Kornimate/medical-research-clean huggingface dataset:
initialization of methadone in primary care, randomized intervention research for preventing hcv transmission practices

Conditions: Hepatitis C; Substance Dependence; Methadone

Summary: the rapid scale up of opioid substitution treatment (ost) for drug users mainly achieved through the possibility of prescribing buprenorphine in primary care has been successful in reducing hiv prevalence among drug users but still inadequate for reducing the spread of hcv. to date, methadone in france can only be initialised in drug centres but gps can prescribe methadone after stabilisation of dosages. this study was born as an answer to a request from the french minister of health that supports the initialisation of methadone in primary care in order to improve coverage by ost (now 70%) in drug users.

we aimed to test the non inferiority of the proportion of non users of street-opioids after one year of treatment in patients inducted in primary care (pc) vs.those inducted in a specialised center for substance dependence (csapa). in this multisite, open-label, randomised controlled non-inferiority trial, opioid dependent individuals were randomized to start methadone either in pc or in a csapa. after stabilization of methadone dosage (\~2 weeks), patients could change arm. follow-up assessments through medical questionnaires and phone interviews was scheduled at month 0 (m0, enrolment) m3, m6, m12. the opiate treatment index (oti) was used for computing the proportion of patients reporting no use of street opioids in the last month at m12 (primary outcome) in those inducted in pc or in a csapa and the non inferiority margins. primary analysis was by intention to treat (itt)

Eligibility criteria:
inclusion criteria: * 18 to 70 years patients needing methadone for their opioid dependence who are either naives of methadone treatment (prescribed) since at least 1 month * need to switch from buprenorphine to methadone treatment * negative test for pregnancy exclusion criteria: * co-dependent on alcohol and benzodiazepines, * inmates, * pregnant women, * individual in irregular situation or who cannot be joined by phone.

Keywords: methadone substance dependence
over 2000 epidural anesthesias for percutaneous nephrolithotomy - a retrospective analysis

Conditions: Nephrolithiasis; Anesthesia, Local

Summary: percutaneous nephrolithotomy (pnl) is a renal lithiasis treatment. it is usually two staged: it begins in the lithotomy position for ureteral catheter placement and retrograde pyelography and, subsequently, an optimal renal access is obtained in the prone position. in most of the centers, the pnl is done under general anesthesia (ga) that is associated with a risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone position. in our department the procedure is usually performed under epidural anesthesia. the aim of this study was to evaluate the epidural anesthesia performed for pnl over the last decade in the medical university of warsaw urology department

percutaneous nephrolithotomy is a renal lithiasis endoscopic treatment. it is usually two staged: it begins in the lithotomy position for ureteral catheter placement and retrograde pyelography and, subsequently, an optimal renal access is obtained in the prone position. the pnl is usually two staged. it begins in the lithotomy position for cystoscopic placement of ureteral catheter and retrograde pyelography and, subsequently, a patient is placed mainly in the prone position for percutaneous access and stone removal. this position offers more options for puncture. in most of the centers, the pnl is done under ga, that is associated with a risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone position. other complications, including blood transfusion, nausea and vomiting or fever, are more often observed after the general then after the regional anesthesia; the cost of general anesthesia is also higher. the regional anesthesia that can be performed independently for the pnl includes spinal, epidural or combined spinal-epidural blocks. a segmental epidural block is better than spinal anesthesia in terms of hemodynamic stability, postoperative analgesia, patient's satisfaction and reduced incidence of postoperative nausea and vomiting. for epidural anesthesia it takes longer to act than for spinal one but it allows avoiding the motor block so the patient can change the position from lithotomy into prone himself with a little assistance. the position of a patient should not be changed rapidly right after the spinal anesthesia has been performed, due to the risk of too high anesthesia level and hemodynamic complications. the aim of the study was to evaluate the epidural anesthesia performed for pnl over the last decade in the medical university of warsaw urology department.

Eligibility criteria:
inclusion criteria: * pnl procedure exclusion criteria: * no pnl procedure

Keywords: epidural anesthesia prone position percutaneous nephrolithotomy
glivec® (imatinib mesylate, sti571) in monotherapy versus glivec®-interferon alpha in the treatment of chronic-phase chronic myeloid leukaemia

Conditions: Chronic Myeloid Leukaemia

Summary: to compare the complete cytogenetic response rate in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia treated with glivec® alone or in combination with interferon at low doses

open, prospective, multicentre, phase iv, comparative and randomised study

Eligibility criteria:
inclusion criteria: 1. patients with newly-diagnosed chronic-phase ph-positive chronic myeloid leukaemia (maximum 3 months as of the diagnosis of the disease, with the date of the cytogenetic study regarded as such). 2. age between 18 and 72 years (both included). 3. performance status \< 2 on the ecog scale (see annex 3). 4. secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6). exclusion criteria: 1. criteria of acceleration or blastic crisis (see annex 7). 2. when there is a compatible family donor in patients aged under 40 years or a non-relative donor in patients aged under 30 years (in whom allogenic transplant is still regarded as first-line treatment), the possibility of performing an allogenic transplant as first therapeutic option should be considered. in any case, as this aspect is still a matter of debate, it is left up to each group to take the relevant decision depending on the institution's policy. 3. administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted). 4. altered hepatic or renal function (sgot, sgpt, total bilirubin and creatinine \> 1.5 times the upper limit of normality). 5. uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure (functional class iii/iv of the new york heart association classification), neuropsychiatric infection or disease (see annex 15). 6. positive serology for hiv. 7. record of cancer in the last 5 years (barring basal cell skin carcinoma and cervical carcinoma in situ). 8. pregnancy or breastfeeding

Keywords: chronic myeloid leukaemia glivec interferon
sh t00186 phase ii/ iii optimal drospirenone (drsp) dose finding and placebo-controlled comparative study

Conditions: Dysmenorrhea

Summary: the purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.


Eligibility criteria:
inclusion criteria: * patients aged 20 years or older at obtaining informed consent * patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment * patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment exclusion criteria: * patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in greater detail in the study protocol) * patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class iii or greater in the cervical smear or endometrial smear examination.) * patients with undiagnosed abnormal vaginal bleeding * patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), or a history of those diseases * patients aged 35 years or older who smoke at least 15 cigarettes per day * patients with migraine accompanied by prodrome (e.g. scintillating scotoma or star-shaped scintillation) * patients with pulmonary hypertension or valvular heart disease complicated by atrial fibrillation, and patients with a history of subacute bacterial endocarditis * patients who are regularly taking nutritional products that contain st. john's wort * patients who underwent surgical treatment for endometriosis by laparotomy, or laparoscopy within 2 months prior to screening * patients who need to use analgesics regularly for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Keywords: dysmenorrhea dysmenorrheal score drospirenone drsp ethinylestradiol
micro-ultrasound for prostate cancer diagnosis

Conditions: Prostate Cancer

Summary: this is a single-center, paired-cohort, prospective study. patients with a clinical suspicion of cspca will receive mpmri and micro-us in two different visits. the results of the diagnostic procedures will determine how many and which type prostate biopsies patients will undergo. during the following visit, patients with both positive mpmri and micro-us, defined as the presence of one or more lesions with pi-rads ≥ 3 and pri-mus ≥ 3 respectively, will receive a 12-core trusbx in addiction to mri-tbx and micro-us-tbx (group 4). patients with both negative mpmri and micro-us will receive a 12-core trusbx (group 1). patients with only positive mpmri will receive mri-tbx and 12-core trusbx (group 2). patients with only positive micro-us-tbx will receive micro-us-tbx and 12-core trusbx (group 3). our hypothesis is that the sensitivity for cspca (defined as prostate cancer with gleason score ≥ 3+4) of micro-us will be superior or at least equal to that of mpmri. despite the introduction of the mpmri and mri-tbx has improved the diagnostic pathway of pca, the proportion of men with negative mpmri with a cspca is still difficult to delineate due to the high variability of mpmri negative predictive value (npv) and specificity. in this context, a specific standardization of the use of micro-us may play a crucial role to optimize pca diagnostic pathway. moreover, a direct comparison between micro-us and mpmri might be useful to determinate whether micro-us could be more accurate than mpmri for pca diagnosis. furthermore, in patients with suspicion of pca the combined use between mpmri and micro-us might increase the detection of cspca and reduce the number of unnecessary biopsies, improving mpmri limitations in npv and specificity. demonstrating that micro-us provides a similar sensitivity for cspca as compared to mpmri may lead to its definitive inclusion in daily clinical practice, potentially replacing mpmri, streamlining the current diagnostic pathway of pca.


Eligibility criteria:
inclusion criteria: * men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy * serum psa ≤ 20ng/ml * suspected stage ≤ t2 on rectal examination (organ-confined prostate cancer) * fit to undergo all procedures listed in protocol * able to provide written informed consent exclusion criteria: * prior treatment for prostate cancer * prior diagnosis of prostate cancer * contraindication to mri (e.g. claustrophobia, pacemaker, estimated gfr ≤ 50mls/min) * contraindication to prostate biopsy * men in whom artifact would reduce the quality of the mri * previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work * unfit to undergo any procedures listed in protocol
effect of tahneek on hypoglycemia in newborn infants

Conditions: Neonatal Hypoglycemia; Infant, Small for Gestational Age; Macrosomia, Fetal; Intrauterine Growth Restriction; Premature Infant; Neonatal; Hypoglycemia, Diabetes, Maternal

Summary: tahneek is an arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. neonatal hypoglycemia is common in the first few days after birth. up to 15 % of normal newborn babies will have low blood glucose concentrations. it has been demonstrated that treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing the hypoglycemia, and also reduced the rate of nicu admission. investigators study is using dates to asses its effect on hypoglycemia in infants at risk.

tahneek is an arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. it is a noble practice in islam, with which the newborn is greeted upon entering into life, usually before milk feeds. it is done by rubbing a softened date on the palate of the new-born just after the birth. the tahneek also exercises the muscles of the mouth and helps with the circulation of blood in the mouth - this may help the baby to be able to suck and take mother's milk. neonatal hypoglycemia is common in the first few days after birth. up to 15 % but the incidence in babies with risk factors is much greater upto 50 % in infants of diabetic mothers, large and small babies and 66 % in preterm babies. neonatal hypoglycemia is associated with brain damage, death and developmental delay in later life. treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing hypoglycemia, and thus reducing the rate of nicu admission for hypoglycemia. investigators study is using dates to asses its effect on hypoglycemia in infant at risk.

Eligibility criteria:
inclusion criteria: * babies at risk of hypoglycemia less than 1 hour old admitted to the normal nursery. * infants of diabetic mothers (any type of diabetes) * late preterms (34 - 37 weeks' gestation) * low birth weight (\< 2.5 kg ) or small for gestational age * large for gestational age (\> 4 kg or \> 90th centile on fenton's growth chart) exclusion criteria: * major congenital abnormality including severe cleft lip and palate. * babies requiring nicu admission immediately after birth * babies less than 34 weeks of age. * babies whose parents refused to consent

Keywords: tahneek neonatal; hypoglycemia, diabetes, maternal neonatal hypoglycemia late preterm infants prevention iugr
induction chemotherapy and toripalimab followed by radiotherapy in unresectable laryngeal/hypopharyngeal carcinoma

Conditions: Laryngeal Cancer; Hypopharyngeal Cancer

Summary: the aim of this study is to define whether combination of induction chemotherapy and pd-1 inhibitor (toripalimab) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.

historically, induction chemotherapy has been shown to increase laryngeal-preservation rate, improve disease-free survival and reduce the risk of distant metastasis. however, the prognosis of locally advanced laryngeal/ hypopharyngeal carcinoma remains poor. recently, phase i-ii clinical studies demonstrated excellent pathological response of induction pd-1 inhibitor with/without chemotherapy for locally advanced head and neck cancer. the aim of this study is to define whether combination of induction chemotherapy and pd-1 inhibitor (toripalimab) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.

Eligibility criteria:
inclusion criteria: * pathologically confirmed, unresectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma due to extensively local invasion or medical comorbidities (t3-4b, n0-n3, m0); * age between 18-75 years; * signed inform consent; * had at least one measurable lesion according to recist 1.1 criteria * anticipated overall survival more than 3 months; * satisfactory performance status: ecog (eastern cooperative oncology group) scale 0-1; * normal organ function and bone marrow function; * hbv dna\<500 iu/ml（or 2500 copies/ml）and hcv rna negative ; * male and no pregnant female, able to adapt birth control methods during treatment. exclusion criteria: * hypersensitivity to toripalimab, paclitaxel or cisplatin; * suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years; * severe, uncontrolled heart disease; * receive vaccine or live vaccine within 28 days prior to signing the informed consent; * equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent; * surgery or trauma within 28 days prior to signing the informed consent; * received other immune checkpoint inhibitors previously; * severe, uncontrolled infections within 28 days of prior to signing the informed consent; * active, known or suspected autoimmune disease; type i diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit; * history of interstitial lung disease; * hiv positive; * hepatitis b surface antigen (hbsag) positive and hbv-dna ≥500iu/ml, or 2500cps/ml; positive hcv rna; * other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors; * women of child-bearing potential who are pregnant or breastfeeding.

Keywords: induction chemotherapy immunotherapy toripalimab radiotherapy
sulcular bristle tip technique (sbtt) with an electric toothbrush

Conditions: Gum Bleed

Summary: in this study, all subjects will be given an electric toothbrush. half of the participants will be instructed on how to use the sulcular bristle tip technique (sbtt). the other half of participants will be asked to follow the brushing instructions in the user manual. the study's primary aim is to compare the use of the sbtt with an electric toothbrush in reducing bleeding on probing with the use of an electric toothbrush used without personal professional instruction.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * subjects must show \> 20% buccal/lingual cervical sites with bleeding on probing (bop) * subjects must have \> 24 natural teeth excluding third molars * subjects must have had a professional dental prophylaxis within three months of beginning the study * subjects must be willing to brush with electric toothbrush twice daily. * subjects who are randomized into group 1 must be willing to be taught and to demonstrate the sbtt * subjects who are randomized into group 2 must be willing to follow the sonicare dfu from philips oral healthcare; however, will otherwise be uninstructed until after the study has been completed * subjects must be willing to refrain from any oral hygiene for at least 12-18 hours prior to each study follow-up visit. exclusion criteria: * subjects who use tobacco products * subjects who are currently pregnant (self-reported) due to the greater bleeding tendency caused by hormonal changes * subjects with fixed or removable orthodontic appliances * subjects whose restorations violate or potentially violate the biologic width. * subjects with irregular restoration margins or overhanging margins within 1mm of the crest of the marginal gingiva. * antibiotic treatment at the time of the initial examination or during the month prior * subjects with cervical probing depth \>3 mm * subjects with systemic diseases that affect the gingiva * subjects taking medications that affect the gingiva * subjects who cannot read/write/speak english

Keywords: sulcular bristle tip technique sbtt brushing plaque
a deep learning method to evaluate qt on ribociclib

Conditions: Breast Cancer; Ribociclib

Summary: "deep-learning" is a fast-growing method of machine learning (artificial intelligence, ai) which is arousing the interest of the scientific committee in many medical fields. these methods make it possible to generate matches between raw inputs (such as the digital signal from the ecg) and the desired outputs (for example, the measurement of qtc). unlike traditional machine learning methods, which require manual extraction of structured and predefined data from raw input, deep-learning methods learn these functionalities directly from raw data, without pre-defined guidelines. with the advent of big-data and the recent exponential increase in computing power, these methods can produce models with exceptional performance. the investigators recently used this type of method using multi-layered artificial neural networks, to create an application based on a model that directly transforms the raw digital data of ecgs (.xml) into a measure of qtc comparable to those respecting the highest standards concerning reproducibility. the main purpose of this trial is to study the performance of our dl-ai model for qtc measurement (vs. best standards of qtc measurements, tcm) applied to the recommended ecg monitoring following ribociclib prescription for breast cancer patients in routine clinical care. the investigators will acquire ecg with diverse devices including simplified devices (one/three lead acquisition, low frequency sampling rate: 125-500 htz) to determine if they'll be equally performant versus 12-lead acquisition machine to evaluate qtc in this setting.


Eligibility criteria:
inclusion criteria: * adult female patients requiring start of ribociclib based therapy for a breast cancer in their standard of care, as per their summary of product characteristic's indications * association with hormone-based therapy in combination is authorized (aromatase inhibitors or fulvestrant) * able to provide an informed consent exclusion criteria: * any allergy or contra-indication to ribociclib as mentioned in their as summary of product characteristic's * patients presenting a condition precluding accurate qtc measurements on electrocardiogram, i.e paced ventricular rhythm, multiples premature ventricular or supra-ventricular contractions, ventricular tachycardia, supraventricular arrhythmia (including atrial fibrillation, flutter or junctional rhythm) * patients with an atrial pacing and sinus dysfunction * patients presenting a contra-indication for ecg measurement, or with a device rendering ecg measurements impossible (i.e. diaphragmatic pacing) * patients presenting a contra-indication to ribociclib start; including association with prohibited drug potentializing the risk of tdp

Keywords: deep learning ribociclib qtc values