Kornimate/medical-research-clean huggingface dataset:
expression of different proliferation biomarkers in adreno-cortical tumors

Conditions: Adrenal Cortex Neoplasms; Adrenal Cortex Diseases

Summary: in adrenal tumors, the investigators will examine if there is any correlation between wiess criteria, prognosis of the tumor, and the different labeling index of the following proliferation biomarkers: mcm3, mcm2, ki-67, p53, neuropilin -1, metallothionein, semaphorin-3a.

one of the problems in managing adrenocortical tumors is the ability to distinguish between benign and malignant tumors, while needle biopsy is unable to distinguish between the two situations. therefore, when imaging tests demonstrate a suspected malignant adrenal tumor, surgical excision of the tumor is needed. usually, the histological wiess criteria are used in order to determine malignancy. however, there are cases when adrenal tumors were defined by wiess criteria as benign but metastasized later. moreover, there is no reliable test than can determine prognosis. ki-67 labeling index is a proliferation biomarker which is used to tell more about the malignant potential and prognosis of adrenal carcinoma. in various types of tumors, proliferation biomarkers are used in attempt to tell about prognosis. in this study, the investigators will examine whether some biomarkers can differentiate between adrenal carcinoma and adenoma and if the degree of expression of these markers is correlated with prognosis. the investigators will retrospectively collect 30 cases of adrenal carcinoma, 30 cases of adrenal adenoma and 10 cases of normal adrenals. all specimens are preserved with formalin. the investigators will re-review the wiess criteria and all samples will be analyzed for the index labeling of the following proliferation biomarkers: mcm3, mcm2, ki-67, p53, neuropilin -1, metallothionein, semaphorin-3a. the investigators will examine if there is any correlation between the labeling index of each biomarker, wiess criteria and prognosis of the tumor.

Eligibility criteria:
inclusion criteria: * adrenal carcinoma * adrenal adenoma * normal adrenal tissue exclusion criteria: * na
analgesia nociception index in orthognathic surgery

Conditions: Postoperative Pain

Summary: this study aims to determine whether goal-directed analgesia using ani(analgesia/nociception index) can improve the quality of postoperative recovery in patients undergoing maxillofacial surgery.


Eligibility criteria:
inclusion criteria: * adult patients 18 or older undergoing maxillary, mandibular, or bimaxillary surgery under general anesthesia. * adult patients who can provide written informed consent to participate in the study, understand the procedures of this study, and be able to complete patient-reported questionnaires adequately. * adult patients who have made an informed decision to participate in this study and have given written consent. exclusion criteria: * patients with asa physical status 4-5 * emergency surgery * patients with chronic pain and related pain medications * patients with hypersensitivity to general anesthesia drugs and pain medications * patients with arrhythmia * pregnant women * others deemed unsuitable by the investigator
acute preoperative stress and hypotension after spinal anesthesia. sas for "salivary amylase and stress "

Conditions: Planned Cesarean Section

Summary: spinal anesthesia is the technique of choice for planned cesarean section. it is associated with a high frequency of maternal hypotension. hyperactivity of the sympathetic system assessed with the lf/hf ratio (heart rate variability analysis) predicts the severity of maternal hypotension after spinal anesthesia. increased lf/hf ratio may be explained by maternal stress that can be measured with salivary amylase. the goal of this study is to assess the relationship between salivary amylase and severity of maternal hypotension after spinal anesthesia for planned cesarean section.

salivary amylase, heart rate variability, spielberger state-trait inventory are assessed on the morning of surgery, on the surgical ward, and repeated in the operating room, before performing spinal anesthesia. spinal anesthesia use hyperbaric bupivacaine (11 mg), sufentanil (5 µg) and morphine (100 µg). prophylactic treatment of hypotension uses a continuous infusion of ephedrine (0.6 mg/ml) and phenylephrine (10 µg/ml). rate of the continuous infusion is adapted to keep maternal systolic blood pressure between 95-105% of preinduction values. total dose of ephedrine and phenylephrine infused from spinal anesthesia to delivery of the newborn is recorded (about 20 minutes for the estimated time frame). association between stress markers and total dose of vasoactive drugs will be tested with the spearman's correlation coefficient. the study is observational. the subjects do receive a therapeutic intervention but the investigator does not assign patients to this intervention since this intervention is a routine care (spinal anesthesia for planned cesarian section) that would have been performed in the absence of the study.

Eligibility criteria:
pregnant women undergoing planned cesarean section under spinal anesthesia

Keywords: stress anxiety cesarean section spinal anesthesia hypotension
a long-term safety follow-up study for patients treat with wu-cart-007

Conditions: T-cell Acute Lymphoblastic Leukemia; T-cell Lymphoblastic Lymphoma

Summary: this study will provide long-term follow-up for patients who have received treatment with wu-cart-007 in a previous clinical trial. in this study, patients will be followed for up to 15 years after their last dose of wu-cart-007 for evaluation of delayed adverse events, presence of persisting wu-cart-007 vector sequences, and overall survival and progression-free survival.

this long-term follow-up (ltfu) study is designed to follow patients for up to 15 years after wu-cart-007 infusion to evaluate the persistence of the wu-cart-007 cell clones and to explore any unanticipated genetic consequences secondary to the introduction of genetically modified cells. long-term toxicity, subsequent anti-cancer therapy, and survival status will be monitored. patients will transition to this ltfu study when they meet the criteria for discontinuation from the main study or after completing 24 months of follow-up in the main study. patients will be contacted every 6 months for the first 5 years following wu-cart-007 administration and then yearly, for up to 10 years, for a total of 15 years of follow-up after prior wu-cart-007 treatment or until death, whichever occurs first. patients will be evaluated either at the treating site or by the patient's primary health care provider (hcp). patients will be required to allow key sponsor contacts to continue to access medical records so that information related to their health condition and initial treatment response may be obtained.

Eligibility criteria:
inclusion criteria: patients that received wu-cart-007 in the context of any investigational study will be eligible to participate in this long-term follow-up study. exclusion criteria: not applicable

Keywords: t-all t-lbl
biomime stent in all-comers pci patients registry

Conditions: Coronary Artery Disease

Summary: biomime stent is a novel sirolimus-eluting stent (ses) (meril life sciences pvt. ltd., gujarat, india) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. however no data regarding the efficacy and safety of this stent in an "all-comers" patient population treated with percutaneus coronary interventions (pci) have been published so far. in this registry the investigators aimed to collect clinical and angiographic information about an extensive "all-comers" employ of this novel stent.


Eligibility criteria:
inclusion criteria: * any coronary artery disease treated with percutaneous coronary intervention and a biomime stent exclusion criteria: * patients \<18 years old

Keywords: drug-eluting stents coronary artery disease sirolimus absorbable implants
a double-blind group comparative study to evaluate the long-term safety and effectiveness of two different doses of aerosol pentamidine in the prophylaxis of pneumocystis carinii pneumonia in aids patients with multiple episodes of pcp

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to evaluate and compare the safety, tolerability, and effectiveness of long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had multiple episodes of aids associated pneumocystis carinii pneumonia (pcp).


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * zidovudine (azt). patients must have: * aids. * recovered from their most recent episode of pneumocystis carinii pneumonia (pcp). patients must be at least 2 weeks status post therapy for acute pcp. * adequate pulmonary function (vital capacity = or \> 65 percent of predicted; forced expiratory volume, 1 s = or \> 55 percent of total fev; and corrected pulmonary diffusion capacity \> 50 percent of predicted). * patients must be free of acute medical problems. exclusion criteria co-existing condition: patients with the following are excluded: * aids-defining opportunistic infection prior to entry such as toxoplasmosis and cryptococcosis. * pulmonary kaposi's sarcoma. * asthma poorly controlled by medication. * receiving active therapy for tuberculosis. concurrent medication: excluded: * active therapy for tuberculosis. patients with the following are excluded: * requiring ongoing active therapy for an opportunistic infection at time of study entry. * aids-defining opportunistic infection prior to study entry such as toxoplasmosis and cryptococcosis. * pulmonary kaposi's sarcoma. * unwilling to sign informed consent. * asthma poorly controlled by medication. * unwilling to cooperate with study procedures. * receiving active therapy for tuberculosis. prior medication: excluded within 30 days of study entry: * antiretrovirals (other than zidovudine (azt)). * immunomodulating agents. * corticosteroids. prior treatment: excluded within 7 days of study entry: * transfusion. * patient cannot be transfusion dependent (requiring blood transfusion more than once per month). active substance abuse.

Keywords: aids-related opportunistic infections pneumonia, pneumocystis carinii pentamidine dose-response relationship, drug aerosols acquired immunodeficiency syndrome
low psoas index and cardiac assistance: no excess mortality at d28 post implantation

Conditions: Ventricular Assist Device

Summary: the frailty syndrome is important to consider in perioperative cardiac assistance. one of its components is the patient's sarcopenia. this can be assessed by measuring the size of the psoas muscle. for this purpose, one of the most studied measures seems to be the measurement of the psoas index. this is a contouring of the psoas muscle, performed on an axial section of a ct scan, at the level of the l4 vertebra, which is then matched to the body surface. however, there is no standardization of measurements and volume acquisitions, and different image processing is also described. a radiological evaluation of the psoas could overcome this difficulty and provide a rapid and available screening tool for sarcopenia.


Eligibility criteria:
inclusion criteria: * major subject ((≥18 years old) * subject who underwent surgery for placement of a ventricular assist device between 01/02/2014 and 30/06/2018 * subject who has not expressed opposition to the reuse of his or her data for research purposes exclusion criteria: * subject having expressed opposition to participate in the study * absence of ct scan available at the time of implantation or ct scans older than one year prior to surgery and those older than 72 hours postoperatively * no anthropometric data available * subject under legal protection * subject under guardianship or curatorship

Keywords: ventricular assist device vad sarcopenia psoas index cardiac assistance cardiac assistance surgery
effect of adiposity and associated local microbial factors on healing and progression of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: diabetic foot ulcers (dfus) and their associated complications like amputations are increasingly becoming a problem in low and middle income (lmi) countries. obesity (increased body fat/adiposity), which has been shown to complicate many diseases, is also increasing in lmi setting. it is however not certain whether increased adiposity, may make it difficult for dfus to heal. investigators aim to understand whether increased adiposity and accompanied local microbial factors have any negative impact on healing and progression of dfus.

a prospective cohort of 300 individuals with type 2 diabetes presenting with diabetic foot ulcers (dfus) at an outpatient clinic will be recruited. at baseline, participants will be stratified into normal and high adiposity groups as measured by bioelectrical impedance analysis (bia). both groups will receive dfu management according to locally appropriate standards of care and followed-up for 24 weeks or until complete wound healing, whichever occurs first. local microbial characteristics, presence or absence of infection and other clinical parameters will also be assessed, and compared between the two groups. enrolling 150 participants per group will have a minimum power of 80% to detect a 20% difference in cumulative incidence of complete ulcer healing (at the 5% level of statistical significance) between the normal and high adiposity groups.

Eligibility criteria:
inclusion criteria: * history of type 2 diabetes mellitus (t2dm) * presence of participant's signed informed consent * age 30 years and above at the time the participant is signing the consent * tanzanians of african origin (black tanzanians) * presence of diabetic foot ulcer (dfus) (new or recurrent) exclusion criteria: * known patients with congestive cardiac and/or renal failure. * any patients with absolute or relative contraindication for tissue biopsy (for incident cases) * patients with obvious signs of gangrene * dfu patients with non-healing ulcer of more than 52 weeks duration. * dfu patients with below normal body mass index bmi (bmi below 18).

Keywords: adiposity diabetic foot ulcer anti-microbial resistance
tornier shoulder outcomes study to examine safety and functional outcomes in shoulder arthroplasty and fracture patients

Conditions: Shoulder Arthroplasty and Fracture Repair

Summary: the tornier shoulder outcomes study is designed to collect safety and efficacy data on designated commercially available tornier shoulder repair products. in addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products.


Eligibility criteria:
inclusion criteria: * 18 years or older * willing and able to comply with the requirements of the study protocol * considered for treatment with one or more tornier shoulder arthroplasty or fracture devices included in this study exclusion criteria: * patients who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
evaluation of axillary lymph node metastasis status of breast cancer based on pathological images and virtual staining

Conditions: Virtual Staining; Lymph Node Metastasis; Breast Cancer; Digital Pathology

Summary: the goal of this observational study is to develop an artificial intelligence model to transform unstained lymph node tissue slice images directly into stained images. the main questions it aims to answer are: can the virtual staining model generate hematoxylin and eosin (h\&e) and immunohistochemistry (ihc) images suitable for clinical diagnosis from unstained paraffin-embedded lymph node slice images, including those from breast axillary lymph nodes and other tumor lymph nodes? can the virtual staining model generate h\&e and ihc images suitable for clinical diagnosis from unstained frozen sentinel lymph node slice images from breast cancer patients? researchers will retrospectively collect paraffin-embedded lymph node slices from tumor patients and prospectively collect frozen sentinel lymph node slices from breast cancer patients.


Eligibility criteria:
inclusion criteria: part 1: female patients aged 18-75 with breast cancer; undergoing surgical excision of breast cancer and sentinel lymph node biopsy/axillary lymph node dissection; lymph nodes with clear postoperative paraffin pathological results. part 2: patients aged 18-75 with one of the following cancers: thyroid, lung, esophagus, stomach, colorectal, prostate, bladder, or cervix; undergoing surgical resection of lymph nodes; lymph nodes with clear postoperative paraffin pathological results. part 3: female patients aged 18-75 with breast cancer; undergoing surgical excision of breast cancer and sentinel lymph node biopsy; sentinel lymph nodes with clear postoperative paraffin pathological results. exclusion criteria: part 1 / part 2: lymph node diagnosis is missing; absence of lymph node component in the slice. part 3: sentinel lymph node diagnosis is missing; absence of lymph node component in the frozen slice.
safety and pharmacokinetics (pk) of hokt3g1 (ala-ala) in type 1 diabetes mellitus (t1dm)

Conditions: Diabetes Mellitus, Insulin-Dependent

Summary: to assess the tolerability and safety of hokt3g1 (ala-ala) after a 12-day dosing regimen administered via intravenous infusion. to assess the pharmacokinetics of hokt3g1 (ala-ala).


Eligibility criteria:
to be eligible * participants will have type 1 diabetes, diagnosed within the previous 12 months and established by standard american diabetes association criteria. * all participants will have autoantibodies: either anti-gad65, anti-ica512, or if treated with insulin for less than 7 days, anti-insulin. * the age range will be between 8 and 30 years; and * a minimum weight of 34 kg.
a sbt-based protocol-directed program in difficult-to-wean patients

Conditions: Respiration, Artificial

Summary: weaning patients from a ventilator is one of the most challenging processes in an intensive care unit. the investigators aimed to determine whether spontaneous breathing trial (sbt)-based protocol-directed weaning combined with the high-flow nasal cannula (hfnc) could be superior to routine sbt-based weaning in reducing the duration of mechanical ventilation (mv) in difficult-to-wean patients.


Eligibility criteria:
inclusion criteria: * age ≥ 16 years old * mv for more than 48 hours * intubated or tracheostomized exclusion criteria: * pregnancy * irreversible respiratory failure caused by neurodegenerative disorders, such as alzheimer disease, motor neuron disease, or multiple system atrophy * pre-existing decision to limit life support * waiving of mv during treatment * terminal stage of severe illness

Keywords: protocol-directed weaning mechanical ventilation high-flow nasal cannula spontaneous breathing trial
benefits of tablet-based serious games to promote speech production in young children with hearing disabilities

Conditions: Deafness; Hearing Loss

Summary: learning to speak is a major challenge for children with hearing impairments. nowadays, special devices such as conventional hearing aids, bone-anchored hearing aids (baha) or cochlear implants (ci) allow successful rehabilitation of patients with hearing disabilities. to obtain maximum benefit from these technical aids, instrumented hearing impaired children require specific and intensive speech therapy to compensate for speech development delays. in addition, it is also of primary importance that during daily life (e.g., at home, at school) children are provided with sufficient and good quality auditory stimulation. the main goal of this project is to encourage speech production with an edutainment tool that can be used at home and that is adapted to the specific needs of young hearing impaired children. for this purpose, the investigators have recently designed an innovative educational solution: funspeech, a tablet-based set of video games that respond exclusively to sound and speech. the aim of this serious game is to encourage hearing impaired children to produce controlled sounds in terms of rhythm, intensity, and pitch. these are the main abilities required for controlled speech production. finally, this serious game aims to support the parents' key role in the speech learning process by offering an effective solution that is easy to use at home with young children.


Eligibility criteria:
inclusion criteria: * diagnosed with mild to profound hearing loss, * optimum instrumented hearing (hearing aids, baha or ci), * language development delay confirmed by a speech therapist, * enough sensorimotor, cognitive and communication skills to play with tablet-based games, * french mother tongue exclusion criteria: * additional impairments which affect language development or the use of funspeech (e.g. motor, orofacial, sensory, cognitive), * refusal of the participant's representative(s) to participate in the study, * refusal of the participant's representative(s) to participate in a modality of the study, * if the child/participant refuses to collaborate in two measures of language level.

Keywords: serious game speech development speech production cochlear implant hearing aid bone anchored hearing aid