bioihbjkbjnl/mcl2 huggingface dataset:
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases
Condition: Brain Metastases
MeSH terms: Neoplasm Metastasis; Neoplasms, Second Primary; Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial was designed to investigate the efficiency and toxicity of fractionated
      stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain
      metastases.
    

Detailed description: 
      This is a single-arm, single center, phase II trial to investigate the feasibility and
      toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple
      brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no
      smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.
    

Intervention name(s): Fractionated Stereotactic Radiotherapy; Temozolomide
Intervention type(s): Radiation; Drug
Intervention description(s): The regular fraction modes were as follows: a. lesions≥3 cm：52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions<2cm：36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm：40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem：50-60Gy/2.5-3Gy/20f.; concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2*5d, q28d, 6cycles
Other intervention name(s): FSRT; TMZ
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple brain metastases; large brain metastases; meningeal metastases; fractionated stereotactic radiotherapy; temozolomide
Evaluation of the Accuracy, Safety and Robustness of a Single-input-single-output (SISO) Model-based Predictive Closed-loop System to Guide Patient-individualized ICU Sedation
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate the accuracy, safety and robustness of a
      single-input-single output (SISO) model-based predictive closed-loop system to guide
      patient-individualized ICU sedation.
    


Intervention name(s): SISO model-based predictive closed-loop system
Intervention type(s): Device
Intervention description(s): The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.
Advancing the Standard of Care for Pin Site Care
Condition: Diabetes Mellitus; Open Reduction External Fixation
Study type: Interventional

Summary: 
      The purpose of this study is to prospectively evaluate the effect of Active Leptospermum
      honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and
      also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to
      published reports of routine standard pin site care.
    

Detailed description: 
      Up to 20 Diabetic Mellitus patients undergoing Open Reduction External Fixation (OREF) for
      foot and/or ankle fusions, fracture repair, or osteotomy will be enrolled to receive weekly
      Medihoney pin site care until frame removal. Standard size dressings and application
      technique will be used at each pin site with prefabricated materials. No procedures, tests or
      interventions will be performed exclusively for research purposes or more frequently than the
      standard of care. Upon completion of the study, pin sites sepsis rates will be compared to
      published reports for standard pin site care.
    

Intervention name(s): MediHoney HCS dressing
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Surgical Intervention; Honey
The Effect of Caffeine on Acupuncture Analgesia With the Human Pain Model
Condition: Pain
Study type: Interventional

Summary: 
      This is a single center, double blind, randomized, parallel-group study to assess the effect
      of 200mg caffeine,400mg caffeine and decaffeinated on acupuncture analgesia with the human
      pain model.
    

Detailed description: 
      Aim: To evaluate the effect of caffeine on acupuncture analgesia with the human pain model.

      Design: Double blind, randomized controlled trial will be performed in Chengdu. The study
      including two pain models : Potassium pain model and Capsaicin pain model. Both models
      including the following several groups: 200mg caffeine group, 400mg caffeine group, and
      decaffeinated group. Participants will be randomly assign to the three groups. Each
      participants will receive coffee drinking and acupuncture intervention. Each subjects of the
      Potassium pain model will receive be measured the pain at baseline, 30 minutes after drinking
      coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention
      completed. Blood samples will be collected at baseline, 30 minutes after drinking coffee, 30
      minutes during acupuncture and 30 minutes after acupuncture intervention completed. Each
      subjects of the capsaicin pain model will be measured the spontaneous pain with VAS scale and
      the area of hyperalgesia with Von Frey hair at the time of 5 minutes after topical
      application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during
      acupuncture and 30 minutes after acupuncture intervention completed. Blood samples will be
      collected at the time of 5 minutes after topical application of capsaicin, 30 minutes after
      drinking coffee, 30 minutes during acupuncture and 30 minutes after acupuncture intervention
      completed.
    

Intervention name(s): acupuncture; 200mg caffeine; 400mg caffeine; Decaffeinated
Intervention type(s): Device; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): therapeutic acupuncture treatment with actual needles; 8g coffee, po; 16g coffee, po; decaffeinated coffee, po
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Acupuncture; caffeine; pain
Study Using Citrate to Replace Heparin in Babies Requiring Extracorporeal Membrane Oxygenation (ECMO)
Condition: Heart Defects, Congenital; Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency; Heart Defects, Congenital; Congenital Abnormalities
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the safety and efficacy of citrate to provide
      anticoagulation of an ECMO circuit without patient anticoagulation. The standard method of
      providing ECMO circuit anticoagulation is the use of heparin which also anticoagulates the
      patient and increases the risk of patient bleeding.
    

Detailed description: 
      Extracorporeal membrane oxygenation (ECMO) is a form of extended heart/lung bypass support
      that has been used to treat more than 650 patients over 20 years at Vanderbilt. Over 29,000
      patients have been treated worldwide. Bleeding is the most common complication during ECMO
      because of systemic anticoagulation with heparin. It is most commonly seen in patients
      following surgery either preceding or while on ECMO support. Regional citrate anticoagulation
      for hemodialysis was first introduced in 1961. It is the ideal alternative to heparin in
      patients who are at increased risk for bleeding. It permits effective anticoagulation across
      the extracorporeal circuit without impacting the patient's systemic coagulation. Citrate
      functions by binding free calcium, thereby inhibiting coagulation in both the intrinsic and
      extrinsic coagulation pathways. The purpose of this study is to evaluate the use of citrate
      as a regional anticoagulant in the ECMO circuit in high risk infants less than one year of
      age.
    

Intervention name(s): sodium citrate
Intervention type(s): Drug
Intervention description(s): Continuous infusion of 4% sodium citrate at 300 ml/hour into ECMO circuit
Intervention MeSH terms: Citric Acid; Sodium Citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Defects, Congenital; Extracorporeal Membrane Oxygenation; Citric Acid; Heparin; Respiratory Insufficiency
Cord Blood Transplantation for Sickle Cell Anemia and Thalassemia
Condition: Hematologic Diseases; Anemia, Sickle Cell; Beta-Thalassemia; Hematopoietic Stem Cell Transplantation
MeSH terms: Anemia; Thalassemia; Hematologic Diseases; beta-Thalassemia; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will develop a national cord blood bank for siblings of patients with
      hemoglobinopathies and thalassemia.
    

Detailed description: 
      BACKGROUND:

      During the past decade, a number of advances have been made in the treatment of patients with
      sickle cell anemia and thalassemia. Among these advances is allogeneic bone marrow
      transplantation, which is the only current treatment that offers a potential for cure. In
      sickle cell anemia, transplantation has been performed in patients who have had advanced
      organ damage. In thalassemia, transplantation has been performed before having any evidence
      of iron-related tissue damage. Due to concerns over engraftment and graft versus host disease
      (GVHD), transplants for patients with hemoglobinopathies have been limited to situations in
      which a human leukocyte antigen (HLA) compatible donor existed. Unfortunately, an HLA-matched
      related donor is often not available. Umbilical cord blood (UCB), a recently recognized
      source of hematopoietic stem cells, has been used to successfully transplant bone marrow to
      over 500 patients. The potential advantage of cord blood over other donor sources of stem
      cells is the minimal risk of high-grade GVHD (even without complete HLA compatibility).

      DESIGN NARRATIVE:

      This study will establish a national sibling donor cord blood (SDCB) program, evaluate its
      use in a multi-center pilot study of transplantation, and develop a Web-based data management
      system to support these two projects. A multi-center pilot study was conducted on cord blood
      transplantation in children with either sickle cell disease or thalassemia. The investigators
      tested the hypothesis that a novel immunosuppressive conditioning regimen (fludarabine,
      cyclophosphamide, and busulfan) and post transplant therapy (mycophenolate mofetil and
      cyclosporine) would improve engraftment rates and prevent disease recurrence. The effect of
      SDCB transplantation on hematologic parameters and GVHD was monitored. Enrollment in the
      study was suspended on December 29, 2003. The protocol was revised, replacing the previous
      conditioning regimen of fludarabine, busulfan, and cyclophosphamide with a more conventional
      regimen of rabbit anti-thymocyte globulin (Sangstat), busulfan, and cyclophosphamide. The
      revised protocol is open for enrollment.
    

Intervention name(s): Sangstat; Cyclophosphamide; Busulfan; Mycophenolate Mofetil; Cyclosporine; Cord Blood Transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Cyclophosphamide; Busulfan; Cyclosporins
Primary purpose: Treatment
Calcium and Bone Mass in Young Females
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      We originally suggested that calcium in the diet is important in determining the amount of
      bone (bone mass) that builds up in young adults. We are testing the effect of calcium on bone
      mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age of
      the girls was 11 years, and they had not yet reached puberty. The study will also provide
      information about the effect of calcium on body composition (body fat) and blood pressure in
      young women.

      We have been giving calcium to one group of participants in this study and giving a placebo
      (an inactive pill, or "sugar pill") to the other group. The results of this research will be
      important in preventing osteoporosis, because building more bone as a young person should
      reduce a woman's chances of developing osteoporosis later in life.
    

Detailed description: 
      This study evaluates the effect of calcium on bone mass accretion over 7 years in a cohort of
      354 young females who were in pubertal Stage II at the start of the study. The average age of
      study participants at entry was 11 years; at the end of the study participants were 18 years
      old.

      The study looks at skeletal development under the influence of heredity, nutrition (calcium),
      and physical exercise. We gave calcium to participants in one arm of this clinical trial
      calcium. Participants in the other arm of the trial were given a placebo. The main outcome
      variable is the bone mass measured at different skeletal regions.

      The study will also provide data about the efficacy of calcium supplementation with regard to
      hypertension prevention and obesity. The results of this research will be important in
      preventing osteoporosis.
    

Intervention name(s): Calcium
Intervention type(s): Drug
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Osteoporosis; Dietary calcium; Puberty; Bone density; Bone mass; Primary prevention of osteoporosis
Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this open-label, 2-period, fixed-sequence study is to characterize the plasma
      pharmacokinetic profiles of midazolam, dabigatran, pitavastatin, atorvastatin, and
      rosuvastatin following a single oral dose administration of a microdose cocktail in healthy
      participants, in participants with mild, moderate, severe (not on dialysis) renal impairment,
      and in participants with end-stage renal disease (ESRD; on dialysis).
    


Intervention name(s): Midazolam oral solution; Dabigatran and pitavastatin oral solution; Atorvastatin and rosuvastatin oral solution; Rifampin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Midazolam hydrochloride 10 μg (1 mL of 10 μg/mL oral solution), administered orally as part of a microdose cocktail; 375/10 μg dabigatran etexilate and pitavastatin (1 mL of 375/10 μg/mL oral solution), administered orally as part of a microdose cocktail; 100/50 μg atorvastatin and rosuvastatin (2 mL of 50/25 μg/mL oral solution), administered orally as part of a microdose cocktail; Rifampin 600 mg single dose (two 300 mg capsules) administered orally
Intervention MeSH terms: Rifampin; Midazolam; Dabigatran; Atorvastatin; Rosuvastatin Calcium; Pitavastatin; Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Activity Trackers for Improving BP
Condition: Hypertension; Cardiovascular Risk Factor; Physical Activity; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The study aims to determine if use of physical activity trackers coupled with provider
      feedback will increase awareness of young adults of their physical fitness and improve blood
      pressure levels. The goal of this pilot study is feasibility, with a secondary goal of
      examining potential effect sizes for planning purposes for a larger randomized controlled
      trial.
    

Detailed description: 
      Increasing physical activity levels may improve cardiovascular health and BP levels in young
      individuals, especially if such strategies promote healthy lifestyles. Physical activity is
      currently recommended for adults CV health, but physical activity levels are known to be low
      in populations with diabetes or chronic kidney disease. One prior study of the use of
      pedometers (not associated with wireless technology or provider feedback) in children with
      CKD did not significantly improve physical activity levels. Supervised walking appeared to
      provide some benefit in individuals with type II diabetes, but overall compliance was poor.
      Interview of adolescents and young adults with chronic illnesses has shown preference for the
      use of electronic devices and online tools for disease management.Thus, use of sophisticated
      electronic devices such as FitBits© (wireless pedometers worn on the wrist that sync with
      cell phones) may improve disease control by engaging young patients in self-monitoring of
      their own health and lifestyle behaviors. This pilot study aims to determine if use of
      FitBits© coupled with provider feedback will increase awareness of young adults of their
      physical fitness and improve blood pressure levels.
    

Intervention name(s): FitBit
Intervention type(s): Device
Intervention description(s): Daily use of physical activity tracker coupled with biweekly provider telemonitoring and feedback for 6 months and then additionally without feedback for an additional 6 months
Other intervention name(s): physical activity tracker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and tolerability of TAK-063 when
      administered as multiple oral doses at escalating dose levels in participants with stable
      schizophrenia and in healthy Japanese participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-063. TAK-063 is being tested to find a
      well-tolerated dose and also to treat schizophrenia. This study will look at how well
      different doses of TAK-063 are tolerated in healthy people of Japanese descent and in people
      with stable schizophrenia.

      Five dose levels will be examined, starting at the lowest, in each population with 10
      participants in each dose level. These participants will be randomized to receive TAK-063 (8
      subjects) and placebo (2 subjects) once daily (QD) for 7 days.

      In total, approximately 60 participants will be enrolled in the study. This trial will be
      conducted in single site in the United States. The overall time to participate in this study
      is up to 42 days. Participants will make 2 visits to the clinic, including 8-10 days
      confinement to the clinic, and will be contacted by telephone 7 days after last dose of study
      drug for a follow-up assessment.

      Dose escalation and the actual choice of the subsequent dose level will only occur following
      a review of the blinded data from the previous cohorts.
    

Intervention name(s): TAK-063; TAK-063 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-063 tablets; TAK-063 placebo-matching tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
The Effects of a Jump Rope Exercise Program on Body Composition and Self-efficacy in Obese Adolescent Girls
Condition: Prehypertension; Blood Pressure; Abdominal Obesity; Self Efficacy; Adiposity; Insulin Sensitivity
MeSH terms: Prehypertension; Insulin Resistance; Obesity, Abdominal; Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study was to examine the impact of a 12-week jump rope exercise program
      on body composition, blood pressure, insulin resistance, and academic self-efficacy in
      prehypertensive adolescent obese girls. Forty-eight prehypertensive adolescent obese girls
      participated in this study. The girls were randomly divided into the jump rope exercise
      intervention group (EX, n=24) and control group (CON, n=24). The EX group performed a jump
      rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks
      (sessions 50 minutes in duration). The CON group did not participate in any structure or
      unstructured exercise protocol. Blood pressure, body fat percentage, waist circumference,
      blood glucose and insulin, homeostatic model assessment - insulin resistance, and Academic
      Self-Efficacy were measured before and after the 12-weeks study.
    


Intervention name(s): 12-week jump rope exercise program
Intervention type(s): Other
Intervention description(s): Each jump rope exercise session of the program was performed for 50 minute, with a 5 minute warm-up and cool-down. Sessions were performed once a day, 5 days a week, for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool-down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased form 40-50% heart rate reserve (HRR) in weeks 1-4 and 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Ever subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: exercise intervention group, control group
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: adolescence; exercise; body composition; insulin sensitivity; obesity; academic self-efficacy
Human Milk Oligosaccharides and Childhood Diarrhoea
Condition: Acute Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      Assessment of the impact of oral Human Milk Oligosaccharides (HMO) application on acute
      diarrhoea and the development of prolonged and persistent diarrhoea in paediatric patients
      hospitalized with acute diarrhoea.
    

Detailed description: 
      The trial is single site, double blind, randomized of HMO addition (1.5 g /day) to standard
      of care in paediatric diarrhoea patients. HMO application and follow-up of the children at
      home will be done for 2 weeks. Control patients receive only the standard of care (ORS plus
      zinc). A breastfed group of diarrhoea patients will serve as reference group.

      The total sample size is 495 patients. Patients will be females and males aged 6 months to 2
      years old with acute diarrhoea.
    

Intervention name(s): Oral rehydration solution; Zinc; Human milk oligosaccharides; Breastfeeding
Intervention type(s): Other; Other; Other; Other
Other intervention name(s): ORS; HMO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Children; Diarrhea; Human milk oligosaccharides