bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Multiple-Ascending Dose (Japan)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin
      in diabetic Japanese subjects administered for 14 days
    


Intervention name(s): Dapagliflozin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, once daily up, to 14 days; Tablets, Oral, 0 mg, once daily, up to 14 days
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Significant cognitive impairment (executive functions, memory, attention) is common in
      schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and
      atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years,
      alternative non-pharmacological therapeutics have been developed in schizophrenia. These
      techniques called cognitive remediation specifically target cognitive deficits. The first
      cognitive remediation available for patients was designed to stimulate new learning, or
      relearning, of cognitive tasks, and thus to improve certain deficient domains. These
      procedures were efficient in improving cognition as measured by neurocognitive tests but
      their impact on functioning and daily life was weak. In a second time, compensatory
      remediation has been developed. Compensatory approaches seek to make improvements in the
      patient's functioning by avoiding areas of impairment and recruiting other intact cognitive
      domains or by creating a supportive external environment. In recent meta-analysis
      compensatory remediation has larger effect-size than classical cognitive remediation, with an
      impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of
      California) developed and tested a group-based, manualized, compensatory cognitive training
      intervention.

      Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily
      transposable in community care. Our team translated this method into French. The
      investigators planned a cost -utility study between CCT and treatment as usual in
      schizophrenia patients with less than 10 years of evolution.
    

Detailed description: 
      This study will take place over 3 years with a recruitment period of 18 months. After
      verification of the eligibility criteria and signature of the consent, the patients will be
      divided into 2 groups by randomization: the intervention group and the control group. The
      duration of participation of the subjects will be 12 months. Assessments are available in 4
      steps (V1 at inclusion, V2 at 3 months, V3 at 6 months and V4 at 12 months). These visits
      include an assessment of the functioning of patients, symptomatology, quality of life,
      treatment and care received at all visits, occupational activity and cognitive assessment and
      social knowledge at V1 and V4.
    

Intervention name(s): Compensatory cognitive training; Usual
Intervention type(s): Other; Other
Intervention description(s): In addition to the usual care, method of compensatory cognitive remediation; Usual care
Other intervention name(s): CCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive remediation, cost-effectiveness analysis
Effect of Anesthetic Agents on Optic Nerve Sheath Diameter
Condition: Uterus Myoma; Uterine Cancer
MeSH terms: Uterine Neoplasms
Study type: Interventional

Summary: 
      The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on
      intracranial pressure of female patients undergoing laparoscopic-robotic surgery.
    

Detailed description: 
      Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure.
      Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial
      vasculature and increases intracranial pressure. On the other hand, propofol decreases
      intracranial blood pressure and intracranial pressure is maintained or decreases.

      Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial
      pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy
      are evaluated.
    

Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): 1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.; 2-5 mcg/ml of propofol is used for maintenance of anesthesia.
Other intervention name(s): sevoflurane anesthesia; propofol anesthesia
Intervention MeSH terms: Anesthetics; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Tolerance and Utilization of Agave Inulin in Healthy Adults
Condition: Tolerance
Study type: Interventional

Summary: 
      The objective of this study is to assess the tolerance and utilization of agave inulin. This
      will be accomplished through analyses of breath and fecal samples to quantify fermentation
      end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and
      short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial
      populations will also be measured in fecal samples.
    

Detailed description: 
      The objective of this study is to assess the tolerance and utilization of agave inulin. This
      will be accomplished through analyses of breath and fecal samples to quantify fermentation
      end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and
      short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial
      populations will also be measured in fecal samples.
    

Intervention name(s): Agave Inulin; Placebo
Intervention type(s): Other; Other
Intervention description(s): 3x3 Latin square with 3 periods; control- 0 (zero) grams/day inulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Bashan on Glucose in Type 2 Diabetes Patients and Its Related Mechanisms
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study aimed to observe the effect of targeted diet on blood glucose improvement in type 2
      diabetic patients by continuous glucose monitoring and to explore the possible mechanism of
      targeted diet on blood glucose improvement in type 2 diabetic patients.
    

Detailed description: 
      Subjects were studied on 2 occasions, separated by at least 7 days, in a randomized fashion.
      The order of the enteral infusions was randomized and facilitated by a biostatistician who
      generated the randomization code and a research officer who prepared the study solutions, but
      were not involved in data collection or analysis. Each occasion would last for 14 days
      maintaining daily eating habits without intervention and take 180ml mineral water or Bashan
      three times a day after meals. During the 2-week test, all subjects will still wear
      continuous glucose monitoring systems. Before and after the intervention, the standard meal
      test would be carried out on the subjects, and the samples of serum and feces, etc. of the
      subjects would be collected for the following tests.
    

Intervention name(s): Bashan; water
Intervention type(s): Dietary Supplement; Other
Intervention description(s): a vegetable plant based compound drink add after three meals for 14 days; water as placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: type 2 diabetes; glucose; TIR
Local Anesthetic Properties of Neosaxitoxin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in
      humans
    

Detailed description: 
      Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at
      neuronal level. Its activity is express as blocking the axonal conduction, stopping the
      propagation of the nerve impulse. The objective of the present work is to evaluate the
      neosaxitoxin efficacy and safety as local anesthetic in a human trial

      Methods: Randomized, double-blind, placebo-controlled trial, with 10 healthy volunteers. The
      anesthetic effect will be evaluated using a standardized human sensory and pain model. TSA
      Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters:
      sensory threshold for warm and cold, pain thresholds for heat and cold and mechanical touch
      perception threshold.
    

Intervention name(s): Neosaxitoxin
Intervention type(s): Drug
Intervention MeSH terms: Neosaxitoxin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Local Anesthetic; Neosaxitoxin
Efficacy of Almonds Added to Chronic Statin Therapy
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the effects of 100-110 grams of almonds (about ¾
      cupful) daily on the lipoprotein profile when given to patients on a statin drug. The study
      will compare the effects on the lipoprotein profile to patients who eat almonds and those
      patients not eating almonds.
    

Detailed description: 
      The primary objectives of this study are to determine the changes in the lipid profile
      [LDL-C, HDL-C, triglycerides, total cholesterol], LDL-C particle size, and the emerging risk
      factor Lp(a) when 100-110 g of almonds daily are added to statin therapy. Also, all subjects
      will receive Step I dietary counseling.
    

Intervention name(s): Almonds
Intervention type(s): Dietary Supplement
Intervention description(s): 100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin
      time-action profiles and glucose responses when preadministered in the setting of continuous
      subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham
      injection).
    

Detailed description: 
      There is a recognized need for more rapid insulin action than is available from current
      rapid-acting analog products. In addition, current products have inconstant absorption and
      action profiles over the course of infusion set life. Previous human studies of prandial
      insulin preparations have used co-mixtures of rHuPH20 (study drug) with insulin delivered to
      study participants by subcutaneous injection and have demonstrated acceleration of insulin
      absorption and action. CSII has been used clinically for the treatment of diabetes over the
      last three decades, and a previous study using a co-mixture of rHuPH20 during CSII showed
      that the combination resulted in a more consistent and ultrafast profile of insulin
      absorption and action across infusion set use as compared to rapid analog insulin alone.
    

Intervention name(s): Rapid Acting insulin with pre-treatment of rHuPH20; Sham injection
Intervention type(s): Drug; Device
Intervention description(s): Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.; A sham injection will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.
Other intervention name(s): Humalog; Hylenex; placebo
Intervention MeSH terms: Insulin, Short-Acting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Type 1 Diabetes Mellitus; Type 1 Diabetes; T1DM; Continuous Subcutaneous Insulin Infusion (CSII); CSII; Insulin pump; Insulin; rHuPH20; Hylenex; recombinant human hyaluronidase (rHuPH20); Recombinant hyaluronidase
Articaine Efficacy and Safety for Children Below Age of 4-years
Condition: Behaviour Assessment; Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pain control is one of the significant behavior determinants in the dental office and shaping
      the future attitude toward dentistry, especially in children. One of widely used local
      anesthetic agents is articaine hydrochloride because of its superior potency, over
      traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of
      articaine efficiency and apply it in children.
    


Intervention name(s): Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml; lidocaine hydrochloride 2% and epinephrine 1:100000
Intervention type(s): Drug; Drug
Intervention description(s): Local anesthetic agent; Local anesthetic agent
Intervention MeSH terms: Lidocaine; Epinephrine; Carticaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Articaine, local anaesthesia, child, pain
Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study was to find out whether the bioavailability of PT Dexa Medica's
      formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the
      innovator's product (Prexum® 4 mg, Servier).
    

Detailed description: 
      The participating subjects were required to have an overnight fast and in the next morning
      were given orally one tablet of the test drug (Perindopril 4 mg tablets of PT Dexa Medica) or
      one tablet of the reference drug (Prexum® 4 mg, Servier).

      Blood samples were drawn immediately before taking the drug (control), and at 20, 40 minutes,
      and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 192 hours after drug administration.

      Three weeks after the first drug administration (washout period), the procedure was repeated
      using the alternate drug.

      The pharmacokinetic parameters, including AUCt, AUCinf, Cmax, t max, and t1/2, were
      determined based on the concentrations of the perindopril parent compound and the metabolite
      perindoprilat, using high-performance liquid chromatography method with tandem mass
      spectrometry detector (LC-MS/MS).
    

Intervention name(s): Perindopril 4 mg tablets of PT Dexa Medica; Perindopril 4 mg tablets of Servier
Intervention type(s): Drug; Drug
Intervention description(s): Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.; Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Other intervention name(s): Test Product: Perindopril 4 mg tablets of PT Dexa Medica.; Each tablet contains perindopril tert-butylamine salt 4 mg; Reference product: Prexum® 4 mg, produced by Servier.; Each tablet contains Perindopril tert-butylamine salt 4 mg.
Intervention MeSH terms: Perindopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Perindopril; Perindoprilat; Bioequivalence; Pharmacokinetic; Angiotensin-converting enzyme inhibitor
Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers
Condition: Corneal Defect
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal
      Peptide Eye Drops in Healthy Volunteers.
    

Detailed description: 
      The subjects enrolled in this study are healthy volunteers, divided into single dose groups
      and multiple doses groups with dose escalation.The study is designed to assign the subjects
      to five single-dose groups from low to high (0.0005%, 0.001%, 0.002%, 0.004% and 0.008%), and
      three multiple-dose groups (0.002%, 0.004% and 0.008%), with both male and female subjects in
      each group. This clinical trial is a double-blind design.
    

Intervention name(s): Germinal peptide eye drops
Intervention type(s): Drug
Intervention description(s): Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Other intervention name(s): Germinal peptide
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SKin Uncertainties Modeling
Condition: Unrecognized Condition
Study type: Interventional

Summary: 
      The study is based on measurement device and will provide a database of viscoelastic
      properties of the forearm skin among healthy volunteers.

      These data will be used to develop a mathematical model representative of the mechanical
      behavior of the skin.
    


Intervention name(s): Cutiscan® CS 100
Intervention type(s): Device
Intervention description(s): Repeated measures on healthy volunteers skin (forearm) are performed using Cutiscan® CS 100 device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: skin, non lesional, arm
MOTIONPODTM Validation in Free-living Conditio
Condition: Obese; Healthy Volunteers
Study type: Interventional

Summary: 
      In this study, the investigators propose to assess the validity in measuring physical
      activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn
      multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope)
      with an automatic activity/posture recognition algorithm and an activity-specific multilinear
      prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure
      (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly
      labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns
      will be compared to those of two existing activity or movement monitors: the triaxial
      accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with
      accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the
      cost of a calibration of the heart-rate/EE relationship that limits its use in large
      population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years
      of both gender and with broad range of body mass index and physical activity level. The
      subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total
      of 14 days in everyday life conditions and complete a physical activity diary. In half of the
      subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW.
      The other 60 subjects will be studied twice, one month apart, to test the reproducibility of
      the measures.
    


Intervention name(s): MOTIONPODTM device validation
Intervention type(s): Device
Intervention description(s): MOTIONPODTM validation in free-living conditions using gold standards, including the DLW method
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Energy expenditure; physical activity; accelerometer; magnetometer; monitoring; free-living conditions; doubly labelled water
Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This project assessed the feasibility of transcranial alternating current stimulation in the
      gamma band to lower beta-amyloid load and improve memory performance.
    

Detailed description: 
      Thirteen individuals with aMCI received eight 60-minute sessions of 40-Hz (gamma)
      transcranial alternating current stimulation (tACS) in a single-arm design. Outcome measures
      were assessed pre- and post-intervention.
    

Intervention name(s): Transcranial alternating current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial alternating current stimulation (tACS) will be applied at 40 Hz (gamma band) during eight sessions over the course of a month.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral
      administration of different doses in healthy Chinese subjects.

      To evaluate the safety and tolerability of lurasidone after single oral administration of
      different doses in healthy Chinese subjects.
    

Detailed description: 
      Single administration, double-blinded, placebo-controlled (3 subjects in each group will take
      placebo) and 3 dose groups (20 mg, 40 mg and 80 mg). There are three groups which are 20mg
      lurasidone or placebo, 40mg lurasidone or placebo and 80mg lurasidone or placebo.

      This study comprises a screening period (between signing of the informed consent form and Day
      -2), baseline period (Day -1), treatment period (Days 1-3) and ending of study examination
      period (Days 8-11 after the last sample collection for PK evaluation).
    

Intervention name(s): 20mg lurasidone; 40mg lurasidone; 80mg lurasidone; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.; single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.; single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: pharmacokinetic; lurasidone; single dose