Kornimate/medical-research-clean huggingface dataset:
endo gia™ stapler with endo gia™ reload with tri-staple™ technology in a pulmonary resection

Conditions: Lung Cancer

Summary: the objectives of this clinical trial are to compare the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as \> 5 days by the society for thoracic surgery) when using the endo gia™ stapler with endo gia™ sulu with tri-staple™ technology in a pulmonary resection via video assisted thoracoscopic surgery (vats).


Eligibility criteria:
inclusion criteria: * the subject must be 18 years of age or older. * the subject must be scheduled to undergo wedge resection or lobectomy via video assisted thoracoscopic surgery (vats) for a lung nodule suspicious for or clinically proven to be primary lung cancer. * the subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure. * the subject must be willing and able to comply with all study requirements and have understood and signed the informed consent. exclusion criteria: * the subject is pregnant or breastfeeding. * the subject is scheduled to undergo sleeve lobectomy, segmentectomy, bi-lobectomy, pneumonectomy or lung volume reduction surgery (lvrs), or lung biopsy for suspected interstitial lung disease. * a rib-spreading thoracotomy incision is scheduled to be performed, however the use of an access incision without rib-spreading for specimen removal or to facilitate hilar dissection is allowed. vats procedures that are converted in the operating room to open procedures are not exclusionary. * the subject has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected. * the subject is scheduled to receive intra-operative brachytherapy. * the subject has other severe illnesses that would preclude surgery such as unstable angina or myocardial infarction within 3 months. * re-operative surgery is excluded if it is on the same side as the previous surgery. * investigator determines that participation in the study may jeopardize the safety or welfare of the subject. * the subject is unable to comply with the follow-up visit schedule

Keywords: lung cancer lobectomy wedge resection
a study of fz-ad005 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)

Summary: a first-in-human, open label, phase i study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of fz-ad005 in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. patients able to give written informed consent; 2. age ≥ 18 and ≤ 75 years old, male or female; 3. patients have histological or cytological diagnosis with advanced solid tumors ( especially sclc or lcnec); 4. willingness to provide tumor tissue for testing ; 5. have measurable lesions defined in recist v. 1.1; 6. expected survival ≥ 3 months; 7. eastern cancer cooperative group (ecog) performance status 0-1; 8. patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment. exclusion criteria: 1. patients who have had previous treatment with any anti-dll3 antibody； 2. have had other malignant tumors in the past 5 years; 3. patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose; 4. have active cns (central nervous system) metastasis； 5. had undergone major surgery or severe trauma within 4 weeks prior to the first dose; 6. had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment; 7. patients have psychiatric history; 8. female patients who are breastfeeding or pregnant; 9. other reasons that researchers believe are inappropriate to participate in this study.
the effects of a single session of rhythmic movement program on selected biopsychological parameters in pd patients

Conditions: Parkinson Disease; Rhythm

Summary: the aim of the present study is to examine the acute effects of a specially designed musicokinetic (msk) program for patients with parkinson's disease (pd) on a) anxiety levels b) select kinematic and kinetic parameters, and c) frontal cortex hemodynamic responses, during gait initiation and steady-state walking.

this is a blind cross over randomized control trial (rct) in which 13 volunteers with pd will attend a 45 min msk program under the following conditions: a) synchronous learning format, b) asynchronous remote video- based, and c) control conditions. changes in gait biomechanics and frontal cortex hemodynamic responses will be examined using a 10-camera 3d motion analysis (vicon t-series, oxford, uk), and a functional near-infrared spectroscopy (f-nirs - portalite, artinis, nl) system, respectively, while anxiety levels will be evaluated using the hamilton anxiety rating scale.

Eligibility criteria:
inclusion criteria: * hoehn and yahr (h\&y) parkinson disease scale i-iii * no restriction on disease duration, * no restriction on type of drug therapy * stable antiparkinsonian medication of at least 6 months * data collections will be "on" medication * no participation to any other exercise program for at least 2 months * 100% attendance of the session. exclusion criteria: * dementia * deep brain stimulation, * cancer, * cardiovascular diseases * poor visual capability * poor or auditory capability * musculoskeletal problems * no stable antiparkinsonian therapy

Keywords: musicokinetic education rhythm dance anxiety gait walking kinematics walking kinetics dlpfc hemodynamics
tocotrienol and bevacizumab in metastatic colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: this double blind, randomized phase ii trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. half of the patients will receive tocotrienol and the other half placebo. treatment is planned for a period of maximum six months and will be discontinued earlier in case of progression or unacceptable toxicity.


Eligibility criteria:
inclusion criteria: * histopathologically verified adenocarcinoma of the colon or rectum * metastatic disease * planned treatment with folfox or capecitabine combined with bevacizumab * evaluable disease according to recist 1.1 * performance status 0-2 * expected survival ≥ 3 months * patient acceptance to collection of blood samples for translational research * age ≥ 18 years * contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted. * adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): * wbc ≥ 3.0 x 109/l or neutrophils (anc) ≥ 1.5 x 10\^9/l * platelet count ≥ 100 x 10\^9/l * hemoglobin ≥ 6.0 mmol/l * serum bilirubin ≤ 2.0 x uln * serum transaminase ≤ 2.5 x uln * serum creatinine ≤ 1.5 uln * urine dipstick for protein ≤ 2+, if the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents ≤ 1g. * written and orally informed consent exclusion criteria: * other active malignant disease within 5 years prior to inclusion in the study. * other experimental therapy within 28 days prior to treatment initiation. * underlying medical disease not adequately treated. * surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab. * cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment * bleeding tumor * pregnant or breastfeeding women * fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment. * hypersensitivity to one or more active substances or auxiliary substances

Keywords: colorectal cancer tocotrienol natural killer cells circulating tumor dna
mi-based prep intervention

Conditions: PrEP Uptake

Summary: gay, bisexual and other men who have sex with men (msm) are the group at highest risk of hiv infection in the united states. pre-exposure prophylaxis (prep) has demonstrated high efficacy in preventing hiv infection among msm. however, uptake in clinical settings has been slow for several reasons, including low awareness and education, low perceived hiv risk, concern for side-effects, and stigma associated with taking the medication. the purpose of the proposed study is to develop and evaluate a brief motivational interviewing (mi) intervention to promote prep uptake among msm during the course of routine hiv screening at a public sexually transmitted disease (std) clinic.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. assigned male at birth and currently identify as male 3. score at least 10 on the hiv incident risk index for msm 4. hiv-negative based on results of antibody test 5. english- or spanish-speaking 6. have access to a working phone 7. have not taken prep exclusion criteria: 1. have previously taken prep 2. symptoms of acute hiv infection at baseline 3. hiv positive 4. a clinical contraindication to prep (e.g., renal dysfunction) 5. non-english or non-spanish speaking
ureteral stent-related pain and mirabegron (spam) trial

Conditions: Nephrolithiasis

Summary: ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and or stone fragments. they are often associated with pain, voiding often, the need to urinate quickly and finding blood in the urine called "lower urinary tract symptoms" or luts for short. there is randomized studies showing the efficacy of α-blockers such as tamsulosin in relieving "stent symptoms" (pain and luts). there is emerging but limited evidence to show that antimuscarinic medications, used to treat overactive bladder (oab) have some efficacy in decreasing stent symptoms. mirabegron is a beta-agonist used to decrease oab symptoms. mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in treating oab symptoms. conventional antimuscarinic medications often have bothersome side effects like dry mouth, constipation, blurred vision and cognitive impairment. this may limit their use in some populations. mirabegron is well-tolerated with a good safety profile and therefore may be useful in treating stent symptoms without the bothersome side effects commonly seen with antimuscarinic medications. . the investigators hypothesize that mirabegron is effective in decreasing ureteral stent related luts and pain.


Eligibility criteria:
inclusion criteria: * age ≥18 years * first presentation for ureteroscopy for this particular stone * planned insertion of double j ureteral stent * planned ureteral stenting ≥5 days * follow-up conducted at the queen elizabeth ii health sciences centre exclusion criteria: * bilateral ureteral stents to be inserted * stent already in situ prior to ureteroscopy * patients with congenital renal abnormalities (ie: horseshoe kidney, ectopic kidney, etc) * patients with urinary diversion * patients with a history of interstitial cystitis/painful bladder syndrome, chronic prostatitis, or neurogenic bladder * indwelling foley catheter * active urinary tract infection * patients currently taking antimuscarinics, mirabegron, or α-blockers * patients with contraindications to receiving either mirabegron or tamsulosin (ie: urinary retention, end-stage renal disease, orthostatic hypotension, uncontrolled hypertension, known qt prolongation, severe aortic regurgitation), significant cognitive impairment, pregnancy, and active urinary tract infection * planned upcoming elective cataract surgery * suspected or confirmed ureteral perforation

Keywords: ureteric stents luts lower urinary tract symptoms
compassionate use of corlux® (mifepristone) in the treatment of signs and symptoms of endogenous cushing's syndrome

Conditions: Cushing's Disease; Cushing's Syndrome

Summary: this is a compassionate use study. in addition to providing compassionate use access to mifepristone, objectives of the study will be to evaluate the safety and utility of mifepristone in the treatment of the signs and symptoms of endogenous cushing's syndrome when given on a compassionate use basis. the study will only enroll subjects whose physicians have determined that medical treatment is needed to control the symptoms or signs of hypercortisolemia.


Eligibility criteria:
inclusion criteria: 1. have a confirmed diagnosis of endogenous hypercortisolemia caused by acth dependent or acth independent etiologies including: * cushing's disease that (more than one may apply) * has recurred after primary pituitary surgery * has persisted despite pituitary surgery (failed pituitary surgery) * has been treated with radiation therapy to the pituitary * is not treatable with surgery * exists in subjects who are not candidates for or who refuse surgery * ectopic acth * ectopic crf secretion * adrenal adenoma * adrenal carcinoma * adrenal autonomy 2. have documented biochemical evidence of endogenous hypercortisolemia which includes elevated urinary free cortisol. 3. require medical treatment of hypercortisolemia. exclusion criteria: individuals not eligible to be enrolled into the study are those who: * have de novo cushing's disease and are surgical candidates for pituitary surgery. * have an acute or unstable medical problem, which could be aggravated by mifepristone treatment. * taking medications within 14 days of the baseline visit (day 1) that a) have a large first pass metabolism largely mediated by cyp3a4 and a narrow therapeutic margin and/or b) are strong cyp3a4 inhibitors. * female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study. * have received investigational treatment (drug, biological agent or device) within 30 days of screening * have a history of an allergic reaction or intolerance to corlux (mifepristone) * have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic cushing's syndrome), factious or therapeutic use of acth * have pseudo-cushing's syndrome. * postmenopausal women with an intact uterus who have experienced unexplained vaginal bleeding within 12 months of screening are excluded.

Keywords: cushing's disease cushing's syndrome cushings pituitary ectopic acth secretion
traumatic long-term memory of pain in humans

Conditions: Pain; Traumatic Memory

Summary: few studies have focused on understanding the mechanisms underlying pain memory in humans. thus, this project aims to investigate the link between pain memorisation and memorisation of the associated context by addressing the issue of pain conditioning. the study is composed of two successive parts: one pilot then one experimental. the goal is to understand pain memorisation processes by analysing the parallel between pain memorisation and memorisation of a traumatic event. by using immersive virtual reality, investigators aim to show that contextual pain conditioning is associated with : 1- a specific neural networks; 2- a reactivation of vegetative and behavioural reactions related to pain as well as electro-physiological markers when re-exposure to the specific pain-conditioning-context; 3- an implicit hypermnesia of the pain-associated context and a struggle to extinguish conditioning; 4- a favoured elaboration of false memories of the contextual pain. the emitted hypothesis suggests that a cortical and behavioural mnemonic trace is created during encoding of pain in association with its context, and that the latter can reactivate although the pain itself has disappeared. this implicit cortical mnemonic trace, evoked by the simple pain-associated context, could explain the notion of pain print persisting at long-term in patients suffering from chronic pain.


Eligibility criteria:
inclusion criteria: * healthy subject * subject between 18 and 50 years old * subjects having given their written consent * subjects with health insurance exclusion criteria: * prior addiction to drugs * prior neurological issues * chronic pain (neuropathic or non-neuropathic) * pregnant/breast-feeding women * absence of efficient contraception method for the duration of the study (1 month) for participants of procreation age (no inclusion limitation for male participants of procreation age) * subjects under chronic analgesic treatment or having taken an analgesic treatment in the 24 h preceding the experiment * heart issues * subjects under justice surveillance * subjects participating in another study which inclusion period overlaps with the one from this study

Keywords: pain traumatic long-term memory
interval training and performance in mountain bikers

Conditions: Physical Activity

Summary: the aerobic fitness is important for mountain bikers, but riders should also be able to generate maximal and supramaximal efforts in some crucial phases of the competition. although there is an increase interest in high-intensity aerobic training, to investigators knowledge, there are no studies examining the effects of interval (intv) or intermittent training (intm) in mountain bikers. the aim of this study was to compare the effects of intv and intm on aerobic fitness variables (peak power output, wmax, lactate threshold, and onset of blood lactate accumulation) but more importantly on performance as measured using a controlled mountain bike race, i.e. simulation. the investigators hypothesized that intv and intm training were equally effective in improving wmax, lactate threshold and onset of blood lactate accumulation, but intv was superior in enhancing performance in mountai bike race simulation.this hypothesis is due to studies that have shown higher gains in performance with long duration of aerobic high intensity interval training in comparison to the shorter training at a higher intensity.

the study is a controlled and randomized trial.

Eligibility criteria:
inclusion criteria: * specific training in the mountain bike sport exclusion criteria: * use of pharmacological substances

Keywords: aerobic interval training supramaximal training
study of inter- and intra-rater reliability of the clinician erythema assessment scale

Conditions: Erythema; Rosacea

Summary: this is a study to evaluate inter- and intra-rater reliability of the clinician erythema assessment scale. there is no treatment (intervention) associated with this study.


Eligibility criteria:
inclusion criteria: * rosacea exclusion criteria: * unwilling to remove all facial make-up
decrease of post-operative complications by scvo2 monitoring an optimisation of cardiac flow

Conditions: Cardiac Flow

Summary: in operating theater, one of the bigger purpose of anesthetist-resuscitator is to optimize vascular filling (vf) because of a failure or an excess of filling is deleterious for the patient. several studies have assessed the traditionnal vf based on the clinic and the vf guided by quantitative critereas. thus studies have showed a decrease of morbidity and duration of patients' stay whose the vf was guided even on the long term. so, formal recommandations of experts (fre) on the perioperative filling strategy of the sfar ( anesthesia and resuscitation francophone society) advise to titrate the perioperative vascular filling of high risk patients guiding on a mesure of end-systolic volume (esv). the inscrease of esv answering to filling confirmed the vf realized is relevant and authorized its pursuite while the absence of an increase of the esv after a filling test signifies the useless and deleterious character of this one. the optimization of perioperative hemodynamics consists in adapting the patient's cardiac output to his metabolic needs. eto, swan-ganz: limit of its application to the routine. the central venous oxygen saturation (scvo2) is simple and safe, the evaluation of the adjustment of o2 inputs compared to the needs. the industry has developed continuous monitoring systems by reflection spectrophotometry using optical fibers installed in the central venous pathways. in daily practice, the stricto sensu application of fre leads to administering an vf up to the limit of the preload dependence without evaluating the adequacy of the cardiac output, which is not a physiological situation. this filling is therefore sometimes performed solely on the criteria of preload dependence while it is potentially deleterious for the patient. no study has compared a strategy based on the use of scvo2 and preload dependence with current recommendations based solely on preload dependence. our hypothesis is that the continuous monitoring of the scvo2 in the superior cave territory in intraoperative would allow to detect the patients with an inadequacy of the cardiac output and thus to select the only ones requiring a vascular filling. this would reduce postoperative complications related to overfilling, without exposing the patient to episodes of tissue hypoperfusion.


Eligibility criteria:
inclusion criteria: * \>50 years old * asa score ≥ 2 * requiring a major intra-abdominal scheduled surgery * lasting more than 90 min * in the visceral surgery, vascular surgery, urological surgery and gynecological surgery sectors exclusion criteria: * \<18 years old * pregnant or brest feeding patients * no consentement * unstable acute pathology at the time of surgery (acute heart, respiratory or renal failure, severe sepsis or septic shock, hemorrhagic shock); * rhythm disorders type acfa early intervention; * palliative surgery, asa 5; * patient under guardianship or curatorship.
peripheral histamine 1 receptor blockade in ibs: multicenter trial

Conditions: Irritable Bowel Syndrome (IBS)

Summary: purpose: to evaluate the efficiency of irritable bowel syndrome (ibs) patients treatment with the h1-receptor antagonist ebastine. design: double blind randomized placebo controlled trial. ibs patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).


Eligibility criteria:
inclusion criteria: * irritable bowel syndrome (ibs) (rome iii criteria): subtype with diarrhea or mixed form * age 18-65 years exclusion criteria: * ibs subtype with constipation * medication: antidepressants or h1-receptor antagonists * pregnancy, breast feeding * co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases
phase ii study to determine predictive markers of response to bms-734016 (mdx-010)

Conditions: Unresectable Stage III or IV Malignant Melanoma

Summary: the purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to bms-734016 (mdx-010).


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of unresectable state iii or iv malignant melanoma (excluding ocular melanoma); a pre- and post-treatment fresh core or excision tumor biopsy must be provided.
effect of vitamin d replacement during winter months in patients with hypertension

Conditions: Hypertension; Vitamin D Deficiency

Summary: high blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. blood pressure exhibits a seasonal variation with a tendency to increase during winter months. vitamin d deficiency is more common during months where uvb radiation from the sun is absent, and vitamin d has been associated with high blood pressure. this study will evaluate the effect of vitamin d replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.


Eligibility criteria:
inclusion criteria: * well-regulated arterial hypertension * office blood pressure \> 120/70 mmhg exclusion criteria: * pregnancy or nursing * cancer * alcohol abuse * continuous glucocorticoid or nsaid treatment * 24-hour blood pressure \> 150/95 mmhg * hypercalcemia

Keywords: hypertension blood pressure vitamin d winter cholecalciferol arterial stiffness renin angiotensin aldosterone calcium