Kornimate/medical-research-clean huggingface dataset:
efficacity, safety and cost of intravenous morphine titration alone or combined to ketamine

Conditions: Postoperative Pain

Summary: this is a randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine.

randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine

Eligibility criteria:
inclusion criteria: * age \> 18 yrs * scheduled surgery * general anesthesia * asa i to iii * able to use a vas * no psychological disorders, able to speak french exclusion criteria: * age \< 18 yrs * locoregional anesthesia or analgesia * allergia to morphine or ketamine * morphine or ketamine contraindication * pregnancy or breast-feeding

Keywords: postoperative pain analgesia morphine titration ketamine
acute effects of hiit vs. mict on hrv

Conditions: Myocardial Infarction

Summary: heart rate variability (hrv) is impaired in patients after myocardial infarction. most studies so far have proved chronic beneficial effects of different types of exercise on hrv parameters. data on acute effects of different types of exercise training (e.g. high intensity interval training \[hiit\] and moderate intensity continuous training \[mict\]) is scarce. patients in the study will perform both hiit and mict in a random order and in-between break of at least 48 hours. a 5-minute high resolution ecg recording will be performed before and immediately after both hiit and mict.


Eligibility criteria:
inclusion criteria: * myocardial infarction in last 120 days * sinus rhythm exclusion criteria: * contraindications for exercise training * uncontrolled dysrhythmias * heart failure nyha iv stage * cognitive impairment * pregnancy

Keywords: exercise training high intensity interval training moderate intensity continuous training heart rate variability myocardial infarction
a study to evaluate the use of apremilast in patients with psoriatic arthritis, naïve to biological treatment

Conditions: Arthritis, Psoriatic

Summary: observational, prospective and multicenter study in approximately 25 sites nationwide. the investigators participating in this study will be rheumatologists specializing in this pathology. the study will include patients diagnosed with psa (according to the caspar diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration. recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. the decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study, which will not occur earlier than 6 months (± 4 weeks after treatment start). therefore, the choice of the therapeutic strategy will be made independently by the physician. before entering the study, all patients shall sign an informed consent to participate in the study, including permission to retrieve data from their medical records and to complete questionnaires regarding their quality of life. to avoid recruitment biases and obtain a homogeneous cohort regarding treatment duration, all consecutive patients who attend to a routine follow-up visit and have been prescribed apremilast 6 months (+/- 4 weeks) before the baseline visit, will be offered to enter the study. all consecutive patients who can be contacted 6 months (+/- 4 weeks) following initiation of treatment with apremilast will be approached for entry to minimize bias in patient selection


Eligibility criteria:
inclusion criteria: * men and women older than 18 years. * patients diagnosed with psoriatic arthritis according to the caspar criteria\*. * patients who, following the routine clinical practice, initiated treatment with apremilast 6 months (±4 weeks) before their inclusion in the study. * patients naive to biologic treatments. exclusion criteria: * patients who reject to sign the informed consent. * patients enrolled in a clinical trial within the 4 weeks preceding the baseline visit or for the duration of apremilast treatment.

Keywords: psoriatic arthritis apremilast cc-10004 biologic treatments
breast cancer, aromatase inhibitor therapy, and sexual functioning: the effects of vaginal testosterone therapy

Conditions: Breast Cancer; Vaginal Dryness; Dyspareunia; Sexual Health Quality of Life

Summary: it is well documented that women who have breast cancer may experience a decrease in quality of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically aromatase inhibitors (ais). women taking ais are more likely to report unpleasant urogenital and vaginal symptoms due to the physiologic suppression of estradiol. this treatment can impair sexual functioning and cause a decreased sexual health quality of life. at the present time, there are no food and drug administration (fda) approved medications for the vulvovaginal or sexual side effects related to the use of ais. the lack of treatment options is concerning because the number of women diagnosed with breast cancer continues to increase; their longevity, also, continues to increase with the use of newer adjuvant chemotherapies. local health care practitioners have observed that the benefits of vaginal testosterone for sexual health in breast cancer survivors are similar to the benefits of vaginal estrogen in women without breast cancer. the purpose of this study is to evaluate the impact of using a daily compounded vaginal testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of vulvovaginal symptoms accompanying the use of ais and their associated quality of life and sexual functioning.


Eligibility criteria:
inclusion criteria: * women with breast cancer * currently taking an aromatase inhibitor (ai) * age \> 50 years of age * postmenopausal, or two years since last menstrual cycle * urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse * changes in sexual health quality of life/sexual functioning since starting ai therapy exclusion criteria: * the use of other treatments for breast cancer such as chemotherapy or radiation within the past 12 months * a known sensitivity to medications containing testosterone * the use of exogenous hormone replacement therapy (hrt) in the past three months, including systemic and local estrogen or testosterone therapy

Keywords: vaginal testosterone vaginal atrophy female sexual dysfunction aromatase inhibitors
phase iii multicenter, open-label, randomized trial of induction versus induction plus maintenance foscarnet ( foscavir ) therapy for gastrointestinal cmv disease

Conditions: HIV Infections; Gastrointestinal Diseases

Summary: primary: to compare the frequency of and time to relapse of cytomegalovirus (cmv) gastrointestinal disease following foscarnet induction therapy only versus induction plus maintenance therapy. secondary: to determine frequency of and time to recurrence of gastrointestinal symptoms, response rate of pathological lesions, and incidence of nongastrointestinal cmv disease in this patient population.

patients receive intravenous foscarnet either as induction only for 4 weeks or as induction for 4 weeks followed by maintenance for 22 weeks. all patients are followed for 26 weeks or until relapse.

Eligibility criteria:
inclusion criteria patients must have: * aids. * cmv gi disease. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * non-gi cmv disease. * ulcerative colitis, inflammatory bowel disease, or other condition that may interfere with study results. * other gi pathogens. concurrent medication: excluded: * drugs that may interact with foscarnet. * systemic acyclovir, ganciclovir, or acyclovir prodrug. * drugs known to affect renal function. prior medication: excluded: * prior foscarnet in extremis. * investigational agents other than 3tc or d4t within 7 days prior to study entry.

Keywords: foscarnet cytomegalovirus infections acquired immunodeficiency syndrome
scripps v: intracoronary brachytherapy for recurrent restenosis after multiple drug-eluting stents

Conditions: Coronary Artery Disease; Coronary Restenosis

Summary: this study is a prospective study of patients treated at scripps clinic with intracoronary brachytherapy for recurrent restenosis within drug eluting stents.

this is an investigator-initiated protocol examining the effectiveness of intracoronary brachytherapy using the novoste beta-emitting catheter for recurrent stenosis after treatment with multiple drug-eluting stents. while intracoronary brachytherapy has been used for this purpose by clinicians for some time, data supporting this clinical decision-making is lacking. currently, when cardiologists find restenosis after implanting a drug-eluting stent, they often place a stent that elutes a different drug within that stent. if a patient presents with restenosis in the segment that has already been treated with both sirolimus and paclitaxel-eluting stents, further options are limited. intracoronary brachytherapy is often used in this scenario, but the efficacy of this approach has not been well studied. the investigators recently reviewed the clinical outcomes of five patients who underwent intracoronary radiation after drug-eluting stents. they discovered only one episode of target vessel revascularization and no episodes of stent thrombosis. while this sample is small, investigators believe that a prospective study will provide important information regarding this approach.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. eligible for percutaneous coronary intervention. 3. target lesion with recurrent restenosis (\>50% by visual estimate) previously treated with any 2 or more combination of des stents. 4. signs or symptoms of ischemia attributable to the target lesion, or stenosis \> 50% by visual estimation of the lesion during angiography. 5. target lesion is located within a native coronary artery or bypass graft. 6. be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up. 7. able to understand and sign informed consent. exclusion criteria: 1. confirmed pregnancy at the time of index pci. 2. has known allergies to aspirin, and to both clopidogrel (plavix ®) and ticlopidine (ticlid ®). 3. has known allergies or contraindication to heparin and bivalirudin (angiomax ®). 4. has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study. 5. any serious disease condition with life expectancy of less than 1 year. 6. unsuccessful coronary revascularization procedure (residual stenosis \> 30%). 7. angiographic evidence of thrombus. 8. no previous intracoronary radiation to the target artery.

Keywords: coronary artery disease coronary restenosis brachytherapy
optical coherence tomography in patients with radiotherapy for head and neck cancer

Conditions: Head and Neck Cancer; Radiotherapy

Summary: the purpose of this study is to determine whether any eventual skin damage caused by radiation therapy can be detected and monitored at a subclinical level via optical coherence tomography (oct). another key question is whether subclinical oct detected skin damage correlates with acute and late clinical toxicity.

head and neck cancer patients that meet the eligibility criteria and singned the informed consent will undergo oct-measurements before, during and after the course of radiation therapy. at the same time-points the skin areas are evaluated with dermatoscopy and patients are asked to self-assess their quality of life (eortc qlq c30 and respective head and neck module h\&n 43). before the onset of radiation therapy radiation sensitivity analysis will be performed with in-vitro irradion of peripheral blood lymphocytes (fish).

Eligibility criteria:
inclusion criteria: * patients with cancer located at: nasopharynx, oropharynx, hypopharynx, larynx, oral cavity and definitive or adjuvant radiation- or radio-chemotherapy exclusion criteria: * reduced mental capacity * treatment with c225 cetuximab * bearded patients * overt skin disease * vast tattoos in the neck region

Keywords: optical coherence tomography oct head and neck cancer radiotherapy radiation therapy skin toxicity radiation sensitivity fish quality of life eortc qlq c30 eortc h&n 43 radiochemotherapy
randomized trial: high power short duration versus ablation index

Conditions: Atrial Fibrillation Paroxysmal; Catheter Ablation

Summary: the single procedure success rates of durable pulmonary vein isolation (pvi) for paroxysmal atrial fibrillation (paf) varies between 80 and 90 %. this prospective, randomized study investigated the efficacy of pulmonary vein isolation with rf-energy following the close protocol with standard energy application (30 watts) versus pvi with rf-energy with high power settings (45 watts).

a total number of 176 patients undergoing de-novo catheter ablation for paroxysmal af are planned to be randomized to two different treatment arms. in group-a patients, pvi was performed with rf-energy with standard power settings of 30 watts in a temperature-controlled mode. the ablation procedure in group b was performed with rf-energy with higher power settings of 45 watts. in both groups the ablation is performed with ablation index (ai) and following the close protocol (ai and ≤ 6 mm interlesion distance using a surround flow catheter, biosense webster thermocool stsf). a total of 88 patients are planned to be randomized into each group, the follow-up period will be 12 months after the first procedure. the primary endpoint is freedom of all atrial arrhythmias after one procedure. the secondary endpoint is procedural time. the third endpoint is safety.

Eligibility criteria:
inclusion criteria: * paroxysmal atrial fibrillation * written informed consent exclusion criteria: * inability to obtain written informed consent * persistent atrial fibrillation
influence of aromatase inhibitors and gnrh analogs to treat uterine leiomyoma by vaginal hysterectomy

Conditions: UTERINE LEIOMYOMA

Summary: the investigators aimed to assess if use of aromatase inhibitors could decrease volume of uterine leiomyoma and cause same percentage of adverse effects during its use compared to gnrh analogs.

uterine leiomyoma is the most prevalent benign gynecologic tumor in women. standard treatment is surgical (hysterectomy or myomectomy), and depends of many variables. if these tumors are large, preoperative assessment with clinical treatment may be useful in order to decrease its volume, improve hematologic patterns and modify surgical approach (vaginal or abdominal). it is well know that gnrh analogs can cause these goals; however, aromatase inhibitors are new promising drugs which are being used for reducing uterine leiomyoma's volume and few observational studies have shown this fact. the investigators are aiming to compare both treatments in a randomized controlled trial and see if it both treatments are similar or not in decreasing uterine leiomyoma's volume, influencing operative time, blood loss during surgery.

Eligibility criteria:
inclusion criteria: * women over 40 years, uterine volume higher than 300 ml, minimal anatomic conditions for vaginal surgery exclusion criteria: * active gynecologic malignancy
comparison of h-fire and turp in treating benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: this trial is comparing the effects and safety in treating men with benign prostatic hyperplasia between high freqnence irreversible electroporation and trans urethral resection prostate.

a prospective, single-center, randomized controlled trial comparing the efficacy and safety of high-frequency irreversible electroporation and trans urethral resection prostate for benign prostatic hyperplasia one hundred and seventy-six patients with benign prostatic hyperplasia will include in this study. the clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-freqnence irreversible electroporation; arm 2, transurethral resection prostate. the primary outcome is the change in maximum urinary flow rate and urinary symptoms by questionnaire of international prostate symptom score at 3 months after surgical treatment.

Eligibility criteria:
inclusion criteria: 1. age over 40 years old 2. ipss\>8 3. qmax \<15ml/s 4. prostatic volume range of 30 to 100ml, measured by mri 5. fully understand the clinical trial protocol and sign the informed consent exclusion criteria: have a history of prostate cancer or patients suspicious of prostate cancer neurogenic bladder metal implants in their body previous history of prostatic or urethral surgery with catheterisation more than 2 weeks any other conditions that investigator judges that participations who are not suitable for this trial

Keywords: benign prostatic hyperplasia high freqnence irreversible electroporation trans urethral resection prostate
dilatation versus endoscopic laser resection in simple benign tracheal stenosis

Conditions: Tracheal Stenosis

Summary: multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.

an observational study suggests the superiority of endoscopic laser resection over dilatation in idiopathic tracheal stenosis but little litterature has been published on the subject. hence we decided to design a prospective multicenter open label randomized controlled trial to compare the two interventions. patients refered for endoscopic treatment of a simple benign tracheal stenosis will be randomized to endoscopic laser resection or dilatation. randomisation will be stratified for center, type of stenosis (idiopathic vs other) and history of previous endoscopic treatment. patients will be blinded to treatment but not physician. all patients will be treated with proton pump inhibitors.

Eligibility criteria:
inclusion criteria: * benign simple tracheal stenosis (length of stenosis \<1cm without underlying cartilage damage) with planned endoscopic treatment (first treatment or recurrence) exclusion criteria: * less than 18 years old * pregnant * incapacity to give informed consent * underlying inflammatory suspected to be the cause of stenosis (ex : granulomatosis with polyangitis)
a retrospective review of liver resection rate in metastatic colorectal cancer patients following downsizing treatment with chemotherapy plus cetuximab in normal uk national health service clinical practice

Conditions: Metastatic Colorectal Cancer

Summary: this study is a multi-centre retrospective observational research study which will be conducted in uk centres with specialised liver surgical services. the study will involve retrospective review of medical records of patients with metastatic colorectal cancer (mcrc) with metastases confined to the liver, defined locally as unresectable without downsizing therapy at first review by a hepatobiliary multi disciplinary team (hpb mdt). erbitux is available for use in combination with chemotherapy as a downsizing treatment for patients with previously unresectable metastases. the study aims to examine liver resection rates achieved in normal clinical practice in order to inform national health service (nhs) clinical and policy decision making and to further understanding of how cetuximab is used in a standard clinical setting. this study intends to estimate the proportion of patients with unresectable liver metastases who undergo liver resection following downsizing treatment with chemotherapy plus cetuximab.


Eligibility criteria:
inclusion criteria: * patients who had mcrc and metastases confined to the liver * patients in whom downsizing regimens are recommended * patients in whom downsizing treatment included cetuximab * patients referred to hepatobiliary multi disciplinary team (hpb mdt) between 01.01.2010-31.03.2011 exclusion criteria: * patients who are considered to have immediately resectable liver metastases as determined by the hpb mdt * patients who are considered to have never resectable liver metastases as determined by the hpb mdt * patients who were aged less than 18 at date of initiation of cetuximab * patients who are enrolled in a clinical trial during the data collection period * patients who are receiving private healthcare for the treatment of mcrc * according to summary of product characteristics (smpc)

Keywords: erbitux crc mcrc liver metastases
the effects of ageing on the 'pharmacokinetic and clinical observations in people over fifty'

Conditions: HIV Positive; Ageing

Summary: the purpose of this study is to identify medical conditions that may cause particular problems to individuals receiving care for hiv infection over the age of 50. in addition, as the effects and potentially the side effects, of hiv medication may change with age, this study will also investigate the association between age and differing effects of antiretroviral therapies such as treatment outcomes, side effects and the levels of drugs in blood. results from this study may inform future hiv treatment guidelines on how we monitor individuals with hiv infection. the results may also assist in the design of future studies for the treatment of diseases associated with ageing.

multicentre, prospective, observational study over 3 years. our study will describe the impact of advancing age on the experience of living with hiv in england and ireland. to address this we will establish cohorts of hiv-positive people aged \>50 and \ 50 years. 1. to analyse the incidence and outcomes of co-morbidities in older-hiv-positive people and their relationship with demographic/clinical factors. 2. to evaluate associations between antiretroviral drug concentrations and age, and to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities. 3. to contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older hiv-positive patients. 2000 will be recruited in all either white or black african individuals (self reported) 1000 will be over 50 years of age and hiv positive, 500 will be under the age of 50 and will be hiv positive and 500 will be over the age of 50 and be hiv negative.

Eligibility criteria:
inclusion criteria: older hiv-positive cohort (n=1000): * documented hiv infection * age \>50 years at study entry * self defined white or black african ethnicity * likely route of hiv acquisition via sexual exposure either by male to male exposure if white or by heterosexual exposure if white or black african * able to comprehend study patient information leaflet -younger hiv-positive cohort (n=500): * documented hiv infection * age \<50 at study entry\* * self defined white or black african ethnicity * likely route of hiv acquisition via sexual exposure either by male to male exposure if white or by heterosexual exposure if white or black african. * able to comprehend study patient information leaflet * this group will comprise of at least 150 subjects in each of the following age groups: 20-29, 30-39, 40-49 years. recruitment will be monitored by the study monitoring team. hiv-negative cohort (n=500): * documented negative hiv test at screening * age \>50 years at study entry * self defined white or black african ethnicity * registered with a general practitioner and gives permission for contact with that general practitioner. exclusion criteria: * in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study * life expectancy less than 6 months

Keywords: hiv ageing