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documents/10.1001_jama.2016.20939/protocol.html +13 -13
documents/10.1001_jama.2016.20939/protocol.lines.json +0 -0
documents/10.1001_jama.2016.20939/protocol_mmd.zip +1 -1
documents/10.1001_jama.2016.20939/protocol_tex.zip +1 -1
documents/10.1001_jama.2016.20939/sap.html +4 -4
documents/10.1001_jama.2016.20939/sap.lines.json +0 -0
documents/10.1001_jama.2016.20939/sap_mmd.zip +2 -2
documents/10.1001_jama.2016.20939/sap_tex.zip +2 -2

documents/10.1001_jama.2016.20939/protocol.html CHANGED Viewed

@@ -2,7 +2,7 @@
 <html lang="en-US">
 <head>
     <meta charset="UTF-8">
-    <title>4b95529e-2753-4538-9c69-4188fb0ca56e</title>
     <meta name="viewport" content="width=device-width, initial-scale=1">
     <link rel="stylesheet" href="https://cdn.mathpix.com/fonts/cmu.css"/>
     <style>html,body {
@@ -1238,17 +1238,17 @@ during routine clinic follow-up or via phone call for time to first recurrence,
 B) Schema</div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="enrollment">
 Enrollment</h2>
-<div><figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-09.jpg?height=197&amp;width=115&amp;top_left_y=631&amp;top_left_x=1007" alt="" data-align="center"></figure></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="randomization">
 Randomization</h2>
 <div>Stratified by major chemotherapy type and center<br>
-<figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-09.jpg?height=171&amp;width=106&amp;top_left_y=992&amp;top_left_x=769" alt="" data-align="center"></figure></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="paxman-scalp-cooling-system">
 Paxman Scalp Cooling System</h2>
-<div><figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-09.jpg?height=177&amp;width=121&amp;top_left_y=1364&amp;top_left_x=571" alt="" data-align="center"></figure></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="no-scalp-cooling">
 No Scalp Cooling</h2>
-<div><figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-09.jpg?height=173&amp;width=108&amp;top_left_y=1366&amp;top_left_x=1366" alt="" data-align="center"></figure></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="assessment">
 Assessment</h2>
 <ul>
@@ -2689,9 +2689,9 @@ The Orbis Scalp Cooler is composed of the following components:</div>
 Main Unit</h2>
 <div>This comprises a plastic-fronted, coated steel cabinet which contains the refrigeration unit, coolant tank, recirculation pump, mains power and fuse block, microprocessor control unit; a touch-screen user interface is built in to the plastic front cover of the unit. The back of the unit features the mains power inlet, mains power and recirculation on/off switches, a sight glass for visualizing the level of liquid coolant in the coolant tank and a capped top-up port for addition of liquid coolant. The unit is fitted with 4 swivel castors - one on each corner of its base - to provide for unit mobility; it also has a lifting handle on each side to enable the unit to be lifted over obstacles (should this be required). The two castors at the front of the unit feature a foot-operated brake mechanism to allow the unit to be secured in position prior to its use. The unit also features a height-adjustable, stainless steel support arm for the coolant lines.</div>
 <div class="table" number="1">
-<div class="caption_figure">Figure 1: Photograph of front aspect of Orbis Scalp Cooler model Orbis 2</div><div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-58.jpg?height=1872&width=1803&top_left_y=438&top_left_x=150" alt="" style="max-width: 100%;"/></div></div>
 <div class="table" number="2">
-<div class="caption_figure">Figure 2: Photograph of rear aspect of Orbis Scalp Cooler model Orbis 2</div><div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-59.jpg?height=2049&width=1874&top_left_y=474&top_left_x=92" alt="" style="max-width: 100%;"/></div></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="physical-characteristics%3A">
 Physical characteristics:</h2>
 <div>Height: 25.2 inches<br>
@@ -2754,7 +2754,7 @@ The cooling caps are supplied with integral outward and return cooling lines com
 male and one female quick release coupling, for connection to the corresponding connectors on the outward and return coolant lines.</div>
 <div>The silicone cap is supplied non-sterile and is reusable.</div>
 <div class="table" number="3">
-<div class="caption_figure">Figure 3: Photograph of Orbis Scalp Cooler Cooling Caps</div><div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-62.jpg?height=716&width=1380&top_left_y=552&top_left_x=569" alt="" style="max-width: 100%;"/></div></div>
 <div>Speedfit quick<br>
 release<br>
 couplings</div>
@@ -2774,7 +2774,7 @@ Software Configuration</h2>
 <div>The software within the touch screen controller unit is written in C Programming language and serves three functions:<br>
 a) the touch screen displays a menu-driven, graphical user interface (GUI) which provides information to the user concerning the operational status of the scalp cooling unit; it also prompts the user to initiate certain actions relating to the scalp cooling procedure and provides a timer count-down function (for scalp cooling sessions). The software GUI does not, however, directly control the scalp cooling process. An example of the GUI home screen (system powered on and at operating temperature but recirculation pump not yet switched on) is shown in figure 4.</div>
 <div class="table" number="4">
-<div class="caption_figure">Figure 4: Photograph of Orbis Scalp Cooler Touch Screen Displaying GUI</div><div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-63.jpg?height=603&width=826&top_left_y=1022&top_left_x=657" alt="" style="max-width: 100%;"/></div></div>
 <div>b) the software monitors the temperature of the coolant in the coolant reservoir, interpreting an incoming resistance signal from the temperature probe in the coolant tank using a standard mathematical algorithm which accounts for nonlinearity of the probe over a known temperature range. The software also electronically switches the compressor on or off in response to the measured temperature, when pre-set upper and lower temperature limits ( <span class="math-inline ">
 <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="5.599ex" height="1.781ex" role="img" focusable="false" viewBox="0 -705 2474.6 787"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2212" d="M84 237T84 250T98 270H679Q694 262 694 250T679 230H98Q84 237 84 250Z"></path></g><g data-mml-node="msup" transform="translate(778,0)"><g data-mml-node="mn"><path data-c="35" d="M164 157Q164 133 148 117T109 101H102Q148 22 224 22Q294 22 326 82Q345 115 345 210Q345 313 318 349Q292 382 260 382H254Q176 382 136 314Q132 307 129 306T114 304Q97 304 95 310Q93 314 93 485V614Q93 664 98 664Q100 666 102 666Q103 666 123 658T178 642T253 634Q324 634 389 662Q397 666 402 666Q410 666 410 648V635Q328 538 205 538Q174 538 149 544L139 546V374Q158 388 169 396T205 412T256 420Q337 420 393 355T449 201Q449 109 385 44T229 -22Q148 -22 99 32T50 154Q50 178 61 192T84 210T107 214Q132 214 148 197T164 157Z"></path></g><g data-mml-node="TeXAtom" transform="translate(533,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mo"><path data-c="2218" d="M55 251Q55 328 112 386T249 444T386 388T444 249Q444 171 388 113T250 55Q170 55 113 112T55 251ZM245 403Q188 403 142 361T96 250Q96 183 141 140T250 96Q284 96 313 109T354 135T375 160Q403 197 403 250Q403 313 360 358T245 403Z"></path></g></g></g><g data-mml-node="mi" transform="translate(1714.6,0)"><path data-c="1D436" d="M50 252Q50 367 117 473T286 641T490 704Q580 704 633 653Q642 643 648 636T656 626L657 623Q660 623 684 649Q691 655 699 663T715 679T725 690L740 705H746Q760 705 760 698Q760 694 728 561Q692 422 692 421Q690 416 687 415T669 413H653Q647 419 647 422Q647 423 648 429T650 449T651 481Q651 552 619 605T510 659Q484 659 454 652T382 628T299 572T226 479Q194 422 175 346T156 222Q156 108 232 58Q280 24 350 24Q441 24 512 92T606 240Q610 253 612 255T628 257Q648 257 648 248Q648 243 647 239Q618 132 523 55T319 -22Q206 -22 128 53T50 252Z"></path></g></g></g></svg></mjx-container></span> and <span class="math-inline ">
 <mjx-container class="MathJax" jax="SVG"><svg style="vertical-align: -0.186ex;" xmlns="http://www.w3.org/2000/svg" width="5.599ex" height="1.781ex" role="img" focusable="false" viewBox="0 -705 2474.6 787"><g stroke="currentColor" fill="currentColor" stroke-width="0" transform="scale(1,-1)"><g data-mml-node="math"><g data-mml-node="mo"><path data-c="2212" d="M84 237T84 250T98 270H679Q694 262 694 250T679 230H98Q84 237 84 250Z"></path></g><g data-mml-node="msup" transform="translate(778,0)"><g data-mml-node="mn"><path data-c="34" d="M462 0Q444 3 333 3Q217 3 199 0H190V46H221Q241 46 248 46T265 48T279 53T286 61Q287 63 287 115V165H28V211L179 442Q332 674 334 675Q336 677 355 677H373L379 671V211H471V165H379V114Q379 73 379 66T385 54Q393 47 442 46H471V0H462ZM293 211V545L74 212L183 211H293Z"></path></g><g data-mml-node="TeXAtom" transform="translate(533,363) scale(0.707)" data-mjx-texclass="ORD"><g data-mml-node="mo"><path data-c="2218" d="M55 251Q55 328 112 386T249 444T386 388T444 249Q444 171 388 113T250 55Q170 55 113 112T55 251ZM245 403Q188 403 142 361T96 250Q96 183 141 140T250 96Q284 96 313 109T354 135T375 160Q403 197 403 250Q403 313 360 358T245 403Z"></path></g></g></g><g data-mml-node="mi" transform="translate(1714.6,0)"><path data-c="1D436" d="M50 252Q50 367 117 473T286 641T490 704Q580 704 633 653Q642 643 648 636T656 626L657 623Q660 623 684 649Q691 655 699 663T715 679T725 690L740 705H746Q760 705 760 698Q760 694 728 561Q692 422 692 421Q690 416 687 415T669 413H653Q647 419 647 422Q647 423 648 429T650 449T651 481Q651 552 619 605T510 659Q484 659 454 652T382 628T299 572T226 479Q194 422 175 346T156 222Q156 108 232 58Q280 24 350 24Q441 24 512 92T606 240Q610 253 612 255T628 257Q648 257 648 248Q648 243 647 239Q618 132 523 55T319 -22Q206 -22 128 53T50 252Z"></path></g></g></g></svg></mjx-container></span> ) are recorded. The software also monitors the flow rate of the liquid coolant returning to the coolant tank via signals received from turbines placed in the coolant return tube;<br>
@@ -2854,7 +2854,7 @@ EORTC QLQ-C30 (version 3)</h2>
 <td style="text-align: center; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom: none !important; border-top: none !important; border-top-style: solid !important; border-top-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; " colspan="4"></td>
 </tr>
 <tr style="border-top: none !important; border-bottom: none !important;">
-<td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom: none !important; border-top: none !important; width: auto; border-bottom-style: solid !important; border-bottom-width: 1px !important; " rowspan="2"><figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-70.jpg?height=33&amp;width=39&amp;top_left_y=805&amp;top_left_x=275" alt="" data-align="center"></figure></td>
 <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Not at All</td>
 <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">A Little</td>
 <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">Quite a Bit</td>
@@ -2888,7 +2888,7 @@ EORTC QLQ-C30 (version 3)</h2>
 <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">4</td>
 </tr>
 <tr style="border-top: none !important; border-bottom: none !important;">
-<td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; "><figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-70.jpg?height=110&amp;width=813&amp;top_left_y=1138&amp;top_left_x=279" alt="" data-align="center"></figure></td>
 <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">1</td>
 <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">2</td>
 <td style="text-align: left; border-right-style: solid !important; border-right-width: 1px !important; border-bottom-style: solid !important; border-bottom-width: 1px !important; border-top: none !important; width: auto; vertical-align: middle; ">3</td>
@@ -3091,11 +3091,11 @@ For the following questions please circle the number between 1 and 7 that best a
 6</li>
 </ol>
 <div>Very poor<br>
-<figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-71.jpg?height=463&amp;width=463&amp;top_left_y=1700&amp;top_left_x=1254" alt="" data-align="center"></figure></div>
 <div>Very poor<br>
 Excellent<br>
 © Copyright 1995 EORTC Quality of Life Group. All rights reserved. Version 3.0<br>
-<figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/4b95529e-2753-4538-9c69-4188fb0ca56e-71.jpg?height=112&amp;width=117&amp;top_left_y=2331&amp;top_left_x=285" alt="" data-align="center"></figure></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="hospital-anxiety-and-depression-scale-(hads)">
 Hospital Anxiety and Depression Scale (HADS)</h2>
 <div>Tick the box beside the reply that is closest to how you have been feeling in the past week.<br>

 <html lang="en-US">
 <head>
     <meta charset="UTF-8">
+    <title>2ba50e9e-afe4-4227-92ef-99d5f23d6e0b</title>
     <meta name="viewport" content="width=device-width, initial-scale=1">
     <link rel="stylesheet" href="https://cdn.mathpix.com/fonts/cmu.css"/>
     <style>html,body {
 B) Schema</div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="enrollment">
 Enrollment</h2>
+<div><figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/2ba50e9e-afe4-4227-92ef-99d5f23d6e0b-09.jpg?height=197&amp;width=115&amp;top_left_y=631&amp;top_left_x=1007" alt="" data-align="center"></figure></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="randomization">
 Randomization</h2>
 <div>Stratified by major chemotherapy type and center<br>
+<figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/2ba50e9e-afe4-4227-92ef-99d5f23d6e0b-09.jpg?height=171&amp;width=106&amp;top_left_y=992&amp;top_left_x=769" alt="" data-align="center"></figure></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="paxman-scalp-cooling-system">
 Paxman Scalp Cooling System</h2>
+<div><figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/2ba50e9e-afe4-4227-92ef-99d5f23d6e0b-09.jpg?height=177&amp;width=121&amp;top_left_y=1364&amp;top_left_x=571" alt="" data-align="center"></figure></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="no-scalp-cooling">
 No Scalp Cooling</h2>
+<div><figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/2ba50e9e-afe4-4227-92ef-99d5f23d6e0b-09.jpg?height=173&amp;width=108&amp;top_left_y=1366&amp;top_left_x=1366" alt="" data-align="center"></figure></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="assessment">
 Assessment</h2>
 <ul>
 Main Unit</h2>
 <div>This comprises a plastic-fronted, coated steel cabinet which contains the refrigeration unit, coolant tank, recirculation pump, mains power and fuse block, microprocessor control unit; a touch-screen user interface is built in to the plastic front cover of the unit. The back of the unit features the mains power inlet, mains power and recirculation on/off switches, a sight glass for visualizing the level of liquid coolant in the coolant tank and a capped top-up port for addition of liquid coolant. The unit is fitted with 4 swivel castors - one on each corner of its base - to provide for unit mobility; it also has a lifting handle on each side to enable the unit to be lifted over obstacles (should this be required). The two castors at the front of the unit feature a foot-operated brake mechanism to allow the unit to be secured in position prior to its use. The unit also features a height-adjustable, stainless steel support arm for the coolant lines.</div>
 <div class="table" number="1">
+<div class="caption_figure">Figure 1: Photograph of front aspect of Orbis Scalp Cooler model Orbis 2</div><div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/2ba50e9e-afe4-4227-92ef-99d5f23d6e0b-58.jpg?height=1872&width=1803&top_left_y=438&top_left_x=150" alt="" style="max-width: 100%;"/></div></div>
 <div class="table" number="2">
+<div class="caption_figure">Figure 2: Photograph of rear aspect of Orbis Scalp Cooler model Orbis 2</div><div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/2ba50e9e-afe4-4227-92ef-99d5f23d6e0b-59.jpg?height=2049&width=1874&top_left_y=474&top_left_x=92" alt="" style="max-width: 100%;"/></div></div>
 <h2 type="section" data-unnumbered="true" class="section-title" id="physical-characteristics%3A">
 Physical characteristics:</h2>
 <div>Height: 25.2 inches<br>
 male and one female quick release coupling, for connection to the corresponding connectors on the outward and return coolant lines.</div>
 <div>The silicone cap is supplied non-sterile and is reusable.</div>
 <div class="table" number="3">
+<div class="caption_figure">Figure 3: Photograph of Orbis Scalp Cooler Cooling Caps</div><div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/2ba50e9e-afe4-4227-92ef-99d5f23d6e0b-62.jpg?height=716&width=1380&top_left_y=552&top_left_x=569" alt="" style="max-width: 100%;"/></div></div>
 <div>Speedfit quick<br>
 release<br>
 couplings</div>
 <div>The software within the touch screen controller unit is written in C Programming language and serves three functions:<br>
 a) the touch screen displays a menu-driven, graphical user interface (GUI) which provides information to the user concerning the operational status of the scalp cooling unit; it also prompts the user to initiate certain actions relating to the scalp cooling procedure and provides a timer count-down function (for scalp cooling sessions). The software GUI does not, however, directly control the scalp cooling process. An example of the GUI home screen (system powered on and at operating temperature but recirculation pump not yet switched on) is shown in figure 4.</div>
 <div class="table" number="4">
+<div class="caption_figure">Figure 4: Photograph of Orbis Scalp Cooler Touch Screen Displaying GUI</div><div class="figure_img" style="text-align: center;"><img src="https://cdn.mathpix.com/cropped/2ba50e9e-afe4-4227-92ef-99d5f23d6e0b-63.jpg?height=603&width=826&top_left_y=1022&top_left_x=657" alt="" style="max-width: 100%;"/></div></div>
 <div>b) the software monitors the temperature of the coolant in the coolant reservoir, interpreting an incoming resistance signal from the temperature probe in the coolant tank using a standard mathematical algorithm which accounts for nonlinearity of the probe over a known temperature range. The software also electronically switches the compressor on or off in response to the measured temperature, when pre-set upper and lower temperature limits ( <span class="math-inline ">
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+<td style="text-align: left; border-left-style: solid !important; border-left-width: 1px !important; border-right-style: solid !important; border-right-width: 1px !important; border-bottom: none !important; border-top: none !important; width: auto; border-bottom-style: solid !important; border-bottom-width: 1px !important; " rowspan="2"><figure style="text-align: center"><img src="https://cdn.mathpix.com/cropped/2ba50e9e-afe4-4227-92ef-99d5f23d6e0b-70.jpg?height=33&amp;width=39&amp;top_left_y=805&amp;top_left_x=275" alt="" data-align="center"></figure></td>
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 <div>Very poor<br>
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 <div>Very poor<br>
 Excellent<br>
 © Copyright 1995 EORTC Quality of Life Group. All rights reserved. Version 3.0<br>
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 <h2 type="section" data-unnumbered="true" class="section-title" id="hospital-anxiety-and-depression-scale-(hads)">
 Hospital Anxiety and Depression Scale (HADS)</h2>
 <div>Tick the box beside the reply that is closest to how you have been feeling in the past week.<br>

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