bioihbjkbjnl/mcl2 huggingface dataset:
Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I, open-label, randomized, 3-period crossover study was designed to determine the
      relative bioavailability of ipatasertib administered as capsule and tablet formulations to
      healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be
      determined. Participants will be randomized to one of six treatment sequences to receive
      three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in
      the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the
      fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations
      will be performed throughout the study. Time on study is expected to be 3 weeks.
    


Intervention name(s): Ipatasertib (capsule); Ipatasertib (tablet)
Intervention type(s): Drug; Drug
Intervention description(s): Orally administered single dose of Ipatasertib formulated as a capsule.; Orally administered single dose of Ipatasertib formulated as a tablet.
Other intervention name(s): GDC-0068 (capsule); GDC-0068 (tablet)
Intervention MeSH terms: Ipatasertib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and
      to study its link with an energetic balance change.
    

Detailed description: 
      The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and
      to study its link with an energetic balance change.

      Twenty parkinsonian patients will be randomised : the delay between inclusion and
      neurostimulation wil be lengthened 3 months for one group, compared to the second one. The
      energy expenditure, at rest and after ingestion of a test meal, will be compared between the
      group of patients that had been neurostimulated and the group whose intervention has been
      postponed. Weight changes, energy intake, leptin level, neurophysiological parameters will be
      compared between both groups, and the nature and repartition of the weight gain will be
      assessed in the neurostimulated group. An eventual link between motor factors,
      pharmacological factors, and gain weight will be studied.
    

Intervention name(s): Deep brain stimulation
Intervention type(s): Procedure
Intervention description(s): Brain Stimulation of the Subthalamic Nucleus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Parkinson; deep subthalamic stimulation; pharmacological treatment
Assessment of Competence in Colonoscopy Using Motion Capture
Condition: Sensitivity Training Groups
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion
      analysis. In order to develop a non-biased tool to monitor competence.
    

Detailed description: 
      To compare a group of novices to a group of experienced endoscopists performining
      colonoscopy.

      Analyzing the motion pattern of the performers using a Kinect. Use the contrasting group
      method to set standards.
    

Sampling method: Non-Probability Sample
Study population: 
        Doctors in gastroenterology
      
Keywords: simulation; training; colonoscopy; standard setting
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
Condition: Diabetes, Type I
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes
    


Intervention name(s): Technosphere Insulin; Active comparator
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation, 15U/30U; sc injectable insulin
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Esophageal Manometry in Mechanically Ventilated Patients
Condition: Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      Esophageal pressure measurements are used in to determine chest wall elastance and calculate
      lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated
      esophageal balloon catheter is then placed in the esophagus to measure tidal variations in
      esophageal pressure.

      In this study high resolution solid-state manometry technique was used to provide detailed
      and continuous measurements of esophageal pressures in the different parts of the esophagus.
      Measurements were performed during ongoing mechanical ventilation at different levels of
      endexpiratory pressure.
    

Detailed description: 
      Esophageal pressure measurements are used in to determine chest wall elastance and calculate
      lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated
      esophageal balloon catheter is then placed in the esophagus to measure tidal variations in
      esophageal pressure.

      In this study high resolution solid-state manometry technique was instead used to provide
      detailed and continuous measurements of esophageal pressures in the different parts of the
      esophagus. The manometry catheter has 36 circumferential sensors at 1 cm intervals. Each
      sensor has 12 pressure-sensitive segments that add to the signal at that location.
      Measurements were performed during ongoing mechanical ventilation at different levels of
      endexpiratory pressure. Possible differences in tidal variations in esophageal pressure in
      different parts of the esophagus were assessed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Mechanically ventilated patients in the critical care unit and in the operating room.
      
Keywords: esophageal pressure; chest wall elastance; lung elastance; transpulmonary pressure
Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets
      in Chinese patients with hepatitis B
    


Intervention name(s): Entecavir maleate tablets; blank Baraclude tablets; Blank maleate entecavir tablets; Baraclude tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Entecavir; Maleic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Mechanism of Sox4 Transcription in Regulation of Angiogenesis in Hepatocellular Carcinoma
Condition: Translational Research of SOX4 in Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Two hundred HCC patients with partial hepatectomy were enrolled as a cohort for observational
      study. The inclusion criterion was intended curative hepatectomy for HCC patients by image
      analysis, and the exclusion criteria were unresectable disease, synchronous cancers,
      recurrent cancers, or distant metastasis. The study endpoint was 30 March 2019, and tumor
      staging was based on the 8th edition of the American Joint Committee on Cancer (AJCC) TNM
      staging system for HCC
    

Detailed description: 
      To determine the role of SOX4 in tumor progression in patients with HCC, we examined SOX4
      expression through immunohistochemistry (IHC) staining of 200 formalin-fixed and
      paraffin-embedded (FFPE) HCC specimens . The SOX4 high group of patients was associated with
      positive etiology of hepatitis B virus (P = 0.044), tumor size >5 cm (P = 0.014), thrombus
      formation (P = 0.012), higher microvessel density (MVD) (P = 0.012) in tumor lesions, and
      distant metastasis (P <0.001).

      Cox regression analysis showed that patients with elderly age (P <0.001), higher ⍺-fetal
      protein (AFP) (P = 0.045), presence of cirrhosis (P = 0.008), and SOX4 high in tumor specimen
      (P = 0.042) were independent risk factors . The SOX4 high group performed significantly worse
      regarding overall survival (OS) (P = 0.043) and disease-free survival (DFS) (P = 0.019) based
      on the Kaplan-Meier analysis.
    

Intervention name(s): microvessel density
Intervention type(s): Other
Intervention description(s): the vessel numbers in high power field with Anti-CD31 staining in tumor specimen
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        subjects with pathologic diagnosis of hepatocellular carcinoma
      
Keywords: SOX4; angiogenesis; microvessel density
Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
Condition: Fracture Healing
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an international, multi-center study to determine the efficacy, safety, and
      tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status
      post surgical fixation.
    


Intervention name(s): Placebo; Romosozumab
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous (under the skin) injection; Administered by subcutaneous injection
Other intervention name(s): AMG 785; Evenity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AMG 785; Proximal Femur; Fracture Healing; Hip Fracture
GM-CSF for Immunomodulation Following Trauma (GIFT) Study
Condition: Critical Injury (Trauma) in Children
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The GIFT study is a prospective, multi-center, interventional trial using the drug GM-CSF for
      the reversal of innate immune suppression in critically injured children. The study will be
      conducted in two phases, a dose-finding phase then an efficacy phase. The dose-finding phase
      is the current active phase of the study. The central hypothesis of the study is that
      immunomodulation with GM-CSF will result in reduction in the risk of nosocomial infection
      after critical injury in high-risk children through safe, rapid, and sustained improvement in
      innate immune function.
    

Detailed description: 
      The current phase of the study is an open-label dose-finding phase in which critically
      injured children undergo prospective, serial immune function testing in the first few days
      after injury. If a subject's immune function (as measured by whole blood ex vivo LPS-induced
      TNF-alpha production capacity) is below a critical threshold, the subject will receive GM-CSF
      at a dose of 30, 62, or 125 mcg/m2 per day for three days. Enrollment is stratified by
      pubertal status (Tanner 1 or Tanner > 1) and by presence or absence of severe traumatic brain
      injury (TBI). Dose-finding is being conducted independently in each of these strata. The
      outcome variable for the dose-finding phase of the GIFT study is restoration of TNF-alpha
      production capacity and monocyte HLA-DR expression by the end of treatment, persisting to
      post-trauma day 7. A subsequent randomized, placebo-controlled trial with nosocomial
      infection as the primary outcome variable is planned once dose-finding is complete. This
      study is being conducted by the NICHD's Collaborative Pediatric Critical Care Research
      Network (CPCCRN) with Nationwide Children's Hospital as the primary site. The study design
      information currently displayed on this site refers to the dose-finding phase of the project.
    

Intervention name(s): GM-CSF
Intervention type(s): Drug
Intervention description(s): GM-CSF is to be administered IV at one of four possible dosing regimens (three days at a dose of 30, 62, or 125 mcg/m2 per day, or an extended dosing regimen of 125 mcg/m2/day through post-trauma 6) if severe innate immune suppression is identified on post-trauma days 1, 2, or 3.
Other intervention name(s): sargramostim; leukine
Intervention MeSH terms: Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; trauma; critical; GM-CSF; immune
Fit Physicians: Use of Activity Monitors and Activity Integration Program in First Year Medical Students
Condition: Motor Activity; Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      Using FitBit activity monitors, physical activity levels will be monitored in first year
      medical students. Body Composition will be measured as well.
    

Detailed description: 
      Using fitness trackers and exercise testing, it will determine if participating in a novel
      program that incorporates wellness into the academic term will improve fitness.

      An estimate, 120 students will enroll in this study. Men and women aged 18-55 years of age
      that are just entering medical school. Students who are currently pregnant will not be
      allowed to participate in this study.

      Participation will involve 2 visits at the start of the academic school year, and two visits
      at the end of the academic school year.

      These visits will entail you undergoing a body composition scan measured by an duel energy
      x-ray absorptiometry (iDEXA) machine. The scan takes approximately 15 minutes. Subjects may
      be asked to perform an exercise stress test on a treadmill. The exercise test is
      approximately 40 minutes. Subjects may be asked to participate in a fitness program 2x a
      week, and may be asked to wear a Fitbit Flex™ activity tracker on the wrist for the duration
      of the school year. Investigators will be accessing academic grades to use for statistical
      purposes only. Subject names will never be given to any other party other than the
      investigators involved.
    

Intervention name(s): iDEXA Scan; Wellness Lectures; Exercise intervention; Activity monitor
Intervention type(s): Radiation; Other; Other; Other
Intervention description(s): Subjects will receive pre study and post study scans to assess body mass composition; Subjects in the Fit Physician Arm will be required to attend monthly wellness lectures; Subjects in the Fit Physician Arm will be required to attend weekly exercise interventions; Subjects in the Fit physician arm and the activity monitor arm will receive activity monitors to assess their activity level throughout the academic year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Medical student; Activity Monitor; Medical school; Fitness
The Efficacy of Steroid Therapy in Vestibular Neuritis
Condition: Vestibular Neuritis
MeSH terms: Vestibular Neuronitis; Neuritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to compare the treatment effectiveness of steroid therapy for
      vestibular neuritis by using video head impulse test.
    

Detailed description: 
      This study was a prospective, randomized controlled study. The enrolled vestibular neuritis
      patients were randomized to conservative treatment or steroid treatment when they are
      diagnosed with caloric test. After initial vestibular work-up including caloric, video head
      impulse tests, and a questinnaire (DHI), the patient was examined with the same tests again
      at 6 months later. The efficacy of steroid for the patients with vestibular neuritis would be
      determined by the comparison of the data of each group.
    

Intervention name(s): Ginkgo biloba & Methylprednisolone; Ginkgo biloba
Intervention type(s): Drug; Drug
Intervention description(s): Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month. Methylprednisolone 48 mg/day(per oral, once a day for first 9 days. And then methylprednisolone tapering was started every 2 days. The entire duration of methylprednisolone treatment was 14 days.; Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.
Other intervention name(s): Ginexin; Methylprednisolone; Ginexin
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vestibular neuritis; Vertigo; Head impulse test; Steroid
Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
Condition: Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and effect on body weight
      and other obesity-related factors of different doses of BMS-830216, compared to placebo. The
      study will also determine the amount of BMS-830216 in the blood.
    


Intervention name(s): BMS-830216; BMS-830216; BMS-830216; BMS-830216; BMS-830216; BMS-830216; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsules, Oral, 30 mg, once daily, 28 days; Capsules, Oral, 100 mg, once daily, 28 days; Capsules, oral, 300 mg, once daily, 28 days; Capsules, oral, 600 mg, once daily 28 days; Capsules, oral, 1200 mg, once daily, 28 days; Capsules, Oral, to be determined, once daily, 28 days; Capsules, Oral, 0 mg, once daily, 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Articaine vs Dexmedetomidine Supplemented Articaine
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study to test efficacy of adding dexmedetomidine to articaine on sensory,
      motor and duration of analgesia during hemodialysis fistula creation under ultrasound guided
      supraclavicular block
    

Detailed description: 
      Adult fifty patient with chronic renal failure on hemodialysis, scheduled for arteriovenous
      fistula creation under ultrasound guided supraclavicular block. Patients were randomly
      allocated in two group. The articaine group (group A) received 40 ml articaine hydrochloride
      2% and articaine-dexmedetomidine group (group AD) received 40 ml. Of articaine 2% mixed with
      dexmedetomidine (1micogram/kg)
    

Intervention name(s): Articaine; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Vial; Vial
Intervention MeSH terms: Dexmedetomidine; Carticaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hemodialysis
Short Versus Long Protocol for IVF and IVF+ICSI
Condition: Infertility; Ovarian Hyperstimulation Syndrome; Quality of Life; Live Birth
MeSH terms: Infertility; Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to

        1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)

        2. quality of life (2. outcome measure)

        3. live birth rate (2. outcome measure)

        4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol
           and vascular endothelial growth factor in follicular fluid(not only compared between
           GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS
           and patients becoming pregnant and not becoming pregnant (2. outcome measure), and

        5. number of oocytes removed per treatment, number of embryo transfers per treatment and
           number of spontaneous abortions per treatment (these three parameters are tertiary
           outcome measures).

      In addition to the above mentioned efficacy outcome measures the safety outcome measure
      "frequency of known side-effects" will be compared between the two protocols.
    

Detailed description: 
      Patients: 1100 patients are randomized prospectively to either treatment. Stratification:
      =<36 y/>36 y, IVF/ICSI, and treatment centre.

      Methods: OHSS is quantified by consecutive measurements of weight, abdominal diameter,
      ultrasound measurements of ascites and ovarian volume, paraclinical parameters, and by a
      systematic patient questionnaire. Furthermore it is registered if the patients have been
      hospitalized and/or have had ascites drainage performed due to OHSS. Data from the first 100
      patients are used together with Golans OHSS-classification, to make a more precise definition
      of OHSS. This definition is applied prospectively on data from the remaining patients.

      Quality of life is gauged by a questionnaire. Child birth rate is ascertained by a pregnancy
      response questionnaire and by obtaining data from the Danish National Birth Registry.

      Statistics: The study is designed to be able to show a 50% reduction of OHSS comparing short
      to long protocol.
    

Intervention name(s): Patients receiving short protocol IVF/ICSI-treatment.; Long protocol
Intervention type(s): Drug; Drug
Intervention description(s): Injection s.c. Orgalutran® (Ganirelix)0.25 mg once daily from day 5 of FSH-stimulation until HCG-day; Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OHSS; quality of life; IVF; ICSI; GnRH-agonist; GnRH-antagonist