Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of chp-her2 and chp-ny-eso-1 protein with ok-432 in antigen-expressing cancers

Conditions: Esophageal Cancer; Lung Cancer; Stomach Cancer; Breast Cancer; Ovarian Cancer

Summary: mixed cancer vaccines, chp-her2 protein and chp-ny-eso-1 protein, are to be studied to evaluate the safety and immune responses in patients who are positive either or both antigens. nine patients will be enrolled, who are refractory to standard therapies for cancer or at high risk to relapse. chp-her2 and chp-ny-eso-1 are subcutaneously given on bimonthly basis, together with ok-432(picibanil) as an immunoadjuvant. six doses will be given. toxicity profiles will be monitored, and antigen specific humoral anad t cell responses will be described.


Eligibility criteria:
inclusion criteria: 1. histological confirmation of cancer. 2. her2 expression in tumor cells scored as 1+ or more which should be confirmed by ihc using at least two antibodies (archived issue; see appendix 1 and reference 1 for methodology). or ny-eso-1 expression by reverse transcriptase and polymerase chain reaction (rt-pcr) analysis (appendix 2), preferably, or immunohistochemistry 3. patients must 1. are at high risk of recurrence, more than 25% of probability, after complete resection or even after post-operative adjuvant treatment, and effective adjuvant therapy is not available or refused; or 2. have metastatic disease, and treatment has failed, or in the situation where effective therapy is not available, or has been refused. 4. complete recovery from surgery (at least 4 weeks). 5. laboratory values within the following limits: hemoglobin 9.0 g/dl or more, or 10.0 g/dl or more if \ 1.5 x 109/l lymphocyte count \>0.5 x 109/l platelet count \>100 x 109/l serum creatinine ≤ 1.8 mg/dl serum bilirubin ≤ 2 mg/dl 6. performance status \> 70 (karnofsky scale) and life expectancy \>3 months. 7. age 18 years or more. exclusion criteria: 1. clinically significant heart disease (nyha class iii or iv). 2. cardiac dysfunction; less than 50% of ejection fraction by echocardiogram. 3. immunodeficiency disease. 4. other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders. 5. previous bone marrow or stem cell transplant. 6. metastatic disease to the central nervous system, unless treated and stable. 7. known hiv antibody positivity. 8. anaphylactic reaction to previous vaccination. 9. hypersensitivity to penicillin 10. chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas). 11. concomitant treatment with steroids. topical or inhalational steroids are permitted. 12. participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. 13. pregnancy or nursing . 14. refusal, by women of childbearing potential, to use medically acceptable means of contraception. 15. mental impairment that may compromise the ability to give informed consent. 16. lack of availability for immunological and clinical follow-up assessment.
evaluation of 3aps in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this phase iii study is to evaluate the efficacy and safety of 3aps compared to placebo (inactive substance pill) in patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: patients may be included in this study if they meet all of the following criteria: * male or female (age 50 years and older): female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal). * diagnosis of probable alzheimer's disease based on the national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds-adrda criteria). * severity of dementia of mild to moderate degree as assessed by the mini mental state examination (mmse) performed at the screening visit. * patient must be living in the community with a reliable caregiver. participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver. * potential participant must be treated with conventional alzheimer's disease therapies and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period. * fluency in english, french or spanish (oral and written). * signed informed consent from potential participant or legal representative and caregiver. exclusion criteria: patients will not be eligible to participate in the study if they meet any of the following criteria: * potential participant with any other cause of dementia. * life expectancy less than 2 years. * potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease. * use of an investigational drug within 30 days prior to the screening visit or during the entire study. * previous use of 3aps. patient recruitment is done by participating centers.

Keywords: alzheimer disease
sinolpan® pharmacy non-interventional study - quality of live

Conditions: Rhinosinusitis Acute; Rhinosinusitis Chronic; Bronchitis

Summary: this non-interventional study investigates the quality of life of patients suffering from rhinosinusitis. patients who seek advice in a pharmacy and choose to intake sinolpan® or sinolpan® forte or to use nasally applied α-sympathomimetics can participate in this anonymous patient survey.

within the scope of this non-interventional observational study, the quality of life of rhinosinusitis patients under self-medication with the 1,8 - cineole preparation sinolpan® or sinolpan® forte (sinolpan® group) or with a nasally applied α-sympathomimetic (control group) is investigated during conditions of daily life. patients who seek advice from a pharmacy regarding the treatment of their symptoms and who choose sinolpan® (forte) or a nasal α-sympathomimetic can participate in this study and are asked to complete a questionnaire before and after the treatment. for organizational reasons, the recruitment of patients for the sinolpan® group (planned number of patients: 500) or the control group (planned number of patients: 50) is conducted in different pharmacies. the primary objective of this anonymous data collection is to assess the quality of life in patients with rhinosinusitis. the german version of the rhinosinusitis quality of life questionnaire, which was only recently validated in a doctoral thesis, is used for this purpose. additionally, for patients in the sinolpan® group who also suffer from bronchitis, the bronchitis severity score is determined. in addition, data on side effects and tolerability of the treatment as well as on patients' satisfaction are collected.

Eligibility criteria:
inclusion criteria: * suitable patients for the sinolpan® group are patients aged 18 years or older who seek advice from a pharmacy regarding the treatment of their acute or chronic (rhino) sinusitis and, where appropriate, their bronchitis and who choose the intake of sinolpan® (forte) for therapy. * suitable patients for the control group are patients aged 18 years or older who seek advice from a pharmacy regarding the treatment of their acute or chronic (rhino) sinusitis and who choose to apply nasal α-sympathomimetics for therapy. exclusion criteria: * according to the instructions for use

Keywords: quality of life
study on effects of defect closure in laparoscopic repair of direct inguinal hernia

Conditions: Hernia; Direct Inguinal Hernia; Seroma Following Procedure

Summary: the defect closure was found to have higher pain and less seroma formation at various intervals of time following tep for moderate-large direct inguinal hernia. although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested.

inguinal hernia is a common and widespread condition from which millions of people suffer. repair of an inguinal hernia is one of the most frequently performed operations in general surgery. totally extraperitoneal (tep) and transabdominal preperitoneal (tapp) repair are the principal techniques in laparoscopic hernia repair. laparoscopic hernia repair is recommended for bilateral and recurrent inguinal hernias. it has also been recommended for patients with primary unilateral inguinal hernia, contingent on the availability of surgical expertise and resources, due to a lower incidence of post-operative pain and chronic pain. seroma formation is a frequent complication of laparoscopic mesh repair of moderate-large direct inguinal hernia defects. while rates of seroma formation have been reported to be as high as 10-30%. several attempts have been made to reduce the incidence of seroma formation, such as tacking the transversalis fascia (tf) to the ramus of the pubis, closing the direct inguinal hernia defect via the endoloop technique, and filling the potential dead space with fibrin glue. however, there is a potential increase in the risk of infection and also a risk of chronic pubic bone pain from the tack staples or vasculo-nervous injury if fixing the tf to the abdominal wall, which would lead to extra discomfort for the patient. the closure of a direct hernia defect with a barbed suture not only closes the defect superficially but also exterminates the defect cavity; consequently, the incidence of seroma formation has been greatly reduced. however, there is still controversial evidence regarding the choice of the two procedures in terms of reducing the rate of seroma formation and pain. thus, it is ambiguous which surgical technique should be considered best to repair an inguinal hernia. in this study, we tried to evaluate the technical aspect of direct defect closure in laparoscopic tep inguinal hernia repair and its effect on the primary outcomes in terms of seroma formation and pain at different time intervals, along with the secondary outcomes such as operative time, length of postoperative hospital stay, days to resume normal activities, recurrence, and intraoperative complications like injury to the vas, vessel, and visceral injury or peritoneal tear.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * uncomplicated direct inguinal hernia (≥m3) exclusion criteria: * defect size ≤m2 * complicated hernia (irreducible, obstructed, or recurrent hernia) * patients unfit for general anesthesia

Keywords: tep direct hernia closure seroma formation pain
increased lung volume as controller therapy for asthma

Conditions: Asthma

Summary: this is an early phase clinical trial to test the efficacy of elevating lung volume with positive expiratory pressure (cpap) as a controller therapy for asthma in patients with a bmi ≥ 30 kg/m2. there will be two phases to this trial. phase i: in the first phase we will determine the optimal duration of cpap that is effective as a controller therapy in asthma. up to 9 participants will complete this this phase. phase ii: the 2nd phase will be a randomized double-blinded controlled trial of sham cpap versus cpap 10 (using the duration of cpap determined in phase i) as a controller therapy for asthma, and also to determine the effect o airway reactivity in healthy people with a bmi 30 kg/m2 and above. twenty people with asthma and twenty controls will complete this phase.

the effect of 10 versus 0 cmh2o cpap on airways responsiveness to inhaled methacholine will be studied using an adaptive "3+3" phase i/ii study design. dose titration phase (phase i): the efficacy of 8 hours of cpap on airway responsiveness will be tested in three subjects. efficacy will be defined as a 25% improvement in the impedance response to methacholine in all three subjects. if this occurs in all subjects, shorter durations of cpap will be studied (4 hours then one hour). conversely, if "dose escalation" is required, 3 nights, then 7 nights of cpap will be studied. randomized-controlled study phase (phase ii): participants will be randomized to cpap 10 or sham 0. the duration of cpap will be determined in the dose titration phase. the effect on response to inhaled methacholine, lung function and asthma control will be determined in patients with asthma and a bmi ≥ 30 kg/m2, and also in healthy controls without asthma

Eligibility criteria:
inclusion criteria for people with asthma: 1. physician diagnosis of asthma 2. pc20 to methacholine \< 16 mg/ml 3. ige \< 100 iu/ml 4. ages 18-65 years 5. bmi \>=30 kg/m2 inclusion criteria for controls: 1. no physician diagnosis of asthma 2. pc20 to methacholine \> 16 mg/ml 3. ige \< 100 iu/ml 4. ages 18-65 years 5. bmi \>=30 kg/m2 exclusion criteria: 1. fev1 \< 60 % predicted 2. other significant disease that in the opinion of the investigator would interfere with study. 3. inability to perform required testing. 4. smoking within last 6 months. 5. ≥ 20 pack year smoking history 6. inability to provide informed consent 7. pregnancy 8. known obstructive sleep apnea/ high likelihood of obstructive sleep apnea 9. asthma exacerbation in the prior 6 weeks 10. stoke or heart attack in the prior 3 months 11. known aortic aneurysm 12. renal failure 13. a known severe heart, vascular, liver, renal, or hematological disease 14. active allergic rhinitis 15. recent eye surgery (within the last month)

Keywords: asthma obesity
to demonstrate the relative bioavailability of cilostazol 50 mg tablets under fasting conditions

Conditions: Pain

Summary: to demonstrate the relative bioavailability of cilostazol 50 mg tablets under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
lumbar segmental stabilization and tens in lumbar disc herniation

Conditions: Lumbar Spine Disc Herniation

Summary: the purpose of this study was to compare the efficacy of method lumbar segmental stabilization and transcutaneous electrical nerve stimulation (tens) on pain, functional disability and ability to activate the transversus abdominis (tra) of individuals with chronic back pain caused by disc herniation.

objective: to contrast the efficacy efficacy of method lumbar segmental stabilization and tens on pain, functional capacity and ability to activate the tra of individuals with chronic back pain caused by disc herniation. design: sixty patients are being randomized into two groups namely: lumbar segmental stabilization (ls ) (specific exercises for the muscles transversus abdominis and lumbar multifidus) (n = 30) and tens group (tg) (n = 30) receiving assistance under a current of transcutaneous electrical nerve stimulation (tens). groups were contrasted regarding pain (visual analogical scale and mcgill pain questionnaire), functional disability (oswestry disability questionnaire) and tra muscle activation capacity (pressure biofeedback unit = pbu). the program lasts for 8 weeks, and sessions happen twice a week, with duration of one hour each. evaluations will be performed before, after and with a follow-up six months after treatment. significance level is established at 5%.

Eligibility criteria:
inclusion criteria: * chronic low back pain (pain for more than three months) or sciatica caused by disc herniation diagnosed by magnetic resonance imaging or computed tomography exclusion criteria: * prior back surgery, * cancer, * rheumatic diseases or infection. patients involved in sports or resistance training for the lumbar spine during the three months prior to the beginning of treatment or other causes of pain and sciatica such as lumbar spinal canal stenosis and lumbar spondylolisthesis have also been excluded.

Keywords: lumbar disc herniation clinical trial exercise therapy tens
safety and treatment outcome study of prochymal® (remestemcel-l) intravenous infusion in subjects with treatment-resistant crohn's disease

Conditions: Crohn's Disease

Summary: protocol 620 provides prochymal(r) adult human mesenchymal cells to specifically chosen crohn's disease patients at participating centers who typically have already demonstrated good response in another prochymal study, are not eligible for other prochymal studies, and in the view of the investigator, would not benefit significantly from other crohn's therapies but would benefit from use of prochymal. the study is not placebo-controlled or randomized.


Eligibility criteria:
inclusion criteria: * currently active moderate-to-severe crohn's disease * exhausted standard-of-care options * age 18 to 70 inclusive * body weight between 30 and 150 kg * adequate renal function * not at risk for tuberculosis (tb) activation or re-activation exclusion criteria: * biologic therapy for crohn's within last 8 weeks * confirmed adverse reactions during prior prochymal study participation * alcohol or substance abuse, current or within past 6 months * active hiv or hepatitis b or c infection * surgery or trauma with 6 weeks * allergy to bovine or porcine products * elevated serum liver enzymes * elevated serum bilirubin * active malignancy within 5 years (other than some resected skin cancers) * bacteremia or other serious bacterial or fungal infection within 3 months * colonic dysplasia * unstable arrhythmia or serious heart condition
impact of a patient decision aid for treatment of aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: this project will evaluate the impact of a patient decision aid created by the american college of cardiology for patients considering treatment of aortic stenosis. the decision aid describes surgical aortic valve replacement (savr) surgery and transcatheter valve replacement surgery (tavr).

the pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. the study will recruit patients at massachusetts general hospital or at the university of colorado health heart and vascular center, anschutz medical in denver, colorado and randomly assign them to usual care arm or decision aid arm. the decision aid will be given to the participant in clinic at the time of their appointment. patient participants in both arms will be asked to complete a short survey after the visit. the survey will assess knowledge, treatment preference, shared decision making (sdm), and decisional conflict. analyses will compare the two arms on these outcomes to generate preliminary data on impact of the intervention.

Eligibility criteria:
inclusion criteria: * adults 18-85 years only * english speaking * severe aortic stenosis, defined as an aortic valve area \< 1 cm2 * never had avr or who had previous avr \> 6 months previous * patients perceived by the clinician to be at low or intermediate risk for savr exclusion criteria: * concomitant disease of another heart valve or the aorta that required either transcatheter or surgical intervention

Keywords: shared decision making
a study to test how food influences the amount of bi 1323495 in the blood of healthy men

Conditions: Healthy

Summary: the main objective of this trial is to assess the effect of food on the pharmacokinetics of an oral tablet formulation of bi 1323495 by investigating the relative bioavailability following single dose administration under fed and fasted conditions.


Eligibility criteria:
inclusion criteria: * healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests * age of 18 to 45 years (inclusive) * body mass index (bmi) of 18.5 to 29.9 kg/m\^2 (inclusive) * signed and dated written informed consent prior to admission to the study, in accordance with good clinical practice (gcp) and local legislation exclusion criteria: * any finding in the medical examination (including blood pressure (bp), pulse rate (pr) or electrocardiogram (ecg)) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * history of relevant orthostatic hypotension, fainting spells, or blackouts * chronic or relevant acute infections * history of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients) * use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause qt/qtc interval prolongation) * intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered * further exclusion criteria apply
benefits study of respiratory-gated pet acquisition in lung disease

Conditions: Lung Cancer; Non Small Cell Lung Cancer; Chronic Obstructive Pulmonary Disease

Summary: fluorodeoxyglucose (fdg) positron emission tomography (pet) is now widely used for cancer imaging purpose, notably for preoperative work-up. it aims at visualizing organs metabolism. in case of cancer, metabolism is, classically, increased and some hot spots are visible on pet images. because of respiratory motion some lung tumours (especially the smallest ones) can be falsely interpreted by the clinician. the investigators developed a respiratory-gated pet method in order to reduce the motion issue. the investigators designed a study to investigate its effect on lung cancer (primary or metastasis) to check if it improves the sensitivity/specificity of pet imaging of the lungs. to that aim, patients presenting a lung nodule on a ct examination can be proposed to participate this study. after the standard pet acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated pet acquisition is performed without additional injection. after that, a breath-hold (\~10s) ct is performed.


Eligibility criteria:
inclusion criteria: * patient has one or more lung lesion(s) less than 35 mm visible on a ct image * age : over 18 years * patients gave their written informed consent exclusion criteria: * pregnancy * patient has at least one lesion more than 35 mm in its great axis

Keywords: pet/ct 18f-fluoro-2-deoxyglucose lung neoplasms respiratory motion