bioihbjkbjnl/mcl2 huggingface dataset:
The Multi-Sensor Distance Accuracy Study
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of the study is to test the accuracy benefit of having two glucose sensors (over
      one sensor alone) when they are positioned: 2mm, 10mm, 20mm, or 30mm apart. It is not yet
      known how close two sensors can be and still work correctly.
    

Detailed description: 
      An artificial pancreas system will likely require multiple glucose sensing elements to
      function safely. It is not yet known how close two glucose sensors can be placed and still
      work properly. Meaning, if one is reading inaccurately,and the other is positioned adjacent
      to it, will it read inaccurately also, defeating the purpose of having two sensors. Twenty
      adult subjects with Type 1 diabetes will wear four Medtronic REAL-Time glucose sensors during
      two separate 10-hour studies. The inter-sensor distances of each pair to be tested will be:
      2, 10, 20, and 30mm apart. The sensors will be inserted the day prior to the study day to
      allow for signal stabilization and calibration. During the study day, arterialized venous
      blood will be drawn every 15 minutes to measure blood glucose. The sensor values and
      interstitial values will be recorded from each sensor receiver at each time point. Subjects
      will be fed two standardized meals and given pre-meal insulin based on their typical insulin
      to carbohydrate ratio.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        clinical practice Type 1 patients
      
Keywords: glucose sensor; Inter-sensor distance
Reducing Sedentary Time in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      To determine the change in sedentary time and number of steps/day for older patients with
      heart failure at risk for mobility disability who receive a program to decrease sedentary
      behavior versus a standard program to increase exercise.
    


Intervention name(s): Reducing Sedentary Behavior; Physical Activity Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.; The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: sedentary time; number of steps/day; mobility; disability
The Effects of r-metHuIFN-Gamma on the Lungs of Patients With AIDS
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To determine safety and tolerance of administering aerosolized recombinant interferon gamma
      (IFN-gamma) for 4 weeks in patients with AIDS. To examine activation of alveolar macrophages
      by aerosolized IFN-gamma administration. To determine if subcutaneous (SC) injection of
      IFN-gamma can activate alveolar macrophages in AIDS patients.
    


Intervention name(s): Interferon gamma-1b
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Interferon-gamma
Primary purpose: Treatment
Keywords: Pulmonary Alveoli; Macrophage Activation; Interferon-gamma, Recombinant; Injections, Subcutaneous; Aerosols; Acquired Immunodeficiency Syndrome
Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3
      months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome
      in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active
      controls.
    

Detailed description: 
      There will be 3 groups of treatment; each group will consist of 43 subjects with the
      treatment regimens :

        -  Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal

        -  Treatment II : 1 tablet of aspirin 80 mg once daily, after meal

        -  Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal

      Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring
      Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational
      drug will be performed at baseline and end of study (Month 3rd). General condition of the
      subjects will be followed-up every month over three months of study medication.

      Physiotherapy will be provided to the subjects by the assigned Physiotherapist.
    

Intervention name(s): DLBS1033; Aspirin; Clopidogrel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet of DLBS1033 490 mg thrice daily, after meal; 1 tablet of aspirin 80 mg once daily, after meal; 1 tablet of clopidogrel 75 mg once daily, after meal
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DLBS1033; Lumbrokinase; Acute ischemic stroke; Bleeding profile; Clinical outcome; Aspirin; Clopidogrel
The Effect of Brief Bodyweight Exercise on Acute Glycemic Control in Healthy Inactive Adults
Condition: Exercise
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      This study will investigate whether an 11-minute bodyweight exercise session can improve
      short-term glycemic control. Glycemic control refers to the process of how the body regulates
      blood sugar. The process can be measured in different ways. This study will use a small
      device called a continuous glucose monitor to measure changes in glucose levels over a
      24-hour period. Participants will complete two trials and the investigators will compare
      glycemic control after the exercise session and a control period that does not involve
      exercise. Food intake will be controlled such that each participant will consume the same
      diet in both conditions. This study will help determine whether a single session of
      bodyweight exercise affects glycemic control.
    

Detailed description: 
      This study will investigate whether an 11-minute bodyweight exercise session can improve
      short-term glycemic control. Glycemic control will be assessed using continuous glucose
      monitoring for 24 hours following exercise or a control condition that does not involve
      exercise. The exercise and control periods will be directly supervised by a study
      investigator. Participants will complete two trials in a randomized, crossover manner
      separated by 7 days. Food intake will be controlled such that each participant will consume
      the same diet over the 24-hour period of measurement in both conditions. Standardized meals
      will be provided to participants prior and following the exercise and control conditions.
      This study will determine whether a single session of bodyweight exercise affects glycemic
      control as primarily assessed by mean 24-hour glucose.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): A single session of bodyweight exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Glycemic Control
Oxaliplatin, Irinotecan, and Capecitabine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill
      more tumor cells.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine
      when given together with oxaliplatin and irinotecan and to see how well they work in treating
      patients with advanced or metastatic colorectal cancer that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose and recommended phase II dose of capecitabine
           administered in combination with oxaliplatin and irinotecan in patients with
           unresectable advanced or metastatic colorectal cancer. (Phase I)

        -  Determine the efficacy of this regimen in these patients. (Phase II)

      Secondary

        -  Determine the tolerability of this regimen in these patients. (Phase II)

      OUTLINE: This is a multicenter, phase I dose-escalation study of capecitabine followed by a
      phase II study.

        -  Phase I: Patients receive oxaliplatin IV over 2 hours on days 1 and 15, irinotecan IV
           over 1 hour on days 8 and 22, and oral capecitabine twice daily on days 1-29. Treatment
           repeats every 5 weeks for up to 6 courses in the absence of disease progression or
           unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

        -  Phase II: Patients receive capecitabine at the MTD and irinotecan and oxaliplatin as in
           phase I.

      After completion of study treatment, patients are followed every 2 months for 1 year and then
      every 4 months thereafter.

      PROJECTED ACCRUAL: A total of 23-32 patients (3-12 for the phase I portion and 20 for the
      phase II portion) will be accrued for this study within 2.75 years
    

Intervention name(s): Capecitabine; irinotecan hydrochloride; oxaliplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): capecitabine; irinotecan hydrochloride; oxaliplatin
Intervention MeSH terms: Capecitabine; Oxaliplatin; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
Condition: Hepatic Insufficiency & Healthy Subjects
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in
      subjects with impaired liver function in comparison with healthy subjects
    


Intervention name(s): Zanubrutinib
Intervention type(s): Drug
Intervention description(s): A single oral dose of 80 mg Zanubrutinib will be administered.
Intervention MeSH terms: Zanubrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BGB-3111; Zanubrutinib; pharmacokinetics; healthy subjects; hepatic impairment
Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of LMT1-48(Probiotics)
      compared to a placebo in reducing the body fat in overweight subjects
    


Intervention name(s): LMT1-48; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): capsules containing Probiotics; capsules that did not contain any probiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to assess the safety profile of YAZ in Chinese women, including
      adverse drug reactions (ADRs).

      The secondary objectives are to investigate the rate of unintended pregnancies, the cycle
      control for subjects with and without preceding abortion, the bleeding pattern of subjects
      with and without preceding abortion (including the abortion-related bleeding pattern) and the
      efficacy in moderate acne vulgaris.

      Another objective is to investigate the effect on dysmenorrhea.
    


Intervention name(s): EE20/DRSP (YAZ, BAY86-5300)
Intervention type(s): Drug
Intervention description(s): YAZ (DRSP 3 mg/EE 20 µg), oral route, 6 cycles of 28 days per cycle, each cycle comprising 24 days of active tablets followed by 4 days of placebo tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: birth control,; contraceptives safety,; contraceptives efficacy,; moderate acne vulgaris
Pilot RCT of an Obesity Intervention for Primary Care Pediatrics: Helping HAND
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This is a feasibility study to evaluate a 6-month obesity treatment intervention (Helping
      HAND: Health Activity and Nutrition Directions) for pediatric primary care clinics. The
      program targets 5-8 year old children and their parents to change the child's lifestyle
      behaviors and the associated parenting practices to improve the child's weight status. Four
      community clinics participated. Families were recruited from clinics and after informed
      consent and baseline data have been obtained, the families were randomized into one of two
      groups: (1) the treatment group who immediately participated in Helping HAND or (2) the wait
      list control group, who started the program 7 months later. Data were gathered on all the
      participating children and their parents at three time points: baseline, post the
      intervention (month 7) and post the wait list control group completing the intervention
      (month 14).

      This was a pilot study to test the feasibility of an obesity prevention plus program
      delivered in the child's primary care clinic. The primary outcome was family attendance to
      the 3 data-collection meetings with research staff and the 6 prevention plus intervention
      sessions with a trained Health Advisor.
    


Intervention name(s): Helping HAND (Healthy Nutrition and Activity Directions)
Intervention type(s): Behavioral
Intervention description(s): 6-month behavioral intervention targeting 5-8 year old children and their parents to improve the child's lifestyle behaviors to improve their weight status. The families met monthly with trained Health Advisors for individual sessions in the pediatric clinic with phone calls in between visits to check on progress.
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Other
Keywords: child; primary care; treatment; parenting; lifestyle behaviors
Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine
Condition: Prevention of Meningococcal Infection
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Persistence of antibodies and kinetics of B cell response in healthy children after
      vaccination with MCC vaccine
    


Intervention name(s): Meningococcal C conjugate vaccine
Intervention type(s): Biological
Intervention description(s): Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Meningococcal Meningitis; vaccines; conjugate; immunology; children; antibody persistence
Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement
Condition: Fasciitis, Plantar
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      Physical treatment with focused shock waves is effective in the treatment of tendonitis. Food
      supplements could facilitate the healing of tendinopathies when combined with shock wave
      therapy.
    

Detailed description: 
      A single-blind, randomized prospective study (level of evidence IB) was designed. Patients
      with plantar fasciitis were recruited and randomized to group A and group B. Group A was
      treated with focused shock waves alone and group B with a combination of focused shock waves
      and tendon supplement. Pain remission (primary endpoint) and functional recovery (secondary
      endpoint) are monitored in both groups at three time points (Months 0, 3, and 6).
    

Intervention name(s): Tendisulfur Pro; Focused shock wave
Intervention type(s): Dietary Supplement; Device
Intervention description(s): Dietary supplement based on Methylsulfonylmethane (2.5 g), hydrolyzed collagen (1 g), L-arginine (1 g), L-lysine (500 mg), Vitamin C (500 mg), Bromelain (200 mg), Chondroitin sulfate (150 mg), Glucosamine (150 mg) [17, 18], dry extracts of turmeric (100 mg), Boswellia (100 mg) and Myrrh (50 mg); We delivered 2000 shots per session using a low/medium energy level (range between 0.01 and 0.175 milliJoule/mm2) depending on the patient's tolerance during treatment with a frequency of 4 Hz.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: focused shock waves; tendinitis; natriuretics
Analysis of Re-biopsy Specimens in Advanced NSCLC With Acquired Resistance of EGFR-TKI Targeted Therapy
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The objective of the study is to reveal the acquired resistance mechanism of the first and
      second generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) in
      tissue and plasma using Next Generation Sequencing (NGS) and the difference of ctDNA in
      plasma and DNA in biopsy samples is compared and the consistency of two samples was observed.
      At the same time, the sensitivity, specificity and the consistency of detecting T790M
      mutation using ddPCR, Cobas and NGS were compared.
    

Detailed description: 
      With the deepening of the concept of tumor management, it is necessary to monitor the
      patient's gene during the course of treatment, especially in patients with acquired
      resistance of the first generation EGFR-TKI. Re-biopsy can effectively provide tissue samples
      as a "gold standard" for gene detection samples. While, the plasma circulating tumor DNA
      (ctDNA) detection is an important sample of gene detection and the treatment when tissue
      samples cannot be assessed. However, due to tumor heterogeneity and ctDNA detection technique
      sensitivity, plasma ctDNA and tissue samples of the test results are inconsistent. Therefore,
      the difference between re-biopsy tissue samples and plasma ctDNA samples will provide strong
      evidence for the application of plasma ctDNA in TKI-resistant patients.

      The study was designed as a prospective and single center study. Fifty patients will be
      enrolled into the study and the clinical data of patients, including smoke history, cancer
      history, location, pathology, gene mutation status and so on of the first biopsy samples will
      be collected and recorded in a case report form. For patients recruited in the study, lesions
      which were assessed as progressive disease(PD) will be obtained by interventional pulmonology
      technology. And about 20ml peripheral blood will be collected at the same time. The tissue
      will be divided into two parts, one part was sent to Pathology Department of Shanghai Chest
      Hospital and will be processed with paraffin-embedded, and for those diagnosed NSCLC, the
      other part will be extracted with DNA and performed NGS for the qualified DNA sample and
      using Cobas to detect the T790M mutation. The matched peripheral blood will also be extracted
      with DNA and performed NGS and ddPCR.
    

Intervention name(s): Miseq sequencer
Intervention type(s): Device
Intervention description(s): The sequencer will be used to detect the gene mutations of the re-biopsy tissue samples and peripheral blood samples obtained from patients.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Next generation sequencing; Re-biopsy; Acquired resistance; Tissue sample; Peripheral blood
A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to investigate the short- and long-term effects of perampanel on
      cognition, growth, and development in adolescents.
    

Detailed description: 
      This study consisted of the Core Study and the Extension Part A and B. The Core Study
      consisted of 2 phases: Prerandomization and Randomization. The Prerandomization Phase lasted
      up to 1 week, during which participants were assessed for their eligibility to participate in
      the study. The Randomization Phase consisted of 3 periods: Titration (6 weeks), Maintenance
      (13 weeks), and Follow-up (4 weeks; only for those participants not rolling over into the
      Extension Phase). During the Core Study Titration and Maintenance Periods, participants were
      randomized into perampanel (2 to 12 mg per day) or placebo treatment groups in a 2:1 ratio
      within each of the age-matched categories (ie, greater than or equal to 12 to less than 15
      and greater than or equal to 15 to less than 18).

      The extension phase consisted of part A (Conversion Period - 6 weeks and Maintenance period -
      25 weeks) and Part B (Optional Extension Phase -52 weeks). The maximum duration for
      participation in Part B was 52 weeks.
    

Intervention name(s): Perampanel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg titrated up to 8-12 mg maximum; taken once daily.; Matching Placebo taken once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment