Kornimate/medical-research-clean huggingface dataset:
tolerability of switching to duloxetine for the management of diabetic nerve pain

Conditions: Diabetic Neuropathy, Painful

Summary: this study is to compare the tolerability of different methods for switching from another medication to duloxetine for the management of diabetic nerve pain. the primary objective is to compare the most gradual method with the most abrupt method, to see if they have different tolerability.


Eligibility criteria:
inclusion criteria: * you must have been diagnosed with diabetic peripheral neuropathic pain. * you must have been taking the same dose of amitriptyline once daily at bedtime for at least four (4) weeks. * you must have stable glycemic control. * you must be able to visit the doctor's office once a week for ten (10) weeks. exclusion criteria: * you are in the acute recovery phase following myocardial infarction. * you have major depressive disorder, an anxiety disorder, or some other psychiatric illnesses that the doctor will ask you about. * you are allergic to amitriptyline or duloxetine. * you are currently taking an anticonvulsant, cisapride (propulsid), or if you have taken an opioid for three or more consecutive days during the 14 days prior to visit 2. * you have uncontrolled narrow angle glaucoma.
objective evaluation of postoperative positioning in macular hole surgery

Conditions: Macular Hole

Summary: the macular hole formation takes place in the centre of the retina. a closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. the investigators have developed a positioning measuring device which can measure the extent of supine positioning time. patients are to carry the positioning measuring device during the first postoperative 24 hours. hereby the investigators search new knowledge concerning patients compliance and its relation to macular hole closure.


Eligibility criteria:
inclusion criteria: * primary macular hole * duration less than 24 months * informed consent exclusion criteria: * secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres) * previous vitreomacular surgery * age under 18 years * unable to sign
stenting and resection for stage iv colorectal cancer endoscopic stenting and colorectal resection in stage iv

Conditions: Colorectal Neoplasm

Summary: patients with stage iv obstructing colorectal cancer and unresectable liver metastses, with general and local conditions not a risk for coliorectal resection, will be randomized to have either endoscopic stenting or colorectal resection

patients with obstructing colorectal cancer, stage iv with not resectable metastases will be considered . patients with acceptable general and local conditions, to allow a safe surgical resection will be considered. patients will be randomized to have endoscopic stenting or colorectal resection. all patients will receive postoperative chemio therapy

Eligibility criteria:
inclusion criteria * patients with stage iv obstructing colorectal cancer and liver metastases * liver metastases not resectable exclusion criteria -patients considered at high risk for colorectal resection

Keywords: colorectal cancer liver metastases stage iv
prevalence of microcirculatory alterations in intensive care patients

Conditions: Critical Illness

Summary: recent research has focused on the investigation of sublingual microcirculatory alterations in different patient categories, like cardiac surgery and sepsis. the microcirculation plays a pivotal role in tissue oxygenation and can be non invasively visualized by sidestream dark field (sdf) imaging. the objective is to carry out a international multi center study to investigate the prevalence of microcirculatory alterations in intensive care patients. up to the present time, a comprehensive prevalence study like this has not been carried out.

visualization of the sublingual microcirculation at a fixed time point with sdf- or ops-imaging in all adult patients of participating intensive care units, regardless of their underlying disease. concurrently, data on both patient characteristics (e.g. severity of illness, treatment) and icu characteristics will be obtained.

Eligibility criteria:
inclusion criteria: * \> 18 * informed consent exclusion criteria: * injury to the maxillofacial area * recent maxillofacial injury

Keywords: microcirculatory alterations sdf imaging
evaluate the efficacy and safety of dwj1506 and dwj1507

Conditions: Dyslipidemias

Summary: the purpose of this study is to determine the efficacy and safety of dwj1506 and dwj1507 in the patients with dyslipidemia.


Eligibility criteria:
inclusion criteria: 1. adults aged 19 years or over 2. patients with ldl-c levels ≤ 250 mg/dl, tg \< 500 mg/dl 3. subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study exclusion criteria: 1. severe congestive hear failure 2. current active liver disease 3. the use of prohibiterd concomitant therapies 4. severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc. 6.women who were of childbearing potential without contraception, pregnant, or breastfeeding
ultrasound-based breast cancer screening in chinese women

Conditions: Breast Cancer

Summary: in the present study, the investigators will screen breast cancer of the chinese women based on ultrasound and aim to compare the risk evaluation model of pumch model which was established by our previous work with other risk models.

early detection of breast cancer through screening has been a common practice in the united states and several european countries for decades. it is effective in reducing the mortality of breast cancer and improving the postoperative quality of life of patients. mammography has been the standard imaging method for the screening, however, our previous study has shown that ultrasound is more sensitive and less expensive than mammography. in the present study, the investigators will screen breast cancer of the chinese women based on ultrasound and aim to evaluate the risk model (pumch model) which was established by our previous work.

Eligibility criteria:
inclusion criteria: * written informed consent； * residence from community or working units exclusion criteria: * pregnancy； * lactation； * known metastatic cancer； * signs or symptoms of breast disease； * presence of breast implants, breast surgery within prior 12 months； * had mammography or ultrasound exam within prior 12 months * males.

Keywords: breast cancer screening ultrasound risk model
platelets in pregnancy

Conditions: Hypertensive Disorder of Pregnancy

Summary: this is a prospective observational cohort study of platelet phenotype in pregnant patients at high-risk for the development preeclampsia. blood samples will be collected prior to the initiation of daily aspirin and again in the second trimester to evaluate for platelet changes during pregnancy in patient's as a result of aspirin use and their association with adverse perinatal outcomes.


Eligibility criteria:
inclusion criteria (case group): * pregnant patients receiving prenatal care prior to 17 weeks at nyu langone health- obstetrics \& gynecology associates * age 18-50 years * singleton viable gestation * pregnant patients at high risk of preeclampsia: patients meeting uspstf recommendation for low-dose aspirin (81 mg/day) prophylaxis for preeclampsia based on clinical risk factors (see below) inclusion criteria (control group): * pregnant patients receiving prenatal care prior to 17 weeks at nyu langone health- obstetrics \& gynecology associates * age 18-50 years * singleton viable gestation * pregnant patients at low risk of preeclampsia: patients who do not meet uspstf recommendation for low-dose aspirin (81 mg/day) prophylaxis for preeclampsia based on clinical risk factors. exclusion criteria (case and control group): * allergy to aspirin * antithrombotic or antiplatelet therapy * anemia (hemoglobin \ 600) * known hemorrhagic diathesis * planned delivery outside of nyu
feasibility testing of plant-based meal replacement products made with manitoba crop ingredients for weight loss and diabetes remission

Conditions: Weight Loss; Prediabetes; Diabetes

Summary: the goal of this clinical trial is to advance the development of the wi meal replacements by evaluating the acceptance and feasibility of the meal replacements within the wellness institute's weight loss clinic program (wlc). the main questions it aims to answer are: * to determine whether the incorporation of wi meal replacements into their weight loss clinic design is feasible. * to determine whether weight loss is supported by a plant-based meal replacement. * to assess efficacy of the meal replacements by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-meal replacement weight loss program members. * to assess remission of diabetes and pre-diabetes. researchers will compare the wlc program plus meal replacements to the wlc program without the meal replacements to evaluate the implementation of the meal replacements into the wlc. participants will follow their wlc program for 16 weeks, and those in the intervention group will begin their meal replacements. participants will have a choice on what type of meal replacement they will consume each day (either a bar or a shake) and will record this in the product consumption log.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 years or above * live within the province of mb * ability to give written informed consent in english. * enrolled in the wellness institute weight loss clinic exclusion criteria: * female participant who is pregnant, lactating or planning pregnancy during the course of the program. * participants with known allergies to the meal replacement ingredients * has an active eating disorder

Keywords: weight loss clinic meal replacement
biopsychosocial approach of the cancer-related fatigue (biocare factory)

Conditions: Breast Cancer

Summary: one of the most common and stressful side effects of the disease and associated treatments is cancer-related fatigue. it deeply disrupts quality of life and can have a negative impact on patient survival. however, cancer-related fatigue is largely underestimated by patients and poorly taken into account by clinicians. one of the reasons for its poor management is a lack of knowledge of the underlying mechanisms and risk factors. although a multiplicity of factors are associated with the appearance of cancer-related fatigue, we do not know their respective share, nor the nature of their interactions. the phenomenon studied reveals complex and systemic interactions between the biological, psychological and social dimensions. recent systematic reviews clearly identify 2 locks currently preventing a better understanding of the mechanisms of cancer-related fatigue: i) lack of longitudinal studies, ii) lack of interdisciplinary studies. it is precisely these two challenges that the biocare factory project wishes to respond to.


Eligibility criteria:
inclusion criteria: * patient followed at the victor hugo clinic, le mans. * patients aged \>or= 18 and \< 80 years old at the time of inclusion * patients with a histologically proven primary breast cancer from stage i to iiic * naive patient of anti-cancer treatment for this cancer * agreement to participate in the study by written, informed and signed consent of the patient * affiliated patients or beneficiaries of a social security scheme * ecog performance status score ≤ 2 exclusion criteria: * comorbidity which can explain the symptoms of fatigue (long-term illness other than cancer, chronic fatigue syndrome) * breathing difficulties requiring the use of respiratory assistance * signs of polyneuropathy, amyotrophy or myasthenic syndrome * contraindications to physical exercise linked to heart failure. * treatment based on psychostimulants, psychotropics, antidepressants, antiepileptics or benzodiazepines for more than 3 months at the time of the study * presence or history of psychosis, bipolarity or severe depression * history of stroke * history of chronic fatigue * history of musculoskeletal disorders of the lower limbs * pregnancy, breastfeeding * patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons
non-invasive respiratory monitor

Conditions: Neuromuscular Diseases; Healthy Volunteers

Summary: this study will clinically evaluate a newly developed respiratory monitor - pneurip. the pneurip uses respiratory inductance plethysmography (rip) bands to measure key breathing indices non-invasively. this study compares the pneurip to an existing respitrace system (carefusion, yorba linda ca). 10 normal children and 10 children with breathing difficulties will be monitored with both systems.

firstly, ten healthy children will participate in a trial to evaluate the pneurip. they will be fitted with the bands around their abdomen and chest. the pneurip will be connected to the bands through electrodes. breathing is then measured wirelessly with an ipad. they will be asked to lie down. they are asked to breath normally then asked to breath with a resistive elements to place in their mouth. the resistive elements makes it difficult to breath (similar to breathing through a straw). they will breathe for 3 minutes for both conditions as we record their breathing with the pneurip and the respitrace. these data will be compared. secondly, a group of 10 subjects from the outpatient muscle clinic will be fitted with the chest and abdomen bands. the respitrace monitor and the pneurip will record their breathing patterns. data from the two systems will then be compared.

Eligibility criteria:
inclusion criteria: * healthy volunteers * neuromuscular disease subjects with mild breathing difficulty * capable of following verbal instructions exclusion criteria: * severe breathing difficulties
hydrocortisone vs prednisolone in ai (hyper-aid)

Conditions: Adrenal Insufficiency

Summary: this study is designed to collect data on individuals with adrenal insufficiency who are changing treatments from hydrocortisone to prednisolone, or vice versa. it will compare anthropometric, biochemical and subjective health outcomes between both treatments.

in the uk, oral immediate release hydrocortisone divided in three doses daily has been the traditional treatment. the most common regimen in clinical practice uses doses of 10 mg on waking, 5 mg at lunch time and 5 mg in the afternoon. once daily prednisolone is another regimen in clinical use and now prescribed at less than 5mg daily. it has a longer duration of action and a smoother pharmacokinetic profile compared to hydrocortisone. moreover, prednisolone is much more cost-effective than hydrocortisone with 5mg tablets. prednisolone is less commonly used due to perceived concerns regarding loss of bone mineral density leading to osteoporosis, increased insulin resistance leading to steroid induced diabetes, and rises in blood pressure and weight leading to increased cardiovascular risk. this belief is perhaps driven by the fact that most clinicians encounter prednisolone in the context of the treatment of asthma, rheumatoid arthritis etc. where far higher doses are employed. where effects on bone health have been noted, they have been in association with higher doses of prednisolone (7.5mg) than those employed today (2-5mg). although conventionally prednisolone 5 mg is assumed to be bioequivalent to hc 20 mg (ratio 1:4), newer studies suggest that the ratio may be nearer 1:6-8 i.e. lower doses can be used.

Eligibility criteria:
inclusion criteria: * aged 18 - 85 years * male or female * diagnosed with adrenal insufficiency (ai) for over 6 months according to standard diagnostic criteria * established on stable hydrocortisone or prednisolone replacement, dose not altered for at least 4 months * individuals taking other hormone replacements are accepted providing that their replacement doses have not altered for at least 3 months; * individuals who are able and willing to give written informed consent to participate in the study exclusion criteria: * individuals who are unable to give informed consent * pregnancy (determined by patients self-reporting pregnancy status) * patients using the combined oral contraceptive pill

Keywords: glucocorticoids prednisolone hydrocortisone
a study to evaluate safety and efficacy of amb-05x injections in subjects with tgct

Conditions: Pigmented Villonodular Synovitis; TGCT; Tenosynovial Giant Cell Tumor

Summary: amb-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor

amb-051-07 is an open-label, adaptive, dose-ranging study with long-term extension which will enroll up to 48 adult subjects with tenosynovial giant cell tumor for intra-articular doses over a 24-week dosing period (part 1) with a part 2 open-label extension of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.

Eligibility criteria:
inclusion criteria: 1. subject ≥ 18 years 2. tgct with only 1 joint involvement 3. symptomatic measurable disease of at least 1 cm based on recist v1.1 4. stable prescription of analgesic regimen 5. agrees to follow contraception guidelines 6. women of childbearing potential must have a negative pregnancy test 7. adequate hematologic, hepatic, and renal function exclusion criteria: 1. prior investigational drug use within 4 weeks or 5 half-lives of baseline 2. previous use of therapeutics targeting csf1 or csf1r or oral tyrosine kinase inhibitors within 3 months prior to baseline 3. history of extensive or reconstructive surgery on the affected joint 4. active cancer (either currently or within 3 mo before baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy) 5. metastatic or malignant transformation of tgct 6. hepatitis c virus (hcv) or hepatitis b virus (hbv) or human immunodeficiency virus (hiv) 7. known active tuberculosis 8. significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history 9. women who are breastfeeding 10. a screening fridericia-corrected qt interval (qtcf) ≥ 470 ms 11. mri contraindications (e.g., pacemaker, loose metallic implants) 12. history of hypersensitivity to any ingredient of the study drug 13. history of drug or alcohol abuse within 3 months before baseline 14. any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment or interfere with interpretation of study results and, in the investigator's opinion, make the subject inappropriate for this study 15. subjects who, in the investigator's opinion, should not participate in the study for any reason, including if there is a question about their ability to comply with study requirements

Keywords: pigmented villonodular synovitis tenosynovial giant cell tumor tgct pvns
the arthritis, diet, and activity promotion trial

Conditions: Knee Osteoarthritis

Summary: the primary purpose of this study was to determine the effect of dietary weight-loss, exercise training, or a combination of both on physical function in overweight and obese adults with knee osteoarthritis (oa). in secondary analyses, the effect of weight-loss and/or exercise on oa progression, self-reported pain and inflammation were examined. in post-trial analyses, the effect of dietary weight-loss on total mortality was determined.


Eligibility criteria:
inclusion criteria: * age ≥ 60 years. * bmi ≥ 28 kg/m2. * knee pain on most days of the month. * sedentary lifestyle pattern (\<20 min exercise per week for last 6 months) * self-reported difficulty with at least one of the following: walking 1/4 mile, climbing stairs, kneeling, bending, stooping, shopping, lifting, self-care. * radiographic evidence of grade 1-3 knee osteoarthritis. exclusion criteria: * serious medical condition that precludes safe participation in exercise such as heart disease (angina, congestive heart failure), severe hypertension, copd, renal or liver disease, insulin-dependent diabetes. * mini-mental state exam score \<24. * inability to walks without a cane. * reported alcohol consumption \>14 drinks/week. * inability to complete protocol. * st segment depression. * participation in another research study.

Keywords: knee osteoarthritis weight-loss exercise obesity physical function total mortality
intracardiac echocardiography system

Conditions: Heart Diseases

Summary: to evaluate the safety and effectiveness of intracardiac ultrasound imaging system in sonosemi medical co., ltd.

a prospective, multicenter, randomized controlled, non-inferiority clinical trial was designed. in the experimental group, intracardiac and large blood vessel imaging, intracardiac doppler flow assessment and guidance of intracardiac intervention were performed by intracardiac ultrasound imaging system of sonosemi medical co., ltd. the control group was treated with soundstar 3d diagnostic ultrasound catheter (sndstr10g) and vivid iq, intracardiac and macrovascular imaging of the heart, assessment of intracardiac doppler flow, and guidance for intracardiac intervention. after meeting the entry criteria, they will be randomized by an electronic randomization system, and the researchers will conduct a clinical trial based on the results of the randomization, intracardiac and large vessel imaging, intracardiac doppler flow assessment, and guidance of intracardiac intervention were performed in both groups

Eligibility criteria:
inclusion criteria: 1. patients aged ≥18 years and ≤85 years, regardless of gender, 2. patients who planned to undergo intracardiac and macrovascular imaging, intracardiac doppler flow assessment, and intracardiac intervention, 3. subjects who could understand the purpose of the trial, were willing to cooperate with interventional treatment and follow-up, participated in the trial voluntarily and signed a written informed consent. exclusion criteria: 1. known complication of sepsis, thrombosis or severe peripheral vascular disease; 2. angina class iv ccs or nyha class iv cardiac function, 3. severe coagulopathy unable to perform vascular puncture, 4. known to be severely allergic to the materials used in the study; 5. pregnant or lactating women, or those who had planned to become pregnant during the trial; 6. those who were enrolled in any other drug or medical device clinical trial and had not yet left the group; 7. other conditions that the investigator judged unsuitable for enrollment.