Kornimate/medical-research-clean huggingface dataset:
optimization of the management of non-traumatic intracerebral hemorrhage (opt-ich)

Conditions: Intracerebral Hemorrhage

Summary: intracerebral non-traumatic intraparenchymal hemorrhages (ich) account for 15 to 20% of strokes. one third of the patients dies within the month following ich, and survivors often experience residual disability with a high risk of recurrent ich, other serious vascular events, and neurological complications such as epilepsy and dementia. encouraging but preliminary data suggest a favorable trend in terms of survival rates in recent years. this is partly due to improved management of patients with ich, which must be early (the concept of "time is brain") and carried out by expert personnel (medical and paramedical) in specialized units. the main objectives of the study are: * to evaluate the management of patients with ich in the acute phase within the university hospital of tours by analyzing the procedures adopted in the various relevant departments (neurovascular units, neurosurgery, medical or neurosurgical intensive care, geriatrics); * to evaluate whether the systematic implementation of a dedicated protocol (see \*) for the management of patients with ich is associated with a reduction in mortality and disability in the short and long term.

the project consists of 2 parts: * retrospective, monocentric, observational study. inclusion of all patients presenting with ich admitted urgently to the university hospital of tours between 2018-2021. * prospective, monocentric, observational study. inclusion of all patients presenting with ich admitted urgently to the university hospital of tours. each patient will benefit from management according to a protocol which will include: * emergency mri with contrast injection (contrast-enhanced brain ct scan if contraindicated); * admission to the neurovascular unit unless hemodynamically unstable or intubated; * first intravenous antihypertensive injection with a goal \< 1 hour from arrival at the hospital; * anticoagulation reversal with a goal \< 1 hour from arrival at the hospital; * standard laboratory tests + coagulation study ; * neurosurgical consultation upon arrival at the department; * follow-up mri at 24-48 hours or earlier if clinical worsening; * diagnostic work-up for the evaluation of hypertension-related end organ damage (transthoracic echocardiogram, retinography , proteinuria); * contrast-enhanced follow-up mri at 3-6 months; * neurological evaluation at 6 months and 2 years; * when applicable a neuropsychological evaluation at 6m and 2 y;

Eligibility criteria:
inclusion criteria: * aged over 18 years * emergency admission to the university hospital of tours * having an ich on imaging performed upon admission (ct scan or mri) at the university hospital of tours exclusion criteria : - patient who has given their opposition to the collection of their data
efficacy study of vitamin d supplementation to meticillin resistant staphylococcus aureus (mrsa) carriers

Conditions: Methicillin Resistant Staphylococcus Aureus; Vitamin D3 Deficiency

Summary: the purpose of this study is to treat persistent mrsa carriers with vitamin d supplementation during a 12 month to see if the number of mrsa positive patients can be reduced.


Eligibility criteria:
inclusion criteria: 1. persistent mrsa-carriers as defined as 2 mrsa-positive bacterial cultures from at least one location, at least 3 months apart and during 3 years prior to inclusion. 2. men and women aged ≥18-75 3. signed 'informed consent' 4. negative pregnancy test (u-hcg) and have to accept the use of adequate anti-conceptive method (contraceptives, hormone/copper-spiral). exclusion criteria: 1. should not be on vitamin d supplementation at least 6 months prior to inclusion. 2. serum level of 25-hydroxy vitamin d3 \>75 nmol/l 3. ongoing and continuous antibiotic treatment. the patient should be off antibiotics at least 30 days prior to inclusion 4. known sarcoidosis 5. primary or secondary hyperparathyroidism 6. kidney failure as defined as a normal age-adjusted creatinin. 7. long term systemic treatment with corticosteroids or other immunosuppressive medication 8. taking thiazides 9. hypercalcaemia (verified by a laboratory result younger than 2 month) 10. ongoing malignancy disorder 11. if plans to leave the stockholm county within 12 months of inclusion 12. history of kidney stones 13. pregnancy (ongoing or planned) 14. breastfeeding women 15. taking part of another clinical study involving drugs 16. hypersensitivity to cholecalciferol and/or any of the excipients 17. other criteria that could jeopardize the study or its intention as judged by the investigator
comparing the effect of vaginal misoprostol with dinoprostone in term pregnancies

Conditions: Preeclampsia; Fetal Death; Fetal Membranes, Premature Rupture

Summary: hypothesis (h0): labor duration and obstetric complications are not significantly different in the three groups (misoprostol-dinoprostone-oxytocin).


Eligibility criteria:
inclusion criteria: * term pregnancy * singleton * vertex * bishop score below 6 exclusion criteria: * history of drug reaction * medical disease * iugr * oligohydramnios * vaginal bleeding * fetal anomaly * uterine scar

Keywords: iufd postterm rom
effect of enamel matrix proteins on clinical attachment level and alveolar bone in periodontal maintenance patients

Conditions: Periodontal Bone Loss

Summary: the purpose of the study is to determine the effect of enamel matrix protein derivative on an inflamed, periodontal-involved tooth. the hypothesis to be studied is that enamel matrix derivative protein with increase the clinical attachment level is localized sites of advanced periodontal disease.

the purpose of this study is to determine if local application of a commercially-available, fda-approved preparation of enamel-matrix protein derivatives is effective in increasing clinical attachment levels (primary outcome), as well as alveolar bone (secondary outcome) compared to standard mechanical therapy in patients on periodontal maintenance therapy (pmt). subjects will be divided into two groups for additional therapy in a 6-9 mm interproximal periodontal pocket at baseline: 1) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of the enamel matrix protein derivate or 2) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of saline. samples/measurements will be obtained at the designated experimental site at baseline, 2 weeks, 6 and 12 months during pmt: 1) digital radiograph (baseline and 12 months only; bone height measurements), 2) presence of explorer-detectable supragingival plaque, 3) 30-second gingival crevicular fluid (gcf) sample (markers of inflammation, bone turnover), 4) recession from the cemento-enamel junction, 5) probing pocket depth and bleeding on probing (bop). following the 12-month visit, the research-specific interventions and measurements in the experimental quadrant will be removed from routine pmt.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic advanced adult periodontitis * one quadrant with at least one 6-9 mm interproximal pocket * overall good systemic health * willingness to sign consent form exclusion criteria: * systemic diseases which significantly impact periodontal inflammation and bone turnover (e.g. rheumatoid arthritis) * taking drugs which significantly impact periodontal inflammation and bone turnover * surgical periodontal therapy within the past year * pregnant or breast-feeding females
study comparing the immune response of fluarix and fluzone influenza vaccines

Conditions: Influenza

Summary: the purpose of this study is to compare two licensed influenza vaccines (fluzone and fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months after vaccination.

* experimental design: multi-center, randomized (1:1), observer-blind, active-controlled study in 2 parallel groups with approximately: * study vaccine: full dose of fluarix by im administration. * control vaccine: full dose of fluzone by im administration. * two scheduled visits per subject at days 0 (visit 1) and 21(visit 2) with blood sample collected at each visit to evaluate the immune response. there will be a final contact with each subject 6 months after vaccination for safety follow up and study conclusion. * vaccination schedule: one im injection at day 0. * type of study: self contained.

Eligibility criteria:
inclusion criteria: * all adults 18 years and older. * subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards) should be enrolled in the study. * written informed consent obtained from the subject. * if the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions . exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. * has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study. * history of hypersensitivity to a previous dose of influenza vaccine. * history of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate. * acute disease at the time of enrollment. (acute disease is defined as the presence of a moderate or severe illness with or without fever. all vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature \<37.5°c (99.5°f) / axillary temperature \<37.5°c (99.5°f)). * history of guillain barré syndrome within 6 weeks of prior receipt of inactivated influenza virus vaccine. * pregnancy and lactating females.

Keywords: prophylaxis: influenza virus infection
use of scaffolds for treatment of gingival recession associated with interproximal tissue deficiency

Conditions: Recession; Periodontal Diseases

Summary: this study will seek to evaluate the predictability and efficacy of a computer aided design-computer aided manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration. 40 gingival recessions associated with interproximal tissue deficiency will be divided into two groups: control group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone + scaffold; n = 20).

the treatment of gingival recessions associated with interproximal bone and gingival tissue deficiency, and also the absence of interdental papilla, are major challenges within the periodontics due to lacking predictability. however, an intervention in these cases is extremely important, since the presence of these defects is associated with aesthetic, phonetic, hypersensitivity and may be associated with other dental damages. this study will seek to evaluate the predictability and efficacy of a computer aided design-computer aided manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration. 40 gingival recessions associated with interproximal tissue deficiency will be divided into two groups: control group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone + scaffold; n = 20). a split-mouth design will be used with both procedures performed at the same surgical time.

Eligibility criteria:
inclusion criteria: * presenting at least two single-rooted teeth with miller's class iii and iv recessions with norland \& tarnow class i, ii or iii papilla deficiency exclusion criteria: * history of periodontal surgery at the area on the last 12 months * use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids) * pregnant * smokers * diabetics * history of head and neck radiotherapy * teeth without adjacent mesial and distal contact * teeth with mobility * malpositioned teeth * teeth with endodontic treatment * teeth without a visible cementoenamel junction

Keywords: periodontal disease recession black space
assessment of the nutritional status of pregnant women and optimization of prenatal care services

Conditions: Pregnancy

Summary: a national survey in niger found that women and children are at risk of undernutrition and that many pregnant women don't visit health centers during pregnancy as often as is recommended. the aim is to assess the nutritional and health status of pregnant women in the zinder region and to understand their knowledge, attitudes and practices related to health and nutrition during pregnancy. in collaboration with the medical district of zinder the prenatal care services will be optimized and the programmatic impact on gestational weight gain and anemia prevalence will be assessed.


Eligibility criteria:
inclusion criteria: * pregnant exclusion criteria: * pregnant women, who have severe illness warranting immediate hospital referral

Keywords: iron and folic acid supplements anemia gestational weight gain
ultrasound findings in diabetic pregnancies

Conditions: Diabetes

Summary: the goal of our study is to identify ultrasonographic markers that can predict adverse neonatal outcomes. specifically, we hypothesize that an increase in fetal liver volumes will increase transcutaneous bilirubin (tcb) in the newborn and thus jaundice requiring phototherapy. this information can be used in patient counseling and to guide future screening protocols for ultrasound in individuals with diabetes.

this is a single center, prospective case control study. cases will be collected prospectively and control subjects will be data collected retrospectively from the reference population of the human placenta project (irb #15-09-fb-0179). if patients agree to participate, one ultrasound will be performed at 30-34 weeks' gestation to look at the fetal parameters as described below. it is standard of care for all patients with pregestational diabetes to receive growth ultrasounds throughout their pregnancy. patients who are diagnosed with pregestational diabetes at evms routinely undergo an ultrasound at 30-34 weeks' gestation. therefore, ultrasound data will be collected during their scheduled 30-34 week ultrasound visit and no additional ultrasounds will need to be performed. at the time of enrollment, the pi or other study collaborator will ensure that the patient has previously had a detailed ultrasound evaluation (code 76811). these patients will then be followed prospectively until delivery. the neonates of the study patients will be followed via chart review after delivery.

Eligibility criteria:
inclusion criteria: * patients who enter pregnancy with a diagnosis of type i or type ii diabetes mellitus. * pregnant women between the ages of 18-45 * live, singleton gestation * understanding and ability to give informed consent exclusion criteria: * patient unwilling or unable to provide consent * intrauterine fetal demise (no fetal heart beat identified and documented by two physicians) * age less than 18 years of age * multifetal gestation * chromosomal abnormality * congenital infection (toxoplasmosis, cytomegalovirus, rubella, varicella zoster, parvovirus b19 * major fetal congenital malformations (such as: major congenital heart defect, omphalocele, open neural tube defect, etc)
histological segmentation of the superficial femoral artery from microscan to ct using artificial intelligence

Conditions: Peripheral Artery Disease; Femoropopliteal Stenosis

Summary: the femoropopliteal artery segment (fpas) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. the atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. the study of these plaques and their differentiation in imaging and histology in the fpas has already been the subject of research. to treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules. there is no non-invasive method (imaging) to accurately differentiate lesions along the fpas. the analysis is performed from the preoperative ct scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue. this microscanner can be used ex vivo. in the framework of a project, the learning algorithm was be créated (convolutional neural networks) to automatically segment microscanner slices: after taking fpas from amputated limbs, we correlated ex-vivo microscanner images of the arteries with their histology. the correlation was then performed manually between the microscanner images, and the histological sections obtained. the algorithm well be trained on these slices and validated its performance. the validation of the ct and microscanner concordance was the subject of scientific publications.

the aim of this study is to evaluate the technical feasibility of histological segmentation by the fpas algorithm from ct. the results of this study will provide initial data to evaluate the interest of a subsequent larger scale study to validate the diagnostic capabilities of automated segmentation

Eligibility criteria:
inclusion criteria: * male or female of legal age * subject with a planned transfemoral amputation in the vascular surgery department of the hôpitaux universitaires de strasbourg as standard care * subject with a ct as part of standard care * subject who has given his/her non-opposition to participate in the study exclusion criteria: - impossible to give the subject informed information (subject in emergency situation, difficulties in understanding)
the combination of low-dose rituximab and atra as the treatment of steroid-resistant/relapse immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and atra in patients with steroid-resistant/relapsed itp.

immune thrombocytopenia (itp) is a severe bleeding disorder. approximately 2/3 of patients achieve remission from first-line therapies. however, the underlying mechanism of steroid-resistant or relapsed itp is not well understood; thus, treatment remains a great challenge. rituximab has been shown to partly improve the complete remission rate of itp. all-trans retinoic acid (atra) has an immunomodulatory effect on haematopoiesis, making it a possible treatment option. a multicentre prospective study was performed in non-splenectomized itp patients who were either resistant to a standard dose of corticosteroids or had relapsed. patients were randomized to the low-dose rituximab+atra and the low-dose rituximab monotherapy groups. platelet count, bleeding and other symptoms were evaluated before and after treatment. interim analysis was scheduled at 50% through recruitment. adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and atra in patients with steroid-resistant/relapsed itp.

Eligibility criteria:
inclusion criteria: * itp confirmed by excluding other supervened causes of thrombocytopenia; * platelet count of less than 30×10\^9/l at enrollment; * patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation; * ecog\<2. exclusion criteria: * secondary immune thrombocytopenia (e.g., patients with hiv, hcv, helicobacter pylori infection or patients with systemic lupus erythematosus) * congestive heart failure * severe arrhythmia * nursing or pregnant women * aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria * creatinine or serum bilirubin levels each 1•5 times or more than the normal range * active or previous malignancy * patients with other diseases were undergoing treatment with immunosuppressants * patients with itp had received rituximab

Keywords: all-trans retinoid acid rituximab steroid-resistant refractory low-dose
a long term safety study of infliximab (remicade) in in ulcerative colitis patients

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.

this is a long term, multicenter, international safety study to evaluate targeted long-term safety information on patients who have participated in infliximab(remicade) clinical studies in ulcerative colitis that require long-term safety follow-up. all patients who received at least one dose of study drug (infliximab or placebo) in the primary studies (c0168t37 ,c0168t46, c0168t72) are eligible to participate in this long-term safety follow-up study (c0168t62). patients will begin participation in c0168t62 at the time of their last safety visit in the primary study and will be followed for 5 years. no study agent will be administered. information on deaths, serious infections, new malignancies (including colorectal cancer) and new autoimmune diseases and surgical procedures (including colectomy) and hospitalizations for the treatment of ulcerative colitis will be collected. information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if patients received infliximab after the end of the primary study. in addition, data on dysplasia of the colon will be collected from patients who were identified in the primary study to be at high-risk for colon cancer and were required per protocol to undergo a follow-up colonoscopy as part of long-term safety follow-up. all adverse events, including non-serious adverse events, will also be collected.

Eligibility criteria:
inclusion criteria: * all patients enrolled in three phase 3 janssen-sponsored (c0168t37, c0168t46, c0168t72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up * patients must have received at least 1 dose of study agent to be eligible for participation in the study exclusion criteria: - patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. in addition, patients participating in a study extension to the primary study are not eligible for participation in the c0168t62 study during the study extension participation

Keywords: ulcerative colitis infliximab remicade safety
3d autotransplantation of teeth

Conditions: Tooth Loss

Summary: the study aims to clarify the usefulness of 3d-printed replicas in association with autotransplantation of teeth in children and young adults.


Eligibility criteria:
inclusion criteria: * need for tooth transplantation * open apex tooth available for transplantation exclusion criteria: * facial syndrome * chronic facial pain * allergy to replica material