bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients
      which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis
      is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better
      quality of life. 60 patient will be enrolled and followed during one year.
    

Detailed description: 
      Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients
      which focuses on patient autonomy, carbs counting and insulin dose adaptation. In this study
      we plan to enroll 60 patients who will be educated toFIT and followed during one year.
      Patient will follow normal path of eductation which is composed of a 3 days inpatient
      admission, a medical visit one month after the education, and a 4hours reminder session six
      months after the education. We will compare HbA1c, hypoglycemia, weight, before the
      education, and after. Patient will also wear a continuous glucose sensor during one week
      before, at month 6 and month 12 to allow comparison of glucose variablity.
    

Intervention name(s): Education to Functional Insulin Therapy
Intervention type(s): Behavioral
Intervention description(s): Intake of Continuous Glucose Monitor for 5 to 7 days
"Functional Insulinotherapy" training during 3 days, blood sampling, autoevaluation and QOL questionnary.
1 month after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes
3 months after the training: Blood sampling, vital signs and data on diabetes
6 months after the training: 2 sessions of training, blood sampling, autoevaluation and QOL questionnary, vital signs and data on diabetes, Intake of Continuous Glucose Monitor for 5 to 7 days
9 months after the training: Blood sampling, vital signs and data on diabetes
1 to 3 weeks before last visit: Intake of Continuous Glucose Monitor for 5 to 7 days
12 months after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes, autoevaluation and QOL questionnary
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Functional Insulin Thearpy; Carbs counting; Type 1 diabetes mellitus; Insulin pump; Treatment by external insulin pump
Zevalin-BEAM/BEAC With Autologous Stem Cell Support as Consolidation in First Line Treatment of Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine if outcome for patients with mantle cell lymphoma is
      improved by adding radioimmunotherapy to high-dose regimen before auto-transplant in patients
      who are not in CR after induction therapy.
    

Detailed description: 
      Mantle cell lymphoma is considered to have the worst outcome of all non-Hodgkins lymphomas.
      Since 1997, the Nordic Lymphoma Group has conducted phase II studies in order to improve the
      results for this lymphoma subtype. The first study included high-dose therapy with autologous
      stem cell support in the first line of treatment. The results showed the importance of a high
      quality response to pre-transplant induction treatment, and that CHOP-based regimen alone did
      not achieve this. Thus, the second trial was designed to improve remissions by including
      Rituximab and high-dose Ara-C. Results now show that a high rate of molecular remission in
      the bone marrow was achieved, and the 3-year FFS was improved in comparison to the first
      study (80% vs 24%). Furthermore, patient who had a molecular relapse (t(11;14) or IgV-gene)
      were treated with 4 doses of Rituximab and many converted back to be PCR negative.

      The present and thus third phase II study aims to improve the high-dose regimen by adding
      Zevalin radioimmunotherapy in patients who are not in CR prior to transplant. Data from the
      last trial show that patients not in CR at this point have a worse outcome (3 year FFS of
      63%, vs 85% for CR patients). Monitoring for molecular relapse in the bone marrow will be
      done, and patients who become PCR positive will be treated with Rituximab in order to
      evaluate the value of this strategy.
    

Intervention name(s): 90Y-ibritumomab tiuxetan (Zevalin)
Intervention type(s): Drug
Intervention description(s): 90Y-ibritumomab tiuxetan (Zevalin) at 0.4 mCi/kg is administered one week prior to start high-dose chemotherapy (BEAM/BEAC) in patients who have not achieved CR after induction therapy. Predosing with rituximab 250 mg/m2 one weeks prior to radioimmunotherapy and the same day.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mantle cell lymphoma; Zevalin; 90Y-ibritumomab tiuxetan; Radioimmunotherapy; High-dose therapy; First line
UCLA Fitness and Memory Study of Activity In Mild Cognitive Impairment (AIM)
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      This project will examine the relationship between physical activity levels, brain structure
      and memory function in adults with Mild Cognitive Impairment (MCI) aged 60 to 75. The study
      will follow 30 adults with age-associated memory impairment or MCI over the course of 18
      months. During this time, subjects' physical activity levels will be measured regularly and
      related to both the thickness their hippocampus and to their memory performance. Subjects
      will be recruited and screened for major health problems at UCLA. Physical activity will be
      tracked for two weeks using accelerometers at baseline and every 6 months during the study.
      At baseline and at the end of the study, subjects will undergo a structural MRI brain scan to
      measure hippocampal thickness, as well as a neuropsychological evaluation to measure memory
      function. The study will seek to determine the relationship between physical activity level,
      hippocampal thickness and memory performance in older adults with age-associated memory
      impairment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Southern California Residents with memory complaints aged 60-89.
      
Biospecimen description: 
      Whole blood
    
Keywords: Physical Activity, Aging, Memory, Cognitive Impairment, MRI, Neuroscience
A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Chiropractic Adjustive Technique
Condition: Low Back Pain; Headache; Shoulder Pain
MeSH terms: Shoulder Pain; Back Pain; Low Back Pain; Headache
Study type: Interventional

Summary: 
      There are a variety of treatment approaches used by the chiropractic profession. Some of
      these require forceful joint manipulation and some do not. This study is designed to compare
      outcomes of two such techniques that are common to chiropractic practice. The hypothesis is
      that there is no difference between forceful and non-forceful approaches to treatment.
    

Detailed description: 
      The comparison will permit a one month treatment period for both techniques and a three week
      follow-up. Patients will be assessed at baseline (intake), and at specified intervals and at
      three weeks following the termination of care.
    

Intervention name(s): spinal manipulation & patient education/nutrition
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Treatment
Keywords: chiropractic; spinal manipulation; low back pain
Development of Bone Grafts Using Adipose Derived Stem Cells and Different Scaffolds
Condition: Overweight
MeSH terms: Overweight
Study type: Observational

Summary: 
      The repair of large osseous defects remains still unsolved. Aim of this study is to isolate
      and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore,
      our research idea is to pre-engineer large synthetic bone grafts and study the
      vascularization process in vivo.
    


Intervention name(s): Cell Culture
Intervention type(s): Procedure
Intervention description(s): Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted for reconstructive surgery
      
Biospecimen description: 
      Human adipose-derived stem cells from human fat
Effectiveness Analysis of Active Stretching Versus Active Stretching With Low Frequency Currents
Condition: Muscular Diseases
MeSH terms: Muscular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether active stretching with low frequency
      currents are more effective than active stretching in the treatment of hamstring shortness
      syndrome in children.
    

Detailed description: 
      In 2012 we studied 51 young footballers with Short Hamstring Syndrome in Spain. Three groups
      were formed:

        1. Stretching+Transcutaneous Electrical Nervous Stimulation (TENS);

        2. Active stretching;

        3. Conventional stretching.

      Parameters: straight leg raise test (SLR), popliteal angle with the passive knee extension
      test (PKE) and the toe-touch test (TT).

      The inter-group means were compared and clinically relevant parameters calculated [relative
      risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to
      treat (NNT)].
    

Intervention name(s): Active stretching
Intervention type(s): Procedure
Intervention description(s): The participants performed three specific exercises of static active stretching of the hamstring muscles, maintaining the maximum tightness that was tolerable without pain for 15 seconds. Each exercise were performed twice, with a total of six repetitions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Young adult; Muscle Stretching Exercises; Range of Motion, Articular
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults
Condition: Atopic Dermatitis; Pruritus
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out if investigational device, RD047-26, is safe and
      useful for the treatment of mild to moderate atopic dermatitis.
    

Detailed description: 
      RD047-26, a device, may be tolerable and effective for the treatment of mild to moderate
      atopic dermatitis with associated pruritus in adults. The treatment effect will be evaluated
      by the subject and investigator.
    

Intervention name(s): RD047-26
Intervention type(s): Device
Intervention description(s): RD047-26 emollient gel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Pruritus
Reliability of Functional Outcome Measures in Plantar Fascitis Patients
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Observational

Summary: 
      Plantar Fasciitis (PF) is the most common foot condition treated by healthcare providers,
      striking approximately 2 million Americans each year. Nevertheless its causes are still not
      known. The risk factors for PF are known and the diagnosis, which is based on clinical
      assessment, is relatively simple. Still most of the treatments for PF focus on short term
      symptoms relief instead of prevention or reduction of recurrence.

      Physical therapy treatment that focuses on reducing the symptoms for the long run and
      prevention, should include outcome measures, which if found to be reliable, will make the
      diagnosis clearer. Diagnosis based on reliable clinical and functional measures will assist
      the physical therapist to understand the major deficiencies of the patient, and accordingly
      to help him to make the right decision in choosing treatment. Also comprehensive knowledge of
      the characteristics of PF may enable selection of appropriate preventive measures.
    

Detailed description: 
      Objectives:

      Characterize the unilateral PF syndrome using functional outcome measures, while comparing
      them to the healthy foot of the same patient. In addition the study will investigate the
      reliability of these functional outcome measures in PF patients.

      Methodology:

      Individuals referred to physiotherapy for PF will be assessed for eligibility and consent for
      the study. They will undergo two evaluations on the same week to evaluate the test- retest
      reliability of the functional measurements.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals referred to community physiotherapy center for plantar Fasceitis treatment.
      
Keywords: Plantar Fasciitis; Physiotherapy
Edulcorants Effect in Caries Risk Schoolchildren
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This double-blind RCT aimed to evaluate the effect of sugar-free snacks on caries risk in 6-9
      years-old schoolchildren. Considering a 20% difference among groups, the number of subjects
      needed per group was set in 87. Two-hundred-seventy-one children at risk for caries measured
      through Cariogram were selected and randomly assigned to three groups consuming twice a day
      snacks containing Stevia or Maltitol or sugar for 42 days. Parents filled out a standardized
      questionnaire regarding personal, medical and oral behavioural information. Bleeding on
      probing, plaque pH and cariogenic microflora were assessed at baseline (t0), after 21 (t1)
      and 42 days of snacks' use (t2) and 120 days after the end of use (t3). Cariogram was also
      repeated at t2.
    


Intervention name(s): delivery of snacks
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects were randomly assigned to three groups (blue, green and yellow), receiving a single type of snack for 42 days. Block randomization ensured similar proportions of participants in each group. All subjects received snack packets (six cookies each) on a weekly basis. Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks. Both participants and investigators were blinded to the treatment assignment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Tamoxifen in Treating Patients With Primary Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using tamoxifen
      may fight liver cancer by blocking the absorption of estrogen. It is not yet known whether
      receiving tamoxifen is more effective than no further therapy in treating patients with
      primary liver cancer.

      PURPOSE: Randomized phase III trial to compare high-dose tamoxifen with no further treatment
      in treating patients with liver cancer that cannot be surgically removed.
    

Detailed description: 
      OBJECTIVES: I. Assess the therapeutic role of tamoxifen in patients with inoperable
      hepatocellular carcinoma in terms of overall survival and quality of life.

      OUTLINE: This is a randomized, double blind, placebo controlled study of tamoxifen. Patients
      are randomized to one of 3 treatment arms. Arm I: Patients receive placebo orally twice daily
      for one year. Arms II and III: Patients receive tamoxifen, at 1 of 2 different doses, orally
      twice daily for one year. Quality of life is assessed before treatment and then monthly
      thereafter. Patients are followed monthly until death.

      PROJECTED ACCRUAL: This study will accrue 300 patients.
    

Intervention name(s): tamoxifen citrate
Intervention type(s): Drug
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Primary purpose: Treatment
Keywords: localized unresectable adult primary liver cancer; advanced adult primary liver cancer; adult primary hepatocellular carcinoma
Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients
      with mild to moderate atopic dermatitis (AD).
    


Intervention name(s): CLS001; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): topical gel; topical gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to evaluate the effect of once daily itraconazole on
      the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.
    


Intervention name(s): BI 409306; Itraconazole; BI 409306
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral single dose of BI 409306; Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole; Oral single dose
Intervention MeSH terms: Itraconazole; BI 409306
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Acute Effect of Interval-walking
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Four months of interval walking training (IWT) is superior to energy-expenditure matched
      continuous walking training (CWT) with regards to weight loss and improvements in glycemic
      control. The reason for this is unclear. One potential explanation for the differential
      outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined as
      the elevated oxygen consumption measured during the hours following an exercise bout. A large
      EPOC means greater energy expenditure which, if energy intake does not change, leads to a
      greater weight loss. This weight loss may subsequently improve glycemic control

        -  Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on glycemic
           control in type 2 diabetics and to assess mechanisms responsible for differences (if
           any). It is hypothesised that IWT will be more advantageous for improving glycemic
           control.

        -  Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC.
           It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.
    


Intervention name(s): Interval Walking; Continuous walking
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Interval exercise; Interval training; Continuous exercise; Continuous training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glycemic control; excess post-exercise oxygen consumption
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2
Condition: Influenza (Pandemic)
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian
      flu vaccine with and without adjuvant 2 in healthy, young adults. The study is divided down
      into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test
      article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment
      following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts
      of the study.
    


Intervention name(s): Monovalent Avian Influenza VLP (H5N1); Monovalent Avian Influenza VLP (H5N1); Monovalent Avian Influenza VLP (H5N1); Adjuvant; Monovalent Avian Influenza VLP (H5N1); Adjuvant; Monovalent Avian Influenza VLP (H5N1); Adjuvant; Saline Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Dose A without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21; Dose B without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21; Dose B with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21; Dose C with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21; Dose D with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21; Placebo; intramuscular, deltoid, Day 0 and Day 21
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Persistence of seroprotective antibody concentrations & immunological memory shown by the
      ability to mount a response to a challenge dose of HBV vaccine
    


Intervention name(s): hepatitis B vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylaxis for hepatitis B disease
Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers
Condition: Imaging of the Brain and Antipsychotics; Neuronal Network Changes
Study type: Interventional

Summary: 
      To detect the effect of second-generation antipsychotic drug on the neural activity.
    

Detailed description: 
      To detect functional correlation changes in the brain with anti-psychotic drug administration
      as compared to placebo, and b.) to measure if these changes correlate with the plasma level
      of anti-psychotic, and c.) to evaluate if these changes correlate with drug induced symptoms
      and changes in cognitive function.
    

Intervention name(s): Risperidone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.; We gave oral liquid without active risperidone (pt and provider were both double blinded)
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Imaging; Risperidone; Placebo; antipsychotic