Kornimate/medical-research-clean huggingface dataset:
necessity of tsh suppression therapy in active surveillance for thyroid cancer patients.

Conditions: Thyroid Cancer; Papillary Thyroid Carcinoma

Summary: this study is a multicenter randomized controlled trial conducted in korea. a parallel, two-group randomized design will be with thyroid stimulating hormone suppression therapy group(low tsh group; intervention) is different from the without thyroid stimulating hormone (tsh) suppression therapy group(high tsh group; control).

patients diagnosed with papillary thyroid cancer who wanted active surveillance and meet the inclusion / exclusion criteria will be randomized 1: 1 into two groups: the high tsh and low tsh group. during the study period, thyroid hormone supplementary doses will be determined according to the dose-adjustment protocol established for each target tsh range.

Eligibility criteria:
inclusion criteria: * thyroid nodule of 1.0 cm or less confirmed as bethesda category v (suspicious for ptc) or vi (ptc) based on cytopathological examination, or bethesda category iii (atypia of undetermined significance) with a confirmed braf v600e mutation. * patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. additionally, no evidence of extrathyroidal extension (ete) should be present, and the tumor must not belong to high-risk subtypes of ptc (e.g., diffuse sclerosing, columnar cell, or solid subtype). * non-pregnant women of childbearing potential (confirmed by medical history taking) exclusion criteria: * hyperthyroidism * if the investigator determines that you are not suitable for clinical research participation considering the following comorbidities: * myocardial infarction or cerebrovascular accident within the last three months. * diseases with limited life expectancy or potentially impairing the patient's ability to comply with at least five years of treatment or follow-up.

Keywords: active surveillance
precision vaginal microbiome transplantation in women with bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: the aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.

the volunteers will be recruited from the women who come to the hospital to do the bacterial vaginosis test. after being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire. then, posterior fornix of vagina secretions will be taken from each volunteer to perform 16s rrna gene sequencing microecology assessment , clue cell detection and amine test. after 2weeks ,1 month ,3 months,6 months,12 monthssince the entry, each volunteer will be asked to go back to research center to do the same sampling and examination as previously did in entry.

Eligibility criteria:
inclusion criteria: 1. history of sexual behaviour 2.18-55 years old 3. women were diagnosed as bacterial vaginosis exclusion criteria: 1. during pregnancy, or within 8 weeks after delivery; 2. presence of systemic diseases (such as sle, malignant tumors, etc.)
clinical study of umbilical cord mesenchymal stem cells (uc-msc) for treatment of knee osteoarthritis

Conditions: Osteoarthritis of the Knee

Summary: osteoarthritis (oa) is one of the most common joint diseases that is considered a chronic degenerative disorder. there is no effective therapy available today. this prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * 30-70 years old. * no serious infection, chronic diseases, diabetes and tuberculosis. * osteoarthritis of the knee with grade1-3 defined by the modified kellgren-lawrence classification. * written informed consents were obtained from all subjects. exclusion criteria: * pregnant women or cognitively impaired adults. * inflammatory or post infectious arthritis. * intra-articular drug injection within the previous 2 months. * serious medical illness with a life expectancy of less than 1 year. * prior admission for substance abuse. * arthroscopy during the previous 6 months. * systemic autoimmune rheumatic disease. * poorly controlled diabetes mellitus. * immunosuppressive or anticoagulant treatments. * treatment with corticosteroids in the 3 months prior to inclusion in the study. * nsaid therapy within 15 days prior to inclusion in the study.

Keywords: osteoarthritis (oa) mesenchymal stem cells(msc)
f15 recharge free axonics snm system clinical study

Conditions: Urinary Urge Incontinence (UUI); Urinary Frequency (UF); Fecal Incontinence (FI)

Summary: multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (oab) and/or fecal incontinence (fi) employing the axonics recharge free snm system.

a clinical evaluation to comply with new european medical device regulations (eu mdr) guidelines. multicenter, prospective, non-randomized, single arm study for oab and/or fi to assess the safety and performance of the food and drug administration (fda) approved axonics recharge free sacral neuromodulation (snm) system, model 4101. the product is currently marketed under the name f15 in the united states.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. primary indication of overactive bladder (oab) (urinary urgency incontinence (uui)/ urinary frequency (uf)) or fecal incontinence (fi) who are not candidates for, or who have failed conservative treatment 3. willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year. exclusion criteria: 1. any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis) 2. any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements 3. previously underwent an external sacral neuromodulation (snm) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder) 4. history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 5. a female who is breastfeeding 6. a female with a positive urine pregnancy test
associations of nighttime light exposure during pregnancy with neonatal jaundice：a multi-centre prospective study in china

Conditions: Jaundice, Neonatal

Summary: make a neonatal jaundiced nomogram on chinese jaundice data by joinning the major neonate centers all around china.

this was a multi-centre prospective study. all infants included were born in 8 hospitals in the southern, eastern, northern, western and central regions of mainland china in 2019. a total of 20839 transcutaneous bilirubin(tcb) measurements were performed with 2977 neonates at designated time points. the mean ntl exposure during pregnancy was respectively calculated based on each participant's residential address over the study course. the primary outcome was whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life. the effect of maternal nocturnal light exposure on neonate jaundice analyzed with lasso regression and random forest machine learning methods.

Eligibility criteria:
inclusion criteria: gestational age more than 35 weeks(≥35) - exclusion criteria: all kinds of congenital diseases, infants with pathologic jaundice -

Keywords: nighttime light exposure ，neonatal jaundice，china
investigation of the effectiveness of thoracic mobilization exercise in fibromyalgia patients

Conditions: Fibromyalgia

Summary: the aim of this study is to investigate the effects of mobilization exercises applied to the thoracic region on pain, anxiety, depression, disease impact questionnaire, sympathetic and parasympathetic activity in patients diagnosed with fibromyalgia.

the patients included in the study were randomly divided into two as thoracic mobilization group and control group and will be included in the treatment programs after the initial evaluations. patients in both groups will receive a treatment of 11 sessions in total, 5 sessions per week. participants will be evaluated twice before and after treatment with the fibromyalgia impact questionnaire, beck anxiety and beck depression questionnaires. in addition, the e-motion faros device will be used to measure heart rate variability. measurements of heart rate variables will be made before and after the first day of treatment, before and after the 11th session, and on the 45th day.

Eligibility criteria:
inclusion criteria: * being diagnosed with fibromyalgia by a specialist physician according to the 2013 american association of rheumatology diagnostic criteria * being between the ages of 18-45 exclusion criteria: * those with neurological deficit * during menopause and postmenstrual period * diagnosed with diabetes * those with neuropathic disease * those with chronic inflammation * have immunodeficiency * those with cardiac disease * patients who are pregnant
a registry study of patients hospitalized with confirmed covid-19

Conditions: COVID-19

Summary: the design of this registered study aims to evaluate the efficacy and safety of paxlovid in the treatment of hospitalized covid-19 patients, and to explore factors related to the efficacy and safety of paxlovid.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of covid-19 infection. 2. presence of at least one high-risk factor, including age ≥60 years, diabetes, hypertension, cardiovascular disease, stroke, chronic liver or kidney disease, cancer, history of smoking or obesity. exclusion criteria: * no specific exclusion criteria in this study.

Keywords: hospitalized paxlovid
"principle test" for isolation and characterization of circulating cancer cells (ctc)-cxcr4+.

Conditions: Neoplasm Malignant

Summary: this is multicentric, interventional, non farmacological and prospective study.

the new clg platform, a prototype owned by irccs pascale institute, is able to reconstruct a pmn for the capture of ctcs able to extravasare and colonize tissues at distance, a fundamental requirement to begin the process of metastasis formation. the purpose of the study is to evaluate in vitro the effectiveness of clg in the isolation, recovery and subsequent molecular characterization of ctcs from peripheral blood of patients suffering from solid neoplasms (endometrium, kidney, colorectal, glioblastoma and lung).

Eligibility criteria:
inclusion criteria: * age ≥18 * signature of informed consent * advanced solid neoplasm with metastases exclusion criteria: * age \<18 * refusal to sign informed consent
benefit of immunoprophylaxis on fibrosis to reduce viral load after liver transplantation

Conditions: Liver Transplantation

Summary: an open-label randomized multicenter clinical study comparing three regimes of immunosuppression : (a) tacrolimus and steroids, (b) antithymocyte induction therapy and full dose of tacrolimus, (c) antithymocyte induction therapy with mycophenolate mofetil and a reduced dose of tacrolimus.


Eligibility criteria:
inclusion criteria: * patients who received a first liver transplantation, * presenting with a qualitative or quantitative pcr positive for hepatitis c virus at time of transplantation, whatever the transaminase activity, * women of childbearing potential with a negative pregnancy test, * male or female patients who agree to use an effective method of contraception, * patients who signed a written informed consent form to participate in the study, * patients who are compliant and likely to follow the visits specified by the study protocol exclusion criteria: * • preoperative serious renal impairment (serum creatinine levels \> 200 µmol/l), * repeat transplantation, * multiple organ transplantation, * transplantation performed with an organ transplant obtained from a living donor or a reduced or shared organ grafts, * serious concomitant disorder, * positive serology for hbs antigen or hiv positive at time of enrollment, * previous history of nonhepatic cancer (except for localized skin cancer), * presence of a hepatocellular carcinoma, for which the primary lesion exceeds 5 cm or is complicated by portal thrombosis or metastatic disease, * an investigational product or therapy administered less than one month before entry into the study.

Keywords: liver transplantation, hepatitis c virus, immunoprophylaxis
detection and treatment of sarcopenia and myosteatosis in older african americans

Conditions: Sarcopenia

Summary: the objectives of this study are to: 1) validate a rapid, portable, cost-effective method for screening myosteatosis and sarcopenia using diagnostic ultrasound, and 2) investigate a novel approach to progressive resistance exercise involving eccentric muscle actions that will counter the local effects of myosteatosis and sarcopenia in african americans.

the rationale for this study is the need to proactively address health disparities associated with age-related skeletal muscle dysfunction. age-related changes in muscle may be characterized by sarcopenia (i.e., loss of muscle mass) and/or myosteatosis (i.e., excessive intramuscular adipose tissue). these changes may result in physical impairments that may be exacerbated by the lack of a formal screening and diagnosis process for older adults in standard healthcare settings. myosteatosis may compound the effects of sarcopenia and play a significant role the age-related functional decline and higher incidence of type 2 diabetes observed in african americans in comparison to other ethnic/racial groups. the initial phase of the study will involve the assessment of older african americans (n = 70) to characterize muscle size and quality in comparison to a younger reference group (n = 70). participants randomly selected from the older subject pool will be assigned to either the eccentric exercise group or the concentric exercise group for 12 weeks of a supervised strengthening exercise regimen.

Eligibility criteria:
inclusion criteria: * an african american adult. * between 18 and 30 years of age, or between 65 and 85 years of age. * able to independently walk at home and in your community (use of an assistive device like a cane or a walker is acceptable). exclusion criteria: * uncontrolled hypertension or other cardiovascular disease. * a body mass index of 32.5 or above may be an exclusion criterion if the x-ray technician determines that dimensions of the scanning bed are not adequate for a reliable examination. * a musculoskeletal condition that would stop you from performing the physical assessment tests. * muscle weakness due to neurological disease or injury (such as stroke or spinal cord injury). * moderate to severe sepsis (blood infection) or edema (such as swelling of a limb). * been hospitalized over the last three months. * history of a broken arm or leg bone because of osteoporosis.

Keywords: sarcopenia aging myosteatosis exercise screening
evaluation of splenic metabolic activity with 18fdg-pet in hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the splenic activation in hypertensive patients, as compared to normotensives, using fdg-pet/ct imaging. moreover, the investigators will investigate whether the splenic metabolic activity relates to the expression of circulating inflammatory proteins (high-sensitivity c-reactive protein \[hscrp\]), interleukin-1b (il-1b), tumor necrosis factor-a (tnf-a) or to immune profiles of activated t cells.


Eligibility criteria:
inclusion criteria: * absence of prior cancer diagnosis or remission from cancer at the time of fdg-pet/ct imaging (from at least 6 months) * age ≥ 30 and ≤ 85 years * absence of acute cardio/cerebrovascular disease (myocardial infarction, stroke, transient ischemic attack, revascularization) * absence of acute or chronic inflammatory or autoimmune disease * diagnosis of presence/absence of hypertension, on the basis of documented medical history exclusion criteria: * diabetes * atrial fibrillation * use of anti-inflammatory drugs in the week preceding the fdg-pet/ct imaging * chronic use of anti-inflammatory drugs
dfd01 spray vs comp01 lotion hpa axis suppression study in patients with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to evaluate the potential of dfd01 spray to suppress the hpa (hypothalamic-pituitary-adrenal) axis as compared to comp01 lotion when applied twice daily for 15 days.


Eligibility criteria:
inclusion criteria: 1. subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis. 2. subjects with psoriasis involving 20 to 50% bsa, not including the face, scalp, groin, axillae and other intertriginous areas. 3. subjects must have an iga grade of at least 3 (moderate) at the baseline visit 4. subjects whose results from the screening acth stimulation test are considered normal (cortisol level \>18 ug/dl at 30 minutes post stimulation) and show no other signs of abnormal hpa function or adrenal response. - exclusion criteria: 1. current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. 2. history of organ transplant requiring immunosuppression, hiv, or other immunocompromised state. 3. have received treatment for any type of cancer within 5 years of the baseline visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the baseline visit. 4. use within 60 days prior to the baseline visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) 5. use within 30 days prior to the baseline visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene)2) puva therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) uvb therapy. 6. use within 30 days prior to the screening visit of any product containing corticosteroids. inhaled, intraocular, intranasal, etc. steroids are not allowed. 7. subjects who have an abnormal sleep schedule or work at night. 8. subjects with a known history of acute adrenal crisis, addison's disease or decreased adrenal output, low pituitary function or pituitary tumors. 9. subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
management of patients with suspected of sleep apnea-hypopnea syndrome from primary care

Conditions: Sleep Apnea Syndrome

Summary: obstructive sleep apnea syndrome (osa) is characterized by the manifestation of excessive sleepiness secondary to repeated obstruction of the upper airway during sleep and cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders. epidemiological studies in our country have shown that osa is a highly prevalent disease in the general population, affecting 2-4% of the adult population. the most important clinical manifestations of osas is a deterioration in the quality of life and an increase in cardiovascular disease. osa is also associated with traffic accidents. therefore, and considering the medical complications of osa, as well as the sociolaboral impact and its negative impact on quality of life and survival; is stated that this disease is a public health problem that requires the physician to identify patients eligible to treatment. moreover, it has been shown that undiagnosed patients, duplicate the consumption of health resources, comparing when the diagnosis and treatment has been established. finally, we have a highly effective treatment using positive pressure in the upper airway (cpap) that has been shown to be effective and cost-effective. the current situation in which all patients diagnosed with osa and receiving different treatments are monitored and controlled by the sleep units (su) is an oversized medicine specialist at the expense of primary care (pc). our working hypothesis is: "by the coordination of actions at various levels including interactive training equipment ap, use the bilateral (su-ap) of electronic medical records and the use of new technologies can be achieved in ap satisfactory management of the diagnostic and therapeutic process of patients with suspected osa. patients assisted in both areas have a level of clinical response, satisfaction, compliance and avoidance of complications, similar to that obtained with monitoring by su. in addition, management by ap will be more cost-effective than in the su."


Eligibility criteria:
inclusion criteria: * men and women over 18 years old * suspected osa patients (chronic snoring, apneas, excessive daytime sleepiness) or resistant hypertension * written informed consent signed exclusion criteria: * patients with impaired lung function (sd. overlap, obesity hypoventilation, and restrictive disorders) * severe heart failure * severe chronic pathology associated * psychiatric disorder * periodic leg movements * pregnancy * other dyssomnias or parasomnias * patients already treated with cpap

Keywords: osa osas sleep apnea management primary care sleep unit cost-effectiveness ess
evaluation of heel offloading devices for reducing heel contact pressures in healthy volunteers

Conditions: Heel Pressure Ulceration Prevention Strategies

Summary: prevention of heel pressure ulceration is a major clinical concern. clinical research has shown that heel-offloading devices are effective at preventing heel ulceration when compared to no offloading or sub-optimal offloading methods (i.e. use of a hospital pillow to offload the heel). as a result, a plethora of heel-offloading devices have been developed that utilize different designs and materials to offload the heel. despite the availability of these devices, some healthcare facilities still employ no heel offloading or utilize sub-optimal heel offloading strategies. it is also difficult for clinicians to compare the effectiveness of different heel offloading device without conducting extensive clinical evaluations. pressure mapping of the pressure experienced by the heel while offloaded offers a potential method to assess the effectiveness of different heel offloading strategies. the primary hypothesis of this study is that the three tested heel offloading devices will significantly decrease the heel contact forces compared to no offloading and sub-optimal heel offloading conditions. the secondary objective is to quantify differences in heel contact forces experienced by the heel when placed in each heel offloading device to demonstrate the utility of pressure mapping as a tool to evaluate the effectiveness of different heel offloading devices. the study will recruit 21 healthy volunteers as research subjects with 7 having a normal bmi, 7 having an overweight bmi, and 7 having an obese bmi. pressure mapping will be conducted on each research subject for seven randomly applied conditions while the patient lies comfortably in a hospital bed. the seven conditions include no heel offloading, 3 sub-optimal offloading conditions, and offloading in 3 different heel-offloading devices. pressure measurements corresponding to the heel will be used to determine the average peak pressure contact force for each research subject in each condition.


Eligibility criteria:
inclusion criteria: * 18 years old or older * no musculoskeletal injury in the past month * body mass index (bmi) between 18.5 and 39.9 exclusion criteria: * 17 years old or younger * musculoskeletal injury in the past month * pregnant or lactating female * history of heel pressure ulceration * bmi below 18.5 or above 39.9

Keywords: heel pressure ulcer pressure mapping