bioihbjkbjnl/mcl2 huggingface dataset:
Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1
Condition: Heroin Dependence; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid
      dependence.
    

Detailed description: 
      The objective of this study is to determine the safety and efficacy of a
      buprenorphine/naloxone combination tablet for opiate dependence treatment.
    

Intervention name(s): Buprenorphine/naloxone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: opioid dependence
A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe
      and works better than increasing the amount of sulfonylurea a patient takes
    

Detailed description: 
      All subjects will participate in a lead-in period, and qualifying subjects will continue into
      a short-term randomized treatment period. Subjects who complete the short-term period will be
      eligible to enter the long term extension period. Also, subjects in the short-term period who
      have an elevated blood sugar that requires additional medication for blood sugar control
      (defined as rescue) will be eligible to enter the long-term treatment extension period where
      they will receive metformin.Rescue treatment with metformin is also available during the
      long-term extension period for subjects who meet glycemic criteria.
    

Intervention name(s): Saxagliptin; Saxagliptin; Glyburide; Placebo; Glyburide; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT]); Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).; Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT); Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT); Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT); Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Other intervention name(s): BMS-477118; BMS-477118
Intervention MeSH terms: Metformin; Saxagliptin; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Use of Manual Therapy to Treat Low-Back and Hip Pain
Condition: Low Back Pain; Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain (LBP) is a common problem in the adult population with many approaches to
      treatment, but no clear answer. One of the causes of LBP, musculoskeletal pain, can be
      triggered by spasm of the deep muscles of the back and pelvis. This study, therefore, focuses
      on treating pelvic muscle pain as a way of lessening LBP.
    

Detailed description: 
      Osteopathic manipulative medicine (OMM) is a well-researched standard of care in the
      treatment of low back pain (LBP). Under the heading of OMM, many different modalities exist
      to decrease a patient's somatic dysfunction. Among the most commonly used are high velocity
      (thrusting through an immobilized joint) and muscle energy (engaging a restrictive barrier
      using the patient's own strength).

      Although a very common complaint, there is no exact etiology for LBP. Many different theories
      exist, including postural disturbances, leg length discrepancies, and even genetic
      predispositions. A study in Spine finds that among those with chronic LBP there is a subgroup
      of people with reduced hip flexion, and concludes that hip motion should be considered in
      treatment of patients with LBP. Currently, there exists no research on the manipulation of
      hip flexors in the treatment of LBP. This study, therefore, will test the efficacy of OMM on
      the deep pelvic musculature as a way of decreasing LBP.
    

Intervention name(s): Osteopathic Manipulative Medicine; Sham Manipulation
Intervention type(s): Procedure; Procedure
Intervention description(s): Pelvic balancing, myofascial release of the anterior pelvis.; Neutral positional, gentle palpation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Hip pain
Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
Condition: Drug Overdose; Opioid-Related Disorders
MeSH terms: Drug Overdose; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose
      of naloxone administrated intramuscular and to identify an appropriate intranasal dose that
      could achieve systemic exposure comparable to an approved parenteral dose. To also determine
      the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to
      determine the safety of intranasal naloxone with respect to nasal irritation.
    


Intervention name(s): Naloxone
Intervention type(s): Drug
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink
Condition: Healthy; Mild Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the safety of consumption of three times the
      standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.
    


Intervention name(s): 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).; 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
Intervention type(s): Other; Other
Intervention description(s): 1 = Intervention 1 (3 test products/day); 2 = Intervention 2 (3 control products/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Plant sterol; Hypercholesterolemia; dairy
Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
Condition: Finger Injuries; Soft Tissue Injuries
MeSH terms: Wounds and Injuries; Soft Tissue Injuries; Finger Injuries
Study type: Interventional

Summary: 
      Multiple digital injuries are often complex and severe, and the commonly used local and
      regional flaps may not be feasible. The authors reconstruct soft tissue defects of the
      fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.
    

Detailed description: 
      At final follow-up, we measure the sensibility of the flaps using the static 2-point
      discrimination test. The Static 2-point discrimination test determines the minimal distance
      at which a subject can sense the presence of two needle. The modified American Society for
      Surgery of the Hand guidalines are used to stratify discriminator measurements(excellent <6
      mm, good 6-10 mm, fair 11-15 mm, poor >15 mm). Each area is tested 3 times with a
      Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers are considered proof of
      perception before proceeding to another lower value. We stopp at 4mm as a limit of 2PD and
      consider this normal. The measurements are performed at a single time point at final follow
      up.
    

Intervention name(s): Dorsal digito-metacarpal flap
Intervention type(s): Procedure
Intervention description(s): The dorsal digito-metacarpal flap is a vascular island flap based on the dorsal digital artery and dorsal metacarpal artery. It has a longer vascular pedicle and provides tissue coverage of similar quality as that of normal glabrous skin but not sacrifice the digital artery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: defect,; dorsal branch of the digital artery,; dorsal digital flap,; dorsal metacarpal artery flap.
Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      The primary objective of the study is to determine the association between prospectively
      measured disability (Expanded Disability Status Scale [EDSS]) with quality of life (Multiple
      Sclerosis International Quality of Life Questionnaire [MusiQoL]) at 3-month intervals up to 1
      year in a real life setting of multiple sclerosis (MS) patients treated with natalizumab. The
      secondary objectives of this study are as follows: To evaluate the cumulative probability of
      sustained EDSS changes at 1 year following natalizumab treatment initiation; To evaluate the
      association between disability (EDSS), fatigue (Fatigue Scale of Motor and Cognitive Function
      [FSMC]), sexual dysfunction (Multiple Sclerosis Intimacy and Sexuality Questionnaire-19
      [MSISQ-19]), depression (Beck Depression Inventory-Fast Screen [BDI-FS]) and neurocognitive
      function (Symbol Digit Modalities Test [SDMT]) with EuroQol-5D Questionnaire (EQ-5D) at 3 to
      6-months intervals up to 1 year after initiation of natalizumab treatment; To assess the
      relationship between clinical disease-free status (no EDSS increase of 1.0 and no relapse)
      and MusiQoL at 1 year following natalizumab treatment initiation; To record the number of
      clinical relapses and relapses requiring steroid treatment at 3-months intervals up to 1 year
      after initiation of natalizumab treatment; To describe changes in work impairment (Work
      Productivity and Activity Impairment in MS [WPAI-MS]) at 3-months intervals up to 1 year
      after initiation of natalizumab treatment; To describe any change in the percentage of
      disability pension and occupation after 1 year of natalizumab treatment; To record the
      incidence and number of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse
      Reactions (SUSAR) throughout the study
    


Intervention name(s): natalizumab
Intervention type(s): Drug
Intervention description(s): As described in the treatment arm
Other intervention name(s): Tysabri; BG00002
Intervention MeSH terms: Natalizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been
        prescribed natalizumab under standard clinical care.
Evaluation of Physician Volumetric Accuracy During Filler Injections
Condition: Injection Site
Study type: Interventional

Summary: 
      Objectives

        1. Evaluate the ability of aesthetic physicians to accurately inject a specific amount
           (i.e., 0.2cc) of HA soft tissue filler; and

        2. Investigate the effect of different HA gel properties (e.g., G', cohesivity,
           viscoelasticity) on an injector's performance accuracy.
    


Intervention name(s): Injection of filler material
Intervention type(s): Behavioral
Intervention description(s): Subjects will be blind folded and asked to deposit 0.2cc's of each of the four investigational products, in a randomized order. First, over a weight and then into a porcine membrane.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Omega-3 Fatty Acids for Treatment of Depression in Adolescents
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Adolescence is the highest risk period for depression onset. More than 1.3 million youths
      suffer from major depression annually in the United States, and there is evidence for an
      increasing trend. Because many adolescents have their first depressive episode in adolescence
      and adolescent depression often leads to recurrent mood disorders in adults, effective
      treatment during early illness can minimize the negative consequences of initial and repeated
      episodes. Although some antidepressants (particularly Selective serotonin reuptake inhibitors
      (SSRIs)) are effective treatments for juvenile depression, recent warnings about suicide and
      the use of SSRls highlight the need for new and safe treatment for juvenile depression. Data
      in adults suggest that supplementation with polyunsaturated fatty acids (PUFA) might be
      useful for the treatment of depression. The purpose of this study is to investigate the
      safety and efficacy of PUFA for the treatment of adolescent depression.
    


Intervention name(s): Fish Oil; Cognitive Behavior Therapy; Placebo
Intervention type(s): Dietary Supplement; Behavioral; Other
Intervention description(s): Omega-3 fatty acid supplements.; Adolescents receive cognitive behavior therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent Depression; Depression; Teenage Depression; Los Angeles
Clinical Effect Evaluation of Laparoscopic Surgery for Ovarian Benign Tumors by Different Approaches
Condition: Laparoscope; Malignant Ovarian Tumor; Single-site Surgery
MeSH terms: Ovarian Neoplasms
Study type: Observational

Summary: 
      Main purpose: To compare the intraoperative and postoperative recovery of laparoscopic
      surgery for ovarian benign tumors through different approaches; Secondary objective: Will
      vNOTES increase the risk of cesarean section during pregnancy and affect the quality of
      sexual life after surgery.
    


Intervention name(s): operation ways
Intervention type(s): Procedure
Intervention description(s): nothing
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        nothing
      
Keywords: Transumbilical laparoendoscopic single-site surgery,Giant malignant ovarian tumor
Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving
      Chemo-Radiotherapy.
    

Detailed description: 
      STUDY PLAN

        1. Only the principal investigator, sub-investigators, and research nurse will be
           approaching potential participants. The above listed also will be the only consentors
           for the study. The recruitment process will occur during the outpatient visits being
           held at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. HIPAA (Health
           Insurance Portability and Accountability Act ) and guidelines and good clinical practice
           will be followed at all times to ensure that the privacy of participants included in the
           recruitment process are strictly guarded.

        2. Patients will be registered by the Radiation Oncology clinical subjects coordinator
           after eligibility is confirmed and informed consent is obtained.

        3. The EORTC (European Organization for Research and Treatment of Cancer)QLQ- C30 (Quality
           of Life Questionnaire), QLQ-CR38 (Quality of Life Questionnaire), and QLQ-CR29 (Quality
           of Life Questionnaire) forms will be completed by patients at the following time point:

             1. Within 3 weeks prior to start of radiotherapy

             2. During the 4th week of radiotherapy (when treatment-related symptoms are expected
                to peak)

             3. Approximately one month after completion of radiotherapy during a follow-up visit

        4. The QOL forms (QLC-C30, QLQ-CR38, and CR29) will be self-administered surveys. A nurse
           or other healthcare provider will be available to help the patient with any questions
           regarding the QOL forms.

        5. The symptom inventory will be collected in an interview by a nurse or other healthcare
           provider at the following time points: d. Within 3 weeks prior to start of radiotherapy
           e. Once weekly during radiotherapy f. Approximately one month after completion of
           radiotherapy during a follow-up visit.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males or females greater than or equal to 18 years of age with a working diagnosis of
        rectal cancer.
      
Keywords: Rectal Cancer; Chemoradiation; Rectal Cancer receiving chemoradiation.
Effect of Oral Cinnamon Intervention in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This double blind placebo control study with supplementation of oral Cinnamon is being
      conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may
      lead to improvement in body composition and metabolic parameters.
    


Intervention name(s): Cinnamon; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution
Condition: Caries Arrested
MeSH terms: Heart Arrest
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it
      with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12
      months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries
      depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and
      was compared (follow-ups to baseline)to check for caries arrest.

      Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA
      - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3
      - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine
    


Intervention name(s): Silver diamine fluoride; Sodium fluoride varnish
Intervention type(s): Drug; Drug
Intervention description(s): Silver diamine fluoride is a topical medication composed of 25% silver, 5% fluoride, 8% ammonia, and 62% Deionized water, used to treat and prevent dental caries and relieve dentinal hypersensitivity.; It is a topical application with an active ingredient of 5% sodium fluoride(22,600ppm fluoride).it prolongs the contact time between the fluoride and tooth surface and promotes remineralization and inhibits demineralization.
Other intervention name(s): FAgamin SDF38%; VOCO profluorid varnish
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Caries arrest ,interproximal caries, primary molars, SDF
A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
Condition: Sleep; Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional

Summary: 
      It is well recognized that physical activity/exercise is an effective intervention to improve
      sleep, reduce pain and improve function in a variety of pain conditions. Traditional
      interventions to increase physical activity are challenging in older adults due to extensive
      staffing requirements and low adherence. The investigators plan to conduct a pilot trial in a
      cohort of older adults (without dementia) with both chronic musculoskeletal pain and
      nocturnal sleep complaints to test the effectiveness of a 12-week personalized behavioral
      intervention (compared to a control group) embedded within a smartwatch application in older
      adults. 27 cognitively intact elders were enrolled and randomly allocated to intervention or
      control group. Participants in the intervention arm received a 2-hour in person education
      session, and personalized, circadian-based activity guidelines, with real time physical
      activity self-monitoring, interactive prompts, biweekly phone consultation with the research
      team, and financial incentives for achieving weekly physical activity goal. The control group
      received general education on physical activity in older adults and continue routine daily
      activity for 12 weeks.
    


Intervention name(s): ELDERFITNESS; Control
Intervention type(s): Behavioral; Other
Intervention description(s): In person training: Participants will receive a 2-hour in person education session with the exercise trainer. Self-monitoring: Subjects will self-monitor subjects' level of physical activity (steps & minutes of moderate activity) using the smartwatch. The Google calendar and Fitbit apps will send messages and alerts to the subject's smartwatch that encourage subjects to achieve subjects' daily goals. If a participant has low activity for 3 consecutive days, the research assistant will call the participant to either encourage the participant to adhere to the plan or provide a modified plan after consulting the exercise trainer.
Phone consultation: Subjects will have biweekly phone consultation with the research team members to receive guidance and adjustment on activity plans. Financial incentives: The intervention will include financial incentives. Specifically, when the daily activity goal is achieved for more than four days per week, a $5 reward will be given to subjects.; General education on physical activity for older adults and continue daily activity and healthcare routine. Participants will also receive a Go4Life program book from the National Institute on Aging.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care