bioihbjkbjnl/mcl2 huggingface dataset:
Estrogen, Diabetes, and Endothelial Function
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study planned to learn more about women and how the drop in estradiol levels during
      menopause may affect their cardiovascular risk. With aging, the arteries that are located
      around the heart get stiffer, and this increase in arterial stiffness can lead to a number of
      health problems such as high blood pressure and heart disease. In this study, the
      investigators examined whether a short-term drop in estrogen levels caused arteries to become
      stiffer, and explored potential reasons for stiffening arteries.
    

Detailed description: 
      Participants completed two study visits. The baseline study visit occurred during the early
      follicular phase of the menstrual cycle, confirmed via take-home ovulation testing. On the
      day of the baseline study visit, all participants underwent ovarian sex hormone suppression
      with GnRHant therapy (cetrorelix acetate, 0.25 mg/day) delivered daily as subcutaneous
      injections for a 1-week period. Participants were randomized to one of two concurrent
      intervention groups: transdermal estradiol patch (0.075 mg/day) (+E2) or placebo patch (+PL)
      and returned for a follow-up visit after 1 week of the intervention. Both study visits
      included collection of anthropometric measures, a fasting blood sample, measures of arterial
      stiffness, flow-mediated dilation, and endothelial cells via an intravenous catheter.
    

Intervention name(s): Cetrorelix acetate, 0.25 mg/day; Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release; Placebo patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All participants self-administered GnRHant daily between the baseline and follow-up visits (cetrorelix acetate, 0.25 mg/day).; Active estradiol transdermal patch.; Placebo patch designed to match active Climara patches.
Other intervention name(s): Cetrotide; GnRHant; Climara
Intervention MeSH terms: Cetrorelix; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to either receiving a gonadotropin-releasing antagonist (GnRHant) with estradiol add-back (+E2) or placebo (+PL). Investigators and participants were blinded to randomization status until the study was completed.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Bioequivalence Trial of Alprazolam 2 mg Tablets
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of alprazolam (tablets) are
      bioequivalent.

      Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 mg
      (Pharmacia & Upjohn). One tablet was the single dosage.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 26 healthy volunteers, both genders, adults between 18-50
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Alprazolam 2mg tablets; Alprazolam 2 mg tablets
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product
Other intervention name(s): Tafil 2 mg Pharmacia & Upjohn SA de CV; Zamoprax 2 mg GlaxoSmithKline Mexico SA de CV
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Alprazolam; Anxiety disorders; Mexico
A Pilot Study to Assess the Safety, PK and PD of Insulin Injected Via MicronJet or Conventional Needle
Condition: Intradermal Injections
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics
      injected via the MicronJet in comparison with a conventional needle.
    

Detailed description: 
      Administration of insulin to the skin has many potential advantages including improved
      kinetics and reduced pain. Today, insulin is injected to the SQ space, using, in most cases,
      various devices incorporating standard metal needles and usually causing considerable pain
      and discomfort to the patients. NanoPass has developed a microneedle based needle substitute
      for intradermal injections. This device requires minimal expertise and is expected to cause
      minimal or no pain during injections.

      The objective of this study is to compare the pharmacokinetics and pharmacodynamics of
      insulin Novorapid® (Novo Nordisk) injected via the MicronJet device intradermally, to a
      conventional needle injected to the SQ space.
    

Intervention name(s): MicronJet; MicronJet
Intervention type(s): Device; Device
Intervention description(s): The micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection.; MicronJet, Intradermal Injection
Other intervention name(s): Microneedles
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: MicronJet (microneedles); Intradermal
Fetal Cardiac Strain Imaging Research
Condition: Myocardial Deformation
Study type: Observational

Summary: 
      Cardiac disease in children may start early in life and evidence of cardiac disease can be
      seen during prenatal life. A variety of diseases diagnosed during fetal life can put children
      at risk for cardiac disease. The accurate assessment of cardiac function is important in
      these patients. A type of imaging scan called "fetal echocardiogram" is used to measure the
      contractility or squeeze of the heart. The fetal echocardiogram is a painless test and
      completely non-invasive.

      This study aims to recruit women and fetuses to determine if this imaging scan can be used
      throughout the pregnancy to measure heart squeeze and develop normal values to help doctors
      better diagnose fetuses who may have cardiac disease before they are born.
    

Detailed description: 
      The subject will have to complete 6 fetal echocardiograms. A fetal echocardiogram is picture
      of the unborn baby's heart in motion made by bouncing sound waves off the heart and recording
      the echo. The procedure will be very similar to the ultrasounds that the subject is already
      receiving as part of her prenatal care.

      The scans will start at week 20 of the subject's pregnancy and repeat every 3 weeks until
      week 38 of birth (whichever occurs first). The appointments will last approximately 30
      minutes each and will be performed by one of two sonographers trained specifically in fetal
      echocardiography. One additional echocardiogram will be performed on the infant after birth,
      within the first two months of life. In addition to the scans, study staff will access the
      subject's medical record to collect information such as: age, ethnicity, race, medical
      history and health insurance status.
    

Intervention name(s): Fetal Echocardiogram
Intervention type(s): Other
Intervention description(s): Subjects will then have sequential, abbreviated fetal echocardiograms performed by designated, highly trained, and experienced sonographers every 4 weeks, from 20-36 weeks.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at the obstetrics clinic at Texas Children's Hospital Pavilion for Women at the
        time of their second trimester screening ultrasound will be asked to volunteer to take part
        in the study.
      
Keywords: Heart disease; Echocardiogram; Ultrasound; Heart defect; Heart Dysfunction; Pediatric Cardiologists; Prenatal
A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive
Condition: Denture Retention
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the hold properties of two experimental denture
      adhesives using established maximum incisal BF methodology.
    

Detailed description: 
      This will be a single-centre, controlled, randomized, single-blind (with respect to the
      examiner performing the incisal BF measurements), 4-treatment, 4- period, cross-over study to
      evaluate the maximum maxillary BF in a population of full maxillary denture wearers. A
      currently marketed denture adhesive will be used as a positive control, whilst use of no
      adhesive will be employed as a negative control.
    

Intervention name(s): Super Poligrip Free; Experimental Denture Adhesive 1; Experimental Denture Adhesive 2
Intervention type(s): Device; Device; Device
Intervention description(s): A single application of 1 gram of Super Poligrip Free will be applied topically to oral tissues via the upper denture.; A single application of 1 gram of Experimental Denture Adhesive 1 will be applied topically to oral tissues via the upper denture.; A single application of 1 gram of Experimental Denture Adhesive 2 will be applied topically to oral tissues via the upper denture.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility
Social-software iMproving wARfarin Therapy
Condition: Anticoagulants Causing Adverse Effects in Therapeutic Use; Patient Compliance
Study type: Interventional

Summary: 
      Poor anticoagulation quality is a major problem among Chinese patients receiving warfarin
      therapy in traditional health care settings. Improving warfarin therapy has been crucial for
      Chinese patients. Wechat is social-software in China. Most of all Chinese adults use Wechat,
      as well as our patients. So we set up a Wechat-based mini-program to instruct Chinese
      patients' warfarin therapy. We aim to assess whether social software could improve warfarin
      therapy in Chinese patients by conducting a single-centre, open-label, prospective,
      randomized clinical trial.
    

Detailed description: 
      Social software is becoming a necessary of life. Wechat, powered by Tencent company, is the
      most popular social software in China. People can chat with others no matter how far away
      from each other.

      Anticoagulation Quality is very important for patients receiving warfarin anticoagulation
      therapy, which is usually evaluated Time in therapeutic range (TTR). It is reported that TTR
      is very low (38.8%) in China patients. So we are planning to introduce the social software to
      set up a bridge for clinicians and their patients, to instruct warfarin therapy. We aim to
      investigate whether social software could be used to improve warfarin anticoagulation quality
      of Chinese patients.

      We planned to enrol enough eligible patients receiving warfarin therapy due to the mechanical
      valves in a randomized controlled trial. Warfarin-treated patients were assigned to social
      software management group ( in which warfarin therapy was guided via the social platform by
      experienced clinicians) or to the traditional management control group (in which warfarin
      therapy was managed with traditional model). The primary outcomes the first time to bleeding
      or thrombotic events, the secondary outcomes were an elevation in time in therapeutic range
      (TTR) of international normalized ratio (INR), reduction in INR variation and number of
      extremely high INR results during 18 months.
    

Intervention name(s): Social-software management
Intervention type(s): Behavioral
Intervention description(s): Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TTR; INR; Warfarin; social software
Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin
      that has been sensitized to heat by ultraviolet light. This study is designed to see if this
      is also true in man.
    


Intervention name(s): PF-04531083 100mg; PF-04531083 2000mg; Placebo suspension; Placebo tablet; Oxycodone 20mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral PF-04531083 100mg suspension single dose; Oral PF-04531083 2000mg suspension single dose; Oral Placebo suspension (matched to PF-04531083 suspension); Oral Placebo tablet (matched to Oxycodone); Oral Oxycodone 20mg (Oxycontin) controlled release formulation
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; cross-over; randomized; placebo and active controlled; heat pain; UVB-Induced pain model
Evaluate Efficacy and Safety in Chinese Patients With Infantile-Onset Pompe Disease With One Year Alglucosidase Alfa Treatment
Condition: Glycogen Storage Disease Type II
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To evaluate effect of 52-week treatment with Alglucosidase Alfa in the extension of survival
      and improvement of cardiomyopathy measured by Left Ventricular Mass Index in Chinese patients
      with infantile-onset Pompe Disease.

      Secondary Objectives:

        -  To observe the improvement of physical growth, motor and cognitive development of
           52-week treatment with Alglucosidase Alfa in infantile-onset Pompe Disease from the
           baseline.

        -  To observe the efficacy on survival free of invasive ventilation, use of any ventilation
           support of 52- week treatment with Alglucosidase Alfa in Chinese patients with
           infantile-onset Pompe Disease.

        -  To evaluate the safety and tolerability of Alglucosidase Alfa in Chinese patients with
           infantile-onset Pompe Disease.
    

Detailed description: 
      Total of 56 weeks in the study period, including an up to 28-day screening period and 52-week
      treatment period, followed by 30-day post-treatment observation period.

      After the end of 52-week treatment, patients' guardians could choose to participate in a
      patient assistance program (PAP) sponsored by Sanofi and launched before first patient out
      (FPO) or reimbursement from social insurance for continued treatment.
    

Intervention name(s): ALGLUCOSIDASE ALFA (MYOZYME)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: cake or powder for injection
Route of administration: intravenous infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Methotrexate and Infliximab
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      Combination Methotrexate and Infliximab:Influence of immunogenicity on the efficacy of
      infliximab in patients with Ankylosing Spondylitis.
    

Detailed description: 
      Forty consecutive patients will be recruited from the rheumatology clinic of the Prince of
      Wales Hospital with AS meeting the modified New York criteria with active disease as defined
      (see below). They will be randomized to receive MTX 7.5 mg/week initially with a weekly 2.5mg
      increment until 15mg/week dosage is reached,( i.e by week 6) or a placebo together with folic
      acid 5mg daily for a period of 16 week. After 16 weeks, all patients will receive infliximab
      at 5 mg/kg per dose, at weeks 16, 18, and 22 (3 doses), and will continue with MTX 15 mg/week
      or placebo. Thereafter, they will be followed up at week 30, 38 weeks. MRI changes in the
      sacroiliac joints (SI) before and after infliximab treatment.
    

Intervention name(s): Infliximab and MTX
Intervention type(s): Drug
Intervention description(s): MTX 15mg weekly Infliximab 5mg/kg given at day 0, wk 2, wk6
Other intervention name(s): remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ankylosing Spondylitis; MTX; Infliximab
Study to Evaluate Safety and PK of NTM-1634 vs Placebo Administered Intravenously in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety and pharmacokinetics of NTM-1634 in healthy subjects.
    

Detailed description: 
      NTM-1634 drug product is a mixture of four human monoclonal IgG1 antibodies.

      This study is a randomized, double-blind, placebo controlled dose escalation study of three
      dose cohorts. Cohort A: 0.33mg/kg; B: 0.66mg/kg; and C: 1 mg/kg.
    

Intervention name(s): NTM-1634; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NTM-1634 drug product is a mixture of four human monoclonal IgG1 antibodies. Three dose cohorts (A: 0.33 mg/kg B: 0.66 mg/kg, and C: 1 mg/kg).; placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        -  To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion
           during the first hour after a standard meal in comparison to insulin aspart in obese
           subjects with type 2 diabetes.

      Secondary Objectives:

      Pharmacodynamic objectives:

        -  To assess the effect of insulin glulisine on the postprandial plasma glucose excursion
           during 6 hours after a standard meal in comparison to insulin aspart.

      Pharmacokinetic objective:

        -  To assess post-prandial plasma insulin excursion after a standard meal, in each
           treatment groups

      Safety objective:

        -  To assess the safety of insulin glulisine in comparison to insulin aspart
    

Detailed description: 
      Duration of treatment: two study days separated by a 7-day wash-out period

      Duration of observation:

        -  screening period of 1-2 weeks, >2 study days (with a wash-out period of 7 days between
           the study days),

        -  Follow-up visit (within 2 weeks after the end of the study treatment period).
    

Intervention name(s): Insulin glulisine; Insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Insulin glulisine 100 U/ml, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal; Insulin aspart: 100 U/mL, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal
Other intervention name(s): Apidra; NovoRapid
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sedation and Ease of Weaning From Mechanical Ventilation
Condition: Respiratory Failure; Midazolam Overdose; Chronic Obstructive Pulmonary Disease; Weaning Failure
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency
Study type: Interventional

Summary: 
      Daily interruption of sedation is one of the modalities which is known to enhance early
      weaning and separation from mechanical ventilation . Daily sedation interruption is also
      known to help decreasing incidence of ventilator associated pneumonia. The new modality is no
      sedation.
    

Detailed description: 
      there is an increase of incidence of chronic obstructive lung disease associated respiratory
      failure which necessitates invasive mechanical ventilation. It is well known that one of the
      bundles for enhanced recovery of such cases is the daily interruption of sedation . Recently
      studies have demonstrated the feasibility of just using sedation for initiation of mechanical
      ventilation, then utilization of no sedation technique as a more this offers less side
      effects .
    

Intervention name(s): Daily interruption of midazolam
Intervention type(s): Drug
Intervention description(s): daily at 7 am midazolam infusion will be stopped spontaneous breath trial will be done
Other intervention name(s): sedation interruption
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers
Condition: Simvastatin Pharmacokinetics and Gut Microbiome
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase 1 clinical trial is to evaluate the effects of the environmental change in
      intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy
      male volunteers. For change of intestine environment, especially the gut microbiota,
      investigators will administer PO vancomycin for 7 days, tid.
    


Intervention name(s): Vancomycin 250Mg Capsule
Intervention type(s): Drug
Intervention description(s): Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.
Other intervention name(s): simvastatin
Intervention MeSH terms: Vancomycin; Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; simvastatin; vancomycin; gut microbiome