Kornimate/medical-research-clean huggingface dataset:
low weight heparin prophylaxis for placental-mediated complications of pregnancy

Conditions: High Risk Pregnant Women; Placental Insufficiency; Preeclampsia

Summary: this is a multicenter, randomized, open-label, parallel groups study to test the hypothesis that prophylactic low molecular weight heparin (lmwh) (enoxaparin) initiated before 14 weeks of gestation could improve maternal and perinatal outcome in women at high risk for developing placental-mediated pregnancy complications.


Eligibility criteria:
inclusion criteria: * pregnant women ≥18 years * gestational age \< 14 weeks at randomisation * one or more of the following complications in a previous pregnancy: * severe pe resulting in delivery before 32 weeks of gestation * newborn weight less than the 10th percentile and documented abnormal doppler in the umbilical artery during pregnancy before 32 weeks gestation * abruption of placenta * unexplained intrauterine death between 20-41,6 weeks of gestation secondary of placental insufficiency or * uterine arteries pulsatility index (mpi) doppler ≥95th percentile at 11-14 weeks of gestation. exclusion criteria: * multiple pregnancy * abnormal thrombophilia study * alcohol or illicit drug use * severe fetal malformations or chromosomal abnormalities * previous history of infertility ( 3 or more early miscarriages) * maternal hiv, cytomegalovirus or toxoplasma infection * known fetal abnormality or chromosomal defect at randomisation * women with previous venous or arterial thrombotic event * organic lesions that could increase the hemorrhagic risk: gastric ulcus, stroke, a recent hemorrhagic event, high risk situations for hemorrhagic event * known allergy to heparin or lmwh, thrombopenia or thrombosis episode due to heparin treatment * contraindication to lmwh * an absolute indication for anticoagulant therapy: venous deep thrombosis, pulmonary embolism, ovaric hyperestimulation, cardiophaty, others * metabolic disorders a risk for development of pe and/or iugr: type i diabetes, hipertiroidism, chronic renal insufficiency

Keywords: pregnancy preeclampsia placental insufficiency
historical data analysis of complete remission in children with r/r acute lymphoblastic leukemia (all)

Conditions: B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Summary: an historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (all).

a retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory b-precursor acute lymphoblastic leukemia (all)

Eligibility criteria:
inclusion criteria: * pediatric (age less than 18 years) patients with relapsed or refractory b-cell precursor all, specifically those with * 2nd or later relapse after chemotherapy (with no prior transplantation), * relapse after hsct, or * refractory disease * had treatment for relapsed or refractory disease between 2005-2012 * has data available on all treatment, including number of salvage treatments, response status after therapies, and hsct exclusion criteria: * no cns involvement at relapse * no previous treatment with blinatumomab

Keywords: all, pediatric, leukemia, childhood, lymphoblastic, lymphoma, acute, precursor cell
manual vs. automatic local activation time annotation for guiding premature ventricular complex ablation

Conditions: Ventricular Premature Complexes; Catheter Ablation

Summary: current navigation systems incorporate algorithms for automatic identification of local activation time (lat). however, data about their utility and accuracy in premature ventricular complex (pvc) ablation procedures are scarce. this prospective, randomized study analyzes the accuracy and effectivity of an algorithmic method based on automatic annotation of the maximal negative slope of the unipolar electrogram within the window demarcated by the bipolar electrogram, compared with conventional, manual annotation during pvc ablation procedures.

this is a prospective, randomized, controlled and international multicenter study. the investigators aim to analyze the accuracy of lat annotation using a novel algorithmic method (wavefront, carto, biosense webster, diamond bar, california, usa) (wf), based on automatic annotation of the maximal negative slope of the unipolar electrogram (u-egm) within the window demarcated by the b-egm, by comparison with conventional, manual annotation in a multicenter cohort of patients referred for pvc ablation. further on, the automatic annotation of lat will be aided by an ecg recognition pattern algorithm (included in the last version of carto), which is intended to avoid wrong annotation of ventricular complexes other than the clinical pvc. the investigators hypothesize that automatic lat annotation (using wf and the ecg recognition algorithm) could be superior to conventional, manual annotation in terms of mapping success and could reduce both procedure time and radiofrequency time.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * indication for pvc ablation. * signed informed consent. exclusion criteria: * age \< 18 years. * pregnancy. * pvc ablation procedures guided by pace-mapping (paso® module); eg. low burden of pvcs during the study, mechanical impact during activation mapping. * impossibility to perform activation mapping with the required density of points in the region of interest (see section 4.5.3). * concomitant investigation treatments. * medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. patient's refusal to participate in the study.

Keywords: premature ventricular complex catheter ablation activation mapping wavefront
the effect of magnesium on maternal mood, cognitive function, and birth experience

Conditions: Depression, Postpartum

Summary: magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. the primary aim of this study is to determine if women who receive magnesium are less likely to experience postpartum depression. other aims include examining the relationship between receiving magnesium and cognitive function and birth experience.

this prospective observational study of women with hypertensive disorders of pregnancy (gestational hypertension or preeclampsia) seeks to evaluate a number of markers of maternal postpartum well-being, including maternal mood, breastfeeding, cognitive function, maternal-infant attachment, maternal perception of control, and postpartum pain between women who did and did not receive magnesium prophylaxis in the peripartum period. this project will include 300 women recruited from the obstetrical service at prentice women's hospital. women will be included if they are at least 34 weeks gestation, have a singleton pregnancy, and have been diagnosed with a hypertensive disorder of pregnancy (either gestational hypertension or preeclampsia). women will be exposed to magnesium for the indication of preeclampsia at the discretion of their obstetric provider. intrapartum baseline magnesium serum levels will be drawn for all women. for women who are receiving a magnesium infusion, serum magnesium levels will be repeated during the magnesium infusion (after receipt of the bolus infusion). for women who elect to receive neuraxial analgesia, csf will be obtained and central magnesium levels drawn at the time of epidural placement. prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review. surveys will be administered to assess potential confounders of depression. a baseline self-reported depression survey, the quick inventory of depressive symptoms-self report (qids-sr) will be administered followed by a structured clinical interview for diagnosis (scid), the gold standard for psychiatric research diagnosis. women will be contacted at two weeks and again at six weeks postpartum and the qids-sr will be administered. for women with positive screens, a phone-based mini will be performed.

Eligibility criteria:
inclusion criteria: 1. pregnant or immediately postpartum women 2. age 18 and over 3. singleton gestation 4. diagnosis of hypertensive disorder of pregnancy 5. gestational age of at least 34 weeks 6. english-speaking exclusion criteria: 1. women not meeting the above criteria 2. prior receipt of magnesium during pregnancy 3. intrauterine fetal demise or neonatal demise 4. chronic hypertension
efficacy and safety of seroquel extended release (xr) in acute schizophrenia

Conditions: Schizophrenia

Summary: the purpose of the study is to determine whether treatment with quetiapine xr (seroquel xr) tablets for 3 weeks will improve their agitation when they have acute psychosis.


Eligibility criteria:
inclusion criteria: * requirement for treatment of acute episode of schizophrenia (according to dsm-iv diagnostic criteria) * panss total score of ³ 75 * cgi \> 4 exclusion criteria: * any dsm-iv (diagnostic and statistical manual of mental disorders 4th edition) axis i disorder not defined in the inclusion criteria * patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others * substance or alcohol dependence at enrollment

Keywords: acute schizophrenia
real-world study of efficacy and safety of icis and tkis therapy for hcc

Conditions: Hepatocellular Carcinoma; Programmed Cell Death 1; Effects of Immunotherapy

Summary: china is a high-risk area of hepatocellular carcinoma (hcc). although chinese population accounts for 18.4% of the global population, the number of new hcc patients accounting for about half of the global, which seriously threatens the lives and health of the people. the investigators establish multi-center, retrospective research methods, collecting the data of hcc treatment with system treatment (icis and tkis) plus or without local treatment in the last 3 years, comprehensive assessment of their efficacy and safety, explore whether the efficacy of system treatment combination local treatment showed better effect compared with system or local monotherapy. our study will find a new way to improve the prognosis of hcc patients.

this was a multi-center, retrospective study involving 2000 patients with hcc receiving icis (programmed cell death protein-1 (pd-1) or programmed cell death ligand 1 (pdl-1)) and tkis (lenvatinib or sorafenib), icis and tkis plus local treatment (tac, hepatic artery infusion chemotherapy (haic), radiofrequency (rf) ablation, microwave ablation, radiotherapy, etc.), and local monotherapy between jan, 2019 and dec, 2021 in china. efficacy was evaluated with objective response rate (orr), disease control rate (dcr), progression-free survival (pfs), time to tumor progression (ttp), and 1year and 2 years overall survival (os). treatment-related adverse events (traes) were recorded and graded. efficacy and safety of three groups were compared. stratified analysis was performed according to patients baseline characteristics and medication regimen for combination therapy.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hepatocellular carcinoma * treated with icis (pd-1 or pdl-1) therapy plus tkis (lenvatinib or sorafenib) * treated with local therapy (tace, haic, rf ablation, microwave ablation, radiotherapy, etc) * treated treated with icis plus tkis and local therapy * have complete medical record that can complete the or or 1 year os assessment and follow-up. exclusion criteria: * patients who do not have complete medical record and follow-up information after treatment； * the researchers have evidence that it is not suitable for this study

Keywords: lenvatinib sorafenib programmed cell death 1 real-world study transcatheter arterial chemoembolization
the effect of strawberries in a cholesterol-lowering dietary portfolio

Conditions: Hyperlipidemia; Cardiovascular Diseases; Hypercholesterolemia

Summary: the purpose of this study is to determine whether addition of strawberries to a dietary portfolio of cholesterol-lowering foods will improve compliance and so increase the effectiveness of the dietary portfolio in lowering cholesterol and improving cardiovascular risk factors.

we have shown in 1-month metabolic studies that the dietary portfolio can lower cholesterol to the same extent as first generation statins (cholesterol-lowering drugs). in the on-going long-term 'real world' study using this dietary portfolio, only one-third of participants were able to achieve similar cholesterol reductions at the end of 1 year. varying compliance has been identified as the main issue why the other two-thirds could not achieve a similar level of reduction. we believe the addition of strawberries to this diet, by virtue of their beneficial components (fibre and antioxidants)and by replacement of less desirable foods (fatty deserts), may further improve the chd risk profile of a very effective cholesterol reduction strategy. method: 454 g of strawberries per 2000 kcal per day will be provided for a one-month period to approximately 40-50 subjects on a long-term dietary portfolio study, all of whom have been on the diet for at least 6 months to 1 year. the active dietary components consist of viscous vibers (including oat bran), soy products (including soy milk), almonds and plant sterols (sterol enriched margarine). strawberry recipes will be used to enhance compliance of these components. subjects will undergo the study in a randomized crossover design where the control will be the dietary portfolio with additional 65 g oatbran bread (without psyllium) replacing the strawberries. bloods will be taken at weeks 0, 2 and 4 of each treatment period; and at one month prior to and after the 8-week study while on the long-term dietary portfolio.

Eligibility criteria:
inclusion criteria: * healthy adult men and postmenopausal women currently enrolled in the long-term dietary portfolio study * body mass index \<32 kg/m2 * constant body weight over last 6 months preceding the onset of the study * fasting ldl cholesterol concentration\>4.1 mmol/l at diagnosis exclusion criteria: * women of child-bearing potential * major cardiovascular event (stroke or myocardial infarction) * positive molecular diagnosis of familial hypercholesterolemia * secondary causes of hypercholesterolemia (hypothyroidism, unless treated \& on a stable dose of l-thyroxine, renal or liver disease) * use of cholesterol-lowering medications * serum triglycerides \>4.5 mmmol/l * blood pressure \> 145/90 mmhg * diabetes and or major disorders such as liver disease, renal failure or cancer * major surgery \<6 months prior to randomization * alcohol consumption \> 2 drinks per day

Keywords: strawberry almond soy protein viscous dietary fibre plant sterols portfolio diet blood lipids compliance blood pressure
estrogen and the outer eye in women during fertility treatment

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to determine the relation between estrogen and progesterone levels, and between dryness of the eyes, in women during their fertile years.

women during their fertility treatments will be submitted to the research. the research will include 3 meetings with a doctor from the ophthalmology department. each meeting will be individual for each participant of the research. the meetings will take place during the day of regular appointment of the participant to the fertility clinic. meeting #1: during first visit to the fertility clinic for the stimulation process. during this day will be done: 1.submission of the patient to the research and signing on letter of agreement 2.blood tests for estrogen, progesterone, luteinizing hormone (lh) 3.eye examination: 3a. filling of schein questionnaire 3b. examination of the external eye: 1.microscope, 2.schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 3c. checking the intra ocular pressure with tonometer meeting #2: during visit to the fertility clinic for the egg collection (about 10 days after meeting #1) during this day will be done: 1.blood tests for estrogen, progesterone, luteinizing hormone (lh) 2.eye examination: 2a. filling of schein questionnaire 2b. examination of the external eye: 1.microscope, 2.schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 2c. checking the intra ocular pressure with tonometer meeting #3: during visit to the fertility clinic for the pregnancy test (about 14 days after meeting #2) during this day will be done: 1. blood tests for estrogen, progesterone, luteinizing hormone (lh) 2. eye examination: 2a. filling of schein questionnaire 2b. examination of the external eye: 1.microscope, 2.schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 2c. checking the intra ocular pressure with tonometer collection and summary of all the data end of the research

Eligibility criteria:
inclusion criteria: * women during fertility treatment * without any known eye diseases * no current or past history of treatment against dry eye exclusion criteria: * known eye disease * current or past history of treatment against dry eye

Keywords: dry eye fertility treatment meibomian gland dysfunction supra physiologic estrogen level
safety study of s-caine peel (skin numbing cream) before a painful dermatologic procedure in children

Conditions: Pain

Summary: the purpose of this study is to evaluate the safety of one treatment of s-caine™ peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in children. this study will also evaluate how well the s-caine™ peel eases the pain of the procedure.

the practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies. skin biopsies, shave excisions, deep excisions, electro-surgical procedures, intralesional injections, and laser surgery are frequently performed by dermatologists on a daily basis. some pain accompanies almost all of these procedures, and a local anesthetic is commonly used. traditionally, intracutaneous injection of lidocaine (with or without epinephrine) has been the anesthetic of choice. however, patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections. as a result, topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia. s-caine™ peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation of lidocaine and tetracaine. s-caine peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. s-caine peel is not occluded during application. the pain associated with medical procedures is often under-treated in children. children often undergo painful procedures with little or no anesthetic, even when effective therapy is available. reasons for not providing available therapy in children include concerns over adverse side effects, as well as the length of time necessary to provide adequate anesthesia. recent guidelines strongly advocate for the proactive treatment of pain in children, including the pain associated with medical procedures.

Eligibility criteria:
inclusion criteria: * patient is 0 through 17 years of age. * patient requires a minor or major dermal procedure. * patient's legal guardian is able to read and understand a written informed consent and has signed and dated a written informed consent. the patient must provide assent whenever possible. exclusion criteria: * patient has known allergies, contraindications or sensitivities to lidocaine, tetracaine, or other local anesthetics of the amide or ester type or to any components of the test materials. * patient has known active atopic dermatitis at the designated treatment site. * patient has damaged, denuded or broken skin at the designated treatment site. * patient is pregnant or breastfeeding. * patient has participated in an investigational study or clinical trial of an unapproved drug within the previous 30 days. * patient was born prematurely (less than 38 weeks). * patient has enrolled in any previous study involving s-caine peel.

Keywords: pain
sagittal plane correction with pass-lp device in adult deformity patients

Conditions: Lumbar or Thoraco-lumbar Adult Deformity

Summary: the purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the quality of life for patients with adult scoliosis, treated with a polyaxial system (pass® lp system) during the 2 years after a spinal fusion surgery.


Eligibility criteria:
inclusion criteria * lumbar or thoraco-lumbar adult deformity requiring posterior spinal instrumentation and fusion like: * scoliosis * kyphosis * kyphoscoliosis * patient with a cobb angle ≥ 30° and/or confirmed sagittal imbalance defined as sagittal vertical axis (sva) more or equal to 5cm and/or a loss of lumbar lordosis versus the pelvic incidence * patient ≥ 21 years old * surgery that requires 4 or more levels to be operated * patient with complete pre-operative radiographic data: antero-posterior and lateral standing full spine x-rays (from hips to c2) and lateral bending x-rays (standing) * patient able to complete a self-administered questionnaire * patient able to sign a consent form exclusion criteria * patient operated with posterior spinal fusion without pass lp device * patients who required a vertebral column resection technique surgery * neuromuscular scoliosis or diseases and any neuro-related pathology * spinal cord abnormalities with any neurologic symptoms or signs * primary abnormalities of bones (e.g. osteogenesis imperfecta) * recent significant trauma * patient is involved in current medical litigation * metabolic spinal pathology * pathologic obesity (bmi \> 40) * patients with infection (in particularly osteomyelitis) * patient \< 21 years old * pregnancy or intended to get pregnant during the next 3 years * insulin-dependent diabetes * all other contra-indications given in the pass® lp system instructions for use * patient unable to sign an informed consent form * patient unable to complete a self-administered questionnaire

Keywords: deformity adult lumbar thoraco-lumbar sagittal vertebral alignement (sva) oswestry disability index (odi)