptoms of
      ulcerative colitis in a daily diary.

      This multi-center trial will be conducted worldwide. The overall time to participate in this
      study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be
      contacted by telephone 6 months after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Vedolizumab; Adalimumab placebo; Adalimumab; Vedolizumab placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Vedolizumab infusion; Adalimumab placebo-matching injection; Adalimumab injection; Vedolizumab placebo-matching infusion
Intervention MeSH terms: Adalimumab; Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Drug Therapy
Children, Perennial Allergic Rhinitis (PAR), l-t Growth
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on
      growth in children with perennial allergic rhinitis over 12 months.
    


Intervention name(s): Budesonide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Rhinocort AQUA
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Allergic rhinitis; Perennial allergic rhinitis; Paediatric; Growth; budesonide; Rhinocort AQUA
A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Activity of Oral AB1010 in Adults Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity
      of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis
    

Detailed description: 
      To evaluate the activity of oral AB1010, administered at two dose levels during 12 weeks to
      patients with moderate to severe chronic plaque psoriasis, assessed on :

      i)Body Surface Area (BSA), Psoriasis Area and Severity Index (PASI), Overall Lesion Severity
      (OLS), Physician's Global Assessment (PGA) and Patient's Global Psoriasis Assessment (PGPA)
      ii)clinical and biological safety parameters iii) pharmacokinetic profile of AB1010
    

Intervention name(s): Masitinib; Masitinib; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6 mg/kg/day; 3 mg/kg/day; Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe Psoriasis; Kinase Inhibitor; Masitinib
Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use
Condition: Nicotine Addiction; Cigarette Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes
      will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked
      to switch for 12 weeks to ad libitum use of combustible cigarettes (matched to subjects'
      menthol preference) containing either 0.4, 1.4, 2.5, 5.6 or 16.9 mg nicotine (standardized
      nicotine yields ranging from 0.02-0.80 mg/cigarette), respectively. Each group will include
      32 heavy (≥ 20 cigarettes/day), and 32 light smokers (≤10 cigarettes/day), who are
      hypothesized to be more sensitive to nicotine's reinforcing effects. Participants will also
      have free access to nicotine-containing e-cigarettes (JUUL) throughout the 12-week period.
      Abuse liability of combustible cigarettes will be assessed by behavioral (cigarettes/day,
      time to first cigarettes), self-report (rewarding effects, withdrawal symptoms) and
      biochemical indices (expired air carbon monoxide, cotinine blood sampling).

      In laboratory sessions, we will measure nicotine thresholds for detecting and recognizing the
      addictive, rewarding effects of smoking. This study is designed to help the FDA identify a
      target nicotine threshold that will not attract young people to smoking or induce relapse in
      former smokers. Additionally, we will determine the level of cigarette nicotine reduction
      that will be tolerated without inducing dissatisfaction in smokers, information that is
      relevant to the FDA for designing a stepwise nicotine reduction policy that can be
      implemented without widespread objections. The knowledge gained from this project will
      greatly increase our knowledge of nicotine addiction and will help frame an FDA policy
      relating to the regulation of the nicotine content of tobacco. Ultimately, a well-designed
      nicotine reduction policy has the potential to greatly reduce the enormous toll of death and
      disease caused by cigarette smoking.
    


Intervention name(s): Smoking research cigarettes with e-cigarette; Nicotine discrimination thresholds
Intervention type(s): Drug; Drug
Intervention description(s): Smoking research cigarettes with varying levels of nicotine with unlimited access to 15 mg/ml nicotine-containing e-cigarettes.; Measure of nicotine thresholds for detecting and recognizing the addictive, rewarding effects of smoking.
Other intervention name(s): Spectrum Cigarettes; JUUL e-Cigarette; Halo G6 with Tribeca e-liquid
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Time Schedules for Sending Invitations to Colonoscopy Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The attendance rate to population based primary screening colonoscopy within NordICC trial
      (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%.
      The aim of this study is to compare the effect of two different time schedules for sending
      invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening
      naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive
      invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO
      group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are
      participation in screening colonoscopy within 6 months from the date of invitation, response
      and acceptance rate before sending a reminder. The study is powered to detect 7% difference
      in participation in screening colonoscopy.
    


Intervention name(s): Six and three time schedule; Four and two time schedule
Intervention type(s): Other; Other
Intervention description(s): Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.; Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: screening colonoscopy; attendance; response; colorectal cancer
Serum Endocan Levels in Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      In this study the investigators aimed to investigate whether there is a relation between
      polycystic ovary syndrome and serum endocan levels.
    

Detailed description: 
      Polycystic ovary syndrome is a disorder which is associated with insulin resistance,
      diabetes, obesity, and cardiovascular disease. Endothelial dysfunction, which is known to be
      an early marker of atherosclerosis, has also been shown to have an association with poycystic
      ovary syndrome. In this study the investigators aimed to investigate whether there is a
      relation between polycystic ovary syndrome and serum endocan levels. For this purpose the
      investigators designed a prospective study including two groups. The diagnosis of polycystic
      ovary syndrome was made in the presence of ;oligo- and/or anovulation,clinical
      hyperandrogenism and polycystic ovaries. Clinical hyperandrogenism was defined by the
      presence of hirsutism , acne, or the presence of androgenic alopecia, body mass index (BMI)
      was calculated as weight in kilograms divided by the square of height in meters. The two
      groups are compared considering their serum endocan levels,follicle stimulating hormone
      (FSH), luteinizing hormone (LH), Dihydroepiandesterone sulphate (DHEAS), total testesterone
      (TT), estradiol (E2) and thyroid stimulating hormone (TSH), fasting blood glucose,
      triglyceride, total cholesterol, high density lipoprotein, low density lipoprotein, and
      C-reactive protein (CRP) levels.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        84 women with PCOS and 84 healty women as control group.
      
Biospecimen description: 
      serum samples,centrifuged
Transcranial Magnetic Treatment (TMS) in Unipolar Depression
Condition: Unipolar Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in
      patients with depression.

      In this study, the investigators seek to increase their understanding about how rTMS improves
      depression, and to determine which form of rTMS is most effective for depression, when used
      in combination with antidepressant medication.
    

Detailed description: 
      Patients will be assigned for 4 treatment arms, receiving either left high frequency plus
      right low frequency, or left high frequency plus right sham, or left sham, plus right low
      frequency, or left sham plus right sham treatment. All subjects will receive treatments for
      10 days and will be followed for another 4 weeks.
    

Intervention name(s): Transcranial Magnetic Stimulation (TMS)
Intervention type(s): Procedure
Intervention description(s): treatment for 10 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation; TMS
Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial
Condition: Covid19; Venous Thromboembolism
MeSH terms: COVID-19; Thrombosis; Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 3

Summary: 
      The Michelle trial is expected to provide high-quality evidence around the role of extended
      thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.
    

Detailed description: 
      Background: The devastating COVID-19 pandemic is associated with a high prothrombotic state.
      It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV
      2 or indirectly by the cytokine storm and endothelial damage, or by a combination of
      mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for
      every patient with COVID-19 after bleed risk assessment. However, there is much debate
      regarding the best dosage regimen, and there is no consensus on the role of extended VTE
      prophylaxis.

      Design: This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg OD for
      35+/-4 days versus no intervention after hospital discharge in COVID-19 patients who were at
      increased risk for VTE and have received standard parenteral VTE prophylaxis during
      hospitalization, with a composite efficacy endpoint of symptomatic VTE, VTE-related death,
      and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed
      tomography pulmonary angiogram on day 35+/-4 post-hospital discharge.

      Summary: The Michelle trial is expected to provide high-quality evidence around the role of
      extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical
      practice.
    

Intervention name(s): Rivaroxaban 10 MG
Intervention type(s): Drug
Intervention description(s): No intervention
Other intervention name(s): No intervention
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg OD for 35+/-4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization, with a composite efficacy endpoint of symptomatic VTE, VTE-related death, and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35+/-4 post-hospital discharge.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Covid19; Venous Thromboembolism; Direct oral anticoagulants; Rivaroxaban
A Study to Assess the Effect of Ticlopidine on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of ticlopidine on the pharmacokinetics
      (PK) of intranasally administered esketamine.
    


Intervention name(s): Esketamine; Ticlopidine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will self-administer one intranasal spray of 14 mg esketamine at Time 0 and again 5 minutes later on Day 1, a total dose of 56 mg in Treatment Period 1 and 2.; Participants will receive 250 mg ticlopidine tablets orally twice daily on Day -9 through Day 1 in Treatment Period 2.
Other intervention name(s): JNJ-54135419
Intervention MeSH terms: Ticlopidine; Esketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-labeled study of Divalproex Sodium Extended Release (Depakote ER), testing
      its efficacy for the treatment of mania in children between the ages of 6-12 who have been
      diagnosed with Bipolar I, Bipolar II, and Bipolar Spectrum Disorders. This is an exploratory,
      pilot study, seeking to determine whether Divalproex Sodium Extended Release is efficacious
      and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum
      disorder, and the study results will be used to generate hypotheses for a larger randomized
      controlled clinical trial with explicit hypotheses and sufficient statistical power.
    

Detailed description: 
      Initial clinical evidence suggests that Divalproex Sodium may play a therapeutic role in the
      management of pediatric bipolar disorder. Its new Extended Release formulation offers the
      advantage of once a day dosing. Although the precise mechanisms by which Divalproex Sodium
      exerts its therapeutic effects remains unknown, it has been suggested that its activity may
      be related to increased brain concentrations of gamma-aminobutyric acid (GABA). Although the
      shorter acting formulation Divalproex Sodium is FDA approved for the treatment of adult
      bipolar disorder, its Extended Release formulation is currently only FDA approved for adults
      for the prophylactic treatment of migraine headaches and has not yet been studied in patients
      with mania. Three studies of Divalproex Sodium have documented safety and efficacy of this
      compound, as well as superiority over placebo, in the treatment of adults with bipolar
      disorder.

      This medication has not, however, been adequately investigated in children. The proposed
      study includes 1) an 8-week acute period, during which participants are observed during
      weekly visits, and up to an 8-month extension period, during which participants see a study
      clinician on a monthly basis, to document the response rate 2) assessment of the impact of
      Divalproex Sodium Extended Release on functional capacities (quality of life, psychosocial
      function) and cognition, 3) careful assessment of safety and tolerability.
    

Intervention name(s): divalproex sodium extended release
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar disorder; mania; depakote ER; children
Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective
      postoperative analgesia of the lower extremity following total joint arthroplasty. The
      purpose of this study was to compare these two techniques when used with intravenous
      patient-controlled analgesia and the use of patient-controlled analgesia alone for
      postoperative pain management following unilateral total hip arthroplasty.
    

Detailed description: 
      above may be applied
    

Intervention name(s): continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA
Intervention type(s): Procedure
Intervention description(s): 0.5% Ropivacaine bolus of 30 ml. followed by ropivacaine 0.2%at 10 ml/hr via CLPB vs. CFB.
Hydromorphone 0.3 mg demand only every 10 minutes via IV PCA.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Continuous lumbar plexus,Femoral,hydromorphone
Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora
    


Intervention name(s): VIGAMOX
Intervention type(s): Drug
Intervention description(s): 1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single
Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of a guided imagery intervention on
      perceived stress in pregnant adolescents.
    

Detailed description: 
      Pregnant adolescents attending a local alternative education program will be subjects of this
      study. Students will participate in four, 15 minute guided imagery sessions over about a 4-6
      week period. They will complete a pregnancy specific stress questionnaire before beginning
      and after completion of the guided imagery protocol. The students will also complete a short
      9-question stress measure before and after each of the individual guided imagery sessions.

      The specific aims are:

        1. to evaluate whether a guided imagery intervention reduces perceived stress in pregnant
           adolescents; and

        2. to evaluate whether a guided imagery intervention enhances well-being in pregnant
           adolescents.

      The hypotheses are that the intervention will reduce perceived stress and enhance well-being
      in these subjects. The purpose of this study is to assess whether employing a guided imagery
      intervention with pregnant teens and education will reduce perceived stress levels and
      improve well-being.
    

Intervention name(s): Guided Imagery
Intervention type(s): Behavioral
Intervention description(s): A fifteen minute recording of gentle music together with soft talking to guide relaxation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Geodon in Weight Loss Study for Bipolar Disorders
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This research study is designed to determine if replacing your current antipsychotic and/or
      mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being
      conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to
      be an effective medication for overweight or obese patients with bipolar disorder. There will
      be approximately 25 patients enrolled in this study.
    


Intervention name(s): Ziprasidone/Geodon
Intervention type(s): Drug
Intervention description(s): Ziprasidone/Geodon
Intervention MeSH terms: Ziprasidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment