bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Cisatracurium on Sccinylcholine-induced Fasciculations
Condition: Fasciculations
MeSH terms: Fasciculation
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the effects of different doses of cisatracurium pretreatment on
      succinylcholine-induced fasciculations.
    

Detailed description: 
      Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into
      three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium,
      respectively. General anesthesia was induced 3.5 min later, train of four stimulation was
      monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal
      intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of
      fasciculations, intubating conditions, time and extent to maximal depression of twitch and
      time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively,
      serum potassium before cisatracurium pretreatments, at intubating time, and 5 min after
      intubation were recorded.
    

Intervention name(s): Cisatracurium
Intervention type(s): Drug
Intervention description(s): Different groups received different pretreatments of cisatracurium.
Other intervention name(s): Dose
Intervention MeSH terms: Cisatracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study Evaluating the Pharmacokinetic Profile of Novel Formulations of RHUDEX®
Condition: Formulation Finding
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are:

        -  To compare the pharmacokinetic profiles of RhuDex administered as two novel oral
           formulations

        -  To identify the lead formulation and optimise the pharmacokinetic profile by modifying
           the quantitative composition of that formulation

        -  Optional: To assess the intravenous pharmacokinetics of RhuDex following administration
           of an IV microtracer of [14C]RhuDex
    


Intervention name(s): RhuDex
Intervention type(s): Drug
Intervention description(s): Part 1:
Regimen A: Rhudex Formulation in Labrafac/ Gelucire Regimen B: Rhudex Formulation in Labrafac/ Aerosil single dose
The formulation platform (A or B) that shows the best potential to achieve the target PK profile and shows acceptable safety and tolerability will be progressed into part 2 of the study. The purpose of part 2 is to optimize the selected formulation platform. This will be achieved by administrating up to four different formulation compositions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients
Condition: Antiphospholipid Antibody Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to see if the CoaguChek XS is accurate in measuring
      International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome
      (APL) receiving warfarin therapy.
    

Detailed description: 
      Antiphospholipid Antibody Syndrome (APL) is an autoimmune disease that increases ones risk
      for blood clots. Therefore, these patients receive anticoagulation therapy with warfarin.
      Point of care devices such as the CoaguChek XS are often used to monitor International
      Normalized Ratio (INR) in patients on warfarin. However, the antibodies present in patients
      with APL may lead to false INR results when using the CoaguChek XS. This study will compare
      the accuracy of the CoaguChek XS in measuring INR in patients with APL by measuring INR by
      the CoaguChek XS and a standard lab as a reference point. Patients on warfarin for
      indications other than APL will be measured by both methods as well to serve as a control
      group.
    

Intervention name(s): CoaguChek XS; Standard Lab Draw
Intervention type(s): Device; Procedure
Intervention description(s): CoaguChek XS will be used to measure INR in patients with APL; Patients on warfarin for any indication other than APL will measure INR by venous lab draw
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office
        visit with pharmacy.
      
Keywords: Anticoagulation; International normalized ratio; Warfarin
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after
      14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by
      hyperinsulinemic euglycemic clamp.
    

Detailed description: 
      The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese
      (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD®
      (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment
      3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of
      insulin resistance, lipid and glucose metabolism will be performed; before and immediately
      after the treatment. Furthermore, the therapy compliance will be verified using the method of
      drug counting and therapeutic drug monitoring (TDM).
    

Intervention name(s): Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat; Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir; Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): STRIBILD® QD, d1-14; Truvada®/ Kaletra® 200/50 mg QD, d1-14; Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14
Other intervention name(s): STRIBILD®; Truvada® / Kaletra®; Truvada®/Prezista®/Norvir®
Intervention MeSH terms: Ritonavir; Lopinavir; Darunavir; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Cobicistat; Elvitegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ART, HIV, insulin resistance
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-201 Clinical Trial
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Observational

Summary: 
      This is an open-label follow up study to evaluate the safety for the subjects with
      ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.
    

Detailed description: 
      This is an open-label follow up study to evaluate the safety for the subjects with
      ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.

      ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells.
      Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as
      vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can
      enhance wound healing and regeneration of new tissue, finally may provide a new option in
      treating a Diabetic Foot Ulcer.
    

Intervention name(s): ALLO-ASC-DFU; Standard therapy
Intervention type(s): Biological; Other
Intervention description(s): Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention.; Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention.
Other intervention name(s): Allogeneic mesenchymal stem cells
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of
        ALLO-ASC-DFU-201.
The Effect of Cigarette Smoking / Smoking Cessation on Skeletal Muscle Mass, Strength and Functional Capabilities
Condition: Smoking Cessation; Body Composition, Beneficial; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Observational

Summary: 
      Tobacco smoke is probably the single most significant source of toxic chemicals that humans
      are exposed to. Smoking is associated with a variety of pathological conditions such as
      cardiovascular and pulmonary diseases. In addition to the known harmful effects of cigarette
      smoking, several epidemiological studies identified tobacco use as a risk factor for
      sarcopenia, the loss of skeletal muscle mass and strength with advancing age. Previous
      studies examined skeletal muscles of smokers in comparison with muscles of non-smokers and
      found structural and metabolic damage in muscles of smokers.

      Quitting of smoking is known to be associated with weight gain. A previous study examined the
      effects of smoking cessation on body composition of post-menopausal women using dual-energy
      x-ray absorptiometry (DEXA). It was found that women who successfully quit smoking for a
      period of 16 months have significantly increased their body weight, fat mass, muscle mass and
      functional muscle mass in comparison with non-quitters women. For the first time, it was
      shown that smoking cessation is associated with an increase of functional muscle mass. Yet,
      the effects of quitting of smoking on muscle mass and muscle functional capabilities of
      younger subjects remain unclear. Therefore, we aim to investigate the effects of smoking
      cessation on muscle mass, muscle function and strength in heavy smoker's subjects. Our
      findings may shed light on the beneficial effects of smoking cessation regarding the status
      and function of skeletal muscle in heavy smokers and as a possible strategy to prevent or
      delay the progression of sarcopenia.

      Research hypothesis: Smoking cessation among adult heavy smokers will lead to increase in
      skeletal muscle mass and improvement of muscle function and strength compared with continued
      smokers.
    

Detailed description: 
      Body composition and muscle function were assessed at the beginning of a smoking cessation
      program and again after 12 months. Changes in body composition and muscle function were
      compared between continued smokers and quitters.
    

Intervention name(s): Assessment of body composition and muscle function
Intervention type(s): Device
Intervention description(s): Assessment of body composition by DEXA and BIA Measurement of muscle function by hand-grip dynamometer and physical tests Comparison between quitters and continued smokers
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were recruited from support groups of smoking cessation conducted at "Clalit
        Health Services" at Haifa and Western Galilee district.
Active Play Intervention for Preschoolers
Condition: Exercise
Study type: Interventional

Summary: 
      The goal of this randomized clinical trial is to examine the effects of a planned movement in
      preschool-aged children. The main question is to determine

      * What are the effects of a planned movement program on physical activity, body composition,
      fundamental motor skills, and time on task in preschool children aged 3-5 years?

      Researchers will compare a planned movement program to a control group, where current
      instruction is implemented.
    

Detailed description: 
      A majority of preschool children do not participate in the recommended levels of physical
      activity and are deficient in fundamental motor skills. These deficits may also impact body
      composition. Preschool teachers serve as the gateway to providing physical activity
      opportunities at preschool but many fail to do so. As play is developmentally appropriate for
      preschools and part of many curriculums adding active elements to play may be a feasible
      solution for teachers to implement physical activity opportunities. This project will
      evaluate the effect of a planned movement program that incorporates elements of active play
      on preschoolers' body composition, physical activity, time on task, and fundamental motor
      skills at week 0, week 12, and week 24. Physical Activity will be assessed throughout the
      school year with a wrist-worn wearable accelerometer. Body composition will be assessed with
      a foot-to-foot bioelectrical impedance scale. Fundamental motor skills will be assessed by
      the Peabody Developmental Motor Scales 2nd Edition and Time on-task will be measured by
      observing children in their classroom. The outcomes of this study will be used to implement
      sustainable physical activity programming for preschoolers.
    

Intervention name(s): Active Play planned movement program
Intervention type(s): Behavioral
Intervention description(s): Teachers will implement an addition two physical activity opportunities that incorporate active play each day for a potential dose of 20-30 minutes per day and 100-150 minutes per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two preschools. One will be randomized to the intervention and one to the control group.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Preschoolers; Active Play; Teacher guided interventions
Comparison of the Effect of Tipranavir and Ritonavir or Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Zidovudine in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to characterize the effect of two dose combinations of
      tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered twice
      daily on the pharmacokinetics (PK) of zidovudine (ZDV) and zidovudine-glucuronide (GZDV) as
      well as the effects of zidovudine on the pharmacokinetics of TPV/RTV
    


Intervention name(s): Tipranavir (TPV) low; Ritonavir (RTV) low; Tipranavir (TPV) high; Ritonavir (RTV) high; Zidovudine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Norvir®; Retrovir®
Intervention MeSH terms: Ritonavir; Zidovudine; Tipranavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare the Amount of Meloxicam in the Blood When it is Taken as Capsules or as Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to investigate the relative bioavailability of Movalis
      capsules 15 mg (Test, T) versus Movalis tablets 15 mg (Reference, R).

      The secondary objective of the study is to establish bioequivalence of Movalis capsules 15 mg
      (Test, T) versus Movalis tablets 15 mg (Reference, R).
    


Intervention name(s): Meloxicam Capsule (Test); Meloxicam Tablet (Reference)
Intervention type(s): Drug; Drug
Intervention description(s): single dose; single dose
Other intervention name(s): Movalis; Movalis
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mulberry Leaf Extract and Blood Glucose Control in Diabetics
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Mulberry leaf teas or extracts are used as a natural remedy for diabetes in some countries.
      Animal studies have shown some effect of mulberry leaf extract on blood glucose. The purpose
      of this trial is to assess the effect of mulberry leaf extract on type 2 diabetics, by
      measuring blood glucose two hours after eating a meal and taking a capsule containing either
      mulberry leaf extract or a placebo.
    

Detailed description: 
      Patients will participate in a double blind randomized cross over trial for 6 weeks. Four 2
      weeks, half of the type 2 diabetic patients will receive mulberry leaf capsules three times
      per day with meals (made from Mulberry Zuccarin tablets - New Nordic, 400 mg of mulberry leaf
      extract per tablet) and half will receive placebo capsules. Following a one week wash out
      period, the treatments administered to each group will be reversed for the next 2 weeks, and
      data will continue to be gathered for a final wash out week. Patients will keep a diary of
      food, exercise, and fasting glucose each morning as well as at least one 2 hour pc glucose
      each day. Weight, hemoglobin A1C, liver function tests, and renal function tests will be done
      at baseline and at the end of the 6 weeks. As well, blood pressure will be monitored when the
      2 weekly batches of medication are distributed, and at the end of the 6 weeks.
    

Intervention name(s): Mulberry leaf extract effect on post prandial blood glucose
Intervention type(s): Dietary Supplement
Intervention description(s): Mulberry leaf extract (400 mg, Mulberry Zuccarin, New Nordic) or placebo will be administered with meals to type 2 diabetics. Half the patients will receive mulberry leaf extract for the first two weeks and half will receive placebo. Following a one week wash out period, the interventions will be reversed for another 2 weeks, followed by a final wash out period. Subjects will keep diaries of food, exercise, daily fasting glucose, and at least one 2 hour pc glucose per day for the 6 weeks of the trial.
Baseline renal function blood work and urine, liver function blood work, hemoglobin A1C, weight, and blood pressure will be done. These will be repeated at the end of each subject's 6 weeks in the trial. In addition, blood pressure will be checked with the distribution of the each 2 week batch of medications.
Other intervention name(s): Mulberry Zuccarin, 400 mg tablets. New Nordic (Sweden)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes mellitus type 2; mulberry leaf extract; post prandial blood glucose
Modulation of Visual-Spatial Learning in Healthy Young Adults by tDCS
Condition: Healthy Young Adults
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether a combination of intensive training of
      visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation
      (tDCS) leads to an improvement of learning and memory in healthy young adults and to examine
      the underlying neuronal mechanism.
    


Intervention name(s): tDCS; training
Intervention type(s): Device; Behavioral
Intervention description(s): transcranial direct current stimulation (tDCS); intensive training of visual-spatial abilities (in LOCATO task)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: healthy young adults; tDCS; LOCATO task; visual-spatial learning
Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke
Condition: Cerebral Infarction
MeSH terms: Ischemic Stroke; Cerebral Infarction; Infarction
Study type: Observational

Summary: 
      While perinatal ischemic stroke is the most frequent form of childhood stroke, early
      determinants of outcome remain poorly understood. Two main structural biases limit the
      accuracy of most studies: heterogeneity of the population and short follow-up.

      Perinatal ischemic stroke includes several conditions that differ in pathophysiology and
      timing of occurrence. Yet, it is not surprising that risk factors and outcome depend
      primarily on the type of stroke. Age at evaluation also plays a major role after a neonatal
      insult. Even though the original lesion is static and focal in perinatal stroke, its
      consequences grow over time within the maturing brain and affect all fields of
      neurodevelopment.

      The objective of the AVCnn study was to delineate the determinants, clinical and imaging
      presentation, mechanism, and long term outcome of a category of perinatal stroke (neonatal
      arterial ischemic stroke: NAIS). This led to the AVCnn cohort, which now gives us the
      opportunity to regularly monitor a large cohort of children having suffered an NAIS.
    

Detailed description: 
      Between November 2003 and October 2006, a cohort of one hundred symptomatic term newborns
      with AIS confirmed through early brain imaging has been constituted.

      Regular contacts with the families and their local physician have been maintained since
      enrollment. In 2010, families were asked through postal mail to participate in the 7 years
      assessment (AVCnn7ans). Those who accepted were contacted by phone by the coordinators of the
      study during the months preceding the child's seventh birthday and invited to attend a
      presentation in person of the current project. This evaluation took place face-to-face for a
      whole day in a medical setting close to the family residence. The evaluation team included a
      neuropsychologist, a speech therapist and either a pediatric neurologist or a pediatric
      physical and rehabilitation medicine practitioner.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children who have had an ischemic arterial stroke between November 2003 and October 2006,
        in France, who was included in "AVCnn cohort" and who accept an psychological and physical
        examination at 7 years
      
Keywords: neonatal arterial ischemic stroke; language development; global intellectual functioning; motor abilities
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021
      in adult hypogonadal male subjects.
    


Intervention name(s): LPCN 1021
Intervention type(s): Drug
Intervention description(s): Oral testosterone undecanoate
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tyrosine for Methamphetamine Dependence - 1
Condition: Amphetamine-Related Disorders
MeSH terms: Amphetamine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate efficacy of tyrosine as a treatment for
      methamphetamine dependence in an outpatient treatment setting providing group psychosocial
      interventions. Examine effect of tyrosine on abstinence, retention in treatment, and
      craving."
    

Detailed description: 
      Evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient
      treatment setting providing group psychosocial interventions. Examine effect of tyrosine on
      abstinence, retention in treatment and craving.
    

Intervention name(s): Tyrosine
Intervention type(s): Behavioral
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: amphetamine dependence