bioihbjkbjnl/mcl2 huggingface dataset:
Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The intervention consists of an individual counseling session, telephone counseling (7
      calls), given by a psychologist, and a pedometer. The intervention is based on cognitive
      behavioral therapy, the Diabetes Prevention Program, the first Step Program and Motivational
      Interviewing. The taxonomy of behavior change techniques is also taken into account. The
      duration of the intervention is six months. The individual session takes place one week after
      the baseline measurements, together with the participants' follow-up appointment with their
      endocrinologist. The individual session takes place at the endocrinology department and is
      expected to last approximately 30 minutes. In addition to the session, the participants of
      the intervention group receive a pedometer and a pedometer diary for six months. Participants
      of the intervention group also receive telephone counseling from the psychologist during 24
      weeks. They receive a call every two weeks for four weeks and then every four weeks for the
      next 20 weeks, good for a total of seven counseling calls. The calls are expected to last
      approximately 20 minutes. The Control Group has no intervention at all and receive their
      usual care.
    


Intervention name(s): Daily physical activity, pedometer and counseling
Intervention type(s): Behavioral
Intervention description(s): Individual counseling session, telephone counseling (7 calls), given by a psychologist and a pedometer, based on cognitive behavioral therapy, the Diabetes Prevention Program, the first Step Program and Motivational Interviewing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Induction of Labour With a Double Balloon Catheter
Condition: Labor, Induced
Study type: Observational

Summary: 
      The objective of this study is to provide a comprehensive analysis of various time intervals
      (1:1). In addition to evaluating the time interval until delivery after completion of
      induction, the study also aims to investigate the rate of vaginal births and the type of
      combination therapy used (including the method of implementation and subsequent induction).
    

Detailed description: 
      Approximately 22% of births in Germany are induced annually using either medicinal,
      mechanical, or sequential mechanical/medicinal methods, with oxytocin and prostaglandins
      being the available drug options. Double balloon catheters have been used in clinics for over
      a decade for mechanical induction of labour, resulting in cervical ripening and possible
      onset of labour through endogenous prostaglandin release. This method is associated with low
      rates of uterine tachysystole and maternal and neonatal morbidity.

      The recommended placement time for the double balloon catheter is 12 hours, typically
      performed at night in an inpatient setting, which may cause early exhaustion and fatigue for
      patients. However, a study has shown that a shorter insertion time of 6 hours is equally safe
      and effective, without any time savings beyond the shortened insertion time.

      This study aims to investigate the feasibility and effectiveness of shortening the induction
      birth interval from 12 to 6 hours. The investigators hypothesize that this will result in a
      shorter induction birth interval with comparable maternal and neonatal outcomes. This
      analysis will test the effectiveness of the shortened induction birth interval.
    

Intervention name(s): induction of labour with double balloon catheter placement for 6 hours; induction of labour with double balloon catheter placement for 12 hours
Intervention type(s): Procedure; Procedure
Intervention description(s): catheter placement for 6 hours beginning in the morning at around 8 a.m.; catheter placement for 12 hours in the evening at around 8 p.m.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        tertiary center, women undergoing induction of labour
      
Keywords: double balloon catheter; cervical ripening; time to delivery
Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism
Condition: Caffeine; Diet, Healthy; Fat Burn; Cognitive Change; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this investigation was to examine the acute effects of consuming two different
      fitness drink formulas on the physiological response at rest and to exercise in healthy men
      and women.
    

Detailed description: 
      Thermogenic fitness drinks containing ~200mg of caffeine have been reported to accelerate the
      metabolism, increase energy, and consequently promote increased fat oxidation. However,
      determination of the efficacy of lower caffeine concentrations may provide additional options
      for individuals with preferences for reduced caffeine intake. Therefore, the aim of this
      study was to evaluate different fitness drink formulas containing a total of 100mg and 140mg
      of caffeine on the physiological response at rest and to exercise.

      This study utilized a randomized, double-blind, placebo-controlled design. All participants
      completed three testing visits during which they consumed the placebo, the 100mg caffeine
      formula, and the 140mg caffeine formula. Blood samples, blood pressure, heart rate, resting
      energy expenditure, substrate oxidation, and neurocognitive assessments were collected at
      baseline and repeated 30, 60, and 90 minutes post-ingestion. Immediately following the last
      cognitive assessment, a maximal graded exercise test with gas analysis was conducted on a
      cycle ergometer to evaluate physical performance and maximal fat oxidation during exercise as
      well as the physiological response prior to and following exercise.
    

Intervention name(s): Fitness Drink Formula
Intervention type(s): Dietary Supplement
Intervention description(s): Single drink provided following baseline assessments
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Study to Assess the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Cetirizine Alone on Symptoms in Patients With Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy on nasal congestion and other allergic
      symptoms and the onset of action of an oral combination of cetirizine and pseudoephedrine in
      comparison to the single substances under controlled pollen exposure in an Environmental
      Challenge Chamber (ECC).
    


Intervention name(s): Cetirizine; Pseudoephedrine; Cetirizine with Pseudoephedrine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cetirizine; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
MG98 in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have
      advanced solid tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.

        -  Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this
           patient population.

        -  Evaluate the effectiveness of this treatment regimen in these patients.

      OUTLINE: This is a dose escalation, multicenter study.

      Patients receive MG98 IV over 2 hours twice weekly for 3 weeks. Courses are repeated every 4
      weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

      The dose of MG98 is escalated in cohorts of 1-6 patients until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose limiting toxicity.

      Patients are followed at week 4, then at least every 3 months until relapse of disease.

      PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 10-12
      months.
    

Intervention name(s): MG 98
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study has a randomized multiple-dose, placebo-controlled, parallel group design
      consisting of a 2-week open placebo Run-in Period followed by a 6-week Treatment Period with
      placebo, test product (budesonide 80 microgram [μg]/formoterol fumarate dihydrate 4.5 μg), or
      reference product (Symbicort® inhalation aerosol).
    

Detailed description: 
      This is a pivotal trial that will examine the therapeutic equivalence of a new generic
      fixed-dose combination product containing budesonide 80 μg/formoterol fumarate dihydrate 4.5
      μg and reference listed drug (RLD) Symbicort® inhalation aerosol in adult participants with
      chronic but stable asthma as defined in National Asthma Education and Prevention Program
      Expert Panel Report 3 (NAEPP 3) guidelines. To ensure adequate study sensitivity, the test
      and reference products should both be statistically superior to placebo (p<0.05) with regard
      to the bioequivalent study primary endpoints. Participants will be provided a generic placebo
      pressurized metered-dose inhaler (pMDI) device for use during the 2-week Run-in Period for
      device training.
    

Intervention name(s): Generic Budesonide/Formoterol Fumarate Dihydrate; Symbicort® (Budesonide/Formoterol Fumarate Dihydrate); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral inhalation, generic formulation of the brand-name product.; Oral inhalation, brand-name product.; Oral inhalation, no active ingredient.
Other intervention name(s): Symbicort Turbohaler®
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to:

        -  evaluate the safety profile of a single intravenous administration of AIGIV (containing
           either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg,
           180 mg/kg or 360 mg/kg total IgG, GAMUNEX® (immune globulin intravenous (human) 10%
           caprylate/chromatography purified). GAMUNEX is a trademark of Talecris Biotherapeutics.

        -  evaluate the pharmacokinetic (PK) profile of a single intravenous administration of
           AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as measured by
           lethal toxin neutralizing antibody (TNA).
    


Intervention name(s): AIGIV 3.5 mg/kg; Gamunex 90 mg/kg; AIGIV 7.0 mg/kg; Gamunex 180 mg/kg; AIGIV 14.0 mg/kg; Gamunex 360 mg/kg
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.; Gamunex 90 mg/kg total IgG as a single intravenous infusion.; AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.; Gamunex 180 mg/kg total IgG as a single intravenous infusion.; AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.; Gamunex 360 mg/kg total IgG as a single intravenous infusion.
Other intervention name(s): human immune globulin intravenous
Intervention MeSH terms: Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anthrax; Human Anthrax Immune Globulin Intravenous; Safety; Pharmacokinetics
STAMPP-HTN in a High-risk Rural Population of Women
Condition: Hypertension in Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine if monitored blood pressure paired with education
      reduces maternal mortality and morbidity during the post-partum period in a high-risk rural
      population of women.
    

Detailed description: 
      Women with hypertension during pregnancy are at an increased risk of maternal mortality
      (death during or within 42 days of termination of pregnancy) and hypertension related
      morbidity. Black women, women with lower education and less access to health care resources
      also have increased maternal mortality and morbidity. This project will use Bluetooth enabled
      blood pressure devices to monitor blood pressure in a population of postpartum women at
      increased risk for maternal mortality and morbidity. We will compare the number of postpartum
      hypertensive incidences and severities to a population of women who did not have a postpartum
      blood pressure control intervention.
    

Intervention name(s): Home Blood Pressure Telemonitoring
Intervention type(s): Device
Intervention description(s): Women will complete a 9-question survey (pre-education) prior to discharge and will go over an education video a study team member. Once discharged, women will be asked to measure their blood pressure daily for the first postpartum week, and then weekly until postpartum week 6. Women who have a doctor's visit scheduled during the first 10 days, a member of the study team will meet them there to assess blood pressure and answer any questions. Women who do not have a visit scheduled they will have a telehealth visit during days 8-10 to complete the same assessments. At the final visit, participants will measure their blood pressure via HBPT, prior to returning the unit, complete a post-education questionnaire, a post-study questionnaire and have any questions or concerns addressed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Hypertension; Blood Pressure; Post-Partum; Telemonitoring
Use of Novel High-protein Food Products To Reduce Insulin Resistance
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This controlled weight loss trial in adults at cardiometabolic risk (elevated
      triglyceride/HDL ratio) followed a randomized, cross-over design and utilized novel,
      high-protein pasta and cereal to examine the physiological impact of stealth substitution of
      dietary carbohydrate with protein derived from soy concentrates, wheat protein isolates, and
      dried egg whites. Pasta dishes were prepared using high-protein orzo and fusilli pasta (Zone
      PastaRxTM) or conventional, gluten-free pasta, and high-protein flaked cereal (ZoneTM cereal)
      was matched with conventional flaked cereal. Participants were instructed to follow an energy
      restricted diet (-500 kcal/d) and incorporate a test food into each of three meals over a
      24-hour period. The diet-induced changes in body mass and lean body mass were tracked as well
      as changes in in insulin sensitivity and common blood biomarkers.
    


Intervention name(s): Food product: high-protein pasta and cereal
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery
Condition: Cardiac Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to examine the efficacy of levosimendan in terms of reducing postoperative
      mortality and severe morbidity in patients undergoing non-emergent surgery for coronary
      revascularisation with or without ischaemic mitral regurgitation and who may or may not
      require repair or replacement of the mitral valve and have a LVEF < 35%.
    


Intervention name(s): Levosimendan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Levosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose.; Placebo group patients will receive a perfusion of 5% glucose solution. This clear solution, free of visible particles, will have 0.4mg of riboflavin sodium phosphate, 100mg of anhydrous alcohol and water for injection up to 1ml added to it. This solution will be calculated as a dose of 0.1µg/kg/min.
Intervention MeSH terms: Simendan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Observational

Summary: 
      Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using
      18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).
    

Detailed description: 
      Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using
      18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).
      The following hypothesis will be tested: Antidepressant response or remission in depressed
      BPD patients will be associated with changes in cortical (prefrontal, parietal, premotor) and
      paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior cingulate, and
      anterior insula) regions, consistent with SRI antidepressant response in unipolar depressed
      patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Bipolar Depression
Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, Open label, Single center, Prospective study to compare efficacy and safety of
      Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on
      Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological
      Response Induced by Entecavir
    

Detailed description: 
      A randomized, Open label, Single center, Prospective study to compare efficacy and safety of
      Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on
      Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological
      Response Induced by Entecavir (E + VIP)
    

Intervention name(s): Peginterferon alfa-2a; HBV vaccination; Entecavir
Intervention type(s): Biological; Biological; Drug
Intervention description(s): once weekly 180 μg subcutaneous injection for 48 weeks; 1.0 mL (20 μg) intramuscular injection at 4, 8, 12 and 28 weeks; Continue Entecavir(0.5mg) for 100 weeks
Other intervention name(s): Pegasys; Euvax B Inj; Baracrude
Intervention MeSH terms: Peginterferon alfa-2a; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis B; Pegasys; Euvax B; Baracrude
Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the potential interaction and subjective effects between intravenous
      cocaine and SYN117 in non-treatment seeking cocaine dependant subjects
    


Intervention name(s): SYN117 Placebo; SYN117 80 mg; SYN117 160 mg; Cocaine 10mg; Cocaine 20mg; Cocaine 40mg; Saline
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo; SYN117 80 mg; SYN117 160 mg; IV Cocaine 10mg; IV Cocaine 20mg; IV Cocaine 40mg; IV Cocaine Placebo
Intervention MeSH terms: Cocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Correlation Between Angle Closure Glaucoma Data and Lens Zonule Status
Condition: Primary Angle Closure Glaucoma
MeSH terms: Glaucoma; Glaucoma, Angle-Closure
Study type: Observational

Summary: 
      The goal of this observational study is to discuss the correlation between primary
      angle-closure glaucoma and the state of the suspended ligament of the lens and the
      pathogenesis of PACG by measuring the biological data of primary angle-closure glaucoma and
      observing its anatomical changes.
    

Detailed description: 
      Patients clinically diagnosed with Primary angle-closure glaucoma (PACG) and normal control
      patients from December 2020 to January 2022 were enrolled in this study.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From December 2020 to January 2022, patients with primary angle-closure glaucoma and normal
        control patients were diagnosed for the first time and intended to undergo cataract surgery
        in the ophthalmology department of the First Affiliated Hospital of Shandong First Medical
        University (Shandong Qiandfo Hospital).
      
Keywords: primary angle closure glaucoma; UBM; lens zonule
Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects
Condition: Health Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate
      the effect of multiple doses of Fluconazole, a CYP3A4 and CYP2C9 inhibitor, on the
      pharmacokinetics (PK) of CTP-543 in healthy subjects
    


Intervention name(s): CTP-543; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): 12 mg on Day 1 and Day 7; 200 mg once daily on Days 3 through to Day 8
Intervention MeSH terms: Fluconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: CTP-543