Kornimate/medical-research-clean huggingface dataset:
the impact of an epidural ropivacaine-neostigmine injection for perineal analgesia at the end of labor.

Conditions: Pregnancy; Vaginal Delivery

Summary: perineal pain after childbirth occurs in the majority of women (with or without episiotomy). perineal pain can become source of chronic pain in 9%-12% of the cases. neostigmine a cholinesterase inhibitor at a dose of 500µg combined with sufentanil or ropivacaine (=local anaesthetic) is an analgesic. the goal of this study is to examine the effect of the use of epidural neostigmine for perineal analgesia at the end of the labor on acute pain and on the development of chronic pain post partum.

the goal of epidural analgesia during labour is to obtain an analgesia with a minimum of "motor block". absence of motor block at the time of the childbirth allows to decrease the rate of instrumentation (forceps, vacuum extractor). when the parturient approach complete cervical dilatation (8-10 cm), the anaesthetist must perform a last epidural injection for perineal analgesia. generally a local anaesthetic is used (ex : ropivacaine). adjuvant can be associated to local anaesthetic (sufentanil, clonidine and more recently neostigmine) to maximize local anaesthetic without increasing motor block. neostigmine, a cholinesterase inhibitor, increase concentration of acetylcholine on synaptic level and stimulate analgesic mechanisms mediated by this acetylcholine on dorsal horn of spinal cord. perineal pain after childbirth appears in most of the women with or without episiotomy. (mac arthur am j obst. gynecol. 2004). this perineal pain can become source of chronic pain in 9%-12% of the cases. neostigmine, a cholinesterase inhibitor at the dose of 500µg, combined with sufentanil or ropivacaine (=local anaesthetic) has an analgesic effect. the goal of this study is to examine the effect of epidural neostigmine for perineal analgesia at the end of the labour and on the development of chronic pain post-partum. inclusion criteria : any parturient of 18-45 years, normal pregnancy, at full term and having an effective epidural anaesthesia during labour. exclusion criteria : multiple pregnancy, obstetric pathology, refusal of participation. randomisation : 2 groups of 30 patients method : installation of the epidural catheter : - injection of ropivacaïne + sufentanil perineal analgesia : * ropi group : epidural injection of ropivacaine * neostigmine group : epidural injection of ropivacaine and neostigmine evaluation of vas, vital signs of parturient and fetal heart rate, instrumentation rate. evaluation of immediate post-partum pain (48hours) and use of analgesic medication in the ward. evaluation of chronic pain after 10 days and 1 month.

Eligibility criteria:
inclusion criteria: * any parturient of 18-45 years * normal pregnancy * at full term * having an effective epidural anesthesia during labor exclusion criteria: * multiple pregnancy * obstetric pathology * refusal of participation

Keywords: pregnancy vaginal delivery
percutaneous cryoablation peripheral lung cancer

Conditions: Lung Cancer

Summary: this study is focus on percutaneous cryoablation,which was for the treatment of medically inoperable peripheral lung cancer.the patients who were agreed to attend the study will accept the operation. after the operations,they will follow up according to the plan.

the patients who were agreed to attend the study conclude early stage lung cancer and solitary metastatic lung cancer.

Eligibility criteria:
inclusion criteria: medically inoperable peripheral lung cancer diameter no more than 3cm exclusion criteria: 1. refusal of participation 2. tendency to bleed to that can't receive percutaneous cryoablation. 3. severe cardiopulmonary dysfunction and other indications that can't receive percutaneous cryoablation.

Keywords: lung cancer percutaneous cryoablation treatment of medically inoperable
possibilities of interpreting the night-to-day ratio specified by 24-hour blood pressure monitoring

Conditions: Cardiovascular Diseases

Summary: specify the risk rate of incorrect patient classification based on night-to-day ratio specification from singular 24-h abpm in comparison to the results of 7-day abpm monitoring

the subjects in the study are divided into 4 groups: group 1 (40 healthy men and women without exercise); group 2 (40 healthy exercise-training men and women); group 3 (40 patients with ischemic coronary artery disease without exercise); and group 4 (51 patients with ischemic coronary artery disease following cardiovascular rehabilitation). the subject of the evaluation is the percentage rate of incorrect subject classification (dipper, non-dipper, extreme dipper, and risers) based on the mean blood pressure values for 7 days and from seven independent 24-hour cycles (the mean value mode).

Eligibility criteria:
inclusion criteria: * healthy volunteers (without any disease, including the cardiovascular ones, and without any kind of treatment) * patients with chronic ischemic coronary artery disease * patients treated with ace inhibitors, beta-blockers or statins. * to visit routinely in the health centres where the study is carried out exclusion criteria: * age under 18 years, * pregnant, or breast-feeding, * patients on dialysis or being followed by nephrology, * severe physical or cognitive limitations, * intolerance to the method of measurement

Keywords: ambulatory blood pressure monitoring hypertension night-to-day ratio exercise
study for epidemiology and characterization of myelodysplastic syndromes (mds) and juvenile myelomonocytic leucemia (jmml) in childhood

Conditions: Myelodysplastic Syndromes; Juvenile Myelomonocytic Leukemia

Summary: the aim of the study is to improve the accuracy of diagnosis for children and adolescents with mds by a standardized review of morphology and standardized cytogenetic and molecular analysis. the primary objectives of the study are: * to evaluate the frequency of the different subtypes of mds in childhood and adolescence by a standardized diagnostic approach * to evaluate the frequency of cytogenetic and molecular abnormalities: specifically using array-cgh to evaluate the frequency of subtle chromosomal imbalances, i.e. gains and losses of defined chromosomal regions, and amplifications. specifically using mfish to identify unknown chromosomal aberrations, particularly subtle translocations involving new candidate genes, and to better define chromosomal breakpoints. the secondary objectives of the study are: * to assess survival for children and adolescents with mds and jmml * to evaluate relapse rate, morbidity and mortality in children with mds and jmml treated by hsct


Eligibility criteria:
inclusion criteria: * written informed consent by the caretakers and whenever possible the patient's assent. * confirmed diagnosis of mds or jmml (morphology, cytogenetics) * myeloid leukemia of down syndrome (patients aged \> 6 years). * age less than 18 years exclusion criteria: * denied informed consent and/or assent by caretakers/patient. * myeloid leukemia of down syndrome (patients \< 6 years). * participation in another study within the last 4 weeks (except for therapy optimizing studies in cancer or bone marrow failure disorders and studies in diagnostics).

Keywords: mds jmml ewog-mds myelodysplastic syndromes (mds) juvenile myelomonocytic leukemia (jmml)
a study to assess the feasibility of an e-health system (zemy) designed to manage symptoms in participants with breast cancer under anti-cancer treatment

Conditions: Breast Cancer

Summary: this is a three-month open-label, multicenter, interventional, single arm study located in france, designed to assess feasibility and reliability of the e-health zemy software medical device under investigation for use by participants with breast cancer, who are starting an anti-cancer treatment at any stage of the disease, to manage disease symptoms and anti-cancer treatment-related toxicities while at home.


Eligibility criteria:
inclusion criteria: * female patients with breast cancer starting a treatment including oral and/or parenteral anti-cancer drugs (chemotherapy and/or targeted therapies, hormonotherapy) * inter-cycle duration between hospital visits ≥14 days (this period of time is estimated to be consistent with a need for support during the home setting period) * patients shall be prescribed loperamide or any other anti-diarrheic treatment in case of diarrhea and prescription for any medication indicated in case of nausea/vomiting * able to speak and read french and to use a smartphone embedding zemy, in the investigator's judgment * able to comply with the study protocol, in the investigator's judgment * patient affiliated to the national social security or beneficiary to such insurance. exclusion criteria: * pregnant * already enrolled in a clinical study involving experimental medication or ehealth device * concomitant malignancy * ecog score \>2 * treated with single hormonotherapy, single surgery or single radiotherapy, immunotherapy. * patient whose mental state renders her unable to understand the nature, purposes, and consequences of the study * patient not trained to the use of zemy * patient not trained to take her blood pressure measurement * patient deprived of her liberty by judicial or administrative order.
temporomandibular disorder in use of levonorgestrel intrauterine system

Conditions: Levonorgestrel Adverse Reaction; Temporomandibular Joint Disorders; Temporomandibular Disorder

Summary: the goal of this clinical trial is to investigate the possible role of levonorgestrel intrauterine system use(liu) in the pathogenesis of temporomandibular joint disorder (tmd). in this clinical trial, levonorgestrel intrauterine system patients (n=30) aged 25-50 and control group patients (n=30) with the same demographics and age range are used. the main questions it aims to answer are: to compare the frequency of temporomandibular dysfunction in women using the levonorgestrel intrauterine system with the control group of the same demographic and age range. the levonorgestrel intrauterine system use group consisted of 50 women who had previously a mirena implanted by a gynecologist at least 3 months ago due to menstrual bleeding and pelvic pain. the control group included 50 randomised healthy women who had regular menstrual cycles and were not taking any medication.


Eligibility criteria:
inclusion criteria: * being a woman * having used an intrauterine device for at least 3 months * being between the ages of 18-50 * being in american society of anesthesiologists-1 and american society of anesthesiologists-2 systemic status exclusion criteria: * patients with craniofacial syndrome * patients with a history of head and neck trauma * isolated muscle tenderness or previous surgery on tmj * patients with rheumatological disorders * patients with an additional gynecological disease other than endometriosis * lack of cooperation with the patient.

Keywords: mirena levonorgestrel intrauterine system temporomandibular disorder
extension study of mt-1303 in subjects with crohn's disease

Conditions: Crohn's Disease

Summary: the primary objectives of the study are: -to evaluate the long-term safety and tolerability of mt-1303 in subjects with moderate to severe active crohn's disease（cd）


Eligibility criteria:
inclusion criteria: * the subject completed 14 week treatment period in the double blind mt-1303-e13 study as per protocol. exclusion criteria: * permanent discontinuation of study medication prior to the end of treatment visit in mt-1303-e13

Keywords: crohn's disease
study to observe the change in microbiome in human derived sample and the relation with clinical response before and after the anti-tnf treatment in ibd patients

Conditions: Inflammatory Bowel Disease

Summary: this study will be conducted to observe the difference in microbiome composition between healthy participants and inflammatory bowel disease (ibd) participants with no anti-tumor necrosis factor (anti-tnf) treatment.


Eligibility criteria:
1. inclusion/ exclusion criteria: 1. inclusion criteria for inflammatory bowel disease (ibd) participants: * male or female, age ≥ 19 years at the time of informed consent * confirmed diagnosis of ibd * participants who are naïve to anti-tumour necrosis factor (anti-tnf) 2. exclusion criteria for ibd participants: * contraindication to anti-tnf including active tuberculosis (tb), sepsis, or other severe opportunistic infection, etc. 2. inclusion/ exclusion criteria: 1. inclusion criteria for non-ibd participants: * participants who have not been diagnosed with ibd * participants who don't have any other intestinal disease except ibd * participants who are naïve to anti-tnf 2. exclusion criteria for non-ibd participants: * participants who have been on medication to treat underlying disease for the previous 3 months

Keywords: crohn's disease ulcerative colitis
efficacy/safety of lansoprazole in patients with frequent heartburn

Conditions: Heartburn

Summary: heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. this study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.


Eligibility criteria:
inclusion criteria: 1. experiencing heartburn at least 2 days per week over the past month. 2. having heartburn that responds to heartburn medication. 3. be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study. exclusion criteria: 1. having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy). 2. be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study. other protocol-defined inclusion or exclusion criteria may apply.

Keywords: heartburn, frequent heartburn, proton pump inhibitor, lansoprazole
study of injectable naltrexone and oral bupropion among cigarette smokers with schizophrenia

Conditions: Smoking Cessation

Summary: the purpose of this study is to assess the feasibility and safety of injectable naltrexone (ntx;380 mg) in conjunction with oral bupropion (bup; 450 mg daily)ntx-bup administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia.


Eligibility criteria:
inclusion criteria: * fluent in english; * diagnosed with schizophrenia spectrum disorder that is currently stable; * report regular cigarette smoking, average cigarette per day ≥ 5 in the past 4 weeks, and present a breath co≥10 ppm. * meet subjective and objective (urinary drug screen) measures of non-opioid use. * if female, present a negative pregnancy test, not be currently breast feeding, and agree to use acceptable birth control methods and receive periodic pregnancy tests during the course of the study. * able to give written informed consent * obtain an evaluation to sign consent (esc) score above 10. exclusion criteria. * have suicidal or homicidal ideation requiring immediate attention. * previous use of bupropion or naltrexone in the past 30 days. * currently enrolled in treatment for tobacco use. * meet diagnostic and statistical manual of mental disorders (dsm-5 )criteria for alcohol and other substance use disorders excluding nicotine and marijuana. * report a history of epilepsy, seizure disorder or condition increasing risk of seizure, or head trauma with neurological sequelae. * have a current eating disorder. * be medically unstable or taking medications that are contraindicated with using naltrexone or bupropion.

Keywords: schizophrenia spectrum disorder
wide-field and high resolution in vivo imaging in visualizing lesions in patients with oral neoplasia undergoing surgery

Conditions: Oral Cavity Neoplasm

Summary: this clinical trial studies wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth (neoplasia) undergoing surgery. diagnostic procedures, such as wide-field and high resolution in vivo imaging, are devices that let researchers look at a wide area of the lining of the mouth by shining different colors inside the mouth and taking pictures and this may help doctors to decide if a mouth lesion has a high risk of being pre-cancerous or cancerous.

primary objectives: i. to evaluate the feasibility for assessing oral mucosa in vivo with wide-field and high resolution images obtained using new optical imaging devices composed of cameras and microscopes, and with a topically administered contrast agent. ii. to develop and evaluate algorithms to classify tissue as normal (including hyperkeratosis, hyperplasia, and inflammation) or abnormal (any grade of dysplasia or cancer) based on quantitative parameters extracted from the optical images. secondary objectives: i. to determine the percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye. ii. to identify qualitative and quantitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions. outline: patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (high-resolution microendoscope \[hrme\]) at baseline, after induction of general anesthesia, and prior to surgery. after completion of study, patients are followed up for 3 months.

Eligibility criteria:
inclusion criteria: * adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head \& neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible * ability to understand and the willingness to sign a written informed consent document (icd) exclusion criteria: * known allergy to proflavine or acriflavine * pregnant or nursing females * the participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
a retrospective study of the effectiveness and safety of nivolumab in advanced/metastatic non-small cell lung cancer (nsclc) patients in japan

Conditions: Non-Small Cell Lung Cancer

Summary: a retrospective study of the effectiveness and safety of nivolumab in advanced/metastatic non-small cell lung cancer (nsclc) patients in japan


Eligibility criteria:
inclusion criteria: * previously treated advanced/metastatic nsclc patients treated with nivolumab at least once from 01-apr-2016 through 31-dec-2016 exclusion criteria: patients who meets the inclusion criteria will be included in the analysis to describe real-world clinical usage of nivolumab. however, patients treated with nivolumab falling in following criteria will be excluded for analysis for the other primary endpoint; overall effectiveness: * history of participation in any clinical trials prior- or post-nivolumab treatment * patients who are a part of a post-marketing surveillance study other protocol defined inclusion/exclusion criteria could apply
combination chemotherapy following gm-csf in treating patients with multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. gm-csf may make cancer cells more sensitive to the effects of chemotherapy. combining more than one drug with gm-csf may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy, consisting of cyclophosphamide plus vincristine, following gm-csf in treating patients with multiple myeloma that has not responded to previous treatment.

objectives: i. determine the response rate of multiple myeloma patients when treated with cyclophosphamide and vincristine after cycling myeloma cells with sargramostim (gm-csf). ii. evaluate whether labelling index (li) changes influenced by gm-csf would predict a group of patients that will respond to this particular course specific design. iii. determine the toxicity of gm-csf in these patients. outline: patients receive subcutaneous injections of sargramostim (gm-csf) once a day for 5 days. two to 3 days later, patients receive cyclophosphamide iv over 30-45 minutes on day 1, vincristine iv bolus on day 8, and oral prednisone 4 times a day on days 1-4. patients also receive subcutaneous injections of gm-csf starting on day 2 and continuing for 10 days or until neutrophil count is at least 1000/mm3. treatment continues every 3 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. patients who achieve at least stable response receive gm-csf 3 times a week for up to 2 years. patients are followed every 3-6 months. projected accrual: a maximum of 30 patients will be accrued.

Eligibility criteria:
disease characteristics: histologically proven multiple myeloma pancytopenia related to multiple myeloma allowed failed or progressed after at least 2 chemotherapy or biologic therapy regimens patient characteristics: age: 16 and over performance status: not specified life expectancy: not specified hematopoietic: platelet count at least 50,000/mm3 absolute neutrophil count at least 750/mm3 hepatic: sgot/sgpt less than 3 times upper limit of normal bilirubin less than 5.0 mg/dl renal: not specified other: no active infection requiring intravenous antibiotics not hiv positive not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: see disease characteristics may have failed prior bone marrow transplant no other concurrent colony stimulating factors concurrent immunoglobulin allowed chemotherapy: see disease characteristics concurrent pamidronate allowed endocrine therapy: not specified radiotherapy: concurrent standard radiation therapy to treat extra-skeletal and/or skeletal tumor sites allowed surgery: not specified other: concurrent epoetin alfa for anemia allowed

Keywords: refractory multiple myeloma stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
clinical application and validation of innovative tourniquet

Conditions: Compartment Syndrome of Forearm

Summary: background: tourniquets are the basic equipment for nurses to perform blood draws, and venous indwelling needles for congestion, or for hemostasis. therefore, forgetting to remove the tourniquet is a common problem that leads to blood circulation being blocked, and even severe tissue necrosis occurred. purpose: the study aimed to evaluate whether this innovative tourniquet could prevent forgetting to remove the tourniquet, and improve the satisfaction of care. research design: this clinical research trial was a quasi-experimental study designed for a single group with pre-and post-test. we will recruit 160 nurses in high-risk units of the hospital. the delay in removing the tourniquet as our study outcome is defined as the removing time delay of one minute. expected results: the research results will provide some evidence of the efficacy of intelligent tourniquets.


Eligibility criteria:
inclusion criteria: nurse group: we included nurses who have working experience of more than 3 months, and are willing to use an innovative tourniquet.