Kornimate/medical-research-clean huggingface dataset:
examining the feasibility of prolonged ketone supplement drink consumption in adults with type 2 diabetes

Conditions: Diabetes; Hyperglycemia; Ketosis

Summary: ketones are a source of energy and signaling molecule that are produced by the body when not consuming any food or consistently eating a low-carbohydrate "keto" diet. blood ketones can be used as a source of energy by the body, but they may also act as signals that impact how different cells in the body function. recently, ketone supplements have been developed that can be consumed as a drink. these supplements can raise blood ketones without having to fast or eat a "keto" diet. previous studies have shown that these supplement drinks can lower blood sugar without having to make any other dietary changes. drinking these ketone supplements may therefore be an effective strategy to improve blood sugar control and influence how cells function. to find out if it is feasible for people with type 2 diabetes to drink these ketones supplements regularly over 90 days, we will compare between two groups in this study: one group that will be asked to drink ketone supplements, and one group that will be asked to drink a placebo supplement.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes by a physician at least 1 year prior * stable use of glucose-lowering medications for at least three months * must be able to read and understand english in order to complete the study questionnaires exclusion criteria: * competitively trained endurance athlete * actively attempting to gain or lose weight * having a history of mental illness or existing neurological disease * having a history of cardiovascular events in the last two years, hypoglycemia, irritable bowel syndrome, or inflammatory bowel disease * are currently taking sglt2 inhibitors or insulin * are using more than 2 classes of glucose-lowering medication * currently following a ketogenic diet or regularly taking ketone supplements * unable to commit to a 90-day trial * being unable to follow remote guidance by internet or smartphone * currently taking natural or over-the-counter supplements specifically designed to lower blood glucose (e.g., berberine, bitter melon)
internet-administrated treatment of anxiety disorders

Conditions: Anxiety Disorders; Depression

Summary: the purpose of this study is to determine whether tailored internet-administered cbt is a feasible treatment for anxiety disorders in clinical settings.


Eligibility criteria:
inclusion criteria: * over 18 years * fulfill the criteria for at least one anxiety syndrome exclusion criteria: * ongoing psychological treatment * suicidal prone * ongoing alcohol addiction
vascular inflammation stratified by body size phenotype

Conditions: Atherosclerosis; Obesity; Metabolic Syndrome

Summary: * vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18fdg-pet is a promising novel tool for identifying and quantifying vascular inflammation within atherosclerotic plaque * recently, unique subsets of obese individuals, such as metabolically obese but normal weight (monw) and metabolically healthy obese (mho), have been getting an attention * therefore, the purpose of this study is to examine the relationship of vascular inflammation,measured by fdg-pet, with various body sized phenotypes


Eligibility criteria:
inclusion criteria: * healthy patients for visiting routine medical check in our clinic exclusion criteria: * history of cvd (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) * stage 2 hypertension (resting blood pressure, ≥160/100 mmhg) * history of inflammatory conditions that affect the study results * taking medications that might affect inflammatory status, including steroid and non-steroidal anti-inflammatory drug within 6 months * or malignancy or severe renal or hepatic disease
a study of asp1941 in participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the objective of this study is to evaluate the efficacy, safety and pharmacokinetics of asp1941 in male and female patients with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * established diagnosis of type 2 diabetes mellitus * fasting serum c-peptide level \> 0.6 ng/ml * hba1c between 7.0 and 10.0% * body mass index between 20 and 45 kg/m2 exclusion criteria: * serum creatinine \> upper limit of normal * proteinuria (albumin/creatinine ratio \> 300 mg/g) * dysuria and/or urinary tract infection * significant renal, hepatic or cardiovascular diseases * ketosis * hypertension * severe gastrointestinal diseases

Keywords: diabetes mellitus, type 2 asp1941
gastrointestinal endoscopy in patients with prothrombotic conditions: the endohem registry

Conditions: Gastrointestinal Bleeding; Cardiovascular Complication; Anticoagulants; Circulating, Hemorrhagic Disorder; Gastrointestinal Endoscopy

Summary: this observational study evaluates the safety of gastrointestinal endoscopy in patients on oral anticoagulants (vitamin k antagonists, rivaroxaban, dabigatran, edoxaban, and apixaban). this registry aims to assess the incidence, characteristics and risk factors for cardiovascular and bleeding events associated with an endoscopic procedure. besides, it aims to evaluate the differences between vitamin k antagonists and doacs users and to estimate the impact of anticoagulation withdrawal time on the primary and secondary outcomes.


Eligibility criteria:
inclusion criteria: * age \>= 18 years. * patients with preoperative use of oral anticoagulants (vitamin k antagonist, apixaban, edoxaban, rivaroxaban or dabigatrán) undergoing gastrointestinal endoscopy. * patients on oral anticoagulants (vitamin k antagonist, apixaban, edoxaban, rivaroxaban or dabigatran) presenting with gastrointestinal bleeding, regardless of receiving gastrointestinal endoscopy. * signed informed consent. exclusion criteria: * negative to participate in the study.

Keywords: gastrointestinal endoscopy oral anticoagulants gastrointestinal bleeding cardiovascular event
revolade tablets specified drug-use survey

Conditions: Aplastic Anemia

Summary: this is a multicenter, single-arm, non-interventional study (nis) to confirm the safety and efficacy of eltrombopag in anti-thymocyte globulin (atg) treatment naive pediatric patients with aplastic anemia (aa).

the objective of this survey is to confirm the safety and efficacy of eltrombopag in atg treatment naive pediatric patients with aa. eltrombopag should be administered according to the dosage and administration specified in the latest version of the package insert. the observation period is 1 year (364 days) from the start of treatment with this product, regardless of whether treatment with eltrombopag is continued or not. however, if hematopoietic stem cell transplantation is performed within 1 year after the start of treatment with eltrombopag, the observation period shall be until the date of hematopoietic stem cell transplantation.

Eligibility criteria:
inclusion criteria: * patients whose legally acceptable representative has given written consent for cooperation in this survey prior to enrollment in this survey * patients aged ≥ 6 years and \< 18 years at the start of treatment with eltrombopag * pediatric patients with aa who receive eltrombopag for the first time in combination with atg after the approval of additional dosage and administration for "atg-naïve pediatric patients with aa" exclusion criteria: * patients who have received atg without concomitant use of eltrombopag * patients with congenital aa * patients with suspected or confirmed diagnosis of myelodysplastic syndrome (mds) at the start of treatment with eltrombopag * patients who have received any drug products containing the same ingredient as eltrombopag (including investigational products)

Keywords: nis pediatric aplastic anemia aa revolade tablets eltrombopag drug-use survey
a multicenter, randomized, controlled trial of prednisone combined with ursodeoxycholic acid in the treatment of primary biliary cholangitis with moderate to severe interface hepatitis characteristics

Conditions: Primary Biliary Cholangitis (PBC)

Summary: about 1/3 of patients with primary biliary cholangitis (pbc) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to udca treatment. however, as it is not yet sufficient to diagnose autoimmune hepatitis or overlap syndrome, it is difficult to initiate immunosuppressive therapy such as steroids according to current guidelines. the aim of this study is to explore whether pbc patients with moderate to severe interfacial inflammation can benefit from udca combined with prednisone therapy, and its treatment safety.


Eligibility criteria:
inclusion criteria: 1. voluntarily joining the group, able to understand and sign an informed consent form; 2. 18 years old ≤ age ≤ 75 years old; 3. the diagnosis of primary biliary cholangitis follows the aasld international diagnostic and treatment guidelines (meeting two of the following three criteria: ama or gp210, sp100 positive; elevated serum alp levels; pathological manifestations include non suppurative cholangitis and destruction of the interlobular bile duct; 4. liver histology suggests moderate to severe interfacial hepatitis (moderate,\&lt;50% portal or fibrous septa destruction, severe,\&gt;50% portal or fibrous septa destruction) with serum alt\&lt;5 \* uln, serum igg\&lt;2 \* uln, and negative serum anti smooth muscle antibodies; 5. not receiving udca, hormone or other immunosuppressive therapy before enrollment; 6. alp\&gt;1.67 \* uln. exclusion criteria: * history or presence of other concomitant liver diseases. * alt or ast \&gt; 5×uln, tbil \&gt; 3×uln. * if female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating. * allergic to fenofibrate or ursodeoxycholic acid. * taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users. * recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites. * patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse). * creatinine \>1.5×uln and creatinine clearance \<60 ml/min. * currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen). * planned to receive an organ transplant or an organ transplant recipient. * needing liver transplantation within 1 year according to the mayo rick score. * any other condition(s) that would compromise the safety of the subject or compromise

Keywords: primary biliary cholangitis interface hepatitis ursodeoxycholic acid corticosteroids
facilitating neuroplastic changes of acute stroke survivors

Conditions: Stroke

Summary: this project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. it involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. the early acute stroke rehabilitation device will be evaluated in this clinical trial.

stroke survivors often experience loss of motor control and impaired function. immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. however, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. to address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. the early acute stroke rehabilitation device will be evaluated in this clinical trial.

Eligibility criteria:
inclusion criteria: * acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment) * hemiplegia or hemiparesis * 0≤manual muscle testing (mmt)\<=2 * age 30-85 * ankle impairments including stiff calf muscles and/or inadequate dorsiflexion exclusion criteria: * medically not stable * associated acute medical illness that interferes with ability to training and exercise * no impairment or very mild ankle impairment of ankle * severe cardiovascular problems that interfere with ability to perform moderate movement exercises * cognitive impairment or aphasia with inability to follow instructions * severe pain in legs * severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion) * pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee

Keywords: stroke paraplegia acute
safety and pharmacokinetics of orodispersible bt-11 in active eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: the proposed phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral bt-11 in active eosinophilic esophagitis.


Eligibility criteria:
no patients enrolled
airway limitation study: study in primary care centers of chronic bronchitis in long-term cigarette smokers of at least 40 years of age with symptoms of cough and shortness of breath

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the study does not involve testing of a drug (no treatment intervention). the study will will use spirometry (breathing tests) in subjects of 40 years of age and older with a history of cigarette smoking with chronic bronchitis to check their disease status and whether or not they have copd. also, study subjects will be asked to complete a questionnaire (to answer a list of questions on paper).


Eligibility criteria:
inclusion criteria: - male or female - ≥40 years of age - current or previous cigarette smoker with a history of cigarette smoking of ≥10 pack/years - self reported symptoms of chronic bronchitis where chronic bronchitis is defined as the presence of productive cough for at least 3 months in each of the successive 2 years - completion of written informed consent prior to study participation - subject must be able to read, comprehend, and record information in english. exclusion criteria: - regular use (i.e., prescribed for use on a daily basis) of the following respiratory medications for the six months prior to the study visit: ipratropium, ipratropium/albuterol combinations, tiotropium, salmeterol, formoterol, inhaled corticosteroids, inhaled corticosteroid/long-acting beta-agonist combinations, theophyllines, oral beta-agonists. - previous lung surgery, including, lung transplant, lung resection, lung volume reduction surgery, etc. - current diagnosis of a significant lung condition other than chronic bronchitis, including, asthma, lung cancer, cystic fibrosis, pulmonary fibrosis, bronchiectasis, active tuberculosis, sarcoidosis, or alpha-1-antitrypsin deficiency. - any medical or physical condition that would interfere with the adequate performance of spirometry. - evaluation and/or treatment by a pulmonary specialist (e.g., pulmonologist or allergist) within 3 years of the study visit. - a spirometrically confirmed diagnosis of copd. - have, in the opinion of the investigator, evidence of current alcohol, illegal drug or solvent abuse. - limited ability to provide a valid informed consent due to serious uncontrolled psychiatric disease, intellectual or cognitive deficiency, poor motivation or other relevant condition which in the opinion of the site principal investigator will interfere with the subject's participation in the study. - pregnant females. - participating investigator, sub-investigator, study coordinator, employee of the participating investigator or family members of the aforementioned site staffs.

Keywords: chronic obstructive pulmonary disease (copd) chronic bronchitis spirometry
role of antibodies against glutamate receptors and double stranded dna in epilepsy patients

Conditions: Epilepsy

Summary: the investigators will check the serum of epilepsy patients for antibodies against glutamate receptors and double stranded dna. they will characterise the patients (by the kind of epilepsy, autoimmune disease comorbidity, and cognitive profile).


Eligibility criteria:
inclusion criteria: * 120 epilepsy patients from the epilepsy clinic and emergency room (er) * controls: 100 patients with other neurological diseases and no epilepsy; and 30 healthy volunteers.
the use of leucocyte platelet rich fibrin (l- prf) covered perforated guided tissue membrane for treatment of periodontal intrabony defects

Conditions: Periodontal Diseases

Summary: this study is the first to investigate the effect of leucocyte platelet rich fibrin (l-prf) combined with perforated membrane in order to treat infrabony defects and assess their combined effect in clinical attachment level gain and filling of base of the defect (bd). the main hypothesis was that if the l-prf act as a chemoattracttant for a higher number of periosteal derived periodontal cells (pdpcs) and gingival mesenchymal stem cells (gmscs) encouraging their passage through the membrane perforations.

a randomized (controlled) clinical trial which included forty sites with intrabony interproximal defects (2- or 3-wall) premolar/molar teeth assessed for clinical parameters. the four treatment modalities were randomly allocated by a predetermined computer generated randomization list (www.randomizer.org) into four equal groups; group i (control group) open flap debridement (ofd): included intrabony defects treated by open flap debridement (ofd).group ii perforated membrane (pm): included intrabony defects treated by perforated membranes.group iii leucocyte-platelet rich fibrin (l-prf): included intrabony defects treated by leukocytes platelet rich fibrin (l-prf). group iv leucocyte-platelet rich fibrin + perforated membrane (l-prf + pm): included intrabony defects treated by leucocyte platelet rich fibrin \& perforated membranes.

Eligibility criteria:
inclusion criteria: * both genders aged from 18- 60 years. * patients free from any systemic diseases that may contra-indicate periodontal surgery (ahmed y. gamal et al., 2014). * two- or three-wall intrabony defects in premolar/molar teeth without furcation involvement, that are measured from the alveolar crest to the defect bottom in diagnostic periapical radiographs of ≥ 3 mm (reynolds et al., 2015). * probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm at the site of intrabony defects 4 week after the phase one therapy (ahmed y. gamal et al., 2014). * free from any periapical pathosis. * patients willing and able to return for multiple follow up visits and perform oral hygiene instructions. * absence of occlusal interference, mobility and open interproximal contact. * good fulfillment to plaque control instructions following initial therapy. exclusion criteria: * smokers. * pregnant and breast feeding females. * periodontal surgical treatment in the previous 12 months at the involved sites. (a. y. gamal et al., 2016) * persistence of gingival inflammation after phase i therapy. * vulnerable groups as handicapped, mentally disabled, prisoners and orphans.

Keywords: perforated membrane l-prf guided tissue regeneration vertical defects intrabony defects
a study to evaluate the effects of ocrelizumab on immune responses in participants with relapsing forms of multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \[tt\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \[23-ppv\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \[13-pcv\], influenza vaccine, keyhole limpet hemocyanin \[klh\]) after administration of a dose of ocrelizumab (ocr) in participants with relapsing multiple sclerosis (rms).


Eligibility criteria:
inclusion criteria: * diagnosis of rms in accordance with the revised mcdonald criteria * received at least one previous immunization against tt or tetanus and diphtheria (dt/td) or tetanus, diphtheria, and acellular pertussis (dtap/tdap) * expanded disability status scale (edss) at screening from 0 to 5.5 points, inclusive * for sexually active female participants of reproductive potential, use of reliable means of contraception exclusion criteria: * contraindications for or intolerance to oral or iv corticosteroids, including iv methylprednisolone, according to the country label * known presence of other neurologic disorders * treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis
intravenous silibinin in combination with peg-interferon and ribavirin in nonresponders

Conditions: Hepatitis C

Summary: by chance the investigators found that iv. silibinin has a potent antiviral effect against the hepatitis c virus. based on the results of the dose finding study (published) te optima dosing schedule is explored.this study will be evaluate whether the highest active dose given for the optimal time combined with standard of care will result in a sustained virologic response (=cure of hepatitis c).

since the publication of the first data the optimal dosing schedule is investigated

Eligibility criteria:
inclusion criteria: * nonresponders to full dose peg-ifn/rbv therapy * liver biopsy within the last 2 year exclusion criteria: * intolerance to one of the study drugs * coinfection with hiv/hbv

Keywords: silibinin chronic hepatitis c peginterferon ribavirin nonresponders efficacy of iv. silibinin safety
treatment of recurrent glioblastoma with fractionated radiotherapy combined with cadonilimab

Conditions: Recurrent Glioblastoma

Summary: the purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with cadonilimab combined with fractionated radiotherapy.


Eligibility criteria:
inclusion criteria: 1. . written and signed informed consent. 2. . male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent. 3. epitentorial glioblastoma confirmed by pathology; diagnosis of recurrence through clinical imaging evidence. 4. the maximum diameter of recurrent tumor is less than 6 cm. 5. concurrent radiotherapy and chemotherapy with standard stup treatment scheme in the past. 6. the interval from the last radiotherapy is more than 6 months. 7. kps (karnofsky function status score)\>60. exclusion criteria: 1. prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment. 2. concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies. 3. multiple malignant gliomas. 4. subtentorial glioblastoma or extracranial metastatic lesions. 5. active autoimmune diseases. 6. known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (hiv).