bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3475766 in Healthy Participants
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of LY3475766 when given to participants
      with high levels of blood fat called triglycerides. It will also investigate how the body
      processes the study drug and the effect of the study drug on the body. Information about any
      side effects will be documented. This study will last up to 16 weeks for each participant.
    


Intervention name(s): LY3475766 - IV; LY3475766 - SC; Placebo - IV; Placebo - SC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered IV; Administered SC; Administered IV; Administered SC
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries
Condition: Caries,Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the long-term effectiveness of a lay health advisor
      (LHA) intervention on immigrant children's caries and preventive behaviors.This randomized
      controlled trial included mother-child pairs in the intervention group (IG) and a
      brochure-only control group (CG), respectively. The IG received a four-week one-on-one
      session by an LHA on caries-related knowledge and brushing techniques. Baseline and follow-up
      surveys were used to collect the data in caries experience and maternal caries preventive
      behavior.
    

Detailed description: 
      A randomized experimental design was used. Vietnamese women whose children aged 2-6 years
      were recruited through churches, Chinese schools, immigrant service centers, kindergarten, or
      recommendations from LHAs in Kaohsiung City in Taiwan. Overall, 30 and 25 Vietnamese
      mother-child pairs were randomized into the IG and CG. G*Power (version 3.1.9.4) was used for
      power analysis. A power analysis was established by effect size as the mean difference of
      filled teeth change between baseline and 8-month follow-up measurement between the IG and CG,
      with sample size and 0.05 alpha level. The power was greater than 0.802, and research results
      have adequate power.All children underwent oral examination at baseline and at 1-week, 2- and
      8-month follow-ups. Each child was examined by a dentist in accordance with the primary
      dentition caries experience.Each immigrant mother completed surveys at baseline and at 1-week
      and 8-month follow-ups.
    

Intervention name(s): LHA intervention; brochure-only
Intervention type(s): Behavioral; Other
Intervention description(s): For the IG, a 4-hour lesson consisting of 4 chapters and leaflets was delivered over 4 weeks, with one chapter per hour per week. Each LHA visited the assigned mother in the IG four times in a 4-week period.; brochure-only for control group (CG)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Caries; immigrant; Lay health advisor; preventive behavior; oral hygiene
Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals
      (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the
      response to treatment is comparable in both how it works and any side effects. Xeomin® is
      approved by the United States Food and Drug Administration (FDA) for the treatment of
      cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment
      intervals. An investigational use is one that is not approved by the FDA.
    

Detailed description: 
      Dystonia is a movement disorder which is characterized by sustained, involuntary muscle
      contractions which frequently causes twisting and repetitive movements or abnormal postures
      of the trunk, neck, face, or arms and legs. In focal dystonia, the abnormal movements involve
      a single area of the body. A commonly described form of focal dystonia is cervical dystonia
      (CD). Botulinum toxin treatment can be offered as a treatment option for the treatment of CD.

      The current practice for botulinum toxin injection treatment is to inject patients every 3
      months. However, not all patients receive continuing benefit from botulinum toxin injections
      for an entire 3 months. In a recent survey, approximately 45% of patients report that they
      would prefer a treatment cycle of less than 10 weeks.This study will compare Xeomin®, a
      botulinum toxin treatment, in shorter treatment intervals (Short Flex dosing) to the standard
      interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in
      both how it works and any side effects. Xeomin® is approved by the United States Food and
      Drug Administration (FDA) for the treatment of CD. The use of Xeomin® is investigational in
      regards to shorter treatment intervals. An investigational use is one that is not approved by
      the FDA.

      The purpose of this research study is to evaluate the efficacy of the Short Flex dosing of
      Xeomin® compared to the Long Flex dosing regimen of Xeomin®, using a standard scale completed
      by the doctors and subjects as well as questionnaires that ask subjects to rate symptoms of
      CD.
    

Intervention name(s): Xeomin®
Intervention type(s): Biological
Intervention description(s): Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A
Other intervention name(s): botulinum toxin; botulinum toxin type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth
      in different ways. Some block the ability of tumor cells to grow and spread. Others find
      tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy
      uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy, cetuximab, and
      radiation therapy before surgery may make the tumor smaller and reduce the amount of normal
      tissue that needs to be removed.

      PURPOSE: This phase I/II trial is studying the side effects of giving capecitabine and
      irinotecan hydrochloride together with cetuximab and radiation therapy and to see how well it
      works in treating patients undergoing surgery for locally advanced rectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To assess the downstaging effectiveness and tolerability of neoadjuvant
           chemoradiotherapy comprising capecitabine, irinotecan hydrochloride, cetuximab, and
           radiotherapy in patients with locally advanced rectal cancer.

      OUTLINE: This is a multicenter study.

      Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-6 and irinotecan
      hydrochloride IV over 1 hour once weekly in weeks 2-5. Patients also undergo pelvic
      radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 in weeks 2-6.

      Patients undergo surgery 8 weeks after completion of chemoradiotherapy.

      After completion of study treatment, patients are followed up at 6, 12, 24, and 36 months.

      Peer Reviewed and Funded or Endorsed by Cancer Research United Kindom (UK).
    

Intervention name(s): cetuximab; capecitabine; irinotecan hydrochloride; neoadjuvant therapy; therapeutic conventional surgery; radiation therapy
Intervention type(s): Biological; Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Capecitabine; Irinotecan; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the rectum; Locally advanced rectal cancer
A Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-348
Condition: Hypertension and Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348
    

Detailed description: 
      A Phase 1 Clinical Trial to evaluate the tolerability and pharmacokinetics in healthy adult
      volunteers after administration of CKD-348 and co-administration of CKD-828, D097, D337.
    

Intervention name(s): CKD-348; CKD-828, D097, D337
Intervention type(s): Drug; Drug
Intervention description(s): QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD-348
Magnesium and Metabolic Syndrome
Condition: Diabetes Mellitus; High Blood Pressure; Hypomagnesemia
MeSH terms: Hypertension; Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective : to test the BP lowering-effect of oral magnesium supplementation, as magnesium
      chloride (MgCl2) solution, 2.5 g daily, in uncomplicated hypertensive type 2 diabetic
      subjects with decreased serum magnesium levels Design : Randomised double blind placebo
      controlled trial. Setting : Outpatients with type 2 diabetes from Durango, city in northern
      Mexico Subjects : 82 subjects between 40 and 75 years of age with type 2 diabetes serum
      magnesium deficiency and uncomplicated hypertension.

      Interventions : During 4 months the intervention group received 2.5 gr of magnesium chloride
      (50 ml of a solution containing 50 gr of MgCl2 by 1000 ml of solution ). Controls received
      inert placebo.

      Main outcome measure: Change in blood pressure. Increase of serum magnesium Secondary
      outcomes measures: Changes in lipid profile
    


Intervention name(s): Magnesium chloride; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Subjects in the intervention group received 2.5 gr of MgCl2 daily during 4 months, from a solution solution containing 50 gr of MgCl2 by 1000 ml.; Subjects in the control group received inert placebo once per day during 4 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Hypertension; Hypomagnesemia
Effect of Rifampin (RIF) on the Pharmacokinetics (PK) of Oral Cabotegravir (CAB) in Healthy Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment
      and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used for
      treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known inducer
      of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4
      (CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction between
      CAB and RIF is possible. This study will be a phase I, single-center, open label,
      fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg)
      when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg
      administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable
      subjects for this study.
    


Intervention name(s): CAB; RIF
Intervention type(s): Drug; Drug
Intervention description(s): CAB 30 mg as 1 tablet will be administered orally with 240 mL of water in the fasted state.; RIF 600 mg as 2 capsules of 300 mg will be administered orally with 240 mL of water in the fasted state.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: rifampin; drug interaction; pharmacokinetics; cabotegravir
Explorative Open Label Study of Efficacy Profile of Neurexan® in Experimental Acute Stress Setting in Healthy Subjects
Condition: Acute Stress Reaction
MeSH terms: Fractures, Stress; Stress Disorders, Traumatic, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to explore the efficacy of acutely dosed Neurexan using an
      experimental stress test called the Trier Social Stress Test
    

Detailed description: 
      An acute stress reaction is a biopsychological condition arising in response to an event
      which is individually regarded as emotionally stressful. The onset of a stress response is
      associated with specific physiological actions in the sympathetic nervous system, both
      directly and indirectly through the release of adrenaline and to a lesser extent
      noradrenaline from the medulla of the adrenal glands. These catecholamine hormones facilitate
      immediate physical reactions by triggering increases in heart rate and breathing,
      constricting blood vessels. The other major player in the acute stress response is the
      hypothalamic-pituitary-adrenal axis.

      Although stress has been described as a non-specific psychophysiological response to
      environmental stimuli, it is possible to discern specific bodily stress responses caused by
      specific emotional reactions to novel, ambivalent or uncontrollable situations and stimuli.
      For example, social stress induces elevated cortisol levels, particularly if the stressor is
      uncontrollable, unpredictable, and constitutes a social-evaluative threat due to the judgment
      of others such as in the Trier Social Stress Test). Usually, the TSST induces a two-fold
      increase in saliva cortisol with peaks around 10-20 min. after stress test termination. Also,
      an average increase in heart rates of around 20 beats per minute (bpm) is observed during the
      TSST. In addition, emotional states and feelings have been shown to be affected by this
      stress test, such as marked increases in stress perception,anxiety and emotional insecurity
      as well as decreases in mood, calmness and feeling awake.

      Preliminary results indicate that Neurexan® may improve coping abilities in stressful
      situations. This study aims to investigate the effect of Neurexan® on subjectively perceived
      nervousness and tension during an acute stressful situation and to characterize the efficacy
      profile of Neurexan®.
    

Intervention name(s): Neurexan®
Intervention type(s): Drug
Intervention description(s): 0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute stress reaction; stress; stress perception; physiological stress response; Neurexan
An Evaluation of Internet-based Carbohydrate Counting Education for Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Helping individuals with diabetes to control their blood sugars through self-management is an
      important goal, and counting carbohydrates (CHO) remains a key part of diabetes education and
      management. There is very little research examining CHO counting education with adolescents
      who have type 1 diabetes (T1DM). The purpose of this pilot study is to evaluate a newly
      developed internet-based teaching module of CHO counting for adolescents, ages 12-17 years,
      with T1DM and who do not regularly CHO count and require instruction. A secondary aim is to
      assess feasibility for a future, larger-scale clinical trail. An effective web-based CHO
      counting tutorial could be used to strengthen current diabetes education programs and may
      serve as a basis for developing other teaching modules. Advantages of web-based teaching
      include convenience, increased accessibility, and the ability to review and reinforce
      teaching concepts through repetition. It may also encourage adolescents to take the
      initiative for their own diabetes care, beginning with a self-directed, active learning
      experience.
    


Intervention name(s): In-person Carbohydrate Counting Class; Online Carbohydrate Counting Tutorial
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An in-person carbohydrate counting class led by a registered dietician. The in class session covers topics including the role of CHO in nutrition and diabetes, sources of CHO, different CHO and non-CHO foods, resources for CHO counting, label reading, and meal planning. This is the standard procedure for CHO counting education at SickKids.; A web-based CHO counting tutorial that covers the same concepts reviewed during the standard in-person instructional session held at SickKids. A teen delivers the educational messages in short segments using techniques designed to maintain the viewer's attention (e.g., visuals of food portions and short segment highlights to emphasize important points). The online module includes brief interactive question/answer components for reinforcement. The secure online tutorial will be accessible for one week through a link provided by REDCap. Users will be able to repeat sessions, log on and off during sessions, and choose specific modules for repetition/review. The investigators will be able to capture the number of times patients log on and detail frequency and specifics of usage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 1 Diabetes Mellitus; Adolescents; Carbohydrate Counting; Glycemic Control; Self-Management; T1DM
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese
      patients with relapsing multiple sclerosis (MS)
    


Intervention name(s): FTY720; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally once daily for 6 months; Administered orally once daily for 6 months
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FTY720,; MS
Weight Loss With Meal-Replacement Therapy in Teens
Condition: Obesity, Severe; Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity; Obesity, Morbid; Weight Loss
Study type: Interventional

Summary: 
      This study seeks to examine whether meal-replacement therapy is able to enhance weight loss
      among teens with severe obesity. In addition, we are also interested in examining the degree
      of weight loss needed to improve important cardiometabolic risk factors among adolescents.
    

Detailed description: 
      This study will involve 130 adolescents (ages 13-17 years old) participating in meal
      replacement therapy and will last one year (12 months).

      Participants will be asked to strictly follow the individually-prescribed eating regimen,
      which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for
      dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric
      allotment will be tailored for each individual (number of shakes and frozen meals) by
      calculating the average daily caloric deficit necessary to achieve negative energy balance
      (using the metabolic rate/energy expenditure data). Shakes/meals will be provided free of
      charge - fruits/vegetables will be purchased by the participants. Guidance will be provided
      regarding the use of the meal replacement shakes at school, and participants will be
      encouraged to engage in family meal sessions despite eating different foods.

      We will measure the changes in resting metabolic rate, traditional clinical risk markers (TG,
      HDL-c, LDL-c, TC, glucose, insulin), vascular function, weight-related quality of life, and
      physical activity.
    

Intervention name(s): Meal-replacement Therapy
Intervention type(s): Dietary Supplement
Intervention description(s): We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Cardiometabolic; Meal-replacement therapy
A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents
Condition: Influenza; Pandemic Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza
      vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of
      immunogenicity and safety.
    


Intervention name(s): H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated); Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011
Intervention type(s): Biological; Biological
Intervention description(s): 2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age; Booster vaccination at Day 360 after first vaccination (only in subjects who received the 7.5 µg dose of the H1N1 pandemic influenza vaccine)
Other intervention name(s): Inflexal V
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention