bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Sunitinib in Patients With Advanced Cholangiocarcinoma
Condition: Unresectable and Advanced Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is considered
      as the reference treatment in first line chemotherapy. However, the outcomes of these
      patients remain limited and therefore more effective drugs are warranted. The context of the
      disease and current data on sunitinib suggest that sunitinib may have activity in patients
      with advanced non resectable cholangiocarcinoma.

      Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity
      of sunitinib in such a patient population.
    

Detailed description: 
      The primary objective is to evaluate the overall survival of patients with advanced and
      unresectable cholangiocarcinoma treated continuously by sunitinib as second line at the dose
      of 37.5 mg per day, after one line of chemotherapy and to determine whether sunitinib
      deserves further studies in this indication.

      The secondary objectives are

        -  To evaluate the criteria of efficacy

        -  To evaluate the effects of sunitinib on tumor angiogenesis

        -  To characterize the safety profile of sunitinib

        -  To identify markers associated with response to sunitinib
    

Intervention name(s): Sunitinib
Intervention type(s): Drug
Intervention description(s): sunitinib dose :37.5mg/day
Other intervention name(s): sutent
Intervention MeSH terms: Sunitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholangiocarcinoma
The Incretin Effect in Patients With Gestational Diabetes Mellitus
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      The aim of this study is to evaluate the reduced incretin effect observed in patients with
      T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and
      iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post
      partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in
      patients with other forms of DM. The investigators estimate that approximately 90 % of the
      patients with GDM re-establish a NGT 2-3 months post partum. This particular group of
      patients provides a unique possibility for demonstrating the reversibility of the reduced
      incretin effect in relation to optimal glycaemic control.
    


Observational model: Case-Crossover
Sampling method: Probability Sample
Study population: 
        Pregnant women above the age of 18 years with GDM) (Controls: pregnant women above the age
        of 18 years with NGT)
      
Keywords: GDM; incretin effect; gestation; reversibility
Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Single centre, open-label, random order, cross-over trial, recruited over a period of
      approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn
      subjects may be replaced.

      This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in
      smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test
      called impulse oscillometry.
    

Detailed description: 
      Cigarette smoking in asthma is associated with poorer asthma control and a higher frequency
      of asthma attacks. Despite this, smoking cessation rates are very low due to the highly
      addictive nature of tobacco smoking. Asthma in smokers is particularly challenging to manage
      because it is resistant to the beneficial effects of inhaled corticosteroids, the main
      treatment for asthma.

      Unfortunately, there is no guideline consensus regarding how to best manage asthmatics who
      smoke. Research studies in asthma tend to exclude smokers because of concerns about
      recruiting patients with chronic obstructive pulmonary disease (COPD). Hence, there is an
      unmet need for research studies in asthmatics who are unable to stop smoking.

      In view of the above, we propose to assess the effects of two different types of
      bronchodilators (inhalers which help open up the airways), in asthmatics who continue to
      smoke.

      Participants will receive both of the following drugs for 2-4 weeks in random order, with a
      2-3 week washout period in between:

      Olodaterol which is a new long-acting bronchodilator. Olodaterol combined with tiotropium
      (dual bronchodilators). We wish to compare these inhalers using a sensitive pulmonary
      function test called impulse oscillometry.
    

Intervention name(s): olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg; olodaterol 2.5 mcg
Intervention type(s): Drug; Drug
Intervention description(s): Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily; Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily
Other intervention name(s): Spiolto Respimat 2.5mcg/2.5mcg; Striverdi Respimat 2.5mcg
Intervention MeSH terms: Bromides; Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tiotropium; olodaterol; smoker; cigarette; bronchodilator
Effects of Napping in Sleep-Restricted Adolescents
Condition: Sleep Deprivation; Sleep
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      To examine the neurobehavioural responses to two successive cycles of sleep restriction and
      recovery in adolescents, and to determine the benefits of napping on cognitive performance,
      alertness, and mood. 57 participants, aged 15 to 19 years old, were divided into nap and
      no-nap groups. Both groups underwent two cycles of sleep restriction and recovery over 15
      days. The nap group received an afternoon sleep opportunity lasting 1 hour.
    

Detailed description: 
      57 participants (aged 15 to 19 years old) were grouped into nap and no nap groups. Both
      groups took part in a 15-day protocol that started with 2 9-hour adaptation and baseline
      nights, followed by two successive cycles of sleep restriction (5-h time-in-bed [TIB];
      01:00-06:00) and recovery (9-h TIB; 23:00-08:00) intended to simulate the weekday sleep loss
      and weekend attempt to 'catch up' that are familiar to high school students. The nap group
      received a 1-hour nap opportunity at 14:00 following each sleep-restricted night, while
      participants in the no nap group watched a documentary. Sleep was monitored with
      polysomnography on 9 selected nights. Cognitive performance, subjective sleepiness, and mood
      were assessed 3 times daily (10:00, 15:45, and 20:00).

      All participants stayed in air-conditioned, twin-share bedrooms with en-suite bathrooms.
      Bedroom windows were fitted with blackout panels to ensure participants were not woken up
      prematurely by sunlight. Earplugs were also provided, and participants were allowed to adjust
      the temperature of their bedrooms to their personal comfort. 3 main meals were served each
      day, with snacks being provided for upon request. Caffeinated drinks, unscheduled sleep, and
      strenuous physical activities were prohibited.

      Outside of scheduled sleep, meal, and cognitive testing times, participants spent the
      majority of their free time in a common room that was illuminated by natural and artificial
      lighting. They were allowed to read, play non-physically exerting games, watch videos, and
      interact with research staff and other participants. Participants were under constant
      supervision by the research staff.
    

Intervention name(s): Nap
Intervention type(s): Behavioral
Intervention description(s): A 1-hour daytime nap opportunity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: nap; sleep restriction; recovery sleep; cognitive performance; subjective sleepiness; mood; neurobehavioural functions
Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients
Condition: Anesthesia; Obesity, Morbid; Dexmedetomidine
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a
      primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as
      secondary outcomes in morbidly obese patients with restrictive lung disease undergoing
      abdominal surgery.
    

Detailed description: 
      Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic,
      anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved
      both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients
      undergoing lung cancer surgery.

      The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in
      obstructive lung disease, but there are little information about its effect in morbidly obese
      patients with restrictive lung disease .
    

Intervention name(s): Dexmedetomidine 0.6; Dexmedetomidine 0.3; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.6 μg/kg/hr for one hour.; Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.3 μg/kg/hr for one hour.; Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics Study of CKD-11101 and NESP After SC Administration in Health Male Volunteers
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after
      SC administration in health male volunteers
    

Detailed description: 
      Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once subcutaneously.
      (crossover) Every time before and after taking each medication, PK parameters and safety of
      CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some
      tests(Laboratory test, V/S and Physical Examination, etc) respectively.
    

Intervention name(s): NESP 60μg; CKD-11101 60μg
Intervention type(s): Drug; Drug
Intervention description(s): Administrated NESP 60μg once subcutaneously; Administrated CKD-11101 60μg once subcutaneously
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CKD-11101; NESP; Darbepoetin alfa; Anemia; subcutaneous; Pharmacokinetics; Phase 1
Efficacy and Safety of CO2 vs Room Air Insufflation During ESD for Gastric Tumor
Condition: Gastric Tumor
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Insufflation is essential procedure to observe the lumen of gastrointestinal tract in
      gastroscopy or colonoscopy Currently, most of hospital in Korea are using room air for
      insufflation According to recent clinical studies have shown that carbon dioxide have better
      safe and reduce stomachache than room air when endoscopy and endoscopic procedure is
      performed.

      However, there was still no research data or study in Korea. In this study, the investigators
      will try to make comparison between Carbon dioxide and room air insufflation for endoscopic
      submucosal dissection for Gastric Tumor and investigate the efficacy and safety
    


Intervention name(s): CO2 or room air insufflation during ESD for gastric tumor
Intervention type(s): Procedure
Intervention description(s): CO2 insufflation group : CO2 will be insufflated via the endoscope during procedure as needed, Room air insufflation group : Room air will be insufflated via the endoscope during procedure as needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the initial safety, tolerability, pharmacokinetics, and
      pharmacodynamics of MK-8655, after single and multiple daily oral administrations to
      participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting
      plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.
    


Intervention name(s): MK-8655; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.; Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes
Effectiveness of Breathing Exercises as Therapeutic Play on Respiratory Status Among Children With Lower Respiratory Tract Disorders
Condition: Respiratory Status
MeSH terms: Respiratory Tract Diseases
Study type: Interventional

Summary: 
      The study evaluates the effectiveness of Breathing Exercises as Therapeutic Play on
      respiratory Status among children with Lower respiratory Tract Disorders. patient were
      allocated into two groups- Experimental group and Comparison group. Experimental Group
      received Breathing Exercises as Therapeutic Play after administration of Nebulization therapy
      and comparison Group received no Breathing Exercises.
    

Detailed description: 
      The subjects were selected by Purposive sampling technique and allocated into 2 groups i.e
      experimental and comparison group. the total sample size for the study was 60 children i.e 30
      in Experiment Group and 30 in Comparison group.

      Experimental Group- Pre-assessment of respiratory status among children was assessed. Then
      after 5 minutes of administration of Nebulization, breathing exercises as therapeutic play
      (balloon inflation, candle blowing, blow air into water with a straw was administered for 15
      minutes once in a day for 3 days consecutively and then post-assessment was taken daily 5
      minutes after the administration of breathing exercises as therapeutic play.

      Comparison Group- Pre-assessment of respiratory status among children was assessed. Then only
      nebulization therapy was administered and then post-assessment was taken daily after 25
      minutes of administered.
    

Intervention name(s): Breathing Exercises as Therapeutic Play
Intervention type(s): Other
Intervention description(s): On day 1, pre- intervention assessment of respiratory status was done before administration of breathing exercises as therapeutic play and after 5 minutes of administration of Nebulization therapy, breathing exercises was administered among children for 15 minutes once in a day and then after 5 minutes 1st post-intervention assessment was done on same day.
On 2nd day again after 5 minutes of administration of Nebulization therapy, breathing exercises was administered among children for 15 minutes once in a day and after 5 minutes again post-intervention assessment was done on same day.
On 3rd day again after 5 minutes of administration of Nebulization therapy, breathing exercises was administered among children for 15 minutes once in a day and after 5 minutes again post-intervention assessment was done on same day.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breathing exercises; Respiratory status; Nebulization therapy; lower respiratory tract disorders
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess and compare the pharmacokinetic properties of YM178
      in normal subjects and those with mild, moderate and severe renal impairment.
    


Intervention name(s): YM178
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): mirabegron
Intervention MeSH terms: Mirabegron
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: mild, moderate, and severe renal impaired subjects; normal renal function subjects; Glomerular filtration rate (GFR); Modification of Diet in Renal Disease (MDRD) formula; YM178; pharmacokinetics
A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This was a long-term follow-up study to evaluate the durability of sustained virologic
      response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical
      outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in
      prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus
      (HCV) infection.
    

Detailed description: 
      This was a Phase 2/3, multicenter study offered to participants who received at least one
      dose of an ABT-493- and/or ABT-530-containing regimen at any dose level in an eligible prior
      AbbVie Phase 2 or 3 study for the treatment of chronic HCV and elected to enroll in this
      study. The participant must have completed the follow-up period of the prior eligible AbbVie
      study. Participants were followed for a total of approximately 3 years after their last dose
      of DAA in the previous HCV clinical study. The 3 years were inclusive of any post-treatment
      period in the prior study, as well as any gaps between the end of the prior study and
      enrollment in this study.
    

Intervention name(s): ABT-493; ABT-530
Intervention type(s): Drug; Drug
Intervention description(s): ABT-493 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.; ABT-530 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.
Other intervention name(s): Glecaprevir; Pibrentasvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Chronic hepatitis C; Hepatitis C virus; Sustained virologic response; Hepatitis C; Direct Acting Antiviral
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
Condition: Lumbar Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH®
      Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc
      Disease (DDD) at one level from L1 to S1.
    


Intervention name(s): TRIUMPH® Lumbar Artificial Disc
Intervention type(s): Device
Intervention description(s): The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low back pain; Leg pain; Discogenic pain; Degenerative Disc Disease (DDD); Herniated disc; Radiculopathy
Impact of Endogenous E2 on SSI and GH Rebound
Condition: Normal Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Endogenous estrogens maintain growth hormone (GH) secretion in postmenopausal women by
      potentiating endogenous GH-releasing hormone (GHRH) drive and restraining somatostatin
      inhibition of GH release.
    

Detailed description: 
      Systemic concentrations of testosterone (Te), estradiol (E2), GH, IGF-I and IGFBP-3 decline
      in healthy aging individuals (1-3). Sex-steroid deprivation accentuates GH and IGF-I
      depletion, since Te and E2 stimulate GH and IGF-I production in older adults, hypogonadal
      patients of all ages, and patients undergoing gender reassignment (1,2,4). Tamoxifen blocks
      the effect of Te, suggesting involvement of E2 in GH's stimulation in men (5). E2 also
      stimulates GH secretion in women, putatively via the nuclear estrogen receptor (ER-alpha)
      (1,2,6,7). Because Te, E2 and GH fall with menopause, and Te is converted to E2 by
      aromatization in the body (8-10), we postulate that diminished Te concentrations, Te→E2
      concentrations and low E2 mediate low GH output in older women. What remains unknown is
      whether the low E2 levels in postmenopausal women retain GH-stimulating effects. To test this
      notion would require blocking: (i) aromatase-enzyme activity, which mediates E2 synthesis
      from Te, and/or (ii) estrogen receptor-alpha, which transduces most of E2's stimulation of
      the GH axis.
    

Intervention name(s): Fulvestrant; Anastrozole; Placebo; Somatostatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Fulvestrant; Anastrozole; Somatostatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science