bioihbjkbjnl/mcl2 huggingface dataset:
Family Planning in Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      This study explores the lived experiences of family planning for women with inflammatory
      bowel disease (IBD) and their partners during the reproductive stages of pre-conception,
      pregnancy and the postnatal period through qualitative interviews. Insights from existing
      literature alongside findings from interviews and focus groups with patients and healthcare
      providers to develop an intervention to address the issues and support needs as identified by
      study participants.
    

Detailed description: 
      This study will be conducted in 3 phases:

      Phase 1: Literature review (0-9 months). The research literature on pregnancy outcomes and
      factors affecting family planning decisions of women and men diagnosed with IBD will be
      systematically searched and reviewed. The findings will be used to prepare a topic guide to
      be used in the interviews with women and their partners.

      Phase 2: Interview study (10-20 months). A topic guide prepared in Phase 1 will provide a
      structure for in-depth interviews to explore the experience of family planning by women
      diagnosed with inflammatory bowel disease (IBD) and their partners. Detailed face-to-face
      interviews will be voice recorded and transcribed verbatim. Each interview may last
      approximately 45-60 minutes, giving participants sufficient time to share their experience. A
      total of 24-30 women diagnosed with IBD will be interviewed, where possible selecting 8-10
      women at different family planning stages (pre-pregnancy, pregnancy and post-delivery). 3-4
      women's partners for in each group, to explore partner's perspective of the pregnancy or
      pre-conception experience.

      Phase 3: Intervention development with focus group interview (21-24 months). The Phase 2
      findings will be used to prepare a draft of the intervention to address the issues and
      support needs as identified by study participants. A group of patients (3-4) and healthcare
      practitioners (3-4) will be recruited to take part in a joint discussion (focus group
      interview) on intervention acceptability, and the comments will be used to further develop
      the intervention.
    

Intervention name(s): Interview
Intervention type(s): Other
Intervention description(s): Participants will be interviewed on their experience of family planning and inflammatory bowel disease.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women with inflammatory bowel disease (IBD), partners of women with IBD and healthcare
        professionals working with women with IBD will be recruited via patient groups and
        secondary care IBD clinics.
Normal Liver Stiffness by MR Elastography
Condition: Liver Diseases
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR
      elastography to determine normal liver stiffness values.
    

Detailed description: 
      MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring
      of liver disease in the pediatric population. There is, however, little data specific to the
      use of this technique in children with existing data and techniques largely extrapolated from
      adult studies. Existing studies suggest that liver stiffness values may be different between
      children and adults [Etchell, Xanthakos]. As such there is an unmet need for uniquely
      pediatric data in both healthy and diseased cohorts. To address the need for such data, the
      investigators plan a multi-site, prospective study of healthy pediatric (<18 years of age)
      volunteers to determine normal liver stiffness measured by MR elastography across the range
      of MRI equipment.
    

Intervention name(s): MRI; Blood draw
Intervention type(s): Device; Diagnostic Test
Intervention description(s): Will receive a one time research MRI (MR elastography); Will receive a one time blood draw to confirm healthy liver status
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to investigate the efficacy and safety of the humanized
      anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in
      combination therapy with methotrexate (MTX) in patients with an inadequate response to
      treatment with MTX.

      Furthermore, in patients who have been able to achieve control of disease activity via the
      above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is
      restarted after disease recurrence.
    

Detailed description: 
      In this study, we aim to prospectively and randomly evaluate efficacy for changes in clinical
      remission and joint destruction in RA patients in treatment with TCZ monotherapy(SWITCH) and
      in combination therapy with MTX(ADD-ON), and also to investigate the best therapeutic
      approach to achieve discontinuation.
    

Intervention name(s): Tocilizumab plus methotrexate; Tocilizumab
Intervention type(s): Drug; Drug
Intervention description(s): Tocilizumab 8mg/kg 4weeks (i.v.) plus methotrexate up to 52weeks.The dosage of MTX will be fixed at least 24 weeks from the start of the study.; tocilizumab 8mg/kg/4weeks (i.v.) up to 52weeks.
Other intervention name(s): Actemra; Methotrexate; Actemra
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus
      rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal
      suppositories(7 days) is better than using metronidazole vaginal suppositories only in
      preventing the recurrence of bacterial vaginosis (BV).
    

Detailed description: 
      Studies have shown that oral probiotics can significantly promote the recovery of vaginal
      flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This
      project aims to evaluate the efficacy of oral probiotics (Umeta-Miyue, Lactobacillus
      rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days) with metronidazole vaginal
      suppositories(7 days) in the treatment of bacterial vaginosis and to explore the correlation
      between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and
      intestinal feces at the time of baseline phase, the first month after treatment, the third
      month after treatment and the sixth month after treatment.
    

Intervention name(s): "Probiotics" and "Metronidazole"; Metronidazole Vaginal
Intervention type(s): Drug; Drug
Intervention description(s): Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days); Metronidazole Suppositories,qd, 7 days
Other intervention name(s): Umeta-Miyue, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14 and Metronidazole Suppositories; Metronidazole Suppositories
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ablation and Left Atrium Reduction During Mitral Valve Surgery for Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to estimate left atrial volume reduction surgery concomitant
      with the maze procedure and mitral valve repair/replacement in patients with atrial
      fibrillation with an enlarged left atria.
    

Detailed description: 
      The Cox-Maze procedure has been a gold standard for the treatment of atrial fibrillation.
      Success of the modified maze procedure after valvular operation with an enlarged left atria
      and persistent and longstanding persistent atrial fibrillation remains suboptimal. The
      question addressed was: In adults undergoing a maze procedure for atrial fibrillation does
      left atrial size reduction compared to maze surgery alone improve maze surgery success?
    

Intervention name(s): maze procedure; mitral valve surgery; left atrial reduction
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The scheme of lesion pattern: "box" lesion + line to mitral valve + line from "box" to left atrial appendage. The ablation procedure was performed by using a dry bipolar radiofrequency ablation clamp. The left atrial appendage was excluded in all cases.; For mitral regurgitation or stenosis, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, a valve replacement will be performed.; The enlarged left atria are plicated (suture technique) between the left and right pulmonary vein down to the inferior end of left atrial incision on the half-moon shape.
Other intervention name(s): surgical ablation; radiofrequency ablation; mitral valve repair; mitral velve replacement; left atrial volume reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Mitral valve
A Study of Aleglitazar in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of
      aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6
      treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active
      comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po
      daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on
      study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    


Intervention name(s): Actos; Placebo; aleglitazar
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 45mg po daily; po daily; Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Is There a Relationship Between Hyperlipidemia and Periodontitis?
Condition: Hyperlipidemia, Periodontal Disease
MeSH terms: Periodontitis; Periodontal Diseases; Hyperlipidemias; Hyperlipoproteinemias
Study type: Observational

Summary: 
      The aim of present study is to investigate any relationship between hyperlipidemia and
      periodontal disease regarding the periodontal parameters and plasma lipid parameters, along
      with age, gender, brushing habit, body mass index, dietary habit, physical activity, alcohol
      consumption.

      In this cross sectional study, a total of 160 individuals were divided into two groups based
      on their metabolic status: hyperlipidemic group (n=97) and normolipidemic group (n=63).
      Plaque index, gingival index, bleeding on probing (BOP), probing depth (PD), clinical
      attachment level (CAL) clinical parameters and community periodontal index of treatment needs
      (CPITN) scores were measured. Triglyceride (TG), total cholesterol (TC), low density
      lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C) levels had
      been determined previously during individuals routine systemic examinations. Daily brushing
      habits and interdental cleaning together with dietary habits, alcohol consumption and
      physical activity levels were also recorded.
    


Intervention name(s): No intervention was applied
Intervention type(s): Other
Intervention description(s): No intervention was applied
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 240 subjects were examined among patients who attended to the Department of
        Periodontology, Marmara University or the Turkish Heart Foundation and had their plasma
        lipid values determined within the last 3 months. Out of 240, 160 subjects (57 male, 103
        female, age range 35-65 years) eligible for this study were selected.
      
Keywords: HDL cholesterol; Hyperlipidemia; LDL cholesterol; Periodontal disease; Triglyceride
A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      In the present study, it is planned to observe a population of 100 ED patients treated
      previously with udenafil and for whom their physician decided to switch them to sildenafil
      because of poor udenafil tolerance and/or poor efficacy.
    


Intervention name(s): sildenafil
Intervention type(s): Drug
Intervention description(s): tables, 25,50,100 mg, on demand, 1 month
Intervention MeSH terms: Sildenafil Citrate
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        - Patients, aged >18 years and having been switched to sildenafil after a previous
        treatment with udenafil proved ineffective and/or was poorly tolerated. The evaluation of
        udenafil ineffectivness should be performed after attempt intercourse 2 times a week over
        the course of four weeks.
      
Keywords: Erectile Dysfunction udenafil sildenafil treatment satisfaction
Gonadal Function in Young to Middle Aged HIV-infected Men
Condition: Human Immunodeficiency Virus; Hypogonadism, Male; Erectile Dysfunction
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Erectile Dysfunction; Hypogonadism; Eunuchism
Study type: Observational

Summary: 
      HIV infection is associated to premature decline of serum testosterone. However, prevalence
      and biochemical characterization of hypogonadism in HIV-infected men are still to be well
      defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary
      data suggest that it is poorly associated with serum testosterone in this context.
    

Detailed description: 
      The aim of this study is to evaluate the gonadal function of young to middle aged
      HIV-infected men in order to characterize hypogonadism by assessing circulating total
      testosterone with either Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS) or
      chemiluminescent immunoassay. Furthermore, secondary aim is to assess the erectile function
      through the use of validated questionnaires (International Index of Erectile Function (IIEF)
      15 and 5).
    

Intervention name(s): No intervention is provided
Intervention type(s): Other
Intervention description(s): No intervention is provided
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort of Young-to-Middle Aged HIV-infected Patients
      
Biospecimen description: 
      Blood sample for hormonal assay
Renal Replacement Therapy Plus Extracorporeal Carbon Dioxide Removal
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      This study aims to assess whether in patients with acute kidney injury (AKI) requiring
      mechanical ventilation, a strategy that combines renal replacement therapy (RRT) and
      extracorporeal carbon dioxide removal (ECCO2R) allows reduction of tidal volume and plateau
      pressure. Systemic Inflammatory Response and Safety Variables will also be analysed.
    


Intervention name(s): RRT plus ECCO2R
Intervention type(s): Device
Intervention description(s): Patients with acute kidney injury will be treated with Renal replacement therapy associated to extracorporeal carbon dioxide removal in a single treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AKI; Extracorporeal Carbon Dioxide Removal; Renal Replacement Therapy; Mechanical Ventilation
Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of
      two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and
      Caucasian healthy volunteers.
    

Detailed description: 
      The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for
      two different dose regimens of BG00012. The study will evaluate BG00012 administered over a
      24-hour period.

      The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy
      volunteers.
    

Intervention name(s): BG00012 Dose 1; BG00012 Dose 2
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Intravenous Magnesium During Robot Assisted Prostatectomy
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effect of intravenous magnesium on
      blood pressure after Trendelenburg position during robot assisted prostatectomy.

      The secondary purpose of this study is to investigate the effect of intravenous magnesium on
      pain after robot assisted prostatectomy.
    


Intervention name(s): Magnesium Sulfate; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h; the same bolus and infusion volumes of normal saline
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of a Middle School Comprehensive Sexual Health Media Literacy Education Program
Condition: Safe Sex
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized controlled trial of a media literacy
      education program for middle school students with the goal of enhancing decision-making
      skills to prevent early and risky sexual behavior and teen pregnancy, and encourage healthy
      relationships.
    


Intervention name(s): Media Aware-Sexual Health
Intervention type(s): Behavioral
Intervention description(s): 10-lesson middle school, comprehensive sexual health media literacy education program. Each lesson take approximately 50 minutes to teach and will be taught every school day for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of the study are to assess the safety and tolerability of a single dose of
      SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of
      Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2
      (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute
      lymphoblastic leukemia (ALL) in Japanese participants.
    


Intervention name(s): SHP674
Intervention type(s): Biological
Intervention description(s): SHP674: powder for solution for injection, IV (administered by 1 to 2 hours of drip infusion), dose determination : if BSA ≥0.6 m^2: 2500 IU/m^2 every 14 days if BSA <0.6 m^2: 82.5 IU/kg every 14 days
Other intervention name(s): Pegaspargase
Intervention MeSH terms: Pegaspargase
Intervention model: Single Group Assignment
Intervention model description: The intervention study model is sequential in results section of record.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukemia
The Spine Kinematics and Center of Pressure Excursion During Functional Task Vertebral Compression Fractures Subjects
Condition: Posture; Vertebral Compression Fracture
MeSH terms: Fractures, Bone; Fractures, Compression
Study type: Observational

Summary: 
      This study aimed to assess the sensory and kinematic components of the limits of stability
      (LOS) test in patients with vertebral compression fracture (VCF) .
    

Detailed description: 
      This study enrolled adults with VCF (VCF group), older adult without spinal deformity (NE
      group), and young adults (NY group). The Biodex balance system was employed to calculate the
      balance score and the LOS of participants. An inertia motion system was used to record
      kinematic data. The center of pressure (COP) signals of postural stability and LOS were used
      to calculate the frequency power spectrum for interpreting the sensory component.
    

Intervention name(s): no drug intervention
Intervention type(s): Other
Intervention description(s): no drug or treatment intervention
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study enrolled 13 adults with VCF, 13 older adult without spinal deformity, and 13
        young adults.