bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Effect of AZD9291 on the Blood Levels of Rosuvastatin, in Patients With EGFRm+ Non-small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of
      epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer
      (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase
      inhibitor (TKI) agent.

      Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of
      rosuvastatin, following multiple oral dosing of AZD9291 in the fasted state.

      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will
      provide for additional safety data collection. All patients from Part A who completed
      treatment may continue to receive AZD9291 80 mg once daily as a single agent until: disease
      progression; they are no longer deriving clinical benefit; or any other reason.
    


Intervention name(s): Pharmacokinetic sampling - AZD9291; AZD9291 tablet dosing; Rosuvastatin; Pharmacokinetic sampling - rosuvastatin; Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention type(s): Procedure; Drug; Drug; Procedure; Procedure
Intervention description(s): Blood sampling to measure AZD9291; Part A: AZD9291 80mg tablet taken from Days 4 to 35. Part B: AZD9291 80mg tablet taken daily for 12 months.; Rosuvastatin (BCRP substrate) 20mg taken once daily on Days 1 and 32 (Part A) .; Blood sampling to measure rosuvastatin levels; Blood samples to measure levels of AZ5140 and AZ7550
Intervention MeSH terms: Osimertinib; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oncology; cancer; non small cell lung cancer; anticancer drug; pharmacokinetics; AZD9291; rosuvastatin; EGFR genes
Feasibility Study Using Run-to-Run Control to Optimize Continuous Glucose Sensor Bias
Condition: Diabetes
Study type: Observational

Summary: 
      The purpose of this 12 week feasibility study is to see how much more accurate a continuous
      glucose monitor (CGM) might be in individuals with type 1 diabetes if the investigators
      personalize sensor calibrations to the user, based on previous wear.
    

Detailed description: 
      The purpose of this 12 week study is to see how much more accurate a continuous glucose
      monitor (CGM) might be if we personalize the sensor calibration algorithm for each
      individual. The calibration algorithm is a mathematical calculation built into the CGM.
      Currently, the CGM asks for a regular blood test (finger stick) measurement twice a day in
      order to make its calibration algorithm more accurate. Our goal is to keep refining the
      calculating ability so that it will provide personalized blood sugar control throughout the
      day for each individual using the sensor with the CGM.
    

Intervention name(s): Continuous Glucose Monitor
Intervention type(s): Device
Intervention description(s): CGM sensor calibration individualization
Other intervention name(s): CGM
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 diabetes
Comparative Study Evaluating the Effect of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients
Condition: End Stage Renal Disease on Dialysis
MeSH terms: Kidney Failure, Chronic; Vascular Calcification
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on
      circulating levels of calcification regulators and to assess their safety in patients on
      regular dialysis patients.
    

Detailed description: 
      Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity
      and mortality, especially in chronic kidney disease .

      It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as
      overall mortality and even poor arteriovenous graft maturation .

      Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor
      of tissue calcification, functional vitamin K deficiency may contribute to high vascular
      calcification (VC) burden in haemodialysis patients; this is process in which mineral is
      pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such
      as the aorta and the coronary, carotid, and peripheral arteries.

      it is Prospective, Randomized,Placebo Controlled Study
    

Intervention name(s): Vitamin K1; Vitamin k2; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): vitamin k1 tablets; vitamin k2 45 ug tablets twice daily; placebo tablets
Other intervention name(s): Phylloquinone; menaquinone
Intervention MeSH terms: Vitamins; Vitamin K; Vitamin K 2; Vitamin K 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction Study of Isavuconazole and Cyclosporine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of cyclosporine in healthy adult subjects.
    

Detailed description: 
      Subjects will be enrolled to receive a single dose of cyclosporine on Day 1 followed by a
      10-day wash-out period (time from cyclosporine dosing to isavuconazole dosing). On Days 11
      and 12, isavuconazole will be dosed three times daily (TID). On Days 13 through 18,
      isavuconazole will be administered once daily (QD). All subjects will be administered a
      single dose of cyclosporine on Day 15. Subjects will be confined in the study center from Day
      -1 until Day 5 and from Day 10 until Day 19.

      A follow up visit will be scheduled approximately 7 ± 2 days after final dosing of
      isavuconazole.

      Blood and urine samples will be taken at various times during the study.
    

Intervention name(s): isavuconazole; cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557; Neoral
Intervention MeSH terms: Cyclosporine; Isavuconazole; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Isavuconazole; Cyclosporine; Healthy Volunteers; BAL8557; Pharmacokinetics of isavuconazole; Pharmacokinetics of cyclosporine
Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the dose-response relationship of AVE0010 administered once daily and twice daily
      with chronic dosing in metformin-treated subjects with type 2 diabetes
    


Intervention name(s): LIXISENATIDE (AVE0010)
Intervention type(s): Drug
Intervention MeSH terms: Lixisenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes
Hydration Intervention in Children
Condition: Dehydration in Children
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      The investigators are conducting this research study to determine learn how daily habits and
      fluid choices impact children's health, sleep, cognitive function and mood. The investigators
      look to determine if a hydration intervention using an alternative beverage may impact these
      variables in children.

      Maintaining an appropriate level of hydration throughout the day has multiple health
      benefits. Maintaining a desirable hydration status improves overall health and wellbeing
      (mood, reaction time, sleep quality, cognitive function, etc.) in adults, but negative health
      and mental effects of hypohydration are not fully understood in an adolescent population.
      Maintaining appropriate hydration in adolescents presents unique challenges with respect to
      schedule (e.g. the availability of fluid during the school day and after school activities)
      as well as ensuring the most beneficial beverage choice. Adolescents can be very meticulous
      regarding their preferred beverage (e.g. choosing a sugary drink over water) and parents
      prefer their children consume the healthiest option for their food and beverages, often times
      leading to conflict.

      Therefore the purpose/goal of the proposed study is to determine if a hydration intervention
      using an alternative sweetened beverage will improve hydration and other overall health (e.g.
      cognitive function, sleep quality, mood etc.)

      The investigators hypothesize, that by giving children an alternative tasty option, they will
      consume more fluids which may lead to improving and maintaining their chronic hydration
      state. Implementing a beverage intervention with a sweet alternative option (i.e. Creative
      Roots) could improve hydration levels in adolescents. In turn, possibly improving mood,
      reaction time, sleep quality, and cognitive function. All of which are vital in the overall
      development of the adolescent.
    


Intervention name(s): Creative Roots
Intervention type(s): Dietary Supplement
Intervention description(s): The Creative Roots beverage is a coconut water-based drink with three flavors Mixed Berry, Watermelon Lemonade, and Peach Mango. The ingredients are as follows and are the same for all three flavors: water, coconut water concentrate, citric acid, stevia leaf extract, natural flavor, rosemary extract (to preserve flavor). Contains: coconut
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
Condition: Diphtheria; Poliomyelitis; Hepatitis B; Tetanus; Acellular Pertussis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immune response and reactogenicity of GSK
      Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine,
      administered concomitantly as a three-dose primary vaccination course.
    


Intervention name(s): Pediarix TM, Infanrix penta TM; Hiberix TM
Intervention type(s): Biological; Biological
Intervention description(s): The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.; The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Intervention MeSH terms: PENTA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition
Condition: Intestinal Failure-associated Liver Disease
MeSH terms: Liver Diseases; Intestinal Failure
Study type: Observational

Summary: 
      This is a multi-center prospective cross-sectional observational study that will assess the
      prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more
      days per week. Liver disease will be determined by the presence of choline deficiency,
      cholestasis (confirmed by elevated serum alkaline phosphatase (ALP) liver isoenzyme level),
      and steatosis (confirmed by magnetic resonance imaging-derived proton density fat fraction
      (MRI-PDFF).

      The objective of this study is to investigate the presence/prevalence of liver disease in
      patients dependent on PN (≥4 days a week).
    

Detailed description: 
      Eligible participants will provide blood samples at Visit 1 to determine choline deficiency,
      elevated serum ALP liver isoenzyme level and liver dysfunction, and complete one imaging
      study (MRI-PDFF) at Visit 1 to assess steatosis.

      The purpose of this study is to understand and document critical epidemiological data related
      to choline deficiency and the incidence of liver disease in patients dependent on PN (≥ 4
      days a week) and to better understand this patient population to help determine who might
      benefit from innovative treatments including IV Choline Chloride treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will enroll male and female adults and adolescent participants 12 years and
        older who are dependent on PN (≥ 4 days a week) in the primary care clinic setting.
      
Keywords: Intestinal failure-associated liver disease (IFALD); IFALD; Liver disease; Parenteral nutrition; Choline deficiency; Hepatic steatosis; Cholestasis; parenteral nutrition-associated liver disease
Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The purpose was to evaluate histomorphometrically the early healing at implants installed in
      sites prepared with either a sonic device or conventional drills.
    

Detailed description: 
      Sixteen volunteer patients will be recruited. Two titanium mini-implants will be installed in
      the distal segments of the maxilla in recipient sites prepared with either a sonic device or
      conventional drills. Biopsies containing the mini-implants will be retrieved after 2 weeks in
      eight patients, and after 6 weeks in the other eight patients. Histomorphometric analyses
      will be performed
    

Intervention name(s): implant placement
Intervention type(s): Device
Intervention description(s): Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
Other intervention name(s): implant surgery, prosthesis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Using Partners to Enhance Long-Term Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study involves an evaluation of the role of domestic partner support in a comprehensive
      weight loss initiation and maintenance program.
    

Detailed description: 
      Couples will be randomized to a comprehensive weight program directed at patients alone or
      involving their partners. In months 1-6, all patients will receive group-based weight loss
      program. In months 7-18, all patients will receive a telephone-based weight loss maintenance
      intervention. In the partner-assisted arm only, partners will participate in the
      intervention, learning and practicing communication skills and support strategies. In months
      19-24, intervention will be withdrawn to examine sustainability of effects.

      Due to COVID-19, option of doing screening and outcome assessment visits and attending the
      group classes (including exercise) remotely via a video conference may be available. COVID-19
      survey will be administered every 3 month starting at screening/enrollment visit.
    

Intervention name(s): Partner-assisted intervention; Patient-only intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.; All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mesalamine and Reproductive Health Study
Condition: Colitis Ulcerative; Crohn Disease
MeSH terms: Crohn Disease; Colitis, Ulcerative
Study type: Observational

Summary: 
      The purpose of this study is to investigate the relationship of high exposure to dibutyl
      phthalate (DBP) from the use of Asacol with clinical and intermediate markers of male
      fertility, including semen quality, sperm DNA damage, transcript profiles of sperm mRNA and
      sncRNAs, and reproductive hormones.

      Hypothesis 1: High exposure to DBP from the use of Asacol is associated with decreased sperm
      concentration and motility, and increased sperm DNA damage.

      Hypothesis 2: High exposure to DBP from the use of Asacol is associated with decreased serum
      testosterone, altered LH:testosterone ratio, and decreased inhibin-B.

      Hypothesis 3: High exposure to DBP from the use of Asacol is associated with altered
      transcript profiles of sperm mRNAs and sncRNAs.
    

Detailed description: 
      There are 2 ways you can participate in the study.

      OPTION 1 involves 6 one-hour visits to the Massachusetts General Hospital (MGH) Andrology
      Clinic over a 9 month period. At each visit you would be asked to fill out questionnaires and
      to provide a urine, semen, and blood sample. Following Visit 2, you are asked to switch your
      brand of mesalamine medication. After 4 months, you change back to your original brand of
      medication. The change in medication will be done in consultation with your primary GI
      doctor. If the cost of co-payment is greater for the new brand of medication, we will provide
      compensation to cover the difference. In the case you do not have prescription drug health
      insurance coverage, the study will reimburse up to $4000 to cover the cost for Asacol,
      Pentasa or Lialda medication taken during your study participation.

      OPTION 2 involves 4 one-hour visits to MGH Andrology clinic. At each visit you complete
      questionnaires and provide a blood, urine and semen sample. You are eligible for Option 2 if
      you are currently taking Asacol or Asacol HD and do not want to change your medication.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men between the ages of 18-55 who have inflammatory bowel disease.
      
Biospecimen description: 
      Blood for hormones, urine for phthalates, semen for DNA and RNA
    
Keywords: Inflammatory Bowel disease
Effect of a High-Protein Diet and/or High-Intensity Training on Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to determine the combined effects of a high-protein diet and
      high-intensity training on metabolic syndrome risk factors in women aged 30-65.
    

Detailed description: 
      High-protein diet interventions have been shown to be effective in reducing triglycerides and
      increasing high-density lipoprotein cholesterol concentrations. Low-volume, high-intensity
      cycling exercise has shown to elicit positive effects on metabolic syndrome risk factors such
      as triglyceride concentrations. The objective of this study was to determine the combined
      effects of a high-protein, reduced carbohydrate diet and high-intensity interval training on
      metabolic syndrome risk factors in women. The second primary aim is to investigate the effect
      of the macronutrient content of the post-exercise meal consumed following an acute bout of
      interval training on postprandial metabolism.
    

Intervention name(s): Sprint Interval Exercise; Higher PRO Diet; Higher CARB Diet
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Participants will undergo sprint interval training on a cycle ergometer 3 times weekly for 6 weeks. Each training session begins with a 5-minute active warm-up. The warm-up is followed by 4-7 bouts of 30 seconds of all-out sprints and 4 minutes of active recovery.; Participants in the PRO and PRO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the high protein diet.; Participants in the CHO and CHO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the higher carbohydrate diet.
Other intervention name(s): High Intensity Training; Sprint Interval Cycling; Higher Protein Reduced Carbohydrate Diet; Conventional Higher Carbohydrate Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cardiovascular disease; diabetes mellitus
Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy
Condition: Diabetes in Pregnancy; Gestational Diabetes; Texting Interventions
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

Summary: 
      Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to
      adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can
      be minimized with tight glucose control. A number of studies in non-pregnant populations have
      highlighted the feasibility, acceptability and efficacy of text messaging interventions for
      improving diabetic compliance and control. This study will investigate whether a text
      messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and
      whether this intervention can improve compliance with diabetes care, glucose control and
      pregnancy outcomes. The study will also assess satisfaction with the intervention itself.
    


Intervention name(s): Text Message Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      Post-marketing surveillance study to evaluate the real world safety and effectiveness of
      Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a
      normal, routine treatment practice by Korean patients with Hepatitis C.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Type C Hepatitis patients who had been prescribed Viekira/Exviera
        (paritaprevir/ritonavir/ombitasvir and dasabuvir) in accordance with approved local label.
      
Keywords: Hepatitis C; Paritaprevir; Ritonavir; Ombitasvir; Dasabuvir