bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Head and Gaze Position on Soft Toric Contact Lens Performance
Condition: Astigmatism; Myopia
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      Primary Hypotheses:

      Senofilcon A will provide significantly less rotation with subjects in a recumbent position
      than Filcon II 3 monthly .

      Etafilcon A will provide significantly less rotation with subjects in a recumbent position
      than Filcon II 3 1 1 day .

      Etafilcon A will provide rotation with subjects a recumbent position non-inferior to
      nelfilcon A. A margin of 5 degrees will be used.

      Secondary Hypotheses:

      Senofilcon A will have significantly better monocular visual performance with subjects in a
      recumbent position than Filcon II 3 monthly.

      Etafilcon A for astigmatism will have significantly better monocular visual performance with
      subjects in a recumbent position than Filcon II 3 1 day.

      Etafilcon A will have monocular visual performance with subjects in a recumbent position
      non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.
    


Intervention name(s): senofilcon A; etafilcon A; nelfilcon A; Filcon II 3; Filcon II 3
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): bilateral daily use soft contact lens; bilateral daily use soft contact lens; bilateral daily use soft contact lens; bilateral daily use soft contact lens; bilateral daily use soft contact lenses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to collect preliminary information on the effect of
      three doses of trazodone/gabapentin FDC products on pain intensity in patients with painful
      diabetic neuropathy after 8-week treatment period.
    

Detailed description: 
      The present phase II study is designed to collect preliminary data on the efficacy and safety
      of trazodone/gabapentin Fixed-Dose Combination (FDC)products for treatment of patients
      affected by painful diabetic neuropathy in a randomized controlled clinical trial. Diabetic
      peripheral neuropathic pain represents an important therapeutic challenge as its
      pathophysiology is not yet fully understood and pain relief is still unsatisfactory. The
      pharmacological treatments, with exception to those targeted to the glycemic control, are
      symptomatic and their use is limited by not universal efficacy, side effects or by the
      development of tolerance. A wide variety of drugs, used both alone and in combination, has
      shown to significantly reduce neuropathic pain when compared with placebo in randomized
      controlled trials, even though pain relief remains inadequate for most of the patients.

      In this contest, Angelini S.p.A is developing a fixed-dose combination medicinal product for
      the treatment of neuropathic pain containing low doses of active ingredients: trazodone, a
      widely used antidepressant drug, and gabapentin which is indicated for the treatment of
      neuropathic pain.
    

Intervention name(s): trazodone/gabapentin 2.5/25 mg; trazodone/gabapentin 5/50 mg; trazodone/gabapentin 10/100; Gabapentin; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): The total daily doses administered will be trazodone 7,5 mg and gabapentin 75 mg.; The total daily doses administered will be trazodone 15 mg and gabapentin 150 mg.; The total daily doses administered will be trazodone 30 mg and gabapentin 300 mg.; The total daily doses administered will be:
600 mg from day 0 to day 6 (±1)
900 mg from day 7 (±1) to day 13 (±1)
1200 mg from day 14 (±1) to day 20 (±1)
1800 mg from day 21 (±1) to day 56 (±2); Two capsules, three times a day, for 8 weeks.
Other intervention name(s): Neurontin
Intervention MeSH terms: Gabapentin; Trazodone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo and reference controlled, placebo unbalanced, double-dummy, dose finding, parallel group, multicentre, international, prospective study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trazodone; Gabapentin; Neuropathic pain; Placebo
To Assess Safety, Tolerability and PK of NEX-20A, a Subcutaneous Prolonged-release Injection to Healthy Subjects
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a single-centre, single ascending dose (SAD) pilot study designed to evaluate the
      safety, tolerability, including local tolerability, and pharmacokinetics (PK) of NEX-20A
      (lenalidomide) after the administration of a single subcutaneous prolonged-release injection
      to healthy male volunteers
    

Detailed description: 
      NEX-20A will be administered in sequential cohorts, 2 standard cohorts and an optional third
      cohort, each comprising 3 subjects. Subjects will be dosed in a sentinel fashion, and all
      available safety and tolerability data up until and including 10 days for the sentinel
      subjects must have been evaluated by the iSRC before dosing the remaining 2 subjects in each
      cohort.Once safety, tolerability and PK data of the last subject in each cohort has been
      collected, and interim data analysis has been conducted, there must be at least 1 week
      between dose escalations.
    

Intervention name(s): NEX-20A
Intervention type(s): Drug
Intervention description(s): Subcutaneous prolonged-release injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Copeptin in Diabetes Insipidus
Condition: Diabetes Insipidus; Primary Polydipsia
MeSH terms: Diabetes Insipidus; Diabetes Mellitus; Polydipsia; Polydipsia, Psychogenic
Study type: Observational

Summary: 
      Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of
      diabetes insipidus against the standard diagnostic test methods.
    

Detailed description: 
      Purpose of this study is to compare the overall diagnostic accuracy of the three following
      diagnostic test procedures in diabetes insipidus (central, nephrogenic) and primary
      polydipsia: a) classical water deprivation test alone, b) classical water deprivation test
      plus plasma copeptin cut-off levels, c) hypertonic saline infusion test plus plasma copeptin
      measurement.

      The investigators hypothesize that firstly b) and c) is better as a). Secondly the
      investigators hypothesize that c) is non-inferior to b).
    

Intervention name(s): Water deprivation test; Water deprivation test; Hypertonic saline infusion
Intervention type(s): Other; Other; Other
Intervention description(s): Classical water deprivation test alone; classical water deprivation test plus plasma copeptin cut-off levels; hypertonic saline infusion test plus plasma copeptin measurement
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care center
      
Keywords: Copeptin; differential diagnosis of polyuria polydipsia syndrome; diabetes insipidus; compulsive water drinking; water deprivation test; Diabetes insipidus (central and nephrogenic)
A Study Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Subjects.
Condition: Anesthesia; Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to
      determine the safety, tolerability (including pain on injection), and PK(only to be assessed
      for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486
      administered as a single IV injection.

      Results from this study will supports further clinical development of HSK3486. This study
      will be performed in compliance with the protocol, International Conference on Harmonization
      Good Clinical Practice (ICH GCP) and local regulatory requirements. Aspects of the study
      concerned with the investigational product will meet the requirements of Good Manufacturing
      Practice (GMP).
    


Intervention name(s): HSK3486; Propofol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
Condition: Healthy
MeSH terms: Weight Gain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the
      administration of risperidone alone or in combination with mifepristone in healthy adult male
      volunteers to determine the average change in absolute weight at Day 28 compared to baseline.
    

Detailed description: 
      This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the
      administration of risperidone alone or in combination with mifepristone in healthy adult male
      volunteers. The primary study objective is to determine the mean change in absolute weight at
      Day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus
      mifepristone or risperidone alone. The secondary study objectives are to determine the mean
      percent change in baseline body weight; and the proportion of subjects that gain less than 5%
      and less than 7% of their baseline body in the treatment groups.
    

Intervention name(s): Risperidone; Mifepristone; Risperidone-matched placebo; Mifepristone-matched placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): risperidone daily for 28 days; mifepristone daily for 28 days; risperidone-matched placebo daily for 28 days; mifepristone-matched placebo daily for 28 days
Other intervention name(s): Risperdal; Corlux
Intervention MeSH terms: Risperidone; Mifepristone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: healthy; weight gain; anti-psychotic; risperidone; mifepristone; mitigation; weight loss
Effect of Tepotinib on PK of CYP3A Substrate Midazolam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study investigated the effect of tepotinib on the pharmacokinetics (PK) of the Cytochrome
      P450 (CYP) 3A substrate midazolam determined from concentrations of midazolam and its main
      metabolite 1-hydroxymidazolam in healthy participants.
    


Intervention name(s): Midazolam; Tepotinib
Intervention type(s): Drug; Drug
Intervention description(s): Participant received single oral dose of 7.5 mg midazolam tablet on Day 1 of treatment period 1 and Day 11 in treatment period 2.; Participants received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 in treatment period 2.
Intervention MeSH terms: Tepotinib; Midazolam
Intervention model: Sequential Assignment
Intervention model description: This is a single sequence cross-over trial.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Tepotinib; Midazolam; Cytochrome P450; Pharmacokinetics
Prospective Study of the Impact of Insulin Pump Therapy in Young Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of the study is to examine glycemic and neuropsychological outcomes in very young
      children with Type I diabetes who are being started on insulin pumps and to compare their
      outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children
      with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections
      with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be
      examined prior to and 12 months after the implementation of insulin pump therapy. These
      subjects will be recruited and followed because they are currently undergoing treatment for
      Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and
      their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not
      be changed by the study team. Outcome measures will examine: glycemic outcomes (overall
      control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children diagnosed with type 1 diabetes for at least one year at the time of study. In
        addition, children must be under the age of 5 years
      
Keywords: type 1 diabetes; continuous glucose sensor monitoring
Examination of the Effects of Four Different Spices on Energy Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study is to examine whether four different spices (ginger, black
      pepper, horseradish and mustard) are able to increase energy metabolism.

      Since chili and other spices have been shown to increase energy expenditure compared to
      placebo, we expect that some or all of the four spices may actually increase energy
      expenditure - although not to a large degree.
    

Detailed description: 
      Several pungent food ingredients, such as chili,and also other bioactive food ingredients,
      e.g. green tea, have been shown to be able to increase energy expenditure and fat oxidation
      during the hours following a meal containing the bioactive ingredient. Furthermore, we will
      also look at the subjects own feelings of appetite and thereby examine whether the appetite
      is affected by the spicy food. We expect to see some small effects on these parameters.
    

Intervention name(s): ginger; black pepper; horseradish; mustard; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): added to a brunch meal; Added to a brunch meal; Added to a brunch meal; Added to a brunch meal; Added to a bruch meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Thermogenesis; Meal-induced thermogenesis; energy expenditure; fat oxidation; bioactive ingredients; spices; ginger; horseradish; black pepper; mustard
Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This single ascending dose (SAD) study in healthy subjects will evaluate the safety,
      tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and
      urine albumin levels) relationships will be explored to support the selection of dosing
      regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the
      efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of
      nephropathy as well as control hypertension.
    

Detailed description: 
      This is an open-label, parallel-group, dose-escalation study to evaluate the safety,
      tolerability and pharmacokinetics of KBP-5074 following a single dose administration of
      KBP-5074 with and without food. The study includes 2 parts.

      Part 1: Pharmacokinetics from each dose cohort will be characterized before initiation of
      dosing in the subsequent cohorts. Eight subjects in each dose cohort will receive active
      drug. The total number of cohorts will be up to 5. Extensive PK samplings will be collected
      prior to and following administration of single dose of KBP-5074.

      Part 2: A separate panel of 6 subjects will receive a single dose of KBP-5074 under fed
      conditions. Extensive PK samplings will be collected prior to and following administration of
      single dose of KBP-5074 under fed conditions.

      Serum and plasma samples for pharmacodynamic markers (plasma aldosterone and serum potassium
      levels) will be collected at pre-dose and postdose in both Part 1 and Part 2.

      The urine samples will be also used for quantitative determination of urinary albumin in both
      Part 1 and Part 2.

      Safety assessments will include monitoring of adverse events (AEs), vital signs (blood
      pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings,
      12-lead electrocardiograms (ECGs), and physical examination findings.
    

Intervention name(s): KBP-5074
Intervention type(s): Drug
Intervention description(s): Comparisons of different doses of study drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"Effect of Dipeptidyl Peptidase IV After Diets in näive Type 2 Diabetic Patients"
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the secretion of glucose, insulin, glucagon,
      C-peptide and lipid profile after isocaloric diets with different nutritional compounds (fat,
      protein and carbohydrate food) in drug näive tipo 2 patients.
    

Detailed description: 
      It is well known that there is a progressive deterioration in beta-cell function over time in
      type 2 diabetes (DM2), as indicated by the UKPDS (United Kingdom Prospective Diabetes Study),
      regardless of therapy allocation, albeit conventional (mainly diet), insulin, chlorpropamide,
      glibenclamide or metformin treatment. Moreover, the pancreatic islet function was found to be
      about 50% of normal at the time of diagnosis, independent of the degree of insulin
      resistance, with the reduction in function probably commencing 10-12 years prior to diagnosis
      and aggravated by increasing fasting plasma glucose levels.

      Optimal metabolic control, especially early intensive glycemic control, plays a role in the
      prevention of progressive beta cell dysfunction and possibly destruction of the betacells
      with worsening of diabetes. Many reports have shown that induction of normoglycemia in DM2
      results in both improved beta cell function and insulin resistance.The major therapeutic
      drawback using native GLP-1 is its very short half-life of less than 2 minutes, following
      exogenous administration, as previously indicated due in part to the protease DDP-IV a
      result, preventing the degradation of native GLP-1 by inhibiting the active of the DDP-IV
      enzyme has emerged as a therapeutic strategy for enhancing endogenous GLP-1 action in
      vivo.Considering that, sitagliptin is the first FDA and ANVISA authorized dipeptidyl
      peptidase-IV (DPP-IV) inhibitor for diabetes treatment and considering the lack of data about
      DPP-IV inhibitor effect over glucose, glucagon, insulin, C -peptide and fats after isocaloric
      diets with different nutritional composition in drug näive patients with type 2 diabetes, we
      designed this study.
    

Intervention name(s): Dipeptidyl Peptidase IV inhibitors
Intervention type(s): Drug
Intervention description(s): Dosage 100 mg each day, once a day, 2 months
Other intervention name(s): Januvia (Merck Sharp Dome); Sitagliptin
Intervention MeSH terms: Sitagliptin Phosphate; Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sitagliptin; Diets; Diabetes type 2; Näive patients
Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression
Condition: Depressive Disorder, Treatment-Resistant
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the efficacy and safety of the compound MIJ821 compared to placebo in
      patients aged from 18 to 65 years diagnosed with treatment-resistant depression. The study
      was conducted in the US and in Europe (Spain). The MIJ821 was administered via infusion on a
      weekly or bi-weekly basis. The efficacy was measured after 24 hours using a specific golden
      standard scale, the Montgomery-Asberg Depression Rating Scale. The study duration was 6 weeks
      of treatment plus 1 month of follow up period.
    

Detailed description: 
      This was a non-confirmatory, multi-center, 6-treatment arm in European (Spain) and
      5-treatment arm in the US (no ketamine arm), randomized, subject and investigator blinded,
      parallel-group, placebo-controlled study in patients with treatment-resistant depression. The
      total duration for each subject in the study was maximum 14 weeks: a screening period of
      maximum 4 weeks, a 36-day treatment period and a 5-week follow-up period.
    

Intervention name(s): MIJ821; Placebo; Ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Different dosages and different regimen for MIJ821; Infusion; Infusion
Other intervention name(s): Ketamine dose to be capped at 40 mg/day for patients over 80 kg
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a non-confirmatory, multi-center, 6-treatment arm in the EU countries and 5-treatment arm in the USA (no ketamine arm), randomized, subject and investigator blinded, parallel group, placebo controlled study in treatment-resistant depression patients. The study allows for the inclusion of subjects seeking treatment for their disease from both an 'inpatient' or 'outpatient' clinic setting.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Refractory Depression; Therapy-Resistant Depression; Treatment Resistant Depression; MDE; MDD; Major depressive disorder (MDD); clinical depression; major depression; unipolar depression; unipolar mood disorder; depression; the blues; mood disorder
A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis
Condition: Cervical Spondylosis
MeSH terms: Spondylosis
Study type: Interventional

Summary: 
      This study aims at evaluating spinal cord structure using diffusion tensor imaging in
      patients with cervical spondylosis.
    

Detailed description: 
      Diffusion tensor imaging (DTI) of the cervical spinal cord will be performed in patients with
      cervical spondylosis with varying degrees of symptoms and in healthy control subjects. Fibre
      tracking of main spinal tracts will be performed. Regions of interest will also be
      identified. Diffusion parameters will be extracted. This will allow quantification of degree
      of damage in of the spinal cord. The findings will be related to motor function measures and
      comprehensive clinical tests of sensory and motor function.
    

Intervention name(s): DTI - Diffusor Tensor Imaging
Intervention type(s): Device
Intervention description(s): Radiology intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Spinal cord; cervical spondylosis; myelopathy