bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacokinetic Study of Modified Release (MR) Formulations of MIN-101 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of
           modified release (MR) formulations of MIN-l0l in healthy male and female subjects

        -  To select 1 MR formulation for use in fed state

        -  To evaluate the effect of food on the bioavailability of MIN-l0l selected MR formulation
    


Intervention name(s): MIN-101
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Food Effect
The Effect of Phototherapy Treatment on Oxygen Saturation Measurement in Newborns
Condition: Hyperbilirubinemia, Neonatal Indirect
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Observational

Summary: 
      This will be a prospective clinical study conducted with the approval of the Clinical
      Research Ethics Committee.

      The influence of phototherapy lights on the accuracy of pulse oximetry will be investigated.
    

Detailed description: 
      Each patient's oxygen saturation will be measured non-invasively via a nondisposable
      polyethylene neonatal probe taped to the infant's palm, toe, or dorsum of the foot. The probe
      will be connected to an Massimo Rad97 pulse oximeter that is standardized at the factory. It
      runs through an automatic systems check when turned on and needs no further calibration
      before being used. The oxygen saturation measurements will be considered valid when there
      will be a normal plethysmographic waveform, a fullscale signal strength bar, and a stable
      heart rate closely approximating an independent electrocardiographic (ECG) pulse rate. The
      pulse oximeter works by using the technology of plethsmography which allows the detection of
      an arterial pulse) with oximetry (which measures oxygen saturation at specific wavelengths).
      The pulse oximeter will be placed on each infant as already described. After a stable pulse
      oximeter reading was obtained, the value will be recorded ("before") and then the probe will
      be covered with a standard disposable diaper, shiny side up. When the reading stabilized, the
      value will be recorded ("during") and then the diaper will be removed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All newborn babies who are receiving phototherapy for indirect hyperbilirubinemia in the
        NICU of the Hacettepe University will be included in the study following the obtaining of
        informed consent by their parents/guardian.

        The oxygen saturation of all babies receiving inpatient treatment in the NICU is routinely
        monitored with a pulse oximeter. In this study, the oxygen saturation of the newborns
        receiving phototherapy will be recorded.
      
Keywords: pulse oximeter, phototherapy, newborn
CoolSculpting in the Abdomen Using Applicator With and Without CCI
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the
      abdomen using an applicator with the Crown Cooling Insert.
    

Detailed description: 
      Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an
      accessory insert.
    

Intervention name(s): CoolSculpting Treatment
Intervention type(s): Device
Intervention description(s): The CoolSculpting device will be used to perform treatments.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Impact Evaluation of a Mobile Health App to Improve Self-control and Health Outcomes of Patients With Type 2 Diabetes Mellitus (T2DM): Pilot Study "NOVAME"
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of this project is to evaluate the effectiveness and cost effectiveness of a
      health app (NOVAME) designed to improve the self-control of patients with T2DM and their
      health outcomes. The central focus of NOVAME is the continuous support to the patient and
      monitoring through the app that will act as a personalized and dynamic virtual coach that
      will help the patient to adopt healthy habits and change their behaviors through training
      plans in different areas: exercise physical, healthy eating, therapeutic education and
      emotional management The design of the evaluation is the randomized clinical trial, in the
      intervention arm patients will use the app NOVAME and in the control group, patients don't
      receive any additional educational or supporting activities beyond the usual activities
      provided by the Canary Islands Health Service (CIHS). The main outcome measure is the change
      in HbA1c at 3 months, requiring a total of 197 patients to detect a difference of at least
      0.4% considering a 10% loss. As secondary measures HbA1c is collected at 12 months and other
      biochemical results (lipids and glucose), BMI and a series of questionnaires to measure
      changes in life habits (diet, physical activity), anxiety and depression, knowledge about
      their disease , degree of empowerment, satisfaction and usability of the app, .. Will be
      collected at 3 and 12 months. The differences between the arms will be measured with mixed
      generalized linear models. The cost effectiveness will be calculated by calculating life
      years adjusted for quality (QALY) and the cost of the disease, including the use of resources
      reported by patients. The benefits of the technology will be expressed in terms of HbA1c and
      QALY.
    


Intervention name(s): mobile app NOVAME
Intervention type(s): Behavioral
Intervention description(s): The training program is divided into 3 periods of 21 days, where each day the patient receives a new formation pill. At the end of one of these periods there will be a week of review in which the patient will receive reminders of the contents that he has already received. These pills will help the patient to acquire healthy lifestyle habits and improve the control of the disease. The length of the program is 84 days, and once completed, the patient can repeat or intensify efforts in the areas he considers and continue to have access to the virtual coach. Patients assigned to the intervention group will receive a brief structured explanation on how to use the application and its contents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy and Safety of Fermented Ginseng Powder on Liver Function
Condition: Fatty Liver, Nonalcoholic
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of fermented
      ginseng powder on improvement of Liver function.
    

Detailed description: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of fermented ginseng powder on improvement of Liver
      function. The investigators measured ALT(Alanine Transaminase) profiles, Liver function
      index, fatty liver grade, lipid metabolism index, total antioxidant capacity, imflammation
      index, and Multidimensional Fatigue Scale.
    

Intervention name(s): fermented ginseng powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.; Placebo for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: ginseng powder; Fatty Liver; Clinical Trial
Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study,
      aiming to investigate whether higher potency of different inhaled corticosteroid confers an
      improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It will
      compare the dose response for topical efficacy via airway responsiveness (to
      adenosine-5'-monophosphate [AMP] challenge), and the dose response for systemic activity via
      24 hour plasma cortisol suppression, and thereby compare the relative therapeutic index, for
      the following inhaled corticosteroids: fluticasone furoate (FF), fluticasone propionate (FP)
      and budesonide (BUD). There will be a screening visit 4 - 42 days before the first dose of
      study treatment, and AMP challenge Provocative concentration 20 (PC20) of <=80 milligrams per
      milliliter (mg/mL) at screening visit 2 i.e. at 4 - 14 days before the first dose of study
      treatment. Subjects will be randomized to one of 5 or 12 treatment sequences, and will have
      one or two treatment periods, each comprising 5 consecutive 7-day phases of escalating doses
      of either FF, FP, BUD or placebo. There will be a 25- to 42-day washout period between
      treatment periods. The study duration for each subject will be approximately 13 or 24 weeks
      including the follow-up period.
    


Intervention name(s): Fluticasone furoate (FF) Dry Powder Inhaler; Fluticasone propionate (FP) Dry Powder Inhaler; Budesonide (BUD) Turbuhaler; Placebo (ELLIPTA or DISKUS)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dry inhalation powder 25 mcg, 100 mcg, and 200 mcg per blister strip will be administered using ELLIPTA for both treatment periods; Dry Inhalation powder 50 mcg, 100 mcg, 250 mcg, and 500 mcg per blister strip will be administered using DISKUS for both treatment periods; Budesonide comprises white to off-white rounded granules, which disintegrate to a fine powder upon slight pressure, will be administered using Turbuhaler for both treatment periods.; Lactose dry powder inhaler will be administered using ELLIPTA or DISKUS for both treatment periods.
Intervention MeSH terms: Fluticasone; Xhance; Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dose-response; AMP challenge; cortisol suppression; dose escalation; therapeutic index
Effectiveness Study of Vilazodone to Treat Depression and to Discover Genetic Markers Associated With Response
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to determine the safety and effectiveness of vilazodone for major
      depressive disorder and to discover genetic markers associated with response. This study will
      enroll approximately 400 patients.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is
      designed to assess the efficacy and safety of vilazodone and to discover genetic markers of
      treatment response associated with vilazodone use in adult patients diagnosed with MDD by the
      DSM-IV-TR criteria. This study will enroll approximately 400 patients.
    

Intervention name(s): vilazodone
Intervention type(s): Drug
Intervention description(s): titration to 40mg tablets qd for 8 weeks
Other intervention name(s): EMD 68843, SB-659746
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression. Genetics, Pharmacogenetics
The Study of Inflammation on Blood Glucose Levels in Obese People
Condition: Obesity
MeSH terms: Obesity; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic subaccute inflammation may underlie the development of diabetes cardiovascular
      disease and other components of the metabolic syndrome. Rodent studies suggest diet induced
      obesity is associated with activation of the IKK/NF-kB pathway and this pathway can be
      inhibited by salicylates. This study seeks to determine the effect of salicylates in
      overweight persons.
    


Intervention name(s): salsalate
Intervention type(s): Drug
Intervention MeSH terms: Salicylsalicylic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obesity; Metabolic Syndrome; Diabetes; Inflammation
Tolerability of Pharmaton PHL 00747 in Healthy, Young Female Subjects of Child-bearing Potential
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and
      film-coated tablets
    


Intervention name(s): Pharmaton PHL 00747 soft gelatine capsules; Pharmaton PHL 00747 film-coated tablets; Placebo film-coated tablets (fct); Placebo soft gelatine capsules
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
HDL-C in Cardiac Syndrome X
Condition: Cardiovascular Diseases; Heart Diseases; Myocardial Ischaemia; Unstable Angina; Microvascular Angina
MeSH terms: Cardiovascular Diseases; Heart Diseases; Angina Pectoris; Myocardial Ischemia; Angina, Unstable; Microvascular Angina; Ischemia
Study type: Observational

Summary: 
      High density lipoprotein cholesterol (HDL-C) is in the centrum of the process of reverse
      cholesterol transport from peripheral cells to the liver[10]. HDL-C promotes endothelial
      generation of nitric oxide (NO) and improves endothelial function and arterial
      vasoreactivity[11]. In several studies, lower HDL-C level was reported to be associated with
      increased coronary artery disease (CAD) risk[12-14]. HDL-C also has anti- inflammatory and
      anti-oxidant activities[15,16]. Concerning anti-inflammatory activity, HDL-C inhibits the
      activation of monocytes/macrophages and neutrophils[17,18] and inhibits the expression of
      endothelial adhesion molecules, such as vascular cell adhesion molecule-1 (VCAM-1) and
      E-selectin[15].

      In this study we aimed to investigate the relation of HDL-C level with systemic inflammatory
      markers in patients with cardiac syndrome X (CSX).
    


Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        CSX was defined as typical chest pain during rest or effort, abnormal test result for
        exercise ECG and myocardial perfusion scintigraphy, and the presence of angiographically
        normal epicardial coronary arteries. Control group was selected from volunteers presented
        to our hospital with the complaint of typical anginal chest pain who had no ischemia on
        myocardial perfusion scintigraphy or during the treadmill exercise test, had similar risk
        profile with the patients (diabetes, hypertension, age, gender) and had normal epicardial
        coronaries at coronary angiography.
      
Keywords: cardiac syndrome X; inflammation; dyslipidemia
The Modifying Eating and Lifestyles at School Study
Condition: Meals; Food Habits
Study type: Interventional

Summary: 
      The purpose of this study is to examine the impact of introducing healthier, chef-enhanced
      foods and/or environmental modifications (choice architecture) on selection and consumption
      of school foods among elementary and middle school students.
    

Detailed description: 
      Project Modifying Eating and Lifestyles at School (MEALS) was a school-based study developed
      by the nonprofit organization Project Bread (www.ProjectBread.org) and the Harvard School of
      Public Health. Project Bread hired a professional chef to work with several schools in a
      low-income, urban school district in Massachusetts to enhance the palatability and nutrient
      profile of the school meals. Four schools were randomly assigned to receive the professional
      chef. Additionally, two schools in that district and four schools in a second school district
      were randomly assigned to receive a behavioral psychology intervention to influence the
      selection and consumption of the healthier foods offered. Selection and consumption were
      assessed at baseline, up to 3 months post-implementation (short-term implementation for
      chef-enhanced meals), up to 4 months post-implementation (long-term implementation for
      behavioral psychology) and/or up to 7 months post-implementation (long-term implementation
      for chef-enhanced meals).

      Primary Aim 1: to examine the impact of introducing healthier, chef-enhanced foods with
      increased palatability on selection and consumption among elementary and middle school
      students. It is hypothesized that there will be an increase in the selection and consumption
      of entrees, fruits, and vegetables in schools where healthier, chef-enhanced foods are
      served.

      Aim 2: to examine the impact of physical modifications to the placement and displays of foods
      in the cafeteria on selection/consumption among elementary and middle school students. It is
      hypothesized that there will be an increase in selection and consumption of entrees, milk,
      fruits, and vegetables when modifications are made.
    

Intervention name(s): choice architecture; Chef-enhanced meals
Intervention type(s): Behavioral; Other
Intervention description(s): Place vegetables at the beginning of the lunch line.
Place fruits in attractive bowls or trays lined with appealing fabric, and place other fruit options next to the cash registers.
Promote fruits and vegetables with prominently displayed signage and images.
Place white milk selection in front of sugar-sweetened milk (e.g. chocolate milk) or at eye-level.; meals prepared by a professional chef with enhanced palatability
Other intervention name(s): Smart Cafe
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Trial Comparing 3 and 4 Week Regimen of Gemcitabine and Cisplatin in Patients With Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate response rate of the 3 week versus 4 week treatment
      of gemcitabine with cisplatin as the first line treatment for non-small cell lung cancer
      patients in China.
    


Intervention name(s): gemcitabine; cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if a drug called topiramate is safe and effective
      as an add-on therapy in the treatment of Obsessive-Compulsive Disorder (OCD). Topiramate is
      an investigational drug for OCD, which means it has not been approved by the U.S. Food and
      Drug Administration (FDA). Topiramate has been approved as an add-on therapy for adults and
      children with partial onset seizures or generalized tonic-clonic seizures, and for patients 2
      years of age and older with a severe form of epilepsy called Lennox-Gastaut Syndrome.

      Up to 96 subjects will be enrolled in this study. This study consists of three phases:
      Washout/Screening Phase, Double-Blind Phase, and Taper Phase. The total expected length of
      your participation in the study is approximately four months.
    

Detailed description: 
      This is a multicenter, outpatient, randomized, double-blind, placebo-controlled,
      parallel-group, study designed to evaluate the safety and efficacy of adjunctive topiramate
      in treating subjects with OCD. The study consists of a washout/screening phase, a
      double-blind treatment phase of 12 weeks, a taper period of approximately 7 days. Upon
      successful completion of the washout/screening phase subjects will be randomized into 1 of 2
      treatment groups: topiramate up to 400 mg/day or placebo. A placebo control will be used to
      establish the frequency and magnitude of changed in clinical endpoints that may occur in the
      absence of active treatment.

      During the double-blind phase, subjects will be seen weekly for the first two weeks and then
      every other week for the remainder of the double-blind phase. Study medication will be
      titrated over the 8-week titration period up to 400mg/day or the subject's maximum tolerated
      dose. After the titration period, the dose will remain stable for the maintenance period
      during which visits will occur every 14 days. At the completion of the maintenance period,
      subjects will taper their study medication over the next 7 days.

      This study will be conducted in up to 96 subjects with a diagnosis of OCD with an onset at
      least 1 year prior to screening supported by the SCID-I. Forty-eight subjects will be
      assigned to topiramate and 48 will be assigned to placebo.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obsessive-Compulsive Disorder; Obsessions; Compulsions; Adjunctive treatment
Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene
Condition: Night Blindness
MeSH terms: Blindness; Night Blindness; Vitamin A Deficiency
Study type: Interventional

Summary: 
      To assess the effect of oral administration of the alga Dunaliella bardawil containing
      approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual
      functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus).
    


Intervention name(s): alga Dunaliella bardawil
Intervention type(s): Dietary Supplement
Intervention description(s): Each patients will be treated with four capsules daily of Dunaliella bardawil for 90 days.
Alga Dunaliella bardawil containing 15 mg approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Beta Carotene; visual functions; Fundus albipunctatus; Night Blindness