Kornimate/medical-research-clean huggingface dataset:
a non-inferiority study comparing two heparin sodium preparations in hip fracture surgery

Conditions: Hip Fracture Surgery

Summary: the primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by eurofarma can be considered non-inferior to the reference product.

the primary objective of the study is to assess the efficacy of unfractionated heparin sodium of porcine origin (eurofarma) in the prophylaxis of vte relative to unfractionated heparin sodium of porcine origin from app pharmaceuticals. the primary endpoint will be the frequency of dvt determined by doppler ultrasound (dus).

Eligibility criteria:
inclusion criteria: in order to be enrolled in this study, eligible patients must meet all criteria below: * icf signing; * aged 60 to 85 years old; * indication of hip orthopedic surgery due to fracture occurred within the last 5 days; * normal coagulation profile or with alterations up to 25% of normal values. exclusion criteria: patients who meet any of the following criteria will not be eligible for the study: * previous hip surgery; * fracture secondary to the presence of metastasis; * recent traumatic brain, thoracic, or abdominal injury (up to 30 days before study start); * recent occurrence (up to 30 days before study start) of cerebrovascular accident; * serum concentration of hemoglobin below 9 g/dl; * prior occurrence (in the last 5 years) of confirmed or suspected thromboembolic event; * occurrence of major bleeding in the last 6 months (any spontaneous gastrointestinal bleeding; central nervous system bleeding; massive epistaxis, or gum bleeding; gross hematuria, or vaginal bleeding); * confirmed or suspected blood dyscrasia; * diagnosis of neoplasm other than in situ in the last 24 months or any active neoplasm (neoplasms in situ do not prevent patient from participating); * liver or kidney failure; * clinically significant gastrointestinal cardiovascular, neurological disease, or laboratory abnormalities, which at the investigator's opinion, may interfere with individual's participation in the study or with assessment of individual's response to treatment; * hypersensitivity to heparin; * previous use (15 days before study start) of oral anticoagulants or expected use during the study (see appendix b); * recent participation (previous 12 months) in a clinical trial.

Keywords: heparin sodium thromboprophylaxis hip fracture surgery.
target-specific immunopet imaging of digestive system carcinoma

Conditions: Malignancy; Digestive Cancer; Digestive System Neoplasm; Digestive System Carcinoma; Digestive System Cancer; Liver Cancer; Stomach Cancer; Colon Cancer; Rectum Cancer; Pancreatic Cancer; Esophagus Cancer; Gallbladder Carcinoma; Small Intestine Cancer; Appendix Cancer; Bile Duct Carcinoma

Summary: the aim of this study is to establish and optimize the target-specific pet/ct imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.

enrolled patients will undergo whole-body pet/ct scans at 1 hours after tracer injection(0.05-0.1 mci/kg). uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively. tumor uptake will be quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv), and accuracy will be calculated to evaluate the diagnostic efficacy. the correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. the exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Eligibility criteria:
inclusion criteria: 1. aged 18-75 years old and of either sex； 2. histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging; 3. capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (icf) and this protocol. exclusion criteria: 1. pregnancy； 2. severe hepatic and renal insufficiency; 3. history of serious surgery in the last month; 4. allergic to antibody or single-domain antibody radiopharmaceuticals.

Keywords: human epidermal growth factor receptor 2 (her2) trophoblast cell surface antigen 2 (trop2) glypican-3 (gpc3) glycoprotein a33 (gpa33) nectin cell adhesion molecule-4 (nectin-4)
evaluation of the "grasp site" after peeling of epiretinal membranes

Conditions: Epiretinal Membrane

Summary: the goal of this study is to compare the novel ilm sharkskin forceps with a conventional ilm forceps utilizing ioct assistance during surgery at this "grasp site". the main questions it aims to answer are: 1. are there differences in grasp attempts between both forceps 2. are there differences in instrument tissue interactions between both forceps 3. are there differences in postsurgical anatomical and functional outcomes at the grasp site between both forceps.

epiretinal membranes are a disease of the retinal surface, that may affect visual acuity acuity and cause metamorphopsia, occurring in approximately 20% of the population older than 60 years. using vitrectomy with membrane peeling, postoperative improvement of visual acuity and metamorphopsia may be achieved in a majority of patients. the surgical method has been used for some time, the first report on the surgical method of vitrectomy with membrane peeling dates back to 1978, and since the introduction of intraoperative optical coherence tomography (ioct), intraoperative iatrogenically induced changes in retinal tissue can be detected and correlated with postoperative changes. our group has been able to record "stretching" of the retinal tissue using this technique and has also been able to record the rarely occurring subfoveal and extrafoveal elevations of the ellipsoidal zone due to membrane peeling. these changes did not significantly affect postoperative visual acuity in our study population but did affect the development of postoperative microscotomas. besides "retinal stretching" during surgery, ilm peeling is shown to be another factor with association of new postoperative microscotomas. new postoperative microscotomas developed in some patients without "retinal stretching" and ilm peeling. apart from these already known iatrogenic changes, the analysis of the "grasp site" at the "starting point" of epiretinal membrane peeling is of great interest, because at this location, grasping of the epiretinal membrane may be difficult especially in case of an adherent erm and superficial retinal lesions may be induced. diaz et al. demonstrated that there are postoperative changes in the "nerve fiber layer" after ilm peeling, but in that study, no recording of instrument/tissue interactions was performed using ioct. the aim of this study is to compare the novel ilm sharkskin forceps with a conventional ilm forceps utilizing ioct assistance during surgery at this "grasp site".

Eligibility criteria:
inclusion criteria: * idiopathic erm * sheduled surgery (vitrectomy with membrane peeling), as defined by vision loss and/or metamorphopsia * age 18 and older * written informed consent for participation in the study exclusion criteria: * macular edema due to other reasons than ierm * pregnancy (pregnancy test will be performed in women of reproductive age)
trial of bortezomib, cytarabine, and dexamethasone in mantle cell lymphoma

Conditions: Mantle Cell Lymphoma

Summary: the purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.


Eligibility criteria:
inclusion criteria: * pathologically confirmed mantle cell lymphoma * relapse or progression after 1-3 lines of previous chemotherapy with or without immunologic agents * ecog performance status 2 or less * adequate hematologic, hepatic, and renal function i. white blood cells ≥ 3,000 /ul ii. absolute neutrophil count ≥ 1,000 /ul iii. platelets ≥ 50,000 /ul iv. hemoglobin ≥ 9.0 g/dl v. total bilirubin \< 2 times upper limit of normal vi. ast, alt \< 2.5 times upper limit of normal vii. serum creatinine \< 1.5 times upper limit of normal exclusion criteria: * previously treated with 4 or more lines of chemotherapy with or without immunologic agents * previously treated with bortezomib * treated with a cytarabine-containing regimen as the last line and within 6 months before registration * other cancer diagnosed within 5 years before registration * uncontrolled symptomatic cns involvement of mantle cell lymphoma * uncontrolled systemic infection * inherited immunodeficiency disease or aids * pregnancy * breast-feeding * peripheral neuropathy of grade 3 or higher * other health conditions considered to be inappropriate for this trial in the primary physician's opinion

Keywords: mantle cell lymphoma bortezomib cytarabine
l-cysteine in peritoneal dialysis

Conditions: Uremia

Summary: over the last decades, peritoneal dialysis has grown worldwide to become one of the most common modalities of renal replacement therapy, particularly in developing or newly industrialized countries, such as india, china, korea, turkey, malaysia, mexico and brazil. peritoneal dialysis has been associated with an initial survival benefit compared to hemodialysis, although this advantage becomes less apparent over time, likely due to the progressive loss of residual renal function and the development of pathological alterations of peritoneum . recent results suggest that an antioxidant therapy by n-acetyl-cysteine oral supplementation may improve residual renal function in peritoneal dialysis patients. this finding may have major clinical relevance, as preserving residual renal function in peritoneal dialysis patients has been associated with improved survival . aim of the present randomized, double-blind, crossover study is to confirm the preliminary evidence of the beneficial effects of antioxidant agents on residual renal function by using the l-enantiomeric form of cysteine in 10 prevalent peritoneal dialysis patients with residual diuresis.


Eligibility criteria:
inclusion criteria: * males and females aged ≥ 18 years; * chronic automated peritoneal dialysis; * residual 24-hour diuresis ≥ 100 ml with less than 30% changes over the three months preceding randomization; * written informed consent. exclusion criteria: * chronic automated peritoneal dialysis therapy since less than three months; * diabetes mellitus; * acute peritonitis during the three months before enrollment; * concomitant treatment with other antioxidant agents (including n-acetyl-cysteine and vitamin c); * cystinuria; * pregnancy or breastfeeding; * childbearing potential without reliable contraceptive methods during the whole study period; * alcohol or drug (excluding tobacco) abuse; * inability to comply with the study procedures during the whole study period, legal incapacity; * cancer and any severe systemic disease or clinical condition that may jeopardize data interpretation or completion of the study.

Keywords: l-cysteine peritoneal dialysis diuresis glomerular filtration rate peritoneal function inflammation
leuprorelin acetate sr 11.25 mg for injection specified drug-use survey "long-term use survey on premenopausal breast cancer patients (96 weeks)"

Conditions: Breast Cancer

Summary: the purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate sr (slow release) 11.25 milligram (mg) for injection (leuplin sr 11.25 mg for injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate sr 11.25 mg for injection (leuplin sr 11.25 mg for injection).

this survey was designed to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate 3 months depot for injection (leuplin sr 11.25 mg for injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate sr 11.25 mg for injection (leuplin sr 11.25 mg for injection). for adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. the powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Eligibility criteria:
inclusion criteria: * premenopausal breast cancer patients (patients with advanced or recurrent breast cancer and patients who received adjuvant therapy). exclusion criteria: * patients with a history of treatment with leuplin sr 11.25 mg for injection

Keywords: pharmacological therapy
validation of a novel, non-dimensional approach for estimation of pressure gradients in aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: a novel, image-based model for estimation of the pressure gradient across stenosed aortic valves is compared against invasively measured pressure gradients from clinical routine.

using temporally resolved computed tomography images, the patient-specific geometry of the stenosed aortic valve during peak systole is reconstructed. using this geometry, the projected area of the aortic valve's orifice (ava) is calculated. additionally, the left ventricular geometry is reconstructed for the complete heart cycle. using the information of the left ventricular volume change, the patient-specific flow profile and peak-systolic flow (q)is calculated. using this information, the pressure gradient is calculated using a power law estimation of the form pg = a \* ava\^b \* q\^c. the model generation and parameter fit is described in \[1\]. to validate this model, retrospective data of patients receiving a catheter-based replacement of the aortic valve (tavi) is collected. for those patients, ct images are already acquired for treatment planning and the invasive pressure measurements are performed during replacement of the aortic valve. therefore, no additionally steps are required. using the ct images the patient-specific aortic valve area ad flow rate are calculated. this information is then used for estimation of the pressure gradient using the power law model. the catheter-based pressure gradient is calculated as the difference between the peak-systolic pressure in the left ventricle and the ascending aorta before implantation of the prosthesis. \[1\] franke et al.; towards improving the accuracy of aortic transvalvular pressure gradients: rethinking bernoulli; medical \& biological engineering \& computing (2020); https://doi.org/10.1007/s11517-020-02186-w

Eligibility criteria:
inclusion criteria: * aortic valve stenosis * treatment via tavi
study of cabaser and sinemet cr for the treatment of nighttime symptoms associated with parkinson's disease.

Conditions: Parkinson Disease

Summary: the study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of parkinson disease.

the trial was terminated prematurely june 26, 2005 due to the inability to re-supply study drug for the planned number of subjects. there were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson disease * must be experiencing sleep akinesia exclusion criteria: * current treatment with other dopamine agonists * nocturnal hallucinations * dementia
a study of dasatinib management among cp-cml (chronic phase, chronic myeloid leukemia) participants initiating dasatinib in a real life setting

Conditions: Chronic Myeloid Leukemia

Summary: this is a prospective, non-interventional study conducted in cp-cml patients receiving dasatinib who are enrolled by a sample of hematologists in france.


Eligibility criteria:
inclusion criteria: * patients aged greater than or equal to 18 years * patients diagnosed with cp-cml * patients who started dasatinib within the last month before inclusion, or on the day of inclusion or within the month after inclusion exclusion criteria: * patients participating in an ongoing interventional trial * patients diagnosed with ap-cml (accelerated phase) or bp-cml (blast phase)
initiation of resuscitation while attached to the cord with congenital diaphragmatic hernia

Conditions: Congenital Diaphragmatic Hernia

Summary: this study aims to measure the cardio-respiratory physiological consequences of initiating resuscitation during placental transfusion (pt) with an intact umbilical cord in infants with congenital diaphragmatic hernia (cdh). pt, mainly via delayed cord clamping, has been shown to offer a higher circulating blood volume, less need for blood transfusion, less need for inotropes in infants. currently infants with cdh receive immediate cord clamping (icc) to facilitate immediate resuscitation including immediate intubation and mechanical ventilation. with the development of a resuscitation platform (inspire), resuscitative care can now be commenced from birth in infants with cdh to benefit from pt.


Eligibility criteria:
inclusion criteria: * newborn infants with an antenatal diagnosed cdh. exclusion criteria: * severe antepartum or postpartum hemorrhage. * any obstetrical concern. * lack of parental consent.
cleft palate surgery and speech development

Conditions: Cleft Lip; Cleft Palate

Summary: compare the outcome of two primary surgeries techniques (von langenbeck and furlow double z-plasty) performed on children with cleft lip/palate to determine if one results in significantly better velopharyngeal competency for speech.

this study is conducted with patients with complete unilateral cleft lip and palate. the subjects will have their palatal clefts surgically repaired by either the von langenbeck or the furlow double z-plasty palatoplasty. patients will be randomly assigned to four groups, to have with the von langenbeck palatoplasty with intravelar veloplasty or the furlow double opposing z-plasty palatoplasty between 9 and 12 months of age or between 15 and 18 months of age. lip repair will be randomized to either the spina or millard method and will be accomplished by six months prior to palatoplasty. the major emphasis will focus on assessment of the near and long term outcomes of the palatal surgeries on velopharyngeal function for speech.

Eligibility criteria:
inclusion criteria: * unrepaired unilateral cleft lip and palate * lip repair surgery to be accomplished by 3-6 months of age * able to return to research site at least once a year for follow-up exclusion criteria: * patients with concomitant conditions (ie. mental retardation, deafness) * patients with simonart band of the cleft * patients who could not return to research site on a yearly basis

Keywords: cleft lip and palate children speech velopharyngeal function congenital facial malformation von langenbeck procedure furlow procedure cleft lip and palate repair unilateral cleft lip and palate
natural cycle vs programmed cycle frozen embryo transfer

Conditions: Infertility; Frozen Embryo Transfer; Preeclampsia and Eclampsia

Summary: the goal of this\[ type of study: randomized controlled trial\]is to compare preeclampsia following natural vs. artificial cycle in patients undergoing frozen embryo transfer. the main question\[s\] it aims to answer is • does nc-fet decreases the incidence of preeclampsia in patients undergoing frozen embryo transfer as compared to ac-fet ? the main objective is to compare the proportion of preeclampsia in women with a viable pregnancy with natural cycle protocol to artificial cycle protocol when practicing frozen embryo transfer. participants recruited will be divided into two arm(1513 per arm). arm 1 will undergo the natural cycle procedure of embryo transfer, and arm 2 will undergo the artificial cycle procedure of embryo transfer. the primary outcome will be the proportion of preeclampsia. the duration of the study is around 2 year.

the research question(pico) addressed is does nc-fet decreases the incidence of preeclampsia in patients undergoing frozen embryo transfer as compared to ac-fet . the hypothesis taken is nc-fet will decrease the incidence of preeclampsia compared to ac-fet. the sample size is taken as 3026 (1513 per arm). the primary objective is to compare the proportion of preeclampsia in women with a viable pregnancy with natural cycle protocol to artificial cycle protocol when practicing frozen embryo transfer. the study outcome of the proportion of preeclampsia after 20 weeks of gestation or 6 weeks post-delivery. there are two arms-arm 1 active comparator: natural cycle and arm 2 control: artificial cycle fet. the randomization is done through random allocation as per computer generated sequence. the blinding/masking is done open labeled. the study duration is from feb 2023 to jan 2025. participation duration is 10 months.

Eligibility criteria:
inclusion criteria: * endometrial preparation with hormone replacement therapy/ natural cycle. * age 21-45 years following an autologous ivf cycle (with or without preimplantation genetic testing for aneuploidy) * bmi \> 18 and \< 30 kg/m2 * endometrial thickness ≥ 7 mm after estrogen therapy or on the day of ovulation * blastocyst embryo transfer exclusion criteria: * uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed müllerian abnormalities) * hydrosalpinx untreated. * recurrent pregnancy loss (≥ 3 previous miscarriages) * recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts) * allergy to study medication * pregnancy or lactation at recruitment * contraindications for hormonal treatment

Keywords: reproduction in vitro fertilization natural frozen embryo transfer artificial frozen embryo transfer preeclampsia
calcitonin gene related peptide-induced headache in patients with familial hemiplegic migraine type 1 and 2.

Conditions: Familial Hemiplegic Migraine

Summary: the aim of the present study is to explore functional consequences of migraine gene mutations on their responses to calcitonin gene related peptide (cgrp)infusion.

calcitonin gene related peptide (cgrp) induces migraine attacks indistinguishable from spontaneous attacks in approximately 50% of migraine sufferers. treatment of spontaneous migraine attacks with an antagonist to cgrp is effective in many patients. these data show that cgrp is involved in both initiation and maintenance of migraine attack. the consequence of migraine gene mutations on relevant migraine pathways has never been tested. the aim of the present study is to explore functional consequences of migraine gene mutations on their responses to cgrp infusion. the project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Eligibility criteria:
inclusion criteria: patients: diagnosis of familial hemiplegic migraine (ihs-classification criteria) caused by mutations in the cacna1a gene and the atp1a2 gene. controls: healthy volunteers exclusion criteria: controls: no primary headache in their own history 2) patients and controls: * a history of cerebrovascular disease and other cns- disease * a history of serious somatic and mental disease * a history suggesting ischaemic heart disease * a history of hypo- or hypertension * daily intake of medication apart from oral contraceptives * abuse of alcohol or medicine (opioid analgesics). * pregnant or breastfeeding women. on the study day: * no intake of a simple analgesic in the previous 48 hours * no headache in the previous 48 hours

Keywords: familial hemiplegic migraine type 1 and 2 cgrp middle cerebral artery superficial temporal artery headache genotype healthy volunteers