bioihbjkbjnl/mcl2 huggingface dataset:
Normotensive and Hypertensive Placental Abruptions
Condition: Abruptio Placentae; Affecting Fetus or Newborn
MeSH terms: Abruptio Placentae
Study type: Observational

Summary: 
      Placental abruption is a significant cause of both maternal morbidity and neonatal morbidity
      and mortality. Most abruptions accept to be related to a chronic placental disease process.
      Therefore, it is very important to understand these processes. To analyze maternal and
      neonatal effects of placental abruption(PA) through a novel classification in the presence of
      hypertension. Initial hemoglobin parameters were also compared to predict pregnancy outcomes
      in addition to hypertension.
    

Detailed description: 
      Objective: We aimed to classify placental abruption according to hypertension status.

      Methods: This retrospective cohort designed study was conducted on 115 pregnant women with
      placental abruption. The main parameters scanned and recorded from the hospital database and
      patient medical files. Two groups were classified regarding of presence or absence of
      hypertension (53 hypertensive, 62 normotensive). Maternal demographical and clinical
      characteristics (abdominal pain, vaginal bleeding) were recorded. APGAR scores below 5 at 1
      and 5 min., fetal or neonatal death, admission and length of stay in Neonatal Intensive Care
      Unit(NICU) were also investigated and compared between the groups.
    

Intervention name(s): clinical assesment
Intervention type(s): Other
Intervention description(s): Comparison of Hypertensive group and normotensive group
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Two groups were formed according to presence or absence of hypertension (53 hypertensive,
        62 normotensive) who has placental abruption.
      
Keywords: Abruptio placenta; complete blood count; hypertension; perinatal outcome.; mean platelet volume
An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Lung Disease; Pulmonary Fibrosis
MeSH terms: Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study GIPF-004 is an open-label, multicenter study that will enroll approximately 250
      patients who complete Protocol GIPF-001. The purpose of this study is to assess the safety
      and efficacy of continued IFN-gamma 1b therapy in this well-defined cohort of patients for up
      to 48 weeks.
    


Intervention name(s): interferon-gamma 1b
Intervention type(s): Drug
Intervention description(s): 200 mcg, SQ, 3x per week
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: idiopathic pulmonary fibrosis; IPF
BLIS - Breastfeeding Levonorgestrel IUD Study
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth
      on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish
      to breastfeed, and are willing to participate in the study will be randomly assigned to
      either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks
      later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery
      between those who get the IUD placed early or later.
    

Detailed description: 
      Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone
      of U.S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women
      initiate use of this method in the post partum period. The major advantage of immediate
      postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive
      method at a time that does not interfere with the intense demands of newborn care, but any
      contraceptive method initiated in the postpartum period must not interfere with
      breastfeeding.

      Our long-term goal is to understand the impact of hormonal contraceptives, initiated early in
      the postpartum period, on breastfeeding. The central hypothesis is that quality of
      breastfeeding is not negatively affected by progestin-only hormonal contraceptives.

      We will pursue three specific aims comparing women randomized to immediate post-placental vs.
      delayed (4-6 week) postpartum LNG IUD insertion:

      Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To
      determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding continuation,
      exclusivity, and satisfaction as well as continuation and satisfaction with the LNG IUD at 26
      weeks postpartum in both groups

      This proposal will support a non-inferiority RCT where participants will be randomly assigned
      to immediate postplacental insertion (within 10 minutes of placental delivery) or delayed
      postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on
      breastfeeding impact of early postpartum initiation of the LNG IUD.
    

Intervention name(s): Levonorgestrel IUD
Intervention type(s): Drug
Intervention description(s): Timing of IUD insertion
Other intervention name(s): Mirena
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Contraception; Birth Control; Levonorgestrel IUD; Mirena IUD
Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis
Condition: Scoliosis Idiopathic
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The investigators collected retrospective data of severe (>80o) and rigid scoliosis patients
      who underwent preoperative traction before correction surgery from 2016 to 2018. The first
      group consisted of patients who underwent Cotrel traction exercises and second group
      underwent continuous-progressively increasing Skull Tongs Femoral Traction (STFT) traction.
      Posterior fusion was performed in all patients. Intraoperative parameters (blood loss,
      operation time and level instrumented) and radiologic change (initial, post-traction and
      postoperative Cobb Angle) was evaluated and analyzed
    


Intervention name(s): Preoperative traction
Intervention type(s): Procedure
Intervention description(s): Compare two methods of preoperative traction (Cotrel traction exercises and skull tongs femoral traction)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        severe (>80o) and rigid scoliosis patients who underwent preoperative traction before
        correction surgery from 2016 to 2018
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
Condition: Central Nervous System Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test the efficacy and tolerability of a multiagent
      chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma
      in the brain.
    

Detailed description: 
      The objective of the study is

        1. To investigate the efficacy and safety of a high-dose methotrexate-based induction
           polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by
           temozolomide maintenance treatment in newly diagnosed primary central nervous system
           lymphoma

        2. To assess the long term outcome concerning neurotoxicity
    

Intervention name(s): Immunochemotherapy
Intervention type(s): Drug
Intervention description(s): Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCNSL; Immunochemotherapy; Intraspinal Depocyt; Maintenance temozolomide
Biomarkers of Bone Resorption in Metastatic Prostate Cancer
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms; Bone Resorption
Study type: Observational

Summary: 
      Biomarkers of bone resorption will be measured in the blood of patients with bone metastases
      from prostate cancer during the course of their illness. Changes in these biomarkers will be
      correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the
      response and/or progression of their cancer. It is hoped that serial measurement of these
      biomarkers may allow therapeutic monitoring in the future with successful individualisation
      of bisphosphonate therapy for metastatic prostate cancer.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        men with hormone sensitive prostate cancer with bone metastases
Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
Condition: Bioelectrical Impedance Measurement of Healthy Adults
Study type: Observational

Summary: 
      Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM
      based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and
      measurement data of the BIA devices on the other hand. The equations are necessary to use the
      device as a Body Composition Analyzer with an acceptable accuracy level for clinical
      practice.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Data of 130 healthy adults are planned to be collected.
      
Biospecimen description: 
      whole blood
Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial
Condition: Electromyoneurography
Study type: Interventional

Summary: 
      Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the
      optimal stimulation site would reduce the stimulation intensities delivered to the patient
      and thus improve the tolerance of this examination.
    


Intervention name(s): Electroneuromyography with ultrasound; Electroneuromyography without ultrasound
Intervention type(s): Other; Other
Intervention description(s): Patients whose electroneuromyography examination will be performed using an ultrasound; Patients whose electroneuromyography examination will be performed without ultrasound (fake tracking)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).
Condition: Perennial Allergic Rhinitis; PAR
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group,
      efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and
      premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
    

Detailed description: 
      This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group,
      efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and
      premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. This study will
      consist of the following periods/visits: Screening , Single-blind Placebo Run-in period,
      Double-blind Treatment period , Follow-up. The total duration of subject participation will
      be approximately 5 months.
    

Intervention name(s): Ciclesonide nasal aerosol 37 mcg; ciclesonide nasal aerosol 74 mcg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37; ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg; Placebo - one dose per nostril
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Delayed Loading Following Repair of a Ruptured Achilles Tendon
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The purpose of the study is to investigate if delayed loading following surgical treated
      Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after
      one year.

      The investigators hypothesize that delaying the gradual introduction of loading in the
      initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the
      clinical outcome one year after surgery (primary endpoint).
    


Intervention name(s): Rehabilitation (physiotheraphy)
Intervention type(s): Other
Intervention description(s): Time of loading, range of motion exercises, strength training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Achilles Tendon Surgery
A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI)
      in the Greek population.
    

Detailed description: 
      The aim of this analysis is to record clinical practice and to collect real world data on the
      clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population. Main
      objectives include to assess physician's choice of treatment in chemoresistant metastatic
      colorectal cancer with FTD/TPI in third line and beyond In addition, the clinicopathologic
      features related to metastatic colorectal cancer (focus on molecular profile), duration of
      treatment, dose modification and toxicity will be analyzed.
    

Intervention name(s): Trifluridine/Tipiracil
Intervention type(s): Drug
Intervention description(s): Trifluridine/ Tipiracil is an oral combination of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride.
Other intervention name(s): FTD/TPI; TAS 102
Intervention MeSH terms: Trifluridine
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Greek patients with mCRC
A Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 1744 CL in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, and pharmacokinetics of BI 1744 CL
    


Intervention name(s): BI 1744 CL; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olodaterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Muscle Progenitor Cell Therapy for Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety of muscle progenitor cells (MPCs) for the
      treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).
    

Detailed description: 
      Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will
      undergo a biopsy of the muscle from the inner thigh under anesthesia. The muscle sample will
      be cultured and expanded for approximately 6 weeks. The product, composed of autologous, ex
      vivo-expanded muscle progenitor cells (MPCs) in suspension, will be delivered via targeted
      injection into the bladder neck sphincter region using either an endoscopic needle via a
      cystoscope or periurethral injection under ultrasound guidance. All subjects will be followed
      at 1 week, 6 weeks, 3 months, 6 months and 12 months post-injection.
    

Intervention name(s): Autologous Muscle Progenitor Cells
Intervention type(s): Biological
Intervention description(s): Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region
Other intervention name(s): MPCs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: urinary incontinence, muscle progenitor cells, MPCs
High-definition tDCS Treatment for Cantonese-speaking Adults Who Stutter
Condition: Stuttering, Adult; Stammering
MeSH terms: Stuttering
Study type: Interventional

Summary: 
      The proposed study aims to investigate the effect of combined transcranial direct current
      stimulation (tDCS) and behavioural speech training in improving speech fluency in
      Cantonese-speaking adults who stutter (AWS), and to examine its maintenance over a 6-week
      period.
    

Detailed description: 
      The proposed study aims to

        1. assess the effect of multiple sessions of tDCS over the supplementary motor area (SMA)
           combined with behavioural speech training on stuttering recovery in terms of a reduction
           of stuttering severity and increased speech satisfaction in Cantonese-speaking AWS;

        2. investigate the maintenance of combined tDCS-behavioural speech training effects on
           speech fluency and speech satisfaction in Cantonese-speaking AWS over a 6-week period.

      Twenty Cantonese-speaking AWS will be randomly assigned to an experimental group and a
      control group. Both groups will receive behavioral treatment for stuttering, including the
      speech prolongation technique, for five sessions. Concurrent with behavioural training, the
      experimental group will receive anodal tDCS (1 mA for 20 minutes), while the control group
      will receive sham tDCS (1 mA for one minute), over the SMA. Stuttering severity and speech
      satisfaction will be assessed independently before, immediately after, one week and six weeks
      after treatment. It is anticipated that AWS will experience reduction in their stuttering
      severity after stimulation, and the improvement will be maintained for a longer period as
      compared with receiving behavioural treatment alone.
    

Intervention name(s): Active-tDCS; Sham-tDCS
Intervention type(s): Device; Device
Intervention description(s): Active-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (20 minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program.; Sham-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (one minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program. Participants will receive initial stimulation for one minute, eliciting a tingling sensation on the scalp then it will be discontinued.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; Stuttering; Speech therapy; Camperdown Program
Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect
      to the proportion of participants with adverse events (AEs) and 2) to evaluate the
      anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric
      Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group.
      There is no formal hypothesis testing in this study.
    


Intervention name(s): V114; Prevnar 13®
Intervention type(s): Biological; Biological
Intervention description(s): V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration; Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
Other intervention name(s): Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE™; PCV13
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention