Kornimate/medical-research-clean huggingface dataset:
caphosol for the reduction of mucositis in patients receiving radiation therapy for head and neck cancer

Conditions: Oral Mucositis

Summary: patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (om). the purpose of this study is to estimate the effect of caphosol on om and to evaluate if caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.


Eligibility criteria:
inclusion criteria: * diagnosed head and neck cancer patients with planned radiation therapy * have at least one of 10 pre-defined anatomic mucosal subsites on view * age \>/= 18 years * life expectancy \>/= 6 months * planned rt to the head/neck * must be able to perform oral rinse exclusion criteria: * active infections of oral cavity * physiologic condition that precludes the use of an oral rinse * hypersensitivity to caphosol ingredients * presence of mucosal ulceration at baseline * poorly controlled hypertension, dm or other serious medical/psychiatric illness

Keywords: caphosol oral mucositis eusa pharma moffitt cancer center
adjuvant anti-recurrence treatment with rapamycin on early-stage hcc

Conditions: Hepatocellular Carcinoma; Rapamycin

Summary: to evaluate the clinical effect of rapamycin combined with tace on early-stage hcc with overexpression of asph after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for hcc patients after operation.


Eligibility criteria:
inclusion criteria: 1. via clinical diagnosis and confirm it is primary liver cancer 2. pathological evidence of hcc 3. estimate tumor can gain treatment of curing operation 4. no evidence for extrahepatic metestasis 5. liver function ：child-pugh a/b 6. bclc stage：0/1；tnm stage：ⅰ exclusion criteria: 1. reject to attend； 2. impossible to come to our hospital for physical examination regularly. 3. cancer epitome、seed focus、lymph node or distant metastasis 4. blood clotting function hindrance; 5, patients with other diseases which may affect the treatment mentioned.

Keywords: aspartate beta hydroxylase transcatheter arterial chemoembolization
late phase ii confirmatory study of de-089 ophthalmic solution in patients with dry eye

Conditions: Dry Eye

Summary: dose response related to efficacy and safety of de-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.


Eligibility criteria:
inclusion criteria: * those who show: * keratoconjunctival disorder confirmed with vital dye staining * abnormal schirmer score results exclusion criteria: * eye disease that needs therapy other than that for dry eye * those who need to wear contact lenses during the clinical study
interdisciplinary pituitary disorders centre of excellence: assessment of patient education tools

Conditions: Pituitary Neoplasms; Prolactinoma; ACTH-Secreting Pituitary Adenoma; Gigantism; Growth Hormone-Secreting Pituitary Adenoma

Summary: the purpose of this research study is to determine the utility of educational materials designed to inform patients of their pituitary condition, in an effort to assist the patients, families, and staff deal with pituitary tumours and related conditions in the best way possible. we have developed a website, informational videos, and a brochure for pituitary tumour patients and their families. the primary outcome measures will be 1) the level of knowledge that patients have of their condition before and after reviewing the materials provided; and 2) ease of use and user satisfaction of the materials. we hypothesize that our informative multimedia educational package will not only improve the health literacy and self-efficacy of patients and their families, but will also improve quality of care.

this study involves a formative evaluation of the health literacy resources that we have already developed. we see approximately 60 new patients a year with pituitary disorders, plus the follow-up patients: all of these patients will be offered the opportunity to participate in the study. these materials include a website (containing videos, illustrations and written materials) and plain language educational brochures. the educational materials include information that patients will need throughout their experience with a pituitary tumour, ranging from the signs and symptoms of tumours, to long-term post-operative lifestyle changes. this evaluation will be a mixed-methods evaluation. part a (think aloud) will use "think-aloud" processes to evaluate the usefulness and ease of use of a website that we have developed with patients and their families. part b (resource assessment) will involve the use of questionnaires followed by semi-structured interviews with patients and families before and after using the resources.

Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years; * capable of providing consent to participate on their own behalf; * diagnosed with a pituitary disorder or have a history of pituitary disorder and a current/former patient at st. michael's hospital, or be a caretaker of someone with a pituitary disorder; * adequate written/verbal english skills. exclusion criteria: * younger than 18 years; * unable to provide consent; * unable to communicate in written/verbal english, as all of the surveys and interviews are administered in english
a study of bms-986253 in combination with nivolumab or nivolumab plus ipilimumab in advanced cancers

Conditions: Cancer; Melanoma

Summary: the purpose of this study is to investigate experimental medication bms-986253 in combination with nivolumab or nivolumab plus ipilimumab in participants with advanced cancers.


Eligibility criteria:
inclusion criteria: * histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per recist v1.1 * at least 1 lesion accessible for biopsy * eastern cooperative oncology group performance status of 0 or 1 exclusion criteria: * participants with cns metastases as the only site of active disease (participants with controlled brain metastases; however, will be allowed to enroll) * participants with active, known or suspected autoimmune disease * participants with conditions requiring systemic treatment with either corticosteroids (\> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration * participants with a known history of testing positive for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids) * cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy other protocol defined inclusion/exclusion criteria could apply
omeprazole and reflux disease - improvement of clinical outcome by genotype-adjusted dosing

Conditions: Gastroesophageal Reflux

Summary: patients with gastroesophageal reflux disease (gerd) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. the individual elimination capacity is genetically controlled and therefore all patients will be genotyped prior to therapy.


Eligibility criteria:
inclusion criteria: * patients with gerd grade a and b (mild to moderate severe disease) diagnosed by routine endoscopy will be recruited in different clinical and ambulant centres of gastroenterology; written informed consent is obligatory * range of age: 20-70 * bmi: 20-30 exclusion criteria: * patients who are allergic to proton-pump inhibitors or show incompatibility * patients who have lactase deficiency * patients who have severe chronic disease * patients who participated in another study during the last three months * patients who are pregnant

Keywords: gastro-oesophageal reflux disease
predictive factors, demographics and mortality for ards in burn patients

Conditions: ARDS, Human; Burns; Lung Diseases

Summary: this retrospective study characterizes the clinical course and identifies four independent predictors of acute respiratory distress syndrome (ards) after burn injury (post-burn ards; pbards). in addition, a clinically useful prognostic score for pbards is introduced (ards burn score), which was derived from these independent predictors. the newly developed score may be helpful for the development of specific treatment strategies.

rationale: acute respiratory distress syndrome (ards) after burn injury (post-burn ards; pbards) is a severe complication associated with a mortality of up to 44%. to date, only few studies have been published on the clinical course and predictive factors of pbards. objectives: to characterize the clinical course of pbards, to identify relevant predictors, including the development of a prognostic score, and to examine outcome parameters such as mortality and hospitalization days. methods: a retrospective analysis of 400 patients admitted to the burns intensive care unit of the university hospital zurich from 2004 to 2009 was performed. multivariate logistic regression was used to determine independent risk factors for pbards. a prognostic score was developed, which was tested with leave-one-out-cross-validation and receiver operating characteristic (roc) curves.

Eligibility criteria:
inclusion criteria: all patients treated at the burns intensive care unit (bicu) of the university hospital zurich (usz) between january 2004 and december 2009. exclusion criteria: exclusions were made because of incomplete or unavailable data, re-hospitalization due to complications of previous burns, and the initial decision not to resuscitate due to unfavorable prognosis.

Keywords: ards, human burns lung diseases risk factors retrospective studies decision support techniques
pharmacokinetics of xuebijing in patients with sepsis

Conditions: Sepsis; Septic Shock; Community Acquired Pneumonia

Summary: pharmacokinetics and disposition of xuebijing compounds in patients with sepsis

xuebijing injection, a five-herb combination approved by chinese fda in 2004, has been widely used as an add-on therapy in routine sepsis care in chinese clinics. a comprehensive pharmacokinetic research on this herbal injection has been conducted in healthy human subjects, and the major circulating xuebijing compounds, as well as their systemic exposure levels and forms and pharmacokinetic characteristics, have been identified. however, it is known that sepsis may induce hepatic, renal and cardiac dysfunction, alter drug metabolizing enzymes and transporters activities, increase capillary permeability, and induce various pathophysiological changes. all these will affect the concentrations at the action sites and pharmacokinetic characteristics of xuebijing compounds, which contribute to the injection's overall therapeutic action, thus influencing the anti-septic efficacy of the injection. the purpose of this prospective, open label study is to identify the circulating xuebijing compounds in patients with sepsis after intravenously dosing xuebijing injection and their systemic exposure forms and levels, pharmacokinetic characteristics, and the associated inter-patient differences of these xuebijing compounds.

Eligibility criteria:
inclusion criteria: * 18≤ age ≤70 years old * community acquired pneumonia patients who met the sepsis-3 criteria from society of critical care medicine (sccm) /european society of intensive care medicine (esicm) with2 ≤sofa ≤13 * to use xuebijing injection as an add-on therapy to treat sepsis decided byclinician * informed consent obtained exclusion criteria: * diagnosis of sepsis for over 48 h * pregnant or lactating women * patients with a history of anaphylaxis or allergyto xuebijing or its component herbs * patients participated in an investigational clinical trial within 30 days prior to this study * patients unable or unsuitable to participate in this study decided by the investigator (i.e., patients whose death are deemed within 48 h or who poorly adhere to the treatment)

Keywords: xuebijing injection sepsis septic shock pharmacokinetics
sexually active adolescent focused education

Conditions: Health Risk Behaviors

Summary: saafe will be pilot tested in 2 geographically distinct areas (washington, dc and deep south) with 100 participants from each site to 1) primarily assess the efficacy of improved self-efficacy, knowledge about hiv/stis and perception of sexual risks by aaas, and (2) secondarily detect intention to be tested for stis and to change sexual risk behavior (i.e., use a condom).

a total of 200 african american adolescents (aaa) males and females will be recruited from washington, dc (n=100) and birmingham, alabama (n=100). at both data collection sites, participants will be randomly assigned to one of two groups during the pilot. the two groups are: 1. intervention group (n=100) - will consist of 50 aaa males / 50 aaa females randomly selected participants who will receive a download of the saafe game and play for at least 30 minutes and as long as an hour, if desired. 2. control group (n=100) - will consist of 50 aaa males / 50 aaa females randomly selected participants. this group will receive dating sim game (called choices). they will also receive pamphlets that provide information on the testing location and care if they have hiv/sti.

Eligibility criteria:
inclusion criteria: * african american female or male * between 15-21 years of age exclusion criteria: * pregnant women * the first 6 weeks post-partum * adolescents younger than 15

Keywords: mobile dating simulation game sexual education hiv sti consent
subcapsular orchiectomy in men with klinefelter syndrome

Conditions: Klinefelter Syndrome

Summary: men with klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed testicular tissue is examined for presence of sperm and cryopreserved in small pieces for fertility treatment and scientific purposes. prior to operation blood samples are frozen in a biobank.


Eligibility criteria:
inclusion criteria: * klinefelter * 15-40 years of age exclusion criteria: * inability to understand the study
study of two complementary and alternative medical treatments for maintenance of weight loss

Conditions: Obesity

Summary: the goal of this study is to pilot test in a group of overweight-obese individuals the feasibility and acceptability and indications of efficacy of two cam treatments, qigong, and acupressure-tat, for improving long term maintenance of weight loss.

the prevalence of obesity is at epidemic proportions, 60% of us adults are overweight or obese. obesity contributes to chronic diseases (diabetes, cardiovascular disease \[cvd\], hypertension, cancer, and osteoarthritis) and to escalating health care costs. weight loss can have a substantial impact on reducing these conditions. substantial efforts have been made in developing effective short-term weight loss programs using behavioral treatments. however, long-term maintenance of weight loss continues to be problematic - many individuals regain the weight lost within a year. innovative intervention options are critically needed to help people successfully maintain weight loss and to fight the obesity epidemic. complementary and alternative medicine (cam) approaches-mind-body, energy healing, and traditional chinese medicine (tcm) approaches may hold great promise for helping improve the maintenance of weight loss.

Eligibility criteria:
inclusion criteria: * bmi 25-35 kg/m 2 * reside in portland metropolitan area * willing to complete the 12-week weight loss program * willing to accept random assignment to one of the three maintenance treatment conditions * willing to provide informed consent exclusion criteria: * medical conditions or treatments that would be contraindicated using a diet \& exercise weight loss treatment * cancer * significant gi disease inappropriate for diet and physical activity intervention * diabetes dependent on insulin or oral hypoglycemic medications * psychiatric hospitalization in past 2 years * conditions that require limitation of physical activity * congestive heart failure * cardiovascular disease (stroke, mi, cabg, ascvd) * taking weight loss medications currently or within past 6 months * previous history of complementary or alternative medicine (cam) weight loss treatment * current acupressure, or qi gong, or acupuncture * reported consumption of more than 21 alcoholic drinks per week * planning to leave the area prior to the end of the program * body weight change \> 10 pounds in the 6 months prior to screening visit one * pregnant, breast feeding, or planning pregnancy prior to the end of participation * current participation in another clinical trial * investigator discretion for safety or adherence reasons * household member of another cam wt participant * unavailable for group sessions

Keywords: overweight weight loss maintenance cam therapy qigong acupressure traditional chinese medicine
effects of exercise on metabolic parameters in classical homocystinuria

Conditions: Homocystinuria

Summary: the aim of this research project is to compare the effect of an aerobic exercise session in two different populations. sampling biological material and collecting health-related personal data entails minimal risks and burdens. participants will be asked to perform 30 minutes of an aerobic exercise on an ergocycle at a fixed power output to correspond to a moderate intensity for a sedentary population.

background among genetic causes of hyperhomocysteinemia, classical homocystinuria, manifest not only with vascular diseases but also with neurological symptoms. this is related to the higher homocysteine concentration of up to 150-300 μmol/l without treatment. recently, some articles have shown that mild and temporary hyperhomocysteinemia may follow exercise in a healthy population. investigators hypothesized that increase in homocysteine may be of greater importance in patients with classical homocystinuria where cystathionine beta-synthase deficiency prevents homocysteine metabolism. objective to investigate the effect of an aerobic exercise in patients with classical homocystinuria on metabolic parameters compared to healthy controls.

Eligibility criteria:
inclusion criteria for subjects: * informed consent as documented by signature * confirmed biallelic mutation of cystathionine beta-synthase deficiency gene (homozygous or compound heterozygous) in an accredited laboratory * continuation of their regular treatment under same dose (e.g. vitamin b6, b9 and b12, betaine) as prior to the study inclusion inclusion criteria for controls: - healthy exclusion criteria: * any clinically instable concomitant disease * individuals with acute cardiac events, syncope, rhythm disturbances or unstable hypertension in the past 6 months * individuals with vitamins b9 or b12 deficiencies * homocysteine \> 100 µmol/l (for subjects) * homocysteine \> 20 µmol/l (for controls)
a 2 week, crossover trial of dietary nitrate in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including copd. the chronic effect of dietary nitrate in obstructive sleep apnea syndrome (osas) has not been reported.

acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including copd. the chronic effect of dietary nitrate in osas has not been reported. the investigators hypothesize that chronic nitrate consumption might increase exercise tolerance, and exhaled no but decrease blood pressure and have little impact on quality of life and pulmonary function. this study is a randomized, double-blind placebo-controlled, crossover trial. at baseline, mid-point and endpoint exercise tolerance, pulmonary function, quality of life and ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. after baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.

Eligibility criteria:
inclusion criteria: * clinically stable, * diagnosed with copd * ambulatory out-patients exclusion criteria: * long term oxygen therapy * pulmonary hypertension * active cardiovascular disease * active skeletal conditions * taking vasodilators * diabetes mellitus
evaluation of hepagam b® in combination with antiviral treatment in hepatitis b liver transplant patients

Conditions: Hepatitis B; Liver Transplantation

Summary: the purpose of the study is to assess the pharmacokinetics, safety and efficacy of hepagam b in combination with antiviral therapy for the prevention of hepatitis b virus (hbv) recurrence following hbv-related orthotopic liver transplant.


Eligibility criteria:
inclusion criteria: * written informed consent * hbsag-positive candidates for hbv-related liver transplant * treatment with antiviral therapy before transplantation as per treating physician's recommendation. (note: it is expected that most patients will receive lamivudine or adefovir dipivoxil pre-transplant. in the case of antiviral resistance, an effective alternative antiviral agent(s) must be used.) exclusion criteria: * multi-organ transplantation recipients * liver re-transplantation except for primary non-function * presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal nodes (larger than 3.0 cm each) (milan criteria) based on information available at baseline visit (ct scan, mri). * patients requiring an olt (orthotopic liver transplant)due to fulminant hepatitis b * olt patients receiving a liver graft from a donor that is positive for hbsag * patients using interferon pre-transplant (as interferon cannot be used post-transplant) * history of iga (immunoglobulin a) deficiency * history of hypersensitivity to blood products. * hiv or hcv positive * use of an investigational product, or participation in another clinical trial during the course of the study (with the exception of quality-of-life or repository studies) * pregnancy or planned pregnancy during the course of the study

Keywords: hbig (hepatitis b immune globulin) chronic hepatitis b recurrence liver transplant