bioihbjkbjnl/mcl2 huggingface dataset:
Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia
Condition: Congenital Adrenal Hyperplasia; Hyperplasia; Adrenal Hyperplasia; Congenital Disorders; Adrenocortical Hyperfunction; Disorders of Sex Development; Urogenital Abnormalities; Genetic Diseases, Inborn; Steroid Metabolic Diseases, Inborn; Adrenal Gland Disease; Hydrocortisone
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolic Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non-randomized crossover design feasibility trial comparing oral
      hydrocortisone treatment with interval bolus delivery (pulsatile) of subcutaneous
      hydrocortisone via infusion pump in children with congenital adrenal hyperplasia. Eight
      children, ages 4-18 yrs, will have 24-hr pharmacokinetic and pharmacodynamic profiles of
      cortisol, 17-hydroxyprogesterone and androstenedione concentrations while on oral
      hydrocortisone therapy (admission 1), during an initial trial of the subcutaneous
      hydrocortisone pump (admission 2), and after 6 weeks of subcutaneous hydrocortisone pump
      treatment (admission 3). An integrated pharmacokinetic and pharmacodynamic model will be used
      to determine cortisol, 17-hydroxyprogesterone and androstenedione parameters to compare the
      duration of time subjects have these concentrations outside acceptable ranges. Funding Source
      - FDA OOPD
    


Intervention name(s): Subcutaneous hydrocortisone; Standard glucocorticoid therapy
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be monitored and receive an interval bolus SQHC dosing regimen that more closely mimics cortisol, 17OHP and D4A circadian and ultradian rhythms than conventional oral HC dosing.; Subjects in this arm will continue on standard oral hydrocortisone therapy
Other intervention name(s): Hydrocortisone delivered via subcutaneous pump
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Glucocorticoids
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a non-randomized crossover study design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adrenal gland diseases; cortisol succinate; hydrocortisone; hyperplasia
Factors Affecting Quality of Life in Patient With Chronic Musculoskeletal Pain
Condition: Quality of Life; Chronic Musculoskeletal Disease; Chronic Pain
MeSH terms: Musculoskeletal Pain; Musculoskeletal Diseases; Chronic Pain
Study type: Observational

Summary: 
      This study included patients who applied to the physical therapy and rehabilitation
      outpatient clinic and were diagnosed with chronic low back pain and osteoarthrosis and met
      the criteria for participation in the study.

      Demografik datas, pain , Functional Limitations and Quality of Life wa evaluated.
    

Detailed description: 
      When treating diseases, clinicians traditionally aim for pain reduction and functional
      recovery. This is also true for chronic musculoskeletal diseases. However, the psychosocial
      support required to improve the general health perception of patients is becoming
      increasingly important. In clinical practice, it is essential to evaluate the quality of life
      and general well-being and to evaluate the patient completely biopsychosocially . Determining
      the factors affecting the quality of life is important in terms of contributing to the
      rehabilitation processes and treatment plans of CMP patients. In this direction, our study
      aims to examine the factors affecting the quality of life.

      When treating diseases, clinicians traditionally aim for pain reduction and functional
      recovery. This is also true for chronic musculoskeletal diseases. However, the psychosocial
      support required to improve the general health perception of patients is becoming
      increasingly important. In clinical practice, it is essential to evaluate the quality of life
      and general well-being and to evaluate the patient completely biopsychosocially . Determining
      the factors affecting the quality of life is important in terms of contributing to the
      rehabilitation processes and treatment plans of CMP patients. In this direction, our study
      aims to examine the factors affecting the quality of life.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Male and female patients who applied to the physical therapy and rehabilitation outpatient
        clinic and were diagnosed with chronic low back pain and osteoarthrosis and meeting the
        criteria for participation in the study will be included in our study.
      
Keywords: quality of life; disabilty; Chronic musculoskeletal pain
Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents
Condition: Adolescent Methamphetamine Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Dr Keith Heinzerling, who is a doctor at UCLA, is doing a research study with Behavioral
      Health Services in the Lincoln Heights neighborhood of Los Angeles to find out if a
      medication called bupropion can help adolescents (age 14-21) reduce or stop using
      methamphetamine. Bupropion is a drug that is already on the market, which means it has been
      approved by the FDA, but it has not been approved to treat methamphetamine abuse. What the
      study is trying to find out is if bupropion helps people to stop using methamphetamine. The
      study lasts up to 14 weeks and involves visits to the BHS clinic in Lincoln Heights twice a
      week. The first two weeks involve completion of questionnaires and assessments, including a
      physical exam, a blood test, EKG (a test that checks for problems with the electrical
      activity of a person's heart), and a psychological interview, to see if you are eligible for
      the study. If you are eligible, then you will be assigned by chance to take either the
      bupropion pills or placebo pills, which are pills that look the same, but contain no
      medication. This type of study is called a "double blind study" because neither you nor any
      of the study staff will know which medication you are taking. During the 8 weeks of taking
      the pills, you'll visit the clinic to complete additional questionnaires and assessments, to
      provide urine samples for testing for methamphetamine, and for once a week drug abuse
      counseling. At the end of your treatment, you'll have another physical exam including blood
      tests and the same test on your heart and then we'll ask you to come to the clinic once a
      week for four weeks for follow-up assessments. You'll be compensated for time spent doing
      research activities and for returning empty medication packages. The total compensation
      possible is $332 in gift cards for places such as Target, iTunes, groceries, and gas.

      Your participation in the study is voluntary and deciding not to participate or deciding to
      stop participating at any time during the study is okay.
    


Intervention name(s): Bupropion SR 150mg tabs; Placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): Bupropion SR 150mg tabs (Zyban) twice daily; One placebo tablet twice daily
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescents; Methamphetamine abuse; Bupropion; Addiction; Pharmacotherapy; Cognitive Behavioral Therapy; Contingency Management; Teens
Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major
      Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK)
      data to guide dose selection for future pediatric studies of levomilnacipran.
    

Detailed description: 
      Study LVM-MD-11 is a randomized, double-blind, placebo- and active-controlled, parallel
      group, fixed-dose study in adolescent patients, ages 12-17 years. The study will be
      approximately 10 weeks in duration:

        -  1-week screening/washout period

        -  8-week double-blind treatment period

        -  1-week double-blind down-taper period

      Participants who meet the eligibility criteria at Visit 2 (Baseline) will be randomized to 1
      of 4 treatment groups: placebo, levomilnacipran 40 mg/day, levomilnacipran 80 mg/day, or
      fluoxetine 20 mg/day.
    

Intervention name(s): Placebo; Levomilnacipran; Fluoxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.; Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.; Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.
Other intervention name(s): Fetzima; Prozac
Intervention MeSH terms: Milnacipran; Fluoxetine; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Microbial Community Composition and Metabolism in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Scientist have begun to realize that many types of bacteria often live together as a complex
      community, and the investigators wish to apply that idea to the bacteria in the respiratory
      system of people with Cystic Fibrosis (CF). It is possible that the survival of the many
      millions of bacteria in the CF lung depends on the production of special chemicals that might
      be made only by very few types of bacteria. If that is true, medicines that interfere with
      those chemicals could treat the lung infections that cause trouble for nearly all people with
      CF. The investigators wish to study the production of several potentially critical chemicals
      by the respiratory bacteria and to examine the effect of those chemicals on the makeup of the
      entire community of bacteria. To detect all the bacteria in that community, the investigators
      will use new methods that use bacterial genetic information and can detect hundreds of
      different types of bacteria in respiratory samples of individual CF patients.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cystic fibrosis patients will be contacted during clinical care visits and inpatient
        hospitalizations.
      
Biospecimen description: 
      throat swabs or sputum
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
Condition: Pneumonia; Diarrhea; Acute Upper Respiratory Tract Infections
MeSH terms: Infections; Pneumonia; Respiratory Tract Infections; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that
      could help them fight off infections like pneumonia. Our study was designed to see if
      children who got supplements of zinc or vitamin A had fewer infections.
    

Detailed description: 
      The Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) study was a multi-year
      nutritionally-stratified, placebo-controlled, double-blind study of low-dose vitamin A and/or
      zinc in 2,582 normal and malnourished urban children aged 6 to 36 months in Quito, Ecuador.
      Four group of ~ 645 children were enrolled in 2000, 2001, 2002, and 2003 with each child
      participating for up to 50 weeks. Children were visited 4 days each week. Outcome measures
      were pneumonia, other respiratory tract infections, diarrheal disease, and growth.
    

Intervention name(s): Zinc (12.5 mg/day); vitamin A 10,000 IU per week
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: acute respiratory infection; acute lower respiratory infection; diarrhea
Erythropoietin in the Prevention of Acute Mountain Sickness
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore
      subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence
      of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m
      plus the presence of one or more of the following: gastrointestinal symptoms (anorexia,
      nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass
      is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO)
      secretion begins hours after ascent and stimulates bone marrow production of red blood cells,
      but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that
      EPO therapy weeks before altitude exposure decrease high altitude illness.

      In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM)
      reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal
      oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the
      basis of this report, USARIEM did not recommend use of recombinant EPO for altitude
      acclimatization.

      However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO
      therapy have been shown to decrease fatigue and increase work capacity and exercise
      tolerance. In addition, improvement in CNS function and cognitive ability has been noted with
      EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold;
      decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are
      symptoms associated with high altitude illness.

      The investigators also reported improved muscle energy metabolism with EPO in dialysis
      patients, but not with RBC transfusion.

      In this study, the investigators will conduct a randomised controlled trial to assess the
      effect of EPO administration on AMS at an altitude of 4,130 m.
    


Intervention name(s): Erythropoietin
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hemoglobin; Erythropoietin; Acute Mountain sickness
Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Observational

Summary: 
      In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have
      been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been
      evaluated the head to head comparison of two drugs. This study is a retrospective study to
      compare the efficacy of two drugs.
    

Detailed description: 
      Among 300 MDS patient, 200 of them have been taking Azacitidine and 100 of them have been
      taking Decitabine. Medical chart of these patients will be reviewed to assess the efficacy
      and safety between two agents.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        MDS patients who are diagnosed at SNUH
      
Keywords: MDS
Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the antiviral effect following three days of dosing
      with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected
      subjects.
    


Intervention name(s): BMS-824393; BMS-824393; BMS-824393; BMS-824393; BMS-824393
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsule, Oral, 50mg, Once Daily, 3 days; Capsule, Oral, 100mg, Once Daily, 3 days; Capsule, Oral, 10mg, Once Daily, 3 days; Capsule. Oral, 1mg, Once Daily, 3 days; Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Primary Peritoneal Cavity Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with
      persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free
           survival or objective tumor response, in patients with recurrent or persistent ovarian
           epithelial or primary peritoneal cancer.

        -  Determine the nature and degree of toxicity of this regimen in these patients.

      Secondary

        -  Determine the duration of progression-free and overall survival of patients treated with
           this regimen.

        -  Determine the effects of prognostic variables, including platinum sensitivity, initial
           performance status, and age, in patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days
      2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride once
      daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
    

Intervention name(s): enzastaurin hydrochloride
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; primary peritoneal cavity cancer
End Growth Results for Conservative Treatment for Idiopahitc Scoliosis
Condition: Scoliosis; Adolescence; Scoliosis Idiopathic
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      This study evaluates in a prospectively collected multicenter cohort the existence,
      characteristics and determinants of EBPCA, the obtained results and their determinant, the
      rate of over- and under-treatment and their determinants.
    

Detailed description: 
      Since an evidence-based personalised conservative approach (EBPCA) to Adolescent Idiopathic
      Scoliosis has never been checked, the investigators studied a prospectively collected
      multicenter cohort with the aim to verify in the different clinical situations 1) the
      existence, characteristics and determinants of EBPCA; 2) the obtained results and their
      determinant; 3) the rate of over- and under-treatment and their determinants. These results
      are expected to check the actual evidence in everyday clinic, to provide a benchmark for
      future studies, and to inform guidelines producers and consequently health policy in high
      income countries, but also and particularly in low-middle income countries where surgery is
      difficult due to the high costs, and missing competences and structures.
    

Intervention name(s): observation; Physiotherapic scoliosis specific exercise; brace
Intervention type(s): Other; Other; Device
Intervention description(s): patients not treated; Specific exercise according to the SEAS (Scientific Exercises Approach to Scoliosis) protocol; different kind of braces being elastic, rigid or very rigid. All devices are custom made. The hours of application per day varied from 18 to 24h.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Scoliotic patients that were referred to a tertiary clinic specialized on spine deformity.
Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen,
      used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over
      first 2 weeks in patients with pediatric bronchial asthma aged 6 to < 15.

      The effect of body weight on the efficacy and safety of montelukast will also be evaluated in
      this study.
    


Intervention name(s): MK0476, montelukast sodium / Duration of Treatment: 4 Weeks; Comparator: ketotifen / Duration of Treatment: 4 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketotifen; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment