Kornimate/medical-research-clean huggingface dataset:
evaluation of lithium and it's effect on clinically localized prostate cancer

Conditions: Prostate Cancer

Summary: laboratory testing has suggested that lithium may decrease the incidence of certain types of cancer, including prostate cancer. additional research has suggested that lithium decreases prostate cancer tumor size over time. this study will investigate the effect of lithium on men with prostate cancer.

as lithium has been shown in an in vitro model to suppress cellular proliferation, and suppress tumor growth in an in vivo xenograft model, we propose to determine its effect on prostate cancer cells in human patients undergoing radical prostatectomy. in this pilot study we plan to assess the toxicity of lithium administration in patients prior to radical prostatectomy. this will include any clinical toxicity as well as any increase in intra-, peri- or postoperative complications.

Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to sign a written informed consent form. * subjects with histologically confirmed local adenocarcinoma of the prostate who have elected to proceed with radical prostatectomy as primary curative therapy. * subjects having no prior administration of lithium or lithium containing medications within 90 days of study enrollment. * subjects \>/= 18 years of age. * ecog (eastern cooperative oncology group) performance status of \</= 1. * adequate renal function defined as gfr (glomerular filtration rate) \>/= 50 ml/min. * use of adequate contraception * ecg (electrocardiogram) within normal limits. * subjects must agree not to take any new vitamin supplements or herbal remedy during the study period. * subjects must be able to safety take lithium carbonate for at least 4 weeks before scheduled prostatectomy. exclusion criteria: * subjects who have received any investigational medication within 30 days of first lithium dose. * subjects currently receiving, or who have had previous hormonal, chemotherapy or radiotherapy for prostate cancer. * subjects with known brain metastases. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to lithium carbonate. * uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.

Keywords: prostate cancer lithium androgen psa
danish observational study of everolimus plus exemestane in hormone receptor (hr) positive, human epidermal growth factor 2 (her2) - metastatic breast cancer

Conditions: Breast Cancer

Summary: an observational study in patients with advanced er+, her2 negative breast cancer, who are treated with everolimus and exemestane in combination. the objective of the study is to assess the safety pattern of everolimus in a real world setting.


Eligibility criteria:
inclusion criteria: * postmenopausal women with hr-positive, her2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved summary of product characteristics (smpc). * patients who started treatment after approval of this indication but before the initiation of this study can be retrospectively included, provided that they have systematically been assessed for adverse events. * the decision to treat the patient with everolimus and exemestane must be independent of the patient's participation in the study. * the patient must provide signed informed consent before any data can be captured. exclusion criteria: - no formal exclusion criteria

Keywords: advanced breast cancer everolimus
priming attachment security within an iapt setting

Conditions: Depression

Summary: there is growing evidence that priming attachment security is associated with improved attitudes towards therapy, increased engagement and decreased levels of depression and anxiety. within the improving access to psychological therapies (iapt) programme a consistent problem has been identified of high dropout rates at step 2 services (i.e. where mild to moderate anxious and depressed patients receive guided self-help interventions). the current study incorporates a feasibility and pilot design. the feasibility element will explore issues related to study design to determine suitability for conducting a future randomised control trial (rct). the pilot study will look at the processes outlined in the protocol to determine whether the study components all work together. moreover, it will preliminarily aim to explore the effectiveness of the attachment security priming intervention on symptoms of depression and anxiety, as well as impaired functioning. both elements of the study will determine whether any changes are needed to the study design or protocol, and whether a future rct is suitable and necessary.

the study is being conducted in an iapt primary care service in north yorkshire. the study will be recruiting 50 participants experiencing mild to moderate depression who are deemed suitable for 'behavioural activation' low intensity guided self-help intervention. following telephone screening for intervention, clinicians will ask clients if they wish to hear more about participating in a research study. if participants say yes, their contact details will be passed on to the researcher who will send them the study information sheet and consent form in the post. if the participant consents to taking part in the research, they will be randomised to receive either treatment as usual (low-intensity guided self-help utilising behavioural activation for depression) or treatment with security priming intervention (treatment as usual with an additional security priming task). they will have between 6-8 sessions as routinely delivered within the service and will be asked to complete measures of depression, anxiety and impaired functioning on a sessional basis. the principal investigator at the study site will collect information regarding attendance to therapy, dropout rates, and 'stepping' clients up to higher-intensity therapies as primary outcomes.

Eligibility criteria:
inclusion criteria: * accepted for behavioural activation guided self-help intervention for depression with study nhs iapt site. * over age 18. * adequate english ability. exclusion criteria: * not suitable for behavioural activation guided self-help intervention for depression with study nhs iapt site. * inadequate english ability.

Keywords: attachment improving access to psychological therapies security priming
antiinflammatoric and antioxidative effect of melatonin in human endotoxaemia

Conditions: Human Endotoxaemia

Summary: this is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. the design is based on 6 days: * day 1: on day time administration of lps. * day 2: on night time administration of lps. * day 3: on day time administration of lps + placebo. * day 4: on day time administration of lps + melatonin. * day 5: on night time administration of lps + placebo. * day 6: on night time administration og lps + melatonin. measuring the inflammatoric and oxidative response of lps and the effect of melatonin compared to placebo on the endotoxaemia.


Eligibility criteria:
inclusion criteria: * men * age 18-49 year. * healthy * no sleepiness disorders. * no medication * asa i exclusion criteria: * allergia to melatonin * women * smoking. * alcohol abuse.
magseed enabled long-term localization of axillary lymph nodes

Conditions: Breast Cancer; Axillary Lymph Nodes

Summary: the purpose of this study is to provide prospective evidence that the use of magseed/sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (nac) is effective.

this is a post-market, prospective, open-label, single arm study of magseed and sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (nac). subjects will have the magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating nac. after completion of nac, the magseed will be localized using the sentimag system during surgery and removed with the targeted lymph node.

Eligibility criteria:
inclusion criteria: * age 18 years or older at time of consent * histologically confirmed ct0-4, n1 breast cancer * axillary lymph node metastasis with pathologic confirmation by needle biopsy * clip placed in the sampled axillary lymph node before initiation of chemotherapy * planned for neo-adjuvant chemotherapy prior to surgical resection * eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and slnd) at the completion of neo-adjuvant chemotherapy * ecog performance status 0-2 exclusion criteria: * distant metastases * inflammatory breast cancer * prior ipsilateral axillary surgical procedure including slnd or axillary node excision * prior history of breast cancer in the ipsilateral breast * history of lymphoma * subject is pregnant * previous radiation to the breast or axilla * pacemaker or other implantable cardiac device in the ipsilateral chest wall

Keywords: neo-adjuvant chemotherapy
intra cranial eeg activity during dexmedetomidine sedation

Conditions: Complex Partial Seizures

Summary: various parts of the brain are sensitive to various anesthetics.we like to study the effect of dexmedetomidine on the different parts of the brain in patients who are coming for dbs electrode removal under sedation.

cortical and sub cortical structures will have different sensitivities to various anesthetics.the objective of this study is to look at the changes in the intracranial electroencephalographic (eeg) characteristics during dexmedetomidine sedation and to determine the differences in the eeg characteristics between cortical and subcortical structures.

Eligibility criteria:
inclusion criteria: * adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation exclusion criteria: * lack of informed consent * hypersensitivity to dexmedetomidine * language barrier * emergency surgery
preoperative gabapentin for acute and chronic post-thoracotomy analgesia

Conditions: Pain

Summary: one dose of either gabapentin or placebo will be given to patients prior to thoracotomy. patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. pain ratings and supplemental medication use will be recorded for 48 hours and will also be assessed at 3 months postoperatively to determine whether the patients who received gabapentin had improved analgesia and/or required less supplemental medication than the placebo group.

the gabapentin dose utilized is 600 mg. the epidural infusion utilizes bupivacaine 0.075% with hydromorphone 10 mcg/cc infusing at 6 cc/hour. the settings for the fentanyl patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour maximum.

Eligibility criteria:
inclusion criteria: * age 45-75 years * undergoing thoracotomy (lobectomy, segmentectomy, wedge resection) exclusion criteria: * undergoing chest wall resection, gastroesophageal surgery * enrolled in another post-thoracotomy analgesic research protocol * pre-existing pain syndrome * current gabapentin or pregabalin therapy * inability to understand the study protocol * coagulopathy * current use of anticoagulants * allergy to medications on protocol * creatinine \>1.3 * moderate or severe aortic stenosis * severe psychological disorders * bacteremia, osteomyelitis, or infection at site of thoracic epidural placement * history of previous thoracotomy * patient declines preoperative epidural catheter placement * prisoners or other institutionalized individuals * severe hepatic, renal or cardiovascular disorders * women who can become pregnant

Keywords: preoperative gabapentin acute pain post-thoracotomy pain epidural analgesia
gastrointestinal dysmotility on aspiration risk

Conditions: Esophageal Motility Disorders; Gastric Motor Dysfunction; Aspiration Pneumonia; Gastro Esophageal Reflux

Summary: the hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. the investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.


Eligibility criteria:
inclusion criteria: 1. are 5-21 years of age; 2. receive \>90% of their calories by enteral tube (i.e., patients take no food or drink by mouth); 3. are determined to be at high risk for aspiration pneumonia based on evidence of impaired airway protective mechanisms, documented by aspiration on video fluoroscopic swallow study; 4. have static neurologic impairment, defined as functional and/or intellectual impairment that results from a chronic neurologic or related diagnosis (e.g., cerebral palsy) with no prospect of progression for at least one year; 5. have chronic respiratory symptoms, defined as coughing, choking, or need for oral suctioning a minimum of three times per week during the prior four weeks. - exclusion criteria: 1. have progressive neurologic impairment; 2. have a history of prior intact nissen fundoplication; 3. are currently taking oral or inhaled antibiotics, including prophylactic antibiotics; 4. are currently taking or have taken in the last four weeks acid suppression (h2 antagonist or ppi); or 5. are fed by gastrojejunostomy rather than by gastrostomy. -
effects of perioperative intravenous dexamethasone on the severity of persistent postsurgical pain after total knee arthroplasty : a prospective, randomized, double-blind, placebo-controlled trial

Conditions: Osteoarthritis of the Knee

Summary: to compare the effects of perioperative intravenous dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.

it is not clear whether perioperative intravenous dexamethasone has an effect on severity of persistent postsurgical pain (ppsp) after total knee arthroplasty (tka). the research hypothesis is that tka patients experience less severe ppsp after administration of perioperative intravenous dexamethasone.

Eligibility criteria:
inclusion criteria: * age \> 40 years (45) * primary knee osteoarthritis diagnosed using the american college of rheumatology criteria (46) * undergoing elective, primary and unilateral total knee arthroplasty * american society of anesthesiology (asa) physical status class 1-3 * bmi \< 40 kg/m2 exclusion criteria: * history of active rheumatic diseases * history of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis * history of previous surgery on the same knee * history of adverse effects from medications to be used in this study * contraindication to spinal anesthesia * history of psychiatric disorders or cognitive impairment * contraindication to corticosteroid agents * poorly controlled diabetes mellitus (hba1c \> 7.5) * poorly controlled hypertension * history of ischemic heart disease or peripheral arterial disease or cerebrovascular disease * hepatic insufficiency (child-pugh score \> 5) * renal insufficiency (creatinine clearance \< 30 ml/min) * history of cataracts or glaucoma or ocular hypertension * history of steroid or immunosuppressive drug use within 6 months of surgery
febridx® method comparison study protocol

Conditions: Acute Respiratory Infections (ARIs)

Summary: the goal of this observational study is to learn about the performance and ease of use of febridx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms. the main question it aims to answer is: • is febridx accurate at differentiating bacterial from non-bacterial respiratory infections when used by untrained operators? trained and untrained participants will run the febridx test on patients with respiratory symptoms to evaluate comparability.

a prospective, multi-center, blinded observational study to demonstrate that the febridx test meets the clia statutory criteria for waiver by providing sufficient assurance that the addition of a new operator population (untrained) and environment of use (waived) will not adversely impact the performance or safety of the test. the study aims to: * demonstrate that febridx® test is accurate and the operator can perform the test with a negligible risk of erroneous result. * as a secondary objective, ease-of-use objective data and subjective feedback relating to the device and its operator interface will be collected at the end of the study and assessed for comparability.

Eligibility criteria:
inclusion criteria: * subject exhibits or reports a new onset measured temperature (oral or tympanic) of greater than or equal to 100.5°f/38°c within 3 days (72 hours) of enrollment or at the visit * subject has clinical suspicion for acute respiratory infection and presents with at least one (1) of the following new onset symptoms beginning ≤ 7 days of enrollment: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath exclusion criteria: * subject is unable or unwilling to provide signed, informed consent * subject is less than 12 years old or over 64 years old * subject has a fever that started more than 3 days (\> 72 hours) prior to enrollment * subject has symptoms of acute respiratory infection that started \> 7 days of enrollment * subject is receiving interferon therapy (e.g. ms, hiv, hbv, hcv) in the last 30 days * subject is in an immunocompromised state (e.g. hiv) or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral steroids, methotrexate, cyclosporine, antimetabolite chemotherapy, interferon therapy) * subject has taken antibiotics or antiviral therapy in the last 14 days * subject received a live viral immunization in the last 14 days * subject has significant trauma or burns (\> 5% total body surface area or full thickness (3rd°)) in the last 30 days * subject has had major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days * subject has a history of a myocardial infarction or stroke in the last 30 days

Keywords: point of care diagnostics crp (c- reactive protein) mxa (myxovirus resistance protein a)
phase i/iia adcd40l immunogene therapy for malignant melanoma and other solid tumors

Conditions: Malignant Melanoma

Summary: in this phase i/ii trial, immunostimulatory gene therapy (adcd40l) will be investigated. in part 1 patients with melanoma will receive adcd40l as mono therapy. in part 2a, patients with melanoma and patients with other solid tumors will receive adcd40l in combination with low dose cyclophosphamide. in part 2b, patients with melanoma will receive adcd40l in combination with one local radiotherapy and cyclophosphamide.

in this phase i/ii trial, immunostimulatory gene therapy (adcd40l) will be investigated. in part 1 patients with melanoma (n=6) will receive adcd40l as mono therapy. in part 2a, patients with melanoma (n=9) and patients with other solid tumors (n=6) will receive adcd40l in combination with low dose cyclophosphamide. in part 2b, patients with melanoma will receive adcd40l in combination with one local radiotherapy and cyclophosphamide. adcd40l is given by weekly injections of 2.5x10e11 vp, 4x; total dose 1x10e12 vp. a maximum of 30 patients will be included in this trial. adcd40l is an adenoviral nonreplicating vector carrying the human cd40l gene. adcd40l infects tumor cells upon intratumoral injection and deliver the cd40l gene into the cells whereupon the virus is destroyed. cd40l is then expressed as a membrane-bound protein and interacts with the cd40 receptor expressed by for example dendritic cells (dcs) in the tumor area. dcs mature upon cd40/cd40l interactions and activates tumor-specific t cell responses.

Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of malignant solid cancer, ecog 0-2. * disease progression on established treatments or patients not eligible to standard options. * signed informed consent must be obtained. exclusion criteria: * pregnancy. * life expectancy less than 3 months. * any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. * patients with severe systemic autoimmune disease. * patients that do not consent to that tissue and blood samples are stored in a biobank.

Keywords: adcd40l adenoviral vector cd40l cd154 malignant melanoma
cervicobrachial neuralgia and sagital balance of the cervical spine

Conditions: Cervicobrachial Neuralgia; Lordosis

Summary: the aim of this observational study is to establish estimation of global lordosis of the cervical spine (from c3 to c7) in patients with cervicobrachial neuralgia.

the main judgement critearia is the estimation in degree of this lordosis measured on eos radiographies, the study includes adults patients with non traumatic cervicobrachial neuralgia caused by discal hernia free from any previous spine surgery.

Eligibility criteria:
inclusion criteria: * adults (\>18 years old) * suffering of cervicobrachial neuralgia caused by cervical hernia on mri diagnosed by a neurosurgeon * with social care rights exclusion criteria: * post traumatic cervicobrachial neuralgia in the past 12 months * anteriority of spine surgery * pregnant patients

Keywords: cervicobrachial neuralgia sagittal balance lordosis
clinician attitudes and behaviors regarding use of pre-exposure prophylaxis (prep) for primary hiv prevention

Conditions: Clinician Attitudes About PrEP

Summary: this is a three phase study designed to examine clinician behaviors with regard to recommending and prescribing pre-exposure prophylaxis (prep) as a primary human immunodeficiency virus (hiv) prevention strategy, and to identify knowledge-related and attitudinal factors associated with these behaviors. each phase consists of the following: phase 1: semi-structured face-to-face or telephone interviews of atn-affiliated clinicians. approximately 10 clinicians will be interviewed. phase 2: development of a new theory-based survey instrument and cognitive interview testing of this survey. approximately five clinicians (of those who participated in phase 1) will be interviewed. phase 3: administration of the newly developed survey to atn-affiliated clinicians. approximately 60 clinicians will be interviewed.


Eligibility criteria:
inclusion criteria: * clinicians (including physicians, nurse practitioners, and physician assistants) that either: provide primary hiv care for hiv-infected and primary care for hiv-uninfected adolescents; or provide primary hiv care to hiv-infected adolescents only; * provides services to adolescents and young adults at atn sites or one of their community partners; * ability to understand spoken english; and * for phase 2 only: prior participation in phase 1. exclusion criteria: * intoxicated or under the influence of alcohol or other substances at the time of consent; * visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior) and in the opinion of the protocol chair would interfere with the ability to give true informed consent; and * for phase 3 only: prior participation in phase 1 or 2 of this study.