bioihbjkbjnl/mcl2 huggingface dataset:
Drug-drug Interaction Study (CKD-501, Ketoconazole)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic
      characteristics of CKD-501 in healthy subject.
    

Detailed description: 
      From day 1 to day 5, Ketoconazole 200mg is administered twice daily to Group 1 patients
      during period 1. Then on day 5,CKD-501 0.5mg is co-administered Group 1 patients at period 1.
      After 28 day-break, period 2 will CKD-501 0.5mg administered on day 5. Period 2 will not
      Ketoconazole administered.

      Group 2 is administered in reverse order.
    

Intervention name(s): CKD-501, Ketoconazole
Intervention type(s): Drug
Intervention description(s): Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.
Other intervention name(s): Lobeglitazone, Ketoconazole
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-Drug interaction between the CKD-501 and ketoconazole
Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients
Condition: Deep Sedation; Dexmedetomidine
Study type: Interventional
Phase: Phase 4

Summary: 
      It is important to choose an appropriate analgesia/sedation technique in pediatric dental
      treatment. Premedication combined with intravenous anesthesia is often used in deep sedation
      technique for pediatric dental treatment and it's a routine in most hospitals. Deep sedation
      has its unique advantages such as avoiding the airway damage with an enhanced recovery.

      Dexmedetomidine is suitable for intranasal mucosal administration as a premedication drug. It
      has been proved with several beneficial characteristics in other clinical procedures.

      This study intends to further explore the characteristics of nasal dexmedetomidine as
      premedication in pediatric oral treatment under deep sedation.
    


Intervention name(s): Dexmedetomidine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.; For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: deep sedation; pediatric; dexmedetomidine; dental treatment
The Role of Genetic Factors in the Development of Myocardial Infarction in the Kazakh Population
Condition: Heart Attack
MeSH terms: Myocardial Infarction
Study type: Observational

Summary: 
      This is a GWAS study that aims to identify possible candidate genes associate to heart attack
      by exploring single nucleotide polymorphism (SNP) in a group of heart attack, in the Kazakh
      population. The investigators hypothesize that the careful phenotyping of the subject sand
      matching with increase the power to find SNP significantly associate with heart attack
    

Detailed description: 
      A genome-wide association study (GWAS) is an approach used in genetics research to associate
      specific genetic variations with particular diseases. The method involves scanning the
      genomes from many different people and looking for genetic markers that can be used to
      predict the presence of a disease. Once such genetic markers are identified, they can be used
      to understand how genes contribute to the disease and develop better prevention and treatment
      strategies.
    

Intervention name(s): DNA analysis
Intervention type(s): Genetic
Intervention description(s): GWAS
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        KAZAKH POPULATION
      
Biospecimen description: 
      Blood
    
Keywords: GWAS
Feasibility Clinical Study of NLA Tool
Condition: Healthy Elder People
Study type: Observational

Summary: 
      The study is to evaluate the feasibility of the NLA tool, a combined assessment of
      nutritional and physical functional status, to provide personalized advice for the
      independence and mobility of elderly.
    


Intervention name(s): Nutrition Status Questionnaires and Physicial Function Test
Intervention type(s): Behavioral
Intervention description(s): Nutrition status questionnaires will be administered, Physical functional status will be tested
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Free-living or institutionalized elderly (65-90years)
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and
      pharmacodynamics of an investigational new drug.
    


Intervention name(s): MYO-029
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Health Services Research
Keywords: Adult; Aged
A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness (level of pain control) and safety
      of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release
      Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had
      a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged
      from the hospital.
    


Intervention name(s): Hydrocodone/Acetaminophen Extended-Release; Hydrocodone/Acetaminophen Immediate Release (NORCO®); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 tablets x 1; 1 tablet q 4 hours x 3; q 4 hours x 3
Other intervention name(s): hydrocodone / acetaminophen extended release
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Acute Pain following Bunionectomy
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in
      subjects with mild and moderate hepatic impairment to matched healthy subjects with normal
      hepatic function.

      This study will also assess the safety and tolerability of single-dose ASP2215 in subjects
      with mild and moderate hepatic impairment and matched control subjects.
    

Detailed description: 
      Subjects will be admitted to the site one day before each study drug administration (i.e. Day
      -1) and confined at the site till the collection of post-dose PK samples (Day 21). For
      subjects with hepatic impairment, subject will discharge on Day 21, and will visit the
      clinical unit on Day 24 (±1 day) and Day 28 (±1 day) for collection of post-dose PK samples.
      End of study Visit For Healthy subjects will take place 1 to 5 days following collection of
      last PK sample.
    

Intervention name(s): ASP2215
Intervention type(s): Drug
Intervention description(s): oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic Impairment; Mild Hepatic Impairment; Healthy; ASP2215; Moderate Hepatic Impairment
Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy
Condition: Hypothermia
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Hypothermia
Study type: Observational

Summary: 
      Controlled Hypothermia has become the standard of care for neonates with moderate to severe
      HIE. Ampicillin and aminoglycosides are drugs that are universally used for the treatment of
      suspected neonatal sepsis, which may or may not be responsible for the etiology of HIE.
      Currently, medication dosage regimens are not altered in the setting of CH. A better
      understanding of the effects of our interventions on this unique population may help us
      tailor our therapy to the specific circumstances of the patient
    

Detailed description: 
      Hypoxic-ischemic encephalopathy (HIE) affects approximately 1 to 2 per 1000 live births and
      remains a cause of significant morbidity and mortality in the neonatal period. In response to
      an anoxic insult, perfusion to vital organs is preserved; however, when this injury is
      profound concomitant injury to nonvital organs is observed. Controlled hypothermia (CH) has
      been accepted as a neuroprotective therapeutic modality for neonates with moderate to severe
      HIE because of its role in attenuating secondary brain injury. Neonates exhibit varying
      degrees of multiorgan dysfunction after a hypoxic-ischemic insult, although the added
      beneficial and potential adverse effects that CH has in these babies have not been completely
      delineated or understood.

      CH has been shown to alter normal physiologic functioning of several organ systems. Specific
      physiologic changes as a consequence of CH have been demonstrated in both animal and human
      models. The observed reduction in cardiac output and reflexive increase in systemic vascular
      resistance in response to CH alter renal perfusion and subsequently reduce glomerular
      filtration . Drugs that are renally cleared may develop a prolonged half-life in this
      setting. Finally, drug metabolism may further be affected by altered hepatic blood flow and
      temperature-dependent effects on hepatic enzyme activity . Collectively, the potential
      effects of CH on drug metabolism and clearance are significant warranting further
      investigation. The investigator aims to evaluate the combined effects of hypoxia and
      hypothermia on ampicillin clearance and excretion
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates 0-24 hours of life
      
Keywords: Ampicillin
Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
Condition: Knee Injuries and Disorders
MeSH terms: Knee Injuries
Study type: Interventional

Summary: 
      The purpose of this CRT study is to compare clinical and functional outcomes of three graft
      types ( Quadriceps tendon with bone versus Hamstring tendon versus Quadriceps tendon without
      bone) for reconstration of anterior cruciate ligament among football players.
    

Detailed description: 
      In the previous studies patellar tendon and hamstring tendon were the most investigated graft
      types. While quadriceps tendon has been investigated a fewer times. And to our knowledge
      there is no control study that compare quadriceps tendon-patellar bone autograft with
      Quadriceps Autograft and Hamstring Autograft as control randomized study.

      All of the patients will be examined before of the surgery and 3, 6, 12, 24 months after the
      surgery to compare the outcome of differnt graft types. While a secand aim of this study is
      to examen the effect of rehabilitation protocol on the short and long term within all of the
      clinical and the functional outcomes.

      The rehabilitation protocol will contain one phase before the surgery and four phases after
      the surgery.The goal of the first phase will be pain and inflammation control, increase ROM
      and muscle strength will be during the second and the third phases.In the last phase all of
      the players have to achieve maximum muscle strength and neuromuscular control.
    

Intervention name(s): ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT; ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT; ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT; Rehabilitation protocol
Intervention type(s): Procedure; Procedure; Procedure; Other
Intervention description(s): Quadriceps tendon with pattlar bone will used for grating; Hamstring tendon with will used for grating; Quadriceps tendon without pattlar bone will used for grating; All patients will receive six months rehabilitation program which aim to recover the strength and function
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ACLR; Quadricepses tendon graft; hamstring tendon graft
Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome
Condition: Cushing's Syndrome
MeSH terms: Cushing Syndrome; Syndrome
Study type: Observational

Summary: 
      Chart review study to collect patient data from medical charts of patients who have been
      treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.
    

Detailed description: 
      A retrospective, multi-center, chart review study to collect patient data from medical charts
      of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal
      Cushing's Syndrome. Treatment with Korlym® will be a minimum 3 months in duration with
      follow-up of a minimum 3 months. Only sites that have been identified to have patients
      appropriate for this protocol will be invited to participate.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No treatment (intervention) was administered.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        ACTH Independent Cushing's Syndrome patients treated with Korlym® mifepristone) as standard
        of care in clinical practice.
      
Keywords: Cushing's Syndrome; Mifepristone; Adrenal; Retrospective; Chart Review
Comparison of Pain of Two Different Methods in Uterine Artery Embolization
Condition: Leiomyoma
MeSH terms: Leiomyoma
Study type: Interventional

Summary: 
      The primary purpose of this study is to compare pain after uterine artery embolization using
      non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with
      symptomatic fibroids
    

Detailed description: 
      Uterine artery embolization(UAE) is a minimally invasive treatment alternative to
      hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE
      remains a major problem. The non-spherical polyvinyl alcohol particle and tri-acryl gelatin
      microsphere are two embolic materials used for UAE.Therefore, the aim of study is to compare
      pain intensity and inflammation after uterine artery embolization using non-spherical
      polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic
      fibroids
    

Intervention name(s): Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere
Intervention type(s): Device
Intervention description(s): One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Binge Eating Disorder and Obesity : Functional MRI Study
Condition: Binge Eating Disorder; Obesity
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      Obesity, defined as BMI> 30kg / m2, is a major public health problem, with devastating
      medical and psychological consequences. 30% of obese suffer from BED type of eating
      disorders. The optimal treatment of obesity remains bariatric surgery, failed in 20% of
      cases. Many arguments are in favor of the involvement of the reward circuitry, with the
      central role of NAc in the pathophysiology of BED and obesity. The recent application and
      effectiveness of DBS (Deep Brain Stimulation) in refractory psychiatric disorders suggest
      that DBS may be of interest in treating obesity and BED with potential target for the NAc.
      This project propose to study fMRI activation of the reward system in response to food
      stimuli to better direct the DBS targets. This is a pilot study to define indication criteria
      based on fMRI to obese BED patients are potential candidates for treatment with DBS.
    

Detailed description: 
      The aim of this functional neuroimaging study is to analyze brain responses to visual food
      cues in obese (body mass index > 97th percentile) adolescents with BED (according to the
      criteria Marcus and Kalarchian) compared with healthy control adolescents in two situations :
      hunger et satiety.

      Fifteen obese adolescents (12/16 years) with BED and fifteen healthy control adolescents will
      be enrolled in the study protocol. Participants will be instructed not to eat food for at
      least 6 hours prior to the first imaging session. After the initial set of functional and
      anatomic scans, participants will be fed a standard calorie meal. Approximately 1 hour later,
      the experiment will be repeated while participants are in a satiated condition. The cortical
      fMRI activation will be measured during the following four experimental visual conditions :
      high calory food, low calory food, disgust and neutral presented in block design.

      First-level and second-level differences in neural activation assessed during functional MRI
      in the different conditions will then be analyzed.
    

Intervention name(s): Functional MRI; ADO-BEDS scale; R-CMAS scale
Intervention type(s): Other; Other; Other
Intervention description(s): functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety; Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria; Evaluate the anxiety
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: fMRI; Deep brain stimulation; Food; Eating; Reward
Development of a Genetic Counseling Patient Preference Intervention for Women at Elevated Risk for Breast Cancer
Condition: Breast Carcinoma
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study develops a genetic counseling patient preference intervention for women at
      elevated risk for breast cancer. This study aims to develop an intervention that may deliver
      educational videos about breast cancer, heredity, multigene tests results and polygenic risk
      score, provide multigene and polygenic test results, obtain information about patients'
      questions/ concerns about test results to use in post-genetic test counseling, and determine
      patient preference (e.g. telephone) for receipt of post-genetic test counseling.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. Develop the Genetic Counseling Patient Preference (GCPP) intervention in collaboration
      with community members.

      OUTLINE:

      Participants attend a focus group over 90-120 minutes providing feedback on GCPP
      intervention.
    

Intervention name(s): Discussion
Intervention type(s): Procedure
Intervention description(s): Attend a focus group
Other intervention name(s): Discuss
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women at elevated risk for breast cancer
IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT
Condition: Autologous Hematopoietic Stem Cell Transplantation; Acute Myeloid Leukemia; Conditioning
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to
      allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched
      donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in
      discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative
      conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.
    

Detailed description: 
      Auto-HSCT is an effective alternative to allogeneic HSCT for intermediate-risk AML without
      HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen. However,
      auto-HSCT with BUCY conditioning regimen appears to have higher relapse rate. To reduce the
      relapse rate, IDA is added in the conditioning regimen. In this study, the safety and
      efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML
      patients undergoing auto-HSCT are evaluated.
    

Intervention name(s): Idarubicin（IDA）; Busulfan (BU); Cyclophosphamide (CY)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Idarubicin was administered at 15mg/m2/day on days -12 and -10.; Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.; Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Intervention MeSH terms: Cyclophosphamide; Busulfan; Idarubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Contrast-Enhanced Whole-Heart Coronary Magnetic Resonance Angiography at 3.0-T: A Multicenter Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      The multicenter study evaluates the diagnostic performance of 3.0 T contrast-enhanced
      whole-heart coronary MRA in patients with suspected coronary artery disease.
    

Detailed description: 
      This is a multicenter trial evaluated the diagnostic ability of 3.0 T contrast-enhanced
      whole-heart coronary MRA to detect significant coronary artery stenosis among patients with
      suspected CAD.

      A total of 272 patients will be prospectively enrolled from 8 cities in China.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive eligible patients scheduled to undergo conventional coronary angiography.
      
Keywords: Coronary Artery; Magnetic Resonance Angiography; Coronary Artery disease; Multicenter Trial; Cardiac MRI
A Study in Healthy Men to Test How Esomeprazole Influences the Amount of BI 1819479 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect of the proton pump inhibitor
      esomeprazole on the pharmacokinetics of BI 1819479 in plasma.
    


Intervention name(s): BI 1819479; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): BI 1819479; Esomeprazole
Other intervention name(s): Nexium®
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment