bioihbjkbjnl/mcl2 huggingface dataset:
CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI)
Condition: Large Reperfused ST-Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effects of POL6326 (CXCR4 antagonist) as a
      stem cell mobilizing agent, on cardiac function and infarct size and on safety and
      tolerability, in patients with reperfused ST-Elevation Myocardial Infarction (STEMI).
    

Detailed description: 
      After acute myocardial infarction and successful stent implantation patients will undergo a
      baseline MRI (magnetic resonance imaging) for eligibility for the study. Patients will
      receive POL6326 or placebo in the first week after STEMI. The primary and secondary endpoints
      will also be determined in a follow-up visit after 12 months. An interim analysis will be
      performed after 50% of the patients have completed the 4 months MRI assessment and may result
      in an adjustment of study size. A number of pre-specified subgroups will be investigated.
    

Intervention name(s): POL6326; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: STEMI; AMI; repair
TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage
      (PPH) following a cesarean section (CS).
    

Detailed description: 
      Regarding the prevention of PPH, recent randomized controlled trials (RCTs) of unclear
      quality have suggested that TXA may reduce blood loss and maternal morbidity, while a
      Cochrane Collaboration review has concluded, that "TXA (in addition to uterotonic
      medications) decreases postpartum blood loss and prevents PPH and blood transfusions
      following vaginal birth and CS in women at low risk of PPH based on studies of mixed quality.
      Further investigations are needed on efficacy and safety of this regimen for preventing PPH.

      Treatment, that is a 10-mL blinded vial of the study drug (either 1g TXA or placebo according
      to the randomization sequence), will be administered intravenously to the participant women
      during the third stage of labor of cesarean delivery.

      The follow-up visit will take place in the postpartum ward of the maternity unit, on D2
      postpartum. This stage will include a venous blood sample to measure plasma concentrations of
      Hb and Ht, urea and creatinemia, prothrombin time (PT), active prothrombin time (aPTT),
      aspartate and alanine transaminase, total bilirubin and fibrinogen, and the completion of a
      self-questionnaire about satisfaction by the women, as well as the assessment of the adverse
      events.

      At 8 weeks postpartum, a self-questionnaire assessing psychological status and well-being
      will be sent to the women. At 12 weeks postpartum, all participants will be contacted by
      phone to assess the incidence of thrombotic and any other significant events.
    

Intervention name(s): Tranexamic Acid Injectable Solution; Sodium Chloride 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): After the routine and prophylactic administration of a uterotonic , the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the woman within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped.; After a routine and prophylactic administration of a uterotonic , the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the patient within 3 minutes afterbirth), slowly (over 30-60 seconds), once the cord has been clamped.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Randomized; double blind placebo controlled trial; prevention; tranexamic acid; postpartum hemorrhage; cesarean
Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Study type: Observational

Summary: 
      The purpose of this research study is to determine the diurnal and nocturnal effects of
      Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.
    

Detailed description: 
      The investigators hypothesize that Travatan Z will significantly lower intraocular pressure
      and increase ocular perfusion pressure during both the diurnal and nocturnal period, during a
      24-hour evaluation, compared to baseline. The investigators further hypothesize that the
      medication effects will persist at 72 hours after discontinuation of the drug.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with open angle glaucoma or ocular hypertension
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose
      combination (FDC) tablet containing linagliptin and metformin extended release compared to
      the free combination of linagliptin and metformin extended release.
    


Intervention name(s): Linagliptin; Metformin; Linagliptin/Metformin FDC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Linagliptin; Metformin; Linagliptin/Metformin FDC
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients
Condition: Nonmelanoma Skin Cancers
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      The study will draw patients from the Transplant Dermatology specialty clinic, where the
      investigators see organ transplant recipients (OTR) for regular screening and serve as a
      regional referral center for this population. Enrollment will be limited to 20 patients.
      Inclusion criteria are organ transplant recipients status, active immunosuppression for at
      least 5 years, and history of at least one NMSC.
    

Detailed description: 
      Patients will receive Levulan Kerastick (aminolevulinic acid) to the face and/or scalp (if
      both are needed, treated separately on back to back days); incubation: 2.5 hours and blue
      light photodynamic therapy utilizing the DUSA BLU-U device; illumination: 1000 seconds (16
      min, 40 secs); administered quarterly for 3 years. Patients who change systemic
      immunosuppression regimens or add or increase systemic chemoprevention while in the study
      will be excluded from the overall analysis. The patients will be evaluated by the principal
      investigator every 3 months, prior to photodynamic therapy (PDT) administration.

      Primary endpoints include:

        1. development of non melanoma skin cancers (NMSC) lesions and

        2. assessment of actinic damage score.

      The primary endpoint will be development of new skin cancers at 3 years, based on comparison
      to rate at baseline from previous (x) year(s) using absolute slope value for number prior to
      treatment vs. number after treatment. The patients will serve as their own controls and the
      investigators will analyze the delta in development of non melanoma skin cancers and actinic
      damage score pre- and post- treatment.

      Additionally, an actinic damage score will be assigned based on the number of actinic
      keratosis on initial evaluation. At each 3 month follow up visit, the actinic damage score
      will be reassessed. The investigators will be able to secondarily analyze the delta in the
      actinic damage score on treatment.
    

Intervention name(s): have Levulan Kerastick (aminolevulinic acid) solution
Intervention type(s): Other
Intervention description(s): Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered
Intervention MeSH terms: Aminolevulinic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age
Condition: Invasive Group B Streptococcus (GBS) Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity
      of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect
      humans from infection.
    


Intervention name(s): GBS glycoconjugate vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Study subjects will receive either GBS conjugate vaccine or placebo. Total study size is 65. Study subjects will be followed for a total of 12 months after their last vaccination.; Subjects will receive one dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: GBS
Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide
      (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.
    

Detailed description: 
      Pegteograstim is a novel monoPEGylated recombinant human G-CSF. In this prospective study,
      the incidence of febrile neutropenia during four cycles of dose dense (DD)
      doxorubicin/cyclophosphamide (AC) with pegtoegrastim support is being investigated.

      The primary objective of this study is to determine the incidence of febrile neutropenia
      during four cycles of DD AC with pegteograstim support (8 weeks).

      Patients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide
      administered intravenously on day 1 every two weeks).

      A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each
      chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).

      Clinical, hematological, and biochemical assessments were done before the start of each
      cycle.

      Adverse events (AEs) were graded using the National Cancer Institute Common Toxicity Criteria
      (NCI-CTCAE version 4.03).
    

Intervention name(s): Pegfilgrastim; Doxorubicin/Cyclophosphamide(AC) treatment
Intervention type(s): Drug; Drug
Intervention description(s): A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).; doxorubicin 60mg/m2 IV every 2 weeks cyclophosphamide 600mg/m2 IV every 2 weeks
Four cycles of dose dense AC treatment will be given every 2 weeks.
Intervention MeSH terms: Cyclophosphamide; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; dose-dense chemotherapy; pegfilgrastim
Unveiling Preclinical Idiopathic Macular Hole Formation
Condition: Idiopathic Macular Hole
MeSH terms: Retinal Perforations
Study type: Observational

Summary: 
      A macular hole is a rupture in the macula. In terms of pathogenesis, as much as 80% are
      idiopathic (Idiopathic Macular Hole, IMH). The normal incidence of this condition is about
      0.17%; however, there is a 10-29% chance of development of a macular hole in the fellow eye
      of patients suffering from unilateral macular hole.

      Our hypothesis is that embedded in the topography of the retina is information that can allow
      for discrimination between healthy eyes and eyes with an increased risk of developing IMH. As
      such, our work aims to develop a system that allows the automatic identification of these
      eyes.
    

Detailed description: 
      A macular hole is a rupture in the macula, the central portion of the retina, responsible for
      sharp, central vision and hence indispensable for most tasks. In terms of pathogenesis, even
      though some can be related to trauma, as much as 80% are idiopathic (Idiopathic Macular Hole,
      IMH). It is theorized that antero-posterior and tangential forces are behind this condition;
      however, no conclusions have been reached. While the normal incidence of this condition is
      about 0.17%, there is a 10-29% chance of developing a macular hole in the fellow eye of
      patients suffering from unilateral macular hole.

      Our working hypothesis is that embedded in the topography of the retina is information that
      can allow for discrimination between healthy eyes and eyes with an increased risk of
      developing IMH. As such, our study consists on the characterisation of the retinal topography
      of fellow eyes of patients with unilateral IMH but no other visible retinal pathologies, and
      of eyes from controls subjects in the same approximate age group. From these topographic maps
      we acquire a series of features (parameters), and using machine learning techniques create a
      system that separates eyes into one of the groups - healthy or at risk.
    

Intervention name(s): Optical Coherence Tomography Scan
Intervention type(s): Other
Intervention description(s): As an observational study, the only interventive action taken is the acquisition of a non-invasive volumetric image of the retina via optical coherence tomography (OCT).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with unilateral idiopathic macular hole and no other visible retinal pathologies.
      
Keywords: Idiopathic Macular Hole
The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia
Condition: Breast Pain
MeSH terms: Mastodynia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of toremifene treatment to the MRI
      findings of the breast in women suffering from premenstrual mastalgia.
    

Detailed description: 
      Benign breast pain is a common complaint of women in western countries. As many as 41-69% of
      women reported having mastalgia sufficient to interfere with their daily routines.
      Approximately 8-10% of premenopausal women suffer monthly from moderate to severe breast
      pain.Tamoxifen has previously been found to be effective in reducing premenstrual mastalgia.
      We showed that another triphenylethylene derivative, toremifene, significantly alleviated
      cyclical breast pain as compared to placebo. In this study women suffering from cyclical
      breast pain are randomly allocated to receive toremifene (20mg) or placebo during the luteal
      phase for three consecutive cycles. The patients are then crossed over after a wash-out
      period to placebo or toremifene, respectively. The MRI investigations are made at two
      occasions during the premenstrual period after three cycles of toremifene and after three
      cycles of placebo.
    

Intervention name(s): toremifene; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The medication is given in tablet form, and the participants are instructed to take one tablet daily from cycle day 15 until the next menstruation. The active (toremifene 20 mg) and control (placebo) tablets were identical in appearance.; tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
Other intervention name(s): magnetic resonance imaging; cyclic breast pain
Intervention MeSH terms: Toremifene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: premenstrual syndrome; mastalgia; toremifene; selective estrogen receptor modulators
The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment
Condition: Pressure Ulcer; Pressure Injury; Pressure Sore; Pressure Ulcer, Buttock
MeSH terms: Pressure Ulcer; Ulcer; Crush Injuries
Study type: Interventional

Summary: 
      Pressure Ulcers are a serious and common problem for residents admitted to long-term care
      facilities and community care patients. They represent a major burden to patients, carers and
      the Healthcare system, affecting approximately 1 in 20 community patients. International
      guidelines recommend the use of pressure redistribution support surfaces, systematic patient
      repositioning and preventive skin care to prevent pressure ulcers.

      It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The
      prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety
      Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms
      across a range of settings, including nursing homes, community nursing and hospitals on a
      monthly basis.
    


Intervention name(s): 22 residentsat risk for PU development; 18 residents at least one PU category III-IV in the sacral area
Intervention type(s): Device; Device
Intervention description(s): mattress in bed
The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning.; mattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning.
In the group of participants with a PU category III or IV, the Pressure Ulcer Scale for Healing Tool (PUSH) will be used to assess and measure change in PU status. The score on the PUSH-tool is defined by the surface area of the PU (length x width), the amount of exudate and the type of tissue in the wound bed.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: support surface; Elderly; Nursing home; prevention; treatment
Association Between Obstructive Sleep Apnea and Bruxism
Condition: Bruxism, Sleep; Obstructive Sleep Apnea
MeSH terms: Bruxism; Sleep Bruxism; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The objective of this retrospective observational study will be to investigate the between
      the Obstructive Sleep Apnea Syndrome (OSAS) and Sleep Bruxism (SB), in individuals diagnosed
      through polysomnography (PSG).
    

Detailed description: 
      The SB and OSAS are sleep disorders with great importance for dentistry. The OSAS is
      characterized by partial or total obstruction of the upper airways. SB is defined as a
      repetitive activity of the mandibular musculature characterized by the tightening or grinding
      of the teeth and/or by the retrusion or propulsion of the mandible. This study retrospective
      observational will be evaluation to investigate the association between OSAS and SB. Data
      from PSG and medical records (n=640) will be collected from January 2012 to July 2018 at
      "Instituto do Sono de Pelotas (ISP)".
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Individuals who have undergone polysomnography at the Instituto do Sono de Pelotas (ISP)
        between March 2012 and July 2018, who meet inclusion criteria.
      
Keywords: sleep bruxism; polisomnography