bioihbjkbjnl/mcl2 huggingface dataset:
Developing an Integrated Model for Home Visitation
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      Perinatal depression is a significant concern, particularly for low-income women. Many cases
      of perinatal depression are complicated by comorbidities such as post-traumatic stress
      disorder symptoms, anxiety, and intimate partner violence. Providing perinatal mental health
      services to women in home visiting programs could have considerable public health
      significance. This study will develop and test an integrated model of mental health services
      embedded within home visitation (HV) programs. This model will (1) incorporate a protocol for
      systematic screening and referral; (2) strengthen formal linkages between HV programs and
      other components of service systems; (3) promote the capacity of service systems to provide
      evidence-based early intervention and treatment for depression; and (4) facilitate the
      receipt of early intervention and treatment services for perinatal depression and comorbid
      conditions. This will be the first model to our knowledge that systematically integrates
      screening, referral, and early intervention and treatment for perinatal depression and
      associated comorbidities within HV programs.

      The specific aims are:

        1. To develop an integrated model of perinatal depression care within HV programs. This
           integrated model ("SCRIPT") will incorporate screening, referral, and individualized
           prevention and treatment services.

        2. To assess the feasibility of implementing the SCRIPT model with high fidelity in two HV
           programs. One HV program-DRUM Healthy Families-will use paraprofessionals as
           interventionists while the other program-M&I Nursing-will use nurses and social workers
           as interventionists.

        3. To determine the impact of the SCRIPT model on depressive symptoms and major depressive
           episodes.
    


Intervention name(s): SCRIPT integrated model
Intervention type(s): Behavioral
Intervention description(s): Perinatal women will be screened for psychosocial risks at time of home visiting enrollment. Women exhibiting elevated depressive symptoms and/or have a history of clinical depression who are not currently clinically depressed will be referred for depression prevention services. Women experiencing a depressive episode will be referred for group CBT. Women who screen positive for elevated anxiety symptoms, PTSD symptoms, intimate partner violence, or substance abuse will be referred to a mental health or social service agencies. If a client is referred for services, the assessment worker will provide written educational materials about the risk factor that is being addressed through the referral. At the first home visit, the home visitor will discuss these educational materials.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Treatment to Quit Smoking
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol evaluates the efficacy of combining pharmacologic treatments for smoking
      cessation, entailing the use of the nicotine skin patch with the nicotinic antagonist
      mecamylamine, with a specific behavioral therapy designed to inhibit the smoking urge.
    

Detailed description: 
      Previous studies have found that nicotine/mecamylamine treatment more than doubles the
      long-term abstinence rates relative to nicotine replacement alone. Recent evidence supports
      the hypothesis that nicotine/mecamylamine treatment prior to smoking cessation partially
      blocks the rewarding effects of cigarette smoking and hence promotes extinction of the
      smoking habit, facilitating subsequent abstinence. The behavioral approach employed is also
      an extinction strategy and involves having smokers switch to de-nicotinized tobacco
      cigarettes for two weeks prior to quitting smoking. It is hypothesized that the use of
      de-nicotinized cigarettes might provide more complete extinction than provided by the partial
      pharmacologic blockade using nicotine/mecamylamine alone. The pharmacologic treatment was
      expected to increase compliance with the de-nicotinized cigarette smoking regimen, because
      subjects' usual brands of cigarettes will be less appealing than in the absence of
      nicotine/mecamylamine treatment. Together the brand-switching and nicotine/mecamylamine
      therapies were expected to reduce cravings and other withdrawal symptoms as well as increase
      long-term abstinence from smoking.
    

Intervention name(s): Mecamylamine; Nicotine Patch; Cigarette brand switching
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Mecamylamine; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Nicotine; addiction; cigarette smoking
Study on the Effectiveness of Gastroscope Operation Quality Control Based on Artificial Intelligence Technology
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      This study aims to construct a real-time quality monitoring system based on artificial
      intelligence technology.
    

Detailed description: 
      Gastroscopy plays an important role in the detection and diagnosis of upper gastrointestinal
      diseases. It is necessary for endoscopists to operate gastroscope according to the
      standardized process, in order to avoid missing early lesions. However, with the rapid
      increase in the number of endoscopies, the workload of endoscopists increases further. High
      workload reduces the quality of endoscopy, resulting in incomplete observation of anatomical
      parts that are easy to be missed in the process of gastroscopy. There are significant
      differences in the operation level of different endoscopists. Therefore, carrying out
      artificial intelligence methods has good academic research and practical value for improving
      the quality of endoscopic diagnosis and treatment.

      Artificial intelligence devices need to use a large number of endoscopic images, based on
      this, we intends to collect endoscopic image data from our hospitals for training and
      validation of the model.
    

Intervention name(s): blind spots
Intervention type(s): Diagnostic Test
Intervention description(s): missed part during map the entire stomach through endoscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who meet the criteria for gastroscopy examination.
      
Keywords: gastric cancer; artificial intelligence; endoscopy
Control and Reward Circuits in Obsessive Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to examine the brain functioning of OCD patients and healthy
      controls before and after treatment with Exposure and Response Prevention (EXRP) therapy.
    

Detailed description: 
      The capacity to coordinate thoughts and actions to execute goal-directed behaviors (cognitive
      control) and the capacity to anticipate, respond to, and learn from reward (reward
      processing) are key processes for human behavior. Dysfunction in these processes has been
      hypothesized to contribute to repetitive thoughts and behaviors in many disorders, including
      obsessive-compulsive disorder (OCD), Tourette Syndrome (TS), and eating disorders. We will
      use multimodal imaging to investigate neural circuits that support cognitive control and
      reward processing, using OCD as a model system. The short-term goal is to clarify how
      circuit-based abnormalities contribute to repetitive thoughts/behaviors; these data will
      inform future transdiagnostic studies. The long-term goal is to identify control and reward
      circuit-abnormalities as targets for new transdiagnostic treatments.
    

Intervention name(s): Exposure & Response Prevention (EX/RP)
Intervention type(s): Behavioral
Intervention description(s): Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: OCD; Functional Magnetic Resonance Imaging (fMRI)
Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury
Condition: NSAID-induced Gastroduodenal Injury; Ulcers; Rheumatoid Arthritis; Osteoarthritis
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine the efficacy and safety of three dose
      levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20
      months.
    


Intervention name(s): Cobiprostone; Placebo; Non-steroidal anti-inflammatory drug
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 18 mcg cobiprostone capsules for oral administration; Matching placebo capsules for oral administration; Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Other intervention name(s): SPI-8811; RU-8811; Matching Placebo; Standard Care
Intervention MeSH terms: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vital Signs Monitoring in Rehabilitation Center Patients
Condition: Comorbidities
Study type: Observational

Summary: 
      Some patients unable to return home from hospital due to physical or mental illness will be
      discharged to a rehabilitation home to restore strength and rehabilitate. This study attempts
      to examine if it is possible to continuously monitor the vital signs in patients discharged
      to a rehabilitation center and whether wearable devices will detect more abnormal vital signs
      than the rehabilitation facility, as well as complication and readmission rates.
    

Detailed description: 
      Patients who are ready to leave the hospital but are deemed unable to return home are
      discharged to a rehabilitation center to regain strength and performance.

      Vital signs are only measured when deemed necessary at the rehabilitation center, in contrast
      to hospital wards, where vital signs are measured intermittently and manually every 8-12
      hours.

      Wearable devices that continuously monitor a patient's vital signs may be able to detect
      patients who are deteriorating, as abnormal vital signs often precede a physiologic decline
      This study aims to determine whether it is possible to continuously monitor patients
      discharged to a rehabilitation center and detect more abnormal vital signs than measurements
      from the rehabilitation center. By attaching three wearable devices to 20 patients, we wished
      to record the vital signs for up to 96 hours, documenting abnormal vital signs as well as
      complications - and readmission rates.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospital patients discharged to a rehabilitation center
      
Keywords: Rehabilitation patients, wireless monitoring, vital signs
A Study of the Effects of Multiple Doses of LY3372689 on the Brain in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study
      will be conducted in healthy participants and will last up to about 10 weeks. Screening must
      be completed within four weeks prior to enrollment.
    


Intervention name(s): LY3372689; [18F]LSN3316612
Intervention type(s): Drug; Diagnostic Test
Intervention description(s): Administered orally.; Administered intravenously (IV).
Other intervention name(s): [18F]MNI-1068
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Mini Implant Facilitated Micro-osteoperforations on the Alignment of Mandibular Anterior Crowding
Condition: Tooth Position Anomalies
Study type: Interventional

Summary: 
      The primary aim of the present study is to evaluate the the efficacy of
      micro-osteoperforation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of
      mandibular anterior teeth
    

Detailed description: 
      Primarily the present study is designed to evaluate the efficacy of micro-osteoperation
      (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior
      teeth. Additionally, the possibility of inducing root resorption, and patient perception of
      pain during the initial phase of treatment.

      Subjects and Methods: Orthodontic patients aged 17-25 years old, non-extraction treatment
      with lower anterior crowding of 4-6 mm using Little's irregularity index. Outcome measures
      included the amount of crowding using Little's irregularity index (LII), apical root
      resorption, and pain perception. The effectiveness of alignment will be tested using t-test,
      while root resorption and pain perception will be tested by the Mann-Whitney U test, and
      Wilcoxon signed-rank test (P<0.05).
    

Intervention name(s): Micro-osteoperforation
Intervention type(s): Procedure
Intervention description(s): Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental group before placing the initial leveling arch wire. MOPs were placed at three sites i.e., interproximally between mandibular canine and lateral incisor on both sides and between central incisors in the midline on labial aspect of mandible.
Other intervention name(s): MOP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK002 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, randomised, double blind, placebo controlled, single ascending dose study and
      multiple dose study. AK002 will be administered as an intra-venous (IV) infusion in eight
      cohorts of single escalating doses and two cohorts with multiple doses. The study will
      comprise of 3 parts: Part A (Cohorts 1 - single ascending dose); Part B (Cohorts 2 to 9 -
      single ascending dose); Part C (Cohorts 10 and 11 - multiple dose).
    

Detailed description: 
      Participants who meet all inclusion and none of the exclusion criteria will be enrolled in
      the study. Safety and tolerability will be evaluated throughout the study. Blood sampling for
      PK and PD analysis will be also collected during the course of the study.

      Up to approximately 48 participants will be enrolled in the study. Participants will be
      screened from -28 days prior to dose administration.

      In parts A and B, participants will be admitted to the unit on Day -1 and will remain
      confined to the clinic until completion of Day 4 procedures. On Day 1, participants will
      receive a single dose of AK002 or placebo and complete study procedures. Participants will
      return to the clinic for follow up at Days 7, 14, 28, 56, 84 and 112 or end of study (EOS)
      visit.

      In part C, In Part C, participants will be admitted to the unit on Day -1 and will remain
      confined to the clinic until completion of Day 2 procedures. On Day 1, participants will
      receive a dose of AK002 or placebo and complete procedures as detailed in Table 2.
      Participants will return to the clinic for follow up at Days 4, 7 and 14, and on Day 28
      participants will receive a second dose of study drug (AK002 or a corresponding placebo) and
      will remain confined to the clinic until completion of the Day 29 procedures. Participants
      will return to the clinic for follow up at Days 31, 35, 42, 56, 84 and 112 or end of study
      (EOS) visit.
    

Intervention name(s): AK002; Placebo
Intervention type(s): Drug; Other
Intervention description(s): IV AK002
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Aerobic Training in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized controlled trial with blinded assessor on the effects of aerobic
      exercise (walking)in patients with Ankylosing Spondylitis.
    

Detailed description: 
      Ankylosing Spondylitis (AS) is a systemic inflammatory disease that affects mainly the spine
      and compromises globally the physical capacity of the patients. Despite new advances in
      pharmacological therapy, physiotherapy and exercise remain essential in the treatment of AS.
      However, the literature lacks studies showing which types of exercises are more effective in
      patients with AS.

      This is a randomized controlled trial with the objective is to evaluate the effects of
      aerobic training on functional capacity, mobility, disease activity, cardiopulmonary capacity
      and cytokine levels (TNF, IL10, IL6 and IL1) in patients with AS.

      The duration of the trial is 24 weeks with the first 12 weeks reserved to exercise programs.
      The participants will be divided in two groups. The intervention group (IG) will perform
      walking for 50 minutes plus global stretching 3 times a week for 12 weeks. The control group
      (CG) will do only stretching exercises 3 times a week for 12 weeks.
    

Intervention name(s): aerobic training; Stretching exercises
Intervention type(s): Other; Other
Intervention description(s): The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.; Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; aerobic exercise
Pulmonary Effects of 100% Biodiesel Exhaust
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Air pollution is a global environmental and health concern, contributing to onset and
      deterioration of respiratory and cardiovascular diseases. As climate change and dependence on
      diminishing fossil fuel supplies have taken center stage in political and scientific debates,
      renewable carbon-neutral fuels like biodiesel receive increasing attention. The most common
      biodiesel within the European Union, rapeseed oil methyl ester (RME) is perceived to be a
      "green fuel", as it is sustainable and of biological origin, and therefore is often predicted
      to be less harmful to human health. Whilst replacing petrodiesel with biodiesel may have
      advantageous ecological impacts, consequences to respiratory health remained largely
      unexplored.

      The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel
      exhaust would result in an acute airway inflammatory response in healthy human subjects, as
      shown previously following exposure to petrodiesel exhaust.
    


Intervention name(s): Bronchoscopy
Intervention type(s): Other
Intervention description(s): The bronchoscopy procedure was performed six hours after completion of the exposure session, with sampling of endobronchial mucosal biopsies, bronchial wash and bronchoalveolar lavage performed under topical anaesthesia.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Air Pollution; Biodiesel exhaust; Bronchoscopy; Metabolomics
Pharmacogenetics of Cannabinoid Response
Condition: COMT Gene Polymorphism
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study attempts to examine genetic influences on the effects of tetrahydrocannabinol
      (Δ9-THC), the active ingredient of marijuana, cannabis, "ganja", or "pot".
    


Intervention name(s): delta 9 tetrahydrocannabinol
Intervention type(s): Drug
Intervention description(s): 0.05 mg/kg of THC dissolved in ethanol intravenously over 20 minutes
Other intervention name(s): Marijuana; cannabis
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: THC; COMT gene polymorphism; schizophrenia; cannabis use
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19
Condition: COVID-19 Vaccine
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and immunogenicity of a
      booster dose of vaccine in participants who are generally healthy or with stable pre-existing
      health conditions. Study details include:

        -  The study duration per participant will be approximately 209 days (28 days screening, 1
           day vaccination, and 180 days follow-up).

        -  The treatment duration will be 1 day. -The visit frequency will be 6 on-site visits (1
           screening visit, 1 treatment visit, and 4 follow- up visits) and 1 phone visit.
    

Detailed description: 
      This is a Phase I, prospective, randomized, open-labeled study to evaluate the safety,
      tolerability, and immunogenicity of a booster vaccination with the MVC-COV1901 or
      MVC1901(Beta). Approximately 120 participants aged ≥18 and <55 years, who received two or
      three doses of MVC- COV1901 vaccines, will be enrolled and divided into two groups. Each
      group will consist of approximately 60 eligible subjects, and for each group the
      randomization will be stratified based on site to three treatment arms (15 mcg of MVC-COV1901
      or 15 mcg or 25 mcg of MVC-COV1901(Beta) in 1:1:1 ratio).
    

Intervention name(s): MVC-COV1901; MVC-COV1901(Beta)-15; MVC-COV1901(Beta)-25
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region. Group A and B; Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901(Beta)-15 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region; Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901(Beta)-25 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COVID-19 Vaccine