bioihbjkbjnl/mcl2 huggingface dataset:
Oral Bacteria on Suture Materials - Clinical Comparison of an Antibacterial-coated and a Non-coated Suture Material
Condition: Bacterial Colonization
Study type: Interventional

Summary: 
      Antibacterial Triclosan-coated suture material (VICRYL PLUS®, Ethicon) and non-coated
      (VICRYL®) was compared for bacterial colonization after third molar extraction. Sutures were
      removed postoperatively and adhered bacteria were investigated.
    


Intervention name(s): Vicryl Plus; Vicryl
Intervention type(s): Device; Device
Primary purpose: Treatment
Keywords: Checking clinical antibacterial effect of Vicryl Plus compared to conventional Vicryl in intraoral surgery; Bacteria
Drug Interaction Study Between AZD3480 and Warfarin
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or
      not, i.e. show the same or altered plasma concentration profiles when co-administered
      compared to administered alone.
    


Intervention name(s): AZD3480; Placebo; Warfarin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AZD3480 capsules qd, 12 days; Placebo capsules qd, 12 days; Warfarin: single dose on day 6
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: AZD3480; Warfarin; Drug interaction
Paris Visual Learning Test: a New French Task for Assess Visual Learning and Memory to Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially memory
      function.

      Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165
      healthy volunteers were studied for its normalization.

      The main objective of the present study is to assess the validity of PVLT by comparing MS
      patients' test results to a database including the test results of 280 healthy control
      subjects, following recommended international standards.
    


Intervention name(s): Paris Visual Learning Test
Intervention type(s): Other
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with multiple sclerosis. The test results will be compared to a database including
        results of healthy control patients.
      
Keywords: Paris Visual Learning Test; visual memory; criterion validity
Reducing Preterm Births in Underserved Pregnant Women
Condition: Preterm Birth; Low Birth Weight <2500 Grams; Verylow Birthweight <1500 Grams
MeSH terms: Premature Birth; Birth Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      Timely screening and management of modifiable conditions can reduce preterm births, yet
      providing effective prenatal risk management systems to meet the unique needs of medically
      underserved populations is complex. If the proposed system proves to be effective in reducing
      preterm births it can improve maternal and child quality of life as well as reduce the
      economic burden of preterm births in the U.S.
    

Detailed description: 
      The primary aim of this proposal is to test the efficacy of a clinic-based, computer-assisted
      intervention system to significantly reduce preterm births in high-risk populations. This
      system will: (1) assess a pregnant woman's unique risks in six modifiable areas associated
      with increased risks of preterm birth including smoking cessation, poor nutrition, domestic
      violence, maternal depression and stress, urinary and reproductive tract infections and
      substance use; (2) provide her with tailored advice and action planning tools on reducing her
      risks; (3) provide her certified nurse midwife or physician with information related to her
      assessed risks and counseling suggestions tailored for her needs, and [(4) promote effective
      referrals to, and successful linkages with community-based support organizations.] Because
      preterm birth rates are much higher for underserved African American women, we are proposing
      to focus the intervention with this population.
    

Intervention name(s): lifestyle support
Intervention type(s): Behavioral
Intervention description(s): computer-based lifestyle improvement support and clinician support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: computer-based behavioral support
Dietary Lipids, Energy Expenditure and Obesity Biomarkers
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the modulation of dietary lipids are
      effective in the treatment of obesity and comorbidities.
    

Detailed description: 
      Obesity is a complex disease of multifactorial etiology and difficult to control. Among
      lifestyle changes proposed to the treatment of this disease and comorbidities, there is the
      modulation of dietary lipid composition. This study aimed to evaluate the effects of the
      modulation of fatty acid (FA) polyunsaturated (PUFA) and monounsaturated (MUFA) in energy
      expenditure (EE), weight loss, body composition, lipid and glycemic profile, free fatty acids
      (FFA), glycerol, adiponectin, leptin, blood pressure (BP), feeding behavior and expression of
      PPARα and PPARγ2 genes in adipose tissue (AT) of obese women. It was conducted a parallel,
      randomized, controlled, single-blind study with dietary intervention (DI) for 60 days, where
      32 women with obesity classes I and II were distributed into three groups: G1 = diet rich in
      n-3 PUFA and n-6 (n = 10); G2 = MUFA-rich diet (n = 11); and G3 = control (n = 11). For G1
      and G2 were prescribed normocaloric diets with similar macronutrient composition, varying
      only the type of lipids offered. In order to achieve the desired intake of unsaturated FA,
      both groups received individual portions of vegetable oils in the form of sachets, which were
      consumed for lunch and dinner (G1 = mix of virgin olive oil [VOO] and soybean oil [SO],
      overall of 35.2g to 52.8g / day; G2 = VOO, overall of 35.2g to 50.6 g / day), besides gelatin
      capsules (G1 = 2 g of fish oil / day; G2 = 1 capsule of 1g of SO / day). G3 was instructed to
      keep their eating habits and consuming placebos (1 sachet of 2g of SO and 1 capsule of 1g of
      SO / day).
    

Intervention name(s): Group 1 - diet rich in n-3 and n-6 PUFA; Group 2 - diet rich in MUFA; Group 3 - Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): In order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days.; In order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days.; Placebo group was instructed to keep their eating habits and consuming placebo for 60 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obesity; lipids; energy expenditure; gene expression
Musculoskeletal Outcomes After Bone Marrow Transplant
Condition: Survivors of Bone Marrow Transplant; Autologous and Allogeneic
Study type: Observational

Summary: 
      The purpose of the study is to evaluate bone mineral density and muscle strength in survivors
      of bone marrow transplant. Association with age, type of transplant, steroids, years since
      transplant, body composition, endocrinopathies, radiation, quality of life and physical
      activity will be explored.
    

Detailed description: 
      Bone marrow transplant survivors are at risk of diminished bone mineral density. Mechanisms
      and risks are not well understood. This study will help identify risks factors for developing
      this complication.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Survivors of bone marrow transplant (autologous and allogeneic) who are at least 1 year
        from transplant.
      
Keywords: Bone Marrow Transplant; Bone Mineral Density; Survivors; Muscle Strength
PHAT Life: Peer Versus Adult-Led HIV Prevention for Juvenile Offenders
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      This application proposes a 2-arm randomized controlled trial comparing the impact of PHAT
      Life on 350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical
      mediators when delivered by Youth Representatives (YR) vs. probation staff (PS). 100
      facilitators will be recruited to deliver the intervention and participate in the research.
    

Detailed description: 
      The main objectives of the proposed study are to compare the effectiveness,
      cost-effectiveness, and sustainability of Youth Representative-led vs. probation staff-led
      PHAT Life in a real-world juvenile probation setting. The Specific Aims of this study are:

        1. To conduct a methodologically-rigorous 2-arm trial comparing the impact of PHAT Life on
           350 13-17 year-old offenders' risky sex, STI, substance use, and theoretical mediators
           when delivered by Youth Representatives (YR) vs. probation staff (PS).

        2. To compare the costs and cost-effectiveness of 100 YR-led vs. PS-led PHAT Life with
           respect to the acquisition of incident STI.

      We hypothesize: (a) Compared to teens in PS-led groups, we expect teens in YR-led groups to
      report less risky sex and substance use at 6-month follow-up, to demonstrate greater
      improvement on theoretical mediators of risk, and to have fewer incident STI infections; (b)
      We expect YR-led PHAT Life to cost less and be more cost-effective than PS-led PHAT Life.
    

Intervention name(s): PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm; PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm
Intervention type(s): Behavioral; Behavioral
Intervention description(s): HIV Prevention Behavioral Health Intervention delivered by Probation Staff; HIV Prevention Behavioral Health Intervention delivered by Youth Representatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention; Juvenile Justice; Sexual Health; Evidence Based Intervention
Oral Fluid Volume Expansion
Condition: Dehydration; Hydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      When subjected to fluid loss or fluid deficiency irrespective of disease or environmental
      factors it is discussed how to rehydrate or how to hydrate prophylactic.

      In medical care it is common to give infusions. However it has increasingly become common to
      hydrate the patient through the mouth even early after bowel surgery. Moreover it is more
      simple to provide energy the natural way.

      Which fluid to give, depends on several factors such as possibility to drink, the volume and
      emptying of the stomach as well as the fluid absorption in the bowel.

      The provided fluid can also influence this process depending on temperature,
      osmolality/tonicity and composition (carbohydrates or salts).

      In this study we wish to study the speed with which the provided fluid is absorbed by the
      bowels and how fast the fluid is distributed to the different body compartments depending on
      it's composition.

      The three fluids will be either tap water, high sodium chloride and a carbohydrate rich
      fluid.
    

Detailed description: 
      The healthy volunteer starts the study by voiding. Then he/she lies down for 30 minutes. A
      blood sample is drawn and thereafter the healthy volunteer ingests one of the three fluids.
      Blood samples are drawn 10 times during the following two hours. Finally the healthy
      volunteer is asked to void and the voided urine is measured. The hemoglobin concentrations
      are used to calculate the blood volume expansion with volume kinetic methods.

      The process is repeated another two times with the two remaining fluids.
    

Intervention name(s): tap water, sodium chloride, carbohydrate rich fluid
Intervention type(s): Other
Intervention description(s): Ingestion of three different fluids at three different occasions separated by at least one week, A, Tap water. B. Sodium Chloride. C. Carbohydrate rich fluid.
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dehydration; Hydration
Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
Condition: Smoking Cessation; Stress; Sleep Disturbance; Nausea
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional
Phase: Phase 4

Summary: 
      This open-label study will evaluate hydroxyzine, a first-generation antihistamine, combined
      with varenicline, to help smokers abstain from smoking during a 12-week trial period by
      diminishing the nausea, stress, anxiety, and sleep disturbances associated with the use of
      varenicline and with nicotine withdrawal.
    


Intervention name(s): Varenicline Pill; Hydroxyzine Pill
Intervention type(s): Drug; Drug
Intervention description(s): FDA approved starter kit of varenicline (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) followed by FDA-approved dose of varenicline (1 mg twice daily) for the remaining 11 weeks; For the first week, participants will receive 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night for the remaining 12 weeks.
Other intervention name(s): Chantix
Intervention MeSH terms: Hydroxyzine; Varenicline
Intervention model: Single Group Assignment
Intervention model description: Open-label, single group study.
Masking: None (Open Label)
Primary purpose: Treatment
YH4808 Postprandial PK/PD Study in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of
      YH4808 after repeated Oral administration and Postprandial state in healthy volunteers
    


Intervention name(s): YH4808; YH4808; YH4808; YH4808
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Group1
adminitration of YH4808 dose1, bid for 2weeks
wash-out period for 3weeks between period1 and period2
adminitration of YH4808 dose2, qd for 2weeks; Group2
adminitration of YH4808 dose2, qd for 2weeks
wash-out period for 3weeks between period1 and period2
adminitration of YH4808 dose1, bid for 2weeks; Group3
adminitration of YH4808 dose2, bid for 2weeks
wash-out period for 3weeks between period1 and period2
adminitration of Nexium tab 40mg, bid for 2weeks; Group 4
adminitration of Nexium tab 40mg, bid for 2weeks
wash-out period for 3weeks between period1 and period2
adminitration of YH4808 dose2, bid for 2weeks
Other intervention name(s): YH4808, Nexium; Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Crossover Study to Assess the Effect of Intravenous Infusion of Piperacillin/Tazobactam on the Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of intravenous (IV) infusions of
      piperacillin/tazobactam on the pharmacokinetics (PK) of JNJ-63549109 after a single oral dose
      of lumicitabine in healthy adult participants.
    


Intervention name(s): Lumicitabine; Piperacillin/Tazobactam
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.; Participants will receive three IV infusions of piperacillin/tazobactam combination product (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours on Day 1.
Other intervention name(s): JNJ-64041575, ALS-008176
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Potential Food Effect And Repeated Dosing of AX-024.HCl In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A: Food effect (a single oral dose of 500 mg AX-024.HCl under fasted and fed states)
      Eight (8) healthy male volunteers will receive a single dose of 500 mg AX-024.HCl in the
      fasted state (10 h overnight fast), and will return 2 weeks later to receive the same dose of
      AX-024.HCl following a meal.

      Part B: Multiple doses (a once daily dose of AX-024.HCl or Placebo for 10 days).

      Part B is a double-blind, dose escalating, placebo controlled, randomised, multiple dose
      study to assess the tolerability, safety and pharmacokinetics in 24 healthy male subjects.
      Subjects will be allocated to one of 2 dosing cohorts. Each cohort will have 12 subjects with
      9 subjects randomised to receive AX-024.HCl and 3 subjects randomised to receive placebo.

      There will be a data review following each dose level. Dose administration in the subsequent
      cohorts will only proceed after satisfactory data review on the blinded safety data and
      plasma PK data in the previous cohort.
    


Intervention name(s): AX-024.HCl; AX-024.HCl
Intervention type(s): Drug; Drug
Intervention description(s): AX-024.HCl will be administered as per the protocol defined frequency and dose level; AX-024.HCl will be administered as per the protocol defined frequency and dose level
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Evaluation of Age-related Skin Changes Using Clinical Probe Measurements and Imaging Modalities in Chinese Subjects
Condition: Age-related Skin Changes
Study type: Observational

Summary: 
      Evaluation of age-related skin changes using clinical probe measurements and imaging
      modalities in Chinese subjects.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Female and male Chinese subjects, between 20 and 79 years old, will be included in the
        study. Subjects will be divided in 6 age-categories: 20-29, 30-39, 40-49, 50-59, 60-69,
        70-79 years (at least 10 subjects per decade and remainder of subjects distributed among
        the groups) in order to evaluate age-related skin changes.
Hydroxyurea and Transfusion
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will prospectively investigate the feasibility, safety, and transfusion
      requirements of adding hydroxyurea to simple chronic transfusions for patients with sickle
      cell anemia already on chronic transfusions.
    

Detailed description: 
      This is a single-arm, prospective study of hydroxyurea added to simple chronic transfusions,
      combination treatment termed hydroxyurea and transfusion (HAT). The primary objective of the
      study is to determine the feasibility of HAT for patients with sickle cell anemia (SCA)
      currently being treated only with simple transfusions for stroke prevention. Secondary
      objectives include: to evaluate the safety of HAT and to determine if HAT decreases
      transfusion requirements in this patient population. Exploratory objectives include: to
      evaluate with HAT changes in pre-transfusion laboratories and biomarkers of cerebrovascular
      disease progression, and to describe changes on brain imaging.
    

Intervention name(s): Hydroxyurea
Intervention type(s): Drug
Intervention description(s): Participants will be started on hydroxyurea 20 ± 2.5 mg/kg/day in addition to continuing simple chronic transfusion every 4 weeks ± 1 week. Hydroxyurea will be dose escalated to achieve a HAT target dose (HAT-TD). Hydroxyurea will be increased by 5 mg/kg/day after 8 weeks of a dose if HAT-TD is not achieved (maximum daily dose 2,000 mg). After HAT-TD has been achieved, minor dose increases may occur if subject grows a significant amount to maintain the same mg/kg dose.
Intervention MeSH terms: Hydroxyurea
Intervention model: Single Group Assignment
Intervention model description: Prospective, single arm, open label study of combination hydroxyurea and simple chronic transfusion.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hydroxyurea; Transfusion
Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations
Condition: Lacerations; Wounds
MeSH terms: Lacerations
Study type: Interventional

Summary: 
      Our research hypothesis in this study is that there is no difference in long-term cosmetic
      outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric
      facial lacerations.
    

Detailed description: 
      The standard method of repair for facial lacerations is to close such wounds with
      non-absorbable sutures. Recently, topical skin adhesives such as n-butyl-2-cyanoacrylate and
      2-octyl cyanoacrylate have been used more frequently as these have been shown to be a faster
      and less painful way to close superficial facial lacerations. However, lacerations that are
      deeper, gaping or occurring along lines of excessive tension, such as the chin, still need
      sutures for repair. Non-absorbable sutures have to be taken out at 4-7 days. This involves
      another physician visit, parental absence from work, and children who need to be taken out of
      school or daycare for a simple suture removal.

      In Part Iof the study, we were able to demonstrate non-inferiority of absorbable sutures to
      nylon sutures. However, we purposely removed all remaining absorbable sutures on the 5-7 day
      follow-up visit. In Part II, we will allow the absorbable sutures to dissolve on their own.
      We will again assess long term cosmetic outcomes, as well parental satisfaction, and short
      and long-term complication rates at 3 months.
    

Intervention name(s): Arm 2: Absorbable sutures; Arm 1: non-absorbable sutures
Intervention type(s): Other; Other
Intervention description(s): use of absorbable catgut sutures in pediatric facial lacerations; Use of non-absorbing sutures
Other intervention name(s): fast-absorbing catgut 5-0 by Johnson and Johnson
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: laceration; wound management; absorbable sutures; cosmetic outcomes