Kornimate/medical-research-clean huggingface dataset:
the role of highly selective androgen receptor (ar) targeted therapy in men with biochemically relapsed hormone sensitive prostate cancer

Conditions: Prostate Cancer

Summary: the proposed clinical trial will study the effects of 12 months of therapy with arn-509 alone, or in combination with an lhrh agonist (lhrha), each compared with lhrha alone, in men with a rapidly rising serum psa after prior definitive local therapy for prostate cancer. the endpoints selected reflect measurable short term effects of androgen deprivation therapy (adt), including quality of life and several metabolic parameters. in addition, the relative effect of each treatment strategy on psa suppression as well as testosterone recovery (and subsequent psa progression) after 12 months of therapy will be evaluated.


Eligibility criteria:
key inclusion criteria: * histologically proven adenocarcinoma of the prostate * rising psa after prior definitive local therapy (radical prostatectomy, external beam radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy with curative intent * psa doubling time less than or equal to 12 months * no evidence of metastatic disease on imaging by whole body bone scan and computerized tomography (ct) or magnetic resonance imaging (mri) of the abdomen/pelvis within 6 weeks prior to randomization * minimum psa 1.0 ng/ml if prior radical prostatectomy +/- adjuvant or salvage radiation; nadir + 2.0 ng/ml if prior rt without prior radical prostatectomy * prior androgen deprivation therapy (adt) allowed if last dose was greater than (\>) 6 months prior to randomization * no prior androgen deprivation therapy (adt) or anti-androgen for biochemical relapse * serum testosterone \> 150 ng/dl at study entry * no history of seizures or medical conditions which may lower seizure threshold key exclusion criteria: * use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 6 weeks prior to randomization * use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 6 weeks prior to randomization * prior bilateral orchiectomy * prior treatment with adt for biochemically relapsed prostate cancer. prior adt as neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation therapy or prostatectomy for biochemically relapsed disease is allowed provided last dose of adt is greater than (\>) 6 months prior to randomization and the screening serum testosterone level is greater than or equal to (≥)150 ng/dl * use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at randomization * any history of seizures or medical condition which lowers seizure threshold

Keywords: men with biochemically relapsed hormone sensitive prostate cancer
efficacy and safety of hip1601 capsule

Conditions: Erosive Gastroesophageal Reflux Disease

Summary: the purpose of this study is to investigate the safety and clinical efficacy of hip1601 in patients with erosive gastroesphageal reflux disease.


Eligibility criteria:
inclusion criteria: * 19≤ age ≤ 75 * esophago-gastro-duodenoscopy la classification ≥ grade a * patients experienced heartburn or acid regurgitation within 7 days of screening day * patients understood the consents and purpose of this trial and signed consent form exclusion criteria: * has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding * has a severe liver disorder(at screening day, ast or alt level exceeds 3 times more than normal upper range) * has a clinically significant renal failure(at screening day, mdrd egfp ≤ 59 ml/min/1.73m2 or serum creatinine \>2.0mg/dl) * uncontrolled diabetes mellitus * before screening egd, a patient who has taken h2-receptor antagonist or ppi within 2 weeks * before screening egd, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic gi, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, nsaids, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)
opioid approach bias modification

Conditions: Opioid Use; Chronic Pain

Summary: to investigate the neurobiological mechanisms underlying opioid approach bias during a pilot rct of opioid approach bias modification. the investigators are combining novel ultra-high field mri technology with the promising treatment of modifying cognitive bias away from detrimental prescription drug use will generate novel neural data and potentially yield a new therapeutic tool to reduce problematic opioid use.

the proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 6-session (over 2 weeks) clinical trial of opioid approach bias modification (oabm) in 20 male and female veterans with chronic pain at high risk for opioid-related adverse events at the san francisco veterans affairs health care system, between ages 18-69. the study consists of screening, 2-week cognitive training, week-3 post-assessment. assessment of the neurobiological mechanisms of opioid approach bias will be administered at baseline and week-3.

Eligibility criteria:
inclusion criteria: * male and female veterans eligible for va services * ages 18-69 * chronic pain (current pain lasting ≥ 90 days) * prescribed chronic opioids (≥ 90 days in past year) * high risk for opioid-related averse outcomes (≥ 20mg morphine equivalent daily dose). exclusion criteria: * psychotic, bipolar disorders or other psychiatric disorders judged to be unstable by the pi * current or past history of the following: intrinsic cerebral tumors, cerebrovascular accident/disease, brain aneurysm, arteriovenous malformations, surgical implantation of neurostimulators or cardiac pacemakers, demyelinating and neurodegenerative diseases, penetrating traumatic brain injury, and any other mri contraindications. * no female participant will be pregnant or actively attempting to conceive to prevent any unnecessary exposure to high magnetic fields or radio frequency energy to the unborn child. * concurrent participation in a treatment study * moderately severe/severe withdrawal from opioids based on a score of 25 or more on the clinical opiate withdrawal scale (cows)

Keywords: opioid approach bias chronic pain
agitation and aggressivity in alzheimer's disease patients: a cohort study

Conditions: Alzheimer Disease

Summary: general hypothesis: hypothesize that a / a symptoms of ad follow a particular course, influenced by associated factors, and a prospective longitudinal observational study specifically evaluating a / a symptoms in patients with ma, living in an institution and at home, would provide useful data for both clinical practice and research. specific hypothesis: hypothesize that in patients with ad with clinically significant a / a there is a correlation between assessment of a / a severity based on specific scales of a / a and overall impression assessment of clinical improvement or worsening of these symptoms by the clinician.


Eligibility criteria:
inclusion criteria: 1256/5000 * patient with ad according to nincds-adrda criteria with or without cerebrovascular component at all stages of the disease. * patient with agitation / aggression (a / a) type spcds, assessed with a score ≥ 4 of at least 1 of the a / a domains, disinhibition, irritability and / or aberrant motor behavior of the npi scale, with a score frequency ≥2 during the inclusion visit. * participation agreement signed by the patient or, in the event of the patient's incapacity, by his / her legal representative or, as the case may be, by the person of trust or family. the patient's ability to sign informed consent is evaluated by a clinician experienced in the field of dementia. * patient with social security if the patient lives at home: * presence of a clearly identified primary caregiver: person from the entourage of the patient who assumes the main part of the care (at least 2 hours at least 3 times during the week) able to complete the questionnaires and to evaluate the patient. * availability and agreement of the carer to accompany the patient during consultations. if the patient lives in an institution: • he / she must have been there for at least 2 months before inclusion. exclusion criteria: 745/5000 * brain pathology (other than ad) that may be the cause of dementia: extensive cerebrovascular disease, parkinson's disease, lewy body dementia, frontotemporal dementia, brain trauma. * a / a secondary to concomitant medications, or to a medical or psychiatric condition * concurrent major depressive episode (dsm-iv). * psychotic symptoms of delirium type and hallucination clinically significant (score ≥ 4 field delusions and / or hallucinations of the npi scale). * presence of concomitant pathologies preventing participation in the study (testing and / or study visits). * concurrent participation in another research that may influence the testing of our study.

Keywords: agitation aggressivity
comparing health services interventions for the prevention of hpv-related cancer

Conditions: Cervical Cancer

Summary: the study aims to identify global and local determinants of hpv vaccine acceptability, hpv vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the hpv vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.

3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. these women will be identified by means of screening registry lists or screening clinical visits. eligible women will receive a study questionnaire on the hpv vaccine. additionally, and independently of participating in the study questionnaire, those who accept will get 3 hpv vaccine doses. depending on country preferences, either cervarix® (glaxosmithkline biologicals, s.a.) at month 0, 1 and 6 or gardasil® (sanofi pasteur msd snc) at month 0, 2 and 6, will be administered. safety data and hpv vaccine compliance will be assessed. a sub study in spain will also analyze acceptability of hpv vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders. two independent informed consent forms will be provided; one for the study questionnaire participation and another for hpv vaccine administration.

Eligibility criteria:
inclusion criteria: * women within the age range of 25-45 * attending cervical cancer screening exclusion criteria: * previous history of hpv vaccine administration
a study to evaluate safety and immune response of novartis meningococcal acwy vaccine in infants

Conditions: Meningitis, Meningococcal

Summary: this study will evaluate the safety and immune response of the novartis meningococcal acwy conjugate vaccine when administered with routine infant vaccinations to healthy infants.


Eligibility criteria:
inclusion criteria: * healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent. exclusion criteria: * subjects with a previous or suspected disease caused by neisseria meningitidis, corynebacterium diphtheriae, clostridium tetani, poliovirus, hepatitis b, haemophilus influenzae type b (hib), pneumococcus or bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with diptheria, tetanus, pertussis (acellular or whole cell), inactivated polio vaccineipv or oral polio vaccineopv, h. influenzae type b (hib) or pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed n. meningitidis (serogroups a, c, w-135, or y), b. pertussis, hib, c. diphtheriae, polio, or pneumococcal infection at any time since birth; any serious acute, chronic or progressive disease

Keywords: meningococcal meningitis vaccine infants meningococcal meningitis meningococcal disease
tapinarof for the treatment of plaque psoriasis in pediatric subjects

Conditions: Plaque Psoriasis

Summary: this is an open-label, multi-center, phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.

this study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. at the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.

Eligibility criteria:
inclusion criteria: * male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit * subject with plaque psoriasis covering ≥ 3% of the bsa at screening and baseline * a pga score of ≥ 2 at screening and baseline * female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods * must not be pregnant * subject, subject's parent, or legal representative must be capable of giving written informed consent/assent exclusion criteria: * psoriasis other than plaque variant * any sign of infection of any of the psoriatic lesions * immunocompromised at screening * screening alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥2.0x the upper limit of normal (uln) * screening total bilirubin \> 1.5x uln * current or chronic history of liver disease * current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix * major surgery within 8 weeks prior to baseline or has a major surgery planned during the study * known history of clinically significant drug or alcohol abuse in the last year prior to baseline * use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation * history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion may interfere with the subject's participation in the study, interpretation of results, safety of the subject or ability to understand and give informed consent * pregnant or lactating females. * history of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation * previous known participation in a clinical study with tapinarof (previously known as gsk2894512 and wbi-1001)

Keywords: plaque psoriasis pediatric phase 3 topical tapinarof
a study of epoetin beta treatment in anemic participants with myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndromes

Summary: this is a phase iv, prospective, multi-center, open-label study to assess the effectiveness and safety profile of epoetin beta (recormon®) for treatment of symptomatic anemia in adult participants associated with low/intermediate-1-risk mds. after screening, eligible participants will be treated with epoetin beta as recommended in the approved label and international guidelines for the use of epoetin in mds participants and the dosage will be adjusted on the basis of erythroid response.


Eligibility criteria:
inclusion criteria: * adult participants with low or intermediate-1 risk mds * no previous treatment with hematopoietic growth factors within 3 months prior to screening * symptomatic anemia (hemoglobin \<10 g/dl) as determined by investigator * serum erythropoietin \<500 milliunits/milliliter (mu/ml) within 14 days prior to the first dose of study treatment * require no red blood cell transfusion or dependent on \<4 units within 8 weeks prior to screening * clinically stable for at least 1 month prior to entry into the study * for female participants of childbearing potential and male participants with partners of childbearing potential, agreement (by participants and/or partner) to use highly effective form(s) of contraception exclusion criteria: * contraindications and/or known hypersensitivity to the active substance and/or any of the excipients of epoetin beta treatment * poorly controlled hypertension as assessed by the investigator * history of acute myeloid leukemia (aml) or high risk for aml * administration of another investigational drug within 1 month before screening or planned during the study period * previously documented evidence of pure red cell aplasia (prca)
efficacy of multidimensional management of mild traumatic brain injury

Conditions: Mild Traumatic Brain Injury

Summary: unfavorable outcomes (uo) are seen in 15 to 20% of patients with mild traumatic brain injury (mtbi). early identification of patients at risk for uo is crucial for suitable management to be initiated, increasing their chances for a return to a normal life. the investigators previously developed a diagnostic tool enabling early identification (8 to 21 days after the injury) of patients likely to develop uo. in the present study, the investigators examined the value and beneficial effects of early multidimensional management (mm) on prognosis. the investigators used a diagnostic tool to classify 221 mtbi patients as uo (97) or fo (favorable outcome) (124). patients whose initial risk factors point to uo are at risk of developing post-concussion syndrome (pcs). uo patients were randomized into 2 groups: a group that underwent mm (cognitive-behavioral rehabilitation) (34) and a group with no specific management (46). at 6 months, these 2 groups were compared and the impact of mm on outcome was assessed. among patients initially classified as fo (101), 95% had fo at 6 months and only 5 had pcs as defined by dsm-iv classification. of the uo patients who received mm, 94% had no pcs 6 months after injury, whereas 52% of the uo patients who did not receive mm had persistent pcs. the effect of mm on the recovery of patients at 6 months, once adjusted for the main confounding factors, was statistically significant (p\<0.001). these results show that the initiation of mm after early identification of at-risk mtbi patients can considerably improves their prognosis.


Eligibility criteria:
inclusion criteria: - patients aged 18 to 65 who have suffered mtbi, have health care coverage, who understand french, who can be followed for 6 months, and who are able to understand, reply, and cooperate. exclusion criteria: * patient intubated and/or ventilated and/or sedated upon arrival at hospital * patient with injury to the medulla and with neurological signs or multiple injuries (at least 1 of which is life-threatening) * brain injury incurred during a suicide attempt * patient presenting psychiatric or psychological disorders that are debilitating and/or interfere with follow-up and/or evaluation * psychoactive treatment ongoing at the time of injury * history of hospitalization in specialized a psychiatric setting and/or sick leave for psychological reasons * patient with a neurological disorder * patient with substance dependence * subject under guardianship or wardship

Keywords: mild tbi quality of life coping strategies symptoms neuropsychological tests pain memory reactive cognitive dimension
validation of a proteomic signature and assessment of viremia in children with fever without source

Conditions: Infectious Disease; Fever; Viremia

Summary: the study is an observational blinded validation study in pediatric patients below 3 years old with a diagnosis of fever without source (fws). in this study the investigators aim to validate the performance of a proteomic signature aiding the physicians to discriminate between viral and bacterial infections in febrile children. the study will also assess the prevalence of human enteroviruses (hev), human parechoviruses (hpev), adenovirus (adv) and human herpesvirus type 6 (hhv-6) viremia, as well as kingella kingae bacteremia in the study cohort.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of fws (fever of less than 7 days with no cause determined by the history or the physical exam) * age \< 3 years old * informed consent (ic) given by parent or legal guardian exclusion criteria: * unavailable blood * comorbidities predisposing to infections such as cancer, primary or secondary immunodeficiency, and iatrogenic immunosuppression inclusion criteria for healthy controls: * age \< 3 years old * informed consent (ic) given by parent or legal guardian * no suspicion of infectious or inflammatory disease at presentation and during the two weeks before.
a pilot study to explore the role of gut flora in parkinson's disease

Conditions: Parkinson Disease; Parkinsons Disease With Dementia; Parkinson-Dementia Syndrome; Parkinson Disease 2; Parkinson Disease 3; Parkinson Disease 4

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding parkinson's disease.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding parkinson's disease.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female patients of any age (interest is given to children to compare with mothers). 3. diagnosis of parkinson's disease exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition 6. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
anti-inflammatory effect of peroperative stimulation of the vagus nerve

Conditions: Postoperative Ileus

Summary: hypothesis: electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead to a faster postoperative recovery after abdominal surgery. aims: in the present study, the investigators want evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. in addition, the investigators want to determine whether vagus nerve stimulation leads to a faster postoperative recovery. to this end, the following aims are formulated: 1. to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing 2. to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire) 3. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery


Eligibility criteria:
inclusion criteria: * patients with ovarium, pancreas or colorectal carcinoma eligible for resection exclusion criteria: * preoperative therapeutic abdominal radiation shorter than 2 weeks prior to surgery * evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis) * american society of anesthesiologists physical-health status classification (asa-ps) \> 3 * poorly regulated diabetes (\> 200 mg/dl (= 11 mmol/l) * surgery due to chronic pancreatitis

Keywords: vagus nerve stimulation postoperative ileus