bioihbjkbjnl/mcl2 huggingface dataset:
Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets
Condition: Nausea and Vomiting, Postoperative; Nausea With Vomiting Chemotherapy-Induced
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover
      bioequivalence study with a 7-day washout between periods. Each treatment was administered
      after an overnight (10 hours) fast.
    

Detailed description: 
      This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence
      crossover study conducted in healthy adult male and female volunteers. Subjects checked into
      the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1.
      Subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior
      to dosing in both periods. Subjects received the 2 treatments in a randomized order with a
      7-day washout between the 2 periods.

      Treatment A: single dose of ondansetron ODFS 8 mg was orally administered, allowed to
      dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water

      Treatment B: single dose of Zofran ODT (containing ondansetron 8 mg) was orally administered,
      allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking
      water
    

Intervention name(s): Ondansetron (ODFS); Zofran (ODT)
Intervention type(s): Drug; Drug
Intervention description(s): Test Article; Comparator
Other intervention name(s): Ondansetron Orally Dissolving Film Strip; Zofran Orally Disintegrating Tablet
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two period study, two treatment, randomized sequence
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence, safety, and tolerability
Cervical Multifidus Muscle Function
Condition: Proprioception; Muscle Activation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the relationship between cervical multifidi
      thickness, cervical spine proprioception and possible reflex activation of cervical multifidi
      through stimulation of joint mechanoreceptors. Cervical mechanoreceptors will be activated
      with an innocuous, nonspecific stimulation. Participants will have cervical spine
      proprioception assessed through joint position sense testing. The multifidus muscle thickness
      and activation state is to be assessed by sonography. These measures are done pre & post to
      the innocuous stimulation. There is no specific hypothesis.
    


Intervention name(s): Nonspecific, Innocuous, Mechanoreceptor Stimulation
Intervention type(s): Other
Intervention description(s): A custom device will be used to provide light manual cervical traction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment
Condition: MDD
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment
      in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective
      serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI)
      response in a school or work environment.
    


Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Treatment 12 weeks) - Up to 3 mg/day, once daily dose, tablets, orally
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; Major depressive disorder; Anxiety Symptoms; School, Work environment; Mental Disorders; Psychotic Disorders; antipsychotic
Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
Condition: Hyperinsulinemic Hypoglycemia; Postprandial Hypoglycemia
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is investigating the effect of a novel glucagon analogue administration
      in gastric bypass operated individuals, who are reactive hypoglycemic.
    

Detailed description: 
      The Roux-En-Y gastric bypass (RYGB) has major health-promoting effects - reversing
      type-2-diabetes, improving dyslipidemia and inducing robust weight loss. However, several
      RYGB-individuals, post surgery, suffers from dumping syndrome and postprandial
      hyperinsulinemic hypoglycemia (PHH) due to the anatomical rearrangement of the
      gastro-intestinal system. Dasiglugaon (also known as (ZP4207) has shown great
      pharmacokinetic- and dynamic effects, compared to other glucagon analogues on the market,
      when administrated to hypoglycemic type-1-diabetics.

      Therefore we aim to examine the effects of two different doses of dasiglucagon on the
      postprandial nadir plasma glucose concentration in RYGB-operated individuals suffering from
      PHH by use of a mixed meal test (MMT).

      The study is designed as a double-blinded, randomised, 3-period, 3-treatment, crossover study
      comprising 3 separate treatment days in which participants will undergo an MMT along with one
      of the following double-blinded interventions:

        1. Subcutaneous (sc) placebo (saline) injection

        2. Sc injection with 80 μg dasiglucagon

        3. Sc injection with 200 μg dasiglucagon
    

Intervention name(s): ZP4207; Placebo (saline)
Intervention type(s): Drug; Other
Intervention description(s): Abdominal SC administration; Abdominal SC administration
Other intervention name(s): Dasiglucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Menopur And Rekovelle Combination Study
Condition: Fertility Disorders
Study type: Interventional

Summary: 
      This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in
      a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on
      the established algorithm, combined with a variable, adjustable dose of Menopur based on body
      weight and ovarian reserve.
    

Detailed description: 
      The initial dose of follitropin delta will be determined at enrolment by the analysis of
      serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body
      weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be
      determined at enrolment by the total follitropin delta dose and body weight in Kg
    

Intervention name(s): Follitropin delta and HP-hMG
Intervention type(s): Combination Product
Intervention description(s): Follitropin delta dose will be determined by AMG and weight in Kg. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight in Kg
Intervention MeSH terms: Follicle Stimulating Hormone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ovarian Response; In vitro fertilization; Controlled ovarian stimulation
Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
Condition: Menopause; Hot Flashes; Vasomotor Disturbance
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      The broad goal of this study is to obtain pilot data to determine the tolerability and
      preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime
      vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose and only at
      night in peri- and postmenopausal women. We hypothesize that the majority of participants
      will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of
      nighttime VMS will improve on low-dose gabapentin dosed at bedtime.
    

Detailed description: 
      Thirty-two peri- and postmenopausal women at the Boston sites (MGH and BWH) were enrolled
      into this open-label pilot study. The study was a 7-week intervention study using open-label
      gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by
      300-mg for 3 weeks, and then 600-mg for 3 weeks. The intervention study followed a 3-week
      screening period to establish a stable baseline for insomnia symptoms and VMS and to
      determine the safety of administering gabapentin in study participants. Tolerability and
      treatment response (insomnia symptoms, nighttime VMS) were assessed systematically at each
      study visit. The dose titration schedule was followed in all participants unless there are
      dose-limiting toxicities.
    

Intervention name(s): Gabapentin
Intervention type(s): Drug
Intervention description(s): The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
Other intervention name(s): Neurontin
Intervention MeSH terms: Gabapentin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MICHAEL Method- Fulfilling Individual Potential to Attain Excellence - as a Tool for Improving Metabolic Control and Quality of Life Among Adolescence With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal
      checks of blood sugar levels, injecting insulin, changing eating habits and physical
      exercise, which requires a real change in the life of the child & adolescent and can cause
      significant damage to the quality of life as well.

      Compliance to treatment is a major challenge for all patients and mostly to adolescence,
      which often worsen their diabetes control at that age.

      The Michael Method is a unique, holistic program to develop and realize an individual's
      emotional, intellectual and behavioral potential, which is based on the belief that every
      human being can excel in every field they choose. The method was developed in 1988 by a
      multi-disciplinary team of professional academic in Israel. Today the Israeli education
      system implements the method in Junior High Schools and High Schools in diverse educational
      sectors. The program is taught at many other various frameworks: teachers' continuing
      education programs, colleges, programs run by the Ministries of Defense and Social Welfare,
      the National Insurance Institute, the National Electric Corporation and in many other public
      and private frameworks.

      The proposed study is aimed to assess whether the Michael Method can be used as a tool for
      improving metabolic control and quality of life among uncontrolled adolescence with type 1
      diabetes
    


Intervention name(s): Michael Method
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 1 Diabetes; Metabolic Control; Quality of Life
Upper GI Handling of Branded vs. Generic Alendronate
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare upper GI handling of fosamax and generic, because the main AE profile of
      alendronate is before systemic absorption in the esophagus; differences could be relevant to
      the side effect profile.
    


Intervention name(s): MK0217, alendronate sodium / Duration of Treatment: 1 Month; Comparator: Alendronate-Teva / Duration of Treatment: 1 Month
Intervention type(s): Drug; Drug
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Investigation of the Serum Mucoprotein 3 (MUC3) Protein Levels in Gestational Hypertensive Disease
Condition: Muc3; Pregnancy Induced Hypertension
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Observational [Patient Registry]

Summary: 
      Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for
      maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein
      takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This
      study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of
      pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20
      gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010-
      January 2011.
    

Detailed description: 
      Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for
      maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein
      takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This
      study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of
      pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20
      gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010-
      January 2011. This is the first study measuring levels of serum mucoprotein three in
      gestational hypertensive disease. MUC3 levels showed a distinctive increase in hypertensive
      diseases of pregnancy compared with the pregnant control group. As a result, it is found that
      plasma mucoprotein 3 levels increase as the severity of hypertensive diseases of pregnancy
      increases; and plasma mucoprotein 3 could be a precursor for the evaluation of the severity
      of the disease.
    

Intervention name(s): draw blood
Intervention type(s): Diagnostic Test
Intervention description(s): draw blood from the all of patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients who were diagnosed with hypertensive disease among the patients who applied to the
        pregnant clinic of Karadeniz Technical University Faculty of Medicine, Obstetrics and
        Gynecology Department with the approval of the KTÜ Faculty of Medicine Research Ethics
        Committee dated 27.05.2010 and 154 number ( 80 cases, including the study group and 20
        normotensive pregnant control group) were included in the study between June 2010 and
        January 2011.
      
Keywords: Muc3; Preeclampsia; Eclampsia; HELLP
A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200
Condition: Absorption, Metabolism and Excretion in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.
    

Detailed description: 
      This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to
      determine the absorption, metabolism, and excretion (AME) of [14C]-PBI-200
    

Intervention name(s): [14C]-PBI-200
Intervention type(s): Drug
Intervention description(s): [14C]-radio-labeled-PBI-200
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking
Condition: Alcohol Drinking; Drinking Behavior; Episodic Memory; Long-term Memory
MeSH terms: Alcohol Drinking; Drinking Behavior
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether hydrocortisone biases formation of
      alcohol-related memories to potentiate drinking.
    

Detailed description: 
      This study aims to 1) Characterize the effect of elevated glucocorticoids during encoding on
      long-term memory for alcohol-related information; 2) Identify the neural mechanisms by which
      glucocorticoids influence encoding of alcohol-related experiences; and 3) Determine how
      glucocorticoid modulation of alcohol-related encoding relates to drinking after retrieving
      alcohol-related memories.
    

Intervention name(s): Hydrocortisone 20 MG; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants receive Hydrocortisone 20 MG; Participants receive placebo
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if a single or repeat intra-articular injection of
      Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to
      determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.
    


Intervention name(s): Gel-200
Intervention type(s): Device
Intervention description(s): Single Intra-articular Injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postural Control Instability in Children With Mild Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Objective: Individuals diagnosed with Autism Spectrum Disorder (ASD) exhibit some type of
      motor control impairment, for instance, motor apraxia and history of gross motor delay that
      could lead to increased risk of fall. This pilot research was designed to assess and
      characterize static postural stability and create a starting point to better understand and
      describe postural control in children with mild autism. Method: We measured static postural
      control with center of pressure (COP) displacement in 10 children with mild autism during
      eight sensory conditions that challenge and cancel the visual, proprioceptive and vestibular
      systems.
    

Detailed description: 
      Materials and methods Institutional Review Board (IRB) approval at the University of Puerto
      Rico, Medical Science Campus has obtained prior the recruitment of the participants. Parents
      of children diagnosed with mild ASD who were interested in the study called the number on the
      recruitment flyer. The PI spoke with the parent to assess whether their child qualified for
      the study based on the following inclusion and exclusion criteria.

      Balance Assessment Protocol

      The balance assessment procedure included the following; each subject was instructed to stand
      on both feet for 15 seconds on the pressure MatScan under eight different conditions. The
      first four conditions were executed over a stable surface and consisted of the following: (1)
      eyes open (EO) -evaluates visual, vestibular and proprioceptive systems, (2) eyes closed (EC)
      -eliminates visual input, evaluates vestibular and proprioceptive system, (3) eyes open while
      moving head up and down (at 60 beats per minute) (EO HUD) -evaluates visual and
      proprioceptive system and alters vestibular input, (4) eyes closed while moving the head up
      and down (EC HUD) -evaluates the effect of removing visual information, and the vestibular
      input being altered. The subjects then performed the same four tasks, this time standing on
      an unstable platform (high quality closed cell foam 19 inches long x 15 inches width x 2.25
      inches)with the purpose of altering the proprioceptive input and increasing dependence on the
      visual and vestibular systems.
    

Intervention name(s): Postural Control Balance Assessment
Intervention type(s): Other
Intervention description(s): Postural Stability Testing Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed 8 balance tasks.
Intervention model: Single Group Assignment
Intervention model description: The balance assessment procedure included the following; each subject was instructed to stand on both feet for 15 seconds on the pressure MatScan under eight different conditions.
Masking: None (Open Label)
Primary purpose: Screening
Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension
Condition: Pregnancy Related; Hypertension in Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Observational

Summary: 
      Background: Pregnancy-induced hypertension (PIH) is responsible for most perinatal and fetal
      mortality. Few programs are patient-centered during pregnancy, increasing the risks of
      misinformation and misconceptions among pregnant women and, as a result, malpractices.
      Objective: This study aims to develop and validate a form to assess the knowledge and
      attitudes of pregnant women about PIH.
    

Detailed description: 
      Many observational studies explored the awareness of pregnant women of PIH, but no structured
      tool is available to assess such awareness. During the past two years, education campaigns
      were postponed and primary care was prioritized. To allow better-informed decisions and
      targeted actions, this pilot study aims to develop and validate a short form to assess the
      knowledge and attitudes of pregnant women about pregnancy-induced hypertension. The long-term
      objective of this study is to provide a practical tool for pregnant women.
    

Intervention name(s): Survey
Intervention type(s): Behavioral
Intervention description(s): A short 25-item tool was developed and can be applied in clinics to assess the awareness of pregnancy hypertension.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women were targeted from five obstetrics and gynecology clinics.