Kornimate/medical-research-clean huggingface dataset:
detect microsatellite instability status in blood sample of advanced colorectal cancer patients by next-generation sequencing

Conditions: Colorectal Neoplasms

Summary: the method to analyze the microsatellite instability (msi) status by next-generation sequencing (ngs) has been established to assess the deficiency of dna mismatch repair (mmr) system. the aim of our study is to evaluate the feasibility and reliability of this ngs method by testing the circulating tumor dna (ctdna) in blood sample of advanced colorectal cancer patients. if the result is positive, the msi status could be easily learned without the acquisition of tissue samples.


Eligibility criteria:
inclusion criteria: * a biopsy proven histological diagnosis of colorectal carcinoma * msi status of tissue sample known by ihc or pcr method * willing to participate and informed consent signed exclusion criteria: * history of other malignant tumors * patients with inflammatory bowel disease * patients with familial adenomatous polyposis * patients treated by surgery or adjuvant treatment * pregnant or lactating women

Keywords: microsatellite instability circulating tumor dna colorectal neoplasms
screening for hpv and cervical cancer in young women with perinatally acquired hiv

Conditions: HIV Infections; Human Papillomavirus Infection; Cervical Cancer

Summary: this is a cross-sectional, observational study of high-risk hpv status, cervical cytology and hpv vaccine uptake and response in young women with perinatally acquired hiv.

this is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-hpv) status, and hpv antibody titres amongst adult women living with perinatally acquired hiv infection (pahiv). eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and hr-hpv with the cepheid genexpert hpv; secondly serum will be assessed for hr-hpv serology. all women with pahiv, vaccinated and unvaccinated for hpv, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling or (2) non-sexually active women, blood sampling only (total n=80). follow up for abnormal smear results or hr-hpv positivity will be arranged through colposcopy.

Eligibility criteria:
inclusion criteria - cohort 1: * perinatally acquired hiv aged 18+ * sexually active * able to give informed consent inclusion criteria - cohort 2: * perinatally acquired hiv aged 18+ * able to give informed consent exclusion criteria - cohort 1: * pregnancy * not sexually active * previous total abdominal hysterectomy * unable to give informed consent exclusion criteria - cohort 2: * unable to give informed consent

Keywords: cervical screening hpv vaccination
the effect of perioperative factors on postoperative outcomes after lung transplantation

Conditions: Postoperative Complications After Lung Transplantation

Summary: 1. evaluate the influence of perioperative factors on postoperative outcomes in patients undergoing lung transplantation patients. 2. to evaluate the feasibility of using pulmonary ultrasound to identify lung complications such as atelectasis and pulmonary edema after lung transplantation 3. observe the changes of perioperative inflammation and immune indexes after lung transplantation


Eligibility criteria:
inclusion criteria: prosedure of lung transplantation, aged more than 18 years old exclusion criteria: secondary lung transplantation, multiple organ transplantation, refusal to participate
placenta, fetal liver, sectional ductus venosus volumes examined by three-dimensional ultrasound in the second trimester

Conditions: Gestational Diabetes; DUCTUS VENOSUS VOLUME; PLACENTA VOLUME; 3D SONOGRAPHY; FETAL LİVER VOLUME

Summary: investigators measured the placenta, fetal liver and ductus venosus volumes of pregnant women with gdm diagnosis and normal glycemic indices in the second trimester.investigators aimed to correlate measurements with maternal/fetal outcomes and evaluate their success in predicting poor obstetric outcomes

gdm screening may not always be possible with ogtt performed in limited weeks of gestation. in addition, mid-trimester ultrasound scanning is done in all pregnancies. therefore, measurement of placental volume and fetal liver volume may be an alternative method for the diagnosis of gdm. in order to predict gdm in the second trimester, the use of 3d sonography and vocal (virtual organ computer aided analysis) technology in high-risk pregnant women and their cost-effectiveness rates should be investigated further. multicenter randomized controlled studies with more patients are needed to be able to say more clearly.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * diagnosed with gdm exclusion criteria: * multiple pregnancy * congenital anomalies * gestational hypertansion * preeclampsia

Keywords: gestati̇onal di̇abetes melli̇tus placenta volume fetal li̇ver volume ductus venosus volume 3d sonugraphy
randomized trial comparing early "trigger" versus delayed "trigger" timing in cycles of controlled ovarian stimulation.

Conditions: Infertility, Female

Summary: this randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (cos) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").

this randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (cos) for cycles in which all embryos will be cryopreserved ("freeze-all cycles"). 1. the early trigger timing will be based on sonographic observation of at least three follicles reaching at least 17mm in diameter. 2. the delayed trigger timing will be based on at least three follicles reaching at least 22mm in diameter.

Eligibility criteria:
inclusion criteria: 1. adult female at least 18 years of age and less than 35 years of age intending to undergo ovarian stimulation for a cycle of ivf with all embryos to be frozen that attain the blastocyst stage. 2. anticipated at least normal ovarian response evidenced by at least 8 antral follicles observed on ultrasound or a serum level of at least 1.5 ng/ml amh. 3. ability read and understand english sufficiently to obtain informed consent. 4. patients with prior ivf cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study. exclusion criteria: 1. any cycle type that would preclude immediate culture to blastocyst stage (e.g. oocyte banking). 2. any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
cpap for motion management in breast radiotherapy; and lung & liver sabr

Conditions: Cancer

Summary: a phase ii trial to determine the proportion of patients where the use of continuous positive airway pressure (cpap) results in a superior radiation plan compared to standard planning procedures. the rationale for using cpap with radiotherapy is based on its ability to increase the tidal volume, flatten the diaphragm thus reducing respiratory excursions.the resultant lung hyperinflation and reduced respiratory excursions can be harnessed for radiotherapy purposes by: 1. displacing the heart away from the radiotherapy field 2. reducing the volume of functional lung irradiated 3. reducing the radiotherapy target motion cpap has been shown to be superior to free breathing radiotherapy (rt), however it remains unclear how much benefit it confers vs other motion management adjuncts such as deep inspiration breath hold (dibh) or 4-dct.

primary objective: to determine the proportion of patients where the use of cpap results in a superior radiation plan compared to standard planning procedures in each patient cohort secondary objectives to determine: * impact of cpap on treatment delivery time; * impact of cpap on total lung volume; * cpap compliance; * patient experience; breast-specific: • comparison of organ at risk (oar) dose constraints between cpap and deep dibh) sabr-specific: * internal target volume (itv) reduction; * oar dose constraints between cpap and standard planning procedures. breast cancer patients will undergo normal free breathing and dibh radiotherapy planning scans. an additional scan with cpap will be done for the purpose of the study. radiotherapy plans will be produced on both the dibh and cpap planning scans. the planning scan with the best dosimetry will be chosen for treatment. if cpap has a better radiation plan, then the patient will have cpap administered during their daily rt. the dibh plans for each patient, will serve as controls sabr patients will undergo the standard 4-d or breath hold ct and then cpap ct for the purpose of the study. respiratory movements will be monitored by varian rpm system. radiotherapy plans will be produced from the standard ct and the cpap ct for comparison. patients will be treated on the best plan the trial aim to recruit 70 patients with invasive carcinoma of the breast undergoing adjuvant radiotherapy that includes breast/chest-wall plus regional lymph nodes, and a convenient sample size of those undergoing sabr to lung or liver

Eligibility criteria:
inclusion criteria: * any patient with pathologically-confirmed invasive breast cancer and planned for adjuvant radiotherapy to the breast or chest-wall with regional lymph node coverage * any patient deemed suitable for lung or liver sabr as per departmental guidelines * must have signed written informed consent exclusion criteria: * cannot tolerate cpap e.g due to severe claustrophobia * re-irradiation

Keywords: sabr cpap breast lung liver
comparison between the effects of implantable gestrinone and oral dienogest in the treatment of endometriosis

Conditions: Endometriosis

Summary: this study aims to evaluate the effects of therapy with implantable gestrinone compared to oral dienogest in relieving complaints related to endometriosis.

patient recruitment will be carried out on a prospective basis and based on the group of patients from the private medical clinics in 4 cities (campina grande - pb, são paulo - sp, são josé dos campos - sp and brasilia-df). the study will include 70 adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seek medical treatment to alleviate complaints related to endometriosis. the selected patients will be randomly allocated into two groups, in a 1:1 ratio. control group (n=35) - treatment with oral dienogest - and test group (n=35) - implantation of gestrinone pellets. follow-up visits will be scheduled after 1 week and 1, 3, 6, 9 and 12 months of initiation of therapy. therapies will be compared with respect to the effects on the severity of dysmenorrhea, dyspareunia and non-cyclical pelvic pain (verbal scale and visual analogue scale), level of uterine bleeding assessed by pbac, systemic effects (hormonal, hepatic, lipid profile, cell concentration red, clotting factor - assessed through blood tests), endometriosis lesions, endometrial thickness (transvaginal ultrasound), body composition (bioimpendance test), quality of life (ehp30) and sexual function (female sexual function index ) - fsfi. data analysis will be carried out using validated statistical software. chi-square or fisher\&#39;s exact tests will be used to compare qualitative variables, while independent t-tests will be used to compare quantitative variables between the two groups. analysis of variance with repeated measures will be used to compare the average pain intensity over time. the significance level for all tests will be p\&lt;0.05.

Eligibility criteria:
inclusion criteria: * adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seek medical treatment to alleviate complaints related to endometriosis, who are not undergoing other therapies to treat them. * patients must have a diagnosis of grade 1 or 2 endometriosis assessed by imaging tests (ultrasound with bowel preparation and/or mri of the pelvis with bowel preparation)14, have a bmi of up to 25kg/m2, and weigh between 50 and 70kg. exclusion criteria: * pregnant patients (supporting test must be presented) * breastfeeding women, using other hormonal contraceptive methods or copper or silver iuds, who have polycystic ovaries, and/or hyperandrogenism. * patients using medications that may interfere with androgen metabolism within 4 weeks of screening or during the study. * patients with a history of liver disease, cardiovascular disease (myocardial infarction, unstable angina or heart failure), active hepatitis, liver neoplasia or renal failure * patient who are scheduled for surgical treatment during the study period.

Keywords: endometriosis implantable gestrinone dienogest
serial ct scans in fractionated stereotactic radiotherapy

Conditions: Brain Tumor

Summary: this study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups.

stereotactic conformal radiotherapy (scrt) combines the precision of the stereotactically guided tumor localisation and the radiobiological advantages of the fractionation. this implies an highly accurate repositioning of the isocenter of the cerebral target at the isocenter of the linac gantry and couch + 30 times. in the use of stereotactic conformal radiotherapy (scrt) accuracy is the mainstay for the treatment of brain tumours. the reason are reduced safety margins around the tumour (or no margins) in order to reduce normal tissue dose. this study aims at providing a quantitative evaluation of the accuracy of two different fixation systems, where one system is also evaluated with two different set-ups. the first approach will be based on the brainlab thermoplastic masque (the masque with (= standard fixation) and without a custom made bite-block), the second will use the brianlab relocatable frame with the bite- block and a home made fixation system. repositioning accuracy will be evaluated in a randomized manner patient-dependent and independent with the two fixation systems mentioned above. the rationale is to determine the margins to define the planning target volume (ptv), it is necessary to know the set-up accuracy of the immobilization system. an overestimation of the ptv would lead to possible toxicity and an underestimation could lead to a geographical miss. the main endpoint of this trial will be the accurate reproducibility of the fixation system evaluated by repeated ct scan.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of brain tumor * fractionated stereotactic radiotherapy exclusion criteria: -

Keywords: brain tumor fractionated stereotactic radiotherapy fixationsystems repositioning
effect of simvastatin on endothelial function in premenopausal women with systemic lupus erythematosus (0733-271)(terminated)

Conditions: Systemic Lupus Erythematosus

Summary: women with systemic lupus erythematosus (sle) are prone to cardiovascular disease. early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.


Eligibility criteria:
inclusion criteria: * female patients over 18 years old * confirmed systemic lupus erythematosus (sle) diagnosis according to american college of rheumatology (acr) * signed informed consent form (icf) exclusion criteria: * patients with ldl-c below 90 mg/dl * pregnant or breast feeding * diabetes mellitus * or any clinically relevant organ disfunction
core stability program in colorectal cancer survivors

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine the effects of physical training program to improve deep stabilizer muscle in colorectal cancer survivors

background: colorectal cancer is the third most common cancer when considering both genders. musculoskeletal alterations have been described related to techniques used during surgery, that it produces an inhibition of deep abdominal muscles. these muscles are in charge of lumbopelvic stabilization muscle linked to reduced ability to maintain independence in daily activity life that could have affected their quality of life objective: the aim objective will be evaluated short and long-term effects of physical activity program for muscle stabilization. methods: 20 colorectal cancer survivors will be recruited from the department of oncology of clínico san cecilio hospital. patients will be randomized in physical activity program group and usual care group. physical activity groups will receive an eight week program form improve the muscle stabilization. discussion: researchers attempts to increase the fitness level and reduce musculoskeletal disorders in colorectal cancer survivors through a physical activity interventions focusing in muscle stabilization.

Eligibility criteria:
inclusion criteria: * patients under partial colorectal resection to treat colon cancer * diagnosis of i, ii or iiia stage of colorectal cancer * completion of adjuvant therapy (except for hormone therapy) * medical clearance of participation exclusion criteria: participants will be excluded if they presents with cancer recurrence or if they will have undergone previous abdominal surgeries or will be diagnosed with concomitant conditions, such as previous lower-back pain or musculoskeletal conditions (e.g., osteoarthritis, fibromyalgia or chronic fatigue syndrome).

Keywords: colorectal-neoplasms,deep-muscles of the back,rehabilitation
the cap-2 trial: effect of direct pulp capping versus partial pulpotomy

Conditions: Dental Pulp Exposure

Summary: cap-2 trial background: this trial is being done in conjunction with an ongoing clinical trial investigating stepwise excavation versus final excavation on deep caries lesions (the cap-1 trial). the investigators lack systematic knowledge concerning the treatment of the exposed pulp and whether the capping of a pulp represents the same outcome as the partial removal of an additional 1-1.5 mm of the pulp tissue (partial pulpotomy). aim: the aim of the cap-2 trial is in a randomised clinical trial to investigate the effect of direct pulp capping versus partial pulpotomy in patients who, from the beginning, have received either a final excavation or a stepwise excavation and where this intervention has led to the exposure of a vital pulp and/or the patient has not gained relief from tooth pain after excavation and placement of a temporary restoration. patients: patients include consecutive patients with deep caries who have been participating in the cap-1 trial, where the pulp exposure to a bleeding pulp is present and/or pain relief has not been obtained. design: the cap-2 trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. patients who fulfill the inclusion criteria will be centrally bloc-randomised in the copenhagen trial unit, copenhagen dk, and stratified by age and pain. the allocation ratio is 1:1. the interventions and products: patients are allocated for direct pulp capping or partial pulpotomy. the patients will not be informed about the results of the randomisation, i.e. the type of intervention. in both groups the patient receives a calcium hydroxide seal covering the exposure and a glass ionomer restoration. the final resin restoration is placed following 4 weeks.


Eligibility criteria:
inclusion criteria: * persons participating in the cap-1 trial, who have received a pulp exposure due to treatment or due to absence of pain relief. exclusion criteria: * the cap-1-treated tooth has ongoing unbearable pain and/or disturbed night sleep. * visible pus from the pulp.

Keywords: pulp capping partial pulpotomy exposure of the pulp
evaluation of cpd mnv as an aid in the diagnosis and risk assessment of sepsis (protocol # sepsis 1-14)

Conditions: Sepsis, Severe Sepsis and Septic Shock

Summary: the investigators hypothesize that cpd parameters will provide improved prediction of sepsis compared to currently employed laboratory parameters. these studies hold the potential to shape practitioner guidelines and improve the timeliness and accuracy with which patients with sepsis are treated today.


Eligibility criteria:
inclusion criteria: * adult (≥18 to 90 years) * patients presenting to the emergency department * cbc (complete blood count) with differential testing performed and cpd data retrieved exclusion criteria: * previously enrolled in this study
procedural pain in children: intervention with the hospital clown

Conditions: Pain, Acute; Venous Puncture; Children, Adult

Summary: this study evaluates the effect of an intervention with a hospital clown compared to standard care on pain experience for acute hospitalized children receiving venipuncture. half of the children will receive an intervention with the hospital clown while the other half will receive standard care.

background: hospitalized children describe the pain associated with painful procedures as one of the worst experiences during hospitalization. these experiences can be traumatic for children and their families. most children are acutely hospitalized with no chance to prepare the child for painful procedures, while others experience repeated hospitalizations. previous negative pain experiences are known to have major consequences for future admissions and procedures. therefore, there is a need for different interventions for pain relief. in 2004, hospital clowns became a part of the team on pediatric wards in denmark. international studies have shown positive effects of hospital clowns on preoperative anxiety in children, but there is limited knowledge of the impact on the child's experience related to painful procedures. the overall purpose of this study is to investigate the effect and impact of the hospital clown as a non-pharmacological intervention on hospitalized children's pain experience and ability to cope during painful procedures in both short and long-term treatment and care. methods: a two-faced mixed methods study design with merging and connecting results and findings. 1. a prospective, randomized open-label trial to identify whether exposure to the hospital clown has an effect on pain experience in acute hospitalized children receiving venipuncture. 2. an ethnographic study to uncover the pain experience and ability to cope during painful procedures in short-term hospitalization. 3. an ethnographic study to uncover the influence related to repeated painful procedures, as well as uncover if a relationship may have a potential long-term impact.

Eligibility criteria:
inclusion criteria: * acutely admitted to the hospital * scheduled for the venipuncture procedure * not prepared for the procedure before coming to the hospital * accompanied by at least one parent exclusion criteria: * subjects with developmental disorders who could not cooperate with self- reporting of pain * subjects who were unable to speak danish or english

Keywords: pain assessment self report hospital clown intervention