bioihbjkbjnl/mcl2 huggingface dataset:
Relationship Between NLR and Prealbumin Levels With Diaphragm Thickness
Condition: Inflammatory Response
Study type: Observational [Patient Registry]

Summary: 
      A study to find the relationship between neutrophil to lymphocyte ratio (NLR) with diaphragm
      thickness of critical patients in ICU.
    

Detailed description: 
      Weaning from ventilator sometimes can be failed and it happened due to several factors. One
      of the causes was Ventilator Induced Diaphragm Dysfunction (VIDD). This VIDD process occurred
      due to thinning process of the diaphragm thickness or decreased diaphragm muscle mass. The
      whole process happened due to inflammatory reaction that usually appeared on patients in
      Intensive Care Unit (ICU). Thus, this study was aimed to find the relationship between
      neutrophil to lymphocyte ratio (NLR) with diaphragm thickness of critical patients in ICU.
    

Intervention name(s): Ratio of Neutrophil to Lymphocyte; Level of Prealbumin Serum
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.; Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who are treated in intensive care unit and using mechanical ventilation from Day 0
        till Day 5. These patients will be checked for their diaphragm thickness, level of
        prealbumin serums, and ratio of neutrophil to lymphocyte.
      
Keywords: diaphragm thickness; neutrophil to lymphocyte ratio; mechanical ventilation
A Study in Healthy Female Participants to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midazolam (Probe Substrate for Cytochrome P450 3A4)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of steady-state concentrations of
      JNJ-56136379 on the single-dose pharmacokinetics (PK) of drospirenone and ethinylestradiol
      (oral contraceptive [OC]) in healthy female participants and to evaluate the effect of
      steady-state concentrations of JNJ-56136379 on the single-dose PK of midazolam (sensitive
      probe substrate for CYP3A4) in healthy female participants.
    


Intervention name(s): Drospirenone/Ethinylestradiol; Midazolam; JNJ-56136379
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of drospirenone/ethinylestradiol 3 mg/0.02 mg (OC) tablets on Days 1 and 21.; Midazolam 2 mg orally on Days 1 and 21.; JNJ-56136379 dose will be administered orally at a dose of 250 mg (as 2 tablets of 100 mg + 2 tablets of 25 mg) on Days 6 and 7 and at a dose of 170 mg (as 1 tablet of 100 mg+ 2 tablets of 25 mg + 4 tablets of 5 mg) on Days 8 to 25.
Other intervention name(s): Betadex clathrate (Yaz)
Intervention MeSH terms: JNJ-56136379; Drospirenone; Midazolam; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Betadex
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This single and multiple ascending dose study is the first evaluation of PF-0626414, a
      Selective Androgen Receptor Modulator in humans. The goal is to assess the safety,
      tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male
      subjects .
    


Intervention name(s): PF-06260414; Placebo; PF-06260414; Placebo; PF-06260414; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format; Subjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format; Subjects will receive PF-06260414 doses (solution) twice daily for 14 days; Subjects will receive PF-06260414 matching placebo doses (solution) of 3, 10, 30, 100mg BID and 60 mg QD for 14 days; Japanese subjects may receive the highest dose of PF-06460414 tested in non Japanese cohort twice daily for 14 days; Japanese subjects may receive PF-06260414 matching placebo doses (solution) twice daily for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Randomized; Double Blind; Placebo-Controlled; Single and Multiple Dose Escalation; Safety Tolerability; PK; PD; PF-06460414
Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      A study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of
      the heart.
    


Intervention name(s): PPM-204
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single blind randomised controlled clinical trial in uncontrolled type 2 Diabetes
      mellitus patients on oral glucose lowering agents, and naive to incretinomimetic.
      Participants will be randomised in two Arms : arm 1 receiving Liraglutide at 1,2 mg/day and
      arm 2 Vildagliptine at 100mg/day over 14 days. The two arms will be compared for 14-day
      changes in insulin secretion and insulin sensitivity.
    

Detailed description: 
      Incretinomimetics include exogenous Glucagon-Like Peptide analogs (GLP1a) such as
      Liraglutide, and inhibitors of Dipeptidyl peptidase IV (DPP4i) that prolong the half-life of
      endogenous GLP1 such as Vildagliptin. It remains unclear which of the two strategies
      (exogenous GLP1 or prolonging half-life of endogenous GLP1) have better short term effect on
      insulin sensitivity and insulin secretion in people living with type 2 diabetes.

      This study aims to investigate the short-term metabolic effects of a GLP-1 analog Liraglutide
      versus a DPP4i Vildagliptin. It is a randomized, controlled, single-blinded clinical trial.
      Study population consists of uncontrolled type 2 diabetes mellitus patients (HbA1c≥7%) under
      mono or bi oral anti-diabetic therapy, naïve of any incretinomimetic treatment. Participants
      are randomized in 2 arms. The intervention in arm 1 consists of add-on subcutaneous
      Liraglutide at 0.6mg/day for 1 week increased to 1.2mg the second week. In the second arm, it
      consists of oral Vildagliptine at 100mg daily for two weeks. The primary outcome is the
      variation in euglycaemic hyperinsulinaemic clamp-derived insulin sensitivity before
      randomization and the day after intervention, secondary outcomes include 14-day changes in
      insulin secretion during a mixed meal tolarance test, body weight and body composition, and
      an indirect calorimetry measured resting energy expenditure. Changes from baseline to 14 days
      in serum creatinine and alanine amino transferase, C-reactive protein and lipid profile will
      also be recorded.
    

Intervention name(s): sub cutaneous liraglutide; Oral Vildagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide 1.2mg/day; Vildagliptin 50mg/day
Other intervention name(s): Victoza; Galvus
Intervention MeSH terms: Liraglutide; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetes; GLP-1; Insulin secretion; insulin sensitivity; Africa; Liraglutide; Vildaglipin
Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin Compared With Dapagliflozin Added on Metformin Alone or Diabetes Medication Naïve Patient in Type 2 Diabetes Mellitus (Stable II Study)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the efficacy on glycemic variability and safety of
      gemigliptin 50 mg orally administered once daily for 12 weeks compared with Dapagliflozin
      10mg in patients with type 2 diabetes mellitus who have inadequate glycemic control on
      metformin alone or diabetes medication naïve patient
    


Intervention name(s): Gemigliptin 50mg; Dapagliflozin 10mg; Diet/exercise questionnaire; Continuous Glucose Monitoring System(CGMS); Metformin
Intervention type(s): Drug; Drug; Procedure; Device; Drug
Intervention description(s): For patients who have been randomized to Gemigliptin(Experimental arm), the patients continue to take a gemigliptin 50mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91)); For patients who have been randomized to Dapagliflozin(Active Comparator arm), the patients continue to take a dapagliflozin 10mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91)); doing exercise with about intermediate intensity(50~70%) for ≥150minutes in total over at least 3 times(every other day) weekly should be recommended and regular diet without greater changes in life style as much as possible during the whole study period.
the questionnaire regarding diet/exercise will be collected at -day 6, day 1, day29, day85, day 91; For patients who have been screening completely, the subjects will be attached CGMS(ipro-2) twice from Visit 2(-day 6) to Visit 3(day 1) and Visit 5(day 85) to Visit 6(day 91); For patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily and continue the same dosage and administration as before participant in the study
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Setmelanotide in Pediatric Patients With Rare Genetic Diseases of Obesity
Condition: Bardet-Biedl Syndrome; POMC Deficiency Obesity; PCSK1 Deficiency Obesity; LEPR Deficiency Obesity
MeSH terms: Bardet-Biedl Syndrome; Laurence-Moon Syndrome; Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3 open-label, one-arm, clinical study to evaluate the efficacy, safety and
      tolerability of setmelanotide over 1 year of treatment, in pediatric patients aged 2 to <6
      years with obesity due to either biallelic variants of the POMC, PCSK1 or LEPR genes or
      Bardet-Biedl Syndrome (BBS).
    

Detailed description: 
      Pediatric patients aged 2 to <6 years with obesity due to either biallelic variants of the
      POMC, PCSK1 or LEPR genes or Bardet-Biedl Syndrome (BBS) will be enrolled into this phase 3
      open-label clinical trial at one of approximately 8 clinical centers in North America,
      Europe, or Australia. All patients will be assigned to receive setmelanotide via daily
      subcutaneous injection for 1 year.
    

Intervention name(s): Setmelanotide
Intervention type(s): Drug
Intervention description(s): All patients will begin treatment at a dose of 0.5 mg of setmelanotide per day. Patients will then increase their dose by 0.5 mg increments, every 2 weeks, until reaching their target maximum dose (not to exceed 2mg daily). The target maximum dose of setmelanotide used in this study will be based on the weight bands.
Other intervention name(s): IMCIVREE
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bardet Biedl Syndrome; POMC Deficiency; PCSK1; LEPR; Obesity; Pediatric Obesity
Study of PTG-300 in Non-Transfusion Dependent and Transfusion-Dependent Beta-Thalassemia Subjects With Chronic Anemia
Condition: β-thalassemia; Ineffective Erythropoiesis; Chronic Anemia
MeSH terms: Anemia; Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 open-label, single-arm design study with dose escalation by subject cohort
      . The study is designed to monitor the PTG-300 safety profile, to obtain preliminary evidence
      of efficacy of PTG-300 for the treatment in β-thalassemia.
    

Detailed description: 
      This is a Phase 2 open-label, single-arm design study with dose escalation by subject cohort
      and with the potential for individual titration (dose increase or decrease) within each
      cohort. The study is designed to monitor the PTG-300 safety profile, to obtain preliminary
      evidence of efficacy of PTG-300 for the treatment of chronic anemia in β-thalassemia and to
      evaluate the appropriate dosing regimen for PTG-300 in the target population
    

Intervention name(s): PTG-300
Intervention type(s): Drug
Intervention description(s): Subcutaneous (SC)
Intervention model: Sequential Assignment
Intervention model description: Multiple PTG-300 dose levels/regimens are planned to be tested for each subpopulation of β thalassemia (NTD and TD) on separate arms:
Cohort 1: 3 mg subcutaneous (SC) weekly
Cohort 2: 10 mg SC weekly
Cohort 3: 20 mg SC weekly
Cohort 4a: 40 mg SC weekly
Cohort 4b: 40 mg SC every 2 weeks
Cohort 7: 80 mg SC weekly
Cohort 8: 40 mg SC twice a week
Additional Cohorts (Cohorts 5,6,9,10, and 11) will include subjects between 12 years of age and less than 18 years of age.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic anemia; β-thalassemia
Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds
Condition: Lid-Parallel Conjunctival Folds
Study type: Interventional

Summary: 
      The aim of the study is to investigate how Lid-Parallel Conjunctival Folds recovers or
      persists after the continued usage or discontinuation of contact lenses or refitting with low
      coefficient of friction lenses.
    


Intervention name(s): Spectacle Lens; Habitual Soft Contact Lens; Test Lens
Intervention type(s): Device; Device; Device
Intervention description(s): Spectacle Lens Only; subject's own contact lens; senofilcon A or narafilcon A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the effect of repeated oral doses of AZD1722 on the pharmacokinetics of
      Cefadroxil
    

Detailed description: 
      A Phase 1, Single-center, Randomized, 2-Way Cross-over, Open-label Study to Evaluate the
      Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Cefadroxil in
      Healthy Volunteers
    

Intervention name(s): Treatment A (cefadroxil alone); Treatment B - AZD1722 followed by cefadroxil
Intervention type(s): Drug; Drug
Intervention description(s): A single 500 mg oral dose of cefadroxil will be given on the morning of Day 1; 15mg oral dose of AZD1722 will be given twice daily from Day 1 to Day 4 followed on the morning of Day 5 by a single dose of 15 mg AZD1722 taken together with a single 500mg dose of cefadroxil
Intervention MeSH terms: Cefadroxil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I, Healthy Volunteers
Effects of Almonds on Insulin Sensitivity in Prediabetes
Condition: PreDiabetes
MeSH terms: Insulin Resistance; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the effects of consuming 1.5 oz almonds twice
      daily on insulin sensitivity and markers of cardiometabolic health in men and women with
      prediabetes.
    

Detailed description: 
      This is a randomized, controlled, two-period crossover study that includes two screening
      visits, and two 6-week test periods, separated by a 4-week washout. Subjects consume twice
      daily, 1.5 oz whole, natural almonds (Active Condition) or low-fat foods high in refined
      starches and added sugars, matched for energy content to the almonds (Control Condition). The
      assigned study products will be dispensed with instructions to consume 2 servings (Active
      Product) or 3 servings (Control Products) each day, starting on day 1. Subjects will be
      screened for prediabetes at the first screening visits. An intravenous glucose tolerance test
      (IVGTT) will be completed at baseline and the end of each treatment period. Fasting blood
      samples will be collected for lipid profile and high-sensitivity C-reactive protein (hs-CRP)
      measurements at all visits. Additionally, blood will be drawn for measurement of
      Apolipoprotein B and A1, lipoprotein particles and subfractions, Interleukin 6 (IL-6) and
      Uric acid at the beginning and the end of each test period. Assessments of vital signs, body
      weight, evaluation of inclusion and exclusion criteria, medication/supplement use, and
      adverse effects will be performed throughout the study. Compliance will be assessed through a
      daily log record, and return of unopened study product.
    

Intervention name(s): 1.5 oz of whole, natural almonds; Low-fat, high refined starches/sugars
Intervention type(s): Other; Other
Intervention description(s): 1.5 oz of whole, natural almonds; Low-fat foods, high in refined starches and added sugars
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis
Condition: Acute On Chronic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate the safety and efficacy of the use of ELAD in
      patients with diagnosed Acute On Chronic Hepatitis, including Acute Alcoholic Hepatitis.
    


Intervention name(s): ELAD plus standard of care treatment; Standard of care
Intervention type(s): Biological; Other
Intervention description(s): Use of ELAD plus standard of care; Standard of care in the treatment of AOCH will be administered
Other intervention name(s): Extra corporeal liver assist system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis; AOCH
Nutritional Status in Children Treated With Advanced Nutrition Therapy
Condition: Body Composition; Children
Study type: Interventional

Summary: 
      Background: There are few studies about nutrition to children and adolescents with cancer,
      and in particular during stem cell transplantation (SCT). Studies from other countries
      suggest that malnutrition is common on admission; the situation decline during treatment and
      may persist for a long time.

      Aim: This project aims to improve the nutritional therapy to children being treated for
      cancer and children undergoing stem cell transplantation
    

Detailed description: 
      Design, methodology and selection: The study consist of two parts: A retrospective study
      (registry study) of malnutrition among all children with cancer, admitted during a two year
      period, and a clinical trial to evaluate the effect of a standardized nutrition protocol for
      children undergoing SCT. Nutritional status is assessed before, during and one year after
      treatment with SCT.

      The subjects are 140 children and adolescents (2-17 years) being treated for cancer and a
      subgroup of 25 patients treated with SCT at Oslo University. The results will be compared
      with a reference group of 25 patients treated with home parenteral nutrition as well as 50
      healthy reference persons in the same age group.

      The methods used for measurement of nutritional status are: Body composition, bone density,
      blood tests, diet record, activity detection and measurement of quality of life. The
      measurements are done on three occasions for patients with cancer and stem cell
      transplantation, and on one occasion with a reference. Information on demographics and
      medical care will be taken from journal. Growth data will be collected from health centres
      when needed. Parents' experiences of children's feeding problems will also be examined.
    

Intervention name(s): Nutritional status
Intervention type(s): Other
Intervention description(s): Body composition and nutrient status
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: nutrient
Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        -  to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and
           lixisenatide given subcutaneously as on-site mix versus separate and simultaneous
           injections of each drug

      Secondary Objectives:

        -  to compare the activity of a single dose of insulin glargine and lixisenatide given
           subcutaneously as on-site mix versus separate and simultaneous injections of each drug

        -  to assess the safety and tolerability of insulin glargine and lixisenatide given
           subcutaneously as on-site mix
    

Detailed description: 
      The study period for one patient is one month in average and it can last up to 7 months (+ 2
      weeks) with post-study and follow-up visits
    

Intervention name(s): Insulin glargine HOE901; Lixisenatide AVE0010
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:solution for injection
Route of administration: subcutaneous; Pharmaceutical form:solution for injection
Route of administration: subcutaneous
Intervention MeSH terms: Insulin Glargine; Lixisenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment