bioihbjkbjnl/mcl2 huggingface dataset:
Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of a low literacy, physician and
      patient-directed intervention to promote colorectal cancer (CRC) screening among the
      medically underserved.
    

Detailed description: 
      This study will test the separate and combined effect of two of these interventions: 1) a
      provider communication skills training using a continuous quality improvement (CQI)
      framework, and 2) a brief, multimedia Patient Education Program (PEP) that incorporates plain
      language, graphic design, and audio voice-over to overcome literacy limitations. Our provider
      intervention has demonstrated efficacy to significantly improve CRC screening recommendation
      rates. Our multimedia program has also been field tested among patients with limited literacy
      and was able to improve patient knowledge and intention to receive screening.

      We will implement both provider-only and combined provider-patient strategies within a
      federally qualified health center network to determine the most effective and efficient
      approach to promote CRC screening in these settings. Results from the study, supplemented by
      cost analyses and the process evaluation will directly inform translational strategies for
      cancer prevention within difficult community-based healthcare settings.
    

Intervention name(s): Physician Intervention; Physician and Patient Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Early Detection of Cancer; Colorectal Cancer Screening
Optic Nerve Sheath Diameter Difference Between Different Injection Volume
Condition: Optic Nerve Sheath Diameter
Study type: Interventional

Summary: 
      Valid method of indirect measurement of intracranial pressure is using optic nerve sheath
      diameter. Different volume of injection is known to affect the degree of increase of
      intracranial pressure.

      This study is desinged to measure the changes of optic nerve sheath diameter and cerebral
      oxygenation when different volume of normal saline was injected.
    

Detailed description: 
      Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during
      caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high
      volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and
      oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of
      visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve
      sheath diameter.

      This study was designed to examine the changes of optic nerve sheath diameter and cerebral
      oxygenation when different volume of normal saline was injected.
    

Intervention name(s): thoracic epidural catheterization
Intervention type(s): Procedure
Intervention description(s): thoracic epidural catheterization for postoperative pain control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Optic Nerve Sheath Diameter, Different volume
Differences in Muscle Activity Patterns and Graphical Product Quality in Children With Graphomotor Impairment
Condition: Graphomotor Impairment
Study type: Observational

Summary: 
      Drawing on a vertical surface, rather than horizontal (such as blackboard) is often used by
      occupational therapists as a way of developing fine motor control and visual motor
      integration in children. In healthy children no difference in graphical quality was shown
      between drawing on vertical or horizontal surfaces. However, this was not investigated in
      children with graphomotor impairments.

      The goal of this study is to determine whether movements produced on a vertical surface
      differ in their performance level and muscle activation patterns compared to movements
      produced on a horizontal surface. The investigators predict that there would be a difference
      in the level of performance between the two surfaces.
    

Detailed description: 
      Drawing on a vertical surface, such as a blackboard (rather than a horizontal surface) is
      often used by occupational therapists as a way of developing fine motor control and visual
      motor integration in children. While there is anecdotal evidence to support this
      intervention, preliminary results in healthy children showed no differences in graphical
      quality while drawing on vertical or horizontal surfaces. This however was not investigated
      in children with graphomotor impairments.

      The goal of this study is to determine whether movements produced on a vertical surface
      differ in their performance level and muscle activation patterns compared to movements
      produced on a horizontal surface.

      The investigators predict that the level of performance on the vertical surface will exceed
      the level of performance on the horizontal surface. Additionally, the investigators
      hypothesize that the proximal muscles will be more activated and fatigued (in longer tasks)
      while drawing on the vertical surface, while the distal muscle will be more activated and
      fatigued while drawing on the horizontal surface.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of Forty five 4-6 years old children, referred to occupational therapy
The Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Lower Jaw Dental Injections
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The inferior alveolar nerve block (shot) is the most frequently used injection technique for
      achieving local anesthesia (numbness) for the teeth in the lower jaw. However, this injection
      does not always result in successful pulpal (tooth) anesthesia (patient felt pain). No study
      has combined mepivacaine and lidocaine anesthetics (numbing solutions) for this type of
      injection (shot). The investigators propose to compare an injection of mepivacaine followed
      by lidocaine to an injection of lidocaine followed by lidocaine to determine if there is a
      difference in effectiveness.
    

Detailed description: 
      One hundred adult male and female subjects will randomly receive two sets of inferior
      alveolar block injections (shots) consisting of; 1.) an injection of 1.8 mL of 3% mepivacaine
      followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, and 2.) an injection of 1.8 mL
      of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000
      epinephrine, at two separate appointments spaced at least two weeks apart, in a crossover
      design. Whether the subject receives the mepivacaine or the lidocaine for the first injection
      will be determined randomly. The doctor will not know whether the subject receives
      mepivacaine or lidocaine for the first injection. The subject will not know which anesthetics
      he/she receives. A pulp tester will be used to test the lower jaw teeth (molars, premolars,
      and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. The data will
      be statistically analyzed.
    

Intervention name(s): mepivacaine + lidocaine followed by lidocaine +lidocaine; lidocaine + lidocaine followed by mepivacaine + lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine; 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine
Other intervention name(s): Combo 1; Combo 2
Intervention MeSH terms: Lidocaine; Mepivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mepivacaine; lidocaine; inferior alveolar nerve block; pulpal anesthesia; mepivacaine/lidocaine; lidocaine/lidocaine
Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
Condition: Obesity; Binge Eating
MeSH terms: Obesity; Weight Loss; Bulimia; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a research study designed to examine the effectiveness of an obesity medication
      (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese
      monolingual (Spanish-speaking only) men and women.
    


Intervention name(s): Xenical + behavioral intervention; Behavioral intervention + placebo
Intervention type(s): Drug; Behavioral
Intervention description(s): 120 mg TID; Behavioral weight loss in Spanish; Behavioral weight loss treatment in Spanish Placebo TID
Other intervention name(s): Xenical
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Binge Eating; Monolingual Hispanic Persons; Orlistat; Behavioral Weight Loss Treatment
Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)
Condition: Oral Chronic Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg
      effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with
      resistant oral cGvHD.
    


Intervention name(s): Budesonide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg TID; 0 mg TID
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      This study will be an observational study in which patients who have been prescribed Deplin®
      are invited to participate in surveys regarding their experiences with Deplin®. The purpose
      of this study is to increase the understanding of the role of L-methylfolate among patients
      who are candidates for Deplin®, provide patients with personalized education and support, and
      contribute to the overall understanding of the needs and concerns of patients being treated
      for depression.
    

Detailed description: 
      Surveys used to conduct this study will be administered via telephone or online by
      InfoMedics, Inc., a company with a system for developing such patient-physician feedback
      programs. Participating physicians will ask their patients to participate in the program
      after Deplin® has been prescribed and provide them with a brochure containing an introduction
      to the program and instructions on how to enroll. Patients self-enroll, take a brief survey
      before starting their Deplin® prescription, and then a follow-up survey after 90 days of
      treatment with Deplin®. As patients complete surveys within the study, their physician will
      receive individualized feedback reports outlining their patient's treatment experience and
      progress. Patients will also receive a copy of their own reports, to help encourage them to
      continue taking Deplin® as directed. Patients will also receive educational materials about
      managing their depression.
    

Intervention name(s): Deplin®
Intervention type(s): Other
Intervention description(s): Deplin® is an orally administered medical food available in a 7.5mg tablet or a 15mg caplet with each containing either 7.5mg or 15mg of L-methylfolate, respectively - which is the primary biologically active and immediately bioavailable form of folate. Dosage for this study will be 1 15mg caplet QD.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Depression Who Have Been Prescribed Deplin®
      
Keywords: L-methylfolate; Deplin; depression; antidepressant; combination therapy; augmentation; folate; folic acid; homocysteine; methionine; MTHFR genotype; C677T mutation; vitamin B6; vitamin B12
Intranasal Delivery of Testosterone and Its Effect on Doping Markers
Condition: Abuse of Anabolic Steroids
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic
      profile during anti-doping testing, which is different than the profile seen when
      testosterone is administered into muscle, on skin or under the tongue.

      Objective: The investigators aim to characterize the unique steroid doping profile following
      administration of intranasal testosterone to healthy, active volunteer subjects.
    

Detailed description: 
      Testosterone is a substance commonly abused in the sporting world despite being banned by all
      American sports leagues, international federations, and the World Anti-Doping Agency. Current
      methods employed to detect exogenously administered testosterone include direct detection
      using isotope ratio mass spectrometry (IRMS) and indirect detection using the athlete
      biological passport (ABP). However, different formulations of testosterone (oral,
      transdermal, sublingual, etc) are expected to result in characteristic IRMS profiles, affect
      the ABP readings in unique ways, and differ in their windows of detection. In 2014, a new
      formulation of testosterone, Natesto, which is administered intranasally, was FDA approved.
      Though only approved for medical use, it is expected athletes may use this product, and its
      effect on steroid doping markers has yet to be determined. Characterization of this detection
      profile is necessary for confirmation of the exact product being administered in an
      anti-doping setting. In this study, the investigators aim to understand the effects on the
      steroid doping profile following a single administration of Natesto to healthy, active
      volunteers. Windows of detection will be determined for the standard dosing of Natesto, and
      the effects on ABP markers and IRMS profiles will also be established.
    

Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention description(s): Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.
Other intervention name(s): Natesto
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Sports Medicine; Men's Health; Athletes; Anti-Doping
The Safety and Tolerability of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir
      Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted
      in Chinese Healthy Adult Volunteers.
    

Detailed description: 
      A study to evaluate the safety and tolerability of ascending single oral doses of metacavir
      enteric-coated capsules using a placebo-controlled design conducted in Chinese healthy adult
      volunteers, and to provide references for the clinical trial of the next phase Ⅰ and Ⅱ.

      48 eligible healthy subjects are involved. According to the set ascending-doses groups,
      subjects will be randomized in a 3:1 proportion to orally take a single dose of Metacavir
      enteric-coated capsule or placebo on the condition of fasting. Each group has 8 people,
      evenly composed of men and women. The beginning dose of the study is 40mg/d.According to the
      dose escalation method, subjects who have successfully completed tests of the previous dose
      group and passed the safety assessment will enter the next dose group with the same method.
      All subjects check in the phaseⅠresearch center one day early before taking the test drug.
      Vital signs and ECG will be observed before and 0.5,1,2,4,8,12,18,24,48,72 hours after
      administration and at the follow-up day which is the 7th day since administration. Laboratory
      tests will be conducted before and 6,24,48,72 hours after administration and at the follow-up
      day , and the adverse drug events are observed throughout the test.
    

Intervention name(s): PNA 40mg; PNA 80mg; PNA 160mg; PNA 240mg; PNA 360mg; PNA 480mg; PNA Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): The beginning dose is 40mg.; The single dose is 80mg.; The single dose is 160mg.; The single dose is 240mg.; The single dose is 360mg.; The single dose is 480mg.; The beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg.
Other intervention name(s): Metacavir Enteric-coated Capsules 40mg; Metacavir Enteric-coated Capsules 80mg; Metacavir Enteric-coated Capsules 160mg; Metacavir Enteric-coated Capsules 240mg; Metacavir Enteric-coated Capsules 360mg; Metacavir Enteric-coated Capsules 480mg; Metacavir Enteric-coated Capsules Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B
Project EAT: Eating and Attitudes in Teens
Condition: Obesity; Adolescent Development; Stress
Study type: Interventional

Summary: 
      Research suggests there is a connection between mood and weight. People who feel stressed or
      depressed are more likely to be overweight than people who don't have these feelings. Some
      individuals turn to food to cope, which can lead to gaining too much weight over time.
      Adolescence is an important time to understand these connections. Patterns of handling stress
      learned during adolescence set the stage for stress management in adulthood. This study is a
      randomized controlled pilot study with 60 adolescents who are at-risk for future, chronic
      obesity. The investigators will test if taking part in a 6-week group program to lower stress
      and improve mood will be helpful to teens at-risk.
    


Intervention name(s): Learning to Breathe; Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six-session group program that involves meditation and interactive activities to learn mindfulness skills for coping with stress; Six-session group program that covers topics important for healthy living such as avoiding drug use, conflict resolution, bullying, sun safety and others
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health(2)
Condition: Healthy Men and Women
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether consumption of the active product affects
      postprandial changes in metabolic indices, in comparison to the control product.
    


Intervention name(s): Very low polyphenol fruit based drink (control); Polyphenol-enriched fruit-based drink - low; Polyphenol-enriched fruit-based drink - high
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Polyphenol; Fruit; Metabolic; Healthy
Effectiveness of a Nurse-led Integrative Health and Wellness Programme Among Newly Diagnosed Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This randomized controlled trial aims to investigate the effectiveness of an integrative
      medicine (traditional Chinese medicine and western medicine) based structured education
      programme for newly diagnosed type 2 diabetes patients. The theoretical frame of this study
      is based on the health belief model and self efficacy theory. The hypotheses of this study
      are: 1) Participants in the intervention group will have higher level of self-management
      behaviour after intervention compared to participants in the control group; 2) Participants
      in the intervention group will have better diabetes knowledge after intervention compared to
      participants in the control group; 3) Participants in the intervention group will have higher
      level of self-efficacy after intervention compared to participants in the control group; 4)
      Participants in the intervention group will be less depressed after intervention compared to
      participants in the control group; 5) Participants in the intervention group will have better
      QOL after intervention compared to participants in the control group; 6) Participants in the
      intervention group will gain greater reduction in HbA1c after intervention compared to
      participants in the control group; 7) Participants in the intervention group will gain
      greater reduction in fasting blood glucose after intervention compared to participants in the
      control group; 8) Participants in the intervention group will gain greater reduction in BP
      after intervention compared to participants in the control group; 9) Participants in the
      intervention group will gain greater reduction in BMI after intervention compared to
      participants in the control group.
    


Intervention name(s): Nurse-led Integrative health and wellness programme
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention group will go through a eight-session structured education programme. The education programme was designed by incorporating the evidences of diabetes care from the western medicine and the philosophy of traditional Chinese medicine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care