Kornimate/medical-research-clean huggingface dataset:
a study to examine the efficacy, safety and tolerability, and pharmacokinetics of exenatide once monthly suspension

Conditions: Type 2 Diabetes

Summary: the purpose of study bcb111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation.


Eligibility criteria:
inclusion criteria: * is at least 18 years old at study start * has been diagnosed with type 2 diabetes mellitus * has hba1c of 7.1% to 11.0%, inclusive, at study start * has been treated with diet and exercise alone or with a stable regimen of metformin, pioglitazone, or a combination of metformin and pioglitazone, for a minimum of 2 months prior to study start * either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: hormone replacement therapy (female subjects); antihypertensive agents; thyroid replacement therapy; or antidepressant agents exclusion criteria: * clinically significant medical condition that could potentially affect study participation including: * acute or chronic pancreatitis * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (men) type 2 * active cardiovascular disease within 3 months of study start * underlying hepatic or renal disease * inflammatory bowel disease, or other severe gastrointestinal diseases (particularly those that may affect gastric emptying, such as gastroparesis, pyloric stenosis, and metabolic surgery) * has had \> 2 episodes of major hypoglycemia in the preceding 6 months before study start * has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start * has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications: * any exposure to exenatide (byetta®, exenatide once weekly, or exenatide suspension), liraglutide (victoza®), or any glp-1 receptor agonist * any dpp-iv inhibitor, sulfonylurea (su), or rosiglitazone (avandia®) within 3 months prior to study start * alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®) within 30 days prior to study start * insulin within 2 weeks prior to study start, or for more than 1 week within 3 months prior to study start * systemic corticosteroids by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption * prescription or over-the-counter weight loss medications within 3 months prior to study start

Keywords: exenatide amylin lilly byetta exenatide once weekly
the efficacy of prednisone and combination therapy with methylprednisolone and cyclophosphamide on imn in stage i.

Conditions: Idiopathic Membranous Nephropathy

Summary: multi-center, prospective, randomized, controlled study to verify the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of stage i membranous nephropathy.

idiopathic membranous nephropathy (imn) is one of the most common cause of adult nephrotic syndrome. prednisolone and methylprednisolone are essential drugs for imn. however, there are no recommendations for the treatment of imn in china. kdigo guidelines recommend combination therapy with methylprednisolone and cyclophosphamide as first-line therapy of imn, but there is a large side effect of cyclophosphamide.there were retrospective study showed that the use of glucocorticoid hormones (including prednisone and methylprednisolone) alone may be effective in patients with membranous nephropathy in asia, but there is no high quality evidence of evidence-based medicine.the study is a randomized prospective controlled multi-centered trial,to compare the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of membranous nephropathy in stage i.

Eligibility criteria:
inclusion criteria: 1. the pathological examination of renal biopsy was consistent with the early idiopathic membranous nephropathy 2. meeting one of the following three condition： * urine protein quantitation \>4g/d,or 50% higher than baseline,rass blocker treat for 6 months without trend of decrease ②serious or disabling complications related to nephrotic syndrome ③in the 6-12 months after diagnosis of idiopathic membranous nephropathy, serum creatinine increased by more than 30%, while egfr egfr≥25ml/min/1.73m2.and excludeing other causes of renal dysfunction exclusion criteria: 1. secondary membranous nephropathy 2. serious complications 3. considering the effect of cyclophosphamide on the of function of sex gland，all patients with childbearing age or fertility requirement cannot participate in this study

Keywords: prednisone alone methylprednisolone and cyclophosphamide membranous nephropathy in stage i
early warning systems, risk of early clinical deterioration

Conditions: Early Clinical Deterioration

Summary: primary purpose of the study was to evaluate the relationship between "news" and "views" scores of patients who were screened retrospectively, early clinical deterioration, return to intensive care and morbidity / mortality.


Eligibility criteria:
inclusion criteria: * over 18 years * patients who were taken back to the intensive care unit in the first 24 hours exclusion criteria: * under 18 years old, * patients undergoing postoperative intensive care, * pregnant women
buprenorphine as a treatment for individuals dependent on analgesic opioids

Conditions: Opioid-Related Disorders

Summary: opioids used to treat chronic pain have a high abuse potential. the purpose of this study is to determine the effectiveness of buprenorphine in treating opioid dependent individuals who abuse opioids that are prescribed for chronic pain.

many individuals who take opioids for chronic pain abuse the opioid medication. buprenorphine is an opioid partial agonist that may be effective in treating individuals who abuse opiate pain medication. the purpose of this study is to compare two buprenorphine dosing regimens in order to determine which regimen is more effective in reducing opiate pain medication use and facilitating successful opioid detoxification. this study will last 27 weeks. participants will receive a maintenance dose of 8 mg of buprenorphine for 6 weeks, followed by a dose reduction in 2 mg increments over the course of the following 20 weeks. all participants will attend weekly clinical management sessions for the duration of the study.

Eligibility criteria:
inclusion criteria: * current opioid analgesic dependence * history of at least 2 years of oral opiate analgesic use * prescribed opioids for chronic pain * pain episode of at least 6 months duration within the 5 years prior to study entry * available for the duration of the study * good general health exclusion criteria: * currently using any illicit substance * meets criteria for alcohol dependence * history of heroin use * history of opiate replacement therapy, including levo-alpha acetyl methadol (laam) or methadone * evidence of current maximal primary pain

Keywords: opioid dependence
a study of different doses of grazoprevir (mk-5172) given with pegylated interferon alfa-2b and ribavirin to treatment-naïve participants with chronic hepatitis c (mk-5172-038)

Conditions: Chronic Hepatitis C (CHC)

Summary: this is a study designed to compare the safety and efficacy of 3 different doses of grazoprevir (mk-5172) combined with pegylated interferon alfa-2b (peg-ifn) and ribavirin (rbv) in treatment-naïve participants with genotype 1 (gt1) chronic hepatitis c (chc). participants will receive 12 weeks of treatment with grazoprevir combined with peg-ifn and rbv, and depending on response at week 4 may go on to receive an additional 12 weeks of treatment with peg-ifn and rbv.


Eligibility criteria:
inclusion criteria: * treatment naive * chronic, compensated hcv gt1 infection * absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis * no evidence of cirrhosis or hepatocellular carcinoma by biopsy or noninvasive testing (e.g. fibroscan and/or fibrotest) * must agree to use two acceptable methods of birth control from at least 2 weeks prior to first dose and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations exclusion criteria: * non-gt1 hcv infection, including a mixed gt infection (with a non-gt1) or a non-typeable genotype. * documented to be human immunodeficiency virus (hiv) positive or co-infected with hepatitis b virus * hepatocellular carcinoma (hcc) or under evaluation for hcc * participating in or has participated in a study with an investigational compound or device within 30 days of signing informed consent * diabetic and/or hypertensive with clinically significant ocular examination findings * current or history of central nervous system trauma, seizure disorder, stroke or transient ischemic attack * chronic pulmonary disease * current or history of any clinically significant cardiac abnormalities/dysfunction * active clinical gout within the last year * history of gastric surgery or history of malabsorption disorders * active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin) * pregnant, lactating, expecting to conceive or donate eggs, or male participant planning to impregnate or provide sperm donation or with a female partner who is pregnant * current moderate or severe depression or history of depression associated with hospitalization, electroconvulsive therapy, or severe disruption of daily functions, or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric disorders * evidence or history of chronic hepatitis not caused by hcv
a preventive, multidisciplinary primary care intervention organized around a therapeutic garden: acceptability to patients suffering from cardio-neurovascular pathology and to those involved in the action.

Conditions: Vascular Disease; Cardiovascular; Atrial Fibrillation (AF); Heart Failure NYHA Class II; Cardiomyopathies; Stroke, Ischemic; Hypertension Resistant to Conventional Therapy

Summary: a preventive, multidisciplinary primary care intervention organized around a therapeutic garden: acceptability to patients suffering from cardio-neurovascular pathology and to those involved in the action.


Eligibility criteria:
inclusion criteria: * age \> 18 years old; * living in the vicinity (+-20 km) of gap, laragne-montéglin, veynes and clermont-ferrand; * having been invited to take part in the intervention by the caregivers of the medical structures * suffering from an ald based on cnam medical criteria (stroke, aomi, rhythm disorders, valvular heart disease, congenital heart disease, stage i and ii heart failure), severe hypertension, chronic coronary disease) exclusion criteria: * heart failure based on cnam medical criteria (ald n°5) stage iii and iv according to nyha classification ; * with a contraindication to physical activity ; * living in an institution; * unable to walk more than 100 m independently; * alzheimer's disease or other dementias based on cnam medical criteria ; * with an unlabelled cognitive impairment limiting comprehension.
assessment of autonomic neuronal changes during moderate rise of intracranial pressure in human

Conditions: Increased Intracranial Pressure Disorders

Summary: the purpose of this project is to determine during moderate rise of intracranial pressure (icp) in awake patient, the change in autonomic function and its influence on cerebral and systemic haemodynamics.

from preliminary data, we know that changes in icp influences both systemic and cerebral haemodynamics, introducing the concept of intracranial baroreflex we have to i) confirm the presence of this intracranial baroreflex, ii) analyze the changes in autonomic function during moderate rise in intracranial pressure (icp) in human, and iii) correlate the changes in cerebral and systemic haemodynamics with autonomic function.

Eligibility criteria:
inclusion criteria: * patient suspect of hydrocephalus with gait problems, urine incontinence and mild cognitive impairment. * signed consent exclusion criteria: * psychiatric problems * severe cognitive decline

Keywords: intracranial baroreflex
salivary epidermal growth factor (egf) concentration before and after treatment of reflux laryngitis

Conditions: Gastroesophageal Reflux Disease (GERD); Chronic Laryngitis

Summary: * saliva plays a key role in the homeostasis of the digestive tract * the reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal and pharyngeal mucosas * there seems to be no correlation between the severity of reflux episodes and the intensity of inflammatory changes, suggesting individual protective mechanisms to refluxate exposure * inorganic and organic salivary changes have been associated to gastroesophageal reflux disease (gerd) and its supraesophageal manifestations, especially reflux laryngitis (laryngopharyngeal reflux- lpr) * decreased salivary epidermal growth factor (egf) concentrations have been found in patients with gerd and lpr, but it is unclear if these are primary or secondary to the disease. * hypothesis: the decreased salivary egf concentrations in patients with reflux laryngitis is primary and therefore would not change after treatment and control of the disease

background \& aims: gastroesophageal reflux disease (gerd) is known to affect the upper airways and may cause a variety of inflammatory changes in the pharynx and larynx. the pathophysiology of the supraesophageal forms of gerd is widely unknown. studies have suggested decreased salivary epidermal growth factor (egf) concentrations in patients with reflux esophagitis and laryngitis. it is however unclear if these abnormalities are primary or secondary. the aim of the current cohort study was to compare salivary egf concentrations in adults with reflux laryngitis before and after treatment and control of the disease to that of healthy individuals. methods: twenty-one patients with reflux laryngitis were studied prospectively at a tertiary teaching hospital. spontaneous whole saliva was sampled before and after a 16-week course of full dose proton pump inhibitor (ppi) twice daily and compared to that of 13 healthy controls. salivary egf concentrations were established using a commercially available elisa kit.

Eligibility criteria:
inclusion criteria: * study group: * symptoms of reflux laryngitis (reflux symptom index- rsi \>13) and videolaryngoscopic signs (reflux finding score - rfs \>7), * positive 24 hour double probe esophageal ph monitoring; * control group: * reflux symptom index (rsi)\<13 * reflux finding score (rfs) \< 7 exclusion criteria: * tobacco, alcohol or other inhaled drug use; * chronic or acute rhinosinusitis; * prior history of surgery to the digestive tract or salivary glands; * prior or current diagnosis of head and neck or digestive tract tumors; * chronic use of drugs known to alter salivary flow and irritate the larynx, such as, diuretics, anticonvulsants, antihistamines, and inhaled steroids

Keywords: larynx gerd saliva epidermal growth factor
analysis of the curative effect of salvage surgery on recurrent laryngeal carcinoma

Conditions: Recurrent Laryngeal Carcinoma

Summary: early laryngeal cancer can be treatment by laser surgery or radiotherapy, intermediate and advanced laryngeal carcinoma mainly surgical treatment. laryngeal cancer is at risk of recurrence after treatment, whether in surgery, laser or radiotherapy. the recurrence rate of laryngeal cancer is about 10% reported at home and abroad. local pain, ulcers, breathing and eating difficulties caused by recurrent laryngeal cancer seriously reduce the quality of life of patients and seriously endanger their lives. therefore, head and neck surgeons are required to make every effort to give them saving treatment in order to improve their quality of life. prolong the patient's life.

medical records and extracted information including age, gender, initial treatment modality of glottis cancer, recurrence time, recurrence site, histopathology, tumor grade according to world health organization (who) grade and tumor stage. stages were defined according to the american joint committee on cancer (ajcc) staging system.

Eligibility criteria:
inclusion criteria: * more than 18 years, * patients with recurrent glottic laryngeal squamous cell carcinoma undergoing salvage surgery exclusion criteria: * postoperative radiotherapy and chemotherapy * loss to follow-up

Keywords: salvage surgery recurrent laryngeal carcinoma experience
digital therapy in self-management of copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive pulmonary disease (copd) patients during the use of inhalant medication, and provide personalized reminders and feedback to patients according to the data. the purpose is to analyze whether this digital intervention scheme can reduce the number of acute exacerbations of copd, improve the management effect of copd, and reduce the burden of disease by improving the medication compliance of copd patients.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with copd 2. aged 40 and above 3. had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks 4. can operate a smartphone proficiently 5. take inhalation medication suits for the inhalation monitoring device as treatment 6. fully understand and be willing to sign the informed consent form exclusion criteria: 1. certain comorbidities (e.g. unstable coronary complications) 2. undergone thoracic, abdominal or ophthalmic surgery in recent 3 months 3. pregnant or lactating women 4. abs allergy history

Keywords: chronic obstructive pulmonary disease adherence inhaled medication self management
it-based sports therapy application in haemophilia

Conditions: Haemophilia; Sports Physical Therapy

Summary: haemophilia is often associated with chronic pain, functional restrictions and negative consequences regarding the individual physical performance, especially on basic motoric skills, activities of daily life and quality of life. caused by high benefits, physical activity is a fixed component and recommendation in the guidelines for the management of haemophilia. several studies showed that goal-directed physical activity is feasible for patients with haemophilia (pwh) without any complications or bleeding episodes. nevertheless, there are difficulties in the implementation of supervised sports therapy for pwh regarding local distributions and uncertainties concerning correct exercise execution on patients´ side and in the monitoring and adequate training regulation from long distances on the therapeutic side. aim of this project is a patient-related and participative development and pre-evaluation of a mobile application to generate an online-guided, individualized home training for pwh, followed by pre-evaluation in terms of a twelve weeks interventional phase. the intention of this project is to show, that a mobile device is an appropriate way to increase physical activity of pwh. due to the development of an innovative trainings application, adapted to the needs of pwh, a larger number of patients should be reached and supported later on in participating on supervised physical exercise to improve the individual physical performance and therefore the quality of life. additionally, with an individualized exercise program also adapted to the specific interests, needs and physical conditions, pwh at any age can be addressed. furthermore, in cooperation with the patient, the medical staff will get systematic information of patients´ exercise activities to generate optimal factor and overall treatment patterns. in addition, on the basis of the mobile device pwh will be able to comprehend their individual exercise performance and to get an overview of the individual trainings progress and improvements of physical performance with the purpose to enhance the processes of self-motivation. detailed instructions and information of exercise execution, need of exercise and physical adaptions to be achieved, will minimize complications and support patients´ self-confident for participating on exercise.


Eligibility criteria:
inclusion criteria: * patients suffering from moderate to severe haemophilia a or b * submitted written consent to participate in the study * approved sports capability and internet access exclusion criteria: * patients suffering from other bleeding disorders * patients without written consent * patients under 18 years of age * patients without sports capability * patients without internet access

Keywords: haemophilia sports therapy trainings application home training
comparative evaluation of diffusion weighted mri and ultrasonography in the detection of breast lesions

Conditions: Breast LN

Summary: this study aims to conduct a comparative evaluation of diffusion weighted mri (dw-mri) and ultrasonography (us) in detecting breast lesions. breast cancer remains a leading cause of cancer-related deaths among women worldwide, necessitating efficient and accurate diagnostic methods. ultrasonography, a commonly used imaging modality, provides valuable insights into breast lesions but has limitations in sensitivity and specificity.

diffusion weighted mri, on the other hand, shows potential for higher accuracy in identifying malignant versus benign lesions due to its ability to assess tissue cellularity and integrity non-invasively. this research will involve a specified number of female participants within a defined age range, focusing on the comparative effectiveness, sensitivity, and specificity of dw-mri and us. the findings are expected to contribute valuable insights into optimizing breast cancer diagnostic protocols, ultimately aiding in earlier detection, better patient outcomes, and possibly reducing the need for invasive biopsy procedures.

Eligibility criteria:
inclusion criteria: * women with suspected breast lesions * breast feeding woman * referred for mri examination. * age 18 years or older * ability to provide informed consent. exclusion criteria: * contraindications to mri or contrast agent * previous breast implant * early pregnancy exclusion criteria \*