Kornimate/medical-research-clean huggingface dataset:
laparoscopic assisted transanal total mesorectal excision for rectal cancer in low site

Conditions: Rectal Cancer

Summary: at present, surgical resection is still the main treatment for the potential cure of rectal cancer. total mesorectal excision (tme) is the gold standard. the traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the mesorectum and separate to the pelvic floor. while transanal total mesorectal excision (tatme) approach could be more directly separate the low mesorectum and relatively simple to complete distal rectal transection, which would bring some considerable advantages. although active learning from abroad, laparoscopic assisted tatme surgery is now in its infancy in china. it is urgent for clinical studies to obtain the results in china. this multicenter, observational study will help to encourage research in this field and to obtain data on the safety and efficacy of this procedure in chinese patients with rectal cancer.


Eligibility criteria:
inclusion criteria: * adenocarcinoma of the rectum by biopsy * the lower edge of the tumor from the anal margin less than 10cm according to mri or rigid endoscopy * tumor diameter less than 4cm * baseline clinical stage i-iii: ct1-3 n0-2 m0 (ajcc v7) * tolerable to surgery * be able to understand and willing to participate in this trial with signature exclusion criteria: * history of malignant colorectal neoplasia * recent diagnosis with other malignancies * patients requiring emergency surgery such as obstruction，perforation and bleeding * tumor involving adjacent organs, anal sphincter, or levator ani muscle * muti-focal colorectal cancer * preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence * history of inflammatory bowel disease or familial adenomatous polyposis * participating in other clinical trails * can not tolerate the surgery * history of serious mental illness * pregnancy or lactating women * preoperative uncontrolled infection * the researchers believe the patients should not enrolled in

Keywords: transanal surgery total mesorectal excision rectal cancer
thyroid function throughout pregnancy with and without iodine supplementation

Conditions: Pregnancy

Summary: goals of the study : 1. to study maternal thyroid function during pregnancy with or without supplementation with pregnancy tablets fortified with iodine 2. to establish reference values of thyroid function at different stages of pregnancy (3 trimesters) 3. to precise screening strategy of iodine deficiency in our population and suggest recommendation for its prevention.

overt maternal hypothyroidism and/or iodine deficiency during pregnancy are linked to mental retardation in their offspring. iodine deficiency may lead to maternal hypothyroxinemia, and even mild hypothyroidism in predisposed women. indeed, thyroid hormones are of paramount importance for fetal brain development. during the first trimester of pregnancy, the only thyroid hormones available to the fetus are from maternal origin. later in pregnancy, fetal thyroid progressively starts producing thyroid hormone, providing that maternal iodine status is adequate (≥200-250 mcg/day). it has been shown recently that mild maternal hypothyroidism may be responsible for discrete neuropsychological impairment in her child, implying a potential benefit for early screening and care during pregnancy. furthermore, iodine deficiency is extremely common in our area (brucker-davis et al 2004). however, there is no official recommendation for screening and prevention, as for gestational diabetes for example. we propose to study healthy pregnant women, screened before 12 weeks of gestation and without thyroid disease. they will be randomized in 2 groups and will therefore take pregnancy tablets, iodine fortified or not (oligobs maxiode -150 mcg/j of iodine, vs oligobs grossesse), in addition to appropriate nutritional advice. their longitudinal study will involve: 1. evolution of thyroid function parameters in the 2 groups, with comparison of maternal thyroid volumes, maternal thyroid hormones levels and cord blood parameters, including thyroglobulin, during pregnancy and in postpartum. 2. establishment of reference ranges for thyroid parameters for each trimester of pregnancy. this public health project rests on our expertise in the care of pregnancies with maternal endocrine and metabolic disease (hieronimus et al 2003-2005) and on a close collaboration of our departments within the pole "mother-child", conveniently located at the same hospital. it will allow us to precise iodine deficiency screening and prevention in our population and to structure and optimize the care for women with thyroid disease screened early in pregnancy (opening of a specific clinic), in order to improve maternal and fetal prognosis

Eligibility criteria:
inclusion criteria: * all women follow-up in the three months of the pregnancy in the chu de nice * maternal thyroid function is between and 0.1\ t4l\>12 pmol/l * person over 18 * signed lit consent * give birth in the chu of nice exclusion criteria: * allergy known in iodine * iodized surcharge defined by an iodurie\> 400 mcg / l * catch of ongoing iodized vitamins of pregnancy * participation in another research protocol

Keywords: woman
women eating with interactive tracking to gain healthily through term pregnancy trial

Conditions: Obesity; Pregnancy; Weight Gain

Summary: obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. the standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counseling. the objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.

obesity and excessive weight gain in pregnancy have significant associated maternal and fetal complications including gestational diabetes, large for gestational age infants, birth trauma, and stillbirth. the rates of obesity in american adults is 34.9% and the rates of excessive weight gain in pregnancy for all women range from 20-40% with even higher rates seen in the obese. such high rates are putting mothers and infants at significant risk.· in 2009, the institute of medicine outlined clear guidelines for suggested weight gain goals based on pre-pregnancy bmi. currently only 30-40% of pregnant women are meeting the suggested weight gain goals and the great majority not meeting the goals are gaining excessive weight. however, despite the high prevalence of excessive weight gain, there is little access to insurance covered nutrition counselling. the standard of care places the responsibility on the providers during prenatal visits to remind patients of their weight gain goals and provide appropriate counselling. this can be challenging due to limited time and resources. however, there is good evidence that diet intervention reduces the risk of excessive weight gain by up to 20%. if appropriate nutritional counselling were available to all patients, the rates of excessive weight gain could be significantly impacted and have widespread improvement in pregnancy outcomes. the cdc has made important progress in providing free nutrition resources online to all patients. this study aims to incorporate this free resource with a sustainable ongoing nutrition counselling to impact the rates of excessive weight gain in pregnancy. the objective of this study is to evaluate a sustainable medical student-assisted longitudinal program of nutritional counseling and web based nutrition tracking for pregnant women on excessive weight gain during pregnancy and the effects on diet choices and fetal and maternal complications.

Eligibility criteria:
inclusion criteria: * pregnancy identified less than 15 week 0 days gestational age * body mass index greater then or equal to 18 exclusion criteria: * multiple gestation * pre-pregnancy diabetes mellitus * hiv

Keywords: obesity pregnancy weight gain
epic-hr: study of oral pf-07321332/ritonavir compared with placebo in nonhospitalized high risk adults with covid-19

Conditions: COVID-19

Summary: the purpose of this study is to determine whether pf-07321332/ritonavir is safe and effective for the treatment of adults who are ill with covid-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. the total study duration is up to 24 weeks.


Eligibility criteria:
inclusion criteria: * confirmed sars-cov-2 infection within 5 days prior to randomization * initial onset of covid-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified covid-19 signs/symptoms present on the day of randomization * fertile participants must agree to use a highly effective method of contraception * has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from covid-19 exclusion criteria: * history of or need for hospitalization for the medical treatment of covid-19 * prior to current disease episode, any confirmed sars-cov-2 infection * known medical history of active liver disease * receiving dialysis or have known moderate to severe renal impairment * known human immunodeficiency virus (hiv) infection with a viral load greater than 400 copies/ml or taking prohibited medications for hiv treatment * suspected or confirmed concurrent active systemic infection other than covid-19 * history of hypersensitivity or other contraindication to any of the components of the study intervention * current or expected use of any medications or substances that are highly dependent on cyp3a4 for clearance or are strong inducers of cyp3a4 * has received or is expected to receive convalescent covid-19 plasma * has received or is expected to receive any dose of a sars-cov-2 vaccine before the day 34 visit * participating in another interventional clinical study with an investigational compound or device, including those for covid-19 through the long-term follow-up visit * known prior participation in this trial or other trial involving pf-07321332 * oxygen saturation of \<92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition * females who are pregnant or breastfeeding

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2)
miglustat / ogt 918 in the treatment of cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis is a genetic disease caused by mutation of the cystic fibrosis transmembrane conductance regulator (cftr). the purpose of the study is to investigate the effects of miglustat on cftr function in cystic fibrosis patients.


Eligibility criteria:
inclusion criteria: * aged 12 years and older * male or female * non-pregnant women who are to remain non-pregnant for 3 months after the end of the study: only women who are surgically sterile, who are in the menopause (no menstruation for at least one year) or those of childbearing potential who are using a reliable method of contraception. reliable methods of contraception for female patients include the following: * barrier type devices (e.g., female condom, diaphragm and contraceptive sponge) used only in combination with a spermicide * intrauterine devices * oral contraceptive agent * depo-provera™ (medroxyprogesterone acetate) * levonorgestrel implants abstention, the rhythm method or contraception by the partner alone are not reliable methods of contraception. for children, a reliable method of contraception must be considered, if appropriate. * accepting for the duration of the study and for 3 months thereafter to use a condom and not to procreate a child (males only) * cystic fibrosis patients homozygous for the δf508 mutation as confirmed by genetic test * signed informed consent prior to any study-mandated procedure exclusion criteria: * any condition prohibiting the correct measurement of the npd such as upper respiratory tract infection * acute upper respiratory tract or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of screening * severe renal impairment (creatinine clearance \< 30 ml/min as per cockroft and gault) * female patients who will not undergo a pregnancy test prior to enrollment in the study * history of significant lactose intolerance * history of neuropathy * history of cataracts or known increased risk of cataract formation * presence of clinically significant diarrhea (\>3 liquid stolls per days for \>7 days) without definable cause within 1 month prior to screening * any known factor of disease that might interfere with treatment compliance, study conduct or interruption of the results such as drug or alcohol dependence or psychiatric disease * fevi \<25% of predicted normal * oxygen saturation at rest \<88% * active or passive smoking as measured using the smokelyzer® * hypersensitivity to miglustat or any excipients * planned treatment or treatment with another investigational drug or therapy (e.g., gene therapy) within 1 month prior to randomization

Keywords: cystic fibrosis miglustat zavesca actelion nasal potential difference transmembrane conductance regulator (cftr)
new concepts in diabetic macular edema (dme)

Conditions: Diabetes Mellitus, With Complications

Summary: intravitreal ranibizumab injection procedure is simple and effective. in management of chronic dme there is no clear anatomical endpoint. visual stability is the primary aim. argon focal laser therapy can be the safe second choice. the combined therapy is successful and practical for chronic dme patients.

settings and design: randomized clinical study subjects and methods: investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group a-75) or focal/direct argon laser after repeated ranibizumab injections (group b-75). the outcomes were the changes in visual acuity letter score and the central subfield thickness (cst) from baseline to one year. visual-acuity letter score, and cst were analyzed with independent t-test and mann whitney-test. general linear model with multivariate analysis was used for visual acuity letter score, and cst in both groups.

Eligibility criteria:
inclusion criteria: * focal maculopathy * diffuse macular edema * diffuse macular edema with ischemic changes exclusion criteria: * ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula * patients with history of stroke or transient ischemic attack * hypersensitivity to ranibizumab or any component of the ranibizumab formulation * uncontrolled glaucoma in either eye (intraocular pressure \[iop\] \>24 mmhg with medication) * evidence of vitreomacular traction (in either eye) * active proliferative diabetic retinopathy (study eye)

Keywords: macula-injection- laser- ranibizumab-edema-thickness
icg-enabled mapping of ovarian sentinel lymph nodes: a feasibility study

Conditions: Ovarian Cancer; Adnexal Mass

Summary: the purpose of this study is to find out how well ovarian sentinel lymph nodes (slns) can be identified with indocyanine green (icg) dye during risk-reducing ovarian surgery.


Eligibility criteria:
inclusion criteria: * women undergoing surgery with the gynecology service at msk. * women undergoing surgery for an adnexal mass without pre-operative suspicion of high stage disease, with or without a hysterectomy °for this protocol, "suspected high stage disease" will be defined as any patient with radiologic or clinical evidence of ovarian cancer which has spread outside of the ovary. thus, only patients with an adnexal mass, or bilateral adnexal masses, are eligible. * women in whom mis surgery is converted to a laparotomy will not be excluded as both surgical approaches, mis and open, will be utilized. * women \>/= 18 years of age * able to provide informed consent * albumin levels within normal range exclusion criteria: * current non-gyn primary malignancy * prior or current history of uterine, cervical, peritoneal, or vulvovaginal malignancy * ongoing anticancer therapy * prior bilateral oophorectomy * known severe anaphylactic iodide allergy * known history of cirrhosis or other chronic liver disease, or women with hepatic dysfunction. * elevated transaminases (alt, ast) and/or alk phos will be evaluated by the treating physician on a case by case basis.

Keywords: ovarian cancer adnexal mass ovarian sentinal lymph nodes 19-271 memorial sloan kettering cancer center sentinal lymph nodes indocyanine green dye icg dye
proclear 1-d multifocal nondispensing study

Conditions: Presbyopia

Summary: this study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.

the aim of this study was to compare the subjective and objective vision. of proclear® 1-d multifocal test lenses (mf) with +0.75d overcorrection of the distance lens power in the nondominant eye compared to the air optix® aqua multifocal (ciba vision) contact lenses in low, medium and high add presbyopic subjects (+1.25 to +2.50 inclusive).

Eligibility criteria:
inclusion criteria: * be between 40 and 65 years of age (inclusive) * require a reading addition of +1.25 to +2.50d (inclusive) * spherical distance cl or spectacle prescription between +3.00d and -5.00d(inclusive) * spectacle cylinder less than or equal to 0.75d in both eyes. * currently has a reading add correction in their spectacle or cl habitual correction (e.g. if myope, removes distance correction to read) * normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00d) * have a minimum 2 weeks soft contact lens experience * be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study) * able to read, comprehend and sign an informed consent * willing to comply with the wear and study visit schedule * monocular best-corrected distance visual acuity ≥ 20/25 in each eye * no gas permeable contact lens wear for 1 month prior to the study exclusion criteria: to be eligible for the study, each candidate must not present with any of the following * any active corneal infection, injury, inflammation, or ocular abnormality * systemic or ocular allergies, which might interfere with contact lens wear * systemic disease, which might interfere with contact lens wear * ocular disease, which might interfere with contact lens wear * pregnant or lactating * strabismus/amblyopia * habitually uncorrected anisometropia greater than or equal to 2.00 d * subjects who have undergone corneal refractive surgery * subjects with keratoconus or other severe corneal irregularity contraindicating lens wear

Keywords: contact lenses
fast assay for pathogen identification and characterization - prospective study

Conditions: Sepsis

Summary: the fapic project will develop a diagnostic system that will identify pathogens and charachterize virulence and resistance. a prospective study will be performed in which blood samples will be collected of patients with suspected sepsis in order to evaluate the diagnostic system. in routine care, blood is drawn of these patients for culture in order to identify the causative pathogen. this process takes 3-5 days. during the study, one extra blood sample will be collected with the same venipuncture, with each blood culture. afterwards, routine diagnosis by blood culture is followed. blood samples will be send to the research laboratories for determination of sensitivity and specificity. the system will not be used in the clinic.


Eligibility criteria:
inclusion criteria: * older than 18 years * suspicion of bacteremia exclusion criteria: * children (\<18 years)

Keywords: molecular diagnosis pathogen identification sepsis bacteremia rapid diagnostics
added value of preoperative contrast enhanced mammography in staging of malignant breast lesions

Conditions: Breast Cancer

Summary: patients diagnosed with breast cancer after routine assessment with digital mammography and ultrasound and scheduled for primary surgery are included in the trial. the patients are randomized 1:1 to go through additional contrast enhanced mammography (cem) or no further imaging preoperatively. primary endpoint is rate of patients with change of treatment: a) mastectomy instead of partial mastectomy due larger unifocal or multifocal extent, b) partial mastectomy instead of mastectomy due to improved demarcation of the tumour area, c) bilateral surgery instead of unilateral due to findings of contralateral cancer, d) neoadjuvant therapy instead of primary surgery due to more advanced disease. rate of reoperation and rate of avoidable mastectomies are secondary endpoints.


Eligibility criteria:
inclusion criteria: * planned primary surgery for suspicious or verified breast malignancy age of 18 years and above signed informed consent exclusion criteria: * planned neoadjuvant therapy on-going pregnancy iodinated contrast agent allergy renal failure (abnormal s-creatinine) untreated thyreotoxicosis severe heart failure myastenia gravis breast implant local recurrence as index lesion inability to understand and comprehend oral and written information of the study

Keywords: contrast enhanced mammography preoperative staging
survival analysis of frail patients with localised colorectal cancer

Conditions: Colorectal Cancer; Surgery; Frailty

Summary: the purpose of this study is to analyse the survival of frail patients with localized colorectal cancer who undergo surgical treatment in comparison with those with palliative treatment

patients with localized colorectal cancer will be visited by a colorectal surgeon who will explain the disease and the surgical treatment. in this visit the patient will be screened for frailty and asked for informed consent. patients who meet the eligibility criteria will be sent to the internal medicine consultant to frailty evaluation, risk assessment and counselling in order to help patient decision process.

Eligibility criteria:
inclusion criteria: * localised colorectal cancer * positive frailty screening exclusion criteria: * none