Kornimate/medical-research-clean huggingface dataset:
the silent cortical infarcts in the cerebral amyloid angiopathy: is there a link with subarachnoid hemorrhage?

Conditions: CADASIL

Summary: the cerebral amyloid angiopathy (caa) is the leading cause of cortical hemorrhage after 65 years. the presence of cerebral infarction is also reported anatomically in the aac. mri studies of these infarcts are rare. they are described as punctate, cortical silent. frequency and pathophysiology is poorly understood. the investigators put the question of a link with hemorrhagic lesions of the aac.

main objective / secondary the objectives are: * to assess frequency of cortical infarcts in the cohort of patients recruited consecutively likely aafc ghpsj since 2007 * to assess the link between the presence of myocardial infarction and the clinical characteristics of patients and * to study the relationship between topography and the brain hemorrhage one hand, meningeal hemorrhage other. inclusion / exclusion any patient who was diagnosed as carrying a probable aac according to the boston criteria and has had a brain mri with the following sequences: classic or enhanced diffusion (or dti b2000), t1, t2 flair, t2eg (t2 \* or swan) methodology this is a non-interventional study single center, including aac patients hospitalized in the hospital group paris saint-joseph from may 2007 to may 2014. clinical patient characteristics were collected from their medical records. patients are aware of the potential use of their data for medical research by information contained in the handbook of the institution. brain mri will be proofread by a neurologist and a neuroradiologist to clarify: * the number and location of myocardial puncture * the number and location of macro-bleeding * the number of microbleeds (micro-bleeding) * the presence and location of subarachnoid hemorrhage and / or hemosiderosis * the location of the puncture infarction compared to macro-hemorrhage and subarachnoid hemorrhage / hemosiderosis: ipsilateral \ 5cm, another location the clinical data and mri will be entered on a file, with data anonymisation. statistical analysis will be done by a neurologist service. number of topics: * it is estimated that enrollment of patients with aac by the unv ghpsj is approximately 10 patients per year. the number of screened patients during the study period should be about 70. * taking into account those whose mri will be judged of insufficient quality (excluded), the number of patients included in the analysis should be around 50.

Eligibility criteria:
inclusion criteria: * any patient who was diagnosed as carrying a probable aac according to the boston criteria and has had a brain mri with the following sequences: classic or enhanced diffusion exclusion criteria: * no conditions

Keywords: cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy
a study of avastin (bevacizumab) and sequential chemotherapy in patients with primary her2 negative operable breast cancer.

Conditions: Breast Cancer

Summary: this single arm study will assess the efficacy and safety of a combination of avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with her2 negative operable breast cancer. patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle). they will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with avastin (15mg/kg on day 1 of each cycle). the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * female patients, \>=18 years of age; * primary her2-negative operable breast cancer; * tumor \>2cm in size; * ecog performance status 0-1. exclusion criteria: * previous treatment for breast cancer; * metastatic disease; * current or recent (within 10 days of first dose of avastin) use of aspirin (\>325mg/day) or full-dose anticoagulants for therapeutic purposes; * clinically significant cardiovascular disease.
new antibiotic to treat pediatric patients with infections due to a specific bacteria (vancomycin-resistant enterococcus)

Conditions: Bacterial Infections

Summary: this study will treat pediatric patients who have infections that are due to a specific bacteria (vancomycin-resistant enterococcus)


Eligibility criteria:
other specific inclusion/exclusion criteria may apply. in order to determine eligibility, further examination by the investigator is necessary. inclusion criteria: * hospitalized/chronic care pediatric patients (birth through 17 years) * known infections due to vancomycin-resistant enterococcus species, including diagnosis of hospital-acquired pneumonia, complicated skin and skin structure infections, catheter-related bacteremia, bacteremia of unidentified source, and other infections * requires a minimum of 3 days of iv medication * patients with mixed infections due to vre \& gram negative bacteria are allowed to enroll in the study. for most of the infections, 2 or more of additional symptoms are required. exclusion criteria: * potentially effective concomitant antibiotic * a high surgical cure rate * medical conditions which would preclude clinical evaluation or require treatment of longer duration than 28 days * 24 hours of antibiotic treatment within 48 hours of study entry (unless pre-approved) * having an infected device that could not be removed

Keywords: pharmacia drug resistance, microbial
impact of the covid-19 infectious epidemic on the management of oncology and onco-hematology patients and on the psychological consequences for patients and caregivers

Conditions: COVID-19; Cancer

Summary: this original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. it will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. we will also assess the psychological impact of the pandemic in patients but also in caregivers


Eligibility criteria:
inclusion criteria: for patients: * adult patient, treated for a solid or hematological tumor * will be treated ou actually treated by oncological treatment carried out at the hospital in day unit of the participating centers: treatment initiated before or during the pandemic with covid-19 for the caregivers: - medical oncologist, hematologist, intern, nurse and caregiver in day unit of hospital
dry needling treatment for biceps tendinopathy

Conditions: Bicep Tendinitis

Summary: biceps tendinopathy is a common cause in shoulder-pain symptoms. the major mechanism is overuse of the biceps muscles. the long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. we will conduct the randomized, single blind experiment to evaluate the immediate, short-term, and long-term effect of dn.

biceps tendinopathy is a common cause in shoulder-pain symptoms. the major mechanism is overuse of the biceps muscles. the long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. common symptoms are pain in the anterior shoulders and radiating pain in the biceps. pain can be further elicited with lifting, pulling and repetitive overhead activity. therefore, it can have a major impact on the patient's activity of daily life. the investigator performed dry needle (dn) treatments with acupuncture needles. stimulating the effected muscle , the investigator move the needle forward and backward several times. muscle twitch may occur by our procedure. the pain caused by myofascial trigger points can be decreased effective simultaneously. so far, there is no solid research or clinical trial to evaluate the efficacy of the treatment yet. the investigator will conduct the randomized, single blind experiment to evaluate the immediate, short-term, and long-term effect of dn. outcome measures include visual analog scale, shoulder pain and disability index, pressure pain threshold, pain-free grip test, muscle tone changes and ultrasonographic evaluation of biceps peritendinous effusion.

Eligibility criteria:
inclusion criteria: 1. subjects older than 20 years of age who can cooperate with the experimental volunteers. 2. suffering from biceps tendon lesions for more than one month, and subjective pain intensity (vas) greater than 5 points. 3. there is a local tender point in front of the shoulder, and the shoulder joint pronation test can induce pain. 4. under soft tissue ultrasound, the thickness of biceps peritendinous effusion (bpe) on the affected side of the biceps tendon is greater than 1 mm. exclusion criteria: 1. there are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women. 2. there has been a history of drug abuse (including excess alcohol) that affects pain assessors. 3. have received shoulder, neck or upper back surgery. 4. people with central or peripheral nerve disease. 5. cognitive impairment, unable to cooperate with the experimenter. 6. patients currently receiving other treatments for biceps tendinopathy

Keywords: dry needling myofascial trigger point muscle tone
clinical investigation of the clareon® intraocular lens (iol)

Conditions: Cataract

Summary: the objective of this study is to compare visual acuity and adverse event outcomes from the clareon intraocular lens (iol) to historical safety and performance endpoint (spe) rates.

upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a clareon iol. subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (visit 0), 1 operative visit (visit 00), and 5 postoperative visits (visits 1-5). visit day calculations for visits 1-5 were based off of the day of surgery (visit 00). primary endpoint data was collected at the final visit (month 12). some sites/subjects participated in a rotational stability sub-study. for the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). the non-study eye (fellow eye) was not implanted with the clareon iol.

Eligibility criteria:
key inclusion criteria: * planned routine cataract surgery in at least one eye; * calculated lens power within the available range; * willing and able to sign an informed consent statement; * clear intraocular media other than cataract. key exclusion criteria: * any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (bcdva) to a level worse than 0.30 logmar; * previous corneal surgery; * rubella or traumatic cataract; * ocular trauma, previous refractive surgery; * current or recent use of certain medications as specified in the protocol; * any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study.
the nasal airway in chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the study is based on the theory of a "unified airway" that considers the nose and paranasal sinuses together with lower airways as one integrated unit. the upper and lower respiratory tracts function as an interdependent physiologic mechanism, and stimuli that trigger changes in one portion of the airway, can provoke similar changes throughout the airway. this is well documented in asthmatic patients but documented poorly in patients suffering from chronic obstructive lung disease (copd). copd is associated with sinonasal symptoms and decreased quality of life. although nasal involvement has been found to directly affect the lower airway, sinonasal disease is under-diagnosed and under-treated in patients with copd. this study is embedded in a larger project where the goal is to gain knowledge supporting the theory of a "unified airway" in patients with copd. here sinonasal, pulmonary and generic health related quality of life will be studied in a group of patients with copd versus a control group. the severity of nasal airway obstruction will be linked to the the severity of pulmonary airway obstruction. assessment of pathological changes in the nose with nasal endoscopy, as well as performing a nasal cytological brushing for the identification of nasal inflammatory responses in the nose, will be conducted in both the control and study group.


Eligibility criteria:
inclusion criteria: * diagnosis of copd: all stages * healthy individuals for the control group exclusion criteria both groups: * asthma * systemic disease such as cystic fibrosis, kartagener syndrome, sarcoidosis * upper airway infection during the last 2 weeks * copd exacerbation during the last 6 weeks * previous surgery in the nose and paranasal sinuses * ongoing treatment for malignant disease * severe depression, alzheimers disease and parkinson's disease * pregnancy or nursing

Keywords: paranasal sinus diseases nasal obstruction
a study of motexafin gadolinium and temozolomide for the treatment of malignant gliomas

Conditions: Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma; Brain Neoplasm

Summary: the purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. secondly, the study will determine how many patients will respond to this treatment.


Eligibility criteria:
inclusion criteria: * at least 18 years old * histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. malignant glioma is defined as any of the following: glioblastoma multiforme (gbm); anaplastic astrocytoma (aa); anaplastic oligodendroglioma; anaplastic mixed glioma; glioma not otherwise specified (except low-grade glioma) * ecog performance status score of 0, 1, or 2 * each patient must sign a study-specific informed consent form exclusion criteria: laboratory values of: * absolute neutrophil count \< 2000/µl * platelet count \< 100,000/µl * ast or alt \> 2 x the upper limit of normal (uln) * alkaline phosphatase \> 5 x uln * bilirubin \> 2 x uln * creatinine \> 2.0 mg/µl and * plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period * women who are pregnant or lactating

Keywords: malignant glioma glioblastoma multiforme gbm anaplastic astrocytoma aa anaplastic oligodendroglioma anaplastic mixed glioma brain tumor brain neoplasm glioma
red-flags index validation in crohn's disease patients

Conditions: Crohn's Disease

Summary: observational prospective study to validate a new index for early diagnosis of crohn's disease (cd)

the study will be conducted in italian referral centers for crohn's disease and will involve general practitioners (gps) for red-flags index validation. the project is divided into two phases. 1. retrospective phase (4 weeks). all the general practitioners participating to the study will extrapolate from their patient's database, the total number of patients with a crohn's disease diagnosis performed in the past. the date of diagnosis will be indicated. no other information will be provided. these data will be then analyzed to obtain, for each gp, the total number of cd diagnosed in each semester. 2. retrospective phase (6 months). gps will administer the red-flags questionnaire to all patients that meet inclusion and exclusion criteria, after informed consent signature. all these patients will be then referred to the nearest referral center, to be evaluated by a gastroenterologist specialized in cd, to confirm or exclude a cd.

Eligibility criteria:
inclusion criteria: 1. at least one of the following symptoms, for at least 4 weeks (either continuous or intermittent) 1. diarrhea (\>3 bowel movements per day) 2. nocturnal diarrhea 3. weight loss (≥5% of usual body weight) 4. abdominal pain (chronic or intermittent) 5. perianal lesions or fistulae or perianal abscess (hemorrhoidal diseases excluded) 2. in the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. the subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. exclusion criteria: 1. known diagnosis of crohn's disease, ulcerative colitis, chronic diverticulosis or any other gastrointestinal disease 2. any clinical condition that, in the opinion of the investigator, can alter stud results 3. inability to understanding and complying with protocol requirements 4. informed consent not signed and dated by the subject

Keywords: early diagnosis
prevalence and risk indicators of peri-implant diseases in china

Conditions: Peri-Implantitis

Summary: the goal of this multicenter cross-sectional study is to investigate the prevalence of peri-implantitis in china. the main questions it aims to answer are: * what is the prevalence of peri-implantitis in china * what are the risk indicators of peri-implantitis in china participants will be invited to a free-of-charge clinical and radiographic examination of conventional dental implants present for over 5 years.


Eligibility criteria:
inclusion criteria: 1. patients having at least one rough surface titanium implant in function for more than 5 years 2. patients treated between january 1, 2013 and december 31, 2017 3. all the implants osseointegrated in the patients' mouth at the time of the examination (including those placed in external clinics) and having at least 5 years of loading, either proven by dental charts or confirmed by the patients, were evaluated exclusion criteria: 1. selected patients were invited to participate in the study by telephone calls on the numbers reported in their medical records, and if no response, the patient was not discarded until at least five attempts on different days have been made 2. periapical and/or panoramic radiographs unavailable 3. history of peri-implantitis and/or peri-implant mucositis treatment 4. refusal to participate in the study
safety of sports for patients with implantable cardioverter-defibrillators

Conditions: Heart Arrhythmias

Summary: the registry will obtain information to determine the safety of sports participation for patients with defibrillators (icds).

patients who are participating in sports who have defibrillators will be invited to participate in a prospective registry to determine the rate of adverse events occurring during sporting activities. patients will be followed for four years and adverse events quantified. yale is the coordinating center for this multicenter registry.

Eligibility criteria:
inclusion criteria: * individuals between the ages of 10 and 60 * has a defibrillator * plays a competitive/organized sport more vigorous than golf or bowling or participates in a dangerous sport exclusion criteria: * children under 10 years (as they engage in primarily recreational sports) * individuals over the age of 60 years (maintain a homogenous population) * inability to give informed consent

Keywords: icd sports
shr-a1811 versus investigator's chemotherapy in recurrent/metastatic breast cancer clinical trial

Conditions: Breast Cancer

Summary: the aim of this study was to evaluate whether the progression-free survival of shr-a1811 was superior to investigator-selected chemotherapy in patients with her2-low recurrent/metastatic breast cancer. to evaluate whether shr-a1811 is superior to investigator-selected chemotherapy in patients with her2-low recurrent/metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. low-her2 expression defined as ihc 2+/ish- or ihc 1+ (ish- or untested). 2. hr-positive breast cancer with at least one endocrine therapy and disease progression was judged by the investigator to no longer benefit from endocrine therapy. 3. has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting. 4. has documented radiologic progression (during or after most recent treatment). 5. has at least 1 protocol-defined measurable lesion. 6. has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions. 7. fertile women (wocbp) subjects agreed to use highly effective contraception and not to breastfeed from the time of study screening until 7 months after receiving the last study medication; a fertile woman must have a negative serum pregnancy test result within 7 days prior to the first treatment. exclusion criteria: 1. has known active central nervous system (cns) metastases. subjects with previously treated brain metastases may participate provided they are stable. 2. a history of human immunodeficiency virus (hiv) infection is known, or has an active autoimmune disease. 3. history of interstitial lung disease or pneumonia requiring oral or intravenous steroids. 4. has moderate or severe cardiovascular disease. 5. active hbv(hepatitis b) or hcv (hepatitis c virus)-infected subjects. 6. any other malignancies within 5 years except for those with negligible risk of metastasis or death.
performance evaluation of the micromedic bronj risk assessment in vitro diagnostic assay

Conditions: Bisphosphonate-related Osteonecrosis of the Jaw

Summary: to evaluate the performance of the micromedic bronj risk assessment in vitro assay (the "bronj assay") in identifying multiple myeloma (mm) and/or other cancer subjects at risk for developing bisphosphonate-related osteonecrosis of the jaw (bronj) following intravenous (iv) administration of bisphosphonates (bp).

the micromedic bronj assay is intended for the qualitative analysis of genetic changes which may be indicative of increased risk to develop bronj osteonecrosis of the jaw (onj) following iv administration of drugs of the bisphosphonate family.

Eligibility criteria:
inclusion criteria: inclusion criteria study group (all of the following): 1. subject is ≥18 years old 2. subject is or was a multiple myeloma and/or other cancer patient who is or has been iv treated with the bp zoledronic acid and/or pamidronate disodium; or; subject is or was a multiple myeloma and/or other cancer patient who is or has been iv treated with the bp zoledronic acid and/or pamidronate disodium and was also treated by oral bp such as sodium alendronate, and in the opinion of the pi, iv treatment was significant enough to be considered as the cause for bronj 3. subject has been diagnosed with bronj at stages 1 or 2 or 3 according to aaoms (american association of oral and maxillofacial surgeons) 4. subject has signed the informed consent or consent can be waived inclusion criteria control group (all of the following): 1. subject is ≥18 years old 2. subject is or was a multiple myeloma and/or other cancer patient who is, or has been iv treated with the bp zoledronic acid and/or pamidronate disodium for at least two (2) years (continuously or cumulatively) 3. subject has not developed any signs or symptoms of bronj 4. subject has signed the informed consent or consent can be waived exclusion criteria: 1. subject has been treated with irradiation to the jaws or head and neck at levels exceeding 35 gy 2. pregnant or lactating women 3. subject has been treated with either bevacizumab or sunitimib 4. subject has been treated with allogeneic hematopoietic stem cell transplantation (hsct)

Keywords: bronj