bioihbjkbjnl/mcl2 huggingface dataset:
Sensitivity to Intravenous Nicotine: Genetic Moderators
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if the mu opioid receptor gene (OPRM1) A118G polymorphism moderates the
      subjective-rewarding effects of intravenous (IV) nicotine in male and female smokers. The
      subjective effects of nicotine will be measured with a Drug Effects Questionnaire, including
      the ratings of "good effects" and "drug liking". We hypothesize that smokers with the AG/GG
      genotype for the OPRM1 A118G will have attenuated subjective-rewarding effects from IV
      nicotine when compared to those with AA genotype.
    

Detailed description: 
      Increasing evidence suggest that MOR contribute to nicotine's rewarding effect. Further, the
      functional OPRM1 A118G variant has been linked to rewarding effects of alcohol in alcohol
      users and to nicotine in female smokers. Since no previous studies examined the influence of
      the A118G variation on pure nicotine responses, the next logical step is to evaluate how this
      genetic polymorphism affects nicotine's rewarding, cognitive, and physiological effects using
      IV nicotine administration in male and female smokers. In addition, the association of the
      G398A polymorphism of the CHRNA5 gene (rs16969968) with maximal response to nicotinic
      agonists justifies examination of this SNP as a moderator of IV nicotine sensitivity in
      humans (Bierut et al. 2008). This SNP will be examined in an exploratory fashion since it is
      not feasible to fully stratify the study sample for multiple SNPs. The frequency of
      rs16969968 SNP ranges from 35%-42% among those of European ancestry, making it feasible to
      examine this variation in our subject sample.

      Currently this study is active and enrollment is continuing. Currently there are 205
      completers and on going.(June 2014)
    

Intervention name(s): saline; Nicotine
Intervention type(s): Drug; Drug
Intervention description(s): intravenous saline; Intravenous nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: smoking, nicotine, cigarettes
The Effect of Canal Dryness on the Quality of Obturation
Condition: Obturation
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate root canal obturation quality. The questions
      to answer are

        -  what is the best protocol for canal dryness before obturation ?

        -  Is compaction necessary ? Volunteer participants will perform root canal treatment in
           teeth planned for extraction due to orthodontic reasons
    


Intervention name(s): Root canal obturation
Intervention type(s): Procedure
Intervention description(s): Root canal dryness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Dydrogesterone in the Treatment of Endometrial Polyps
Condition: Endometrial Polyp
MeSH terms: Uterine Neoplasms; Polyps
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is intended to observe the therapeutic effect of dydrogesterone on endometrial
      polyps and provide a reference for clinical treatment.
    

Detailed description: 
      Endometrial polyps are a common female endometrial lesion.The long-term unrestrained exposure
      of estrogen to local tissue is one of the causes of polyp formation.Studies suggested that
      the progesterone can accelerate the regression rate of endometrial polyps due to its
      antiestrogenic effects.Based on this, investigators intended to observe the therapeutic
      effect of dydrogesterone on endometrial polyps and provide a reference for clinical
      treatment.
    

Intervention name(s): Dydrogesterone
Intervention type(s): Drug
Intervention description(s): The investigators give participants oral dydrogesterone(as described in arm description).After 3 cycles of treatment, the investigators evaluate the treatment effects.
Other intervention name(s): Duphaston
Intervention MeSH terms: Dydrogesterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet in Healthy Volunteers
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of Aripiprazole
      Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male
      volunteers
    

Detailed description: 
      The proposed study is a single centre, bioavailability, open-label, randomized, single-dose,
      3-period, 6-sequence, crossover study under fasting conditions. Each volunteer will be given
      a single dose of the Test formulation in two study periods (with and without water), and a
      single dose of the Reference formulation (with water) in the other study period.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Healthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days
Other intervention name(s): Abilify® 10 mg tablet
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aripiprazole; Oral Soluble Film; Schizophrenia
Impact Study of Community Based Treatment of Neonatal Infection by Health Extension Workers on Neonatal Mortality
Condition: Neonatal Infections
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether community based management of infections
      with antibiotics administered by health extension workers reduce all cause mortality in
      neonates after the first day of life compared to current MOH IMNCI model of referral to
      hospital
    

Detailed description: 
      Although 44% of neonatal deaths in Ethiopia are due to infection, access to treatment for
      neonatal infections is very low for most families. Even though the newly adapted Integrated
      Management of Newborn and Childhood Illness (IMNCI) package includes assessment of newborns,
      if a baby has any danger signs that may be suggestive of infection and is taken to health
      posts, the baby is to be referred to hospital for treatment. Given that only about 5% of
      neonatal deaths occur in hospitals and the distance to hospital is often far and the costs
      prohibitive, very few babies are likely to receive essential lifesaving antibiotics. Evidence
      from India, Bangladesh, and Nepal demonstrates that community health workers can effectively
      manage neonatal infections at home. However it is not known whether and community-based
      management of neonatal infections is effective, feasible and acceptable in the Ethiopian
      context. Local evidence regarding lives saved and cost is required in order to inform health
      policy and programming regarding community-based treatment of neonatal infections.
    

Intervention name(s): Community Based
Intervention type(s): Other
Intervention description(s): In Arm 2 health extension workers will make a diagnosis of Neonatal infection and treat with antibiotics
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Ethiopia; Community; Community based; Health extension Worker; Health Extension Program
Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The objective is to demonstrate if there is no increase in the risk of Sars-Cov-2 salivary
      carriage 7 days after a concert in the group participating in the event compared to a non
      participating group who stayed at home.

      The hypothesis is that a systematic screening of Sars-Cov-2 within the 3 days before the
      event allows to control the risk of transmission and prevent cluster of transmission during
      the concert.
    

Detailed description: 
      Before inclusion, the participants will be able to pre-register to the event via a website.
      They will get an appointment for an inclusion visit at the Accor Arena (Paris Bercy, France).

      During 3 days (from D-3 to D-1), participants with a registration will come to the Accor
      Arena to have a rapid Sars-Cov-2 antigen test (results in 15 min).

      If the test is positive, the participant will be contacted and managed by the medical team in
      charge of the national strategy for positives cases.

      People with a negative test will be included and randomized :

        -  Two kits with tube for collecting saliva samples (for D0 and D7) will be given to each
           participant at this visit

        -  People randomized in the experimental group will receive their concert ticket at a later
           date.

        -  At Day 0, people randomized in the experimental group, will come to the Accor Arena with
           their ticket to participate in the concert. At the entrance, they should give their D0
           saliva sampling kit. The people randomized in the control group will stay at home and
           will send their D0 saliva sample by post mail.

        -  At Day 7 (±1 day) all the participants must return their D7 saliva sampling kit via post
           mail
    

Intervention name(s): Concert; Rapid nasopharyngeal antigen test for Sars-Cov-2; Saliva Sample
Intervention type(s): Other; Diagnostic Test; Diagnostic Test
Intervention description(s): People attending a concert in a closed area, with a mask; A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility; Saliva samples sent by participant at Day0 and Day7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sars-Cov-2; Covid-19; Screening; Concert; Closed area; Standing configuration
Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients
Condition: Cataract; Dry Eye
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The investigational device is an approved biometry device to perform biometric measurements
      preoperatively to calculate the needed IOL power.

      First, two native measurements at the IOL Master will be performed. Thereafter randomly
      assigned artificial tears are instilled in the eye and biometry will be repeated within 30
      seconds, as well as after 2 and 5 minutes.

      At least 24hours after those measurements, two native measurements at the IOL Master will be
      performed. Thereafter, the not yet used artificial tears are instilled in the eye and
      biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.

      Examinations will be implemented in accordance with the approved investigational plan on
      subjects and includes: repeated biometry without and with artificial tear drops.
    


Intervention name(s): High viscous artificial tears; Low viscous artificial tears
Intervention type(s): Device; Device
Intervention description(s): Instillation of one drop high viscous artificial tears; Instillation of one drop low viscous artificial tears
Intervention MeSH terms: Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Biometry will be performed in individuals with age related cataract. Patients will be classified as dry eye or normal eye. Two different artificial tears will be instilled at two time points in a randomized order with a time-lag of at least 24 hours.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to
      lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly.
    


Intervention name(s): etifoxine; lorazepam; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lorazepam; Etifoxine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Phase1 Syudy to Evaluate the Safety and PK/PD of Human Antithrombin III
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1
      study in healthy male subjects was designed
    


Intervention name(s): SK Antithrombin III
Intervention type(s): Biological
Intervention MeSH terms: Antithrombins; Antithrombin III
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Male subjects
Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT
Condition: Pregnancy; Substance Use; Depression; Anxiety
MeSH terms: Substance-Related Disorders; Depression
Study type: Interventional

Summary: 
      Specific Aim 1: Conduct a pilot, small-scale randomized controlled trial to examine
      feasibility and preliminary efficacy of LTW, compared to TAU. Outcomes related to feasibility
      include percentage of eligible patients recruited, study attrition, study retention, and
      mental health and substance use treatment appointment attendance. Outcomes related to
      preliminary efficacy will include participation in screening, referral and treatment as well
      as reduction in mental health and substance use at 1 and 3 months post-study enrollment,
      compared to TAU.

      Specific Aim 2: Conduct a randomized controlled trial to examine the effectiveness of LTW,
      compared to TAU. Outcomes related to effectiveness include attendance to treatment as well as
      reduction in mental health and substance use at 1 and 3 months post-study enrollment,
      compared to TAU.
    

Detailed description: 
      Participants: 450 adult, pregnant or postpartum women

      Intervention: Listening to Women is a mobile phone-based program designed to enhance delivery
      of Screening, Brief Intervention, and Referral to Treatment (SBIRT), an evidence-based
      approach for mental health and substance use screening and treatment for perinatal women.
      This program was created as a result of key informant interviews with obstetric providers and
      pregnant and postpartum women with opioid use disorders. The program utilizes mobile phone
      text message-based screenings with immediate automated feedback, paired with remote care
      coordination and, if appropriate, home-based telemedicine mental health and substance use
      disorder treatment services.

      Design: Specific aim 1: A two arm pilot RCT (N=100) with 2:1 allocation will examine
      feasibility and preliminary efficacy of LTW, compared to TAU. Specific aim 2: A RCT (N=350)
      with 2:1 allocation will examine effectiveness of LTW, compared to TAU. As of the approval of
      amendment #12 the allocation will switch to 1(LTW):2(TAU) for specific aim 2.

      This study is part of the HEAL Initiative (https://heal.nih.gov/).
    

Intervention name(s): Listening to Women
Intervention type(s): Behavioral
Intervention description(s): Participants are enrolled in text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, home-based telemedicine mental health and substance use disorder treatment services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Pregnancy; Depression; Substance Use; Anxiety
TENS in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement
Condition: Total Knee Arthoplasty; Knee Pain
Study type: Interventional

Summary: 
      Total knee arthroplasty (TKA) is among the major advancements for the treatment of knee pain
      and improvement of physical function when conservative management fails to comply with. The
      success of this arthoplasty results in more functional mobility and better quality of life.
      However, management of pain after TKA in post-operative period is a big challenge to deal.
    

Detailed description: 
      Transcutaneous electrical nerve stimulation is a cost effective, non-invasive
      electrotherapeutic modality used in alleviating pain in both acute and chronic conditions
      affecting neuromusculoskeletal system of the body.
    

Intervention name(s): Routine Physical Therapy and Intra-venous analgesic regimen; Transcutaneous Electrical Nerve Stimulation along with Routine Physical Therapy and Intra-venous analgesic regimen
Intervention type(s): Other; Other
Intervention description(s): ROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects; High frequency stimulations via Transcutaneous Electrical Nerve Simulator will be applied. ROM Exercises will be performed and analgesics including the NSAIDs and narcotics as per prescription of surgeon/physician will be given to all subjects
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Arthoplasty; Knee Pain; Post-operative; Transcutaneous electrical nerve stimulation; Intra-venous; Analgesics requirement; Recovery
A Two-Part, Single-Dose Study of the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (MK-8931-009 [P08535])
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics of MK-8931, a ß-secretase inhibitor, in
      participants with renal insufficiency. In Part 1 of the study, pharmacokinetics of MK-8931 in
      participants with severe renal disease and in healthy matched control participants will be
      studied. If data from Part 1 confirms that severe renal impairment does not alter the
      pharmacokinetics of MK-8931 to the extent requiring dosage adjustment, then no further study
      will be required and Part 2 will be optional. If the data does not support this conclusion,
      then Part 2 will be conducted to study the pharmacokinetics of MK-8931 in participants with
      moderate and mild renal impairment compared to healthy matched controls.
    


Intervention name(s): MK-8931
Intervention type(s): Drug
Intervention description(s): Single dose, administered as oral capsules
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Refractive Error and Biometry in Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Refractive Errors; Retinopathy of Prematurity; Premature Birth
Study type: Observational

Summary: 
      The investigators compared long-term refractive and biometric outcomes in children with
      retinopathy of prematurity who received two different anti-vascular endothelial growth factor
      agents.
    

Detailed description: 
      Purpose:

      To compare refractive and biometric outcomes in patients with type 1 retinopathy of
      prematurity (ROP) treated with intravitreal injection of Ranibizumab (IVR), versus
      bevacizumab (IVB), at a corrected age of 3 years.

      Methods:

      A retrospective case series compared cycloplegic refractive statuses and biometric statuses
      in patients who received either IVR or IVB for Type 1 ROP, from April 2011 to April 2014.

      Comparison of refractive errors and biometric findings between the two groups was performmed
      and multivariate analysis of possible factors contributive to visual acuity was also
      performmed
    

Intervention name(s): Bevacizumab; Ranibizumab
Intervention type(s): Drug; Drug
Intervention description(s): intravitreal injection of bevacizumab; intravitreal injection of ranibizumab
Other intervention name(s): avastin; lucentis
Intervention MeSH terms: Bevacizumab; Ranibizumab
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        infants who received intravitreal injection of ranibizumab or bevacizumab as the primary
        treatment
      
Keywords: Bevacizumab; Biometry; Ranibizumab; Refractive error; Retinopathy of prematurity
"CuraMed" and "Curamin" in Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This randomized, placebo-controlled study evaluates the effects of CuraMed ® (BCM-95 ®) and
      Curamin ® in the treatment of osteoarthritis. One group will receive CuraMed, one group will
      receive Curamin and one group will receive placebo.
    


Intervention name(s): Placebo; Curamin; CuraMed
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Dupilumab Skin Barrier Function Study in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      - Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed
      after skin tape stripping (STS) in pre-defined lesional skin in participants with moderate to
      severe atopic dermatitis (AD) treated with dupilumab.

      Secondary Objectives:

        -  Evaluate changes in skin barrier function with TEWL assessed after STS in pre-defined
           lesional and non-lesional skin in participants with moderate to severe AD treated with
           dupilumab in reference to normal skin of healthy volunteers.

        -  Evaluate time course of skin barrier function with TEWL assessed before and after STS in
           pre-defined lesional and non-lesional skin in participants with moderate to severe AD
           treated with dupilumab in reference to normal skin of healthy volunteers.
    

Detailed description: 
      The duration for each participant was a total of approximately 24 weeks.
    

Intervention name(s): Dupilumab SAR231893
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other intervention name(s): REGN668
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment