Kornimate/medical-research-clean huggingface dataset:
evaluation the effects of herbal gargle for chemoradiotherapy-induced oral mucositis of head & neck cancer, a pilot study.

Conditions: Head and Neck Neoplasms; Chemoradiotherapy; Stomatitis and Ulceration

Summary: the aim of the study is to evaluate the effects of herbal gargle on chemoradiotherapy-induced stomatitis in head \& neck cancer patients.

head and neck cancer accounts for about 5% of all cancers worldwide with the age-standardized incidence rate (asir) of hnc increased by 5.4% per year among males and 3.1% among females in taiwan. concurrent chemoradiotherapy (ccrt) is the most common management to treat head and neck cancer. however, ccrt may cause much side effects such as oral mucositis, radiation dermatitis, xerostomia, or infection, which influence food intake, disturb nutritional status and interrupt the course of treatment. traditional chinese medicine (tcm) has been applied to treat cancer side effects for many years. herbal gargle is composed of tcm herbals used for oral mucositis induced by chemoradiotherapy among head and neck cancer. the aim of the trial is to evaluate the effectiveness of herbal gargle. the participants divide into two groups, treatment group and control group. the treatment group receive herbal gargle 150ml and are instructed to hold the gargle in the mouth for 30s and then expectorate it twice a day, 5 days a week for 8 weeks. the control group receive normal saline 150ml for oral mucositis. the subjective questionnaires of eortc qlq-c30, eortc qlq-h\&n35 are assessed twice a week, ctcae for grading of oral mucositis is assessed once a week, vas is assessed everyday for 8 weeks. besides, change of opioid dosage, body weight are also recorded. the crp is assessed before and every week for 8 weeks and the albumin and bacteria culture are assessed before and post-treatment of 4th week and 8th week. the baseline difference of treatment and control group will be analyzed by using independent t-test and the difference of evaluation scores and blood tests between pre-treatment and post-treatment will be analyzed using multivariate logistic regression analysis. a value of p \< 0.05 will be regarded as statistically significant for the above statistical analyses.

Eligibility criteria:
inclusion criteria: * willing to join the trial project and sign the informed consent form. * age more than 20 years-old. * pathology proved to be head and neck cancers. * head and neck cancer patients under radiotherapy or concurrent chemoradiotherapy. * expected life expectancy more than 3 months. * subjects with clear consciousness and can be assessed cooperatively. * subjects are suitable to use herbal gargle evaluated by traditional chinese medicine physicians. exclusion criteria: * subjects can not sing the informed consent form. * systemic infection. * heart, liver and kidney insufficiency * allergy history of traditional chinese medicine * unclear conscious to use herbal gargle.

Keywords: medicine, chinese traditional head and neck neoplasms chemoradiotherapy stomatitis and ulceration
autologous immune killer cells to treat liver cancer patients as an adjunct therapy

Conditions: HepatoCellular Carcinoma; Liver Cancer

Summary: the purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in： 1. reduction of tumor size 2. reducing the relapse rate: reducing the frequency of tace treatment by ikc injections.

this is a phase ii/iii clinical study. blood is drawn from the patient and brought to our laboratory for isolation of immune cells. these immune cells are then proliferated over a two week period and used to produce the patented product ikc (immune killer cells). the ikc will then infused back into the patient to treat the cancer. each patient will receive a total of twelve infusions. 60 patients are anticipated to be recruited. this is a double-arm study, the experimental group will receive ikc treatment along with tace treatment. the control group will receive only tace treatment. 30 patients will be randomized into each arm.

Eligibility criteria:
inclusion criteria: 1. sign and give written informed consent. 2. age≧20 years, but\<80 years. 3. hepatocellular carcinoma by ct, mri, afp, angiography or cytology/biopsy examinations. 4. barcelona staging system stage b and c. 5. never receive tace treatment and comply with the standard of tace treatment. 6. child-pugh stage a and b. 7. ecog performance status 0 to 2. exclusion criteria: 1. participant of other clinical trial within the past 4 weeks of screening period. 2. receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period. 3. carriers of hiv or htlv within the past 4 weeks of screening period. 4. with active acute or chronic infection by (investigator's judgement). 5. other diseases, except hepatocellular carcinoma, which are life-threatening to the patients (by investigator's judgement) for example: 5.1 active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction. 5.2 with previous history of encephalopathy within the past six months. 5.3 involved involving systemically or known central nerve system diseases(brain or meningeal metastasis). 6. women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.

Keywords: hepatocellular carcinoma liver cancer immune killer cells ikc immune therapy immunotherapy cell therapy ivy ivy02
daily step count and achieving goal gestational weight gain

Conditions: Pregnancy Related

Summary: the purpose of this voluntary research study is to determine an optimal step count that aids in achieving the recommended weight gain during pregnancy and to use this count in future studies.

the goal of this study is to contribute to the growing data that show a clear benefit in activity during pregnancy over sedentary behavior. uniquely, this study looks to determine an optimal step count for achieving goal gestational weight gain. in doing so, this will enable clinicians to better counsel patients on a low cost, at home activity that can aid in improved maternal and fetal outcomes. this optimal step count would be used in future randomized clinical trials to determine whether this goal step count could be used to benefit other maternal and fetal outcomes such as gestational diabetes, preeclampsia, preterm labor, cesarean section rates, and birth weight. participation will begin at the patients 18-22 week clinic visit and will last until delivery. at the 18 - 22 week clinic visit a pedometer will be given to the patient. patient will be instructed by a study team member to wear the pedometer on a hip for 7 days every 4 weeks and will submit daily step count for the day via a link to an online submission form which will arrive in the email once a day for 7 days in a row. an email reminder will be received every four weeks to prepare the patient for the reporting of daily step count, if no response is received electronically via the online submission form after 14 days a second reminder will be received. no change in normal activity will be required, instructions will be given to maintain normally activity during the week. the pedometer will be returned when patient arrives to labor and delivery to deliver. the risks of this study are minimal as there will be no diversion from normal daily routine. the results of this research may guide the future studies in walking in pregnancy in relation to maternal, fetal, and neonatal morbidity.

Eligibility criteria:
inclusion criteria: 1. 18 years and older 2. pregnant women 3. a singleton pregnancy 4. gestational age at inclusion 18-22 weeks 5. ability to read and speak english 6. access to a computer 7. cell phone exclusion criteria: 1. multiple pregnancy 2. pregestational diabetes 3. diseases limiting level of physical activity 4. previous bariatric surgery 5. current alcohol use 6. current drug abuse 7. currently in a opioid treatment program 8. history of eating disorder 9. non-english speaking

Keywords: pregnant pregnancy gestational weight weight gain gestational weight gain
noninvasive positive pressure ventilation using helium:oxygen versus air:oxygen in acute respiratory failure in chronic obstructive pulmonary disease patients exposed to sulfur mustard

Conditions: Chronic Obstructive Pulmonary Disease; Bronchiolitis

Summary: to assess the effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in sulfur mustard exposed patients with acute decompensation


Eligibility criteria:
inclusion criteria: * a history of previous exposure to sulfur mustard * worsening dyspnea during the last 10 days * respiratory rate \>25/min * arterial ph\<7.35 * paco2 of \>50 mmhg * pao2 of \<50 mmhg exclusion criteria: * recent pneumothorax (\<1 month) * severe respiratory failure or hemodynamic instability with forthcoming intubation * fio2 of \<0.4 * impaired consciousness or absence of patient cooperation * facial lesions precluding niv
donor-derived viral specific t-cells (vsts) for prophylaxis against viral infections after allogeneic stem cell transplant

Conditions: Allogeneic Stem Cell Transplant; Viral Infection

Summary: the purpose of this research study is to learn more about the use of viral specific t-lymphocytes (vsts) to prevent viral infections that may happen after allogeneic stem cell transplant. allogeneic means the stem cells come from another person. vsts are cells specially designed to fight viral infections that may happen after a stem cell transplant (sct). stem cell transplant reduces your ability to fight infections. viral infections are a common problem after transplant and can cause significant complications. moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. the medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study we are trying to find a way to prevent these infections.


Eligibility criteria:
inclusion criteria: * recipient must be at least 21 days after stem cell infusion * clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent exclusion criteria: * patients who have developed viral infection or reactivation will be ineligible for prophylactic infusions of vsts * active acute gvhd grades ii-iv * uncontrolled relapse of malignancy * infusion of atg or alemtuzumab within 2 weeks of vst infusion. additionally, in patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab levels will be collected in the second week following stem cell infusion. the level must be less than, or equal to, 0.15 prior to infusion of vsts. in patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. they would become eligible for prophylactic vst infusion at that point if there is still no evidence of viral infection at that time.
recurrence of odontogenic keratocyst

Conditions: Odontogenic Cyst

Summary: the aim of current cross over clinical trial is to evaluate the effect of topical 5-fu as adjunct therapy in reducing risk of the recurrence of okcs

the main inclusion criteria in this study will be 48 patients with biopsy proved odontogenic keratocyst with no relevant systemic diseases which might affect healing process. patients will be treated with 5-fu cream (efudex; valeant inc, laval, quebec, canada) after enucleation and peripheral ostectomy of the odontogenic keratocyst. * a detailed preoperative assessment for all patients will be carried out including history taking, clinical and radiographical examination. * all surgical procedures will be carried out under general anesthesia with nasal endotracheal intubation. * through an intraoral incision, the full thickness mucoperiosteal flap will be raised. the entire cyst lining radically enucleated in conjunction with any overlying mucosa, followed by extensive cavity thorough curettage with meticulous evaluation of any residual daughter cyst lining with reduction of the lingual and buccal undercut bony walls to remove residual macroscopic cystic epithelium. * after enucleation and peripheral ostectomy of the okc lesion, a sterile radiopaque quarter-inch ribbon gauze is coated with 5-fu cream and packed into the surgical wound. the wound is closed in the usual manner using 3/0 vicryl leaving a small distal end (approximately1 cm) of gauze exposed to allow for gauze removal at 24 hours postoperatively. all patients will be regularly followed up for 12 months postoperatively clinically and radiographically

Eligibility criteria:
inclusion criteria: * patients with biopsy proved odontogenic keratocyst exclusion criteria: * relevant systemic diseases which might affect healing process.

Keywords: odontogenic keratocyst 5- fluorouracil recurrence
exosomal and free extracellular rnas and proteins as predictive biomarkers for her2 therapies in breast cancer

Conditions: Breast Cancer; HER2 Positive Breast Cancer; HER2 Negative Breast Cancer

Summary: primary objective: (i) to identify panels of rnas and proteins predictive of response to her2 targeted agents, considering clinical responses. (ii) to investigate associations between presence vs. absence (or relative levels) of identified extracellular (ec) rnas/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) to compare her2 positive samples versus her2 negative samples for the existence of rnas/proteins identified in (i) and (ii). secondary objective: to develop a predictive model for use in the her2 positive population based on the most accurate and sensitive combination of the identified biomarkers.

this is a translational pilot study, involving two patient cohorts, designed to identify predictive biomarkers for her2 targeted therapy, which will be validated in a larger future study. cohort 1: 300 newly diagnosed (including metastatic) her2 positive breast cancer patients. cohort 2: 30 newly diagnosed her2 negative breast cancer patients. blood specimens will be taken: * before starting treatment (cohort 1 and 2) * after receiving chemotherapy and before starting her2 targeted treatment (if applicable) (cohort 1) * within one month following 1st treatment of her2 targeted treatment (cohort 1) * approximately every 3 months (coinciding with formal disease assessment) while on her2 targeted treatment for a maximum of 5 years (cohort 1) blood will be processed to serum, which will be analysed for rna and protein biomarkers.

Eligibility criteria:
inclusion criteria: 1. patient with a newly diagnosed (including metastatic) her2 positive breast cancer, who is to commence her2 targeted treatment. or - patient with a newly diagnosed her2 negative breast cancer, who is to commence any type of treatment. 2. patient must be female and aged 18 years or over. 3. patient must provide written informed consent. exclusion criteria: 1. patients who do not fulfil the inclusion criteria mentioned above
eating behaviour and gustatory sensitivity before and after liver transplant in cirrhotic patients

Conditions: Eating Behaviour; Liver Transplant

Summary: today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. in parallel, the metabolic status, itself dependent on liver metabolism, influences food preferences and is modified after the transplantation as the liver recovers its ability to store glycogen, but is not able to inform the brain as the afferent nerve impulses have been suppressed. the innovative aspect of this project is to provide information on the importance of the liver in the regulation of energy homeostasis. the results of this study will improve our understanding of eating behaviour and olfactogustatory sensitivity and allow us to orient liver transplant patients towards appropriate diets.


Eligibility criteria:
inclusion criteria: * persons who have provided written informed consent * persons aged between 18 and 70 years * persons waiting for a liver transplantation (group lt) * persons with stable liver damage * persons waiting for a kidney transplantation (kt) * healthy subjects (control group) no known disease exclusion criteria: * persons without national health insurance cover * persons with chronic infection, * persons with acute infection, * persons with progressive cancer, * persons with an antibiotic treatment, * persons who drink alcohol, * pregnant or breast-feeding women, * persons with an aversion to the foods proposed in the study, * persons taking treatments known to interfere with gustatory and olfactory performance, * adults under guardianship
"guarantee assessment in skin prevention adapted to real life with a connected device after a spinal cord injury."

Conditions: Spinal Cord Injury

Summary: the investigators propose to test an embedded device on the seat of the wheelchair of paraplegic or tetraplegic patients (gaspard), allowing on the one hand the continuous measurement of the pressures of seat, on the other hand a retro-control connected to the cell phone of the participants to inform them on these variables of seat (bad positioning, prolonged supports etc...) this study will be carried out over a long period of time (1 year), in an ergonomic situation of integration in the daily life of the participants. the main objective of this randomized controlled study is to study the difference in the incidence of pressure sores according to the use or not of this device. a qualitative study of the experience and perceived benefit of its use and a medico-economic study are associated to judge the expected interest in making this type of embedded device more systematically integrated into the classic movement equipment (wheelchair and seat cushion) of people with a spinal cord injury


Eligibility criteria:
inclusion criteria: * patients of both sexes with acquired spinal cord injury traumatic or non-traumatic origin of the spinal cord injury * motor level \< c6 * complete or incomplete injury (ais a, b and c impairment scale) * primarily using a manual wheelchair (with or without electric propulsion assistance) as a means of mobility * at least 18 years of age * at any time after the occurrence of the spinal cord injury * patients discharged from the center, with a first post-injury rehabilitation completed * having participated in a specific therapeutic patient education on pressure ulcer prevention * no pelvic pressure sores under medical or surgical treatment at the time of inclusion * no aorto-iliac arterial disease that may promote pelvic ischemia (arterial doppler \<6 months) * patient using a cushion approved by the has * patients with a smartphone exclusion criteria: * congenital spinal cord injury * motor level of the lesion \> or = c6 * incomplete motor lesion (ais d and e) * patients who walk as their primary mode of ambulation * use of an electric wheelchair * minors

Keywords: spinal cord injury pressure ulcer prevention medical advice visual feedback
anti-angiogenetic therapy with radiotherapy for pediatric neuroblastoma

Conditions: Neuroblastoma

Summary: the purpose of this study is to evaluate the safety and efficacy of radiotherapy plus endostar(recombinant human endostatin) in patients with pediatric neuroblastoma.

clinical data proved that endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. so investigators design radiotherapy plus endostar to treat pediatric neuroblastoma to research the rr and safety. investigators believe this treatment regimen may be a new approach to the pediatric neuroblastoma patients.

Eligibility criteria:
inclusion criteria: * participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites. * life expectancy of greater than 12 months. * ecog performance status ≤2 * diagnostic imaging mri and/or ct of the area to be treated within 8 weeks of any treatment. baseline bone marrow biopsy and bone scan (with 99mtc-diphosphonate or mibg scan (131i-mibg or 123i-mibg) from time of original diagnosis is required. * because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document. * participants or their legal guardian must sign consent prior to the initiation of radiation therapy. exclusion criteria: * patients will be ineligible if any prior therapeutic radiation therapy \> 500 cgy has been delivered. * patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone. * individuals with a history of a different malignancy are ineligible except for the following circumstances. individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. * pregnant females are excluded. women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.

Keywords: radiation therapy neuroblastoma
proximal femur reconstruction following resection of primary bone tumors: analysis of the clinical and radiographic results

Conditions: Bone Tumor; Bone Cancer

Summary: from the archives of the rizzoli institute all the patients (approximately 150 patients) undergoing oncological reconstruction of proximal femur from 01/01/1991 to 31/12/2023. a review will be made from the medical records, radiological imaging, and histological data of these patients


Eligibility criteria:
inclusion criteria: * male and female patients surgically treated with an oncological reconstruction of the proximal femur at rizzoli orthopaedic institute between 01/01/1991 and 31/12/2023 * age: 18-90 years old (at the time of primary surgery) * diagnosis of bone sarcoma * patients with available clinical and imaging data exclusion criteria: * at least one inclusion criterion not met

Keywords: proximal femur reconstruction primary bone tumors imaging