bioihbjkbjnl/mcl2 huggingface dataset:
Determining Relationships Among Maternity Stress & Sleep
Condition: Postpartum Depression; Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Observational

Summary: 
      Psychosocial factors, including a previous history of depression, recent stressful life
      events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy
      have been shown to be associated with an increased risk for the development of postpartum
      depression (PPD). Biological mechanisms underlying the relationships among these psychosocial
      risk factors for PPD, and the development of PPD, remain unclear. However, evidence from
      non-perinatal populations suggest that dysregulation in stress-reactive neuroendocrine
      factors may play a role. The primary objectives of this study are: (1) to assess the
      feasibility of enrolling second trimester pregnant women, with or without depression
      histories, into a laboratory-based study protocol which includes a mild psychosocial stressor
      and the collection of venous blood for the measurement of stress-reactive adrenocorticotropic
      hormone (ACTH) and cortisol; (2) to assess the feasibility of retaining participants, for a
      brief postpartum phone interview, after completion of the second trimester assessments; and
      (3) to establish proof of concept for measuring group differences, between women with or
      without depression histories, in second trimester prenatal measures of neuroendocrine stress
      reactivity, depressive and anxious symptoms, recent stressful life events, and sleep quality.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample of pregnant women
      
Biospecimen description: 
      Serum, Plasma, Adrenocorticotropic hormone (ACTH), Cortisol
    
Keywords: depression; postpartum depression; pregnancy; perinatal depression; sleep; life stress
To Evaluate Safety, Tolerability and Pharmacokinetics of GRC 27864 in Healthy Subjects and Elderly Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.
    


Intervention name(s): GRC 27864; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety and pharmacokinetics of drug in healthy volunteers
Efficacy and Steroid Sparing Potential Study of DGLA Cream in Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the steroid sparing potential of DS107E to vehicle in patients
      with moderate to severe atopic dermatitis.

      DS107E or vehicle will be topically administered with a steroid twice a day for the first 7
      days. For the following 28 days DS107E or vehicle will be topically administered twice a day.

      This study will enrol approximately 40 adult patients.
    

Detailed description: 
      Subjects will come to the clinic on 7 occasions: Screening, Baseline, Day 7, Day 14, Day 21,
      Day 35 (End of Treatment) and Day 42 (Follow-up). The primary efficacy variable will be EASI
      (Eczema Area and Severity Index). The secondary efficacy variables will be EASI, IGA
      (Investigators Global Assessment), SCORAD (SCORing Atopic Dermatitis), Target Lesion Score,
      VAS (Visual Analogue Scale), Skin Tolerability, DLQI (Dermatology Life Quality Index),
      Erythema, TEWL (Transepidermal Water Loss) and Time to Rescue Medication.
    

Intervention name(s): DS107E; Vehicle
Intervention type(s): Drug; Drug
Other intervention name(s): Mometasone Furoate; Mometasone Furoate
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Bupivacaine Versus Lidocaine on Inflammatory Regulation
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is testing a local anesthetic (numbing medicine) to suppress pain. Bupivacaine and
      lidocaine are FDA approved local anesthetics that may decrease pain following surgery.
      Patients will receive either 2% lidocaine, 0.5% bupivacaine, or placebo with epinephrine
      1:200,000 as a numbing medicine at the end of root canal surgery. Small pieces of gum will be
      taken before and after surgery and 2 days later to analyze chemicals that may be related to
      pain sensation.
    

Detailed description: 
      We hypothesize that the use of the LLA bupivacaine will promote local inflammation leading to
      increased pain and central sensitization as evaluated by increase in pain at later time
      points. Hence our main hypothesis to be evaluated and statistically tested for our primary
      endpoint (Aim 1) is:

      HO: There is no difference in mean levels of biochemical mediators of inflammation between
      groups.

      HA: The bupivacaine group has higher levels of biochemical mediators following surgery.
    

Intervention name(s): Lidocaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Up to 5 capsules of 2% lidocaine with epinephrine as a reinforcement drug post-operatively; Up to 5 capsules of 0.5% Bupivacaine with epinephrine given post-operatively.
Other intervention name(s): Xylocaine; Marcain, Marcaine, Sensorcaine and Vivacaine.
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Bupivacaine; Inflammation; Pain; Local Anesthetic; peripheral sensitization
Continuous Regional Analgesia After Total Knee Arthroplasty
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 3

Summary: 
      This prospective, comparative and double blind study is aimed to determine if normal saline
      or dextrose 5% in water will modify the stimulation during the insertion of the stimulating
      catheter used for continuous femoral and sciatic blocks in total knee replacement.
    

Detailed description: 
      The operator is blinded to the medium fluid to expand the perineural femoral and sciatic
      nerves before threading in the stimulating catheter. He records all the electric data of
      electrolocation of nerve, which will be compared to determine whether or not a difference in
      intensity is found between normal saline or dextrose 5% in water.
    

Intervention name(s): Glucose 5%; NaCl 0.9%
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Normal saline; Dextrose 5% in water; neurostimulation; Continuous regional analgesia after total knee arthroplasty
Treatment Intensity - Apraxia of Speech
Condition: Aphasia; CVA; Apraxia of Speech
MeSH terms: Aphasia; Apraxias
Study type: Interventional

Summary: 
      A growing neurorehabilitation literature suggests that intense treatment may be desired to
      maximize the effects of therapy following neurologic injury. This investigation is designed
      to facilitate the development of efficacious, clinically applicable treatment for acquired
      apraxia of speech by examining the effects of intensity of treatment (e.g., 9 hours per week
      vs. 3 hours per week, while holding total number of sessions constant) with a group of
      speakers who have chronic apraxia of speech and aphasia.
    

Detailed description: 
      This research was designed to examine the effects of treatment intensity on outcomes
      associated with an established treatment for acquired apraxia of speech (AOS). Intensity in
      the form of dose frequency and total intervention duration was evaluated with Sound
      Production Treatment (SPT). The investigators examined the effects of intense dose frequency
      (nine, one-hour sessions per week) and traditional dose frequency (three, one hour sessions
      per week). Total number of treatment sessions was held constant allowing for comparison of
      total intervention duration (27 sessions over 3 weeks versus 27 sessions over 9 weeks). A
      two-phase, group cross-over design was used. Thirty-six participants with chronic aphasia and
      AOS were recruited. Twenty-four participants completed then entire study and were
      quasi-randomly assigned to one of two treatment groups - intense first or traditional first
      (12 per group). One group received SPT applied with intense dose frequency (SPT-I) followed
      by SPT applied with traditional dose frequency (SPT-T). The other group received the
      treatments in the reverse order (SPT-T followed by SPT-I). A two week no treatment interval
      separated the treatment phases. The outcomes of interest addressed changes in trained and
      untrained speech behaviors.
    

Intervention name(s): Sound Production Treatment (SPT)
Intervention type(s): Behavioral
Intervention description(s): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: apraxia; aphasia; rehabilitation; efficacy; intensity
The Safety of a Hypolipidemic Agent in Healthy Normal Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the blood profile of the N-methylnicotinamide
      (MNA) following administration of TRIA-662 (N-methylnicotinamide Chloride). The secondary
      objectives of the study are to characterize the safety and tolerability of TRIA-662 and to
      assess any potential gender-related differences in the plasma profile of MNA. Changes in
      serum lipid parameters with particular reference to triglycerides, lipoprotein lipase, and
      blood pressure effects will also be noted.
    

Detailed description: 
      A total of 20 subjects volunteers (10 male and 10 female) will receive the following
      treatments administered in a randomized fashion with 2 embedded placebo dosages in each group
      (8 active Males and 8 active females with 2 placebo males and females):

        1. DRUG (Low Dose): Single therapeutic dose of MNA administered as a 90 mg oral dose

        2. DRUG (High Dose): Single therapeutic dose of MNA administered as a 270 mg oral dose

        3. PLACEBO: Placebo for MNA administered as an identically appearing oral dose Each
           treatment period will consist of a 3-day two-night confinement cycle with admission on
           day 1, treatment on day 1 with a single dose of active or placebo with discharge 24
           hours following the last assessment the next morning. A washout period of 5 days will
           separate each treatment period. Standard biochemical and clinical baseline medical
           background and physical examination will occur at screening and at Day -1 to
           assess/confirm entry criteria. During each treatment period, serial plasma samples
           (n=12) for MNA assay will be collected on the treatment day. Safety assessments,
           including vitals signs (blood pressure, pulse rate, respiration rate, and oral body
           temperature), will be performed at screening, at baseline, and at 4 times throughout
           each treatment period. Physical examinations and standard clinical laboratory tests
           (hematology, serum chemistry, and urinalysis) will be obtained at screening, and at
           admission for each treatment period, and prior to subject's final discharge from the
           study. The Lunch meals on the dosing day will be identical in each subject on each
           occasion.

      The pharmacokinetic and safety assessments will be performed at specified times prior to and
      after study MNA administration.
    

Intervention name(s): TRIA-662; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1-MNA Chloride; Double-blind placebo
Other intervention name(s): 1-MNA Chloride; Dummy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
In Vivo Predictive Dissolution 1
Condition: Healthy
Study type: Observational

Summary: 
      This study will: 1. validate MRI motility method with concomitant perfused manometry method
      in healthy adult participants. 2. measure exploratory endpoints of interest including GI
      fluid volumes in 21 adult healthy volunteers studied twice.
    

Detailed description: 
      The gastrointestinal (GI) environment where drug products dissolve has not been studied in
      detail due to limitations, especially invasiveness of existing techniques. Hence little in
      vivo data on GI fluids and motility is available to improve relevance of predictive
      dissolution models and bench dissolution techniques. Recent advances in magnetic resonance
      imaging (MRI) methods could provide novel data and insights. On-going studies at the
      University of Michigan and at the University of Nottingham, using advanced, validated,
      quantitative MRI techniques have already shown that GI fluid (water) volumes can be measured.
      The classical method for measuring GI motility is via a manometric method involving
      intubation, but it is possible to measure GI motility with MRI. Based on our MRI motility
      pilot data and on the literature available, this study aims to test the main hypotheses that
      in healthy adult participants the new MRI method has the potential to replace current
      manometric study protocols and will allow a simultaneous measurement of gastrointestinal
      motility and fluid volumes in the gut during the fasted state. This will establish a solid
      and unprecedented base of in vivo results upon which to base advances in oral pharmaceutical
      product science. For this initial study, the study objectives are therefore: 1. To validate
      the MRI motility method with concomitant perfused manometry method in healthy adult
      participants. 2. To measure exploratory endpoints of interest including GI fluid volumes.
      Twenty one adult healthy volunteers will participate in this replicated study. We will pass a
      thin perfused manometry tube via the nose into the gut of the participants and then take MRI
      images of abdominal areas while bowel motility is being measured via a tube manometric method
      to see how they compare. We will be able also to measure the volume of fluids in the gut.
    

Intervention name(s): MRI and concomitant perfused manometry of bowel motility
Intervention type(s): Diagnostic Test
Intervention description(s): We will carry out serial cine MRI of the bowel. At the same time we will record perfused manometry readings of the bowel in healthy adult participants.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Self-reporting, healthy adult participants, with no restrictions on gender, ethnicity or
        race, recruited by advertisement by poster and flyer
      
Keywords: MRI; motility; perfused manometry; stomach; bowel; water
Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy
Condition: Pleural Diseases
MeSH terms: Pleural Diseases
Study type: Interventional

Summary: 
      This study aims to compare the diagnostic efficiency and reliability of Abrams' needle
      pleural biopsy under computerized tomography guidance with that of cutting-needle pleural
      biopsy under ultrasonography guidance in patients with pleural effusion.
    

Detailed description: 
      Background. In cases with pleural effusion, tissue samples can be obtained through Abrams'
      needle pleural biopsy, thoracoscopy, or cutting-needle pleural biopsy under the guidance of
      computerized tomography or ultrasonography for histopathological analysis. This study aims to
      compare the diagnostic efficiency and reliability of Abrams' needle pleural biopsy under
      computerized tomography guidance with that of cutting-needle pleural biopsy under
      ultrasonography guidance in patients with pleural effusion.

      Methods. Patients with exudative pleural effusion, who could not be diagnosed by cytological
      analysis, will be included in the study. All patients were randomized following the thoracic
      computerized tomography with contrast enhancement. Patients either underwent Abrams' needle
      pleural biopsy under computerized tomography guidance or the cutting-needle pleural biopsy
      under ultrasonography. The two groups will be compared in terms of diagnostic efficiency and
      in terms of complications associated with the methods used.
    

Intervention name(s): CT-Guided pleural needle biopsy with Abrams' needle; Ultrasonography guided cutting pleural needle biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.; Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pleura; biopsy; diagnosis; CT; ultrasonography
Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine
Condition: Cervical Cancer; HPV Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections; Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500
      unique patients globally in Duke and non-Duke protocols to date. The objective is to provide
      colposcopy capability to rural communities in Peru potentially using Telehealth.
      Approximately 10,000 women will receive self HPV test kit for community health workers. Of
      these participants, approximately 1,000 HPV+ participants will be invited to participate in
      this pocket colposcopy study. Approximately 500 of these participants may require treatment
      using thermocoagulation.
    

Detailed description: 
      The goal is to demonstrate that the combination of self-sampling, the Pocket colposcope and
      the thermocoagulator will yield a high proportion of HPV positive women who complete
      treatment and follow-up care. The bulk of this trial will occur over a two-year period in
      Peru. Duke will provide the Pocket colposcope and the Calla application to run the device
      only. Dr. Garcia will recruit and train community women for the distribution of
      self-collection HPV test kits, identify and partner with 10 to 12 health centers in the
      Andean region of Peru, conduct baseline data collection in each health center, procure
      necessary equipment and technology, and conduct training for HPV testing, Pocket colposcopy,
      and thermocoagulation. Within 18 months trained community women will distribute 10,000 HPV
      tests to women within the region. The investigators anticipate that 10% of the women screened
      will be HPV positive and they will be recruited for our trial. As part of the study the
      participants will be followed to determine if the participants attend a health center,
      receive Pocket colposcopy, and if needed whether the participants are treated with the
      thermocoagulator device. All women will be appointed to return to the health center for a
      follow-up evaluation six months post-treatment.
    

Intervention name(s): Colposcopy using pocket colpscope and thermocoagulator
Intervention type(s): Device
Intervention description(s): If HPV+, visualization with pocket colposcope and treatment with thermocoagulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical cancer screening; Pap smear; colposcopy
Antenatal Educational Intervention for Improvement of Breastfeeding
Condition: Breastfeeding
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized controlled trial addresses the impact of simple antenatal breastfeeding
      educational interventions on breastfeeding rates and practice in a tertiary hospital setting.

      Hypothesis: A single antenatal encounter, which includes breastfeeding educational material
      and individual instruction with a lactation counselor, can improve the initiation, duration
      and exclusivity of breastfeeding compared to routine antenatal care or the use of educational
      material alone
    

Detailed description: 
      Breastfeeding rates in many developed countries, particularly in terms of exclusive and
      predominant breastfeeding, often fall short of the recommended practice advised by the World
      Health Organization and the American Academy of Pediatrics. Despite increasing awareness of
      the many advantages of breastfeeding the challenge remains to implement programs that can
      effectively improve short and long-term breastfeeding rates.

      The Singapore National Breastfeeding Survey 2001 (Foo et al, 2005) demonstrated an
      encouraging breastfeeding initiation rate of 94.5%. However only 21.1% continued to
      breastfeed at 6 months with fewer than 5% breastfeeding exclusively.

      The formal preparation of expectant mothers for breastfeeding is not part of routine
      antenatal care in many practices. We feel that it may prove beneficial especially in an
      environment with a low prevalence of breastfeeding. The aim of this trial is to demonstrate
      the impact of single-encounter antenatal education combining educational material with
      individual instruction, on breastfeeding initiation and duration and on infant feeding
      practice, compared with routine antenatal care and educational material alone in a tertiary
      hospital setting.

      401 women are randomized into 3 predetermined groups and are exposed to specific antenatal
      education materials targeting breastfeeding techniques; the control group receives routine
      antenatal care. Data regarding breastfeeding rate, quality and duration is collected over a 1
      year period.

      Comparisons: breastfeeding initiation rate, duration and type among women receiving lactation
      counseling with educational material, educational material without individual counseling, and
      routine antenatal care without educational intervention
    

Intervention name(s): individual lactation counseling and educational material; educational material alone; routine antenatal care without educational intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Educational/Counseling/Training
Keywords: Breastfeeding; exclusive; education; counseling