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Sample translations submitted: 1
English to Swahili: Treatment process General field: Medical Detailed field: Medical: Health Care
Source text - English Treatment Period: Continuous Administration of ARQ 087
During Cycle 1, you will be seen by your Study Doctor weekly, and starting with Cycle 2 you will have bi-weekly office visits.
Cycle 1, Week 1, Day 1
• A review of your current medications and how you have been feeling since your last visit
• A physical examination, including mucous membrane and skin
• Vital signs (temperature, blood pressure, respiration rate and pulse)
• An assessment of your physical condition and ability to function will be documented
• A sample of your fasting blood will be drawn for routine blood tests
• Samples of your blood (approximately 1-2 teaspoons each) will also be drawn for tumor marker evaluation
• Eight samples of your blood (approximately 1-2 teaspoons each) will be drawn for pharmacokinetic analysis. Blood will be drawn once before the first dose of ARQ 087 and then at 1, 2, 4, 6, 8, 10, and 12 hours after the morning dose of study drug
• A sample of your blood will be collected for pharmacodynamic (PD) assessment prior to your first dose of ARQ 087. (PD testing is used to look at how the study drug may affect proteins involved in tumor development and progression.)
• A urine sample will be collected for a urinalysis
• A 12-lead ECG will be performed
• You will receive a weekly supply of ARQ 087. You will be asked to bring any unused study drug to your next study visit
Cycle 1, Week 2 (Day 8; ±3 days)
• A review of your current medications and how you have been feeling since your last visit
• A physical examination, including mucous membrane and skin
• Vital signs (temperature, blood pressure, respiration rate and pulse)
• An assessment of your physical condition and ability to function will be documented
• A sample of your fasting blood will be drawn for routine blood tests
• Samples of your blood (approximately 1-2 teaspoons each) will also be drawn for pharmacokinetic and pharmacodynamic analyses
• You will receive a weekly supply of ARQ 087. You will be asked to bring any unused study drug to your next study visit
Cycle 1, Week 3 (Day 15; ±3 days)
• A review of your current medications and how you have been feeling since your last visit
• A physical examination, including mucous membrane and skin
• Vital signs (temperature, blood pressure, respiration rate and pulse)
• An assessment of your physical condition and ability to function will be documented
• A sample of your fasting blood will be drawn for routine blood tests
• A urine sample will be collected for a urinalysis
• A 12-lead ECG will be performed
• Samples of your blood (approximately 1-2 teaspoons each) will also be drawn for pharmacokinetic and pharmacodynamic analyses
• You will receive a weekly supply of ARQ 087. You will be asked to bring any unused study drug to your next study visit
Cycle 1, Week 4 (Day 22; ±3 days)
• A review of your current medications and how you have been feeling since your last visit
• A physical examination, including mucous membrane and skin
• Vital signs (temperature, blood pressure, respiration rate and pulse)
• An assessment of your physical condition and ability to function will be documented
• A sample of your fasting blood will be drawn for routine blood tests
• A sample of your blood (approximately 1 teaspoon) will also be drawn for pharmacodynamic analysis
• Eight samples of your blood (approximately 1-2 teaspoons each) will also be drawn for pharmacokinetic analysis. Blood will be drawn once before ARQ 087 administration and then at 1, 2, 4, 6, 8, 10 and 12 hours after the morning dose of study drug
• You will receive a weekly supply of ARQ 087. You will be asked to bring any unused study drug to your next study visit
• If you are eligible and depending on the cohort you are enrolled in, a tumor biopsy may be performed
Cycle 1, Week 4 (Day 23)
• A review of your current medications and how you have been feeling since your last visit
• Vital signs (temperature, blood pressure, respiration rate and pulse)
• A blood sample for pharmacokinetic analysis (approximately 1 teaspoon) will be drawn before ARQ 087 administration
Cycle 2 and All Additional Cycles, Week 1, Day 1 (±3 days; Bi-Weekly Visits, Each Cycle is 4 weeks)
• A review of your current medications and how you have been feeling since your last visit
• A physical examination, including mucous membrane and skin
• Vital signs (weight, temperature, blood pressure, respiration rate and pulse)
• An assessment of your physical condition and ability to function will be documented
• A sample of your fasting blood will be drawn for routine blood tests
• Samples of your blood (approximately 1 teaspoons each) will also be drawn for tumor marker evaluation
• A blood sample for pharmacokinetic analysis (approximately 1 teaspoon) will be drawn before ARQ 087 administration
• A sample of your blood will be collected for pharmacodynamics assessment at C2D1, C3D1, C4D1 and C5D1
• A urine sample will be collected for a urinalysis
• A 12-lead ECG will be performed
• During the treatment period, the changes in the size of your tumor will be assessed by means of a CT, PET, or MRI every 8 weeks (e.g., Cycle 3 Week 1, Cycle 5 Week 1) or as clinically indicated
• If indicated, an echocardiography or MUGA scan will be performed every 8-12 weeks (e.g., Cycle 3 Week 1, Cycle 6 Week 1, Cycle 9 Day 1)
• You will receive a two-week supply of ARQ 087. You will be asked to bring any unused study drug to your next study visit
Cycle 2 and All Additional Cycles, Week 3, Day 15 (±3 days)
• A review of your current medications and how you have been feeling since your last visit
• A physical examination, including mucous membrane and skin
• Vital signs (temperature, blood pressure, respiration rate and pulse)
• An assessment of your physical condition and ability to function will be documented
• A sample of your fasting blood will be drawn for routine blood tests
• A blood sample for pharmacokinetic analysis (approximately 1 teaspoon) will be drawn before ARQ 087 administration
• You will receive a two-week supply of ARQ 087. You will be asked to bring any unused study drug to your next study visit
End of Study Treatment
The following procedures will be performed approximately 7 days after your last dose of study drug:
• A review of your current medications and how you have been feeling since your last visit
• A physical examination, including mucous membrane and skin
• Vital signs (weight, temperature, blood pressure, respiration rate and pulse)
• An assessment of your physical condition and ability to function will be documented
• A sample of your fasting blood (approximately 2 teaspoons) will be drawn for routine blood tests
• Samples of your blood (approximately 1-2 teaspoons each) will also be drawn for pharmacokinetic, pharmacodynamics, and tumor marker evaluation
• A urine sample will be collected for a urinalysis
• If you are a female subject capable of having children, some blood (approximately 1 teaspoon) will be tested to determine if you are pregnant
• A 12-lead ECG will be performed
• A CT, PET, or MRI scan will be performed to measure your tumor unless it was done within 4 weeks prior to the end of study treatment visit
• If indicated, an echocardiography or MUGA scan will be performed
• You will need to return all study drug containers and capsules in them back to the study staff
Safety Follow-Up
Approximately 30 days after the end of your treatment, you will be contacted and asked how you are doing. This is done to collect information that may help the study to be more valuable in assessing ARQ 087 as a potential cancer treatment.
As a participant, your responsibilities include:
• Follow the instructions of the Study Doctor and study staff
• Provide truthful information about your medical history, current conditions, and any medications you have taken or plan to take
• Inform the Study Doctor if you have been in a research study in the last 30 days or are in another research study now
• Tell the Study Doctor about any problems you have during the study
• Take the study drug as directed by the Study Doctor and study staff
• Immediately tell the study staff about any side effects, doctor visits, or hospital visits
• Follow instructions and come in for agreed upon visits. If it is necessary to miss an appointment, please contact the Study Doctor or research study staff to reschedule as soon as you know you will miss the appointment
• Tell the Study Doctor or research staff if you believe you might be pregnant or gotten your partner pregnant
• Keep the study drug in a safe place, away from children, and for your use only
• Ask questions as you think of them
• Tell the Study Doctor or research staff if you change your mind about staying in the study
While participating in this research study, you should not take part in any other research project without approval from the Study Doctor of each study. This is to protect you from possible injury arising from such things as extra blood drawing, extra radiological tests, the possible interaction(s) of research drugs, or other similar hazards.
There may be additional blood draws throughout this study required for safety purposes; these will be considered “standard of care”, for medical care and evaluation, and not for research purposes.
RISKS AND DISCOMFORTS
There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Study Doctor if you have any questions.
Side effects of ARQ 087 may include, but are not limited to the following symptoms:
• Loss of appetite
• Weight loss
• Gastrointestinal effects such as mucositis, nausea, vomiting, diarrhea, constipation, esophageal and stomach ulcers, taste changes, indigestion, gastroesophageal reflux disease, and dry mouth
• Changes in red and/or white blood cell count
• Changes in electrolyte levels
• Changes in liver function tests
• Changes in blood glucose levels
• Sensitivity to ultraviolet light sunlight (phototoxicity)
• Fatigue
• Rash
• Dry skin
• Abnormal Electrocardiogram (ECG)
Translation - Swahili Kipindi cha Utabibu:Unywaji Mfululizo wa ARQ 087
Wakati wa duara la 1,utaangaliwa na Daktari wako wa Utafiti kila wiki, na kuanzia duara la 2 utakuwa ukitembelea ofisi yake mara mbili kwa wiki.
Duara la 1, Wiki ya 1, Siku ya 1
• Ukaguzi wa dawa zako za hivi karibuni na jinsi unavyoendelea kuhisi tangu utembee
• Kukaguliwa afya, ikijumuisha utando telezi na ngozi
• Dalili Muhimu (joto, upigaji wa damu, kiasi cha upumuaji na pigo la moyo)
• Kuangaliwa kwa hali yako ya afya na uwezo wa kufanya kazi zitahifadhiwa
• Sampuli ya damu yako inayofunga itatolewa kwa vipimo vya mara kwa mara vya damu
• Sampuli za damu yako (Kiasi cha kijiko 1-2 kila moja) zitatolewa pia kwa ajili ya tathmini ya maki ya uvimbe
• Sampuli nane za damu yako (kiasi cha kijiko 1-2 kila moja) zitatolewa kwa uchambuzi wa famakokainetiki. Damu itatolewa mara moja kabla ya kupewa dawa ya ARQ 087 na kisha katika lisaa la 1, 2, 4, 6, 8, 10, na 12 baada ya kunywa dawa ya utafiti asubuhi
• Sampuli ya damu yako itachukuliwa kwa kuangaliwa famakodainamiki (PD) ukikaribia kunywa dawa yako ya kwanza ya ARQ 087. (Kipimo cha PD kinatumiwa kuangalia jinsi dawa ya utafiti inaweza kuathiri proteni zinazohusishwa katika ustawi na uendeleaji wa uvimbe.)
• Sampuli ya mkojo itachukuliwa kwa uchambuzi wa mkojo.
• ECG-12 itafanywa
• Utapokea ugavi wa ARQ 087 kila wiki. Utaulizwa kuleta dawa yoyote ya utafiti isiyotumika kwa siku ya utafiti inayofuatia
Duara la 1, Wiki ya 2 (Siku ya 8; ± siku 3)
• Ukaguzi wa dawa zako za hivi karibuni na jinsi unavyoendelea kuhisi tangu utembee
• Kukaguliwa afya, ikijumuisha utando telezi na ngozi
• Dalili muhimu (joto, upigaji wa damu, kiasi cha upumuaji na pigo la moyo)
• Kuangaliwa kwa hali yako ya afya na uwezo wa kufanya kazi zitahifadhiwa
• Sampuli ya damu yako inayofunga itatolewa kwa vipimo vya mara kwa mara vya damu
• Sampuli za damu yako (kiasi cha kijiko 1-2 kila moja) zitatolewa pia kwa uchambuzi wa famakokainetiki na famakodainamiki
• Utapokea ugavi wa ARQ 087 kila wiki. Utaulizwa kuleta dawa yoyote ya utafiti isiyotumika kwa siku ya utafiti inayofuatia
Duara la 1, Wiki ya 3 (Siku ya 15 ±siku 3
• Ukaguzi wa dawa zako za hivi karibuni na jinsi unavyoendelea kuhisi tangu utembee
• Kukaguliwa afya, ikijumuisha utando telezi na ngozi
• Dalili muhimu (joto, upigaji wa damu, kiasi cha upumuaji na pigo la moyo)
• Kuangaliwa kwa hali yako ya afya na uwezo wa kufanya kazi zitahifadhiwa
• Sampuli ya damu yako inayofunga itatolewa kwa vipimo vya mara kwa mara vya damu
• Sampuli ya mkojo itachukuliwa kwa uchambuzi wa mkojo.
• ECG-12 itafanywa
• Sampuli za damu yako (kiasi cha kijiko 1-2 kila moja) zitatolewa pia kwa uchambuzi wa famakokainetiki na famakodainamiki
• Utapokea ugavi wa ARQ 087 kila wiki. Utaulizwa kuleta dawa yoyote ya utafiti isiyotumika kwa siku ya utafiti inayofuatia
Duara la 1, Wiki ya 4 (Siku ya 22; ±siku 3
• Ukaguzi wa dawa zako za hivi karibuni na jinsi unavyoendelea kuhisi tangu utembee
• Kukaguliwa afya, ikijumuisha utando telezi na ngozi
• Dalili muhimu (joto, upigaji wa damu, kiasi cha upumuaji na pigo la moyo)
• Kuangaliwa kwa hali yako ya afya na uwezo wa kufanya kazi zitahifadhiwa
• Sampuli ya damu yako inayofunga itatolewa kwa vipimo vya mara kwa mara vya damu
• Sampuli ya damu yako (kiasi cha kijiko 1) itatolewa kwa uchambuzi wa famakodainamiki
• Sampuli nane za damu yako (kiasi cha kijiko 1-2 kila moja) pia zitatolewa kwa uchambuzi wa famakokainetiki. Damu itatolewa mara moja kabla ya unywaji wa ARQ 087 na kisha katika lisaa la 1, 2, 4, 6, 8, 10 na 12 baada ya dawa ya utafiti ya asubuhi
• Utapokea ugavi wa ARQ 087 kila wiki. Utaulizwa kuleta dawa yoyote ya utafiti isiyotumika kwa siku ya utafiti inayofuatia
• Ikiwa unaweza na unategemea kundi la watu mliofungamana, bayopsi ya uvimbe inaweza kufanywa
Duara la 1, Wiki ya 4 (Siku ya 23)
• Ukaguzi wa dawa zako za hivi karibuni na jinsi unavyoendelea kuhisi tangu utembee
• Dalili muhimu (joto, upigaji wa damu, kiasi cha upumuaji na pigo la moyo)
• Sampuli ya damu kwa uchambuzi wa famakokainetiki (kiasi cha kijiko 1) itatolewa kabla ya unywaji wa ARQ 087
Duara la 2 na Miduara Yote ya Ziada, Wiki ya 1, Siku ya 1 (±siku 3; Kutembea Mara Mbili kwa Wiki, Kila Duara ni Wiki 4)
• Ukaguzi wa dawa zako za hivi karibuni na jinsi unavyoendelea kuhisi tangu utembee
• Kukaguliwa afya, ikijumuisha utando telezi na ngozi
• Dalili muhimu (uzito, joto, upigaji wa damu, kiasi cha upumuaji na pigo la moyo)
• Kuangaliwa kwa hali yako ya afya na uwezo wa kufanya kazi zitahifadhiwa
• Sampuli ya damu yako inayofunga itatolewa kwa vipimo vya mara kwa mara vya damu
• Sampuli za damu yako (kiasi cha kijiko 1 kila moja) zitatolewa kwa tathmini ya maki ya uvimbe
• Sampuli ya damu kwa uchambuzi wa famakokainetiki (kiasi cha kijiko 1) itatolewa kabla ya unywaji wa ARQ 087
• Sampuli ya damu yako itachukuliwa kwa uangalizi wa famakodainamiki katika C2D1, C3D1, C4D1 na C5D1
• Sampuli ya mkojo itachukuliwa kwa uchambuzi wa mkojo.
• ECG-12 itafanywa
• Wakati wa kipindi cha utabibu, mabadiliko katika ukubwa wa uvimbe wako utaangaliwa kwa njia ya CT, PET, au MRI kila baada ya wiki 8 (k.m., Duara la 3 Wiki ya 1, Duara la 5 Wiki ya 1) au kama vile imeandika kikliniki
• Ikiwa imeandikwa, ekokardiografia au changanuo la MUGA litafanywa kila baada ya wiki 8-12 (k.m, Duara la 3 Wiki ya 1, Duara la 6 Wiki ya 1, Duara la 9 Siku ya 1)
• Utapokea ugavi wa ARQ 087 kwa wiki mbili. Utaulizwa kuleta dawa yoyote ya utafiti isiyotumika kwa siku ya utafiti inayofuatia
Duara la 2 na Miduara Yote ya Ziada, Wiki ya 3, Siku ya 15 (±siku 3)
• Ukaguzi wa dawa zako za hivi karibuni na jinsi unavyoendelea kuhisi tangu utembee
• Kukaguliwa afya, ikijumuisha utando telezi na ngozi
• Dalili muhimu (joto, upigaji wa damu, kiasi cha upumuaji na pigo la moyo)
• Kuangaliwa kwa hali yako ya afya na uwezo wa kufanya kazi zitahifadhiwa
• Sampuli ya damu yako inayofunga itatolewa kwa vipimo vya mara kwa mara vya damu
• Sampuli ya damu kwa uchambuzi wa famakokainetiki (kiasi cha kijiko 1) itatolewa kabla ya unywaji wa ARQ 087
• Utapokea ugavi wa ARQ 087 kwa wiki mbili. Utaulizwa kuleta dawa yoyote ya utafiti isiyotumika kwa siku ya utafiti inayofuatia
Mwisho wa Utabibu wa Utafiti
Taratibu zinazofuatia zitafanywa kiasi cha siku 7 baada ya kunywa dawa ya mwisho ya utafiti:
• Ukaguzi wa dawa zako za hivi karibuni na jinsi unavyoendelea kuhisi tangu utembee
• Kukaguliwa afya, ikijumuisha utando telezi na ngozi
• Dalili muhimu (uzito, joto, upigaji wa damu, kiasi cha upumuaji na pigo la moyo)
• Kuangaliwa kwa hali yako ya afya na uwezo wa kufanya kazi zitahifadhiwa
• Sampuli ya damu yako inayofunga (kiasi cha vijiko 2) itatolewa kwa vipimo vya mara kwa mara vya damu
• Sampuli za damu yako (kiasi cha kijiko 1-2 kila moja) pia zitatolewa kwa uchambuzi wa famakokainetiki, famakodainamiki, na tathmini ya maki ya uvimbe
• Sampuli ya mkojo itachukuliwa kwa uchambuzi wa mkojo.
• Ikiwa wewe ni wa kike uliye na uwezo wa kuwa na watoto, baadhi ya damu (kiasi cha kijiko 1) itapimwa ili kutambua ikiwa wewe ni mja mzito.
• ECG-12 itafanywa
• Changanuo la CT, PET, au MRI itafanywa ili kupima uvimbe wako iwapo haikufanywa katikati ya wiki 4 ikikaribia kuangaliwa kwa mwisho kwa utabibu wa utafiti
• Ikiwa imeandikwa. ekokardiografia au changanuo la MUGA itafanywa
• Utahitajika kurudisha chupa zote za dawa za utafiti na kapsuli zilizo ndani yake kwa wahudumu wa utafiti
Ufuatilizi wa Usalama
Kiasi cha siku 30 baada ya mwisho wa utabibu wako, utawasilianwa nawe na kuuliza jinsi unavyoendeelea. Hili ufanywa ili kukusanya habari inayoweza kusaidia utafiti kuwa wa umuhimu zaidi katika kuchunguza ARQ 087 kama utabibu unaoweza kuwa wa saratani.
Kama mhusika, wajibu wako unajumuisha:
• Fuata maagizo ya Daktari wa Utafiti na wahudumu wa utafiti
• Peana habari ya kweli kuhusu historia ya tiba yako, hali iliyopo, na dawa zozote ambazo umezitumia au unazopanga kuzitumia
• Mjulishe Daktari wa Utafiti ikiwa umekuwa katika utafiti katika siku 30 za mwisho au uko katika utafiti mwingine kwa sasa
• Mwambie Daktari wa Utafiti kuhusu shida zozote ulizo nazo wakati wa utafiti
• Kunywa dawa ya utafiti kama ilivyoelekezwa na Daktari wa Utafiti na wahudumu wa utafiti
• Waambie wahudumu wa utafiti kwa haraka kuhusu athari zozote, kutembelea daktari, au kutembelea hospitali
• Fuata maagizo na njoo kwa makubaliano ya kutembea. Ikiwa ni lazima ukose miadi, tafadhali wasiliana na Daktari wa Utafiti au wahudumu wa utafiti ili kupanga tena punde unapojua kuwa utakosa miadi
• Mwambie Daktari wa Utafiti au wahudumu wa utafiti ikiwa unaamini unaweza kuwa mja mzito au umemfanya mwenzio kuwa mja mzito
• Hifadhi dawa ya utafiti mahali salama, mbali na watoto, na kwa matumizi yako pekee
• Uliza maswali jinsi unavyoyafikiria
• Mwambie Daktari wa Utafiti au wahudumu wa utafiti ikiwa umebadilisha nia kuhusu kukaa katika utafiti
Ukiendelea kuhusika katika utafiti, haufai kuhusika katika mradi wowote mwingine wa utafiti bila idhini kutoka kwa Daktari wa Utafiti wa kila utafiti. Hii ni ili kukulinda kutokana na kuumia wezekano kunaotokana na mambo kama kutolewa damu zaidi, vipimo zaidi vya rediolojikia, ingiliano(maingiliano) wezekano ya dawa za utafiti, au madhara mengine kama hayo.
Kunaweza kuwa na kutolewa zaidi kwa damu katika utafiti huu wote inayotakikana kwa minajili ya usalama; hizi zitachukuliwa kama "Kiwango cha utunzaji," kwa tiba na tathmini, na sio kwa minajili ya utafiti.
HATARI NA KERO
Kuna hatari, kero, na taabu zinazohusiana na utafiti wowote. Hizi zinahitaji kufikiriwa kwa makini. Unafaa kuongea na Daktari wa Utafiti ikiwa una maswali yoyote.
Athari za ARQ 087 zinaweza kujumuisha, lakini hazipungui kwa ishara zifuatazo:
• Kukosa hamu ya kula
• Uzito kupungua
• Athari za matumbo kama vile miukosaitisi, kuzimia, kutapika, kuhara, kufunga choo, vidonda vya umio na tumbo, mabadiliko ya mionjo, kuvimbiwa, ugonjwa wa kurudisha chakula kwenye umio, na kinywa kilichokauka
• Kubadilika katika hesabu ya seli nyekundu na/au nyeupe za damu
• Kubadilika katika viwango vya elektroliti
• Kubadilika katika vipimo vya utendakazi wa ini
• Kubadilika katika viwango vya glukosi ya damu
• Mapokezi ya mwangaza wa urujuani (fototokzisiti)
• Uchovu
• Vipele
• Ngozi iliokauka
• Elektrokardiogramu isiyokawaida (ECG)
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Experienced Swahili Translator (close to a decade now) in Telecommunication, Medical, Social Sciences, Multimedia and Health. I have donated (as a volunteer) over 148,012 words to Translators Without Borders. My mantra is high quality translations at a very competitive rate.
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