Kornimate/medical-research-clean huggingface dataset:
a phase 1/2 study of personalized psma radiopharmaceutical therapy

Conditions: Cancer; Prostate Cancer; Metastatic Cancer; Metastatic Prostate Cancer

Summary: the goal of this clinical trial is to study a personalized regime of lutetium-177 (177lu) prostate-specific membrane antigen (psma) radiopharmaceutical therapy (rpt) in patients with progressive and/or symptomatic, inoperable psma-expressing cancers of prostatic or other origins. the main questions it aims to answer are: * to establish a dosimetry-based, personalized regime of 177lu-psma * to report on the efficacy of personalized 177lu-psma participants (stratified by risk factors of toxicity) will receive up to 6 cycles of a personalized activity of 177lu-psma based on renal dosimetry. in the phase 1, the prescribed absorbed dose to the kidney will be escalated, to determine the regime that will be administered in the phase 2. the best response within 12 months after the first cycle will be assessed. salvage treatment of 3 cycles may be offered to responders after re-progression.


Eligibility criteria:
inclusion criteria: * \>18 y.o. adults able to provide consent * inoperable or metastatic psma-expressing cancer, with significant psma expression defined as uptake in at least one lesion that is superior to that of the liver on psma positron-emission tomography (pet) within 3 months prior to enrolment * cancer progression documented within 3 months prior to enrolment as per the investigator's assessment, without initiation of another anti-cancer treatment since (excluding palliative radiation therapy to a minority of the tumor burden), unless that anti-cancer treatment was stopped prematurely because of intolerance * for participants with a cancer other than mcrpc, a recommendation from a multidisciplinary tumor board (mdt) in favor of psma rpt must be obtained exclusion criteria: * platelets \< 50 x 106/l * absolute neutrophil count (anc) \< 1.0 x 106/l * eastern cooperative oncology group (ecog) 4 or prognosis \< 3 months, for cancer-related or other serious medical conditions, as per investigator's assessment * known presence of central nervous system metastasis at risk of complication, which cannot be adequately stabilized (e.g. radiotherapy or corticoid prophylaxis), as per investigator's assessment * any condition that would limit the ability to comply with the study protocol, as per investigator's assessment * pregnancy or breastfeeding (e.g. for female participants with non-prostate cancer)

Keywords: prostate-specific membrane antigen 177lu-psma radiopharmaceutical therapy dosimetry personalized
may preoperative waist to height ratio predict postoperative weight loss in bariatric patients?

Conditions: Bariatric Surgery Candidate; Obesity, Morbid

Summary: bariatric surgery is an effective method for treatment of obesity. sleeve gastrectomy is one of surgical methods and became popular in recent years. weight loss rates after bariatric surgery differs among patients. the exact reason of this difference stays unclear. age, nationality, difference between body composition and type of surgery may be in concern. waist to height ratio has become popular recent years as an indicator of cardiomethabolic status. in this study, investigation of the effect of waist to height ratio differences of patients on weight loss following laparoscopic sleeve gastrectomy as a bariatric surgery.

waist to height raito is the major determinator of patients and will be noted in every patient who will fulfil the eligibility criteras defined below and undergo laparoscopic sleeve gastrectomy. demographic data, bmi, body lipid composition, lean body weight also will be noted. all patients will undergo standardized laparoscopic sleeve gastrectomy operation. patients will be follow up during first, third, sixth and one year periods. all parameters noted preoperatively will be measured and noted again. possible statistical difference will be calculated statistically and a cut off value will be seeked.

Eligibility criteria:
inclusion criteria: * 18-65 years old * bmi\>40 kg/m2 * sleeve gastrectomy operation planned patients exclusion criteria: * type 1 or 2 diabetes mellitus * osteoarticular pathology that may restrict postoperative regular physical activity. * apparent mental or psychological disorder that may affect postoperative recommendations * refusal of informed consent for this study
diabetic retinopathy and subclinical signs of disease transition

Conditions: Diabetic Retinopathy

Summary: the prevalence of diabetes mellitus (dm) is increasing worldwide. diabetic retinopathy is the most prevalent complication of dm and a leading cause of visual impairment. some factors are known to temporarily aggravate or improve diabetic retinopathy, but underlying pathophysiologic factors are still unknown. high-resolution imaging techniques of the retina and its supplying vascular networks now allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. in detail, the investigators image study patients with optical coherence tomography (oct) - technology, that provides morphological information of retinal structure and the supplying vessels in a non-invasive way. retinal layer thickness as well as capillary density will be quantified and followed in patients that are in a critical period of disease transition to better understand the process of diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 1 or 2 * age 18-90 exclusion criteria: * media opacities like cataract or vitreous hemorrhage * active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye * structural damage to the center of macula in the study eye * atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (faz) or organized hard exudate plaques * ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies * intraocular surgery (including cataract surgery, yag laser capsulotomy) in the study eye within 3 months preceding day 0, or history of corneal transplantation in the study eye * uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmhg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery * inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded

Keywords: imaging diabetes octa
mobile strategies for women's and children's health: optimizing adherence and efficacy of pmtct/art

Conditions: mHealth; PMTCT; Adherence, Medication; SMS; Maternal Health; HIV/AIDS

Summary: the investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional sms (ie: "push" messaging to participant) vs. bidirectional sms dialogue between participant and provider vs. control (no sms) among hiv-infected kenyan mothers in kenyan pmtct-art for outcomes of art adherence and retention in care.

the investigators will compare trial arms for impact on maternal retention, adherence, virologic failure and resistance and infant hiv or hiv-free survival. the investigators will determine correlates of maternal loss to follow-up and virologic failure and correlates of infant hiv in the overall study and stratified by trial arm. in the bidirectional sms arm, the investigators will determine the rate of sms interactivity, impact of critical time-points on messaging, and characteristics of high and low 'interactors'. the investigators will determine cost-effectiveness of unidirectional and bidirectional sms interventions. these data will contribute a potential scale-able strategy to improve pmtct-art as programs aspire to 'virtual elimination' of infant hiv.

Eligibility criteria:
inclusion criteria: * pregnant, hiv-infected, access to a mobile phone, remaining in study area for two years exclusion criteria: * enrolled in another research study
comparison between insulin pump treatment and multiple daily insulin injections in diabetic type 1 children

Conditions: Diabetes Mellitus, Type 1; Child

Summary: comparison between insulin pump treatment and multiple daily insulin injections in 38 children with type 1 diabetes4-16 years old. outcome metabolic control, quality of life, impact of disease and cost effectiveness. we hypothesised that insulin pump treatment would give a better metabolic control and quality of life.

the current standard of insulin treatment in type 1 diabetes is multiple daily insulin injection therapy (mdii). in the seventies, continuous subcutaneous insulin infusion (csii) was introduced. csii has been gaining popularity, perhaps because of technical advances resulting in improved patient comfort. in children five randomised studies(1-5) were completed to compare mdii and csii. no data were gained about quality of life and impact of disease. in our trial we focussed on quality of life next to metabolic control. the trial was an open-labelled,randomised trial. both efficacy and safety data were collected. the trial started with a 14 weeks run in phase, during all patients started mdii.in the following randomisation phase patients were randomised to continue mdii or to csii.this phase lasted 14 weeks.in the phase thereafter all patients used csii for 14 weeks. the trial was concluded by a 14 weeks allocated patient preference phase. patients were type 1 diabetic children 4-16 years old with poor metabolic control.hypothesis: better metabolic control in csii, better quality of life in csii.

Eligibility criteria:
inclusion criteria: * type 1 diabetes, * diagnosed by the presence of ia-2, * gad-65 or islet cell cytoplasmatic auto antibodies, * daily insulin adminstration or 1 year of longer, * random c-peptide \<200 pmol, * hba1c\>8.0% and/or a history of repeated symptomatic hypoglycaemias, * attending regular school exclusion criteria: * clinical manifest chronic complications, * pregnancy, * co-morbidity, * mental retardation, * psychiatric treatment or symptoms in child or parent, * insufficient dutch language capabilities and absence of telephone at home

Keywords: quality of life child diabetes mellitus type 1 continuous subcutaneous insulin infusion(csii) metabolic control
hypertension longitudinal data platform in tianjin

Conditions: Hypertension

Summary: hypertension is one of the leading causes of death globally, and ranks among the top four risk factors for mortality and dalys in china. however, large-scale population based longitudinal research data source for hypertension is lacking in china. thus, we aimed to establish the first and most extensive hypertension database in china using healthcare data from the tianjin city. this hypertension longitudinal data platformlinked electronic medical records (emr) system 35 stores healthcare data of 1.17 million hypertension patients, from 43 tertiary hospitals and 39 secondary hospitals, along with a public health follow-up management system. data on demographics, diagnosis, drug prescription, laboratory test, physical examination, and cost information were collected, the median follow-up time was 4.3 \[ interquartile range (iqr): 2.7-5.8\] years, and the median number of outpatient visits was 32 (iqr: 15-64) per patient. this database can address research needs including, drug utilization pattern analysis, policy implementation evaluation, digital medical device development, and other real world evidence studies. these researches would provide robust evidence to assist improving patient health outcomes and healthcare system decision-making.


Eligibility criteria:
inclusion criteria: * hypertension first diagnosed between january 1, 2015 and december 31, 2021 * aged 18 years or older exclusion criteria: * none

Keywords: longitudinal data platform electronic health records public health follow-up database
fibromyalgia acupuncture study

Conditions: Fibromyalgia

Summary: the acupuncture treatment in this study is particularly aimed at reducing the pain and other negative health events such as emotional trauma and disability associated with fibromyalgia, while improving the quality of life and promoting general health.

it is hypothesized that acupuncture treatment will be effective in reducing pain and improving lower body strength and overall functionality more than the sham acupuncture treatment in people with fibromyalgia (fm). the purpose of this study is to compare the efficacy of acupuncture with simulated acupuncture in patients with fm using a randomized controlled design. more specifically, the objectives of this study are to determine if acupuncture can (1) reduce pain, (2) improve lower body strength, and (3) improve overall functionality.

Eligibility criteria:
inclusion criteria: 1. participants must be 18 years or older and can be of either sex. 2. a confirmed diagnosis of fm (pain for more than three months) will be required to participate in the study. if they do not have a diagnosis the study clinician or research assistant will examine them and determine their eligibility. 3. all participants must be willing to provide a written informed consent prior to participation and should not have undergone acupuncture treatment in the past. exclusion criteria: 1. acupuncture treatment in the past five years. 2. unwilling to sign informed consent. 3. less than a score of 40 on the fibromyalgia impact questionnaire, 4. involvement in any litigation currently or in the past, 5. simultaneous infection with hiv/hepatitis b virus. 6. severe depression (beck depression score \>21), 7. history of substance abuse or dependence within the past year, excluding nicotine and caffeine. 8. serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical conditions (including unstable hypertension, hypo or hyperthyroidism, or psychological conditions that in the opinion of the investigators would compromise participation or be likely to lead to an adverse response, including injuries or hospitalization, during the course of the study. we will get the information from the health/activity questionnaire. 9. have any dsm-iv axis (major depression, addiction, anxiety) disorder which, in the judgment of the investigators, would interfere with compliance with the study protocol.

Keywords: fibromyalgia acupuncture pain
empowering veterans to communicate with healthcare providers

Conditions: Chronic Kidney Disease Stage 3

Summary: the goal of this va innovation seed project is to test the best approach for the delivery, feasibility, and usability of a patient-centered ckd-qps to facilitate better veteran understanding and engagement in their ckd-care in nephrology clinics at two geographically distinct va hospitals (chicago and dallas) through on-going user feedback in real time.

the goal of this va innovation seed project is to test the best approach for the delivery, feasibility, and usability of a patient-centered ckd-qps to facilitate better veteran understanding and engagement in their ckd-care in nephrology clinics at two geographically distinct va hospitals (chicago and dallas) through on-going user feedback in real time. specifically, the pilot goals are to: 1. test the process of delivering the ckd-qps into clinical workflow to optimize patient and provider use of the qps. we will rely on user (patient and provider) feedback about the feasibility of using the qps in a real world va environment (e.g., time required for visits using the qps, impact on clinical workflow, patient and providers' preferences for delivering the qps to veterans with ckd) to adjust delivery throughout the project period. 2. obtain continuous provider and patient feedback during the project period about qps feasibility, use, patient participation, and provider information-giving and encouragement of question-asking during outpatient clinic visits. 3. test how well iterative adjustments to delivery can help improve ckd-qps patient-reported outcome measures (e.g., satisfaction with provider). the multi-site study will take place at hines, va, and at va north texas health system, in dallas, tx. the intervention entails providing the ckd-question prompt sheet to patients to use during patient-nephrologist (or nurse practitioner or physician assistant) clinic visits. the ckd-qps is a 31-item list of questions about treatment options for ckd. the qps is designed to empower patients to ask questions by reminding them of questions that they may consider asking. data collection entails pre-post clinic visit surveys among ckd patients, a post-clinic interview with ckd patients and nephrologists (separately), and audio-recording the clinic visit. the knowledge gained from this study may improve other patients' satisfaction with care and communication with providers.

Eligibility criteria:
inclusion criteria: 1. adult (age 18+) english-speaking ckd patients stage 3 (egfr = 30-70 ml/min) who are scheduled for a clinic visit will be eligible for participation. 1. up to 60 will receive the qps and all data collection activities 2. up to 10 will be audio recorded only 2. nephrologists (or nurse practitioners or physician assistants) seeing ckd patients in routine clinic visits will be eligible for participation at hines, va. exclusion criteria: 1. ckd patients who are non-english speaking, blind, hard of hearing or deaf, unable to read, and/or who are cognitively impaired will not be eligible for participation.

Keywords: communication patient activation
transesophageal echocardiography (tee) and simulation : a preferred learning path

Conditions: Cardiac Disease

Summary: transesophageal echocardiography (tee) has gradually become the technique of choice for continuous functional examination of the heart despite the significant training required for its interpretation. it has proven to be the safest, fastest, and most reliable technique for diagnosing most intra- and postoperative hemodynamic problems. indeed, the transesophageal route is particularly well adapted to the situation of intubated patients, whether in the operating room, in the outpatient department or in intensive care. it offers images that are easier to obtain and of better quality than the transthoracic route; it can be performed without interfering with surgical activity or resuscitation. however, tee training is often poor during the des training in anesthesia and resuscitation, reserved for the few interns who will learn in a specific department where tee is used on a daily basis. thus, simulation is a logical and recognized means by which technical aspects, mechanisms involved in the understanding of a situation, reasoning and decision making can be analyzed and improved. the rfe sfar 2019 recommendations suggest the use of simulation for the learning of technical gestures in initial training in order to improve their acquisition. this study is therefore part of a technical and diagnostic improvement of a practice, which appears to be essential in several fields in anesthesia and intensive care, for a technique still not sufficiently acquired by many future practitioners.


Eligibility criteria:
inclusion criteria: * 1st or 2nd year desar interns who participated in the continuing education program * interns who agreed to participate in the professional practice evaluation study exclusion criteria : * interns who did not participate in the training * residents who do not agree to take the final test

Keywords: cardiac disease transesophageal echocardiography tee high definition simulator
patient self-administration of cortisol for cortisol-responding disorders in men and women over the age of 17

Conditions: Rheumatic Diseases

Summary: participants diagnosed as having fibromyalgia, osteoarthritis, and rheumatoid arthritis are to be brought to a minimum symptom state using a 3-week period during which they are to ingest modest doses of cortisol tablets with weekly lowered tapered doses. thereafter, the participants are to be taught to self-administer cortisol tablets on the as-needed basis to maintain the minimum symptom state. for this, they are to ingest a smaller-dosage, 5-day tapered regimen of cortisol tablets to quench each reoccurring exacerbation of the disease at its earliest stage. participants are limited to using less than the safe use limit of cortisol per month and are required to include a minimum of 10 days per month during which no cortisol was ingested.

objective: to define why and demonstrate how patient self-administration of cortisol with stress management eliminates chronic inflammation pain within fibromyalgia, osteoarthritis, and rheumatoid arthritis. methods: one thousand seventeen hundred and twenty (1,720) participants with chronic inflammation-containing diseases, were brought to a minimum symptom state using daily-administered cortisol tablets. thereafter, participants used 5-day, small-dosage cortisol regimens to quench subsequent disorder exacerbations to maintain the minimum symptom state. stressors as emotional traumas, infections, allergies, and injuries were minimized to reduce cortisol consumption and participant discomfort. this protocol is compliant with current united states food and drug administration recommendations for cortisol use applied to corticosteroid-responding disorders.

Eligibility criteria:
inclusion criteria: clinical diagnoses of fibromyalgia, osteoarthritis, or rheumatoid arthritis - exclusion criteria: congestive heart failure, stomach ulceration, unstable diabetes, and bipolar disorder -

Keywords: cortisol
sleep disturbances in the 2nd and 3rd trimester

Conditions: Sleep Initiation and Maintenance Disorders; Sleep; Sleep Apnea; Sleep Disorder; Sleep Disturbance; Sleep Apnea, Obstructive; Pregnancy Related; Pregnancy

Summary: sleep disorders and disturbances are mostly underestimated in clinical practice. moreover, this problem is generally neglected by the pregnant themselves. today, it is important to underline any problem that may have an affect to improve the quality of life during pregnancy. this study assesses the sleep quality, insomnia patterns and obstructive sleep apnea in the second and third trimesters of pregnancy.

women with uncomplicated pregnancy in the second or third trimester who apply for the routine check will be included. specific questionnaires will be used to measure the sleep disorders in addition to the socio-demographic measures: pittsburgh sleep quality index, insomnia severity index, berlin questionnaire and stop-bang questionnaire.

Eligibility criteria:
inclusion criteria: * 2nd or 3rd trimester of pregnancy exclusion criteria: * complicated pregnancy * multiple pregnancy * known sleep disorder