bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Effect of Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin.
Condition: Essential Hypertension; Hyperlipidemia
MeSH terms: Essential Hypertension; Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of telmisartan/s-amlodipine on the
      pharmacokinetic properties of atorvastatin.
    

Detailed description: 
      healthy subjects are administrated single-dose over the period Ⅰand Ⅱ(Crossover) of
      telmisartan/s-amlodipine, atorvastatin and atorvastatin.
    

Intervention name(s): Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg; atorvastatin 40mg
Intervention type(s): Drug; Drug
Intervention description(s): 3 Tablets (telmisartan 80mg, amlodipine 5mg, atorvastatin 40mg each one),
oral intake, once in a period
over the period Ⅰ&Ⅱ(crossover); 1 Tablet (atorvastatin 40mg),
oral intake, once in a period
over the period Ⅰ&Ⅱ(crossover)
Intervention MeSH terms: Amlodipine; Telmisartan; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telminouveau; Atorvastatin; Pharmacokinetic; Healthy volunteers
Effect of Metformin on Vascular and Mitochondrial Function in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk
      in type 1 diabetes (T1D). The purpose of this study is to measure the effect of metformin on
      insulin sensitivity, vascular function and compliance, and mitochondrial function in T1D. The
      long term goal is to identify novel non-glycemic approaches to managing cardiovascular
      disease risk in T1D. The results of this study may validate a novel approach to T1D treatment
      that could significantly improve current management of cardiovascular disease risk in this
      high risk population.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily.; Six-week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention.
Other intervention name(s): glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Insulin; Metformin; Vascular; Vessels; Type 1
Pool-based Exercise in Fibromyalgia Management
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management,
      but different non-pharmacologic measures, especially physical therapies and
      psychologically-based interventions, have also shown to be effective in the treatment of this
      disease. The objective of the present randomized controlled trial is to compare the efficacy
      and tolerability of two different modalities of active low-impact exercise in warm water:
      stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting
      60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12
      weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and
      the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck
      Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12
      Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired
      Student's t test, and effect sizes' estimation (ES).
    


Intervention name(s): physical therapy; physical therapy
Intervention type(s): Other; Other
Intervention description(s): physical therapy in warm pool performing stretching; physical therapy in warm pool performing Ai Chi
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibromyalgia; pool-based exercise
Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose
      dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose
      dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma
      without an intent for immediate autologous stem cell transplant.
    


Intervention name(s): Lenalidomide/Low dose Dex; Bortezomib/Lenalidomide/ Low dose Dex; Lenalidomide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lenalidomide/Low dose Dex (LLD); Bortezomib/Lenalidomide/ Low dose Dex (BLLD); Lenalidomide/Low dose Dex (LLD
Intervention MeSH terms: Lenalidomide; Bortezomib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Untreated; Without intent for immediate autologous stem cell transplant
Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of varenicline treatment on cue induced
      craving to smoking using brain imaging. The investigators hypothesize that participants will
      report reduced urges to smoke and will have less activation in parts of the brain associated
      with craving.
    

Detailed description: 
      Treatment with varenicline reduces overall subjective cigarette craving and smoking reward in
      nicotine-dependent smokers. This preliminary study will explore the impact of varenicline
      treatment on smoking cue-induced craving and associated regional brain activation using BOLD
      fMRI. Twenty healthy smokers (10 males, 10 females) will undergo two BOLD fMRI scans with the
      presentation of smoking-related and neutral cues at baseline and after five weeks of
      treatment with open-label varenicline. The investigators hypothesize that participants will
      report reduced urges to smoke on the Questionnaire of Smoking Urges-Brief and have less
      activation of the brain areas associated with craving during the fMRI after 5 weeks of
      varenicline and smoking cessation counseling compared to the baseline scan.
    

Intervention name(s): varenicline
Intervention type(s): Drug
Intervention description(s): Participants will be treated with a standard course of varenicline, 0.5 mg 1 tablet every day for 3 days, then 0.5 mg 1 tab twice a day for four days, and 1 mg 1 tablet twice a day for three months.
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nicotine dependence; tobacco; smoking
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether, after a period of abstinence, adding 6
      weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week
      naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence)
      treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone
      or placebo. All participants will receive alcohol counseling.
    

Detailed description: 
      Subjects will enter the trial after maintaining 4 days of abstinence. During this period
      multiple assessments will be collected. After entering the double blind treatment portion of
      the study, they will be evaluated weekly for the first month, then bi-weekly until week 12
      and again at week 16. There will be two follow-up visits at weeks 28 and 40. Urinary
      riboflavin and pill counts will be utilized to determine compliance with the medication
      regime.

      Comparison(s): Naltrexone (50 mg/day) alone for 16-weeks; naltrexone (50 mg/day) for 16-weeks
      plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks, or inactive
      placebos. All subjects will receive up to 20 sessions of individual alcohol counseling.
    

Intervention name(s): Naltrexone; Naltrexone plus Gabapentin; Inactive Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks; naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks; Placebo
Intervention MeSH terms: Naltrexone; Gabapentin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol dependence; Alcoholism; Heavy drinking
Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina
Condition: Chronic Myocardial Ischemia; Refractory Angina Pectoris; Advanced Coronary Heart Disease
MeSH terms: Heart Diseases; Angina Pectoris; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety and efficacy of targeted intramyocardial
      delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal
      symptoms in subjects with refractory angina and chronic myocardial ischemia.
    


Intervention name(s): Auto-CD34+ cells; Placebo: Diluent used to suspend Auto-CD34+ cells; Standard of care
Intervention type(s): Biological; Biological; Other
Intervention description(s): 10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells; 10 intramyocardial injections of 0.2 mL per injection site of placebo; Standard of care for refractory angina
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
NIRS Levels of Infants in Neonatal Intensive Care
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Observational [Patient Registry]

Summary: 
      Aim: This study was conducted to determine the effect of nursing care practices on the Near
      Infrared Spectroscopy (NIRS) levels of premature infants in the neonatal intensive care unit
      (NICU).

      Materials and Method: This is a cross-sectional, analytical study. It was conducted over the
      period March 1 - April 26, 2019 in the Neonatal Intensive Care Unit (NICU) of Eskişehir
      Osmangazi University (ESOGU) Health Practices and Research Hospital. We did not calculate
      sample size, but included in the study, after the parents had been informed about the
      research, the entire universe of neonates in the NICU who matched the inclusion criteria
      during the period March 1 - April 26, 2019. The study was completed with 40 neonates. Data
      collection was performed with a "Descriptive Data Form," and a "Procedures Performed Chart."
      The data were evaluated with the IBM SPSS 24 package program.
    


Intervention name(s): nursing care practices
Intervention type(s): Behavioral
Intervention description(s): To determine the effect of nursing care practices on Near Infrared Spectroscopy (NIRS) levels in premature babies
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        40 premature newborns
Bioequivalence of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose
      combination (FDC) vs. its monocomponents
    


Intervention name(s): Telmisartan/Amlodipine FDC; Telmisartan; Amlodipine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaccine Response in Patient With Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      Vaccination is established as an effective means of individual and collective protection.
      Hospitalization is an opportunity not to be missed to catch up on vaccinations in certain
      fragile patients. Patients hospitalized in infectious diseases are generally treated for an
      acute or chronic infection that can modulate their immunity and therefore their vaccine
      response. Current vaccine immunogenicity data in immunocompromised patients support a lower
      percentage of responders than observed in immunocompetent patients.

      There is little data to assess the vaccine response (VR) in patients treated for an infection
      (bacteremia, pneumonia, urinary tract infection, etc.). In order to respond to this problem,
      the investigators have chosen to evaluate the vaccine response to Prevenar 13 (PCV13), a
      conjugate vaccine recommended as a prime-boost since 2013, which must be followed by a
      vaccination at 2 months with Pneumovax, an unconjugated vaccine of 23 valences.

      Anti-pneumococcal vaccine coverage in frail people (immunocompromised, heart failure,
      respiratory failure, kidney failure, diabetics) remains low and is estimated at less than 10%
      in 2011, while the bacteria is responsible for severe invasive infections.

      In total, the investigators would like to study the vaccine response at 1 month of
      vaccination with Prevenar 13 in patients hospitalized in infectious disease for sepsis, in
      order to demonstrate the benefit of vaccination per hospitalization.
    


Intervention name(s): Blood sample taken
Intervention type(s): Other
Intervention description(s): For patients with sepsis who require vaccination during hospitalization, we will analyze the immunogenicity of pneumococcal conjugate vaccine (PCV13) by taking blood samples
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
Condition: Asthma; COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether broccoli sprout extract can effect lung
      function measurements in individuals with asthma and COPD.
    

Detailed description: 
      Asthma afflicts 23 million people, results in nearly 13 million ambulatory physician
      encounters, and 440,000 hospitalizations annually. The economic burden for 2010 is estimated
      to run $20.7 billion.

      Although steroids are the mainstay of treatment, they do not "cure" the disease. While
      inflammation may be the inciting factor, other mechanisms must play a crucial role in this
      process. Elevated oxidative stress could cause the kind of chronic inflammation associated
      with asthma, and could provide an explanation for recurrent asthma attacks. Cigarette smoke,
      both primary and secondary exposure, worsens the oxidative stress balance in the airways.
      Thus, the continuing focus on simply treating the inflammation is a barrier to progress. It
      is critical to examine other factors, such as abnormal oxidative stress through specific
      pathways that may affect airway inflammation and asthma attacks.

      One compound, that repairs oxidative stress pathways, is sulforaphane, a food compound found
      in vegetables, including broccoli sprouts. Preliminary data demonstrate that broccoli sprout
      extract (BSE), rich in sulforaphane, improves airflow measures in asthmatics.

      We plan to examine whether the airflow abnormalities in asthma, and the exacerbation from
      cigarette smoke, can be prevented by the administration of BSE, and determine the primary
      inflammatory and oxidative stress signaling pathways involved in the protection provided by
      BSE.
    

Intervention name(s): broccoli sprout extract
Intervention type(s): Drug
Intervention description(s): consumption of broccoli sprout extract for 2 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of
      increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2
      diabetes. To this purpose, a standardized mixed meal test will be ingested with or without
      concomitant administration of sitagliptin (100mg).
    

Detailed description: 
      In men subjects with type 2 diabetes treated with diet and exercise with or without metformin
      treatment as an antidiabetic agent, a standardized mixed meal test will be served with or
      without administration of sitagliptin (100mg).
    

Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 100mg is given before meal ingestion; Placebo is given before meal ingestion
Other intervention name(s): Mixed meal test with sitagliptin; Mixed meal test with placebo
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: GLP-1, GIP, DPP-4 inhibition, iset function
Transcranial Direct Current Stimulation - Tobacco Use Disorder
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers'
      inhibitory control, craving and consumption of tobacco goods.
    

Detailed description: 
      Participating smokers are to receive anodal transcranial direct current stimulation of the
      right dorsolateral prefrontal cortex (rDLPFC) for 20 minutes on five consecutive days.
      Neuropsychological tests on inhibitory control and interviews on smoking habits and craving
      will be applied before and after the first stimulation as well as after the fifth
      stimulation.

      After a follow-up period of three days, smoking behaviour will be assessed in a telephone
      interview.

      Changes in inhibitory control and smoking behaviour will be compared between an active and a
      sham stimulation group.This way the effects of transcranial direct current stimulation on
      tobacco use disorder are to be clarified.
    

Intervention name(s): tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): The participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal cortex for 20 minutes on five consecutive days.; The participants will receive sham tDCS (transcranial direct current stimulation) of the dorsolateral prefrontal cortex for 20 minutes on five consecutive days.
Other intervention name(s): sooma medical; transcranial direct current stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation
Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The prognosis of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or
      modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that
      immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong
      patient survival in a number of cancer diseases. Here investigators intend to compare the
      therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX
      and Anti-PD-1 antibody in patients with metastatic pancreatic cancer.
    

Detailed description: 
      Metastatic pancreatic cancer patients will be enrolled in this trial. Investigators will
      assign patients to the treatment after randomization. The primary endpoint is overall
      survival. Response rate, progression-free survival, drugs related side effects and other
      endpoints events will be recorded and analyzed, to assess the combination treatment with
      modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with
      metastatic pancreatic cancer.
    

Intervention name(s): Combination drug; Chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly; modified-FOLFIRINOX
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic Cancer; Anti-PD-1 Antibody