Kornimate/medical-research-clean huggingface dataset:
should we avoid performing invasive coronary angiography before cardiac surgery in achd patients?

Conditions: Adult Congenital Heart Disease

Summary: the goal of this observational study is to compare two pre-operative methods, that is the invasive coronary angiography (ica), an actual standard diagnostic method, with the coronary computer tomography (cct) to undestand if the only cct is sufficent to confirm the presence of a significative coronary disease and so to identify possible lesions in the coronary ematic circle, for example: stenosis and narrowing of coronary vessels. this observational study included people who have a congenital heart desease with indication of cardiac surgery and, why this disease, who had already performed these two diagnostic methods and/or who will perform them. the main question it aims to answer is: should we avoid performing invasive coronary angiography (ica) before cardiac surgery in people who have congenital heart desease (achd patients)?

the primary aim is to verify the diagnostic reliability of coronary cct to confirm or exclude the presence of significant coronary artery disease in achd patients who are candidates for cardiac surgery compared to ica, the current gold standard. the secondary objectives is to measure the occurrence of side effects and/or complications secondary to ica and cct procedures. to measure the frequency with which each of the two methods is able to identify the presence of coronary anomaly and the correct anatomical relationships between the anomalous coronary artery and the adjacent structures. to compare the waiting times of coronary cct and coronarography, in order to assess their actual availability in daily clinical practice. the primary outcomes of the study are: * non-significant lesions of the coronary tree (stenosis \< 50%) * significant lesions (stenosis ≥ 50%) * limited to cct investigation: coronary tree partially or completely unassessable due to artefacts or extensive calcifications preventing proper assessment.

Eligibility criteria:
inclusion criteria: * adult congenital heart disease patient who is a candidate for cardiac surgery for correction of defect valve, or who performed the surgery after 01.01.2010 * clinical indication for preoperative ica and cct performed less than 12 months apart within 12 months of planned cardiac surgery * age ≥ 18 years * obtaining written informed consent exclusion criteria: * inability to perform ica for any reason (e.g., poor vascular access or anatomical difficulty in reaching the coronary arteries) * patient with severe renal failure on dialysis therapy * patient with previous cerebri stroke
vadoplex critical limb ischemia study

Conditions: Peripheral Artery Disease; Quality of Life; Wound Healing

Summary: in patients with critical limb ischemia (cli) and foot ulcers wound healing is an important goal which can normally only be achieved after sufficient treatment of the underlying ischemia (revascularization either by an operation, e. g. bypass, or a catheter intervention). after successful revascularization everything should be done to improve wound healing because this regularly takes weeks up to several months. one possibility to speed up healing could be treatment with the vadoplex device which delivers an automatic intermittent painless compression of the sole of the foot thereby increasing perfusion of the leg. this system can be easily operated by patients themselves and at home. our goal is to prove that the vadoplex system accelerates healing up and improves quality of life.


Eligibility criteria:
inclusion criteria: * signed informend consent * peripheral artery disease fontaine iv (equals ruterford 5 and 6) with or without neuropathy * foot lesion stage 1 - 4 analogous to 4 wagner classification of the diabetic foot * secondary wound healing if previous surgical wound treatment * previous interventional and/or surgical revascularisation * age above 18 * hosptalized to the beginning of the study exclusion criteria: * primary wound healing if previous surgical wound treatment * uncontrolled local or systemic infection * renal failure on dialysis * inability or insufficient help to operate the vadoplex system * wound dressings that lead to insufficient compression by the vadoplex system (e.g. total contact cast for offloading) * wounds of other than ischemic or neuro-ischemic origin

Keywords: peripheral artery disease critical limb ischemia vadoplex intermittent foot compression
alio wear study: long-term wear of the alio platform

Conditions: End Stage Kidney Disease

Summary: the wear study is long-term interventional study designed to evaluate patient and clinician use of the alio platform, per its fda cleared indications.


Eligibility criteria:
inclusion criteria: * at least 18 years of age. * receiving hemodialysis via an avf or avg in an arm location at the time of study start. * able to wear the smartpatch effectively at the specified location on the arm. * ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. * willing and able to wear the smartpatch as instructed and comply with all interviews, surveys and questionnaires, and schedule of evaluations. exclusion criteria: * skin near the proximity of the av access that is chronically swollen, infected, inflamed, open wounds, lesions, or has skin eruptions. * participation in any other clinical trials involving investigational or marketed products that in the opinion of the investigator could affect the quality of the data. * other conditions that in the opinion of the principal investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
lateral retinacular release in total knee arthroplasty with patellar replacement

Conditions: Anterior Knee Pain Syndrome

Summary: the aim of this study is to assess the effect of systematic lateral retinacular release on anterior knee pain, as well as its impact on the functional and radiological outcomes after total knee arthroplasty with patellar resurfacing.

anterior knee pain is an important cause of persistent pain after total knee arthroplasty. lateral retinacular release has been proposed as a procedure to prevent anterior knee pain syndrome, based on the reduction of lateral tension and improving patellar tracking. however, its effect on anterior knee pain after total knee arthroplasty is not clear when it is not strictly needed to correct maltracking. the purpose of this trial is to evaluate the effect of systematic lateral retinaculare release on anterior knee pain, peformed during a total knee arthroplasty with patellar resurfacing.

Eligibility criteria:
inclusion criteria: * diagnosis of knee osteoarthritis exclusion criteria: * prior major surgery on the same knee (high tibial or distal femoral osteotomy, patellar realignment) * important preoperative malalignment (varus or valgus \>15º or flexion deformity \>15º) * inability to sign informed consent

Keywords: total knee arthroplasty patellar resurfacing lateral retinacular release anterior knee pain
finding the optimal cooling temperature after out-of-hospital cardiac arrest

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: to assess the fraction of subjects surviving with good neurological outcome at 90 days for 3 different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.


Eligibility criteria:
inclusion criteria: * signed informed consent (obtained from their legal representative) * 18 years of age or older and less than 80 years old. * witnessed ohca of presumed cardiac cause * sustained rosc (when chest compressions have not been required for 20 consecutive minutes and signs of circulation persist) * initial shockable cardiac rhythm (documented by ecg or aed) * interval from collapse to advance life support \< 20 minutes * interval from collapse to rosc \< 60 minutes * lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting * systolic blood pressure of \>90 maintained for a least 30 minutes post-rosc without pressors, or with a stable dose of pressors exclusion criteria: * traumatic cardiac arrest * toxicological etiology * known or suspected pregnancy * do not attempt to resuscitate order in force * unwitnessed arrest * in-hospital arrest * anatomy, previous surgery or disease state contraindicating femoral venous access * received neuromuscular blocking agents prior to assessing level of consciousness following rosc * neurological evaluation insufficient/incomplete after rosc but prior to randomization. * body core temperature \< 34ºc at randomization * current inferior vena cava (ivc) filter * known history of acute neurological illness or severe functional disabilities prior to arrest (e.g., seizures, traumatic brain injury, increased intracranial pressures, intra-cerebral hemorrhage, etc). * known hypersensitivity to hypothermia including a history of raynaud's disease * suspected or confirmed acute intracranial bleeding * suspected or confirmed acute stroke * terminal illness or life expectancy of less than 3 months prior to arrest * currently enrolled in another investigational new drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's endpoints (for the purpose of this protocol, subjects involved in extended follow-up trials or registries for products that are currently commercially available are not considered enrolled in an investigational trial). * transferred from a non-participating hospital.

Keywords: target temperature management cooling comatose survivors from ohca good neurological outcome at modified rankin score (mrs) ≤ 3
egg freezing pilot study

Conditions: Infertility; Egg Freezing

Summary: university reproductive associates is conducting a pilot study to study the technique of egg freezing. your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. your participation will include a standard ivf cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. you will receive a significant reduction in your ivf cycle cost.


Eligibility criteria:
inclusion criteria: 1. 10 women between the ages of 18-35 inclusive at time of signing informed consent form. 2. in good general health off of current medications which may confound response to study medications. 3. desire to seek pregnancy actively during the study period by ivf-icsi. 4. a normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study. 5. ability to use the required medications. 6. day 3 fsh level \< 12 iu/ml exclusion criteria: 1. current pregnancy 2. patients with significant anemia (hemoglobin \< 10 mg/dl). 3. patients enrolled simultaneously into other investigative studies that would interfere with this research study.

Keywords: infertility egg freezing fertility preservation
optimization of therapy in adult patients with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma by individualised, targeted and intensified treatment

Conditions: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma

Summary: a phase iv study with the primary goal to optimize therapy of adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma (lbl) by dose and time intensive, pediatric based chemotherapy, risk adapted stem cell transplantation (sct) and minimal residual disease (mrd) based individualised and intensified therapy. study will further evaluate the role of asparaginase intensification, the extended use of rituximab and the use of nelarabine as consolidation therapy in t-all in a phase iii-part of the study. furthermore two randomisations will focus on the role of central nervous system (cns) irradiation in combination with intrathecal therapy versus intrathecal therapy only in b-precursor all/lbl and the role of sct in high-risk patients with molecular complete remission. finally a new, dose reduced induction therapy in combination with imatinib will be evaluated in ph/bcr-abl positive all.


Eligibility criteria:
inclusion criteria: * acute lymphoblastic leukemia (pro-b, common, pre-b, early t, thymic t, mature t) * lymphoblastic lymphoma (b or t-lineage) * age 18-55 yrs * written informed consent * adequate contraception as specified per protocol exclusion criteria: * severe comorbidity or leukemia associated complications * late relapse of pediatric all or all as second malignancy * cytostatic pre-treatment * pregnancy or breast feeding * severe psychiatric illness or other circumstances which may compromise cooperation of the patient * participation in other clinical trials interfering with the study therapy

Keywords: acute lymphoblastic leukemia lymphoblastic lymphoma nelarabine bcr-abl mrd peg-asparaginase rituximab
retrospective study of 110 cases of uterine rupture to determine obstetric and neonatal complications

Conditions: Anomaly Uterus

Summary: this study has for objective to collect medical data from patients with uterine rupture at the childbirth.

this is a retrospective study, gathering data of five maternity in the department of val d'oise in france, during 13 years (between 01/01/2000 an 31/12/2013). the incidence of uterine rupture increases with increasing cesarean rates. it occurs at a rate of 0.08% across all childbirths in france, and 0.5 to 1% of the childbirths on cicatricial uterus in france. although the risk factors are known, it is usually unexpected. this is a serious complication for the mother (mortality \<1%, severe morbidity at 15% ) and for the child (mortality for 3 to 6 % for childbirth at term, neonatal asphyxia for 6 to 15%) that can occur during pregnancy or during labor.

Eligibility criteria:
inclusion criteria: * childbirth with uterine rupture exclusion criteria: * childbirth in a maternity which do not participate to the study

Keywords: uterine rupture
eumetriosis: insights into the pathogenesis of endometriosis

Conditions: Endometriosis

Summary: this study investigates epigenetic changes in menstrual effluent and plasma from women with endometriosis to identify potential non-invasive diagnostic biomarkers for the disease.


Eligibility criteria:
inclusion criteria: * premenopausal * in spontaneous menstrual cycle (no hormonal treatments for the last 3 months) * healthy or with a clear diagnosis of endometriosis via ultrasound, mri or laparoscopy exclusion criteria: * hiv or hepatitis positive * pregnancy
a study to evaluate the safety, pk of gc2129a in healthy volunteers under fed conditions

Conditions: Healthy Volunteers

Summary: the purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of gc2129a in fed conditions to healthy adult volunteers.

this study is an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design to evaluate pharmacokinetics that are not affected by blinding. according to the order of administering the investigational drug for each period, 17 people are assigned to each of the two groups and administered. for healthy subjects, each 17 subjects are assigned to each of the two groups(total 34 subjects). if the subject administrate gc2129a in the first period, the subject will be administrated reference drugs in the second period after washout(over 7 days). conversely, if the subject administrate reference drugs in the first period, the subject will be administrated with gc2129a in the second period.

Eligibility criteria:
inclusion criteria: * a person who is 19 years of age or older at the time of a screening visit * a person with a body mass index (bmi) of 18.0 kg/m2 or more and 30.0 kg/m2 or less with a weight of 50 kg or more (45 kg or more for women) during a screening visit * a person who has no clinically significant congenital or chronic disease during a screening visit and has no pathological symptoms or findings as a result of internal examination exclusion criteria: * persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology. * a person who has a history of gastrointestinal surgery * those who have taken drug metabolism enzymes, such as barbiturate drugs, within one month of the first dose date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date * a person who participates in another clinical trial or biological equivalence test within six months of the first administration date * a person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a blood transfusion within 4 weeks * a person who is deemed unsuitable for participation in this clinical trial by the principle investigator(or the delegated sub-investigator) for reasons other than the above selection and exclusion criteria * in the case of female volunteers, a pregnant woman or pregnant woman is suspected

Keywords: pk gc2129a
internationally adopted children quality of life

Conditions: Children; Quality of Life

Summary: this study evaluates the global quality of life of foreign born adopted children, one to seven years following their arrival in france. investigators will assess global health, behavior, school integration for each child who arrived in france between 2008 and 2013, through an online anonymous survey. investigators, then, will identify variables associated with a lower quality of life in order to improve the support offered to the children.

investigators will use a known and official quality of life score: the pedsql®. this score has never been used in this population so investigators will first have to test its internal validity, so that investigators cannot use it in their global evaluation. the second stage will consist of identifying variables associated with a lower quality of life, as previously determined. investigators will send letters to each family through the adoption department of each area enrolled in our study, to ensure data. parents and children will be required to login to a safe, anonymous, controlled website in order to input their data. the data will be recorded on the internal server of nantes university hospital. this study has been accepted by both the computing and liberties commission (cnil) and nantes university hospital's ethics group in the field of health (gneds) comities.

Eligibility criteria:
inclusion criteria: * all international adopted children, who arrived in france between 2008 and 2013, living in four french districts (loire-atlantique, ille et vilaine, maine et loire and finistère) and accepting to fill the on-line questionnaire of the study exclusion criteria: * children born in france. * children or adoptive parents refusing to participate.

Keywords: adoption children quality of life
activation and recruitment of gil during hp infection

Conditions: Helicobacter Gastritis; Dyspepsia

Summary: helicobacter pylori is a major human pathogen that infects over half of the world population. infection initiates a series of changes in the gastric mucosa, beginning with gastritis and leading in some patients to peptic ulcer disease, mucosa-associated lymphomas, and gastric adenocarcinoma. it is believed that host factors, in particular, the t cell-mediated immune responses may play an important role in the pathogenesis of diseases induced by h. pylori infection. recent results revealed that there were higher ifn-γ secreting cells in gastric infiltrating t cells isolated from h. pylori infected patients than in uninfected patients, suggesting that the th1 response and degree of ifn-γ production is associated with disease severity. meanwhile, recent studies have shown that apoptosis of the gastric epithelium is increased during infection and this response is associated with an expansion of gastric t-helper type 1 (th1) cells. in this project, we are trying to further investigate role of host t cell mediated immune response in pathogenesis of helicobacter infection by characterization of the expression of chemokine receptors on gastric infiltrating lymphocytes. we are going to investigate the mechanisms involving in chemokine/chemokine receptor interaction in recruitment of gastric infiltrating lymphocytes and pathogenesis of gastric mucosa damage in helicobacter infection. this study will be helpful for understanding the mechanisms of activation and recruitment of gastric-infiltrating lymphocytes during gastric inflammation.

specific aim #1: characterization of the gastric infiltrating t cells from h. pylori gastritis patients a. patients h. pylori infected gastritis and asymptomatic patients are selected from national taiwan university hospital. the gastric biopsy specimen are taken from endoscopic biopsy in routine health check up or panendoscopic examination for the despeptic patients. hp negative gastritis patients will also be studied for negative control. b. immunohistochemical identification of t cells and expression of chemokine receptors. specific aim #2 . isolation and characterization of chemokines and chemokine receptors of the infiltrating lymphocytes in h. pylori-associated gastritis tissue a. isolation of gastric infiltrating lymphocyte b. identification of the expression of chemokine receptor in gastric infiltrating lymphocytes by flow cytometry c. detection of expression of chemokines in gastric tissues

Eligibility criteria:
inclusion criteria: * patients receiveing endoscopy examination due to dyspepsia exclusion criteria: * nil