bioihbjkbjnl/mcl2 huggingface dataset:
Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery
Condition: Intrauterine Device
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing
      intrauterine system(IUs) insertion reduces failed insertions, insertion-related
      complications, and pain in Women With no Previous Vaginal Delivery.
    

Detailed description: 
      Long-acting reversible contraception methods are highly effective methods for reduction of
      the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that
      provides reliable, effective and long term contraception for many women. However, the
      insertion procedure can be associated with a troublesome degree of pain that prevent some
      women from choosing its use. Different interventions have been described to decrease pain
      perception during intrauterine device insertion with no agreement on an effective one.
    

Intervention name(s): Dinoprostone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.; one tablet of placebo inserted by the study nurse 6 hours before IUD insertion.
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF
Condition: Acute Liver Failure
MeSH terms: Liver Failure; Liver Failure, Acute; Intracranial Hypertension
Study type: Interventional

Summary: 
      Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation.
      Information would be collected regarding the onset and duration of symptoms, etiology, and
      severity of disease, other baseline clinical features, demographic characteristics, routine
      biochemical and hematological investigations. Patients would also be screened for the
      assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD
      (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found
      to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the
      study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where
      as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate
      of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of
      144-155 mmol/L .Both the groups would receive other supportive measures such as head end
      elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard
      medical treatment.
    


Intervention name(s): Mannitol; 3% hypertonic saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I, First-In-Human Study of TT-00920 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human, randomized, double-blind, placebo-controlled study. The primary
      objectives of the study were to investigate the safety and tolerability and determine the PK
      profiles of single ascending doses (SAD) of TT-00920 administered to healthy subjects. The
      secondary objectives of the study were to assess the effect of food on the PK of TT-00920
      following an oral dose.
    

Detailed description: 
      There will be 4 single-ascending-dose cohorts and 1 cohort for food effect assessment to
      assess the safety, tolerability, and PK profile. A pilot dose of 20 mg will be evaluated in 2
      subjects (all receiving TT-00920) for safety, tolerability, and PK profile before the
      initiation of dose escalation.

      In single-ascending-dose cohorts, 8 subjects per cohort will be enrolled and randomized to
      assess the safety, tolerability, and PK profile. In food effect cohort, there will be 8
      subjects (all receiving TT-00920). Subjects in food effect cohort will receive 2 single dose
      periods (Fasted/ Fed) in an open-label, crossover design.
    

Intervention name(s): TT-00920; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Tablets
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, randomized, single dose, two-sequence, two-periods crossover study,
      separated by 7 days washout interval from the first Study Drug Administration. This study is
      conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release
      (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each
      to healthy adults fed under conditions.

      In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR
      tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to
      receive the treatment that they did not receive in Period 1.

      PARIET is a registered trademark of EISAI Co. Limited.
    


Intervention name(s): IDIAZOLE 20mg DR tabs; PARIET 20 mg DR tabs
Intervention type(s): Drug; Drug
Intervention description(s): IDIAZOLE 20mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.; PARIET 20 mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg rabeprazole sodium.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Fed condition; PARIET 20 mg; IDIAZOLE 20mg; Rabeprazole
Exploratory Study to Determine Tissue Alterations of Advanced Hepatocellular Carcinoma Induced by Electromagnetic Waves of Low Energy Amplitude Modulated to Specific Frequencies During Imaging Study by MRI
Condition: Primary or Metastatic Tumor in the Liver Parenchyma
MeSH terms: Carcinoma, Hepatocellular; Neoplasm Metastasis
Study type: Interventional

Summary: 
      This is an exploratory, national, single-center, open-label study, being conducted at the
      Institute of Education and Research of the Syrian-Lebanese Hospital in collaboration with the
      Radiology Institute, the Heart Institute of the Faculty of Medicine of São Paulo, Hospital
      São Paulo UNIFESP, and the Departments of Physics and Mathematics at the University of São
      Paulo in order to detect the presence of calcium flux change, tumor perfusion and electrical
      properties of tumor tissue when exposed to RF EMF AM by Cancer-frequency specific in patients
      with advanced HCC and correlate these findings with hemodynamic changes assessed by
      non-invasive hemodynamic measurements.

      This study aims to demonstrate the presence of three mechanisms (hypothesis) that could be
      involved in the hemodynamic changes and the specific antitumor effect induced by exposure to
      RF EMF AM cancer-specific frequency. This study is not intended to study a therapeutic or
      diagnostic procedure. For this reason, will not be considered evolutionary clinical data
      during and after the intervention of the study.
    


Intervention name(s): Magnetic Resonance + hemodynamic + infusion of gadolinium
Intervention type(s): Procedure
Other intervention name(s): Magnetic Resonance assessment Hemodynamics + + infusion of manganese chloride
Intervention MeSH terms: Manganese
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease; Pulmonary Emphysema
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the cell therapy with bone marrow
      mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease,
      specifically the pulmonary emphysema.
    

Detailed description: 
      The main feature of the pulmonary emphysema, included in range of the Chronic Obstructive
      Pulmonary Disease (COPD), is the airflow obstruction resulting from the destruction of the
      alveolar walls distal to the terminal bronchiole, without significant pulmonary fibrosis. The
      existing clinical approaches has contributed to the enlargement and amelioration of the
      emphysema patients life quality, although no effective or curative treatment has been
      achieved. The surgical treatment, on the other hand, involves complex procedures and, in the
      specific case of lung transplantation, a lack of donors.

      Considering these aspects, several experimental models have been proposed aiming to increase
      knowledge about the pathophysiological processes and enable new clinical approaches to the
      pulmonary emphysema. The cell therapy, briefly described as the use of cells in disease
      treatment, presents itself as a promising therapeutic approach with great potential
      applicability in degenerative pulmonary diseases. In this way, it is intended in this
      project, the proposition of a protocol to evaluate the safety of cell therapy with pool of
      mononuclear cells from bone marrow in patients with clinical and laboratory diagnosis of
      pulmonary emphysema in advanced stage (stage IV dyspnea).
    

Intervention name(s): Stem cells stimulation; stem cells collection; stem cells infusion
Intervention type(s): Drug; Procedure; Genetic
Intervention description(s): Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.; pullout of 200ml of bone marrow through the puncture of the iliac crest; slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.
Other intervention name(s): Filgrastin - ACHÉ Laboratories.; bone marrow harvest; adult stem cell infusion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; Emphysema; Cell therapy; Bone marrow mononuclear cells; stem cells
Patient Research Cohort: Rapidly Evolving Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Observational

Summary: 
      The primary goal of the research cohort is to facilitate patient access to clinical trials
      testing new therapeutic interventions, or access to second- line treatments.

      Secondary objectives of the research cohort study are to obtain detailed clinical phenotyping
      and immunological analysis of blood samples, aiming to identify and validate biomarkers of
      disease activity and response to treatment and prognostic markers.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients with relapsing-remitting or secondary progressive multiple sclerosis.
      
Biospecimen description: 
      whole blood, serum, white cells
    
Keywords: Multiple Sclerosis
Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation
Condition: Pneumonia; Hematopoietic Stem Cell Transplantation
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      The aim of this study is to determine whether mesenchymal stromal cell (MSC) treatment
      contribute to the good prognosis in patients with transplant-related complication, pneumonia
      post hematopoietic stem cell transplantation (HSCT).
    

Detailed description: 
      Hematopoietic stem cell transplantation (HSCT) is a standard therapy strategy for most
      hematologic disorders and malignancies. Despite the improved survival attributed to advances
      in HSCT including transplantation techniques and supportive care, transplant-related
      pneumonia (severe pneumonia in particular) remains the leading cause of death for most HSCT
      patients and a major challenge for clinicians.

      Mesenchymal stromal cells (MSCs), a form of multipotent cells, have been applied in therapy
      for various intractable disorders. MSC exerts its therapeutic effect through various
      biological functions including immunoregulation, tissue repairing, self-renew and
      differentiating into various cell lines. The American Thoracic Society has also suggested
      MSCs as a cell therapy agent for lung diseases. However, MSC therapy for pneumonia following
      HSCT has not been well investigated.

      By investigating the efficacy of MSC treatment for HSCT-related pneumonia via comparing the
      outcomes in patients with and without MSC treatment, this study will provide a promising
      therapy for HSCT-related pneumonia.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent hematopoietic stem cell transplantation (HSCT) in Guangzhou Women
        and Children's Medical Center and got pneumonia after HSCT.
      
Keywords: Mesenchymal Stromal Cell; Pneumonia; Hematopoietic Stem Cell Transplantation
VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel
Condition: Diabetes Mellitus Type II; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Diabetes Mellitus; Diabetes Mellitus, Type 2; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if, in type 2 diabetic patients undergoing
      treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading
      dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of
      75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at
      24-36 hours of treatment.
    

Detailed description: 
      The VERDI study consists on a randomized, mono-center study comparing the treatment plan of a
      loading dose of prasugrel as opposed to the standard dose in type 2 diabetic patients, who
      suffer acute coronary syndrome, revascularized through an invasive percutaneous strategy with
      a stent. The aim of this study is to determine if, in type 2 diabetic patients undergoing
      treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading
      dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of
      75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at
      24-36 hours of treatment.
    

Intervention name(s): Prasugrel.; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group will receive a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by at least dose of 10 mg prasugrel (1 x 10 mg tablet). Beyond the second day after PCI, these patients will receive double antiaggregation therapy according to their physician´s criteria.; Patients in this group will receive the standard dose of clopidogrel, a daily dose of 75 mg. Beyond the second day post-PCI, these patients will receive double anti aggregation therapy according to their physician's criteria.
Other intervention name(s): Efient, Eli Lilly; Agrelan
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus.; Acute coronary syndrome.; Percutaneous coronary intervention.
Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the influence of tegoprazan or RAPA114 on the Pharmacokinetic
      characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in
      healthy adult volunteers.
    

Detailed description: 
      [Pharmacokinetic Assessments] : Blood concentration of atorvastatin, 2-OH atorvastatin

        -  Primary outcome: AUCτ, Css,max of atorvastatin

        -  Secondary outcome: Tss,max of atorvastatin, AUCτ, Css,max of 2-OH atorvastatin,
           metabolic ratio

      [Sefety Assessments]

      : Safety assessments with adverse event monitoring including subjective/objective symptoms,
      physical examination, vital signs, electrocardiogram, and laboratory test
    

Intervention name(s): Atorvastatin 40 mg; Tegoprazan 50 mg; RAPA114
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Atorvastatin 40 mg; Tegoprazan 50 mg tablet; RAPA114 tablet
Other intervention name(s): Lipitor; K-CAB
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To evaluate if physical exercise intervention leads to an improved asthma control as measured
      by Asthma Control Questionnaire (ACQ-5) in such a magnitude that inhaled corticosteroid can
      be reduces in asthmatics.
    

Detailed description: 
      At least 102 asthmatics will be randomized 2:1 (2 to training group; 1 to control) and
      undergo 6 months of intervention or usual lifestyle.

      Subjects must have confirmed asthma diagnosis, on a stable treatment with inhaled
      corticosteroid, symptomatic and untrained.

      At enrollment and during the study asthma medicine is adjusted based on asthma symptoms
      evaluated by ACQ-5. 6 treatment steps are pre-defined, and if well controlled asthma,
      subjects are down-titrated one step, if uncontrolled, subjects are uptitrated one step.
    

Intervention name(s): High Intensity Interval Training
Intervention type(s): Behavioral
Intervention description(s): Training (HIIT)
Other intervention name(s): Training group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, controlled parallel group, outcome assessor blinded, clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Exercise; Asthma treatment; Inhaled corticosteroid; Rehabilitation
Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.
Condition: Retinal Degeneration; Primary Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Retinal Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several
      degenerative diseases, including retinopathies and glaucoma, however no previous safety study
      involving humans has been conducted. The objective of this study is to evaluate effects of
      autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal
      bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse
      effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence
      tomography, and retinal ganglion cells function.
    


Intervention name(s): Intravitreal transplantation of mesenchymal stem cell; Culture and isolation of autologous bone-marrow mesenchymal stem cells
Intervention type(s): Procedure; Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Control Training for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Depression is frequently characterized by patterns of inflexible, maladaptive, and ruminative
      thinking styles; these patterns themselves are thought to result from a combination of
      decreased attentional control, decreased executive functioning, and increased negative
      affect. Specifically, the dorsolateral prefrontal cortex has been hypothesized to play a
      central role in emotion regulation by recruiting resources necessary for executive control.
      Recent advances have been made in neurobehavioral training strategies as interventions for
      emotional disorders such as depression. Cognitive control training (CCT) uses computer-based
      exercises to recruit and activate prefrontal neural networks via repeated behavioral
      exercises, with the aim of strengthening cognitive and emotional functions. A previous study
      found that severely depressed participants who received CCT exhibited reduced negative affect
      and rumination as well as improved focus and concentration. The present study aimed to extend
      this line of research by employing a more stringent control group and testing the efficacy of
      three sessions of CCT over a two-week period in a community population with depressed mood.
      Forty-eight participants with high BDI-II scores were randomized to CCT or a comparison
      condition (Peripheral Vision Training; PVT). The investigators hypothesized that relative to
      a control condition (PVT), CCT would be associated with less self-reported negative mood and
      emotional reactivity.
    


Intervention name(s): Cognitive Control Training; Peripheral Vision Task
Intervention type(s): Other; Other
Intervention description(s): Three sessions of CCT.; Three sessions of PVT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Depressed mood