bioihbjkbjnl/mcl2 huggingface dataset:
The Effect Of Lavender Essential Oil On Birth Pain
Condition: Labor Pain; Aromatherapy
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The study was planned as a randomized controlled trial to determine the effect of lavender
      oil applied to primiparous women by inhalation and massage methods on labor pain.
    

Detailed description: 
      In universe of the research; Pregnant women who applied to Adana Seyhan State Hospital's
      Marsa Gynecology and Obstetrics Additional Service Building and Obstetrics Service and
      Delivery Room between the dates of the study, accepted to participate in the study
      voluntarily and who met the research conditions included. Numbers 1-2 of a 6-sided dice
      determined by the dice rolling system formed the control group (40 pregnant), numbers 3-4
      were lavender oil inhalation group (44 pregnant), and numbers 5-6 were lavender oil massage
      group (37 pregnant).

      The research was carried out in three stages for the experimental groups and control groups.
      First stage; Informed Voluntary Consent Form and Questionnaire were applied to the pregnant
      women whose groups were determined by the chosen randomization method. Afterwards, for the
      experimental groups according to the group; 10-minute training sessions were given on the
      inhalation method or massage method with aromatic lavender essential oil. In the second
      stage; Data were recorded by dividing the first phase of labor into 3 phases for each group.
      Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied to the
      experimental groups 6 times, before and 30 minutes after the application. At this stage, no
      application was made in the control group, the Visual Analog Pain Scales and McGill Melzack
      Pain Questionnaire were applied at the beginning of each phase, the same forms were repeated
      after 30 minutes and the data were recorded 6 times in total. In the third stage; In the
      postpartum period, the study was completed by applying the Postpartum Period Information
      Collection Form by face-to-face interviews with the experimental groups and the pregnant
      women in the control group.
    

Intervention name(s): Aromatherapy application /massage with lavender oil; Aromatherapy application / inhalation with lavender oil
Intervention type(s): Other; Other
Intervention description(s): The application was applied to 37 pregnant women in total, and the effect of massage with lavender oil on labor pain was investigated.; The application was applied to 41 pregnant women in total, and the effect of inhalation with lavender oil on labor pain was investigated.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The research was planned to define the superiority of inhalation and massage methods applied with lavender oil compared to the control group and each other.
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Labor Pain; Aromatherapy,; Lavender Essential Oil; Aromatherapy with lavender essential oil
Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease
Condition: Sjogren's Disease
MeSH terms: Sjogren's Syndrome
Study type: Interventional

Summary: 
      This aim of this study is to compare the reproducibility of reading of five international
      experts concerning the anomalies of the salivary glands.

      The reproducibility is measure on patients and not on recorded data.
    


Intervention name(s): Ultrasound
Intervention type(s): Procedure
Intervention description(s): Ultrasound examinations are done 5 times
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: reproductibility
Long Term Safety Study of Plecanatide
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Multi-center, open-label, long-term safety study
    

Detailed description: 
      This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg
      daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible
      Screen Failures whose eligibility is confirmed at the end of their participation in the
      double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled.

      Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and
      thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without
      meals.

      Safety and tolerability assessments and patients' self-assessment of disease severity will be
      performed according to the Schedule of Assessments.

      Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit
      within 5 days after stopping study drug.
    

Intervention name(s): Plecanatide
Intervention type(s): Drug
Intervention MeSH terms: Plecanatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise Rehabilitation in Veterans With PAD
Condition: Peripheral Arterial Disease; Intermittent Claudication
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
Study type: Interventional

Summary: 
      Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and
      decreased blood flow to the legs. This may cause difficulty or pain with walking or other
      activities that use leg muscles. Exercise may help improve blood flow in the legs and improve
      the ability to walk. This research project will be conducted patients with PAD that require
      revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation
      or neuromuscular stimulation on leg blood flow, physical function, quality of life and
      general health.
    

Detailed description: 
      Peripheral artery disease (PAD) and its associated declines in physical function impair
      quality of life (QOL) in nearly 20% of older Veterans and result in substantial VA health
      care costs. Revascularization addresses the anatomical pathology, but does not restore
      mobility function and QOL. Optimal therapy may require post-revascularization rehabilitation
      to address lingering defects in skeletal muscle that limit function; however, the current
      standard of care after revascularization does not include rehabilitation. Exercise training
      and neuromuscular electrical stimulation (NMES) may enhance function by increasing muscle
      perfusion to improve outcomes in older Veterans with PAD after revascularization.

      The investigators will enroll Veterans (50-80 years of age) with PAD who are planned for
      percutaneous revascularization. Participants will complete research testing consisting of: a)
      Assessment of mobility function and QOL; and b) Treadmill tests to assess ambulatory
      capacity, and calf muscle perfusion. Participants will undergo screening prior to
      revascularization and will have baseline testing 2-3 weeks after revascularization. After
      post-revascularization testing, patients will be randomized to Exercise-only or NMES-only.
      After completion of the 3-month intervention, participants will repeat all tests to determine
      the effects of the interventions.
    

Intervention name(s): Exercise training; NMES
Intervention type(s): Other; Other
Intervention description(s): The exercise program includes supervised and home-based walking and strength exercise.; This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation; exercise training
Gingival Crevicular IL-34 and CSF-1 Levels in Patients With Periodontitis and Uncontrolled Type 2 Diabetes
Condition: Periodontitis; Diabetes
MeSH terms: Periodontitis
Study type: Observational [Patient Registry]

Summary: 
      Type 2 diabetes mellitus is a metabolic disorder. There is a bidirectional association
      between periodontal disease and DM. Currently there is no data relationship between CSF-1 and
      IL-34, periodontal disease and diabetes.The aim of this study to investigate GCF levels of
      IL-34 and CSF-1 in periodontitis subjects with diabetes.
    

Detailed description: 
      Periodontally healthy (H), periodontitis, and periodontitis with diabetes patients, were
      recruited for this study.

        1. Inclusion criteria for H groups: Individuals with clinically healthy gingiva, no
           attachment and bone loss, and less than 10% bleeding on probing were included.

        2. Inclusion criteria for periodontitis groups: Systemically healthy individuals with
           interdental CAL ≥ 5 mm and PPD ≥ 6 mm were included.

        3. Inclusion criteria for periodontitis with diabetes groups: Type 2 diabetes patients with
           interdental CAL ≥ 5 mm, PPD ≥ 6 mm, and HbA1c ≥ 6.5% were included.

      The plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), PD, and
      clinical AL were used for clinical periodontal assessments. All assessments were done with a
      manual probe. GCF samples were obtained and analyzed using an enzyme-linked immunosorbent
      assay.
    

Intervention name(s): Gingival crevicular fluid
Intervention type(s): Diagnostic Test
Intervention description(s): GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        individuals have diabetes and periodontitis
      
Biospecimen description: 
      Gingival crevicular fluid
    
Keywords: Diabetes,; periodontitis; cytokines
Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
Condition: Uterine Hemorrhage
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic
      acid) can control irregular bleeding during the first 3 months of using Mirena. The study
      drugs tested are tested against placebo ("dummy medication not containing any active drug").
      Treatment period is followed by a one-month period when study drugs are not taken but Mirena
      use is continued.
    


Intervention name(s): Tranexamic acid; Mefenamic acid; Placebo; Mirena (Levonorgestrel IUS, BAY86-5028)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 500 mg 3 times daily per oral during bleeding/spotting episodes; 500 mg 3 times daily per oral during bleeding/spotting episodes; 3 times daily per oral during bleeding/spotting episodes; In vitro release rate 20 microgram/24 hours. Intrauterine system
Intervention MeSH terms: Mefenamic Acid; Tranexamic Acid; Levonorgestrel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uterine Hemorrhage; Contraception; Contraceptive Methods; Intrauterine devices; Mirena
The HOLIDAY (HOw ALcohol InDuces Atrial TachYarrhythmias) Study
Condition: Atrial Fibrillation; Alcohol
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States and it
      has been associated with ethanol use. Understanding how ethanol affects the electrical
      properties of the heart and induces AF has important public health implications. The
      objective of this research is to investigate the mechanistic relationship between ethanol and
      atrial fibrillation in humans by performing a placebo controlled study looking at the
      electrical properties of the heart in patients receiving intravenous ethanol or placebo. The
      investigators hypothesize that ethanol increases the susceptibility of human myocardium to
      atrial fibrillation through electrophysiologic changes in the atrial myocardium in the acute
      setting.
    

Detailed description: 
      The purpose of this study is to look for changes in the electrical properties of heart that
      may be caused by ethanol (commonly referred to as alcohol) and specifically how ethanol may
      trigger episodes of the most common abnormal heart rhythm, atrial fibrillation (AF). This
      study will demonstrate the mechanism of ethanol induced atrial fibrillation and clarify the
      health effects of one of the worlds' most popular drugs (ethanol). With this understanding,
      physicians may be able to better identify those patients most at risk for ethanol induced AF
      and target public health campaigns towards this vulnerable population.

      Patients in this study will undergo an electrophysiologic study both prior to and after
      receiving either an ethanol or placebo infusion. This electrophysiology study will measure AF
      inducibility (the primary outcome), left and right atrial conduction times, and the atrial
      effective refractory period in multiple locations (AERP). The changes in the conduction times
      and AERPs (before and after study drug infusion) will be recorded as secondary outcomes.

      About 100 people will participate in this study. 50 people will be randomized to receive
      intravenous ethanol, and 50 people will be randomized to receive an intravenous placebo. The
      placebo will be in the form of 0.45% saline solution ("half normal saline") and the alcohol
      will be in the form of 6% volume/volume ethanol in 0.45% saline solution.
    

Intervention name(s): Ethanol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6% volume/volume ethanol in 0.45% saline solution.; The placebo with be 0.45% saline solution ("half normal saline").
Other intervention name(s): Alcohol; Saline
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Atrial Fibrillation; Alcohol; Electrophysiologic properties of the atria; Randomized Clinical Study
A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia
Condition: Community-Acquired Bacterial Pneumonia; Lung Infection of Individual Not Recently Hospitalized
MeSH terms: Pneumonia; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 3

Summary: 
      This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline
      Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With
      Community-Acquired Bacterial Pneumonia in Asia.
    


Intervention name(s): Ceftaroline; Ceftriaxone
Intervention type(s): Drug; Drug
Intervention description(s): Two consecutive infusions q12h for 5 to 7 days; One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.
Intervention MeSH terms: Ceftriaxone; Ceftaroline fosamil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Community-Acquired Bacterial Pneumonia
The Effect of Breastfeeding Education Via Hybrid Simulation Method in the Antenatal Period on Postpartum Breastfeeding
Condition: Breastfeeding
Study type: Interventional

Summary: 
      This study aimed to determine the effect of breastfeeding education given to pregnant women
      by a hybrid simulation method in the antenatal period on postpartum breastfeeding. This study
      will be carried out in a family health center in Turkey. Breastfeeding education will be
      given to pregnant women using a hybrid simulation method consisting of a wearable breast
      model and the standard patient in the intervention group. Women in the control group will
      receive only routine breastfeeding education.
    

Detailed description: 
      The research will be conducted as a randomized controlled trial. The stratified block
      randomization methods will be used to assign women to the intervention and control groups.
      The personal information form and Breastfeeding Self-Efficacy Scale Short Form (Antenatal)
      will be implemented to all women before the intervention. Breastfeeding education will be
      given to pregnant women using a hybrid simulation method consisting of a wearable breast
      model and the standard patient to support women in breastfeeding and to ensure the continuity
      of breastfeeding in the postpartum period. Breastfeeding education will be given to women in
      the 32-36 weeks of pregnancy in the antenatal period. The control group will be received the
      routine antenatal breastfeeding education given to all women by healthcare personnel as part
      of the family health center procedures. The Breastfeeding Self-Efficacy Scale Short Form
      (Postnatal) and the LATCH Breastfeeding Assessment Tool will be administered to women in both
      the experimental and control groups within the postpartum fifth days and at sixth week
      postpartum.
    

Intervention name(s): Breastfeeding education using hybrid simulation method; Routine verbal breastfeeding education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to the verbal breastfeeding training given to the pregnant women assigned to the experimental group, breastfeeding training will be given using the hybrid simulation method consisting of a wearable breast model and standard patient practice.; Women in this group will receive oral breastfeeding training, which is routinely given in the pregnant education class and consists of one session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
R3® Acetabular System in Patients With Degenerative Hip Disease
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      This is a prospective, non-randomized, consecutive series, multicenter clinical study that
      will include patients who will have total hip replacement with the R3 Acetabular System.
    

Detailed description: 
      The study design was selected to assess the safety and effectiveness profile of the R3
      Acetabular System in patients with degenerative joint disease requiring primary total hip
      replacement. A non¬-randomized, consecutive series of up to 158 patients will be enrolled,
      and a maximum of 8 sites will participate in the study. Each site is allowed to enroll up to
      22 patients. When 158 patients are enrolled from all sites, enrollment will be stopped,
      regardless of the number contributed from each site. The clinical data from this study will
      be compared with a historical control. The study will include follow up through 5 years.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This clinical study can fulfill its objectives only if appropriate subjects are enrolled.
        All relevant medical and non-medical conditions should be taken into consideration when
        deciding whether a particular patient is suitable.
Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the clinical study is to determine the safety, reactogenicity and immunogenicity
      parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years.

      The research tasks are to:

        -  evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;

        -  evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice
           intramuscularly;

        -  identify the development of adverse reactions to vaccine administration;

        -  study the humoral and cellular immune responses following two doses of the EpiVacCorona
           vaccine.
    

Detailed description: 
      The first phase of the clinical trial is an open trial. The study will enroll 14 men and
      women aged 18 to 30 years, inclusive, who meet the inclusion criteria and have no exclusion
      criteria, whose data will be used for subsequent analysis of safety and immunogenicity.

      The second phase of the clinical trial is a simple, blind, placebo-controlled, randomized,
      parallel-group study. The study will enroll 86 men and women aged 18 to 60 years, inclusive,
      who meet the inclusion criteria and have no exclusion criteria whose, the data will be used
      for subsequent analysis of safety and immunogenicity.

      If volunteers drop out of the study, they will not be replaced.
    

Intervention name(s): EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19); Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)
Intervention type(s): Biological; Other
Intervention description(s): EpiVacCorona vaccine is intended to prevent COVID-19. The vaccine relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins, conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide). The EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations spaced 21-28 days apart.; The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (43 volunteers)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Simple, blind, placebo-controlled, randomized study involving healthy volunteers
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Covid19; SARS-CoV-2; EpiVacCorona; vaccination