Kornimate/medical-research-clean huggingface dataset:
type 2 diabetes mellitus with obesity and dyslipidemia treated by chinese herbal medicine

Conditions: Type 2 Diabetes Mellitus in Obese; Dyslipidemia Associated With Type II Diabetes Mellitus

Summary: this study is a retrospective review of participants who visited department of endocrinology, guang'anmen hospital and accepted traditional chinese medicine formula for at least sis months, from january 2015 to december 2020. all the participants should be diagnosed as type 2 diabetes mellitus, obesity and dyslipidemia. therapeutic effect of traditional chinese medicine will be evaluated based on the changes of blood glucose, body mass index, blood lipids, and blood pressure.

the diagnostic criteria for type 2 diabetes mellitus and obesity are based on the guideline for the prevention and treatment of type 2 diabetes mellitus in china (2020 edition). the diagnostic criteria of dyslipidaemia are based on the chinese guidelines on prevention and treatment of dyslipidaemia in adults (2016, revision edition).

Eligibility criteria:
inclusion criteria: 1. meet at least three of the requirements below; 1) fasting plasma glucose \> 6.1 mmol/l or 2-hour postprandial blood glucose \> 7.8 mmol/l or diagnosed as type 2 diabetes mellitus; 2) body mass index \> 25 kg / m2; 3) total cholesterol \> 5.2 mmol / l; or triglyceride \> 1.70 mmol / l; or low-density lipoprotein \> 3.12 mmol / l; or high-density lipoprotein \ 130 mmhg or diastolic blood pressure \> 85 mmhg or diagnosed as hypertension; 2. received 6 months of continuous chinese herbal medicine treatment; 3. during the period of receiving chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before. 4. during the period of receiving chinese herbal medicine, diet and exercise continued according to the original routine, and the tests would be reviewed in the same institution. 5. aged 18 to 80 years at the time of their consent; 6. signed informed consent. exclusion criteria: * patients who had serious heart, lung, liver, kidney and brain diseases; serious infectious or hemorrhagic diseases; serious nervous system diseases, mental instability; or could not cooperate with treatment were excluded.

Keywords: type 2 diabetes mellitus dyslipidemias obesity chinese herbal medicine retrospective review
efficacy study of free flap monitoring using capillary lactate and glucose measurements

Conditions: Postoperative Complications

Summary: evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments diagnosis in free tissue transfers is realized. these measures are done after surgical reconstructions with free tissue flap, simultaneously with clinical examination. these biological data aren't available to make clinical diagnosis of complication; only clinical examination is allowed in this way. a posteriori, clinical and biological parameters will be compared in order to determine if capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps monitoring.

free tissue flap reconstruction has become a reliable technique. nevertheless, pedicle thrombosis is dreaded, and the earlier the diagnosis of such complications is made, the higher the surgical salvage rate is. clinical monitoring remains the most useful and used monitoring method, but makes late and unreliable diagnosis. numerous studies are searching for ideal monitoring technics with regard to free flaps. nowadays, the most efficient ones often deal with expensive and invasive technics. in this study, capillary lactataemia and glycaemia measurements are evaluated for pedicle impairments diagnosis. measurements of these 2 biological parameters seem to be a powerful screening test of pedicle impairments in microdialysis. but these parameters are measured in this case in interstitial tissues. capillary measurements will probably provide different results, and needs to be evaluated. for that purpose, surgical reconstructions with free tissue flap will be clinically monitored during five days, every hours for the first 24 hours, and every 4 hours for the next 4 days. simultaneously, blind measurements of capillary lactataemia and glycaemia will be performed. biological and clinical data will be systematically written in the corresponding table of the individual register together with the time the examination is done. in this register, all complications and evolutions of the flaps will be recorded. a posteriori, parallel between clinical and biological events will be studied. this multicenter prospective study will show first if capillary measurements of glucose and lactate permit to screen pedicle complications of free flaps. in case of efficacy of this technique, thresholds of glucose and lactate permitting such diagnoses will be calculated in order to define a sensitive screening test. moreover, temporal differences between clinical and biological diagnoses of pedicle impairments will be studied.

Eligibility criteria:
inclusion criteria: * informed patient * signed informed consent * free tissue flap reconstruction * accessible flap for measurements exclusion criteria: * pregnancy * patient under 18 * unaccessible flap

Keywords: free tissue flaps lactic acid glucose thrombosis diagnostic test pedicle postoperative complications diagnosis
self-management of post covid-19 syndrome using wearable biometric technology

Conditions: COVID-19

Summary: the main objective of this pilot study is to evaluate the impact of a self-management intervention using wearable biometric technology on post-covid-19 syndrome. in addition, this pilot-study will provide information regarding validity, feasibility, patient compliance and satisfaction, valuable for the design of a future large-scale study.

this pilot-study uses a one-group before-after design. subjects: a convenience sample of 20 adults 18 years and older in the winnipeg health region with a post-covid-19 infection (≥ 3 months since acute infection) complaining of mild to severe persistent respiratory symptoms. intervention: using the participants' initial assessment, personal characteristics, main complaints/needs and goals, the therapist will adjust the exercise plan and personalize the recommendations (e.g. maximum heart rate) as well as instruct the patients about safety precautions (how to pace themselves, when to seek professional or emergency care). participants will be encouraged to wear the smart shirt as much as they want during the 6 weeks (29), but at a minimum of 1-hour a day (m-f) including while performing the recommended exercises (30-45 min/3 times a week). they should self-monitor their biometric values trying to reach/stay within the target values while wearing the shirt using hexoskin app installed on an ipad provided by the research team or on the participants' personal device if preferred. patients will also complete an online survey reporting symptoms intensity and activities completed, 3 times a week (over 6 weeks). participants would be able to contact the research assistant overseeing the intervention at any time of the study if they have questions or concerns (text message or email). otherwise, they will receive a follow-up phone call every week or if a significant change in their biometrical data is identified.

Eligibility criteria:
inclusion criteria: * post-covid-19 ≥ 3 months after infection. * mild to severe persistent respiratory symptoms * access to a home internet exclusion criteria: * history of neurological disease or mental illness * inability to ambulate independently without supervision * inability to complete basic tasks on a smart phone or tablet

Keywords: long covid-19 persistent symptoms self-management
68ga-nota-bbn-rgd pet/ct in prostate cancer patients

Conditions: Prostate Cancer

Summary: this is an open-label positron emission tomography/computed tomography (pet/ct) study to investigate the diagnostic performance and evaluation efficacy of 68ga-nota-bbn-rgd in prostate cancer patients. a single dose of 111-148 mega-becquerel (mbq) 68ga-nota-bbn-rgd will be injected intravenously. visual and semiquantitative method will be used to assess the pet/ct images.

both grpr and integrin αvβ3 are overexpressed in neoplastic cells of human prostate cancer. to target both receptors, a heterodimeric peptide bbn-rgd was synthesized from bombesin(7-14) and c(rgdyk) through a glutamate linker and then labeled with 68ga. an open-label whole-body pet/ ct study was designed to investigate the safety and dosimetry of 68ga-nota-bbn-rgd and diagnostic performance of 68ga-nota-bbn-rgd pet/ct in patients with primary and/or metastasis prostate cancer.

Eligibility criteria:
inclusion criteria: * must be able to provide a written informed consent, needle biopsy diagnosed as prostate cancer, have undergone whole body bone scan, able to provide basic information and sign the written informed consent. exclusion criteria: * the exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.

Keywords: bbn-rgd pet integrin αvβ3 grpr
pudendal block versus penian block for circumcision in children

Conditions: Regional Anesthesia; Postoperative Pain; Circumcision

Summary: the authors study the efficacy of the pudendal versus penile block for the relief of postoperative pain in children receiving ambulatory circumcision. in this prospective, double-blind, randomized, parallel-arm trial, 60 children recruited during the anesthesia consultation will be allocated a general anesthesia with a pudendal block (pud group) or a penile block (pen group). each block will be made with equal parts lidocaine 1% and ropivacaine 0.75% (0.3 ml/kg).


Eligibility criteria:
inclusion criteria: * circumcision in day surgery hospital exclusion criteria: * allergy to amino-amide local anesthetics * parental consent not received * infection at injection site
functionality of the pulse oximeter and accelerometer portions of a novel wearable device

Conditions: Hypoxic Events

Summary: the purpose of this study is to asses the function of an oxygen sensor and the movement sensor in a novel device prototype.

after informing the patient about the study and the potential risk. the patient is asked to wear a prototype of a novel device to sense oxygen levels and movement for the duration of the visit. the day of the enrolment is when the visit will be completed. the patient is required to complete an overnight sleep test (no more than 15 hrs) with the prototype device worn on their index finger and wrist.

Eligibility criteria:
inclusion criteria: * males and females * 21 years of age or older * suspected to suffer from hypoxic events * able to provide informed consent exclusion criteria: * pregnant
a uk multicentre, health-related quality of life study for children and adolescents with xlh

Conditions: X-Linked Hypophosphataemia

Summary: this study aims to provide health-related quality of life (hrqol) data from children and adolescents with growing skeletons in the united kingdom (uk), including those treated with burosumab or alternative xlh treatment, as part of an updated submission to the smc in early 2023. this study will utilise data from a subset of uk sites already within the xlh registry (including participating scottish sites) and collect additional hrqol data within these sites (that are otherwise not included in the wider xlh registry protocol). the hrqol data will enable the calculation of hrqol to derive the hrqol utility estimates in children and adolescents with growing skeletons for the rss health states, hence addressing an area of uncertainty.

this is a multicentre, non-interventional hrqol study of children and adolescents with growing skeletons using routinely collected xlh registry data and prospectively collected hrqol data. this study will aim to enrol approximately 50 patients from approximately 5 uk centres (currently participating in the xlh registry) over a 6-month period. each patient will be followed for up to 12 months after enrolment. as stipulated, the data collection should not require additional patient visits or data collection within the health service. three types of data will be used in this study: 1. routinely collected data from the xlh registry on patient demographics and clinical data, as well as pedsql hrqol data. 2. hrqol data prospectively collected at enrolment, 6-month and 12-month follow-up by the patient and/or their parent / legal guardian. 3. rss scores within the xlh registry will be used where available, or rss will be centrally calculated retrospectively from radiographs of the affected wrist and/or knee. all rss calculations will be centrally reviewed.

Eligibility criteria:
inclusion criteria: 1. aged ≥4 years and \<18 years. 2. enrolled in the xlh registry via one of the participating uk centres. 3. have at least one of the following: 1. rss calculated at enrolment during a routine clinic visit. or 2. historical radiographs of the affected wrist and/or knee available in the medical chart within the 6 months prior to enrolment, to allow rss to be centrally calculated retrospectively. 4. receiving any xlh treatment (burosumab, oral phosphate and active vitamin d, or other xlh treatment) within 30 days prior to informed consent for this study exclusion criteria: 1. does not have the cognitive capacity to provide informed consent, or their legally designated representative (i.e. parent / legal guardian) does not have the cognitive capacity to provide informed consent. 2. is not expected to have open growth plates for the duration of the study. 3. currently participating in an interventional clinical trial. participation in a compassionate use programme, pre-commercial programme, or investigator initiated study does not preclude a patient from participation in this study.

Keywords: crysvita burosumab x-linked hypophosphataemia (xlh) phex gene mutation
pneumococcal vaccines in patients with asthma

Conditions: Asthma

Summary: investigators are assessing if patients with asthma respond better to the pneumovax vaccine if they are given prevnar initially.

patients will be randomized into either pcv13 and ppsv23 (experimental) or ppsv23 alone (active comparator). at the week 0 time point, the patients will receive either pcv13 (experimental) or ppsv23 (active comparator) and undergo a blood draw of 5ml for assessment of pre-vacation serotype titers. the active comparator group will undergo a 5ml draw of blood for assessment of titers at week 8, 16, and 24 following vaccination. the experimental group will undergo vaccination with ppsv23 at week 8 with 5 ml blood draw for pneumococcal serotype titers as well as a blood draw at week 16 and week 24.

Eligibility criteria:
inclusion criteria: - diagnosis of asthma exclusion criteria: * research exemption requested * history of pcv-13 vaccination * history of cochlear implant * cerebrospinal fluid (csf) leak * congestive heart failure (chf) * diabetes mellitus (dm) * chronic kidney disease (ckd) * human immunodeficiency virus (hiv) * common variable immune deficiency (cvid) * patients who have received the ppsv23 vaccine in the last 5 years * women who are pregnant will also be excluded from the study by performing 2 point of care urine pregnancy tests ( prior to vaccinations)

Keywords: vaccine pneumococcal pneumonia
the restore study, a randomized, controlled, masked (reading center) prospective study

Conditions: Refractive Surgery

Summary: to determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral prk surgery.

prospective open-label interventional study randomized, self-controlled design in which one eye (group a) receives dextenza and the second eye (group b) receives prednisolone acetate 1% qid 1 week, bid 1 week following bilateral prk surgery. all eyes will receive topical moxifloxacin qid for one week. moxifloxacin in used post-op regardless of the research. post-operative evaluations to be performed on day 3 and day 4, month 1, and month 3. phone call survey to be performed on week 2.

Eligibility criteria:
inclusion criteria: * any adult patient who is planned to undergo bilateral prk surgery. * willing and able to comply with clinic visits and study related procedures * willing and able to sign the informed consent form exclusion criteria: * patients under the age of 18. * patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test). * active infectious ocular or systemic disease. * patients with active infectious ocular or extraocular disease. * patients actively treated with local or systemic immunosuppression including systemic corticosteroids. * patients with known hypersensitivity to dexamethasone. * patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator. * patients with a history of ocular inflammation or macular edema. * patients with allergy or inability to receive intracameral antibiotic. * patients on systemic non-steroidal anti-inflammatory drugs (nsaid) greater than 1,200 mg/day * patients with a corticosteroid implant (i.e. ozurdex). * patient with corneal pathology which pre-disposes them to unsatisfactory outcomes. * patients who do not have 20/20 snellen visual acuity potential pre-operatively. * mrse greater than 6 diopters. * greater than 2 diopters anisometropia.
migraine and cvd risk in women

Conditions: Migraine

Summary: the primary goal of this study is to test the effects of a high-fat, high-carbohydrate mixed meal on candidate modulators of cardiovascular disease risk (inflammation, vascular reactivity, sympathetic nervous system tone, and response to pain) in young adult women with migraine compared with healthy young women. this is study enrolling both cases (women with migraine) and controls (women without migraine), with equal numbers of normal weight and obese women in each group. participants will undergo a telephone screening and a single day in-person study visit.


Eligibility criteria:
inclusion criteria (all): * female 18-35 years of age, inclusive * bmi 18.5-24.9 kg/m2, inclusive * bmi ≥30 kg/m2 inclusion criteria (cases only): * diagnosis of migraine per ichd-3-beta (1-10 migraine days per month) exclusion criteria (all): * smoking (current or former) * chronic use of medications, including oral contraceptives * major medical or psychiatry illness (e.g. diabetes, fibromyalgia, major depression/anxiety) * pregnant or nursing * allergies or sensitivity to any of the ingredients of the meal * inability to fast for 10 hours and/or abstain from caffeine intake for 24 hours * treatment with antibiotics or steroids within the previous 3 months * treatment with nsaids within the previous 1 week exclusion criteria (controls only): * migraine headaches, or headaches other than tension-type headaches with a frequency of 1 or fewer days per month
vitamin d and staphylococcus aureus in the diabetes study

Conditions: Infection

Summary: there are indications that the vitamin d status of an individual is related to susceptibility to staphylococcal infections. in the present study we will examine nasal colonisation rate in subjects participating in an ongoing vitamin d intervention study ( 20.000 iu cholecalciferol per week vs placebo) for the prevention of type 2 diabetes in subjects with impaired glucose tolerance.


Eligibility criteria:
inclusion criteria: * participant in an ongoing intervention study with vitamin d exclusion criteria: * none specifically for this study

Keywords: staphylococcus aureus vitamin d
from the model to the adaptation of a therapeutic education program (tep) in cancer research

Conditions: Health Services Research

Summary: the use of oral targeted therapies draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals \[1,2\]. these therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. this situation underlines the importance of a therapeutic education to accompany this "learning" \[3\]. nevertheless, in france, the therapeutic educational programs, built according to the "standards" of the therapeutic education (te), are still very rare in cancer research \[4\]. in may 2012, a therapeutic educational program for these patients has been developed in the oncology department of the teaching hospital of bordeaux through a multidisciplinary team. this program, dedicated to metastatic renal cancer patients treated by oral targeted therapies, becomes here an object of research: modap (action-research).

at the diagnosis, 25 to 30 % of renal cancer patients present a metastatic disease. the prognosis remains dark in spite of the advent of the targeted therapies from 2007. actually, the use of oral targeted therapies, most of the time carried out on an outpatient basis (sunitinib in particular), draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals \[1,2\]. these therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. this situation underlines the importance of a therapeutic education to accompany this "learning" \[3\]. nevertheless, the therapeutic educational programs, built according to the "standards" of the therapeutic education (te), are still very rare in cancer research \[4\]: multiplicity of the pathology (a cancer, cancers), multiplicity of the patients' experiences, the difficulty of implementation? in may 2012, in front of the experience told by the patients and the professionals in the context of metastatic renal cancer, the members of the oncology department of the teaching hospital of bordeaux, the therapeutic educational federation, the coordination cancer centre (3c), an anthropologist, an expert patient and a patient's association developed a therapeutic educational program for these patients \[current approval\]. this program, built on the model of the te in france, becomes here an object of research: modap (action-research).

Eligibility criteria:
inclusion criteria: * age = 18 years old * metastatic renal cancer (carcinoma with clear cells and other subcategories) * indication of a first line of treatment of therapy targeted by sutent © * general who 0-2 state * life expectancy = 12 weeks * agree to participate in modap (therapeutic education) exclusion criteria: * history of other cancer * history of severe psychiatric affection

Keywords: cancer oral therapy compliance anthropology psychology