Kornimate/medical-research-clean huggingface dataset:
study evaluating mst-997 in advanced malignant solid tumors

Conditions: Neoplasms

Summary: the primary objective of this clinical research study is to evaluate the safety, tolerability, and maximum tolerated dose (mtd) of intravenous (iv) mst-997 formulated in intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid tumors.


Eligibility criteria:
inclusion criteria: * documented histological or cytological diagnosis confirming the presence of malignant solid tumor * tumor progression after conventional therapy for cancer or a malignant solid tumor for which no conventional therapy exists * subjects enrolled in the mtd confirmation cohort should have a documented histologic and/or cytologic diagnosis of metastatic breast cancer or non-small cell lung cancer (nsclc) and should not have received more than 2 prior chemotherapy regimens for metastatic disease (adjuvant and neoadjuvant chemotherapy will not be included in the maximum of 2 prior regimens described above) exclusion criteria: * subjects with symptomatic or clinically active central nervous system (cns) metastases. subjects who have had prior treatment with radiotherapy or surgical resection for cns metastases will be permitted if cns metastases have remained stable and have not required any treatment for at least 3 months prior to first dose of test article * history of any other primary malignancy with less than 5 years documentation of a disease-free state (subjects with a history of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ, which have been successfully treated, are not excluded) * recent major surgery (within 14 days before the first dose) or chemotherapy within 28 days before the first dose of mst-997 (42 days if the previous chemotherapy included nitrosoureas or mitomycin c)

Keywords: advanced malignant solid tumors breast cancer
dental care of patients living with hiv

Conditions: HIV Infections

Summary: this study is perform to identify oral diseases of people living with hiv (plwhiv) or co-infected with hbv or hcv.

in the purpose of identifying oral diseases of people living with hiv (plwhiv) or co-infected with hbv or hcv, we would recruit from 15 10 2021 to 15 04 2022 affiliated to social security scheme plwhiv adults followed-up in the infectious diseases department of clermont-ferrand university hospital who accept participate in order to propose dental individual clinical exams. anonymous socio-demograpic, medical and dental data will be reported in redcap. primary outcomes are the number and type of pathologies identified linked to hiv or not. statistical analysed will be performed with stata software. the population will be described by associated numbers and percentages for the categorical variables and by the mean ± standard deviation or median \[interquartile interval\] for the quantitative variables, with respect to their statistical distribution.

Eligibility criteria:
inclusion criteria: * adult patient infected with hiv or co-infected with hiv / hbv or hiv / hcv followed in the infectious diseases department of clermont-ferrand university hospital and affiliated to a social security scheme. exclusion criteria: * minor patient * adult patient unable to express his non-opposition to participating in the study or patient who refuses to participate in the study.

Keywords: hiv dental care
the effect of theory-based education on patient empowerment and self-efficacy in patients with type 2 diabetes

Conditions: Diabete Type 2

Summary: it is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. patient education is a patient empowerment process designed to enable patients to be responsible for their health. with this study, it is considered essential to educate diabetic patients according to the theory of planned behavior and to develop self-efficacy by contributing to patient empowerment in this way.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * 40 years and older * diagnosed with type 2 dm at least 1 year ago * treated at the hospital where the study will be conducted * using antidiabetic agents * no communication problem * contactable by phone exclusion criteria: * those who do not meet the inclusion criteria for the study * participants who did not give consent at any stage of the study and left

Keywords: diabetes theory of planned behavior patient empowerment self-efficacy
the success rate of cryotherapy application in primary molars with signs of irreversible pulpitis

Conditions: Pain, Procedural

Summary: the study is designed as a randomized controlled trial with two parallel groups. children aged 5-9 years with primary molars from suffered symptomatic signs of irreversible pulpitis will be randomly assigned into two groups. the first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block). for the second group, the mandibular second primary molars will be anesthetized using 4% articaine 1:100.000 epinephrine using inferior alveolar nerve block.


Eligibility criteria:
inclusion criteria: * healthy children are classified as i or ii according to asa * presence of at least one mandibular primary molar with symptomatic signs of irreversible pulpitis * presence of at least two-thirds of the root length in periapical radiograph exclusion criteria: * unrestorable crowns * children with systemic, severe behavior or emotional problems * presence of gingival redness, swellings, fistulous of sinus tract * radiographic evidence of internal root resorption, pulp stones or calcifications, and/or bone radiolucency
single dose study of alz-801 prototype tablets

Conditions: Alzheimer Disease

Summary: phase 1, single-center, open-label, non-randomized, sequential single dose 4-period study in 12 healthy subjects to assess the pharmacokinetics of alz-801, tramiprosate and the primary metabolite of tramiprosate, nrm5074, from prototype drug product formulations of alz-801, and to assess effect of food on the bioavailability of alz-801 and tramiprosate of the prototype tablet formulation.

this is a single-center, open-label, non-randomized, sequential, single-dose, 4-period study in 12 healthy adult subjects. subjects are to receive a single oral dose of alz-801 in each of the 4 study periods (regimens a, b, c and d) in a non-randomized, sequential manner, separated by a minimum washout period of 7 days. the washout period is expected to last approximately 14 days to permit interim decisions to take place and to allow for the selection of the formulation of the subsequent regimen. periods of interim analysis will take place following dosing with prototype formulations regimens a, b, and c, during which the pk and safety data are reviewed to determine the dose to be administered in the subsequent treatment period. interim decisions aim to identify a prototype alz-801 immediate release tablet formulation that provides a similar tramiprosate auc and cmax to that of historical values after administration of a 100 mg loose-filled tramiprosate capsule in the fasted state. optimization of the required tramiprosate exposure will be made by adjusting the dose of alz-801 in the prototype tablets using a formulation design space with a target dose range, per tablet, of 171 to 514 mg alz-801 (equivalent to 100 mg to 300 mg tramiprosate). dose selection will be made after a complete review of all data collected from the previous dose group. for dose selection to occur, data is required to be available from a minimum of 8 evaluable subjects with complete safety assessments up to 24 h post-dose, and required safety and pk data (aes, plasma concentrations of alz-801, tramiprosate and nrm5074, and tmax, cmax and auc estimates for alz-801 and tramiprosate).

Eligibility criteria:
inclusion criteria: * healthy males and females * females must be of non-childbearing potential * body mass index (bmi) of 18.0 to 35.0 kg/m2 exclusion criteria: * history of any drug or alcohol abuse in the past 2 years * subjects known to have a creatinine clearance of \<60 ml/min * positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) results * history of cardiovascular, renal, hepatic, neurological, psychiatric, chronic respiratory or gastrointestinal disease as judged by the investigator
examining the efficacy of tdcs in the attenuation of epileptic paroxysmal discharges and clinical seizures

Conditions: Ohtahara Syndrome

Summary: the current study examined the feasibility of high-definition tdcs (hd-tdcs) in reducing epileptiform activity in a 30-month-old child suffering from early onset epileptic encephalopathy. hd-tdcs was administered over 10 intervention days spanning two weeks including pre- and post-intervention video-electroencephalography (eeg) monitoring.


Eligibility criteria:
inclusion criteria: 1. initial diagnosis of ohtahara syndrome/west syndrome/ lennox-gastaut syndrome by a pediatric neurologist using video-eeg 2. ongoing synchronous hypsarrhythmia 3. modified hypsarrhythmia with a consistent focus of paroxysmal discharges 4. signed informed consent of parents/immediate legal guardian 5. age 10 to 36 months 6. infant should be in a steady state indicated by a baseline test of electrolytes and biochemistry blood test, heart rate, temperature, respiratory rate, and saturation. exclusion criteria: 1. metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. 2. history of adverse reaction to neurostimulation 3. significant ecg abnormality
perfusion imaging and ct -understanding relative efficacy

Conditions: Coronary Artery Disease

Summary: to determine the relative efficacy of cardiac computed tomography angiography (ccta) and single positron emission computed tomography (spect) in patients with an intermediate risk of cad.

this study is a prospective, multi-center, within-subject comparative study. one hundred fifty (150) subjects with cath procedures are needed in the study. approximately 300 subjects who meet all of the inclusion/exclusion criteria will be enrolled. the study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease, which are referred for mps for a definitive diagnosis of cad. each subject will undergo the following procedures: * a myocardial perfusion study (mps) procedure, as standard of care; * an iv contrast-enhanced cardiac ct (ccta) procedure; * a cath procedure when the mps and/or cardiac ct examination is deemed positive or equivocal and at the discretion of the referring physicians, as a standard-of-care procedure. when both the mps and ccta are normal, the subject is not required to undergo a cath procedure, but will enter into follow-up. the research staff at each site will perform follow-up for each subject at 12 months (± 15 days) and 24 months (± 15 days) and 36 months (± 15 days) after the completion of the cardiac ct procedure.

Eligibility criteria:
inclusion criteria: * patients with an intermediate probability risk for coronary artery disease. * subject has symptoms of suspected ischemic heart disease. * subject is at intermediate risk for coronary artery disease exclusion criteria: * the subject has undergone a prior ccta within 6 months prior to entering the study. * the subject has a documented history of cad by cath, myocardial infarction (mi), metal stent placement in any of the coronary vessels, or a previous coronary artery bypass graft (cabg) procedure * the subject has hemodynamic or active clinical instability: * acute chest pain (sudden onset); * cardiac shock; * unstable blood pressure (bp); * severe congestive heart failure or acute pulmonary edema.
interval between neoadjuvant therapy and surgery in the treatment of locally advanced rectal cancer (cronos)

Conditions: Rectal Cancer; Neoadjuvant Therapy

Summary: the investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment.

in the treatment of locally advanced rectal cancer, an optimal interval between neoadjuvant therapy and surgery might improve oncological outcomes. besides, those patients who achieve a good response might benefit from active surveillance, avoiding surgical comorbidities. this optimal interval is yet to be defined. this study will aim to better define the role of time interval between the end of neoadjuvant therapy (nat) and tme in spanish regions, together with analyzing the importance of restaging mri and define the basis for implementing a "watch and wait" protocol.

Eligibility criteria:
inclusion criteria: * adult patients suitable for elective surgical resection of biopsy-confirmed rectal adenocarcinoma (0-15 cm from the anal verge) determined by rectal cancer protocol magnetic resonance imaging. * patients treated with long-course neoadjuvant chemoradiotherapy (ncrt). * patients treated with short-course radiotherapy with delayed surgery. * clinical stage iia, iib, iiia, iiib, iiic (ct3/ct4, or cn1/cn2 with any ct, m0) determined by rectal cancer protocol magnetic resonance imaging exclusion criteria: * intolerance or contraindication to planned nat. * patients who have not finished nat for any reason. * patients with unknown ct or cm. * tumors previously treated with local excision or with distant metastatic disease.
longitudinal family/molecular genetic study to validate research domain criteria

Conditions: Mental Disorders; Psychological Disorders; Psychiatric, Diagnosis; Mental Disorders Diagnosed in Childhood

Summary: the purpose of this research is to study new ways of classifying mental disorders in children based on observable behavior and genetics to ultimately diagnose these disorders better.

the nimh research domain criteria (rdoc) initiative seeks to further a long-range goal of contributing to diagnostic systems as informed by research on genetics, neuroscience, and behavior. the rdoc approach is based on identifying the most elemental units of analysis relevant to psychiatric disorders (such as genes and molecules) and using this matrix as a framework for investigation. in this case-control family study, the investigators will be using self-report questionnaires and computer-based tests to develop diagnostic methods for neuropsychiatric disorders in children, their siblings, and their parents. they will do this by recruiting "normal" and "affected" children, their siblings, and their parents. they will look at the subject, sibling, and parents to determine if psychiatric disorders are inherited. "affected" children, ages 6-12, are those who have been diagnosed with a psychiatric disorder. participants will undergo a battery of questionnaires/evaluations and a blood draw. the investigators will determine if the questionnaires and tests that reflect the constructs (such as reward prediction and willingness to work) predict psychopathology and impairment. the blood draw will be genotyped to determine if the measured constructs are associated with neuropsychiatric candidate genes, cross-disorder candidate gens and a cross-disorder polygenic score.

Eligibility criteria:
inclusion criteria: * male or female, ages 6-12. * biological child of parent(s) participating in testing. exclusion criteria: * taking psychotropic medications. * free of uncontrolled medical problems. * major sensorimotor disability (e.g., deafness, blindness). * diagnosed neurological condition. * inadequate command of the english language. * history of head injury with loss of consciousness lasting longer than 10 minutes. * iq estimated at below 80.

Keywords: children mental health family genetic study
mr-target biopsy vs. trus-biopsy in men with suspicious prostate cancer

Conditions: Prostate Cancer

Summary: this paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of mri-targeted biopsy compared to standard 12-core trus biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. the investigators hypothesize that additional mri-targeted biopsy will detect more clinically significant cancers than standard trus biopsy. main objective: to compare mr-target vs. standard 12-cores trus-biopsy for the diagnosis of clinically significant prostate cancer.

before prostate biopsy, all patients be preceded by mpmri. the mpmri is read by an experienced radiologist according to the pi-rads version 2 scoring system. pi-rads scoring system is used to assign a degree of doubt prostate cancer. depending on the pi-rads score, mr targeted biopsy is determined. 1. mr-targeted biopsy using artemis device fusion of mri and ultrasound images would be performed. mr targeted biopsy would be performed by radiologist. 2. next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. this portion will be performed without information of the mri report.

Eligibility criteria:
inclusion criteria: * 1. men undergoing a first-time prostate biopsy to rule out cancer * 2. serum psa ≥3ng/ml, ≤20ng/ml * 3. age≥50 years, ≤80 years * 4. clinical stage ≤t2c * 5. patients must be able to provide written informed consent. exclusion criteria: * 1. patients has any prior needle biopsy of the prostate * 2. patients has a prior history of prostate cancer * 3. patients has a prior history of pelvic radiation therapy or androgen deprivation therapy * 4. patients has a prior history of bph operation * 5. patient with uncorrectable coagulopathies * 6. unable to tolerate a trus guided biopsy. * 7. patients had 5-alpha reductase inhibitor in the past six months. * 8. the patient has had a urinary tract infection or acute prostatitis in the last three months. * 9. any contraindication to mri (severe claustrophobia, pacemaker, mri-incompatible prosthesis, egfr ≤50mls/min)

Keywords: prostate cancer mr-target biopsy artemis
how our immune system can help fight cancer

Conditions: Ovarian Cancer

Summary: there is growing evidence that our immune system can help fight cancer. this has stimulated interest in the development and application of tumor vaccines for several human solid tumors, including epithelial ovarian cancer (eoc). a major obstacle to the development of these vaccines is that there are specialty cells called regulatory t cells that prevent the immune system from attacking all of our organs. these regulatory t cells also prevent our immune system for attacking cancer cells. indoleamine 2,3-dioxygenase (ido), an enzyme that degrades an essential amino acid tryptophan that is necessary for t cells to multiply, however regulatory t cells are less susceptible to low levels of tryptophan, and can still multiply. this allows cancer growth and progression. this may be explained by genetic polymorphisms (changes) in the ido gene, which may alter its function. five of these changes in the ido gene have been described. in this research project, we are asking if you would donate a small piece of your tumor and ascites to see if we can examine your ido gene in the tumor cells and see if any of these gene changes are present. we hope that this will help us understand how the immune system works in eoc. we hypothesize that genetic polymorphisms within the ido gene alter its enzymatic activity and affect the outcome of ovarian cancer patients. these findings have the potential to translate into a method for predicting successful immunotherapy.


Eligibility criteria:
inclusion criteria: * females aged 20-90 who are having surgery to confirm epithelial ovarian cancer. exclusion criteria: * patients who have a diagnosis of non-epithelial histology.

Keywords: ovarian
thoracic combined spinal epidural anesthesia for breast surgery

Conditions: Pain; Breast Diseases

Summary: the aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery.

previous studies of the regional anesthetic techniques such as erector spinae plane block and pectoralis nerve blocks (pecs blocks) additional to general anesthesia have described their use for postoperative analgesia in breast surgery. it has been also reported that these blocks can be used to provide surgical anesthesia in breast surgery . segmental thoracic epidural anesthesia can be used as an alternative anesthetic technique in patients with severe chronic obstructive pulmonary disease and asthma undergoing breast surgery. it has been also reported that thoracic spinal anesthesia was effective and successful in patients undergoing laparoscopic surgery. in this study, efficacy of high thoracic spinal epidural anesthesia in patients undergoing breast surgery will be evaluated.

Eligibility criteria:
inclusion criteria: * patients who will be to undergo elective surgery for breast surgery * american society of anesthesiologists (asa) physical status classification groups i or ii exclusion criteria: * body mass index\>35 kg/m2, * presence of any condition complicating and contraindicating spinal epidural anesthesia.
lenalidomide and dexamethasone for rosai-dorfman disease

Conditions: Rosai-Dorfman Disease

Summary: rosai-dorfman disease (rdd) is a rare, heterogeneous histiocytic disorder. because of the rarity of rdd and a lack of prospective randomized trials, the treatment strategy for rdd is mostly based on retrospective study. steroid was suggested as frontline treatment as rdd with only lymph nodes involvement. studies showed thalidomide or lenalidomide showed some effect in recurrent/refractory skin rdd. the investigators want to analyze the efficacy and toxicity of lenalidomide combined with dexamethasone regimens in the treatment of rdd among adult patients at our hospital.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of rdd * age ≥18 years * eastern cooperative oncology group (ecog) performance status 0-2. * patients must have adequate renal, liver, and bone marrow function as defined by the following criteria: absolute neutrophil count ≥1500 cells per mm3 platelet count ≥100000 cells per mm3 creatinine clearance \[according to cockcroft formula\] ≥60 ml/min. aspartate aminotransferase and alanine aminotransferase ≤2·5×upper limit of normal \[uln\], and total bilirubin ≤2·5×uln; or ≤10×uln in the case of known liver involvement by rdd. * no active or untreated infection. * no cardiac abnormalities. * subject provide written informed consent. * a female is eligible to enter and participate in this study if she is of: non-childbearing potential including ω any female who has had a surgical procedure rendering her incapable of becoming pregnant. ω subjects have experienced total cessation of menses for more than 1 year and be greater than 45 years in age. ⎫ childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, and agrees to use adequate contraception. • male subjects must use an effective barrier method of contraception during the study and for 90 days following the last course of ma if sexually active with a childbearing potential exclusion criteria: * patients had concurrent malignancies. * history of myocardial infarction, or unstable angina, or new york heart association (nyha) grade iii-iv within 6 months prior to day 1. * women who were pregnant or of childbearing potential. * known hiv seropositive, active hepatitis c infection, and/or hepatitis b (defined as hcv rna≥1000 copies or hbv dna ≥1000 copies at screening). * major surgical procedure within 28 days prior to the first dose of study treatment. * presence of uncontrolled infection. * evidence of active bleeding or bleeding diathesis. * any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.

Keywords: rosai-dorfman disease lenalidomide dexamethasone