Kornimate/medical-research-clean huggingface dataset:
open-label study of the safety and immunogenicity of heplisav™ hepatitis b virus vaccine

Conditions: Hepatitis B

Summary: the purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis b virus (hbv) vaccine, heplisav™, in subjects 11-55 years old. the primary hypothesis is that heplisav™ is well tolerated.

this study will evaluate the safety and efficacy of two injections of heplisav™ in subjects 11 to 55 years old. about 200 subjects will be included in the study. once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity. comparison: this study does not include a control treatment; all subjects will receive treatment with heplisav™.

Eligibility criteria:
inclusion criteria: * willing and able to give written informed consent * women of childbearing potential must be willing to consistently use a highly effective method of birth control exclusion criteria: * women who are pregnant or breastfeeding * any previous hbv infection * previous vaccination (1 or more doses) with any hbv vaccine * any previous autoimmune diseases * are at high risk for recent exposure to hbv, hepatitis c virus (hcv) or human immunodeficiency virus (hiv) * received any blood products or antibodies within 3 months prior to study entry * ever received an injection with dna plasmids or oligonucleotides * received any vaccines within 4 weeks prior to study entry * received any other investigational medicinal agent within 4 weeks prior to study entry

Keywords: hepatitis b vaccine hbv vaccine hepatitis b hepatitis hbv vaccine 1018 hbsag
endometrial cancer - lohp alone and with 5fu

Conditions: Endometrial Cancer

Summary: to determine the efficacy (response rate \[rr\], time to progression and survival) of oxaliplatin as a single agent and oxaliplatin in combination with 5 fu in patients with advanced/metastatic endometrial cancer pretreated with one prior chemotherapy regimen containing cisplatin (cddp) or carboplatin and to define the safety profile of each arm of the above mentioned regimens in these patients


Eligibility criteria:
inclusion criteria: * patients aged at least 18 years, with locally advanced, recurrent or metastatic endometrial adenocarcinoma, histologically diagnosed; at least 1 bidimensionally measurable lesion (\> or =to 2 cm on computed tomography \[ct\]/magnetic resonance imaging \[mri\] or \> or =to 1 cm clinical lymph node confirmed by ultrasound or \> or =to 1 cm skin lesion confirmed by photograph with ruler) located in a non-irradiated area measured less than 2 weeks before inclusion, according to the national cancer institute common toxicity criteria (nci-ctc). * patients previously treated for locally advanced/metastatic disease with chemo-radiotherapy (total cddp dose \> or =to 100 mg/m2) or chemotherapy containing cddp or carboplatin with at least 4 weeks' washout period from discontinuation of prior chemotherapy and fully recovered from toxic effects of prior chemotherapy (except for symptomatic peripheral neuropathy \< or =to nci-ctc grade 1 or alopecia). * patients with clinically or radiologically documented pd or recurrence during or after last chemotherapy and hormone therapy (hormone therapy stopped before study entry), eastern cooperative oncology group performance status (ecog ps) \ or =to 3 months, adequate bone marrow reserve, normal renal and liver function (neutrophil count \> or =to 2000/mm³; platelet count \> or =to 100 000/mm³; creatinine levels \ 60 ml/min; total bilirubin level \< 1.5 x uln; \[alanine amino transferase/aspartate amino-transferase \< 2.5 x uln without liver metastases, \< 5 x uln with liver metastases\]). * laboratory values obtained in the week preceding study entry. * signed informed consent (prior to all study procedures)
testosterone-dependent effects on protein biomarkers from healthy males

Conditions: Hypogonadism, Male

Summary: the study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. after three weeks the subjects received an intramuscular injection of testosterone undecanoate. blood samples from just before pharmaceutical castration, three weeks after castration, and one week after injection of testosterone undecanoate were collected representing normal testosterone levels, low testosterone levels, and testosterone at eugonadal levels.


Eligibility criteria:
inclusion criteria: healthy males exclusion criteria: use of anabolic steroids, use of narcotics,
the bear iii trial for bridge-enhanced acl (anterior cruciate ligament) restoration

Conditions: Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture

Summary: bridge-enhanced acl restoration (bear) is a new procedure being developed to treat patients with acl injuries. in the bear procedure, an implant is placed between the torn ends of the acl and the patient's own blood is added to the implant to stimulate ligament healing. we propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. this is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced acl repair (bear) as defined by an 11.5 point difference on the ikdc subjective or objective knee evaluation score at two years after surgery. additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

the bear iii study is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced acl restoration (bear) as defined by an 11.5 point difference on the ikdc subjective or objective knee evaluation score at two years after surgery. additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

Eligibility criteria:
inclusion criteria: acl tear, within 50 days of injury, at least 5% of the acl attached to the tibia. - exclusion criteria: prior surgery on the affected knee, history of knee infection, use of tobacco, use of corticosteroid, chemotherapy, allergy to bovine products or gelatin, history of anaphylaxis, bmi over 35, moderate osteoarthritis. -
prostate cancer individual signature evaluation trial in patients undergoing scheduled prostate biopsy

Conditions: Prostate Cancer

Summary: the purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. such a test will serve to reduce the number of unnecessary prostate biopsies.


Eligibility criteria:
inclusion criteria:. 1. male over the age of 40. 2. patient is scheduled for prostate biopsy for one or more of the following reasons: * psa \> 2.5 ng/ml * rising psa (\>0.5 ng/ml/yr) * lower psa value with other risk factors for prostate cancer (e.g.; family history) * abnormal dre * percent free psa \<15% 3. no prior history of prostate cancer or prostate biopsy. exclusion criteria: * unable or unwilling to provide informed consent

Keywords: prostate cancer
a phase iii clinical study of kw-2246

Conditions: Pain, Cancer

Summary: this study is designed to assess the safety and efficacy of long-term kw-2246 treatment as rescue medication for breakthrough pain.


Eligibility criteria:
inclusion criteria: * provide written informed consent to participate in the study on a voluntary basis. * patients who have been eligible for the confirmatory trial by meeting the inclusion criteria applicable at the time of giving written informed consent and those applicable at the time of randomization, and who have completed the confirmatory trial. * outpatients who live with a caregiver such as a family member, or inpatients. * require rescue medication at least 0.5 times (at least once every two days) but not more than three times per day on average as determined by the investigator. * performance status (ecog) of 3 or less at the time of giving written informed consent. * have a life expectancy of at least three months as determined by the investigator. * be able to receive diary training and have been able to properly complete diaries during the confirmatory trial. exclusion criteria: * have experienced intolerable adverse reactions (as defined in attachment 3) during the confirmatory trial. * have met any of the exclusion criteria applicable at the time of giving written informed consent, those applicable at the time of randomization, or subject withdrawal criteria in the confirmatory trial. * serious respiratory dysfunction. * asthma. * serious bradyarrhythmia. * serious hepatic dysfunction. * serious renal dysfunction. * susceptibility to respiratory depression due to conditions such as increased intracranial pressure, head injury and brain tumor. * patients who have a history of clinically significant adverse reactions to the combination of opioid analgesics and any of the following drugs/substances, and who are currently receiving or expect to receive any of them during the study: central nervous system depressants (phenothiazines, benzodiazepines and barbiturates), inhalation anesthetics, monoamine oxidase inhibitors, tricyclic antidepressants, skeletal muscle relaxants, antihistamines, ritonavir, alcohol, itraconazole, amiodarone, clarithromycin, diltiazem, and fluvoxamine. * history of convulsive seizures (except a single episode of infantile febrile convulsions). * history of hypersensitivity to fentanyl. * pregnant or lactating women, possibly pregnant women, or women who are planning to become pregnant. * patients who are judged by the investigator/subinvestigator to be inappropriate for this study.

Keywords: pain, cancer
study of neurologic progression with motexafin gadolinium and radiation therapy (smart)

Conditions: Brain Neoplasms; Carcinoma, Non-Small-Cell Lung; Metastases, Neoplasm

Summary: the primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with motexafin gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.


Eligibility criteria:
inclusion criteria: * adults (≥18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer; * kps score of ≥70; * each patient must sign a study-specific informed consent form exclusion criteria: * liver metastases; * extracranial metastases in two or more organs; * known leptomeningeal metastases or subarachnoid spread of tumor; * prior whole brain radiation; * plan to use radiosurgery or radiation boost after completion of wbrt; * planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed); * prior total resection of a single brain metastasis; * laboratory values as follows: ldh \> 1.3 x upper limit of normal (uln); anc \ 2.0 mg/dl; ast or alt \> 2 x uln; total bilirubin \> 2 x uln; * women who are pregnant or lactating

Keywords: brain neoplasms/radiotherapy neoplasms/complications/prevention & control, neuropsychological tests, metalloporphyrins/therapeutic use, combined modality therapy, drug therapy, quality of life, cranial irradiation, radiotherapy/targeted, prospective studies, neoplasm recurrence/local, treatment outcome brain metastases brain neoplasms/secondary non-small cell lung cancer
influence of oxidative stress and nutrition biomarkers on the cognitive decline evolution in alzheimer disease

Conditions: Alzheimer Disease

Summary: according to several reports, the oxidative stress and the nutrition could have an impact in the alzheimer disease. the association of these two parameters measurements and the cognitive impairment decline could help in a predictive diagnosis of cognitive decline evolution in patients presenting cognitive disorders. this is a monocentric prospective "routine care" clinical trial on patients showing cognitive troubles especially memory complaints. the objective is to demonstrate a correlation between oxydative stress and nutrition biomarkers and the clinical evolution of patients complaining of cognitive impairments. the neuropsychologic data collection (the mini mental status examination (mmse), the clock test, the grober-buschke test (fcsr-ir), the executive function evaluated by the trail making test, and the medical imaging (by magnetic resonance imaging (mri) or tomography in case of mri contraindication) will be realized during the study inclusion phase in the usual intake of patients. whole blood samples for the oxydative and nutrition biomarkers measurements will be taken at the study inclusion day during the stay at the day hospital dedicated to the routine intake of patients issued from the memory consultation. in this study, the principal evaluation criteria will be the mmse score evolution during the 60 months of the patients follow-up, measured during the routine visits scheduled approximately every 6 months, according to the french national authority for health recommendations. it will allow evaluating the correlation between the cognitive decline evolution measured by mmse during the alzheimer disease or related diseases method during the 2 years follow-up, and the oxydative stress blood markers.


Eligibility criteria:
inclusion criteria: * \>55 years old patient * patient seen during a memory consultation in geriatric unit, lyon sud university hospital * patient or legal representative and/or person of confidence who didn't express his opposition to the clinical assay participation. * patient registered to the general social insurance * complementary health check scheduled at day hospital, conventional hospitalization or regular consultation. exclusion criteria: * patient unable to express his participation refusal and under curatorship or unforced by the court of justice

Keywords: alzheimer oxydative stress nutrition biomarkers
journaling and weight loss

Conditions: Obesity

Summary: this is a pilot study to evaluate the effect of keeping a 'gratitude journal' on the outcome of a weight loss program. all the subjects will be enrolled in the lifesteps weight management program. the experimental group will maintain a gratitude journal and the control group will maintain a 'neutral' journal.

subjects who are referred to the preventive cardiology program for weight management will be enrolled in the study after obtaining informed consent. subjects are enrolled into the program in groups of 10 to 12 every 6 weeks. alternate groups will be will assigned to the two types of journaling. each group will be given specific instructions related to the form of journaling assigned. these instructions will be in addition to the usual care prescribed in the lifesteps® program. in the intervention group, patients will be introduced to gratitude journaling at the beginning of the 12 week class series and asked to journal each day. they will turn in their gratitude journal weekly. at the beginning of each weekly class, five minutes will be spent discussing the journaling. the control groups will not receive the information on gratitude journaling, but instead will be asked to complete a neutral journal in which they will journal in a general manner regarding their experiences participating in the lifesteps® weight management program. these will also be collected weekly. at the beginning of class, five minutes will be spent discussing the journaling. there will be one consent form for the two groups. the instruction (either gratitude journaling or neutral journaling) that will be given to the subjects will reflect the group to which they have been randomized. both types of journals will be reviewed initially, at mid-point and final by the psychologist (robert emmons) to verify the quality of reporting. routine tests- weekly weights study tests: pre/post depression: beck depression inventory ii; pre/post locus of control: multidimensional health locus of control scale; pre/post sf 36 quality of life questionnaire; pre/post gratitude questionnaire

Eligibility criteria:
inclusion criteria: * bmi\>25 * \>18 years of age exclusion criteria: * severe psychiatric diagnosis which in the opinion of the pi would compromise participation in the study. * addiction to alcohol and drugs

Keywords: obesity
an efficacy, safety, and pharmacokinetics study of beloranib in obese subjects with hypothalamic injury

Conditions: Obesity; Over-weight; Hypothalamic Injury; Craniopharyngioma

Summary: the purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.


Eligibility criteria:
inclusion criteria: * obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by bmi ≥30 and ≤60 kg/m2 * greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary * stable body weight for at least 3 months * type 2 diabetes mellitus is allowed exclusion criteria: * males taking gonadotropin replacement therapy (lh/fsh) * subjects who are planning any fertility treatment within 6 months of study participation * use of weight loss agents, including herbal medications, in the past 3 months * current or anticipated chronic use of narcotics or opiates * history of severe psychiatric disorders * type 1 diabetes mellitus * metabolic disorders or genetic disorders linked to obesity * history of any bariatric surgery * participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study * blood loss or donation \>500 ml within the past 3 months * females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation

Keywords: beloranib zgn-440 zgn-440 for injectable suspension zgn-433
pharmacokinetic properties of idalopirdine (lu ae58054) in subjects with and without impaired kidney function

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects


Eligibility criteria:
inclusion criteria: * men or women aged between 50 and 75 years (inclusive) * bmi ≥18.5 kg/m2 and ≤32 kg/m2 at the screening visit. * group a: patients with severe renal impairment renal impairment (creatinine clearance (clcr) ≤29 ml/min) * group b: healthy subjects with normal kidney function (creatinine clearance (clcr) ≥90 ml/min, inclusive) * group c: patients with moderate renal impairment ((creatinine clearance between 30 - 59 ml/min, inclusive) * group d: patients with mild renal impairment (creatinine clearance between 60 - 89 ml/min, inclusive) exclusion criteria: •the subject has taken disallowed medication \<1 week prior to the first dose of imp or \<5 half-lives prior to the first dose of imp for any disallowed medication taken, whichever is longer) other protocol defined inclusion and exclusion criteria do apply

Keywords: kidney impairment
does the preoperative midazolam dose affect postoperative pain?

Conditions: Pain, Postoperative

Summary: to investigate whether midazolam has any effect on postoperative pain in outpatient surgery, the investigators will assess the impact of different midazolam doses on pain scores 24h, 7 days and 3 months after ambulatory surgery. the investigators hypothesize that patients being administered higher midazolam doses will refer more pain.

systemic midazolam prescribed perioperatively might have impact on pain, with studies suggesting antinociceptive and hyperalgesic effects. anxiety might be a confounder in this association. in order to investigate the effect of midazolam on postoperative pain, a clinical trial will be conducted in portuguese ambulatory surgery units. a convenience sample with consecutive design will include patients admitted for open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery under spinal anesthesia. patients will be randomized into 3 premedication groups, and this randomization will be stratified for each centre and each type of surgery. postoperative pain will be blindly assessed by telephone interviews at 24h, 7 days, and 3 months. the investigators will use multiple regression models to explore the interaction of midazolam dose with preoperative anxiety, gender and chronic benzodiazepine use, as they hypothesize there might be a differential effect of midazolam on postoperative pain amongst these subgroups.

Eligibility criteria:
inclusion criteria: * adult patients submitted to open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery in portuguese ambulatory surgery units exclusion criteria: * psychiatric disorders * alcoholism * illiteracy or poor understanding of portuguese language * history of chronic pain under opioids * recurrent surgery * contraindication for midazolam or deep sedation * contraindication for spinal anesthesia

Keywords: midazolam ambulatory surgery
efficacy study of activated prothrombin complex for prevention of bleeds in hemophilia a with inhibitors

Conditions: Hemophilia A With Inhibitors

Summary: the objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (feiba)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.


Eligibility criteria:
inclusion criteria: * hemophilia a, any severity, with documented history of high-titer inhibitor (\>5bu); current use of bypassing agents (pccs, apccs or rfviia) for treatment of bleeds; \>/= 6 bleeds requiring bypassing therapy in the previous 6 months exclusion criteria: * concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet count less than 100,000