bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Bupropion Combined With Behavioral Therapy for Treating Methamphetamine Dependence - 2
Condition: Methamphetamine
Study type: Interventional
Phase: Phase 2

Summary: 
      Methamphetamine is an addictive stimulant drug that strongly activates certain parts of the
      brain. The purpose of this study is to determine the effectiveness of bupropion in
      combination with behavioral therapy for the treatment of methamphetamine addiction.
    

Detailed description: 
      Methamphetamine is a drug that causes excess amounts of the neurotransmitters dopamine and
      norepinephrine to be released into the brain. This overload produces unusual alertness and
      feelings of elation. When the body undergoes methamphetamine withdrawal, it experiences a
      reduction in dopamine and norepinephrine. Bupropion is an antidepressant used for the
      treatment of depression and smoking cessation. Because it functions by increasing the release
      of dopamine and norepinephrine in the brain, bupropion is likely to decrease the negative
      effects of methamphetamine withdrawal. The purpose of this study is to evaluate the efficacy
      of bupropion combined with contingency management (CM) and cognitive behavioral counseling
      (CBT) as a means of treating methamphetamine dependence.

      An initial 2-week screening process will involve participants providing urine samples and
      completing physical and psychological assessments. If deemed eligible for the remainder of
      this double-blind study, participants will be randomly assigned to receive either bupropion
      or placebo over the course of 12 weeks. Participants in both the bupropion and placebo groups
      will receive contingency management and cognitive behavioral counseling. Participants will
      report to one of two clinical research sites three times per week. At each visit,
      participants will be examined by the study staff, provide a urine sample, and receive
      individual cognitive behavioral counseling sessions. At the end of 12 weeks, treatment will
      be stopped. Participants will return to the study site 30 days later for evaluation and to be
      assessed for any possible lingering side effects.
    

Intervention name(s): Bupropion; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction
Condition: Temporomandibular Joint Disc Displacement, With Reduction
Study type: Interventional

Summary: 
      Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type
      A, and repositioning appliance in management of reduced temporomandibular joint disc.
    


Intervention name(s): Low level laser therapy; Botulinum toxin type A; Anterior repositioning appliance
Intervention type(s): Device; Drug; Device
Intervention description(s): Patients will receive low-level laser therapy on the temporomandibular joint disc; Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.; Patients will receive hard maxillary anterior repositioning appliance.
Other intervention name(s): LLLT; Botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study for Evaluating the Safety of a Plant Sterol-enriched Fermented Dairy Product in Japanese Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy
      product over a 4-week period in Japanese healthy adults
    


Intervention name(s): 1-Fermented Dairy Product with Phytosterols (test); 2-Fermented dairy Product with No Phytosterols (control)
Intervention type(s): Other; Other
Intervention description(s): 1- 3 bottles of test product/day; 2-3 bottles of control product/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Japanese healthy volunteers; High LDL-C; dairy drinks; phytosterols
Screening Herbs for Drug Interactions
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to detect potential herb-drug interactions in volunteers.
    

Detailed description: 
      The use of herbal medicines in the treatment of various medical and psychiatric conditions
      has accelerated in the last decade. It has also become evident that herbal medications are
      being used concomitantly with conventional prescription and over-the-counter medications.
      However, the systematic evaluation of the potential of these agents to interact with
      conventional medications has been generally neglected. Compounding this problem is the fact
      that even single entity herbal products can contain a multitude of naturally occurring
      chemicals which serve as candidates for potential herb-drug interactions by inhibiting or
      inducing specific hepatic isozymes. Numerous reports document the importance of
      pharmacokinetic interactions involving inhibition or induction of the cytochrome P450 (CYP)
      enzyme system. In this study, the ten most commonly used herbal products in the US will be
      systematically evaluated for inhibition of CYP 3A4 and 2136, and induction of CYP 3A4.
      Collectively, these enzyme systems are involved in the metabolism of approximately 80% of all
      marketed medications.

      Participants in this study will receive a single dose of the prescription drug alprazolam and
      the over-the-counter cough suppressant, dextromethorphan on two occasions. A combination of
      probe drugs will be given to normal volunteers both in the absence and presence of herbal
      medications. The plasma and urine concentration of these agents and their respective
      metabolites will be determined in order to evaluate individual herbal products degree and
      specificity of enzyme inhibitory or inductive effects.
    

Intervention name(s): herbals
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Evaluation of the Residual Antimicrobial Activity
Condition: Bacterial Overgrowth
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate the residual antimicrobial efficacy of one test
      product as defined by the difference between the number of a challenge bacterial species
      recovered following exposure to the test product and the number recovered when untreated
      (negative control). The challenge bacterial species to be used is Staphylococcus aureus (ATCC
      #6538) (S. aureus). Testing will be carried out using a modification of the standardized test
      method described in ASTM E2752-10 (2015) Standard Guide for Evaluation of Residual
      Effectiveness of Antibacterial Personal Cleansing Products. Bacterial recoveries will be
      assayed after application oftest material, using the forearms as a substrate.
    

Detailed description: 
      At least twelve test subjects (aged 18-65 years), with healthy skin will be used in this
      study, and will use the test product on one arm, and have the other arm untreated as the
      negative control. The test sites on both forearms will be inoculated with suspensions
      containing Staphylococcus au re us (A TCC #653 8), immediately after the 30 minute product
      drying time, and at approximately 2 hours and 4 hours following test material applications.
      The test sites will be sampled using the cup scrub procedure approximately 20 minutes
      following each inoculation. The log 10 microbial recoveries of treated versus untreated sites
      will be the basis for assessing the residual antimicrobial effectiveness of the test product.
    

Intervention name(s): CGB-S-100
Intervention type(s): Drug
Intervention description(s): Alcohol and choline geranate
Other intervention name(s): IonLAST gel (CGB-S-100 gel)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Residual; ASTME2752; Antimicrobial
Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome
Condition: Hypercholesterolemia; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Hypercholesterolemia; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      We will identify the influence of long-term treatment of Pitavastatin compared to
      non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic
      syndrome component score. And we will additionally observe the changes of CVD risk factors
      like lipid profile, abdominal fat, insulin resistance and so on.
    


Intervention name(s): pitavastatin; Lifestyle Modification
Intervention type(s): Drug; Behavioral
Intervention description(s): Pitavastatin 2mg daily once; conducting mainly exercises and diet
Other intervention name(s): Livaro
Intervention MeSH terms: Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pitavastatin; metabolic syndrome; metabolic syndrome risk score; hypercholesterolemia
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The data from this study will be used to compare the kinetic profile of metformin 500mg in
      linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference
      product administered concomitantly with linagliptin 2.5 mg tablet.
    


Intervention name(s): Metformin Single Tablet; Linagliptin/Metformin Combo; Linagliptin Single Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Metformin medium doseTablet; Fixed dose combination; Linagliptin Single medium dose Tablet
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Trial of Simplified Pneumococcal Vaccination in Vietnam II
Condition: Pneumococcal Vaccine
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a single-blind, open-label, randomised controlled trial with five groups. There are
      four different Pneumococcal Conjugate Vaccine (PCV) schedules to be evaluated.
    

Detailed description: 
      This is a single-blind, open-label, randomised controlled trial with five groups. There are
      four different PCV schedules to be evaluated: a 0+1 schedule of PCV10 at 12 months of age
      (Group V), a 0+1 schedule of PCV13 at 12 months of age (Group W), a 1+1 schedule of PCV10 at
      2 and 12 months of age (Group X), and a 1+1 schedule of PCV13 at 2 and 12 months of age
      (Group Y); along with a control group that receives a dose of PCV10 at 24 months of age
      (Group Z). Additionally, all participants will receive four doses of Infanrix-hexa at 2, 3, 4
      and 18 months of age.
    

Intervention name(s): PCV Vaccine
Intervention type(s): Biological
Intervention description(s): PCV vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-blind, open-label, randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product
      variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of
      tiotropium is compared between one Easyhaler product variant administered with and without
      charcoal.
    


Intervention name(s): Tiotropium Bromide Monohydrate; Tiotropium Bromide Monohydrate; Tiotropium Bromide Monohydrate; Tiotropium Bromide Monohydrate; Tiotropium Bromide Monohydrate; Tiotropium Bromide Monohydrate; Tiotropium Easyhaler with oral activated charcoal
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tiotropium Easyhaler 10 µg/dose Product variant D; Tiotropium Easyhaler 10 µg/dose Product variant E; Tiotropium Easyhaler 10 µg/dose Product variant F; Tiotropium Easyhaler 10 µg/dose Product variant G; Tiotropium Easyhaler 10 µg/dose Product variant H; Spiriva 18 µg/capsule inhaled via Handihaler; The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F
Intervention MeSH terms: Bromides; Tiotropium Bromide; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a 2-part 4-period crossover study where the study subjects participate either in part 1 (20 subjects) or in part 2 (20 subjects). Parts can run in sequence or parallel. All study subjects receive single dose of Tiotropium Easyhaler on 3 periods and Spiriva HandiHaler on 1 period.
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food-effect of TRK-750
Condition: Healthy, Peripheral Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an exploratory, randomised, double-blind, placebo-controlled, Phase I study to assess
      the safety, tolerability, pharmacokinetics, pharmacodynamics and food-effect of single and
      multiple, ascending oral doses of TRK-750 in healthy adults and patients with peripheral
      neuropathic pain.
    


Intervention name(s): TRK-750; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TRK-750 capsule; Placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic pain; Neuropathic pain
Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial
Condition: Neurofibromatosis 1; Chronic Pain
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Chronic Pain
Study type: Interventional

Summary: 
      To demonstrate the initial feasibility and determine preliminary impact on clinical outcomes
      of the iCanCope-NF program in a pilot RCT. If successful this pilot study will support
      conducting a larger randomized control trial (RCT). The primary research question is what is
      the feasibility of the iCanCope-NF program? The investigators define feasibility as (1) rates
      of accrual and dropout, daily log-ins, engagement, and outcome measures completed and (2)
      perceptions regarding intervention acceptability and satisfaction; and what are the levels of
      engagement. log-ins, with the intervention? The secondary questions are: (1) how does the
      iCanCope-NF program compare with the control condition in differences of pain and
      pain-related activity limitations, sleep functioning, emotional functioning (depression,
      anxiety), opioid usage, pain catastrophizing, self-efficacy, respondent burden (i.e. Physical
      Functioning, R, Vitality, Social Functioning, Role-Emotional, and Mental Health), and
      psychological flexibility immediately post-treatment (T2), (2) does the iCanCope-NF + CM
      increase the engagement of the iCanCope-NF program as compared to iCanCope-NF without CM, and
      do their corresponding levels of pain and pain-related activity decrease with CM?, and (3) do
      individuals with NF1 utilize the MBAA to help reduce pain symptoms? The investigators
      hypothesize that by customizing and including MBAA to the program for adults with NF1, that
      individuals who engage regularly as seen through Analytics Platform for Evaluating Effective
      Engagement (APEEE) application, will acquire new sets of skills to facilitate pain
      management, while pain as reported with the Brief Pain Inventory will decrease.
    


Intervention name(s): iCanCope; iCanCope+Contingency Management
Intervention type(s): Device; Device
Intervention description(s): The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases; In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: A 1x3 pilot randomized control trial (RCT) (iCanCope-NF, iCanCope-NF +Contingency Management (CM), Control Group) will be conducted with 108 adults with NF1 who suffer from pain.
Masking: Single (Participant)
Primary purpose: Treatment
Study of the Aorta Adaptations to Exercise in Triathletes During Sports Season (CoATri)
Condition: Stiffness, Aortic; Cardiac Remodeling, Ventricular; Vascular Remodeling; Magnetic Resonance Imaging, Functional; Athletes
MeSH terms: Vascular Remodeling; Ventricular Remodeling
Study type: Interventional

Summary: 
      Regular sustained physical activity creates a cardiac remodelling : it is athlete's heart. In
      our preliminary work published in 2016, the investigators demonstrated in a small population
      of triathletes that there is also a vascular remodelling named athlete's artery. Moreover,
      the investigators know that left ventricle and aorta behave together like a couple. So they
      want to study by Cardiovascular Magnetic Resonance Imaging the impact of triathlon on the
      cardiac AND aortic remodelling.
    


Intervention name(s): Cardiac MRI; Applanation tonometry
Intervention type(s): Device; Device
Intervention description(s): Non injected cardiac MRI exam; Applanation tonometry and ECG
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Aortic compliance; Aortic distensibility; CMR; Triathletes; Ventriculo-atrial coupling
Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases
Condition: Myeloproliferative Disorders; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Myeloproliferative Disorders
Study type: Observational

Summary: 
      Goal of the study is to assess the frequency of pulmonary hypertension in patients with
      chronic myeloproliferative diseases. In each patient an echocardiography at rest will be
      performed. In patients without musculoskeletal disease an exercise test (spiroergometry) will
      be performed. Patients with elevated SPAP at rest or with reduced exercise capacity (peak VO2
      < 65%) a right heart catheterization (RHC) will be recommended. Also patients with advanced
      NYHA functional class (III or IV) or with typical PH findings in electrocardiogram will be
      advised to undergo a RHC. Additionally for the evaluation of exercise capacity a 6 MWD will
      be performed.

      This work- up of patients allows clinical and hemodynamic evaluation.
    

Detailed description: 
      Previous small studies and clinical cases have suggested a possible association between
      pulmonary hypertension (PH) and chronic myeloproliferative disorders (CMPD). MPD may cause PH
      through different mechanisms as: high cardiac output, asplenia, direct obstruction of
      pulmonary arteries by megakaryocytes, chronic thromboembolic endothelial pulmonary
      hypertension (CTEPH), porto-pulmonary hypertension (POPH). However, the exact prevalence of
      PH in this group of disorders is not known.

      This study is designed to identify the pulmonary vascular changes and describe the prevalence
      of pulmonary hypertension (defined in this study as mean pulmonary arterial hypertension
      (mPAP) ≥25mmHg as assessed by right-heart catheterization (RHC) or systolic pulmonary
      arterial pressure (sPAP) ≥37mmHg (2.9 m/s) assessed by echocardiography.
    

Intervention name(s): Echocardiography, spiroergometry, cardiac catheterization
Intervention type(s): Other
Intervention description(s): patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with myeloproliferative disorders
      
Biospecimen description: 
      Samples with DNA will be retained for later examinations at the Biobank, in case that the
      patient agrees (extra patient information).

      The blood samples are taken only during routine tests.
    
Keywords: Myeloproliferative disorders; pulmonary hypertension; pulmonary vascular diseases
A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled
      multi-site trial conducted in Canada. Before the start of treatment, the subjects will
      undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment
      duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions
      after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after
      24 weeks of treatment.
    


Intervention name(s): SQ tree SLIT-tablet; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment