Kornimate/medical-research-clean huggingface dataset:
(gi-rads) in preoperative evaluation of adnexal masses

Conditions: Ovarian Cancer

Summary: prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass

after institutional ethical committee approval () and informed consent from the patients, this prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass all women were subjected to the following: 1. detailed history taking: personal history, age, obstetric history, past history and family history. 2. physical examination: general examination, pelvic examination and abdominal examination. 3. investigations: routine labs; cbc, liver and kidney functions, fbs and 2hpp. other labs; cancer antigen 125 (ca 125) as a tumor marker. 4. trans vaginal ultrasound: tvus written informed consent for participation and publication was obtained from each patient after receiving information about the details of the study. confidentiality of patient's records was assured and maintained throughout the study. one hundred (100) patients' pelvises were examined by transvaginal ultrasound in lithotomy position using endo-vaginal transducer and/or transabdominal ultrasound in the supine position in transverse and longitudinal plane and evaluated by b-mode ultrasonography, color, and spectral doppler. two expert examiners with more than 10 years' experience in gynecological ultrasound, performed all examinations and data was stored between one and four representative images on the database. after the examinations, a combination of morphological features, color and spectral doppler features, and then the lesion was evaluated according to gi-rads classification, and the suggested management protocol based on the risk of malignancy. finally, the referral to surgery and decision-making were consulted in accordance with a multidisciplinary team meeting (mdt). a definitive histopathological diagnosis was obtained as a gold standard test for all patients with gi-rads 4 and 5 and some cases of gi-rads 3 patients after laparoscopic or surgical removal of the masses. a morphologic evaluation was performed according to the international ovarian tumor analysis group (iota) recommendations for the following parameters: wall thickness, septation, papillary projections, presence and echogenicity of solid areas, presence of mixed component, cystic component, and presence of ascites and intra-abdominal metastases (peritoneal deposits, liver metastasis, and malignant abdominal lymphadenopathy) was also recorded. pattern recognition analysis was also used for ovarian masses. statistical analysis: the collected data was coded, tabulated, and statistically analyzed using ibm spss statistics (statistical package for social sciences) software version 22.0, ibm corp., chicago, usa, 2013 and microsoft office excel 2007.

Eligibility criteria:
inclusion criteria: * females complaining of pelvic pain due to adnexal mass exclusion criteria: * presence of sure signs of malignancy

Keywords: gynecologic imaging-reporting and data system adnexal masses ovarian cancer
bcg modulation of the recmage-a3 + as15 asci response in the treatment of non muscle invasive bladder cancer (nmibc) patients

Conditions: Bladder Cancer

Summary: in this study, the investigators would like to assess how intravesical bcg schedules after immunization of non muscle invasive bladder patients with the recmage-a3 protein, together with adjuvant as15 (recmage-a3 + as15 asci), may enhance innate and vaccine-specific t cell responses both systemically and locally in the bladder.


Eligibility criteria:
inclusion criteria: * male or female patient with histological confirmation of nmibc * full recovery from surgery (tur) from 1 to 6 weeks * karnofsky performance status of 60% or more * laboratory parameters for vital functions should be in the normal range * women of childbearing potential must use adequate contraception and have negative pregnancy test before and during the whole period of study treatment administration * male patients should avoid behaviors leading to child conception up to 2 months after administration of study treatment exclusion criteria: * muscle invasive bladder cancer * metastatic disease to the central nervous system, for which other therapeutic options, including radiotherapy, may be available * other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders) * any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases(patients with vitiligo are not excluded to participate in the trial) * history of severe allergic reactions to vaccines or unknown allergens * patients require concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents. the use of prednisone, or equivalent, \<0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted * participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent * mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study * lack of availability for immunological and clinical follow-up assessment * for female patients of childbearing potential: positive urine or serum pregnancy test or lactating * known positive hiv test, hbv, hcv.

Keywords: non muscle invasive bladder cancer
phase ii study of ridaforolimus (mk-8669) with metastatic bone or soft-tissue sarcoma patients (mk-8669-030 am1)

Conditions: Sarcoma

Summary: the study evaluates efficacy of ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in japan.


Eligibility criteria:
inclusion criteria: * documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy. * eastern cooperative oncology group (ecog) performance status of 0 or 1 * completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization * adequate organ and bone marrow function exclusion criteria: * presence of brain or central nervous system (cns) metastases, unless successfully treated * prior therapy with rapamycin or rapamycin analogs * ongoing toxicity associated with prior anticancer therapy * history or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation, or pose an additional risk to the patient
bcma chimeric antigen receptor expressing t cells therapy for relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the goal of this clinical trial is to study the feasibility and efficacy of anti-b-cell maturation antigen (bcma) expressing t cells in treating patients with multiple myeloma.

participants with bcma-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. tests required to determine eligibility include disease assessments, a physical exam, electrocardiograph, ct/mri/pet, and blood draws. participants receive chemotherapy prior to the infusion of bcma car+ t cells. after the infusion, participants will be followed for side effects and effect of bcma car+ t cells. study procedures may be performed while hospitalized.

Eligibility criteria:
inclusion criteria: * expected survival \> 12 weeks * diagnosis of multiple myeloma by mwg criteria 20 * patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days * important organs function enough to tolerate this therapy * at least 90 days after stem cell transplantation * accessible to intravenous injection, and no white blood cell collection contraindications * sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the ctl infusion. male partner should use a condom * able to understand and sign the informed consent document. exclusion criteria: * patients with symptoms of central nervous system * patients with second malignancies in addition to multiple myeloma * active hepatitis b or c, hiv infections * any other active diseases could affect the enrollment of this trial * suffering severe cardiovascular or respiratory disease * poorly controlled hypertension * long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment * a history of mental illness and poorly controlled * screening showing target cell transduction efficacy is lower than 30%, or t cell proliferation is not enough for infusion (less than 5 fold) * occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment * women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy * women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion * active systemic infections or uncontrolled infection within 14 days prior enrollment * subjects suffering disease affects the understanding of informed consent or complying with study protocol.

Keywords: bcma car-t multiple myeloma relapsed /refractory
chinese pd-lrrk2 registry

Conditions: Parkinson Disease

Summary: the purpose of the chinese pd-lrrk2 registry(cpd-lrrk2r) is to develop a database of patients of parkinson's disease with leucine-rich repeat kinase 2 (lrrk2) gene variants in mainland china.

parkinson's disease (pd) is the second most common disorder among neurodegenerative diseases. lrrk2 missense mutations are the most common known genetic cause of pd. however, some polymorphisms of lrrk2 such as g2385r and r1628p can also affect the risk of developing pd. the investigators aim to establish a database of pd with lrrk2 variants and characterize the clinical manifestation of these patients in mainland china. method: 1. peripheral blood from patients has been tested to have lrrk2 gene variants. 2. clinical manifestation will be measured by scales and neurological tests. standard scales include: unified parkinson's disease rating scale(updrs), hoehn-yahr stages, non-motor symptoms scale (nmss), mini-mental state examination (mmse), parkinson disease sleep scales (pdss), rapid eye movement sleep behaviour disorder questionnaire(rbdq-hk), epworth sleepiness scale (ess), rome iii functional constipation scale, the scale for outcomes in pd for autonomic symptoms (scopa-aut), parkinson fatigue scale (pfs), cambridge-hopkins restless legs syndrome questionnaire (chrlsq), hyposmia rating scale(hrs), hamilton depression scale, the 39-item parkinson's disease questionnaire(pdq-39), freezing of gait scale(fog), dyskinesia related scales, wearing-off scale(wo). 3. the investigators will also exam the blood biomarkers of pd such as uric acid and peripheral inflammatory markers.

Eligibility criteria:
inclusion criteria: * patients diagnosed with pd by the united kingdom parkinson's disease society brain bank clinical diagnostic criteria or other standard criteria; pd patients detected with positive lrrk2 variants exclusion criteria: -
study of the use of methoxyflurane vs placebo in the management of pain in oral and dental emergencies in adults: metodo (methoxyflurane in odontology)

Conditions: Dental Pain and Sensation Disorder

Summary: with a chronic shortage of dentists in some regions, and an increase in life expectancy and living conditions, the number of patients admitted to oral health emergencies is on the rise. pain is the main reason for consultation, and is particularly exacerbated in the orofacial sphere. dental pain has several etiologies: infectious, inflammatory or traumatic accidents.beyond the ethical aspects of acute pain management, pain relief is a real objective. despite prioritization systems, patients can wait a long time in an unsettled environment, with tired and sometimes aggressive patients. numerous recommendations exist to improve analgesia in emergency departments, but there are still difficulties in effectively and rapidly managing acute dental and orofacial pain. to meet this demand and facilitate the treatment process, an alternative solution using methoxyflurane (penthrox®) could be considered. this product, mainly intended for emergency services, has been approved in europe since 2016 for the "emergency relief of moderate to severe pain associated with trauma in conscious adult patients". thus, it would be interesting to assess the value of methoxyflurane (penthrox®) in the management of pain in oral emergencies as a wait-and-see solution.


Eligibility criteria:
inclusion criteria: * adult patient (\> 18 years) * conscious patient consulting an oral emergency department with pain assessed as moderate to severe nrs greater than or equal to 4 * patient has social security affiliation or who beneficiary of such social security * patients who have given informed consent exclusion criteria: * patients with a history of allergy to methoxyflurane or any of the components of penthrox (take into account family history of severe allergic reactions) * patients with a history of malignant hyperthermia (known or genetic predisposition) * patients with hepatic impairment after use of methoxyflurane or halogenated hydrocarbon anesthesia * patients with severe renal failure * patients with altered level of consciousness, whatever the cause: head trauma, drug or alcohol abuse * patients with cardiovascular instability or respiratory depression * pregnant or breast-feeding patients. therefore, a urine pregnancy test will be performed for all patients of childbearing age eligible to participate in the study * patients under legal protection (guardianship and curatorship) or deprived of liberty * patients unable to speak or read french fluently, unable to understand the principle of a numerical scale, anxiety and satisfaction questionnaires, and unable to cooperate with tests
steady-state pharmacokinetics of rifaximin 550 mg tablets in healthy and hepatically impaired subjects

Conditions: Severe Hepatic Impairment

Summary: the primary objective of this study is to characterize the steady state plasma

the primary objective of this study is to characterize the steady state plasma pk of rifaximin (550 mg bid) in subjects with severe hepatic impairment (meld 19 to 25 and meld \>25), as well as healthy subjects with normal hepatic function.

Eligibility criteria:
inclusion criteria: * hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver cirrhosis and a meld score of ≥19 at screening. note: at least 6 of the hepatically impaired subjects will have a meld score of \>25. exclusion criteria: * subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients and/or vehicles used in the formulation, or any other clinically significant allergies. * subject has participated in an investigational drug or device study within 30 days prior to day 1 (baseline). * subject has any concurrent illness (other than liver cirrhosis), disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the investigator.
ultrasound-guided versus landmark-guided percutaneous dilational tracheostomy in pediatric patients

Conditions: Tracheostomy Complication; Tracheostomy Hemorrhage; Airway Trauma; Percutaneous Tracheostomy

Summary: percutaneous dilatational tracheostomy is one of the most common procedures performed in pediatric intensive care units. the investigators aimed to compare traditional landmark-guided percutaneous dilatational tracheostomy (pdt) and ultrasound-guided percutaneous dilatational tracheostomy in pediatric patients in terms of location, duration, and potential complications related to the procedure.

tracheostomy, one of the most common procedures performed in intensive care units (icu), refers to creating a stoma in the anterior wall of the trachea to maintain airway security. tracheostomy can be formed via a surgical or percutaneous dilatational technique (1). the surgical technique requires the transportation of the patient to the operating theatre, while the percutaneous dilatational technique can be performed in the icu. thus, icu practitioners commonly prefer the percutaneous dilatational technique. percutaneous dilatational tracheostomy can be performed via three approaches: landmark, ultrasound (usg), or bronchoscopy guided. although landmark-guided ptd is a practical approach, there are growing concerns regarding the location of the second and third tracheal rings and injuries to vascular structures and the thyroid gland. usg may be helpful to establish the anatomy of the airway and the vascular and glandular structure of the area. the investigators aimed to compare traditional landmark-guided percutaneous dilatational tracheostomy and usg-guided percutaneous dilatational tracheostomy in pediatric patients in terms of location, duration, and potential complications related to the procedure.

Eligibility criteria:
inclusion criteria: * healthy pediatric patients * between 5 and 13 years old exclusion criteria: * neck anomalies * syndromic patients

Keywords: percutaneous dilatational tracheostomy ultrasound guided tracheostomy landmark guided tracheostomy pediatric patients
an exploratory correlative study of biomarkers in patients with metastatic renal cell carcinoma who have progressed after sunitinib therapy

Conditions: Carcinoma, Renal Cell

Summary: purpose: the purpose of the correlative studies is to evaluate levels of serum factors of circulating vegf and soluble vegfr, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors, measurable disease response and clinical progression. hypothesis soluble markers of angiogenic growth factors and receptors, and circulating endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or sorafenib.

it is recognized that the measurable disease recist criteria response rate with mtor inhibition is likely to be low and that the benefit of such therapy will also include effects on disease stabilization. disease stabilization is difficult to interpret in the phase ii setting. thus, it is desirable to develop biomarkers which will provide additional information on novel treatment effects and how they might relate to disease progression

Eligibility criteria:
inclusion criteria: * all patients enrolled from canadian centres for the wyeth pharmaceuticals sponsored multicenter, open-label phase iii study evaluating second line therapy with either temsirolimus or sorafenib in patients progressing after sunitinib therapy, are eligible for this correlative studies protocol. * patients must provide written informed consent.

Keywords: metastatic renal cell carcinoma biomarkers biomarkers in patients with metastatic renal cell carcinoma who have progressed after sunitinib therapy
left renal vein division for juxtarenal aortic exposure

Conditions: Aortic Aneurysm; Juxtarenal Aortic Aneurysm; Renal Function Disorder

Summary: retrospective study on the outcome of the renal function in patients operated because of juxtarenal aortic aneurysms.


Eligibility criteria:
inclusion criteria: only patients who went for a planned operation because of a juxtarenal aortic aneurysm were included in this retrospective analysis. exclusion criteria: emergency surgery rupture pending rupture
auditory evoked potentials and experimental pain

Conditions: Pain

Summary: monitoring of auditory evoked potentials (aep) in patients during general anaesthesia is commonly used to ensure a sufficient hypnotic level during surgery. the amplitude of aep (aepa) has in clinical settings been found to correlate to pain. the aim of the study was to test, if aepa could detect increasing experimental pain stimulations in healthy volunteers. electric nerve stimulation, cold and heat pain were used as pain models.

during the aep monitoring, healthy volunteers were exposed to experimental pain. at study day 1: firstly, single electric nerve stimulation and repetitive electric nerve stimulations causing temporal pain summation. the stimulations were given at 50, 75 and 100% of the thresholds for pain tolerance and temporal pain summation. secondly, the volunteers were exposed to cold pain by use of two different cold pressor tests (cpt) with water temperatures at 8 and 1 celsius. all measurements were repeated after an hour to test reproducibility. at study day 2: brief thermal stimulation were used with two different temperatures and duration.

Eligibility criteria:
inclusion criteria: * healthy * age 20 - 40 years old

Keywords: aep experimental pain healthy volunteers
misoprostol with mechanical dilation versus oxytocin with mechanical dilation for high-risk pregnancy inductions

Conditions: Cesarean Section; Misoprostol; Oxytocin; High Risk Pregnancy

Summary: the purpose of this study is to specifically investigate whether oxytocin and mechanical dilation decreases the rate of cesarean section compared to misoprostol and mechanical dilation for pregnancies at risk of fetal compromise

this is a single center randomized control trial of two arms. singleton, cephalic, high risk pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol with mechanical dilation. in group a, receiving misoprostol with mechanical dilation, will serve as the control group. group b, oxytocin with mechanical dilation, will serve as the experimental group. the expected duration of participation begins at induction of labor and concludes at time of delivery.

Eligibility criteria:
inclusion criteria: * • age \> 18 years old * singleton, or twins with demise of one * cephalic presentation * intact membranes * hypertension (chronic hypertension, gestational hypertension, pre-eclampsia with/without severe features, superimposed preeclampsia with/without severe features, eclampsia, hellp) * oligohydramnios (afi\< 5cm and/or mvp \<2cm) * fetal growth restriction (efw or ac \<10th percentile) with normal or abnormal (elevated, absent, or reversed) umbilical artery dopplers * abnormal antenatal fetal testing (nst, biophysical profile, decreased fetal movement) prompting induction of labor * suspected placental abruption * poorly controlled pre-gestational diabetes, defined as \>50% abnormal glucose values requiring increasing doses of anti-glycemic agents \>34 weeks, or requiring delivery * gestational age \> 22 weeks * bishop score \< 6 exclusion criteria: * • prior cesarean delivery * allergy to misoprostol * allergy to oxytocin * allergy to silicone/latex * contraindication to vaginal delivery including placenta or vasa previa, placenta accreta/increta/percreta, prior uterine rupture, prior myomectomy entering the uterine cavity and necessitating cesarean delivery, active genital herpes, transverse or oblique fetal lie, umbilical cord prolapse, or hiv viral load \>1000 copies/ml