Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic study of iron isomaltoside 1000 administered by 250 mg iv bolus injection or 500 mg intravenous infusion to patients with non-hematological malignancies associated with chemotherapy induced anaemia

Conditions: Patients With Chemotherapy Induced Anemia (CIA)

Summary: the purpose of this study is to assess pharmakokinetic properties of iron isomaltoside 1000 (monofer®) in doses of 250 mg and 500 mg in patients suffering from chemotherapy induced anemia.


Eligibility criteria:
inclusion criteria: 1. men and women, aged more than 18 years. 2. weight above 50 kg. 3. subjects diagnosed with non-hematological malignancies (solid tumors only) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles. 4. hb \< 12 g/dl. 5. tfs \<20%. 6. serum ferritin \<800 ng/ml. 7. an eastern cooperative oncology group (ecog) performance status of 0 to 2 8. willingness to participate after informed consent. exclusion criteria: 1. anaemia caused primarily by other factors than cia. 2. iv or oral iron treatment within 4 weeks prior to screening visit. 3. erythropoietin treatment within 4 weeks prior to screening visit. 4. blood transfusion within 4 weeks prior to screening visit. 5. imminent expectation of blood transfusion on part of treating physician. 6. iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis). 7. drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes). 8. known hypersensitivity to any excipients in the investigational drug products. 9. subjects with a history of multiple allergies. 10. decompensated liver cirrhosis and hepatitis (alanine aminotransferase (alat) \> 3 times upper normal limit). 11. history of immunocompromise and/or history of hepatitis b and/or c. 12. active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (wbc) and c-reactive protein (crp)). 13. rheumatoid arthritis with symptoms or signs of active joint inflammation. 14. pregnant or breast feeding women. 15. women of child bearing potential who are not using safe contraceptive methods (e.g. intrauterine device, oral contraceptives or surgically sterilized) or who are planning to become pregnant within the study period. 16. planned elective surgery during the study. 17. participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening. 18. untreated b12 or folate deficiency. 19. any other medical condition that, in the opinion of principal investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. example, uncontrolled hypertension, unstable ischemic heart disease or uncontrolled diabetes mellitus.

Keywords: anemia cancer cia
endoresection of the tumor scar or transpupillary thermotherapy for the treatment of large uveal melanomas (endoresection-laser)

Conditions: Uveal Melanoma; Melanoma, Uveal

Summary: study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation


Eligibility criteria:
inclusion criteria: * tumor of 7 mm of thickness or more * patients treated by proton beam therapy * patients aged at least 18 years * patients clearly informed of the study, having received the letter of information and signed the consent exclusion criteria: * massive extrascleral extension posterior to the equator * patients with metastasis at diagnosis. * patients with glaucoma before the radiation therapy * patients with opaque media preventing transpupillary thermotherapy * patients for whom follow up will be difficult due to geographical, social or psychological reasons
multidisciplinary care pathway with electronic patient reported outcomes (epro) post-operative follow-up of breast cancer surgery complications to optimize patient quality of life

Conditions: Breast Cancer

Summary: this project is a follow-on study of the beautify-2 study (nct04957186). the "beautify" (breast cancer quality of life after surgery) program was built by a committee of experts on the basis of reflections carried out within 2 focus groups. an application was developed to track patient reported outcome measures. the study investigators now wish to evaluate the feasibility and impact on pain and quality of life of the "beautify" care pathway on a larger cohort. the study hypothesis is that multidisciplinary care organization will improve the management and the quality of life post-breast cancer surgery.


Eligibility criteria:
inclusion criteria: * breast cancer patient scheduled for surgery * patient able to use a connected electronic object and having a tablet or a smartphone with internet access at home. * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan exclusion criteria: * the subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * the subject unable to express consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship

Keywords: mastectomy quality of life
immediate effects of dlpfc tdcs on attention bias

Conditions: Depression

Summary: this research is being done to test if the investigators can modify or reduce negative attention bias in depression following a single session of transcranial direct current stimulation (tdcs) over the left anodal dorsolateral prefrontal cortex (dlpfc) in patients with mild to severe depression. the study will consist of a single-session tdcs session administered onsite at the johns hopkins university (jhu). after the consent process, participants will complete the study (approximately one hour in duration) with the guidance of a research associate.

this prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to severe depression (based on bdi-ii score range 14-19 for mild and 29-63 for severe) to determine if a single-session of tdcs can alter negative attention bias. the primary objective is to study if single-session tdcs will affect attention bias in depression and is not meant to treat depression. subjects may or may not be receiving treatment for mild-severe depression.

Eligibility criteria:
inclusion criteria: * aged 18-45 * female * mild to severe depression (determined by bdi-ii scores of 14-19 and 29-63, respectively) * if taking antidepressants, medication must be stable ≥ 30 days prior to screening exclusion criteria: * wide-range achievement test-fourth edition (wrat-4) reading subtest standard score \<85 (to ensure understanding of test procedures) * insufficient visual and motor ability to operate the intervention and assessments as judged by treating neurologist or study staff * primary psychiatric disorder other than depression (based on mini) * primary neurologic condition that would prevent ability to participate (as determined by study clinician). * history of head trauma in the last year * medical device implants in the head or neck * history or current uncontrolled seizure disorder * current substance abuse disorder * pregnant or lactating women * skin disorder/sensitive skin near stimulation locations
a study of tq-b3139 capsules in subjects with met-altered advanced non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this is a single-arm, multi-center clinical trial to evaluate the safety and efficacy of tq-b3139 capsules in patients with met gene abnormal advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * 1. eastern cooperative oncology group (ecog) performance status score of 0 to 1; 2. life expectancy ≥12 weeks; 3. met-altered non-small cell lung cancer (nsclc) ; 4. has at least one measurable lesion; 5. previous standard treatment has failed; 6. adequate organ system function; 7. left ventricular ejection fraction (lvef) ≥50%; 8. understood and signed an informed consent form. exclusion criteria: * 1. has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 2. has received c-met inhibitors; 3. has received other system anti-tumor treatment within 4 weeks before the first administration; 4. has received major surgical treatment within 4 weeks before the first administration; 5. has received radiotherapy or any surgery within 2 weeks before the first administration; 6. acute toxicity that is ≥ grade 2 caused by previous cancer therapy; 7. has active infection within 2 weeks before the first administration; 8. has currently uncontrollable congestive heart failure; 9. has currently uncontrollable congestive heart failure; 10. has continuous arrhythmia ≥ grade 2, uncontrollable atrial fibrillation or qtc interval \> 480ms; 11. has uncontrollable effusion; 12. has interstitial lung diseases; 13. has severely unstable central nervous system metastasis; 14. has active viral infection; 15. has multiple factors affecting oral medication; 16. breastfeeding or pregnant women; men unwilling to use adequate contraceptive measures during the study; 17. according to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
effects and safety of clonidine patch on young and middle-aged smokers with mild hypertension

Conditions: Hypertension

Summary: the optimal antihypertensive treatment strategy in young and middle-aged hypertensive adults remains undefined. clonidine controlled-release patches administered once a week might have the advantage of convenience. eclipse trial is intended to explore the effect and patient tolerability of clonidine controlled-release patches (one patch per week for a total of 8 weeks) in the treatment of hypertension in young and middle-aged adults, compared with long-acting antihypertensive drug amlodipine. clonidine patch was demonstrated ameliorating the early withdrawal symptoms during smoking cessation. this trial is also intended to observe its effect on smoking cessation in young and middle-aged male smokers.

the young and middle-aged hypertensive population is growing, but the optimal antihypertensive treatment strategy remains undefined. young and middle-aged adults have poor adherence to antihypertensive medications and are prone to missed doses, and weekly formulations may be potentially advantageous. as a centrally acting antihypertensive agent, clonidine exerts sustained antihypertensive effects by agonizing alpha2-adrenoceptors. clonidine controlled-release patches have the advantage of convenience in that they are administered once a week through a transdermal controlled-release technique to achieve a smooth and sustained action of clonidine. however, there is a lack of evidence from clinical trials on its efficacy and tolerability in the treatment of hypertension in young and middle-aged people. eclipse trial is intended to explore the effect and patient tolerability of clonidine controlled-release patches (one patch per week for a total of 8 weeks) in the treatment of hypertension in young and middle-aged adults, compared with long-acting antihypertensive drug amlodipine. clonidine patch was demonstrated ameliorating the early withdrawal symptoms during smoking cessation and recommended by american cancer society to help people quit smoking. therefore, this trial is also intended to observe its effect on smoking cessation in young and middle-aged male smokers at the same time.

Eligibility criteria:
inclusion criteria: 1. 18-60 years old male with mild hypertension (systolic blood pressure (bp) 140-159 mmhg and/or diastolic bp 90-99 mmhg). 2. history of smoking and a desire to quit. 3. signed informed consent form. exclusion criteria: 1. history of cardiopulmonary and vascular disease. 2. severe liver or kidney disease. 3. night shift workers, drivers, and those who work at height.

Keywords: clonidine patch, hypertension, smoking
6-year antibody check after third vaccination against japanese encephalitis

Conditions: Post Other Specified Vaccination Encephalitis

Summary: the purpose of this study is to determine whether there are persisting antibodies against japanese encephalitis 6 years after the last vaccination with ixiaro(r) and to adapt or confirm mathematical models accordingly.

japanese encephalitis (je) is a potentially devastating mosquito-borne viral disease. the je virus (jev), a flavivirus, is endemic to many regions in asia, and while je is primarily a pediatric disease in the endemic regions, travelers from non-endemic regions to asia are usually naïve to the virus and may be at risk for contracting je at any age. the present study aims to investigate antibody titers at approximately 6 years after the third dose of je vaccine (je-vc), in a cohort of participants from an earlier booster dose trial, to strengthen the statistical model of the duration of protection after the booster.

Eligibility criteria:
inclusion criteria: * subjects who received a booster dose of je-vc in study ic51-311 * subjects who are willing to give written informed consent to participate in the trial exclusion criteria: * subjects who received a further dose of any japanese encephalitis vaccine since study ic51-311 * severe immunosuppression (as result of medical conditions or medication) since study ic51-311, such as history of radiation therapy or cytostatic therapy * simultaneous participation in another clinical study
nutrition matters: a food is medicine intervention for african-american adults with multiple chronic conditions

Conditions: Type 2 Diabetes; Hypertension; Obesity and Obesity-related Medical Conditions; Heart Disease

Summary: african americans have higher rates of diabetes, obesity, heart disease, and high blood pressure. in addition, middle-aged non-hispanic black adults develop multiple chronic conditions (mccs) at an earlier age, which share most of the same risk factors, including poor diet and physical inactivity. the major goal of the proposed project is to develop a culturally tailored intervention focused on improving awareness, knowledge, diet quality, and physical activity in a cohort of aa adults with mccs.

chronic diseases and their risk factors are more common and severe for african americans (aas) and other racial and ethnic minority groups. the cdc reports that non-hispanic blacks are 30% more likely to have high blood pressure and twice as likely as white adults to be diagnosed with diabetes and heart disease or suffer a stroke. in addition, middle-aged non-hispanic black adults have higher levels of chronic disease burden and develop multiple chronic conditions (mccs) at an earlier age. since chronic diseases share most of the same risk factors, including poor diet and physical inactivity, the inherent potential exists for prevention. food is medicine refers to a spectrum of services and health interventions that recognize and respond to the critical link between nutrition and chronic illness. by addressing nutritional needs within the context of health care, food is medicine interventions play an important role in preventing and/or managing many of the chronic conditions that drive health care costs. in addition, social support is a key factor influencing health behavior change and aids in successful weight loss, weight management, and obesity program adherence. thus, this project proposes to pilot a 12-week food is medicine intervention with a 3-month follow-up to improve awareness, knowledge, and healthy lifestyle behaviors - primarily nutrition and physical activity in a cohort of aa adults with mccs. the proposed project will focus on health equity in that it will include nutrition education, interactive cooking demonstrations, the provision of healthy food, and organized walking groups necessary for improved rates of behavior change and the formation of new habits. the proposed project aims to improve physical activity and dietary intakes that influence diabetes, high blood pressure (directly linked to kidney health), and cardiovascular health that disproportionately affect the aa community.

Eligibility criteria:
inclusion criteria: * african american * age 35-64 years old * must have been diagnosed with pre diabetes or diabetes and have one other diagnosed chronic condition, including obesity (bmi \>35), hypertension, and heart disease. exclusion criteria: * individuals with a medical condition that interferes with their ability to modify their diet or engage in physical activity
the effects of tap block on postsurgical pain after minimally invasive partial nephrectomy:

Conditions: Acute Pain; Chronic Pain

Summary: single-center study in order to assess whether the tap block can make extremely beneficial in terms of reducing the acute and chronic pain as well as for use of opioids and side effects related to it in patients undergoing surgery to minimally invasive partial nephrectomy.


Eligibility criteria:
inclusion criteria: * asa score i,ii,ii * patients scheduled for robot assisted partial nephrectomy exclusion criteria: * previous abdominal surgery * inability to provide informed consent * allergy to the anesthetic drugs

Keywords: minimally invasive surgery partial nephrectomy
low glycemic index and load diet for the treatment of acne

Conditions: Acne Vulgaris; Diet Modification

Summary: clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. adult patients with acne where recruited in two groups, a and b. group a received a normal diet according to their metabolic status and group b received a diet with low glycemic index and load. outcomes were measured at week 12.

clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. adult patients with acne where recruited in two groups, a and b. both groups of treatment were treated with doxycycline 100 mg per day plus adapalene 0.1% gel daily for 12 weeks. during pharmacologic treatment, all patients had nutrition counseling monthly. group a received a normal diet according to their metabolic status and group b received a diet with low glycemic index and load. at the end of the trial, the change in acne lesions count was analyzed and also their metabolic status. quality of life was also measured.

Eligibility criteria:
inclusion criteria: * having moderate inflammatory acne * 18 to 25 years old * male * stable weight during the last 3 months exclusion criteria: * previous or actual isotretinoin therapy * antibiotic therapy or during the last 3 months * therapy based on peelings, dermabrasion, laser or intense pulsed light during the last 6 months * endocrine disorders * drug and alcohol consumption during the last 6 months * tabacco use during the last 6 months * lactose intolerance * have eating disorders or gastrointestinal disorders * actual nutrition therapy * have chronic diseases that requires pharmacologic therapy * severe acne that requires isotretinoin therapy

Keywords: acne vulgaris low glycemic diet doxycycline adapalene
12-week study of plecanatide for cic (the cic3 study)

Conditions: Chronic Idiopathic Constipation

Summary: the purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

this is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with cic comparing 2 doses of plecanatide to placebo. the study will be conducted at approximately 180 clinical study sites in the united states (us) and canada. the primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (qd) for 12 weeks in a population of patients with cic. the study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation. there are 6 scheduled study visits, including the screening and follow-up visits. the planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.

Eligibility criteria:
inclusion criteria: * male or female aged 18-80, inclusive * meets modified rome iii criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months * completed a colonoscopy in accordance with aga colon cancer screening guidelines (5 years), with no clinically significant findings * willing to maintain a stable diet during the study exclusion criteria: * loose stool (mushy) or watery (bristol score 6 or 7) stool in the absence of any laxative or prohibited medicine for \> 25% of bms during the 3 months prior to screening visit or during the 14 day pre-treatment assessment * active peptic ulcer disease, diabetes or hypertension not adequately treated or not stable * history of cathartic colon, laxative, enema abuse, or ischemic colitis * fecal impaction within 3 months of screening * patient has had /has any: diseases or conditions associated with constipation (gi or cns), structural abnormality of the gi tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect gi motility or defecation or can be associated with abdominal pain * unexplained and clinically significant "alarm symptoms" including lower gi bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis * major surgery, stroke or mi within 60 days of screening * participated in a previous plecanatide clinical trial

Keywords: cic constipation chronic constipation synergy plecanatide
symptomatic gastroesophageal reflux disease: double blind randomized controlled study of on-demand therapy versus maintenance therapy

Conditions: Gastroesophageal Reflux Disease

Summary: maintenance treatment with proton pump inhibitor (ppi) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (gerd). yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate gerd. on-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. however, whether on-demand ppi therapy achieves similar efficacy of symptom control is uncertain. the aim of this study is to compare the efficacy and quality of life of on-demand and maintenance ppi regimens in long-term management of non-erosive gerd patients. the investigators hypothesize that on-demand ppi treatment is as effective as maintenance ppi.


Eligibility criteria:
inclusion criteria: * weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months exclusion criteria: * erosive esophagitis * concomitant peptic ulcer disease * use of nsaid in recent 4 weeks (low dose aspirin \< 300 mg is allowed) * pregnant or lactating female * illiterate patient (who cannot administer questionnaire) * known hypersensitivity to ppi

Keywords: gerd