bioihbjkbjnl/mcl2 huggingface dataset:
Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
Condition: Smokeless Tobacco Use
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no
      medications have been shown to help chewers quit long-term. High dose nicotine patch therapy
      may improve the chances that chewers can quit for good. If found to be effective, chewers may
      use this treatment to help them quit and reduce their risk for negative health effects.
    

Detailed description: 
      Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco
      (ST) users, and the prevalence of ST use has increased over the past three years. ST is
      increasingly being promoted as a harm reduction strategy for cigarette smoking, and two of
      the world's largest cigarette manufacturers have entered the ST market. ST use is estimated
      to be the greatest exogenous source of human exposure to cancer-causing nitrosamines. ST has
      been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular
      mortality.

      A need for efficacious interventions exists as 64% of ST users report the desire to quit.
      However, no pharmacotherapy has proven efficacy for increasing long-term (> 6 months) tobacco
      abstinence rates among ST users compared to placebo. New pharmacotherapies, drug
      combinations, and improved dosing of existing pharmacotherapies are needed. Previous research
      with nicotine patches for ST users using standard doses (up to 21 mg/day) have not increased
      long-term abstinence rates. However, studies of higher dose nicotine patch therapy (up to 63
      mg/day) in ST users have demonstrated a dose-dependent reduction in tobacco withdrawal
      symptoms as well as preliminary evidence of increased long-term (> 6 months) abstinence rates
      compared to lower doses. The purpose of this study is to evaluate the efficacy of high dose
      nicotine patch therapy (42 mg/day) for increasing the 7-day point prevalence and prolonged
      all tobacco and ST abstinence rates at end-of-treatment (week 8), 12 and 24 weeks compared to
      placebo in ST users who use ≥ 3 cans/pouches per week when all subjects receive behavioral
      treatment for tobacco dependence. To accomplish our aims, we will randomize 60 ST users in a
      clinical pilot study. The work will be conducted at the Mayo Clinic in Rochester, MN.
    

Intervention name(s): nicotine replacement therapy (nicotine patches); placebo NRT
Intervention type(s): Drug; Drug
Intervention description(s): 2- 21 mg patches per day for 8 weeks; 2 placebo patches (containing no active ingredient)per day for 8 weeks
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tobacco use; smokeless tobacco; chewing tobacco; snuff; nicotine replacement; tobacco dependence; tobacco cessation; tobacco abstinence
Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV)
Condition: Chronic Pain Due to Injury
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study is to test the effects of oxytocin on heart rate variability and pupil
      diameter, both of which have subtle effects on the activity rate of the autonomic nervous
      system.
    

Detailed description: 
      This protocol focuses on two measures of autonomic control to quantify central actions of
      oxytocin. First, the study team proposes to examine the influence of oxytocin on heart rate
      variability with focus on its effect on high frequency variability, most commonly ascribed to
      parasympathetic nervous system activity acting to brake sympathetic tone. Intranasal oxytocin
      has been demonstrated to have a large effect size on this measure which can be repeated at
      frequent intervals. As a secondary assessment of parasympathetic activity, the study team
      will measure low frequency fluctuation in pupil diameter, termed hippus, which also reflects
      parasympathetic nervous system activity. This outcome measure can be assessed in 3 seconds
      using equipment currently being used under Institutional Review Board (IRB) approved
      protocols.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oxytocin 10 IU; Placebo
Other intervention name(s): Pitocin; saline
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blinded crossover treatment with oxytocin and placebo (saline)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Volunteer; Oxytocin; Pupillometry
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to learn whether dapagliflozin can help reduce
      blood sugar levels in participants with Type 2 diabetes that is not well controlled on
      metformin alone. The safety of this treatment will also be studied.
    


Intervention name(s): Dapagliflozin; Placebo; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks; Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks; Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Other intervention name(s): BMS-512148
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Metformin; Hypoglycemic Agents; Pharmacologic Actions; Physiological Effects of Drugs
Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia
Condition: Aphasia
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      This is a behavioral speech therapy trial for individuals who have suffered a stroke on the
      left side of the brain and have difficulty speaking. The name of this disorder is called
      'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for
      free (2 hours/day, 5 days/week, 6 weeks).
    

Detailed description: 
      The study design was a single group (n=26) with repeated testing (3 times) pre- and
      post-treatment. All participants received the same treatment protocol (described in detail in
      Appendix A and in Minkina et al. (under review)). In order to control for improvement in
      language function related to passage of time, and for the effect of repeated exposure to
      outcome measures, individuals were randomly assigned to one of two conditions: delayed
      treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed
      group received repeated testing three times before and three times after a six-week delay.
      During the delay phase they were permitted to participate in usual speech-language care
      (e.g., conversation groups and individual therapy).

      Standardized assessments and outcome measures (described in detail below) were administered
      prior to the start of treatment (for both immediate and delayed groups), at the end of the
      delay phase (delayed group only), immediately after treatment termination, and at three
      months post-treatment.
    

Intervention name(s): speech therapy
Intervention type(s): Behavioral
Intervention description(s): individuals will receive 60 hours of behavioral speech therapy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate
      sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the
      treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the
      same formulation. The SR designation was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine fumarate
Intervention type(s): Drug
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MDD; Depression
Absorption, Stable Isotope Appearance and Non-transferrin-bound Iron (NTBI) Profile From NaFeEDTA and Ferrous Sulphate
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Several iron compounds are used for fortification, including ferrous sulphate and NaFeEDTA.
      The absorption profile of these may differ because of differences in their dissolution in the
      gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption.
      As these differences might lead result in varying reactions in the blood stream, the
      appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total
      iron in the plasma will be monitored over six hours in adult women. This is relevant as a
      spike of absorbed iron may increase non-transferrin-bound iron and this could be
      pro-oxidative or increase growth of pathogens. Hepcidin is a key mediator of iron absorption
      and will help explain the potential differences in the plasma iron profile.

      The use of stable iron isotope appearance curves to specifically detect the appearance of
      small amounts of absorbed iron in the blood and distinguish between circulating body iron and
      iron absorbed from the test meal was tested in a pilot study (EK 2008-23). This method is now
      used in a bigger sample to test the differences in absorption profile of ferrous sulphate,
      FePPi and NaFeEDTA given at fortification level with a meal.
    


Intervention name(s): Porridge fortified with either NaFeEDTA; FeSO4
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 265g maize porridge is fortified with 2.5 mg iron as NaFeEDTA.; Maize porridge is fortified with 2.5 mg iron as ferrous sulphate and 45 mg ascorbic acid.
Intervention MeSH terms: Fe(III)-EDTA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: iron absorption; stable isotopes; NaFeEDTA; Non-transferrin-bound iron (NTBI); Hepcidin
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the study drug
      Mirikizumab in participants with active Crohn's Disease.
    


Intervention name(s): Mirikizumab; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: inflammatory bowel disease; IL-23; biologic
Exploratory Study of Coronary Flow Reserve Measurements, a Non-Invasive Method for Coronary Function Measurements
Condition: Atherosclerosis; Inflammatory Activity in Coronary Arteries
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to investigate whether the non-invasive ultrasound method for
      assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow
      reserve (TTDE-CFR), can be used to measure drug effects.
    


Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).; Tablet, oral, once daily for 1 month (double blind)
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: TTDE-CFR; coronary artery function; cardiovascular biomarkers; rosuvastatin; Crestor
Biologic Glue for First Degree Perineal Tears
Condition: Grade 1 Perineal Tears
Study type: Interventional

Summary: 
      The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for
      first degree perineal tears repair
    

Detailed description: 
      This is a prospective randomized trial, comparing the use of octyl-2-cyanoacrylate adhesive
      glue to traditional suturing, for the repair of first degree perineal tears.
    

Intervention name(s): 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate; 3. traditional suturing with vicryl rapid 2X0
Intervention type(s): Device; Procedure
Intervention description(s): adhesive of perineal tears; suturing of perineal tears grade one with vicryl rapid 2X0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adhesive glue, perineal tear, suture
Effect of Small Daily Doses of B-carotene on Breast Milk Retinol
Condition: Vitamin A Status
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine whether breast milk retinol concentration
      increases in response to daily supplementation with small amounts of vitamin A (~600 ug
      RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary
      purpose is to evaluate sampling methods for collecting breast milk samples in a community
      setting. The results of this pilot study will allow us to determine whether milk retinol is a
      useful indicator for evaluating the impact of food-based interventions on the vitamin A
      status of lactating women.
    


Intervention name(s): b-carotene; retinyl palmitate; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamin A; Retinol palmitate; Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: b-carotene; breastmilk; vitamin A
Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect
      metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary
      disease patients.
    


Intervention name(s): Theophylline
Intervention type(s): Drug
Intervention description(s): After oral theophylline 200mg per day for one week, blood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2
Intervention MeSH terms: Theophylline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: COPD; CYP1A2; Theophylline
Tobacco Approach Avoidance Training for Adolescent Smokers-1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two part study. Study 1 will compare Approach Avoidance Training (AAT) responses in
      smokers and nonsmokers in order to confirm that adolescent smokers experience cognitive bias
      towards tobacco-related stimuli.
    


Intervention name(s): AAT experiment
Intervention type(s): Behavioral
Intervention description(s): Smokers and nonsmokers complete AAT experiment
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Nicotine; Smoking; Adolescent; Tobacco
Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
Condition: Breast Cancer; Osteoporosis
MeSH terms: Breast Neoplasms; Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast
      cancer.

      PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or
      osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA
      primary breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess changes in total lumbar spine bone mineral density (BMD) from baseline to 12
           months in postmenopausal women treated with zoledronate for osteopenia or osteoporosis
           and letrozole for hormone receptor-positive, stage I-IIIA primary breast cancer.

      Secondary

        -  Determine changes in total lumbar spine BMD from baseline to 2, 3, 4, and 5 years in
           these patients.

        -  Determine changes in femoral neck BMD from baseline to 1, 2, 3, 4, and 5 years in these
           patients.

        -  Determine time to disease progression in these patients.

      OUTLINE: This is an open-label, multicenter study.

        -  Adjuvant aromatase inhibitor therapy: Patients receive oral letrozole daily for up to 5
           years in the absence of disease progression or unacceptable toxicity.

        -  Osteoporosis management: Patients receive zoledronate IV over 15 minutes on day 1.
           Patients also receive oral elemental calcium twice daily and oral vitamin D daily for 6
           months. Treatment repeats every 6 months for up to 5 years in the absence of disease
           progression or unacceptable toxicity.

      Patients undergo total lumbar spine and hip (femoral neck) bone density testing by dual
      energy x-ray absorptiometry (DXA) at baseline and annually for 5 years.

      After completion of study therapy, patients are followed at 4 weeks.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Intervention name(s): zoledronic acid; Letrozole as adjuvant therapy
Intervention type(s): Drug; Procedure
Intervention description(s): zoledronic acid; standard care
Other intervention name(s): Zometa®; Femara®
Intervention MeSH terms: Zoledronic Acid; Letrozole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; osteoporosis
RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the
      most effective method of emergency contraception vs. the levonorgestrel IUD, the most
      preferred IUD which has never been tested as an emergency contraceptive. This research has
      the potential to increase use of highly effective contraception in a high-risk population and
      lower the persistently elevated rate of U.S. unintended pregnancy.
    

Detailed description: 
      Unintended pregnancy has multiple adverse effects on both maternal and child health. The
      United States continues to have one of the highest rates of unintended pregnancy among
      developed countries. To combat this problem, we are studying initiation of the highly
      effective intrauterine device (IUD) for women presenting for emergency contraception (EC).
      This is an ideal population to initiate highly effective reversible contraception (HERC) as
      they are at high risk of unintended pregnancy and are acting to reduce that risk. We have
      recently demonstrated significantly lower pregnancy rates 12 months after presenting for EC
      among women who selected the copper IUD versus those who selected oral Levonorgestrel (LNG).

      Not only is the copper IUD the most effective method of EC, it is considered a top tier
      anticipatory contraception method and its ability to prevent pregnancy is on par with tubal
      sterilization (less than 1% in the first year with lower failure rates in subsequent years).
      However, women selecting intrauterine contraception have shown a strong preference for the
      LNG IUD. The LNG IUD, is as effective at preventing pregnancy as the Copper IUD, and has some
      non-contraceptive effects that many women see as benefits such as the reduction or
      elimination of menstrual bleeding and menstrual related discomfort. Of currently available
      reversible contraceptives, the LNG IUD has the highest levels of user satisfaction and
      continuation. However, its effectiveness as an emergency contraceptive remains unknown. A
      randomized control trial is necessary to assess the safety and efficacy of the LNG IUD as EC.
      Demonstrating the efficacy, safety, and acceptability of the LNG IUD for EC will improve
      options for women seeking EC and who desire a highly effective method of contraception.
    

Intervention name(s): Copper IUD; Levonorgestrel IUD
Intervention type(s): Drug; Drug
Intervention description(s): Randomization to copper/Paragard IUD for emergency contraception; Randomization to Levonorgestrel/Mirena IUD for emergency contraception
Other intervention name(s): Paragard IUD; Mirena IUD, LNG20 IUD, Levonorgestrel IUD, Liletta IUD
Intervention MeSH terms: Copper; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Emergency contraception; Levonorgestrel IUD; Copper IUD