bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of escalating doses of
      CSL112 after single intravenous infusions in healthy volunteers and to measure the
      pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.
    


Intervention name(s): CSL112 (reconstituted HDL); normal saline (0.9%)
Intervention type(s): Biological; Biological
Intervention description(s): Single escalating intravenous doses of CSL112; Single intravenous dose of normal saline (0.9%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects
Condition: Cardiovascular Diseases; Chronic Disease
MeSH terms: Cardiovascular Diseases; Chronic Disease
Study type: Interventional

Summary: 
      Diet macronutrient relative composition, quality and quantity determines lifestyle disease,
      including cardiovascular disease, development. Our hypothesis is that a high content of
      carbohydrates in the diet contributes to increased insulin level. Moreover, activating
      enzymes promoting inflammatory processes and possibly chronic disease development in the
      body.
    

Detailed description: 
      The most frequent cause of death in both women and men in the western world is cardiovascular
      artery disease (CAD). Well accepted as a lifestyle disease, known risk factors for CAD
      development include changes in blood lipid content and type as well as micro inflammation in
      the arterial wall. Low density lipoprotein (LDL) and triglycerides are increased, high
      density lipoprotein (HDL) is reduced. Furthermore, type II diabetes, metabolic syndrome,
      hypertension, overweight, reduced physical activity and smoking also precede CAD development.
      Common for many of the risk factors is that they are induced by improper diet. Recent
      research has shown that especially total amount, composition and quality of the macro
      nutrients, protein, carbohydrate and fats, is important. In this project we will explore
      changes in blood gene expression in response to a western and a balanced crossover diet
      intervention.
    

Intervention name(s): "Western" versus "balanced" macro nutrient diet composition
Intervention type(s): Behavioral
Intervention description(s): Randomized crossover diet intervention. 6 days on solely one of two isocaloric diets, 8 days washout, and then the other diet for 6 days. Fasting blood sampling before and after each diet intervention period.
Other intervention name(s): western diet; high-carbohydrate, low fat, low protein diet; balanced diet; low-carbohydrate, high fat, high protein diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Nutrigenomics; Gene Expression; Diet, Carbohydrate-Restricted; Life Style; Health Behavior
Proton Boost for Locally Advanced HEAD AND NECK TUMORS
Condition: Epithelial Tumor, Malignant; Neuroendocrine Tumors
MeSH terms: Neoplasms; Neuroendocrine Tumors; Head and Neck Neoplasms; Carcinoma
Study type: Interventional

Summary: 
      The aim of this research project is to test the local response and the acute toxicity (which
      can be observed within 90 days).
    

Detailed description: 
      Local response and acute toxicity are primary endpoints of the trial. At CNAO a proton boost
      is delivered on the PTV1rx (area at high risk of relapse) up to at least 70 Gy [RBE] in 2-3
      Gy [RBE] per fractions for 8-15 total fractions.

      PTV2 rx (area at low or intermediate risk of relapse) will be irradiated with photon IMRT up
      to a total dose of 50-60 Gy [RBE].

      Secondary endpoints of the trial are local control, relapse free survival, overall survival,
      tumor specific survival, intermediate and long term toxicity.
    

Intervention name(s): external beam proton radiation therapy.
Intervention type(s): Radiation
Intervention description(s): Treatment of irradiation with protons beam The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, or at referral Hospitals enrolling head and neck patients for treatment with photon IMRT.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
GOS and Insulin Sensitivity
Condition: Obesity; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern
      high in acetate and that this will lead to beneficial effects on human substrate and energy
      metabolism, we aim to address the following primary objective:

      To investigate the effects of a 12-week supplementation of GOS on peripheral insulin
      sensitivity and body weight control in obese adults with impaired glucose homeostasis.
    


Intervention name(s): Galactooligosaccharide; maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Insulin Sensitivity
Mass Spectrometry in Single Bladder Cancer Cells
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Observational

Summary: 
      The study is a pilot study in the feasibility of a diagnostic technique. There is no current
      data on detection of cisplatin in cancer cells derived from human urine. This study will
      generate preliminary data so that future studies may be done with more definitive end points
      in mind.
    

Detailed description: 
      The aim of this study is to determine the feasibility of using a novel mass spectrometry
      instrument to measure the intracellular concentration of chemotherapeutic drug within an
      active tumor cell. If successful, this technique could be applied to dosage streamlining in
      patients and customization of dosage based on individual tumor characteristics. It also opens
      the door to research on novel chemotherapy agents or agents not typically used in a specific
      malignancy to determine if therapeutic levels can be obtained in tumor cells.

      Personalized chemotherapy is an evolving field with the underlying goal being minimization of
      side effects of treatment while maximizing net patient benefit for therapy. A key difficulty
      in personalized chemotherapy is that the determination of therapeutic benefit comes well
      after the administration of treatment has been completed. For most forms of chemotherapy
      there does not exist a laboratory study that can determine the concentration of therapeutic
      agent within the tumor itself and as such, real time dose adjustments are based only on
      toxicity, not on tumor penetrance.
    

Intervention name(s): mass spectrometry
Intervention type(s): Diagnostic Test
Intervention description(s): mass spectrometry for bladder cancer cells
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with bladder cancer at Stephenson Cancer who are undergoing treatment with
        cisplatin are eligible to participate.
      
Biospecimen description: 
      urine sample, blood sample
    
Keywords: chemotherapy, mass spectrometry
Study to Assess the Safety, Tolerability, PK and PD Response of PE0139 Injection in Adult Subjects With T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, double-blind (Investigator and study subject), placebo controlled
      multiple dose sequential ascending dose study that will enroll up to 47 male and female
      subjects with type 2 diabetes mellitus (T2DM) in up to four cohorts.
    

Detailed description: 
      This study is a randomized, double-blind (Investigator and study subject), placebo controlled
      multiple dose sequential ascending dose study that will enroll up to 47 male and female
      subjects with T2DM in up to four cohorts; (6 active/2 placebo subjects in cohort 1, and up to
      9 active/4 placebo in each subsequent cohort).

      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic
      response of PE0139 in the presence of existing stable non-insulin antidiabetic background
      therapy. Subjects will return weekly for a total of 6 doses of study drug.

      Study remains active, not recruiting as subjects who received active study drug will be
      followed for secondary outcome measures.
    

Intervention name(s): PE0139 Injection; Placebo Injection
Intervention type(s): Drug; Drug
Intervention description(s): PE0139 Injection; Placebo Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Spironolactone Versus Spironolactone Plus Furosemide (SVSSF)
Condition: Cirrhosis; Ascites
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Study type: Interventional
Phase: Phase 4

Summary: 
      The question whether the sequential diuretic therapy, that means using an antialdosteronic
      drug at first and adding a loop diuretic in nonresponders, is better than the combination of
      the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites
      in patients with cirrhosis is still open. Therefore, the aim of the study is to compare
      sequential versus combined diuretic therapy in these patients. One hundred patients will be
      randomized into two groups. Group A will receive potassium canrenoate at the initial dose of
      200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day
      of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to
      150 mg/day. Group B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of
      furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.

      The percentage of responders to dthe diuretic treatment, the time to get the resolution of
      ascites and the rate of adverse effects will be compared between the two Groups of Patients.
    


Intervention name(s): Spironolactone and furosemide; Spironolactone and furosemide
Intervention type(s): Drug; Drug
Intervention description(s): Patients in arm A will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day.; Patients in arm B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.
Intervention MeSH terms: Furosemide; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cirrhosis; ascites; diuretic therapy; potassium canrenoate; furosemide; hyperkalemia; plasma renin activity; nitric oxide; serum sodium concentration; refractory ascites; Nonazotemic patients with cirrhosis and moderate ascites
Rogaratinib (BAY1163877) Human Mass Balance Study
Condition: Clinical Trial, Phase I; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the mass balance and routes of excretion of total
      radioactivity after a single oral 200 mg dose of [14C]rogaratinib given as a solution. For
      further clinical development, human mass balance data are required to elucidate the
      absorption, distribution, metabolism, and excretion (ADME) of rogaratinib.
    


Intervention name(s): Rogaratinib (BAY1163877)
Intervention type(s): Drug
Intervention description(s): Single dose, intake orally, 200 mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mass Balance, metabolism and excretion pattern
Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS)
Condition: ARDS; Covid19; Acute Hypoxemic Respiratory Failure
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury
Study type: Interventional

Summary: 
      Prone positioning is one of the few therapies known to improve mortality in ARDS.
      Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data
      suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing
      traditional prone positioning to prolonged prone positioning in patients with COVID-induced
      ARDS.
    


Intervention name(s): Prolonged Proned Positioning; Traditional Proning Arm
Intervention type(s): Other; Other
Intervention description(s): Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period; Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to
      behavioral trouble such as enuresis, apathy and sleep disorders.

      to prevent this anxiety,many tools can be used for premedication like
      pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as
      parental presence,hypnosis and interactive tablet.

      the purpose of the study is to compare the effect of interactive tablet to oral midazolam.on
      preoperative anxiety in children prior to elective surgery
    

Detailed description: 
      this study is a prospective,randomized, active treatment controlled trial.It enrolls 100
      children .

      after written and informed consent,the study participants were randomly assigned using a
      computer generated table to one of two treatment groups prior to elective surgery.

      Group T: will receive an interactive tablet containing many cartoon's videos 20 minutes
      before the parental separation and until the anesthesia induction Group MD:will receive oral
      midazolam 20 minutes before parental separation with 0.5 mg/kg (max 20mg) Anxiety assessement
      was done using the Modified Yale Perioperative Anxiety Scale( MYPAS) at the separation of
      parents,the admission in the operating room and the anesthesia induction.

      Facial mask acceptance,post operative agitation (PAEDS score: Pediatric Anesthesia Emergence
      of Delirium) and parental satisfaction were also assessed.
    

Intervention name(s): elective surgery; Midazolam; Interactive Tablet
Intervention type(s): Procedure; Drug; Device
Intervention description(s): investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery; Oral Midazolam; interactive Tablet containing many cartoon's videos
Other intervention name(s): we will study the acceptance of the facial mask,the post operative delirium and the parents satisfaction
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Sitagliptin on Progression of Coronary Intermediate Lesion
Condition: Atherosclerosis; Type 2 Diabetes Mellitus
MeSH terms: Atherosclerosis; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor,
      on Progression of Coronary Intermediate Lesion.
    


Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg, 1 tablet per day for 12 months; Placebo,1 tablet per day for 12 months
Other intervention name(s): JANUVIA
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this clinical trial was to look into the
      concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of
      NN1250 in children, adolescents and adults with type 1 diabetes.
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): 0.4 U/kg body weight injected subcutaneously (under the skin), single dose; 0.4 U/kg body weight injected subcutaneously (under the skin), single dose
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases
Condition: Chronic Kidney Diseases; Hemolysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hemolysis
Study type: Observational

Summary: 
      To evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with
      end-stage kidney disease (ESRD).
    

Detailed description: 
      Subjects: patients with ESRD undergoing hemodialysis at the Dialysis Center of Hanyang Guri
      Hospital

      Ocular parameters: visual acuity, intraocular pressure, axial length, OCT Other systemic
      parameters: body weight, ultrafiltration volume, and systolic/diastolic blood pressure

      All measurements were performed near the dialysis center. Measurements were performed on
      Monday (for patients who underwent dialysis sessions on Monday, Wednesday, and Friday) or
      Tuesday (for patients who underwent dialysis sessions on Tuesday, Thursday, and Saturday.

      All parameters were measured before and after the hemodialysis.
    

Intervention name(s): ophthalmologic exams
Intervention type(s): Other
Intervention description(s): ophthalmologic exams such as vision, intraocular pressure, axial length and optical coherence tomography
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with end-stage renal disease who undergoing hemodialysis
Retention, Chewing Efficiency and Masticatory Performance of Partial Dentures Opposing Implant Retained Prosthesis.
Condition: Implant Site Reaction; Implant Complication
Study type: Interventional

Summary: 
      This study aims to evaluate retention ,chewing efficiency and masticatory performance of
      flexible versus CAD/CAM partial dentures opposing to fixed implant retained restorations.
    

Detailed description: 
      in this study 22 patients will be selected following inclusion and exclusion criteria. The
      patients will be divided randomly into two groups.

      Group I patients will receive Versacrylic removable partial denture. group II patients will
      receive CAD/CAM removable partial denture all patients will be given the home care
      instructions at night and brush cleaning of the dentures.

      Measurements of retention using universal testing machine, masticatory performance using
      T-scan III computerized system and chewing efficiency using chewing function questionnaire
    

Intervention name(s): evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge; chewing efficiency by electromyograph(E.M.G); masticatory performance(questionnaire)
Intervention type(s): Device; Device; Other
Intervention description(s): Evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.; Evaluation of chewing efficiency of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.; Evaluation of masticatory performance of Versacryle and CAD/CAM partial dentures by questionnaire on day one, on first month, and on the second month of prosthesis delivery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Retention; Chewing efficiency; Removable Prosthodontics
Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the following items by PET examination in Japanese heathy adult male subjects who
      received single oral administration of TS-091 in an unblinded manner.

        1. Relationship between plasma concentration and H3 receptor-occupancy of TS-091

        2. Time course changes in H3 receptor-occupancy of TS-091
    


Intervention name(s): TS-091
Intervention type(s): Drug
Intervention description(s): Subjects received single-dose of 0.1, 0.2, 0.4, 1, 5, 12.5 and 25 mg of TS-091 (tablets or drug substance powder)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Test the Safety and Efficacy of MK-8998 in Acutely Psychotic Participants With Schizophrenia (MK-8998-004)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the safety and efficacy of treatment with MK-8998 as compared to placebo
      and olanzapine for acutely psychotic patients with schizophrenia. The primary hypothesis is
      that in participants undergoing an acute psychotic episode of schizophrenia, MK-8998 6 to 8
      mg twice daily is superior to placebo in the treatment of symptoms of schizophrenia as
      measured by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS)
      total score at Week 4.
    


Intervention name(s): MK-8998; Comparator: Olanzapine; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK-8998 6 mg capsules twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 8 mg capsules twice daily. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo.; Olanzapine 5 mg tablets twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 5 mg tablets in the morning and 10 mg tablets in the evening. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo.; Placebo tablets matching olanzapine tablets and MK-8998 capsules
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Exacerbation of Schizophrenia