bioihbjkbjnl/mcl2 huggingface dataset:
Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan
Condition: Renal Failure; Left Ventricular Hypertrophy
MeSH terms: Renal Insufficiency; Arteriovenous Fistula; Hypertrophy, Left Ventricular; Fistula; Hypertrophy
Study type: Interventional

Summary: 
      The primary objective is to determine if the use of losartan, an angiotensin II receptor
      blocker, can attenuate left ventricular hypertrophy, independent of its antihypertensive
      effects, in patients with near end stage chronic kidney disease (CKD) who have an
      arteriovenous fistula created.

      Secondary outcomes include the impact of the medication on BNP and hyperkalaemia
    

Detailed description: 
      Study Design: This is a prospective double blind placebo control 2 arm, randomized (1:1)
      parallel group study in patients with near end stage renal failure who require creation of an
      arteriovenous fistula for future haemodialysis. Enrolment will be over a period of 12 months.
      The blinded phase will be for 3 months. The study design is summarized in Appendix 1. The
      study consists of a screening phase, a randomization phase and a treatment phase.

      Patients will be randomized into 2 groups:

        -  Group 1 Losartan (50mg daily blinded) and 25 mg of atenolol

        -  Group 2 Placebo (blinded) and 25 mg of atenolol

      Patients: Patients must comply with specified inclusion and exclusion criteria. The number of
      patients used will be sufficient to show a 15% difference in the left ventricular mass (LVM)
      between the two groups

      Study Endpoints: The primary endpoint is the between group difference in LVM from baseline to
      1 month.

      Statistical Considerations: The analysis will be based upon an 'ANCOVA'-type linear
      regression model that includes baseline LVM and treatment group as explanatory variables, and
      final LVM as the outcome variable.
    

Intervention name(s): losartan
Intervention type(s): Drug
Intervention description(s): losartan 50 mg a day
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Arteriovenous fistula; hypertrophy; losartan
Clinical Trial to Evaluate the Efficacy and Safety of Pravafenix Cap to Verify the Superiority Than Atorvastatin
Condition: Combined Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      1. Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C
           but inadequately controlled triglyceride level by atorvastatin monotherapy

        2. Study objective : The objective of this study is to demonstrate that Pravafenix Cap. is
           clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each
           group after 8 weeks treatment with atorvastatin or Pravafenix Cap. (pravastatin
           sodium/fenofibrate) in patients with adequately controlled LDL-C but inadequately
           controlled triglyceride level by atorvastatin monotherapy in a multicenter, randomized,
           double blind setting.

        3. Phase and design : A multicenter, double blind, randomized, active controlled,
           parallel-design, Phase 3 study

        4. Duration of study : 12 months from the IRB approval date

        5. Duration of administration : 4-week single blind run-in period plus 8-week double blind
           treatment period
    

Detailed description: 
      This study is to Evaluate the Efficacy and Safety of Pravastatin/Fenofibrate Complex in
      Patients With Combined Dyslipidemia With Adequately Controlled LDL-C But Inadequately
      Controlled Triglyceride Level by Atorvastatin Monotherapy. After administrating the
      atorvastatin or Pravafenix Cap. (pravastatin sodium/fenofibrate) for 8 weeks, evaluate the
      variation of the Non-HDL-C for each arm. Ultimatly verificaite the Pravafenix Cap.
      (pravastatin sodium/fenofibrate) have better effects than atorvastatin.
    

Intervention name(s): Pravastatin40mg/Fenofibrate160mg; Atorvastatin Sodium 10mg
Intervention type(s): Drug; Drug
Intervention description(s): Pravafenix(Pravastatin40mg/Fenofibrate160mg); Lipitor 10mg(Atorvastatin Sodium)
Other intervention name(s): Pravafenix(Pravastatin40mg/Fenofibrate160mg); Lipitor 10mg(Atorvastatin Sodium)
Intervention MeSH terms: Atorvastatin; Pravastatin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Screened Health Assessment & Pacer Evaluation
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System
      in a population of patients with a BMI between 35 and 55.
    

Detailed description: 
      The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System
      in a population of patients with a BMI between 35 and 55. Initially, a maximum of 150
      patients will be followed for 12 months in a randomized, placebo-controlled, double-blind,
      multi-center study to evaluate efficacy and safety of the IGS. All patients will be implanted
      with the IGS System and randomized to a control group (IGS OFF) or a treatment group (IGS
      ON). Both groups will follow a 500kcal/day-deficit diet (Appendix A) and participate in
      monthly support group meetings (Appendix E). The study will last for 24 months after
      randomization. The sponsor plans to submit a PreMarket Approval (PMA) application when all
      patients have completed 12 months of post-randomization follow-up. After 12 months from
      randomization, patients will continue to be followed monthly for another year, during which
      all patients will receive gastric electrical stimulation and the long-term efficacy and
      safety and maintenance of weight loss will be evaluated. After 24 months from randomization,
      all remaining patients will have the option to enter an extension study for an additional
      four years, during which the long-term efficacy and safety and maintenance of weight loss
      will continue to be evaluated.
    

Intervention name(s): Transcend II Implantable Gastric Stimulator (IGS), Model 8848
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Other
Keywords: Gastric pacing device; Obesity
Finding the Patient's Voice Diabetes Prevention Programs
Condition: Diabetes Mellitus, Type 2; Prediabetic State
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
Study type: Interventional

Summary: 
      This study uses patient engagement to develop a diabetes prevention program focused on
      adolescents and families.
    

Detailed description: 
      Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger
      age, and is associated with poor outcomes and rising costs, which emphasizes the need for
      prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE
      Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes
      Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for
      mothers and their children, the investigators have encountered several barriers to widespread
      implementation, including:

        1. helping youth/families understand the importance of prevention,

        2. on-going interest and participation, and

        3. differing personal beliefs.

      Patient-centered research is needed to better understand what adolescents/families want in
      prevention initiatives, who should deliver program content, where and when to deliver
      programs in the community, and how adolescents/families wish to be informed of results. The
      investigators believe that by engaging patients and the community in the development process,
      the investigators will be able to obtain workable answers to these questions at a population
      level for high-risk youth/families in "real world" settings.
    

Intervention name(s): Encourage 2.0
Intervention type(s): Behavioral
Intervention description(s): Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes prevention; type 2 diabetes; prediabetes; family
Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Disorders of Excessive Somnolence; Sleepiness; Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to test the effect of modafinil on the negative symptoms, such
      as blunted affect and social withdrawal, of schizophrenic patients and to determine
      modafinil's effect on excessive daytime sleepiness. A secondary purpose of the study is to
      examine the effect of modafinil on cognitive functioning of schizophrenic patients.
    

Detailed description: 
      Twenty six male patients with schizophrenia (twelve with Excessive Daytime Sleepiness and
      twelve without) will be enrolled at the San Diego Veterans Affairs Medical Center. Modafinil
      has been shown to increase alertness in individuals who are pathologically sleepy (Study
      C1538a/301/NAIUS).

      Subjects will be randomized in a 1:1 ratio, stratified by excessive daytime sleepiness (value
      of >=9 on the Epworth Sleepiness Scale). Subjects will receive either modafinil or placebo,
      supplied by the sponsor. The study drug will be taken by mouth once daily in the morning. The
      titration schedule will be as follows:

        1. The beginning does will be 50mg for 2 weeks

        2. The study medication will be increased to 100mg at the week 2 study visit

        3. The study medication will be increased to 200mg at the week 4 study visit and will
           continue for the remaining 4 weeks of the study. If subjects are unable to tolerate
           dosage increases, the dose will be decreased to the previous level.
    

Intervention name(s): Modafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Adjunctive treatment with titrated dose of modafinil; Adjunctive treatment with placebo
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Excessive Daytime Sleepiness
Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction
      and Safety after multiple oral doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy
      Male Subjects.
    

Detailed description: 
      After subjects have signed informed consent voluntarily, they go through screening period for
      within 28 days.

      As period I, subjects of Cohort1 take fimasartan and Amlodipine for 10 days and subjects of
      Cohort2 take rosuvastatin for 6 days.

      And then, as period II, subjects of both Cohorts take fimasartan, Amlodipine and rosuvastatin
      in Cohort1 case for 6 days and in Cohort2 case for 10 10days.

      For Fimasartan, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before
      medication, 10th and 16th day before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and
      24hour after medication(32 times in total).

      For Amlodipine, subjects of Cohort1 have blood sampling 8th, 9th, 14th, 15th day before
      medication, 10th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 24hour after
      medication(30 times in total).

      For Rosuvastatin and N-desmethyl rosuvastatin, subjects of Cohort2 have blood sampling 4th,
      5th, 14th, 15th day before medication, 6th and 16th day before and 1, 2, 3, 4, 5, 6, 7, 8,
      10, 12 and 24hour after medication(28 times in total).
    

Intervention name(s): Fimasartan; Amlodipine; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fimasartan
Effects of Senobi Breathing Exercises in Obese Women
Condition: Obesity
Study type: Interventional

Summary: 
      Previous studies have been done just in studying the relationship between breathing technique
      and obesity and described how it proved helpful in decreasing body fat. This study will be
      very helpful for future researchers as well as in filling the literature gap by explaining
      the importance of SBE (Senobi Breathing Exercise) in correlation with increased body fat,
      compromised lung function and depression in females of age from 30 to 60 years.
    

Detailed description: 
      The study is quasi-experimental study, which is being conducted in a private clinical
      settings in Khushab. Sample size of 20 individuals was calculated using Hamilton Depression
      Scale with effect size 0.97 G Power 3.1.9.2 software. The study participants will be screened
      first, then trained to perform SBE(1-minute maneuver). Participants will be instructed to
      stand upright and tighten their gluteal muscle and then ask them to put one foot in front of
      their body and placing most of their body weight on back foot. Then, ask them to breath in
      for three seconds simultaneously, by raising their hands in the air above their heads. After
      this, instruct them to exhale by using their whole body for pushing air out of the lungs.
      Participants will also guided to tighten all their body muscles while pushing air out. Exhale
      should last for seven seconds. The participants will also guided to repeat this procedure 3
      times in one minute with resting period of 10 seconds. They will perform it 3 times a day for
      3 months. Assessments will be taken at Baseline & after 3 months.
    

Intervention name(s): Senobi breathing exercises
Intervention type(s): Other
Intervention description(s): The study participants will be screened first, then trained to perform SBE (1-minute maneuver). Participants will be instructed to stand upright and tighten their gluteal muscle and then ask them to put one foot in front of their body and placing most of their body weight on back foot. Then, ask them to breath in for three seconds simultaneously, by raising their hands in the air above their heads. After this, instruct them to exhale by using their whole body for pushing air out of the lungs. Participants will also guided to tighten all their body muscles while pushing air out. Exhale should last for seven seconds.
Intervention model: Single Group Assignment
Intervention model description: Quasi experimental Design
Masking: None (Open Label)
Primary purpose: Treatment
Acupuncture for Post-tonsillectomy Pain Control in Children
Condition: Tonsillectomy; Post-Operative Pain; Acupuncture
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      A randomized, controlled, single-blinded study comparing conventional postoperative analgesia
      with paracetamol-on-demand with the same regime plus acupuncture.

      The hypothesis is that postoperative treatment of children undergoing tonsillectomy with
      acupuncture will reduce pain with minimal unwanted effects.
    

Detailed description: 
      A randomized, controlled, single-blinded study comparing conventional postoperative analgesia
      with paracetamol-on-demand with the same regime plus acupuncture.

      The study will be conducted in accordance with the ethical standards of the Helsinki
      Declaration and has been approved by the Human Experimentation Ethics Committee of the Ziv
      Medical Center and the Ministry of Health.

      Patients will be recruited through the preoperative clinic conducted on the day before
      surgery. All parents and children will be given a full explanation of the study by an
      experienced member of the research team before randomization. The explanation will include
      the nature of acupuncture and the proposed treatment. Parents will sign an informed consent.
      Patients randomized to the acupuncture group will have a "trial run" at the time of
      consenting with a member of the research team experienced with performing acupuncture in
      children , in order to familiarize the child and family with the procedure.
    

Intervention name(s): acupuncture
Intervention type(s): Device
Intervention description(s): Sterile, disposable, FDA-approved acupuncture needles will be used. Acupuncture will be performed bilaterally. The needles will penetrate the skin to a depth of 5-10mm and will be kept in place for no more than 5 minutes. The acupuncture points will be: Li 4, Li 11, St 44, according to Chinese acupuncture mapping. Treatment will be repeated at least 3 times during the hospital stay. Treatment will start in the pediatrics department approximately two hours after discharge from the postoperative unit. The 2nd treatment will be given on the same evening, approximately 4-8 hours after the 1st treatment and the 3rd treatment will be given the following morning, approximately 12-18 hours after the 2nd treatment. Exact treatment times will be recorded in the patient's file.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tonsillectomy; Post-Operative Pain; Acupuncture
A Long-Term Study on Safety of JNS001 in Adults With Attention-Deficit Hyperactivity Disorder
Condition: Attention-Deficit / Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate long-term safety and tolerability of JNS001 at
      18 to 72 mg per day in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
    

Detailed description: 
      This is a multicenter, open-label (all people involved know the identity of the
      intervention), dose-titration (to adjust the dose of a drug until optimal result is reached),
      long-term safety study in adult patients with a diagnosis of ADHD. The study consists of the
      Long-term phase (4-week titration period and 44-week maintenance period) and the 1-week
      Post-study phase. The 4 week-titration period is to find the individualized dose for each
      patient regardless of the treatments in the preceding study (JNS001-JPN-A01). Patients will
      be titrated from a starting dose of 18 mg/day for 7 days, and continue with a weekly (+/- 2
      days) increment of 9 or 18 mg until an individualized dose is achieved. The titration period
      will be followed by a 44-week maintenance period which has combined 48-week (1-year)
      treatment duration with the titration period. During the maintenance period, the dose will be
      adjusted between 18 to 72 mg depending on the patients' symptoms. In the post-study phase,
      safety information will be collected after the last dose of the study treatment or premature
      discontinuation. The study drug will be administered with water once daily in the morning at
      doses of 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, or 72 mg per day. The study treatment
      period is 48 weeks (titration period of 4 weeks and maintenance period of 44 weeks).
    

Intervention name(s): JNS001
Intervention type(s): Drug
Intervention description(s): 18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Methylphenidate hydrochloride; Concerta; Adults; Attention-Deficit / Hyperactivity Disorder; ADHD; Long term safety
TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study comprises 2 cohorts, and in each cohort, the study will be conducted as an
      open-label add-on study.

      The purpose of the study is to investigate the pharmacokinetics of each substrate in
      concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort
      A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in
      healthy adult males.
    


Intervention name(s): TRK-700; Digoxin; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): repeated oral administration; single oral administration with/without TRK-700; single oral administration with/without TRK-700
Intervention MeSH terms: Digoxin; Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: TRK-700; PK; Digoxin; Midazolam; Drug-Drug interaction; P-glycoprotein; CYP3A4; MDR1; pharmacokinetics; multidrug resistance 1
Community-Based Conscious Discipline Program in Grenada
Condition: Behavior, Child; Neurocognition, Child; Development, Child
Study type: Interventional

Summary: 
      To improve neurocognitive outcomes in 2-year-old children by implementing a community-based
      intervention program that follows the principles of Conscious Discipline.
    

Detailed description: 
      We aimed to introduce Conscious Discipline (CD) in Grenada as a means of improving
      neurodevelopment in 2-year-old children. The CD intervention promotes improved
      social-emotional connections between parents/guardians and children that reduces harsh
      discipline and corporal punishment and provides an ideal environment for the development of
      higher cognitive functioning (e.g. working memory, inhibition, emotional regulation).

      The intervention is implemented by using a distributed local, train-the-trainer model in
      partnership with the Grenada Roving Caregiver Program, managed by GRENCASE. CD training was
      provided to 85 existing Roving Caregivers, 70 of whom were certified as Conscious Discipline
      Paraprofessionals (CDPPs). Certified CDPPs traveled out to communities and villages
      throughout Grenada, to impart knowledge and skills to new and expecting parents.

      Following the intervention, parents who received CD training were assessed in their ability
      to implement CD skills with their child(ren). Neurocognition was assessed in children
      post-intervention using the INTERGROWTH 21st Neurodevelopmental Assessment (INTERNDA).
      Neurocognitive outcomes were compared between the intervention arm and the waitlist control
      arm of the study.
    

Intervention name(s): Conscious Discipline-Based Environmental Enrichment Intervention
Intervention type(s): Behavioral
Intervention description(s): Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment