bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Pharmacokinetic Profile
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dose, parallel-arm, Phase 1 study to investigate the
      pharmacokinetic profile of a fixed-dose combination tablet of tesofensine and metoprolol
      (Tesomet) and co-administration of tesofensine plus commercial metoprolol in adult healthy
      subjects
    

Detailed description: 
      This is a randomized, open-label, parallel-arm study in 60 healthy male subjects who meet the
      inclusion and none of the exclusion criteria for the study. Each subject will participate in
      a screening period, a baseline period (the day preceding drug administration), and a
      single-dose treatment period with an on-site observation period of at least 48 hours after
      the dose.
    

Intervention name(s): Tesomet "High dose" in fasted condition; Tesomet "Low dose" in fasted condition; Comperator 1 mg tesofensine, 25 mg commercial IR metoprolol, 75 mg commercial ER metoprolol, fasted condition.; Tesomet "High dose" in fed condition
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.; To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.; To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.; To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.
Other intervention name(s): Tesofensine; Metoprolol; Tesofensine; Metoprolol; Tesofensine; Metoprolol; Tesofensine; Metoprolol
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural
      killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial
      chemoembolization (TACE).
    

Detailed description: 
      This is randomized, multi-center, open-labeled, Phase 2a study in patients with HCC after
      transarterial chemoembolization (TACE). A total of 78 patients will be randomized(1:1) into
      one of the two group, to receive adjuvant therapy using MG4101 (allogeneic Natural killer
      cells, Treatment group) or no adjuvant therapy (Control group).

      Patients who were assigned Treatment group will receive 2 cycles of MG4101 (each cycle is 3
      treatments at a frequency of once per week, between each cycle has 3 weeks of withdrawal
      period). After treatment period, patients will undergo follow up for progression and survival
      every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.

      The Control group's patients will will undergo follow up for progression and survival every
      12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.
    

Intervention name(s): MG4101
Intervention type(s): Biological
Intervention description(s): MG4101 is ex vivo-expanded, allogeneic natural killer cells. MG4101 were manufactured from normal healthy donor who underwent lymphopheresis under good manufacturing practice (GMP) conditions.
Other intervention name(s): allogeneic natural killer cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19
Condition: Depression
MeSH terms: COVID-19; Depression; Depressive Disorder
Study type: Observational

Summary: 
      Medical personnel working in the Intensive Care Unit will be examined by means of tests.
      Their aim is to check how work-related stress in a potentially lethal threat affects the
      occurrence of depression, stress, anxiety and sleep disorders. We also want to check whether
      people working in such extremely difficult conditions show no greater interest in death.
    

Detailed description: 
      Every day medical staff working in very difficult conditions of intensive care. The COVID-19
      virus outbreak has set another difficult task for doctors and nurses who have previously had
      a lot of contact with the death of their patients. The appearance of the COVID-19 virus and,
      above all, the inability to effectively treat the infection causes an additional
      psychological stimulus in medical personnel.

      The aim of the study is to assess the occurrence of psychiatric disorders in medical
      personnel dealing with patients suffering from COVID-19 using various psychological tests.
    

Intervention name(s): test
Intervention type(s): Diagnostic Test
Intervention description(s): Beck's Test
Test STAI
Test PSS
the scale of the fascination with death
COPE
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        University Hospital in Cracow ICU depratment
      
Keywords: Healthcare Workers; COVID-19; Mental Health Outcomes
Effect of Preoperative Anxiety on Fetus in Pregnant Women
Condition: Preoperative Anxiety; Cytokines
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      In the preoperative period, 60-80% of the patients had anxiety symptoms. This rate increases
      even more during pregnancy. There are a number of studies examining the role of anxiety
      symptoms on fetal outcome, but the mechanisms that explain the effects of maternal stress are
      not fully understood.

      The most extensively studied cytokines in neuropsychiatric disorders are TNF-α and IL-6 due
      to their effects on the central nervous system. TNF-α levels have been reported to be
      elevated in anxiety disorders. In our study, the investigators aimed to determine the
      relationship between preoperative anxiety levels and fetal cord blood TNF-α and IL-6 cytokine
      levels in pregnant women.
    

Detailed description: 
      This prospective observational study is planned to involve 30 volunteer patients between
      18-40 years of age who will undergo elective caesarean section surgery. People with known
      psychiatric illness and medication use, illiterate, who do not have mental competence to
      understand survey questions and very urgent patients will not be included in the study.

      Preoperative anxiety levels will be determined by the STAI-Continuity scale at the time of
      admission to the anesthesia outpatient clinic and by the STAI-State scale 1 hour before
      surgery.The scales will be scored as normal, mild, moderate and severe anxiety. Psychiatric
      consultation will be requested for patients with severe anxiety. At the end of the cesarean
      section, the concentration of TNF-α and IL-6 cytokines in the blood remaining from routine
      blood gas taken from the umbilical cord will be determined to obtain information about the
      state of fetal well-being.
    

Intervention name(s): Preoperative anxiety levels
Intervention type(s): Other
Intervention description(s): Serums were separated from blood samples taken from all patients in the study, Using the anti-human TNF-α and IL-6 enzyme-linked immunosorbent assay (ELISA) kits in the Elisa device, the TNF-α and IL-6 cytokines will be measured to determine their concentration.
No routine blood will be drawn during the procedures. Preoperative anxiety levels will be evaluated with STAI-Continuity and STAI-Statefulness scale.
Other intervention name(s): Tumor Necrosis Factor-Alfa and İnterleukin-6 cytokine concentrations in fetal cord blood
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This prospective observational study is planned to involve 30 volunteer patients between
        18-40 years of age who will undergo elective caesarean section by Obstetrics and Gynecology
        Department.
      
Keywords: Preoperative anxiety; Umbilical cord blood; Cytokines
Comparison of Monitors of Fluid Therapy
Condition: Hypovolemia
MeSH terms: Hypovolemia
Study type: Observational

Summary: 
      The investigators want to correlate different methods to guide fluid therapy. The
      investigators know that guidance by esophagus doppler technique has improved outcome and want
      to correlate other already used techniques to esophagus doppler.
    

Detailed description: 
      Fluid therapy before and under surgery can be guided by measurement of the hearts ability to
      eject blood (cardiac output). By doing this it has been shown that the occurrence of
      nausea,vomiting and complications generally can be reduced. The function of the heart has
      been measured with a probe in the esophagus in in earlier studies. We want to correlate these
      results with other techniques by which fluid therapy also is guided in daily practice. These
      are: SVO2, modelflow (finapres)and NIRS.

      These methods are noninvasive except SVO2 measurement which requires a central venous
      catheter (CVK). Therefore we have chosen a population in which CVK is standard in our
      institution. We thereby don´t apply any further risks than daily practice and the project is
      considered as a quality assessment of used standards.
    

Time perspective: Prospective
Keywords: Fluid therapy; Monitoring
Shock Wave Therapy for Lateral Hip Pain, Caused by Tendon Pathology
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The aim of this randomized controlled study is to investigate if focal shock wave is an
      effective treatment, with respect to hip pain and lower limb function, in a population
      affected by greater trochanteric pain syndrome with gluteal tendinopathy.
    


Intervention name(s): focused shock wave therapy; ultrasound therapy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shock waves; Greater trochanteric pain syndrome
Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in IBS-D Patients
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are
      three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion
      between these abnormalities is not known. We hypothesis there is a link between them in IBS
      with diarrhoea.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is a common functional disorder which affect around 10% of the
      general population. Abdominal pain and discomfort are associated with transit disorders
      (diarrhea, constipation, alternating). IBS is defined by Rome III criteria.

      For clinicians, IBS remains difficult to treat while its pathophysiology remains not
      completely understood. Visceral hypersensitivity, low grade inflammation and increased
      intestinal permeability are three abnormalities found in IBS patients. Visceral
      hypersensitivity is present in 60% of the patients, while intestinal permeability is
      increased in a subgroup of IBS with diarrhea. Low grade inflammation could be identify with
      faecal calprotectin dosage. The link between this three abnormalities is not clear.

      The goal of our study is to describe the prevalence of these three abnormalities in
      IBS-Diarrhea population and to look for a correlation between low grade inflammation,
      visceral hypersensitivity, increased intestinal permeability and clinical phenotypes.
    

Intervention name(s): Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability
Intervention type(s): Procedure
Intervention description(s): Eleven colonic biopsies are taken in the left colon during colonoscopy. Intestinal permeability is assessed by western blot, qPCR and immunofluorescence for claudin, occludin and ZO-1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Irritable Bowel syndrome; Intestinal permeability; Visceral hypersensitivity; Low grade inflammation
Add-on Dextromethorphan in Bipolar Disorders
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Dextromethorphan has been reported affording neuroprotection on dopaminergic neurons and
      having protective effect against inflammation-related neuron damage. These anti-inflammatory
      and neuroprotective effects of dextromethorphan would suggest potential clinical benefits of
      dextromethorphan add-on therapy to valproate for bipolar disorder patients. This hypothesis
      was based on the findings that the mood stabilizers have been reported to be neuroprotective
      through the release of neurotrophic factors such as GDNF from astroglia. Thus, the
      combination treatment of mood stabilizers and dextromethorphan might improve the therapeutic
      efficacy for bipolar disorder patients.
    


Intervention name(s): Valproate; Dextromethorphan 60 mg per day; Placebo; Dextromethorphan 30 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): VPA plus dextromethorphan 60 mg per day; VPA plus placebo; VPA & Dextromethorphan 30 mg per day
Intervention MeSH terms: Valproic Acid; Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
Condition: Diabetic Nephropathy; Type 2 Diabetes Mellitus; Proteinuria
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Proteinuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus
      placebo on the progression of diabetic renal disease.
    


Intervention name(s): olmesartan medoxomil; Placebo Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Tablets 10, 20, or 40 mg; Matching placebo tablets
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: angiotensin II type I receptor blockers; diabetic nephropathy; end-stage renal disease; renal failure; type 2 diabetes; olmesartan medoxomil
Resistance to Oral Therapy in Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      In the management of non-small cell lung cancer of the adenocarcinoma type, different
      therapeutic strategies can be proposed. These strategies are defined according to the results
      of a biological analysis of blood and/or tissue samples from the lung tumor. Mutations in the
      tumor DNA are sought. Thus, patients with sensitizing mutations can benefit from a treatment
      with a 3rd generation tyroine kinase inhibitor (TKI) whose efficacy has been widely
      demonstrated. Patients without tumor mutations will not benefit. However, resistance to TKIs
      appears after a certain time, often linked to the appearance of new mutations in the tumor.
      For this reason, blood biologic analyses are regularly performed to search for the emergence
      of resistance mutations and to propose a therapeutic alternative as soon as possible.

      These analyses are performed routinely in the laboratory. In the course of these analyses,
      the investigators have identified conventional mutations but also new mutations not
      previously described in the literature.

      Our objective is to list all the molecular abnormalities revealed during blood biological
      analyses, to determine their frequency and to study whether certain abnormalities can be
      linked to resistance to TKI.
    


Intervention name(s): Description of the molecular alterations detected in blood samples of patients treated by osimertinib
Intervention type(s): Other
Intervention description(s): Description of the molecular alterations detected in blood samples of patients treated by osimertinib. This test is usualyy performed routinely to detect conventional mutations including EGFR T790M. We performed panel of genes screeining based on next generation sequencing. Thius, iIn some cases, new mutations can be detected by this assay.
Intervention MeSH terms: Osimertinib
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with metastatic adenocarcinoma
      
Biospecimen description: 
      cell free DNA extracted from blood
    
Keywords: 3rd Tyrosine kinase inhibitor; Cell free DNA; Mutations
A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution
Condition: Worsening Chronic Heart Failure; Diabetic Nephropathy
MeSH terms: Diabetic Nephropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat people who have worsening of chronic heart
      failure, a long-term condition where the heart does not pump blood as well as it should, as
      well as to treat patients who have diabetic nephropathy, a long-term, progressive decrease in
      the kidneys' ability to work properly in patients with diabetes mellitus.

      In this study researchers wanted to learn more about a new substance called finerenone
      (BAY94-8862). Finerenone is a substance that blocks the activation of a protein in the body
      called mineralocorticoid receptor (MR). An increased activation of MR is involved in the
      development of hypertension, organ damage and worsening of heart failure.

      The researchers studied how finerenone moves into, through and out of the body. The
      researchers also looked at how safe finerenone is and how it affects the body. The main
      purpose of this study was to help researchers develop recommendations for the amount of the
      substance (the dosing) to be given to patients with reduced liver function.
    


Intervention name(s): Finerenone (BAY94-8862)
Intervention type(s): Drug
Intervention description(s): Single oral dose of finerenone given as 5 mg immediate release (IR) tablet.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Child Pugh A; Child Pugh B; Liver impairment
Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: Replication and Dose-response.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Autonomic regulation is disturbed in patients with major depressive disorder (MDD), indicated
      by a higher heart rate (HR) and lower heart rate variability (HRV). Moreover, the heart seems
      to be functionally connected via the vagus nerve (VN) to other brain structures that are
      dysregulated in depression, such as the subgenual anterior cingulate cortex (sgACC), and the
      dorsolateral prefrontal cortex (DLPFC), suggesting dysregulated network function in MDD. In
      line with this network dysregulation hypothesis of MDD, optimal transcranial magnetic
      stimulation (TMS) sites are currently thought to be those that show functional connectivity
      to the sgACC such as the DLPFC and multiple studies have shown that stimulation of the DLPFC,
      sgACC and nervus vagus decreased heart rate, suggestive of parasymphatetic action. It is
      hypothesized that this influence on parasympathetic activity can be used as a functional
      outcome measure reflecting adequate targeting of the DLPFC-sgACC network, similar to the
      motor evoked potential (MEP) as functional key measure for primary motor cortex stimulation.
      Recently, a pilot study was conducted, proposing a new functional neuronavigation method for
      localizing the frontal area representation of DLPFC-sgACC connectivity using HR, called:
      Neuro-Cardiac-Guided TMS (NCG-TMS), which is being replicated in the current study. .
    


Intervention name(s): Transcranial magnetic stimulation (TMS)
Intervention type(s): Device
Intervention description(s): Subjects receive TMS on several cortical brain locations, while recording the heart rate.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Target engagement; TMS; Heart-brain pathway; Depression; Neuromodulation; DLPFC; Heart rate