Kornimate/medical-research-clean huggingface dataset:
jalosome® soothing gel efficacy grade 2 or 3 radiodermatitis.

Conditions: Radiodermatitis; Oncology; Quality of Life; Pain

Summary: testing the efficacy of the jalosome® soothing gel in 2 or 3 grade radiodermatitis healing in oncological patients. the investigators would like to know also the efficacy of the device on quality of life and pain.

the overall objective of the study is to evaluate the efficacy of the class iia medical device jalosome® soothing gel in the healing of grade 2 or 3 radiodermatitis, in oncology patients undergoing radiotherapy treatment, during a 8-week observation period. the secondary endpoints are radiodermatitis pain control and quality of life. the investigators would like to involve 30 oncology patients. all oncology diagnosis will be included in this pilot study. the study will adopt a quasi-experimental design with one arm. the results will be used to determine the sample size for a clinical trial in which the class iia medical device jalosome® soothing gel will be compared to usual care.

Eligibility criteria:
inclusion criteria: * patients aged ≥18 years * patients with cancer\* undergoing radiotherapy treatment * patients with grade 2 or 3 radiotherapy lesions who are naive to radiodermatitis treatment or unresponsive to previous treatment * patients who have given written informed consent * patients expected to be followed at the centre for at least 8 weeks * patients with karnofsky performance status(kps) scale ≥ 40 exclusion criteria: * patients with grade 1 and grade iv radiodermatitis * patients with known intolerance to the components in jalosome® soothing gel * patients who have already received radiotherapy in the past on the irradiated area * patients with cognitive impairment that does not allow adequate compliance with the protocol * patients with brain metastases * pregnant or lactating patients * patients with kps \< 40

Keywords: radiodermatitis oncology quality of life pain wound healing
validating a delirium prediction model for critically ill patients

Conditions: Delirium

Summary: the objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a dutch university hospital with the mapping of relevant delirium risk factors the primary aim is to validate the investigators' developed delirium prediction model for critical care patients. a secondary aim is to find differences between delirious patients and non-delirious patients on different aspects of diagnostics, treatment and care, outcome, length of stay, and inflammation. according to dutch law, the need to obtain informed consent was waived by the committee on research involving human subjects (cmo) of nijmegen for this observational study (2007/283).


Eligibility criteria:
inclusion criteria: * all adult patients (18 years and older) admitted at the critical care unit of our hospital exclusion criteria: * admitted \< 12 hours on icu * not able to understand dutch * patients with serious hearing and visibility disabilities * mentally retarded patients * patients suffering from receptive aphasia * delirious before admission

Keywords: delirium critical care risk factors prediction inflammation
high-dose cyclophosphamide for severe refractory crohn disease

Conditions: Crohn's Disease; Crohn Disease

Summary: this research is being done to see if people with crohn's disease who receive high-dose cyclophosphamide have an improvement of their disease, how long the benefit may last, and how safe cyclophosphamide is. this study is for patient with medically refractory disease that is not easily amenable to surgery. cyclophosphamide is an fda-approved chemotherapy medication that is also frequently used to treat autoimmune illness; use of cyclophosphamide for autoimmune disease is not approved by the fda. an autoimmune illness is when the immune system mistakenly attacks self, targeting the cells, tissues, and organs of a person's own body. there are many different autoimmune diseases and they can each affect the body is different ways. crohn's disease is an autoimmune disease that primarily affects the small and large intestines. high dose-cyclophosphamide has been successfully used to treat crohn's, primarily as part of a conditioning regimen for autologous stem cell transplantation. however, this therapy is limited in crohn's because of it's serious infectious risks. this current study involves using high-dose cyclophosphamide without need for stem cell transplantation. this appears to be a safer approach in other autoimmune illnesses that have been studied.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age, males and females will be eligible * moderate to severe crohn's disease (cd) with cdai \> 220, in addition to evidence of ulceration on ileocolonoscopy or active disease on small bowel imaging (in patients with an ostomy, cdai criteria do not apply) * disease progression (primary or secondary non-responder, or reaction to) to at least one anti-tumor necrosis factor (tnf) agent (infliximab, adalimumab, certolizumab pegol), and additionally had disease progression despite one of the following immunosuppressant drugs: azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, natalizumab, vedolizumab * willingness to participate in a clinical trial * approval by enrollment panel, who will collectively decide on the appropriateness of possible study study participants exclusion criteria: * pregnant or nursing women * sexually active men and women who do not agree to use effective means of birth control during treatment period * evidence of primarily fibrostenosing disease without active inflammatory disease on disease staging * co-morbid conditions including cardiac disease with an ejection fraction of \ 2.0, liver disease with total bilirubin \> 2.0, (excluding hyperbilirubinemia secondary to gilbert's disease) or transaminitis \> 3x upper limit of normal. * history of serious allergic reaction to cyclophosphamide * history of malignancy in the last 5 years (excluding non-melanomatous skin cancers) * patients who are pre-terminal * toxic megacolon * active infection * white blood cell count \< 3000 cells/ul, platelets \< 100k / ul, hemoglobin \< 10.0 g/dl * any use of thiopurines, methotrexate or anti-tnf agents in the previous four weeks prior to treatment
a study of pre-hospital treatment of acute myocardial infarction based on diagnosis by interpretation of remotely acquired ecg and thrombolysis with accelerated alteplase ( actilyse®)

Conditions: Myocardial Infarction

Summary: the general aim of this study was to assess the feasibility of treating acute myocardial infarction (ami) by physician-directed pre-hospital thrombosis, using accelerated alteplase (actilyse®) and a diagnostic technique involving remote electrocardiogram (ecg) acquisition by paramedics


Eligibility criteria:
inclusion criteria: * ischemic cardiac pain of \>= 20 minutes and \<= 6 hours * age 18 - 80 years * ability to give informed consent (witnessed verbal or written) * ability to follow protocol and comply with follow -up requirements exclusion criteria: * current participation in another clinical trial * patient will be ineligible for pre hospital administration of actilyse if any of the following apply: * acute myocardial infarction (ami) treated with a thrombolytic agent within the preceding 4 days * bp (blood pressure) \> 180/100 mmhg (on one measurement) * significant bleeding disorder within the past 6 months * major surgery, biopsy of a parenchymal organ, or significant trauma (including any trauma associated with the current ami) within 3 months * history of stroke, transient ischaemic attack, or central nervous system structural damage (e.g. neoplasm, aneurysm, intracranial surgery) * oral anticoagulation * recent (within 10 days) non - compressible vascular puncture * pregnancy (positive urine pregnancy test) or lactation, parturition within the previous 30 days, or female of childbearing potential not using adequate birth control (oral contraception) * severe liver disease, including hepatic failure, cirrhosis portal hypertension (oesophageal varices) and active hepatitis * diabetes with definite history of retinopathy * other serious illness (e.g. malignancy, active infection) * bacterial endocarditis / pericarditis * acute pancreatitis * documented ulcerative gastrointestinal disease during last 3 month, arterial aneurysms, arterial / venous malformations * any other condition that the investigator feels would pose a significant hazard to the subject if the investigational therapy was to be initiated * patients who are not excluded from thrombolytic therapy by the criteria above will, in addition, need to satisfy the following 'inclusion' criteria prior to the pre - hospital thrombolysis: * 12 lead ecg criteria: st segment elevation \>= 0.1 mv in two contiguous electrocardiogram (ecg) standard leads indicative of ami, or st elevation \>= 0.2 mv in two contiguous chest leads and all left bundle branch block (lbbb) with clinical indication of ami
low back health education on physical function and body awareness in academicians

Conditions: Low Back Pain, Mechanical

Summary: this study was planned to investigate the effect of back health education given to academicians on physical function and body awareness. the participants of the intervention group received back health education (back school) in the classroom. after the education program, they participated in exercise training for six weeks (one day a week). the control group was only given an informative brochure on back health and asked to read it.

this study was planned to investigate the effect of back health education given to academicians on physical function and body awareness. the study was completed with a total of 94 (49 female and 45 male) volunteer academicians (intervention group n=47, control group n=47) between the ages of 25-65, with a mean age of 43.22±10.924 years. the participants of both groups were evaluated before and after the 6-week education and training. in order to evaluate physical functions of the participants, one leg standing test (eyes open and closed), half squat test, curl-up test, and sit and reach test were used. the body awareness questionnaire (baq) was used to assess body awareness of the sample. the participants of the intervention group received back health education (back school) in the classroom. after the education program, they participated in exercise training for six weeks (one day a week). the control group was only given an informative brochure on back health and asked to read it.

Eligibility criteria:
inclusion criteria: * taking part in full-time academic staff at ondokuz mayıs university and samsun university in turkey. * to continue his/her career at the university for at least 3 years without break * male and female volunteer academicians between the ages of 25-65 exclusion criteria: * those with any identified back pain problem * those who have undergone spinal surgery * those with neurological problems * those with orthopedic problems * those with cardiac or pulmonary problems (except controlled taking by medicines. * part-time employees

Keywords: academician physical function body awareness low back health back school
adherence to study medication compared to generic topical clindamycin plus generic topical tretinoin in subjects with mild to moderate acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. this study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.


Eligibility criteria:
inclusion criteria: * males or females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris. * subjects must sign written informed consent and agree to come for all study visits. exclusion criteria: * use of experimental drugs within 1 month prior to initiation of study therapy. * pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. females of childbearing potential must agree to use approved birth control methods for the duration of the study. * use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study * use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry. * any skin condition or disease that may require concurrent therapy or may confound the evaluation; * history of hypersensitivity to any of the formulation components; * facial skin cancer or facial actinic keratosis; * use of any photosensitizing agents. * use of isotretinoin within the last 6 months. * chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry. * crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.

Keywords: mild to moderate acne vulgaris
low-dose nilotinib and imatinib combination in chronic myeloid leukemia patients, with failure, suboptimal response or treatment intolerance

Conditions: Leukemia, Myeloid, Chronic, BCR-ABL Positive

Summary: the purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in cml patients with failure, suboptimal response or intolerance to imatinib therapy. the hypothesis is that with low-dose imatinib and nilotinib combination, major molecular response will be achieved in patients not previously obtained with imatinib monotherapy.


Eligibility criteria:
inclusion criteria: * cml patients with failure or suboptimal response to imatinib therapy according to criteria established by the european leukemia net (eln) * patients with grade ii or higher adverse events. * cml patients not suitable for stem cell transplantation. exclusion criteria: * patients in blast crisis. * pregnant women * patients without a contraception method.

Keywords: chronic myeloid leukemia suboptimal response imatinib nilotinib
a collection of case studies in infants with ucd to evaluate infant growth and the safety of a new medical food for ucd

Conditions: Urea Cycle Disorder; Inborn Errors of Metabolism

Summary: original study: study aims to enroll 3-5 children with confirmed urinary cycle disorder (ucd). subjects meeting the inclusion and exclusion criteria are included during the baseline visit. all subjects will receive the investigational product for a period of 16 weeks. at baseline, 2, 4, 8, 12 and 16 weeks the study parameters are assessed. the study amendment aims to collect case studies retrospectively of children who have used ucd anamix infant for at least 16 weeks, in countries where ucd anamix infant is already available on the market. it is aimed to collect the same study parameters of the original study at preferably the same timepoints.


Eligibility criteria:
inclusion criteria: prospective study: * male and female infants diagnosed with ucd, aged from birth to 30 days of age * parent / primary caregiver is able to give informed consent * infants who will receive and will be able to take study medical food as part (40-70%) of their protein requirements in the day retrospective study: * male and female term infants diagnosed with ucd, that started ucd anamix infant when aged from birth to 30 days of age. * parent / primary caregiver is able to give informed consent * infants who received ucd anamix infant as part of their protein requirements (40-70%) in the day for at least 16 weeks. exclusion criteria: * infants \< 5lb 8oz (\< 2.5 kg) at birth * infants \<34 weeks of gestation and using a special premature formula at study start * infants with severe concurrent illness or major congenital malformations, except conditions consequent to urea cycle disorder * infants with suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus) * infants with evidence of significant cardiac, respiratory, haematological, gastrointestinal, or other systemic diseases * infants currently taking cytotoxic drugs * investigator's uncertainty about the willingness or ability of the parent to comply with the protocol requirements * participation in any other study involving investigational products concomitantly or prior to entry into the study * an infant of any personnel connected with the study * infants whose parent / primary caregiver is younger than the legal age of consent
effects of antiviral therapy on patients with hbv-related hcc

Conditions: Hepatocellular Carcinoma; Hepatitis B Virus; Survival

Summary: based on the follow-up data of patients who underwent hepatectomy for hbv-related hcc at the first affiliated hospital of xi'an jiaotong university. patients who met the enrollment criteria were screened for tumor recurrence and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

a retrospective study of patients who underwent hepatectomy for hbv-related hcc at the first affiliated hospital of xi'an jiaotong university from january 2016 to june 2019 was conducted. the clinical data of patients, including demographic features, perioperative laboratory values, surgical information, and pathological data, were collected from the official database for patients' data gathering, also, based on the follow-up data of patients who met the enrollment criteria were screened for tumor recurrence and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Eligibility criteria:
inclusion criteria: age of 18-70 years; initial hepatectomy was performed; positive hbsag results and negative results for antibodies to hepatitis c virus (hcvab) and human immunodeficiency virus; the patient did not undergo antitumor treatment, such as transcatheter arterial chemoembolization, radiofrequency ablation-chemotherapy or radiotherapy, or postoperative liver transplantation; barcelona clinic hepatocellular carcinoma stage 0, a, or b (a few patients with stage c were also enrolled); negative hepatectomy margin; no other tumors. exclusion criteria: undergo antitumor treatment, such as transcatheter arterial chemoembolization, radiofrequency ablation-chemotherapy or radiotherapy, or postoperative liver transplantation; positive results for antibodies to hepatitis c virus (hcvab) and human immunodeficiency virus

Keywords: hepatitis b virus antiviral therapy hepatectomy
embosphere® prostate post market study

Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: prostatic artery embolization with embosphere microspheres is a relatively new procedure. the goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.

this is a prospective, open label post market study to evaluate the long-term safety and effectiveness of prostatic artery embolization (pae) using embosphere microspheres. up to 500 patients with lower urinary tract symptoms (luts) due to benign prostatic hyperplasia (bph) will be enrolled in this single arm post market study. all patients at sites who meet eligibility criteria will be offered participation. long term effectiveness of pae on luts will be evaluated by international prostate symptom score (ipss) at baseline, 3 months, 12 months and 24 months. safety will be assessed by evaluating device or procedure-related adverse events at the same time points, plus at 4 weeks following embolization. erectile function will be assessed at baseline and 12 months by sexual health inventory for men (shim) score. additional treatments for refractory or recurrent luts due to bph post prostatic artery embolization will also be recorded.

Eligibility criteria:
inclusion criteria: * patient has signed informed consent * patient age is 18 years or older at time of informed consent * patient will undergo prostatic artery embolization with embosphere microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms exclusion criteria: * patient is unable or unwilling to provide follow-up information * patient is undergoing prostatic artery embolization for reasons that do not include symptomatic benign prostatic hyperplasia with lower urinary tract symptoms * any other reason the investigator deems cause for exclusion

Keywords: prostatic artery embolization (pae) benign prostatic hyperplasia (bph) lower urinary tract symptoms (luts) embolization embolic embosphere microsphere
mechanisms of social inequalities in post-hospitalization rehabilitation in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: aim: to identify psychological and socioeconomic predictors of cardiac-rehabilitation (cr) attendance and uncover mechanisms of cr non-attendance. design: quantitative, observational, prospective study. hypothesis a: educational-level, comorbidity, anxiety, depression, self-efficacy, cohabitation and distance from residence are predictors of cr attendance. hypothesis b: the expected social gradient in cr attendance is explained partly by differential exposure of comorbidity, anxiety, depression, self-efficacy, cohabitation and distance to the rehabilitation clinic.

design: quantitative, observational, prospective study. self-administrated questionnaires, medical journals and telephone interviews will be used for data collecting.

Eligibility criteria:
inclusion criteria: * patients hospitalized with acute coronary syndrome (acs) to nordsjællands hospital (icd10: di210-di219, di200, di200b, di200c, di23, di24) will be invited to participate in the survey as an ongoing process during the inclusion period (n=267). exclusion criteria: * patients who are not able to submit written consent are excluded. thus, patients with severe cognitive dysfunction or poor language skills are excluded.