Kornimate/medical-research-clean huggingface dataset:
developing a safer and more accurate device for biopsies of suspected prostate cancer

Conditions: Prostate Cancer; Prostate Biopsy

Summary: to evaluate the use of the cambridge prostate biopsy device (camprobe) as a method of undertaking prostate biopsy as part of their clinical management.

to assess patient's experience and complications of the camprobe and compare the results with known published outcomes from standard transrectal biopsies . to use data from the pilot study to determine the feasibility of a randomised trial comparing camprobe with the current standard method of prostate biopsies.

Eligibility criteria:
inclusion criteria: * fit and well enough to undergo a repeat prostate biopsy * men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care * men on active surveillance * men on psa monitoring exclusion criteria: * contraindication for a repeat prostate biopsy * contraindication for a transperineal prostate biopsies * previous perineal or anal surgery * mri suggesting anterior lesion or extra capsular disease * mri suggesting lesion that needs fusion image targeting * unable to lie down and with legs in a stirrup for at least 45 minutes
use of an ocular telemetry sensor in tafluprost treated patients

Conditions: Glaucoma

Summary: this clinical trial is designed to investigate the performance of sensimed triggerfish® during 24-hour continuous iop fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period. the investigation will recruit male and female patients older than 18 years and diagnosed with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the study. patients will be considered enrolled in the study upon signature of informed consent. a screening visit and one 24-hour iop fluctuation monitoring session during a 36-hour hospitalisation, are planned for each patient.


Eligibility criteria:
inclusion criteria: * older than 18 years. * untreated iop of ≥22 mmhg in both eyes. * documented, typical glaucomatous visual field (vf) loss (nasal step, or arcuate, paracentral or seidel's scotoma) determined by automated static threshold perimetry (octopus 100), and glaucomatous optic nerve head cupping (neural rim notching or saucerization) in both eyes. * patients under tafluprost treatment since at least 4 weeks in both eyes. * patients who accept signing an informed consent approved by the ethics committee. exclusion criteria: * patients not able to understand the nature of the research * patients under tutorship * corneal abnormalities in both eyes * subjects with contraindications for wearing contact lenses * history of ocular surgery within the last 3 months * known hypersensitivity to tafluprost or to any of its excipients * full-frame metal glasses during monitoring with sensimed triggerfish® * pregnancy and lactation * simultaneous participation in other clinical research * patients with evidence of ocular infection or inflammation
long term integrity follow-up evaluation

Conditions: Sudden Cardiac Death

Summary: to document the performance of the guidant endotak ez and the reliance defibrillation leads over 5 years.

there are few prospective long term follow-up studies on implanted cardiac device (pacemaker/implantable cardioverter defibrillator (icd)) survivability. this study will evaluate the long term performance (5 years) of the transvenous defibrillation leads (endotak endurance ez and teh endotak reliance. data will be collected at implant, 1 and 6 months, 1,3 and 5 years.

Eligibility criteria:
inclusion criteria: * patients selected for guidant icd system implant, available for follow-up at the defined intervals exclusion criteria: * patients enrolled in other studies, not available for follow-up, \< 18 yrs, unable to sign consent, life expectancy \< 1 year due to a medical condition

Keywords: defibrillator
efficacy and safety of prj212 to improve the memory of patients with mild severity alzheimer's disease

Conditions: Alzheimer Disease

Summary: a 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.

men and women from 60 to 85 years old with diagnosis of mild severity alzheimer's disease, according to the diagnostic criteria established by the national institute of neurological and communicative disorders and stroke and alzheimer's disease and related disorders associations (nincds-adrda).

Eligibility criteria:
inclusion criteria: * patients aged from 60 to 85 years. * patients with a diagnosis of probable or possible alzheimer's disease according to the nincds-adrda. * patients with mild alzheimer's disease according to mmse. * patients with ability to ingest oral medication. * patients able to undergo a mri. exclusion criteria: * pregnant or breastfeeding women or planning a pregnancy during the study. * patients and caregivers unwilling or unable to perform cognitive testing. * patients taking part in an interventional clinical trial. * patients who have a risk of non-compliance to the study procedures. * patients with clinical or significant laboratory abnormalities. * patients treated with concomitant treatment or food supplements which could interfere with evaluation criteria.
evaluation of levator ani muscle injury in primiparous

Conditions: Pelvic Floor Disorders

Summary: pelvic floor muscles play an important role in supporting the pelvic organs. vaginal birth leads to defects in pelvic muscles and hence subsequent pelvic organ prolapse and urinary and fecal incontinence can occur . transperineal ultrasonography study pelvic floor pathology with minimal discomfort to the patient and lower cost than magnetic resonance imaging.

355 eligible egyptian women had been enrolled maternal medical, surgical and obstetrical history was obtained. demographic data (maternal age, maternal body mass index, duration of second stage labor, episiotomy, maternal injuries, neonatal birth weight, and neonatal head circumference were obtained. a modified questionnaire on symptoms of pelvic floor dysfunction was filled by the patients in both visits. vaginal examination with the women to detect any pelvic organ prolapse (quantified according to pop-q classification system. all ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a ge voluson p8 (ge healthcare) equipped with a 4-8-mhz curved array 3d/4d ultrasound transducer. after emptying the bladder, ultrasound was done while the patient in the supine position. the probe was covered with clean glove adjusted and wrapped with an adhesive tape to make it firmly contacted to the probe and then placed on the perineum in the sagittal plane. the field of view angle was set to a maximum of 70° in the sagittal plane and the volume acquisition angle to 85° in the axial plane. two 3d volumes (one with the patient at rest and one during valsalva maneuver) were recorded.

Eligibility criteria:
inclusion criteria: * primipara who had singleton fetus with cephalic presentation were recruited during their first post-partum visit ,1week post-delivery. exclusion criteria: multi para, multifetal pregnancy, congenital anomalies of the genital tract past history of pelvic floor surgery or trauma or inability to come for follow up after 6weeks

Keywords: levator hiatus
trial of adjuvant chemotherapy for gastric cancer

Conditions: Stomach Cancer

Summary: this is a phase iii randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

stomach cancer is the most common cancer in korea and one of the major health problems worldwide. the most effective treatment for gastric cancer is curative surgical resection of primary tumor. however, a substantial number of patients eventually die of recurrences after curative resection. a number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. however, the efficacy of adjuvant chemotherapy is still controversial and varied between western and asian trials. meta-analysis of western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. conversely, some asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. in a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment. this study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Eligibility criteria:
inclusion criteria: * pathologically proven gastric adenocarcinoma * curative resection was done * stage ii, iiia, iiib, iv (including t4, lesions or n3, but excluding m1 lymph node metastasis) * age: 18-69 years old * performance status: ecog 0-2 * adequate bone marrow function (wbc ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl) * adequate renal function (serum creatinine≤ 1.5) * adequate liver function (serum bilirubin ≤1.5 mg/dl, ast/alt ≤ 3 x normal upper limit) * written informed consent was signed by the patient exclusion criteria: * previous chemotherapy or radiotherapy * active ongoing infection which antibiotic treatment is needed * pregnant or lactating women * psychosis or convulsion disorder * ascites in preoperative abdomen ct * systemic disease which interfere the administration of chemotherapy * previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ

Keywords: stomach cancer adjuvant chemotherapy mitomycin cisplatin doxifluridine
telephone oncogériatric followed in the management of elderly patients treated for cancer or haematological malignancy

Conditions: Cancer; Hematologic Malignancy

Summary: there are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment. the oncogériatrique evaluation being time-consuming, requiring the movement of these more or less frail elderly patients, it seems difficult to envisage repeated and systematic standardized geriatric assessments during cancer treatment. geriatric fragility can be detected by telephone. craven et al. has already assessed the telephone follow-up by a nurse in patients treated for cancer, but with the aim to detect toxicities of cancer treatment, patients are not very old (mean age 64.8 years). external evaluation by the nurse coordinator of ucog (coordination unit in geriatric oncology) not knowing the patients included avoids bias of subjectivity in the interrogation. however the telephone monitoring, with the aim to evaluate the evolution of geriatric frailty, has not been specifically studied in the elderly population treated for cancer, while taking oncology load. the investigators wish to study the feasibility and validity of telephone follow-up which could eventually be used routinely to identify patients requiring further medical consultation oncogériatrique.


Eligibility criteria:
inclusion criteria: * patients 70 years and older with cancer or hematologic malignancies; * faced benefit from cancer treatment (systemic treatment, curative radiotherapy) in one of the clinical sites; * addressed in onco-gériatric consultation in the usual routine care sector; * mastery of the french language; * patient affiliated to the social security system; * patient has given its written consent. exclusion criteria: * life expectancy \<3 months * inability to communicate by telephone (deafness, speech disorder, ..) * inability collection of written consent * group 4 sio (international society of geriatric oncology), performance status (ps) 4 * initial mmse (mini-mental state examination) \<18/30 * oncological treatment envisaged: analgesic radiotherapy or exclusive decompressive, brain radiation therapy in toto * patient under guardianship

Keywords: cancer geriatric
characterizing malignant tumors using ultrasound doppler imaging

Conditions: Malignant Tumor of Women's Reproductive System

Summary: the aim of this study is to determine whether ultrasound doppler imaging can identify malignant tumors at a very early stage.


Eligibility criteria:
inclusion criteria: * women presenting for routine abdominal/vaginal ultrasound exclusion criteria: * pregnant women
under the nose face mask to prevent facial pressure ulcers during niv for acute hypercapnic respiratory failure (ahrf)

Conditions: Acute Hypercapnic Respiratory Failure

Summary: noninvasive ventilation (niv) is essential to treat acute hypercapnic respiratory failure. however, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of niv failure by interface intolerance. a philips facemask (model : af541 se oro-nasal mask) has the particularity to display two options for its positioning : a usually used "over-the-nose" positioning or an "under-the-nose" positioning that is supposed to reduce the incidence of facial pressure ulcers while keeping in the same time the qualities of a standard facemask. the goal of this controlled randomized trial is to test the hypothesis that the "under-the-nose" positioning actually reduces the incidence of facial pressure ulcers, compared to the usually used "over-the-nose" positioning. results of this trial should lead to the proposition of a new interface strategy to prevent facial pressure ulcers and therefore to improve the tolerance of niv via the use of facemasks displaying an "under-the-nose" positioning.


Eligibility criteria:
inclusion criteria: * acute hypercapnic respiratory failure * initiation of niv * estimated cumulative time of niv upper than 12 hours for the first 48 hours of hospitalization exclusion criteria: * contraindication for niv (respiratory arrest, impossibility to fit the mask) * intubated patient * patient with a tracheostomy * post-extubation respiratory failure * patient exhibiting facial ulcers or skin lesions located at the insertion points of the mask before its hospitalization * person declining niv * pregnancy * dying person

Keywords: facial pressure ulcers noninvasive ventilation acute hypercapnic respiratory failure
survey on return to work after stroke

Conditions: Stroke

Summary: survey of survivor perspective on critical elements that either facilitate or inhibit return to work after a stroke. critical elements are queried in areas of finances, stroke impairments, interpersonal support, therapeutic support, organization influences, work or job specific issues and psychological issues.

the objective of this project is to more accurately describe the stroke survivor's perspective on return to work. the survey development included qualitative analysis of a set of interviews with stroke survivors to arrive at the critical elements described above, followed by item development with an expert panel and preliminary testing of the wording and format for legibility. the survey is being administered both on-line and by paper through the mail to a wide range of survivors with the objective of obtaining a large, diverse sample. the ultimate goal of the project is to arrive at a refined set of recommendations to inform stroke survivors, health care professionals and employers to increase their sensitivity to the needs and desires of individual attempting to return to work after stroke.

Eligibility criteria:
inclusion criteria: * have returned to work, have thought about returning to work, or have tried to return to work exclusion criteria: * non-stroke disability * retired or no plan to return to work

Keywords: stroke work vocational rehabilitation
emd for treatment of proximal class-ii furcation involvements

Conditions: Generalized Aggressive Periodontitis

Summary: the aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (emd).

proximal class-ii furcation represents a challeng to periodontal therapy. studies show that the ultrasonic non-surgical therapy doesn't work in these defects and the guided tissue regeneration therapy with membranes also demonstrates an unpredictable improvement. therefore, enamel matrix derivative proteins (emd) have been proposed as a periodontal regenerative procedure due to their fundamental role in cementum development.

Eligibility criteria:
inclusion criteria: * diagnosis of generalized aggressive periodontitis (armitage, 1999; american academy of periodontology, 2015); * have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement); * presence of one proximal class-ii furcation presenting probing depth \> 4 mm and bleeding on probing ; * good general health; * agree to participate in the study and sign the informed consent form (tcle) after explaining the risks and benefits; exclusion criteria: * systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - asa iii / iv / v) that contraindicate the periodontal procedure; * have used antibiotics and anti-inflammatories in the last six months; * smoke ≥ 10 cigarettes/day; * pregnant or lactating; * chronic use of medications that may alter the response of periodontal tissues; * indication of antibiotic prophylaxis for dental procedures;

Keywords: enamel matrix derivative proximal furcation randomized clinical trial
validation of a single rest-stress imaging protocol for myocardial perfusion imaging

Conditions: Coronary Artery Disease; Myocardial Ischemia

Summary: we propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia. subjects will undergo single-scan two-injection imaging as well as regular stress single-scan single-injection protocol and the myocardial blood flow of both techniques will be compared.


Eligibility criteria:
healthy volunteers: inclusion criteria: * subjects must be ≥30 and ≤75 years of age; * subjects must provide informed consent prior to study procedures; exclusion criteria: * history of cad, including: * prior abnormal myocardial perfusion study * history of mi * history of angina * coronary artery obstruction \>50% on cta and/or angiography * left ventricular ejection fraction \<50% * any relative or absolute contraindication to adenosine stress, including: * 2nd or 3rd degree heart block * bradycardia (hr\<50 bpm) * recent acute coronary syndrome (acs) * unstable angina * severe heart failure (left ventricular ejection fraction \<15%) * ventricular arrhythmia * severe asthma and/or chronic obstructive pulmonary disease (copd) * baseline hypotension defined as systolic blood pressure \< 90 mmhg * caffeine intake within 24 hours prior to imaging * current use of theophylline, dipyridamole, or carbamazepine * allergy or intolerance to adenosine * positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing; subjects with cad: inclusion criteria * subjects must be ≥30 and ≤75 years of age; * subjects must provide informed consent prior to study procedures; * abnormal myocardial perfusion study within the past 12 months exclusion criteria * revascularization (percutaneous coronary intervention and/or coronary artery bypass) following last myocardial perfusion study * acute coronary syndrome within 30 days * left ventricular ejection fraction \<50% * any relative or absolute contraindication to adenosine stress, including: * 2nd or 3rd degree heart block * bradycardia (hr\<50 bpm) * recent acute coronary syndrome (acs) * unstable angina * severe heart failure (left ventricular ejection fraction \<15%) * ventricular arrhythmia * severe asthma and/or chronic obstructive pulmonary disease (copd) * baseline hypotension defined as systolic blood pressure \< 90 mmhg * caffeine intake within 24 hours prior to imaging * current use of theophylline, dipyridamole, or carbamazepine * allergy or intolerance to adenosine * any clinically significant acute or unstable physical or psychological disease, judged by the investigators, to be incompatible with the study; * radiation exposure exceeds current radiology department guidelines (i.e. 50 msv in the prior 12 months); * female participants only: positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing; * inability to provide written informed consent;
understanding and overcoming the early adaptive resistance to egfr tyrosine-kinase inhibitors in lung cancer patients

Conditions: Lung Cancer, Nonsmall Cell

Summary: epidermal growth factor receptor-tyrosine kinase inhibitors (egfr-tki) are effective therapies for advanced lung cancer patients bearing egfr-activating mutations, but are not curative due to the invariable apparition of resistances. the investigator team have identified a new phenotype related to drug tolerance after egfr-tki treatment that shares several characteristics of a known process of therapy-induced senescence (tis), which could be a major event of drug tolerance in patients. using cutting-edge technologies, patient-derived xenografts (pdx) and circulating tumor cells (ctc), the investigator team will perform an exhaustive characterization of the phenotypic and molecular changes associated with this drug-tolerant state in patients. their results should lead to new therapeutic approaches to eliminate the reservoir of drug-tolerant cells and to prevent emergence of resistance mutations responsible for the relapse of patients.

lung-resist is a translational, monocentric and prospective research study on 40 patients whose objective is to characterize drug tolerant cell (dtc) type cells in patients with a nsclc carrying an egfr mutation and to discover and monitor potentials biomarkers involved in this mechanism of resistance to osimertinib. the study will be offered to patients, and for whom the therapeutic decision was decided collegially during multidisciplinary molecular meetings (molecular tumor board). following informed consent, patients will be registered in a single cohort. in this study, treatment with osimertinib is not studied and will be delivered according to current recommendations

Eligibility criteria:
inclusion criteria: * patient with non operable and / or metastatic non-small cell lung cancer documented histologically. * pathological diagnosis of nsclc carrying an egfr activating mutation associated with sensitivity to the tyrosine kinase inhibitors (tki) (exons 18, 19 and 21). * sufficient tissue sample quantity and quality for translational research * naïve tki-treated egfr patient who can receive first-line treatment with osimertinib or second-line after chemotherapy exclusion criteria: * any patient with an exon 20 egfr mutation. * any disease or pathology that recommend not to perform blood samples collection * any psychological, family, geographical or social condition that could potentially, according to the investigator's judgment, prevent the collection of informed consent or interfere with compliance with the study protocol * patient with a resistance mutation of egfr * patient under state medical assistance * patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curatorship or safeguard of justice

Keywords: lung cancer targeted therapy resistance