bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial
Condition: Peripheral Vascular Disease; Intermittent Claudication
MeSH terms: Vascular Diseases; Intermittent Claudication; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional

Summary: 
      This is a randomised controlled study of patients suffering from intermittent claudication
      (IC), to assess the impact of wearing a Nike FuelBand (NFB) on walking distances, exercise
      levels and quality of life.
    

Detailed description: 
      IC manifests as pain in the calf, thigh or buttock muscles when walking. It is caused by
      narrowing or blockage of the blood vessels in the legs.

      The NFB is a discrete wristband with a built-in accelerometer to measure motion. It provides
      estimates of the number of steps taken and the amount of distance covered each day.

      This study will be conducted over a period of 18 months at Imperial College Trust's vascular
      outpatients service. Patients that meet the inclusion/exclusion criteria will be asked to
      consider participating. Participants will receive routine diagnostic work up with the
      addition of having their walking distances measured on a lab treadmill. They will also have
      their functional status and mood assessed using a questionnaire. These assessments will be
      carried out a total of five times over the course of the study. Patients will not need to
      make any additional visits to hospital.

      Patients will be randomly allocated to either the NFB group or the control group. Patients in
      the NFB group will be given a FuelBand with instructions on how to use it. All patients will
      be given routine instructions on maintaining activity and target daily walking distances.
      Target walking distances will be programmed into the NFB. Patients in the NFB group will be
      asked to record estimates of how far they have walked each day directly from their band. All
      patients will be contacted by telephone at a pre-arranged time to collect recordings.

      Patients will be followed up at their routine 3-month follow up appointment and additionally
      at 6 and 12 months.
    

Intervention name(s): Nike FuelBand (NFB)
Intervention type(s): Device
Intervention description(s): The Nike Fuel Band (NFB) is a wrist-worn sensor with a built-in accelerometer for motion quantification. It is programmed to estimate the number of steps taken per day, and also predict energy expenditure in units known as Nike Fuel. Accompanying software allows the user to set daily targets and monitor their activity through a graphical user interface.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Peripheral vascular disease
Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers
Condition: Health
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye
      drops at different concentrations to normal older healthy adult volunteers for two weeks.
    


Intervention name(s): INO-8875; Placebo control
Intervention type(s): Drug; Other
Intervention description(s): eye drops for 14 days in one eye; Matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adenosine agonist; eye drop; elderly volunteer; older healthy volunteer
Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP)
Condition: Hypophosphatasia (HPP)
MeSH terms: Hypophosphatasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial studies the safety, tolerability, and pharmacology of asfotase alfa when
      given to adults with HPP.
    

Detailed description: 
      Asfotase alfa was formerly referred to as ENB-0040

      Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease
      characterized by defective bone mineralization and impaired phosphate and calcium regulation
      that can lead to progressive damage to multiple vital organs, including destruction and
      deformity of bones, profound muscle weakness, seizures, impaired renal function, and
      respiratory failure. There are no approved disease-modifying treatments for patients with
      this disease. There is also limited data available on the natural course of this disease over
      time, particularly in patients with the juvenile-onset form.
    

Intervention name(s): Asfotase Alfa; Asfotase Alfa
Intervention type(s): Biological; Biological
Intervention description(s): The initial IV dose to be administered to patients was set at one-tenth the no adverse effect level (NOAEL) as determined by one month toxicology studies in animals in which Asfotase Alfa was administered as a single weekly IV dose. The SC doses to be administered are lower than the IV doses and are thought to be near or at the anticipated daily efficacious dose. Dosing will be as follows:
Cohort 1: In Week 1, patients will receive an IV infusion of Asfotase Alfa at a dose of 3 mg/kg. In Weeks 2, 3 and 4, patients will receive weekly SC injections of Asfotase Alfa at a dose of 1 mg/kg SC.; Cohort 2: In Week 1, patients will receive an IV infusion of Asfotase Alfa at a dose of 7 mg/kg. In Weeks 2, 3 and 4, patients will receive weekly SC injections of Asfotase Alfa at a dose of 1.5 mg/kg SC.
Intervention MeSH terms: Immunoglobulin G
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypophosphatasia; Bone Disease; Soft Bones; Low Alkaline Phosphatase; genetic metabolic disorder; alkaline phosphatase; tissue non-specific alkaline phosphatase; rickets; osteomalacia
Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children
Condition: Nutrition; Cognitive Performance; Appetite
Study type: Interventional

Summary: 
      The purpose of the present study is to determine the effects of eggs and egg components on
      cognitive performance and appetite in children aged 9-14 years, as well as to identify the
      underlying physiological mechanisms in this relationship.
    

Detailed description: 
      Children will be asked to refrain from exercising the morning of their test day and inform
      researchers of any illness. Following a 12-hour overnight fast, children will consume a
      standardized breakfast of a cereal bar, fruit cup and orange juice at home (total 330 kcal).
      Children will be asked to avoid consumption of any other food, with the exception of water,
      until arrival at the laboratory 3 hours later.

      At the laboratory, five treatments of: (a) 2 whole eggs, (b) 2 egg whites, (c) 2 egg yolks,
      (d) full fat yogurt isocaloric to the 2 whole eggs, and (e) snack skipping will be provided
      to children 9-14 years on separate days at least 7 days apart. Cognitive performance,
      subjective emotion/mood, and subjective appetite will be measured for 90-minutes following
      snack consumption (n=25). Cognitive performance assessments will include learning and memory,
      spatial memory, attention and processing speed, and executive functions. In a subgroup of
      individuals (n=10), glucose, insulin, incretin hormones (glucagon like peptide1(GLP1) and
      gastric inhibitory polypeptide (GIP)),dipeptidyl peptidase 4 (DPP4), amino acids, fatty
      acids, and choline will be measured for 90-minutes following snack consumption.
    

Intervention name(s): Snack skipping; Whole eggs; Egg whites; Egg yolks; Yogurt
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): No snack provided; 2 whole large eggs scrambled, provided as a snack; 2 egg whites scrambled, provided as a snack; 2 egg yolks scrambled, provided as a snack; A serving of full fat yogurt that is isocaloric to the 2 whole eggs
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A random and within subject repeated measures experiment to study the effects of egg consumption on cognitive performance in children and the underlying physiological mechanisms in this relationship.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Children; Nutrition; Eggs; Cognitive performance; Glycemic response; Appetite; Emotion
A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to
      compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD
      (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1)
      to estimate the geometric mean ratio (GMR) and variability of the maximum observed
      concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or
      determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will
      demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable
      concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values
      for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.
    


Intervention name(s): Etrolizumab; Auto-Injector (AI); Prefilled Syringe With Needle Safety Device (PFS-NSD)
Intervention type(s): Drug; Device; Device
Intervention description(s): Etrolizumab will be administered at a dose of 105 milligrams (mg).; The pre-filled AI will be used to administer etrolizumab.; The PFS-NSD will be used to administer etrolizumab.
Other intervention name(s): RO5490261
Intervention MeSH terms: Etrolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, open-label, randomized phase III study assessing adjuvant capecitabine
      after standard chemotherapy for patients with early triple negative breast cancer.
    

Detailed description: 
      Patients will be stratified as per investigational site, previous adjuvant chemotherapy
      (anthracyclines versus anthracyclines plus taxanes), and number of affected axillary lymph
      nodes (0, 1-3, >= 4). Node negative patients must present a tumour size > 2 cm to be
      eligible. At least 6 lymph nodes must be analysed to confirm the number of affected nodes.
      Patients will be randomised to receive: 8 courses of capecitabine 1000 mg/m2 by mouth, twice
      a day (p.o. bid) for 14 days, followed by a 7 day rest versus observation.

      Tissue samples must be analysed by a central laboratory, to confirm estrogen receptor (ER),
      progesterone receptor (PgR), human epidermal growth factor receptor-2 (HER2), cytokeratins
      (CK) 5/6 and epidermal growth factor receptor (EGFR) status.

      The following data were obtained from the database of the "El Alamo" project. One thousand
      six hundred and twenty-seven (1,627) in total were considered during the years 1990 to 1997.
      The population is formed of patients with operable breast cancer, with surgery, positive
      nodes, and negative hormone receptors, or negative nodes, negative hormone receptors and T2-3
      tumors.

      For these patient groups, estimated 5-year disease-free survival is 64.72%. Assuming an
      exponential distribution, the aim is to detect an increase of 64.72% to 73.7% in 5 years
      Disease Free survival rate corresponds to a Hazard Ratio of 0.701 and a risk reduction of
      about 30%, with a power of 80% using a two-tailed log-rank test at 0.05 and whereas 4 years
      of recruitment period and 3 years of follow-up period. We would need 255 events, 834 patients
      without considering any dropouts.

      Considering a drop-out rate of 5% post-randomization, the final sample size will be 876
      patients, 438 per treatment arm.

      The sample size calculation was performed by the program package "EAST" version 5.2.
    

Intervention name(s): Capecitabine
Intervention type(s): Drug
Other intervention name(s): Xeloda
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Triple-Negative Early Breast Cancer; Maintenance Adjuvant Chemotherapy; Capecitabine; Basal-like genotype; Triple-Negative
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-70_R84-064)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stress, Dietary Lapse and Weight Loss Among Adults With Type 2 Diabetes
Condition: Obesity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Weight Loss
Study type: Interventional

Summary: 
      A clinical trial that uses personal digital assistants (PDAs) to assist in examining the
      relationship between self reported stress, an objective biochemical indicator of stress
      (salivary alpha amylase) and self-reported dietary lapse among type 2 diabetic adults who are
      interested/undergoing in weight loss.
    

Detailed description: 
      In the study, all participants will be provided with a personalized ADA-based diet plan and a
      pre-programmed PDA. They will be required to record their mood and activities into the PDA
      whenever PDA prompts, they break their diet plan, and/or and face significant stress. They
      will also be required to collect saliva samples periodically. In addition to this they will
      be administered the Trier Social Stress Test once during the study, where they will perform
      certain stress inducing tasks like delivering a speech and solving maths problems. Salivary
      samples will be collected before and after these tasks. They will also take various
      questionnaires during each of the 15 to 16 visits. The completed questionnaires, PDA records
      and reports of salivary alpha amylase levels will be analyzed to examine the corelation
      between stress, dietary lapse and weight loss.
    

Intervention name(s): Personalized diet plan and PDA self reporting.
Intervention type(s): Behavioral
Intervention description(s): Participants will be given personalized diet plan with a 0.5- 1 lb weight loss/week, based on each person's goals. He/she will also be prompted by a pre programmed PDA to enter dietary lapses and stress inducing events. Saliva samples will be collected as per the study plan.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Type 2 Diabetes; Obesity; Weight loss; PDA; Stress; Dietary lapse; salivary alpha amylase
Glucosamine and Chondroitin Effects
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected
      by a reduction in serum C-reactive protein.
    

Detailed description: 
      Use of glucosamine and chondroitin have been associated with reduced cancer and overall
      mortality. The aim of this study is to determine whether a common starting dose of
      glucosamine and chondroitin (1500 mg/d + 1200 mg/d, respectively) reduces systemic
      inflammation as reflected by a reduction in high sensitivity C-reactive protein.
    

Intervention name(s): Glucosamine and Chondroitin; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Glucosamine (1500 mg) and Chondroitin (1200 mg)
Other intervention name(s): Nutramax
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Statin Therapy In Cardiac Surgery
Condition: Atrial Fibrillation; Myocardium; Injury
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of STICS trial (Statin Therapy In Cardiac Surgery) is to test whether
      perioperative treatment with Rosuvastatin 20 mg once daily prevents post-operative atrial
      fibrillation and reduces perioperative irreversible myocardial damage in patients undergoing
      elective cardiac surgery.
    

Detailed description: 
      Evidence that pre- or perioperative statin treatment may reduce the occurrence of
      post-operative atrial fibrillation and improve clinical outcome in patients undergoing
      coronary artery bypass graft (CABG) or major vascular surgery has been largely generated by
      observational studies. In a recent meta-analysis of 6 randomized trials (of which only 2 had
      postoperative atrial fibrillation (AF) as a predefined outcome) evaluating the use of
      perioperative statin treatment in patients undergoing cardiac surgery (n=651 patients in
      total - study size between 40 and 200 patients), statin use was found to reduce the patients'
      relative risk of developing postoperative AF by 43% (RR 0.57, 95%CI 0.45,0.72) and their
      absolute risk by 14% (95% CI 8%,20%). Although these findings would be consistent with a
      rapid and, possibly, lipid-independent antiarrhythmic effect of statins, they have important
      limitations (e.g., single-centre, small size, lack of continuous ECG monitoring, mostly
      "ancillary" findings") and less bearing on current clinical practice, as they mostly included
      statin-naïve patients. For these reasons, the recent guidelines for the management of AF have
      not given a strong recommendation for the use of statins in the prevention of postoperative
      AF. Thus, whether intensive statin treatment in the perioperative period is associated with
      prevention of AF, cardio protection, and improved clinical outcome remains to be
      demonstrated.
    

Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin (20 mg od) started not earlier than 8 days before surgery and continued until the 5th post-operative day included;; Placebo started not earlier than 8 days before surgery and continued until the 5th post-operative day included.
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Surgical Procedures, Cardiac; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin; Post operative atrial fibrillation
Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients; a 5-year Follow up Study
Condition: Bone Mineral Density; Femoral Neck Fractures
MeSH terms: Fractures, Bone; Femoral Neck Fractures
Study type: Interventional

Summary: 
      Periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study
      addressing the influence of surgical approach on periprosthetic bone mineral density.
    

Detailed description: 
      Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand,
      Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and
      registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468).Patients between
      70 and 90 years of age with displaced femoral neck fractures, intact cognitive function and
      the ability to walk with or without a walking aid prior to falling were asked for their
      agreement to be enrolled and partition occurred after informed consent.A subgroup analysis
      looking at periprosthetic bone mineral density around the femoral component was part of this
      level 1 single-center randomized trial. 51 patients were enrolled in this DEXA study, and
      future examination of bone remodeling in these patients is now planned.
    

Intervention name(s): Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint
Intervention type(s): Other
Intervention description(s): The measurement will start in the area about 2 cm proximal to the greater trochanter and will stop slightly below the tip of the prosthesis. This is the baseline scan and will be carried out twice with the patient lying on the table, but with movement between each scan. This is done to calculate the CV, Coefficient of Variation. We will use the formula from Wilkinson and associates, where delta is standard deviations (SD) of the difference between the two BMD measurements for each patient. BMD has been measured at baseline, 3 and 12 months. A DXA scan is now planned at 60 months. Changes in BMD related to the 7 Gruen zones will be registered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science