Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of yh14617 in diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the objective of this study is to assess the safety, efficacy and pharmacokinetic of yh14617 after once weekly or biweekly injection in patients with type 2 diabetes mellitus to investigate the optimal recommended dosage. study period is 20 weeks including 12 weeks of treatment period and 8weeks of follow-up period without treatment.


Eligibility criteria:
inclusion criteria: * have signed a written informed consent voluntary, prior to the any procedure * volunteers of aged between 20 years to 75 years * have been diagnosed with type 2 diabetes at least 3 months prior to study * have a body mass index (bmi) of \> 23kg/m2 and have a history of stable body weight during 3 months prior to the first administration (not varying by \> 5% in weight) * have been treated with stable dose regimen of metformin \> 1500mg/day or maximum tolerant dose for at least 3 months prior to the first administration * have an hba1c between 7% and 10% inclusive exclusion criteria: * have been treated with insulin, sulfonylurea, thiazolidinedione class hypoglycemic drugs, exenatide or other glp-1 receptor agonist, dpp4-inhibitor, glucocorticoid and drugs that promote weight loss within 3 months prior to the first administration * have acute disease, other untreated disease or diabetic complications that needs additional treatment * have severe renal disorder(serum creatinine concentration \> 1.5 times of normal upper limit) or liver disorder(liver enzyme \> 2 times of normal upper limit) * have blood pressure \> 160/100mmhg * have been hospitalized due to cardiac disorder(angina, cardiac infarction, heart failure and etc.) within 1 year prior to the first administration * have history of critical disease within 1 year prior to the first administration * have untreated malignant tumor or have history of significant malignant tumor within 5 years prior to the first administration * have fasting plasma glucose(fpg) \> 250mg/dl or have random glucose level \> 350mg/dl * have more than 1 history of severe hypoglycemia that needed others help within 3 months prior to the first administration * have a known allergy or hypersensitivity to drugs * pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study * participated in any other clinical trials within 30 days prior to the first administration * subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons other than above

Keywords: diabetes mellitus yh14617 exenatide yuhan
how easy-to-follow exercises can help cancer patients with anxiety while receiving chemotherapy

Conditions: Cancer; Exercise; Stress

Summary: cancer is one of the main causes of death, and this study looks at how light exercise and stretching might reduce anxiety in patients receiving chemotherapy. the research took place in a hospital's daily care unit and used a study design where each patient was compared to themselves, measuring anxiety before and after the exercise program.


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years old) with cancer receiving chemotherapy * signed patient consent exclusion criteria: * the denial of the patient * the occurrence of side effects from the treatment (such as dizziness, nausea, severe fatigue) * patients with low cognitive level where they could not follow simple instructions * patients with hearing disorders that prevented them from following simple instructions * patients who could not mobilize independently.

Keywords: cancer physiotherapy exercise physical therapy chemotherapy stress
a study of basal insulin analog and insulin analog mid mixture in chinese participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in chinese participants with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes as defined by world health organization (who) criteria * are taking oral anti-hyperglycemic medications (oams) and are judged as oam failure by the investigator * most recent hba1c value ≥7.5% within 12 weeks of study entry * in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment * willing to start with insulin treatment exclusion criteria: * have a diagnosis of type 1 diabetes * have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time) * have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study * are pregnant or breastfeeding, or intend to become pregnant during the course of the study * are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible

Keywords: mid mixture insulin analog basal insulin analog
secondary prevention of stroke through non-drug therapeutic weight reduction

Conditions: Stroke; Obesity

Summary: scenario is a trial to investigate the role of non-drug weight reduction in secondary prevention of stroke. it is a single-blinded, randomized, controlled multicentre trial with two arms. the therapy arm is participating in a comprehensive weight reducing program, whereas the control group takes part in a lecture on healthy nutrition. the primary study objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary prevention of stroke. secondary objectives are functional outcome, cognitive status, post stroke depression, and health-related quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of ischemic stroke * age: 20 - 85 years * bmi ≥ 25.0 kg/m² or waist circumference in men ≥ 94cm and in women ≥ 80cm * functional impairment, which would allow to participate in weight reduction program (mrs 0-4, nihss 0-12) * patient must be capable of understanding informed consent * written informed consent for participation in the study exclusion criteria: * intracerebral hemorrhage as primary cause of stroke (secondary hemorrhage is not an exclusion criterion) * speech disturbance (aphasia or sever dysarthria) * dimming of consciousness * stroke due to arterial dissection or coagulation disorder * drug-related weight changes during previous 3 months * changes in appetite influencing medication listed in appendix during previous 3 months * bariatric surgery in the past * diabetes mellitus with a history of severe ketoacidosis * pregnancy or nursing * severe co-morbid disorders, e.g.: * av-block ≥ 2nd degree * heart insufficiency (nyha \> 2) * pericarditis, pericardial effusion * severe kidney insufficiency (creatinine \> 3 mg/dl; urea \> 150 mg/dl) * hepatic insufficiency (got \> 3 x uln; gpt \> 3 x uln) * severe psychiatric disease within the last six months (psychosis, suicide attempts) * chronic alcohol addiction or drug addiction * hiv- or hepatitis infection * bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to start of obesity program) * cognitive impairment with mmse \< 20 * depression with bdi \> 20 * patients who are unable to give consent to study participation (mmse \< 20, aphasia) * recurrent stroke or myocardial infarction in the period between screening for study participation and start of weight reduction program * simultaneous participation in another clinical trial

Keywords: stroke prevention obesity weight reduction
prevention of anhedonia in children

Conditions: Anhedonia; Depression

Summary: this trial will test the effects of a positive emotion-focused preventive intervention on reward responsiveness in children of mothers with histories of depression and anhedonia.

this study will test the effects of a dyadic preventive intervention, family promoting positive emotion (f-ppe), for 8- to 12-year-old children of mothers with a history of major depressive disorder (mdd) with anhedonia. the study will first test f-ppe effects on child reward responsiveness (r61), and pending evidence of target engagement, effects on real-world experience of interest/pleasure and clinical symptoms of anhedonia will be evaluated in a second, larger clinical trial (r33). f-ppe was designed to increase child positive valence systems function through mother-child training in behavioral and cognitive skills to increase pleasant activities and attention towards/savoring the positive, individual and dyadic goals, and skills practice. for the r61 phase, eligible child participants (n=60 intervention completers) will complete an eeg assessment of neural reward responsiveness, as well as halfway through the intervention (4 weeks) to determine dose effects. children and their biological mothers will be randomly assigned to 8 sessions of f-ppe or a psychoeducation comparison condition (groups will be matched on child sex and baseline rewp). both interventions will be administered through individual telehealth sessions with a masters- or doctoral-level clinician under the supervision of the pis. to ensure treatment fidelity, videotaped sessions will be reviewed for adherence to the protocol, clinicians will participate in weekly group supervision, and supervisors will randomly review recorded sessions for ratings of treatment adherence.

Eligibility criteria:
inclusion criteria: * biological mothers with past or current mdd with anhedonia and their 8- to 12-year-old children * child and biological mother can read and speak fluently in english * child and mother have access to a computer or tablet and internet for videoconferencing * for compensation purposes, child and biological mothers must be u.s. citizens exclusion criteria: * children with past or current major depressive disorder (mdd) and/or anhedonia lasting most of the day, nearly every day for at least 2 weeks based on semi-structured interviews will be excluded * mothers or children with intellectual or developmental disabilities * mothers with past 6 months substance use disorder with moderate or greater severity * children or mothers with a lifetime history of a manic or hypomanic episode/bipolar disorder * children or mothers with a psychotic disorder (e.g., schizophrenia) * children or mothers with visual or hearing impairments that interfere with completing study measures and sessions * child offspring of a mother who has previously participated in the study with another biological child * children taking medications for emotional or behavioral problems other than ssris (stable dose for 6 weeks before time of enrollment) or psychostimulants
seri® surgical scaffold for soft tissue support in revision augmentation surgery

Conditions: Subjects Requiring Revision Breast Augmentation Surgery

Summary: an evaluation of the clinical performance of seri® surgical scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.

this is a single arm prospective study. approximately 4 investigational sites will enroll and follow subjects who meet the study criteria.the study will span a total of approximately 18 months: an estimated 6 months for recruitment and 12 months for follow up. 50 subjects will be enrolled in the study. it is anticipated that given an average of 1.5 operated breasts per subject enrolled for revision augmentation surgery that 75 implantations of seri® surgical scaffold will occur.

Eligibility criteria:
inclusion criteria: * negative nicotine test at screening visit * previous augmentation with silicone-filled or saline-filled breast implants requiring revision augmentation surgery for increased nipple:inframammary fold distance * well vascularized skin flaps that can be approximated without tension exclusion criteria: * bmi (body mass index) that is ≥ 30 kg/m2 * active smoker or have smoked within 6 weeks prior to screening visit * pregnant or nursing * advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy * carcinoma of the breast * previous mastectomy or lumpectomy * abscess or infection in the body at the time of enrollment * had any disease, including uncontrolled diabetes (e.g., hbaic \> 8%), that is clinically known to impact wound healing ability. for example: collagen-vascular, connective tissue or autoimmune disorders (e.g., systemic lupus, rheumatoid arthritis, scleroderma) * subjects with diagnosed diabetes must have hbaic ≤ 8% within 3 months of enrollment * showed tissue characteristics that were clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration * had, or was under treatment for, any condition that may have constituted an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems) * history of prior implantation of any surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) in the breast * implantation of any non-seri® surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) during the study period * product contraindications for use of seri® surgical scaffold per the supplied package insert (e.g., hypersensitivity to silk)

Keywords: breast implant revision augmentation stretch deformity fold malposition bottoming out
dexmedetomidine and bupivacaine intra-articular for postoperative analgesia after knee arthroscopic surgery

Conditions: Post Operative Analgesia

Summary: the aim of this study to compare the analgesic effects of intraarticular dexmedetomidine added to bupivacaine with those of bupivacaine alone after knee arthroscopy

prospective double-blind study perform on 75 patients candidates for anterior cruciate ligament (acl) reconstruction by knee arthroscopy refer to the clinic of al azhar university hospital, assiut, egypt, to evaluate the effect of adding dexmedetomidine to intra articular bupivacaine injection on postoperative pain after knee arthroscopy.

Eligibility criteria:
inclusion criteria: * asa i-ii patients * either sex * aged 18-65 years * candidates for anterior cruciate ligament (acl) reconstruction by knee arthroscopy * exclusion criteria: * the patients with kidney failure, liver failure, valvular and ischemic heart disease , high blood pressure, diabetes, history of infection and malignancy. * history of coagulation diseases, and history of drug allergies to used drugs. * those who consumed nsaids and analgesics 24 h before surgery were excluded from the study.

Keywords: knee arthroscopy bupivacaine dexmedetomidine postoperative pain
nitazoxanide for the treatment of prolonged diarrhea in children

Conditions: Diarrhea

Summary: the purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.


Eligibility criteria:
inclusion criteria: * patients with diarrhea ≥3 days but \<30 days duration. * no visible blood in stool. exclusion criteria: * use of any antibacterial, antiparasitic or antiviral drugs within 5 days of enrollment. * females who are pregnant, suspected of being pregnant or breastfeeding. * serious systemic disorders incompatible with the study. * history of hypersensitivity to nitazoxanide. * patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness according to the investigator's judgment. * patients known to have or suspected of having aids or other immune deficiencies.

Keywords: diarrhea
bph-6: comparison of the urolift system to turp for benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this study is to compare the urolift system treatment to transurethral resection of the prostate (turp) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.

the study is a prospective, consecutive, multi-center, 1:1 randomized study (urolift system:turp). the study is intended to be conducted at up to 20 different centers in europe and canada to enroll up to 100 subjects. subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.

Eligibility criteria:
inclusion criteria: • men \>50 years old with moderate-severe bph exclusion criteria: * size, width of prostate * other medical condition or co-morbidity contraindicative for turp or urolift
topical treatment of bacterial conjunctivitis and its effect on microbial flora

Conditions: Bacterial Conjunctivitis

Summary: topical treatment of bacterial conjunctivitis and its effect on microbial flora


Eligibility criteria:
inclusion criteria: * patients from 1 to 13 years of age that have diagnosis of bacterial conjunctivitis in either or both eyes (for \< 3 days duration) based on clinical observation; matched healthy controls exclusion criteria: * cannot have had bacterial conjunctivitis symptoms as reported by parent for \> 2 days
safety, tolerability, and pharmacokinetics of arct-032 in healthy adult subjects and adults with cystic fibrosis.

Conditions: Cystic Fibrosis

Summary: determine the safety, tolerability and pharmacokinetics of single doses of arct-032 in healthy adult subjects (phase 1) and of two doses in adults with cystic fibrosis (phase 1b).

phase 1 of this study is a single ascending dose, first-in-human study to determine the safety, tolerability, and pharmacokinetics (pk) of arct-032. after screening, healthy adult participants will be randomized 3:1 to inhale a single dose of nebulized arct-032 or placebo. there are 4 planned sequential dose cohorts. after dosing, participants will have follow-up assessments over a 4-week period. phase 1b in adults with cystic fibrosis will enroll after phase 1 is completed and safety data are reviewed. phase 1b is an open-label, two-dose study in adults with cystic fibrosis to assess the safety, tolerability, and pharmacokinetics of arct-032. after completion of screening, each participants will inhale two doses of nebulized arct-032 two days apart. participants will have follow-up assessments over a 4-week period.

Eligibility criteria:
key inclusion criteria: 1. phase 1: healthy males or females aged 18 to 65 years at the time of informed consent. phase 1b: males or females aged 18 to 65 years with confirmed diagnosis of cf documented in subject's medical record 2. body weight between 40-100kg and body mass index between 16-35 kg/m2 3. phase 1: forced expiratory volume (fev1) at screening \>85% of predicted value for age, sex, and height. phase 1b: fev1 at screening between 50% and 100% of predicted value 4. surgically sterile or using an acceptable contraceptive method from the time of signing the informed consent form until at least 30 days after the last dose of study drug. 5. phase 1b only: subjects with cf on cftr modulator therapy must be on a stable regimen for at least 2 months prior to screening. key exclusion criteria: 1. history of illness or condition that might pose an additional risk or may confound study results. 2. pregnant or lactating (breast feeding) 3. history of severe allergic reaction to a liposomal product 4. clinically significant abnormalities in screening laboratory results 5. known history of or positive test for human immunodeficiency virus (hiv), hepatitis c or chronic hepatitis b 6. treatment with another investigational drug, biological agent, or device within 30 days of screening, or 5 half-lives of investigational drug, whichever is longer 7. drug or alcohol abuse within the past year 8. history of moderate to heavy smoking or vaping (\>10 cigarettes/sessions per day) within 6 months prior to the dose of study drug. participants must be willing to refrain from smoking or vaping within 1 week of dosing through day 15 9. systemic or inhaled corticosteroids within 3 months prior to screening (phase 1 only). 10. have any other conditions, which, in the opinion of the investigator or sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study

Keywords: cystic fibrosis, cf
plasma concentration of somatostatin and endocannabinoids after ga and ra in upper extremity trauma surgery

Conditions: Postoperative Pain; Arm Injury

Summary: the application of ra can decrease the central sensitization and chronic pain after trauma surgery. the plasma concentrations of somatostatin and fatty acid amides were not studied up to this time in this kind of settings, so investigators believe that this is the first work that shows how upper extremity nerve blockade changes the plasma concentration of somatostatin and fatty acid amides in upper limb surgery in trauma patients.

total of 100 american society of anesthesiologist (asa) i-iii, adult patients scheduled to elective or emergency trauma surgery of hand/forearm or shoulder are planned to be randomly allocated to general anaesthesia (ga) or ultrasound-guided (ug) brachial plexus block (bpb) group, in this randomized-prospective study after approval by the university research ethics board, pécs university medical school, hungary. all of the patients will receive detailed information about the planned bpb or ga techniques and surgeries, then written informed consents will be obtained. study participants are planned to be assigned randomly into 4 groups (shoulder ga; shoulder ra; hand/forearm ga; hand/forearm ra). standardized ug axillary-supraclavicular (ax-sc) approach to the bp is planned to be performed under sterile conditions, or standardized ga with propofol iv, fentanyl iv, and 1 mac (minimal alveolar concentration) sevoflurane, by experienced anesthesiologists. blood samples will be taken at 0-time point (straight before the administration of bp injection or the induction of ga) and straight after the surgery. the collected serum samples are stored at -70 °c for a maximum of two weeks prior to analysis. qualitative and quantitative determination of endocannabinoids and corticosteroids is performed by supercritical fluid chromatography coupled with tandem mass spectrometry after salting-out assisted liquid-liquid microextraction. for somatostatin measurement, the samples are immediately supplemented with aprotinin (20µl/ml blood sample; gordox 10 kiu/ml (kallikrein inhibitor unit/ml), richter gedeon budapest, hungary) and transported for centrifugation on ice. the pellet is discarded, and the plasma is stored at -80⁰c until further processing. the somatostatin concentration of the plasma sample is determined with both elisa (cea592hu, cloud-clone corp., wuhan, prc) and radioimmunoassay. the results are collected and analyzed. demographic data, vital parameters, and verbal numeric rate of pain intensity are collected prior to and after surgery.

Eligibility criteria:
inclusion criteria: * upper extremity fracture * surgery of hand/forearm or upper arm * unpremedicated patients * scheduled for elective or emergency trauma exclusion criteria: * psycho-mental conditions interfering with consent or assessment * the patient refused to participate * preexisting chronic pain condition * daily analgesic or sedative or steroid consumption * sedative or analgesic premedication * pre-existing neuro-endocrine disorders * antecedent cancer * advanced liver or kidney disease.