bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the
      knee has significantly elevated in the elderly population and youth due to age and sport
      activities respectively. Our aims to treat the knee osteoarthritis are including; reduce knee
      pain and improve its function; return patients to normal daily activities and reduce health
      care costs.

      The current treatments which are already being used for osteoarthritis of the knee patients
      include:

        1. Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal
           anti-inflammatory drugs.

        2. Intra-articular injections of corticosteroids and hyaluronic acid.

        3. Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.

      As the low mitotic activity and lack of blood supply cause little ability for the articular
      cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received
      much more attention due to its capacity to do self-healing in treatment of osteoarthritis of
      the knee.

      PRP consists of several concentrated growth factors in platelets of autologous blood that are
      applied to the different parts of medicine such as reconstruction of damaged tissue. Although
      platelets are well-known to involve in the blood clots formation, but current studies have
      shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells
      and osteoblasts to remove necrotic tissue in addition to participate in healing procedure.

      This study is a prospective, randomized, controlled trial to assess The positive effects of
      platelet-rich plasma injection in 244 patients with osteoarthritis of the knee
    

Detailed description: 
      In this study all eligible patients (Based on the inclusion and exclusion criteria) were
      randomly allocated into two study groups by a Stratified Permuted Block randomization method:
      group A received platelet rich plasma, group B (control group) received only placebo.

      All of the patients underwent a standard long protocol for knee osteoarthritis. All patients
      with grade II,III and IV of radiographic knee OA are selected. On average, in each instance,
      the amount of platelets in the peripheral blood is 4 to 6 times the baseline level.

      Group A: 1-3 cc injection of placebo Group B: 1-3 cc injection of PRP All patients received
      monthly injection for 3 times.
    

Intervention name(s): PRP injection; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Injection of PRP in patients with knee osteoarthritis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PRP PRGF Osteoarthritis
Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam
Condition: Cognitive Performance
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar,
      specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium
      on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium
      and iron status, and on their cognitive performances.
    

Detailed description: 
      Design: double-masked randomized control trial Place: three schools in South Vietnam, Can Tho
      district, South Vietnam Subjects: School children aged 6 to 10 years old, from first grade to
      third grade of 3 primary schools.

      Duration of intervention: 6 months (consumption of Goody or "control bar")

      Study groups: 2 groups:

      Group 1: children will receive micronutrient enriched milk bar. Group 2: children will
      receive the same milk-based food except for the micronutrient fortification.
    

Intervention name(s): food bar
Intervention type(s): Dietary Supplement
Intervention description(s): milk based food bar enriched with micronutrients
Other intervention name(s): Goody
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: anthropometry; zinc; iodine; vitamin D; calcium; school children; food supplement
Intervention Study of Vitamin D Supplementation to Prevent Cardiovascular Disease
Condition: Vitamin D Deficiency
MeSH terms: Cardiovascular Diseases; Vitamin D Deficiency
Study type: Interventional

Summary: 
      This is a 9 months, randomized, single center, open-label, parallel-group study to compare
      the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency
      subjects in China.
    

Detailed description: 
      This is a 9 months, randomized, single center, open-label, parallel-group study to compare
      the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency
      subjects in China.

      Eligibility for participation will be determined by medical history, physical examination,
      and laboratory results obtained during a screening visit. About 300 subjects with vitamin D
      insufficiency or deficiency will be included in this study. All subjects will be given
      informed consent before starting any examination and test. The following data of all subject
      will be collected: liver and kidney function, HbA1c, fasting blood glucose, fasting lipid
      profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D(25OHD),
      serum procollagen type I N propeptide, serum C-terminal telopeptide of type I collagen, s-CTX
      and muscle power and balance.

      After baseline data are collected, eligible subjects will be randomized into each group at a
      1:1 ratio (150 for control group and 150 for vitamin D supplementation group, less than 20%
      drop-off rate is acceptable for this study). The initial vitamin D doses will be based on
      25OHD levels at basis, and this dosage may be changed according be the level of 25OHD until
      the end of this study.

      All subjects in the control group will be followed every half year. All subjects in the
      vitamin D group will be followed by visiting clinic, and will be titrated their doses. Dose
      adjustment should be aimed at achieving the following 25OHD targets: 30ng/ml. If above 25OHD
      target has not been achieved, vitamin D dose should be adjusted. Clinic visit will be
      conducted 3 months later to collect information, such as serum calcium, 25OHD and adverse
      events.

      Complicated examinations will be repeated again after 9 months treatments for both groups,
      including physical examination, liver and kidney function, HbA1c, fasting blood glucose,
      fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy
      vitamin D(25OHD), serum procollagen type I N propeptide, serum C-terminal telopeptide of type
      I collagen, s-CTX and muscle power and balance. Data will be collected and analyzed.
    

Intervention name(s): vitamin D; control
Intervention type(s): Other; Other
Intervention description(s): different doses of vitamin D supplementation; control group
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: vitamin D; cardiovascular; muscle power
Perifosine in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.

      PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have
      advanced solid tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance
           dose schedule in patients with advanced solid tumors.

        -  Determine the qualitative and quantitative toxic effects of this drug in these patients.

        -  Determine the pharmacokinetics of this drug in these patients.

        -  Investigate the relationship between pharmacokinetic parameters and toxicity of this
           drug in these patients.

        -  Determine the recommended starting dose for phase II trials on this drug schedule in
           these patients.

        -  Evaluate the pharmacodynamic parameters on peripheral blood lymphocytes both before and
           during drug administration in these patients.

        -  Determine any changes in the MTD with prolonged administration (3 months, 6 months) of
           this drug in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients receive a loading dose of oral perifosine 4 times a day for 4-8 doses followed by a
      daily maintenance dose. Treatment continues every 28 days in the absence of unacceptable
      toxicity or disease progression.

      Cohorts of 3-6 patients receive escalating loading doses and maintenance doses of perifosine
      until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose
      preceding that at which 2 of 6 patients experience dose-limiting toxic effects.

      PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
    

Intervention name(s): perifosine
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Psychiatric Problems in Children and Adolescents Infected With HIV at Birth
Condition: HIV Infections; Mental Disorders
MeSH terms: Mental Disorders
Study type: Observational

Summary: 
      The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health
      problems or make mental health problems worse in children and adolescents who were infected
      with HIV at birth.
    

Detailed description: 
      Research has shown that HIV is able to penetrate the blood-brain barrier and may
      significantly affect the central nervous system (CNS). Although the effects of HIV on the CNS
      are not fully understood, there is growing evidence that the effects are psychosocial in
      nature; HIV infected children experience higher rates of psychiatric symptoms and
      hospitalizations than their uninfected counterparts. Confounding the HIV CNS relationship is
      evidence suggesting that the CNS effects of HIV may also be related to antiretroviral
      treatment. This study will examine the rates and severity of psychiatric symptoms in both HIV
      infected and uninfected children and adolescents. In addition, this study will determine the
      relationship between duration of antiretroviral treatment and psychiatric symptoms.

      No treatment will be given as part of this study. The study will last for 96 weeks and be
      divided into two parts. In Part 1, HIV infected and uninfected participants and their
      caregivers will complete a series of measures and questionnaires regarding mental health,
      pain, and adherence to treatment. In Part 2, all participants and their caregivers will
      complete a subset of the original measures at Weeks 48 and 96. This follow-up part of the
      study will assess any long-term changes in psychiatric symptoms. In addition, a subset of HIV
      infected and uninfected participants and their caregivers will take part in psychiatric
      interviews at specified study sites. A portion of these interviews will be audio-taped.
    

Intervention name(s): Psychiatric interviews
Intervention type(s): Behavioral
Intervention description(s): Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and their caregivers from specific clinics.
      
Keywords: Treatment Experienced; Treatment Naive; Psychopathology; Anti-Retroviral Agents; Child; Adolescent
Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this protocol is to investigate the acute treatment efficacy, safety, and
      tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and
      adolescents with ADHD.
    


Intervention name(s): Atomoxetine Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim2)
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether microbiome modulation and an experimental
      reduction in plasma LPS concentration improve inflammation and insulin action in insulin
      resistant (obese and T2DM) subjects.
    

Detailed description: 
      In this Aim we will test the hypothesis that lowering lipopolysaccharide (LPS) concentration
      in the circulation will improve systemic (muscle) inflammation and glucose metabolism in
      insulin resistant (obese and T2DM) subjects by protecting the intestinal barrier with a
      synbiotic (Bifidobacterium longum R0175 and oligofructose) or by sequestering LPS in the
      gastrointestinal lumen with sevelamer.
    

Intervention name(s): Maltodextrin; Synbiotic; Sevelamer
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.; Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.; Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
Other intervention name(s): Renvela
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of probiotics ADR-1/GMNL-263
      capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for the treatment of
      adults with type2 DM.
    

Detailed description: 
      Background：Based on animal studies, intake of probiotic bacteria was suggested to improve
      insulin sensitivity by reducing inflammation.

      Objective ： The objective of this study was to determine the effects of supplementation with
      the probiotic strain Lactobacillus reuteri ADR-1(ADR-1) and Lactobacillus reuteri GMNL-263
      (GMNL-263) over six months on metabolic profiles, intestinal microbiota profiles and
      biomarkers of inflammation in type 2 diabetes patents. Methods ： This randomized double-blind
      placebo-controlled clinical trial was performed on 120 diabetic patients. Subjects were
      divided into 3 groups: 40 subjects in the group A received placebo, 40 subjects in the group
      B received ADR-1 (4 x 109 colony-forming units/d), and 40 subjects in the group C received
      GMNL-263. (2 x 1010 cells/d) for 6 months. Fasting blood samples were taken at baseline and
      after intervention to measure metabolic profiles and biomarkers of inflammation including C
      reactive protein (CRP), Interleukin 6 (IL-6) and Tumor necrosis factor-alpha( TNF-α). The
      intestinal microbiota profiles were detected in stool samples by real-time polymerase chain
      reaction (RT-PCR).
    

Intervention name(s): ADR-1; GMNL-263; placebo
Intervention type(s): Other; Other; Other
Intervention description(s): two ADR-1 capsules, once daily, QD; two GMNL-263 capsules, once daily, QD; two placebo capsules, once daily, QD
Other intervention name(s): Lactobacillus reuteri GMNL-89; Lactobacillus reuteri GMNL-263
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: lactobacillus reuteri; type 2 diabetes
Bridging the Gap by Transitional Care
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate patient adherence with discharge diabetes medications
      up to 120 days following pharmacist counseling during hospital stay about diabetes self
      management
    

Detailed description: 
      It is a prospective, randomized, controlled Study. Patients randomized in a 1:1 ratio to
      pharmacist counseling or standard of therapy prior to discharge.

      Standard therapy: Nurses distribute a education pamphlet on diabetes.

      Pharmacist Counseling includes but is not limited to:

        -  Reviewing and explaining their medications (dosing, side effects, route)

        -  Reviewing symptoms and complications of hyper and hypoglycemia

        -  Defining glycemic & non-glycemic goal levels

        -  Explaining the importance of compliance with medications & appointments

        -  Educating on the basics of nutrition and physical activity
    

Intervention name(s): Pharmacist Counseling
Intervention type(s): Other
Intervention description(s): Pharmacist Counseling includes but is not limited to:
Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adherence with discharge diabetes medications; Diabeted mellitus type 2 greater than one year; Patient with provider and prescriptions filled within CCHS
Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol
      sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.
    

Detailed description: 
      Healthy subjects (8 per cohort) will be randomized to either pre-treatment or no
      pre-treatment (4 per group). The initial cohort will receive pre-treatment with cromolyn
      sodium. Subjects will be followed for 2 weeks for safety and tolerability, undergo a 2 week
      washout period and then be assigned to the alternative treatment (i.e., subjects who received
      cromolyn sodium prior to PUL-042 inhalation solution will not receive pretreatment) and then
      followed for an additional 2 weeks.

      Subsequent cohort will receive pre-treatment with albuterol sulfate in a like manner.
    

Intervention name(s): PUL-042 Inhalation Solution; Cromolyn Sodium; Albuterol sulfate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PUL-042; Pre-treatment; Pre-treatment
Intervention MeSH terms: Cromolyn Sodium; Albuterol; Pam2CSK4 acetate and ODN M362 combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; tolerability
Pulse Oximetry_Performance During Severe Signal Interference - PCBA-1 (Printed Circuit Board Assembly)
Condition: Healthy
Study type: Observational

Summary: 
      Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse
      subject population during severe signal interference over a specified saturation range.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Well perfused
      
Keywords: Subjects
Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in
      treating children who have refractory solid tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose and recommended phase II dose of carboplatin and
           irinotecan in children with refractory solid tumors.

        -  Determine the safety profile and dose-limiting toxic effects of this regimen in these
           patients.

        -  Determine the pharmacokinetics of this regimen in these patients.

        -  Determine the preliminary anti-tumor activity of this regimen in these patients.

      OUTLINE: This is a dose-escalation study of carboplatin and irinotecan.

      Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on
      days 1-5 and 8-12. Treatment repeats every 21 days for up to 12 courses in the absence of
      disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

      Patients are followed for at least 30 days.

      PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 6-9
      months.
    

Intervention name(s): carboplatin; irinotecan hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carboplatin; Irinotecan
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific