Kornimate/medical-research-clean huggingface dataset:
high resolution pet-mri before prostate cancer hifu

Conditions: Prostate Cancer

Summary: this prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution dwi and 18f-fluciclovine pet-mri) will detect prostate cancers not seen on standard multiparametric prostate mri in patients considered candidates for focal hifu.

this is a prospective trial to evaluate the effectiveness of 18f-fluciclovine pet-hrmri versus standard mpmri at identifying prostate cancer targets for hifu therapy. participants with clinically localized, unilateral high grade prostate cancer (gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) or at high risk for having unrecognized high grade prostate cancer (overall gleason score 6 with \> half of systematic biopsy cores positive and \> 50% of core involvement in at least one core), interested in hifu would receive both a standard mpmri and 18f-fluciclovine pet-hrmri. participants would then undergo a mapping biopsy using a standard sextant template plus mri/us-fusion targeted biopsy of any lesion suspicious lesion on mpmri or pet-hrmri.

Eligibility criteria:
inclusion criteria: * prostate biopsy consisting of ≥ 10 tissue cores sampled * psa \</=20 ng/ml * ct1-ct2c * either overall gleason score \>/= 7 with gleason grade 4 or 5 component localized to one lobe (i.e. right or left) or overall gleason score 6 with \>/= half of systematic biopsy cores positive and \>/= 50% of core involvement in at least one core * patient considering focal hifu therapy exclusion criteria: * previous local therapy for prostate cancer * inability to receive pet tracer * inability to receive mri * suggestion of extracapsular extension or seminal vesicle invasion on imaging * estimated creatinine clearance \<45 ml/min (cockcroft-gault equation) * any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.

Keywords: diagnostic imaging high-intensity focused ultrasound hifu 18f-fluciclovine high resolution diffusion-weighted imaging
a randomized, open-label, parallel-design pharmacokinetic and pharmacodynamic interaction study of tnm002 and adsorbed tetanus vaccine

Conditions: Tetanus

Summary: this study is designed as a randomized, open-label, parallel-design study to evaluate the effect of tnm002 simultaneously administered with adsorbed tetanus vaccine on the pk, pd and immunogenicity properties of tnm002 and on the pd properties of the adsorbed tetanus vaccine, and to evaluate the safety and tolerability of tnm002 administered alone and simultaneously administered with adsorbed tetanus vaccine.


Eligibility criteria:
inclusion criteria: 1. healthy male or female, 18-55 years of age (inclusive) at enrollment; 2. subjects who voluntarily provide signed written icf; 3. subjects who are able to well communicate with investigator as well as understand and adhere to the requirements of this study; exclusion criteria: 1. previous history of gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncologic, respiratory, immunological, cardiovascular and cerebrovascular diseases, which, as judged by the investigator, may affect the safety of the patient or may affect the pk, pd or immunogenicity assessment of this study; 2. exposure to tetanus vaccines or vaccines containing antigenic components of tetanus toxoid within the past 10 years; 3. exposure to tetanus immunoglobulin, receipt of blood transfusion or use of blood products within the past 6 months prior to screening; 4. history or family history of neurologic symptoms such as convulsions, epilepsy, encephalopathy and psychosis; 5. subjects with thrombopenia or other coagulation disorders, or bleeding constitution or bleeding time prolongation, which may cause contraindications to im injection; 6. subjects with any acute illness requiring systemic antibiotics or antiviral therapy within 7 days prior to screening. subjects with fever within 3 days prior to screening; 7. receipt of immunosuppressants or immunopotentiators, other than inhaled or topical immunosuppressants within 3 months prior to dosing; 8. allergy to the investigational product or its excipients, or have a history of allergy to vaccines or human immunoglobulin products or other therapeutic monoclonal antibodies (mabs); 9. history of surgery within 3 months prior to screening, or planned surgery during the study; 10. known or suspected history of drug abuse within 5 years prior to screening, or with positive urine drug abuse screening result; or a previous history of drug addiction; 11. participation in other clinical studies with the investigational drugs or devices within 3 months or within 5 times the half-life of the specific drugs/biological products prior to dosing, except for observational, non-interventional clinical studies; 12. use of any other drug, including over-the-counter medications and chinese herbal medicines within 14 days prior to dosing ; 13. exposure to other vaccines within 1 month prior to dosing, or plan to receive live vaccines within 3 months after dosing; 14. pregnant or lactating women; other protocol defined inclusion/exclusion criteria may apply.
periodontitis provokes retinal neurodegenerative effects of metabolic syndrome: a cross-sectional study

Conditions: Periodontitis; Metabolic Syndrome; Neurodegeneration; Oxidative Stress; Optic Coherence Tomography

Summary: this cross-sectional study aimed to investigate the retino-choroidal degenerative effects of periodontitis, metabolic syndrome (mets), and the combination of these diseases using optical coherence tomography (oct) measurements. methods: ninety-two patients selected according to inclusion criteria were divided into 4 groups: systemically and periodontally healthy (control), systemically healthy periodontitis (pd), periodontally healthy metabolic syndrome (mets), and periodontitis and metabolic syndrome combined (pd-mets). the systemic inflammatory-oxidative effects of periodontitis and mets were biochemically evaluated using serum tnf (tumor necrosis factor)-α level, il(interleukin)-1β/il-10 ratio, and oxidative stress index (osi: tos/tas). retinal (amt, peripapillary retinal nerve fiber layer thickness (prnflt), and ganglion cell and inner plexiform layers (gcl+t) and choroidal (sfct) morphometric measurements and vascular evaluations (foveal capillary density) were performed via oct angio with swept-source technology. to the best of our knowledge, although there are many clinical studies on the possible effects of mets on retino-choroidal layers, there is a limited amount of evidence on the effects of periodontitis which is from an animal study. moreover, there are no studies on the retinal degenerative effects of the combined presence of periodontitis and mets. in this context, the present study is unique and based on the hypothesis that the alone or combined presence of periodontitis and mets may provoke retino-choroidal degenerative changes through systemic inflammatory stress.


Eligibility criteria:
inclusion criteria: * individuals with stage iii/iv, grade c periodontitis, * patients with at least 20 teeth, * patients diagnosed with mets, * obese \[waist circumference (wc) 80 cm ≥ for women and 94 cm ≥ for men\], type 2 (diabetes mellitus) dm and hypertensive patients. exclusion criteria: * cancer, * any autoimmune disease, * osteoporosis, * active infectious disease (acute hepatitis, tuberculosis, aids), * vitreoretinal, optic nerve or choroidal vascular disease, * acute and chronic ocular diseases (such as cataract, glaucoma, macular degeneration, uveitis, behçet's, scleritis), * history of refractive or intraocular surgery, * immunosuppressive, oral contraceptive, bisphosphonate and antioxidant drug use, * pregnancylactation, * smokers.

Keywords: periodontitis metabolic syndrome neurodegeneration oxidative stress optic coherence tomography
acute metabolic effects of pre-meal consumption of whey in women at risk of gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: the main objective of our study is to investigate the metabolic effects of whey protein (whey protein isolate, wpi, (lacprodan® iso.water. from arla foods ingredients) compared to placebo when consumed by women in risk of gestational diabetes mellitus (gmd) 30 minutes prior to an oral glucose tolerance test (ogtt). we will also investigate any changes in substrate metabolism and energy expenditure using indirect calorimetry. differences in hunger and satiety parameters as well as rate of gastric emptying will also be assessed. furthermore, we will investigate the glucose response when the women consume the intervention at home in their own environment 30 minutes before breakfast in various doses (placebo, 10, 15, 20, 30 g whey). the women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided. the two study days in the laboratory will be repeated 3-9 months after pregnancy. the purpose of this is to be able to compare the metabolic response of pre-meal whey during pregnancy with the response in a not-pregnant state. the study days at home will not be repeated after pregnancy.


Eligibility criteria:
inclusion criteria: * referred to screening for gestational diabetes mellitus by week 24-30 or gdm * bmi 20-35 * normal blood pressure * age \> 18 years exclusion criteria: * special dietary regimes \> 1 month at time of inclusion e.g. ketogenic diet * daily intake of protein supplements * milk allergy or phenylketonuria * celiac disease * medication with effect on glucose metabolism e.g. steroid * do not speak or understand danish * gemelli * polycystic ovarian syndrome * pi finds the patient unfit (like mental illness, too nervous or other) * anemia (hemoglobin \<6 mmol/l) * severe chronic illness * depression * severe nausea/vomiting * non-breakfast eaters
personal protective equipment comfort and user attitude during covid-19

Conditions: Covid19; Student; Physiotherapy

Summary: there are studies in the literature that evaluate the attitude, behavior and comfort level of students who do internships in different disciplines (medicine, pharmacy) towards the use of protective equipment. however, no study evaluating physiotherapy and rehabilitation students was found. therefore, the present study aims to investigate the behaviors and attitudes regarding the use of personal protective equipment of physiotherapy and rehabilitation department students who are interning in the covid-19 pandemic.

a total of 250 participants, who are physiotherapy and rehabilitation intern students in turkey, will be included in the present study. data collection will be carried out using an online survey. the online survey link will be shared via social media accounts and via mail. the questionnaire created through google forms will be delivered to the participants via the link. the link will be active in the data collection process. before the participants start the questionnaire, they will be asked whether they were willing to participate. the socio-demographic characteristics (age, gender, weight, height) and health status (presence of chronic disease and drugs used) will be questioned. in addition, the information about the institution where the internship was held and the duration of the internship, internship hours, time spent at the internship will be collected. personal protective equipment comfort and user attitude evaluation form will be used to evaluate participant's thoughts, attitudes and behaviors towards the use of personal equipment also physical complaints, comfort level due to personal protective equipment.

Eligibility criteria:
inclusion criteria: * the participants included in this study will be aged over 18 years, men or women, an intern student actively during covid-19 pandemic and able to use computer and have an internet connection exclusion criteria: * participants excluded from the study if they not able to understand and read turkish as a language, do not use protective equipment with their own choice; do internship in a different discipline other than physiotherapy and rehabilitation.
a "pre-enrollment" protocol for hiv-infected adolescents

Conditions: HIV Infections

Summary: primary: to identify, characterize, and co-enroll hiv-infected adolescents into existing and future actg (or other nih-sponsored) hiv treatment protocols through the systematic and recurrent assessment of eligibility. to assess the ability of adolescents enrolled in actg 220 to adhere to actg (or other nih-sponsored) hiv treatment protocols; and to define factors that influence the adolescent's ability to enter or adhere to study protocols. secondary: to describe the nature, stage, and progression of hiv infection in adolescents. little is known about hiv-infected adolescents as a group and, as a result, small numbers of them are currently enrolled in actg drug studies. creative approaches are needed to encourage enrollment of hiv-infected adolescents whose socio-demographic profile has made access to nih-sponsored research unlikely.

little is known about hiv-infected adolescents as a group and, as a result, small numbers of them are currently enrolled in actg drug studies. creative approaches are needed to encourage enrollment of hiv-infected adolescents whose socio-demographic profile has made access to nih-sponsored research unlikely. at entry and at every subsequent visit, participants are systematically evaluated for eligibility and willingness to enter actg (or other nih-sponsored) hiv treatment protocols from a menu developed and updated by the pediatric adolescent working group of the actg. a survey of participant attitudes, behaviors, and beliefs is administered and updated semiannually. participants attend clinic visits every 3 months and are followed for a minimum of 6 months, until the end of the study. they receive periodic physical exams, std and gynecologic or genitourinary evaluations, hiv symptom assessment and related diagnoses, tb evaluation, and laboratory tests (hematology and immunology).

Eligibility criteria:
inclusion criteria participants must meet the following criteria: * hiv infection. * not currently enrolled in an actg treatment protocol. exclusion criteria co-existing condition: participants with the following condition are excluded: * no legal provision for consent to participate in clinical research can be determined.

Keywords: acquired immunodeficiency syndrome aids-related complex adolescent behavior
robotic versus laparoscopic approach for rectal cancer surgery

Conditions: Rectal Cancer

Summary: colorectal cancer is a common malignancy in viet nam. laparoscopic surgery becomes a standard treatment in many centers. today, robotic surgery is a new option for treating colorectal cancer with some advantages such as magnified 3d view, precise movements. answer on safety and feasibility of robotic surgery for colorectal cancer are not available in viet nam. therefore, the investigators conducted a study " robotic versus laparoscopic approach for rectal cancer surgery".

rectal cancer is a common surgical disease

Eligibility criteria:
inclusion criteria: * able to provide written informed consent * diagnosis of rectal cancer amenable to curative surgery by anterior resection, low anterior resection, ultra-low anterior resection, abdominal perineal resection, staged t1-t4a, n0-2, m0 exclusion criteria: * advanced cancer not amenable to curative surgery * patient did not agree to participate in research

Keywords: rectal cancer robotic surgery laparoscopic surgery
artificial intelligence analysis of fluorescence image to intraoperatively detect metastatic sentinel lymph node.

Conditions: Breast Cancer; Sentinel Lymph Node

Summary: the purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (sln) using indocyanine green (icg). moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of sln during the surgery, and evaluate the diagnosis consistency of the ai technique and pathological examinations for lymph node with and without metastasis.

assessment of the sentinel lymph node (sln) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. but identification of metastatic lns within the fibro-adipose tissue of the fossa axillaris specimen remains a challenge. recently, indocyanine green (icg) and methylene blue are commonly used in clinical practice. icg as a fluorescent dyes, has effectiveness in mapping slns during surgery. surgeons can follow the fluorescence display to detect sln, and simultaneously capture real-time fluorescent video images. several other groups has been demonstrated that the usage of icg fluorescent surgical navigation system to detect slns in breast cancer patients is technically feasible. but no study investigate the variability between fluorescent images of breast sentinel lymph node with and without metastasis in the existing paper. deep learning (dl) artificial intelligence (ai) algorithms in medical imaging are rapidly expanding. in this study, the investigators aim to develop and validate an easy-to-use artificial intelligence prediction model to intraoperatively identify the sentinel lymph node metastasis status. furthermore, to explore whether this independent and parallel intraoperative lymph node assessment workflow can provide rapid and accurate skull base on lymph node fluorescent images analysis, meanwhile detecting occult lymph node (micro-) metastasis, using optical imaging and artificial intelligence.

Eligibility criteria:
inclusion criteria: * patients aged 18-70 years female. * the preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer. * no clinical examination of suspicious axillary lymph node-positive. * preoperative clinical or radiologic evidence without distant metastases (m0). * the patient has good compliance with the planned protocol during the study and signed informed consent. exclusion criteria: * pregnancy, breastfeeding. * allergy to icg. * former operation or radiotherapy in the axilla or breast or thoracic wall in the same side of breast cancer. * psychiatric or cognitive impairment.
management of cardiovascular risk factors

Conditions: Cardiovascular Risk Factors; Cardiovascular Diseases

Summary: this practical experience should report a retrospective collection of data regarding cardiovascular risk factors of cardiovascular diseases. the goal is an evaluation of the development of the risk profile of cardiovascular patients with simultaneous treatment of hypertension and hyperlipidemia


Eligibility criteria:
inclusion criteria: * patients received a anti-hypertension treatment in addition to cholesterol lowering treatment during the observation period * patients received a cholesterol lowering treatment in addition to hypertension treatment during the observation period * patients received during the observation time new cholesterol lowering and hypertension treatment exclusion criteria: * patients received during the observation time only cholesterol lowering or only anti-hypertension treatment

Keywords: hypertension hyperlipidemia
development of motility and cognition in infants

Conditions: Neurodevelopmental Disorders; Developmental Delay; Development, Infant; Child Development; Cognitive Developmental Delay; Neurophysiologic Abnormality

Summary: pilke study uses wearables for assessing motor development in infants in order to define functional growth trajectories in the normal infants and infants at risk of neurological compromise. in addition, pilke studies correlation of early motor development to later neurocognitive development.

pilke study builds on the recent development of an infant wearable, maiju, a multisensor garment that can be used to quantify infants posture and movement patterns out-of-hospital. the study will recruit typically developing infants (control group) and infants with an identified or suspected risk of neurodevelopmental compromise, as well as infants undergoing orthopedic follow-up for hip issues. infants will be examined and treated according to clinical routine practise, while maiju and other novel measures are added to monitor aspects of neurodevelopment. recordings with maiju will be done every 6-8 weeks from about 5 months to 18 months of age, and the neuropsychological outcome is assessed using bayley scales at two years of age. the study is observational by design, and the trajectories of motor performance are compared to other clinically identified measures of development.

Eligibility criteria:
inclusion criteria: * age at enrollment 5-8mos * typically developing exclusion criteria: * all neurologically significant medical histories during pregnancy, at birth or postnatally * suspicion of developmental delay * suspicion or diagnosis of syndromes with neuromotor symptoms

Keywords: wearable medical wearable human activity recognition growth chart neurodevelopment
diagnostic accuracy to detect hemodynamically significant stenosis by non-invasive surecardio ct-ffr

Conditions: Coronary Artery Disease

Summary: the aim of this study was to determine the diagnostic accuracy of surecardio ct-ffr to detect functionally significant coronary stenosis.

ct acquision and invasive ffr measurement is performed for each patients. the diagnostic accuracy of coronary cta and surecardio ct-ffr is investigated using invasive ffr is used as the reference standard.

Eligibility criteria:
inclusion criteria: * suspected coronary artery disease * hemodynamically stable condition exclusion criteria: * hemodynamic instability * atrial fibrillation * morbid obesity (bmi≥40 kg/m2) * previous stent implantation * recent myocardial infarction (within 30 days) * age \<40 years * renal insufficiency (egfr \<60ml/min/1.73m2) * bronchospastic lung disease requiring long term steroid therapy