Kornimate/medical-research-clean huggingface dataset:
a study comparing hr17031 with insulin glargine in patients with type 2 diabetes

Conditions: Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs

Summary: the aim of this trial is to confirm the efficacy of hr17031 in controlling glycaemia in chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents


Eligibility criteria:
inclusion criteria: 1. male or female, aged 18-75 years at the time of signing the informed consent (both ends included) 2. body mass index (bmi) of 20.0-40.0 kg/m2 (both ends included) 3. diagnosed with type 2 diabetes for at least 90 days prior to screening 4. tested by local laboratory, hba1c is 7.5%-11% (including both ends) 5. before screening, the daily basal insulin dose had been stabilized at 20-40u/ day (including both ends) for at least 60 days 6. when screening: ①metformin monotherapy stable treatment ≥3 months; or ②metformin combined with another oad for stable treatment for ≥3 months; metformin dose ≥1500 mg/ day or maximum tolerated dose. 7. ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen. exclusion criteria: 1. known or suspected allergy to the investigational drug product or its components or excipients; 2. systemic glucocorticoid use within 3 months prior to screening 3. use of weight loss drugs within 3 months prior to screening 4. received insulin therapy within 1 year prior to screening (excluding short-term therapy \[continuous treatment ≤14 days\] or insulin therapy for gestational diabetes); 5. cardiovascular disease, defined as congestive heart failure (nyha iii-iv), unstable angina pectoris, stroke (except lacunar infarction without symptoms), myocardial infarction, coronary revascularization within 6 months prior to screening; and/or coronary, carotid, or peripheral arterial revascularization is planned at screening 6. (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmhg or diastolic blood pressure ≥100 mmhg) 7. proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening; 8. patients diagnosed with mental disorders; mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate; 9. known or suspected abuse of alcohol or narcotics; 10. previous history of pancreatitis (acute or chronic) 11. during pregnancy or lactation;fertile women (wocbp) or men who have fertility plan or unwilling to use appropriate contraceptive methods from the signing of the informed consent to 3 months after last use of the investigational drug product; 12. any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.
elobixibat for chronic constipation without defecation desire

Conditions: Chronic Constipation

Summary: patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. the primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from week 2 of the observation period at week 4 of the treatment period.


Eligibility criteria:
inclusion criteria: at the time of provisional registration * patients diagnosed with chronic constipation using the rome iv criteria for the diagnosis of chronic constipation * age: 20 years or older (at the time of obtaining consent) * gender: any * outpatients * patients for whom written consent can be obtained * patients who can record defecation, etc. in the patient diary at the time of registration ・dosing start criteria patients with the following ・'loss of defecation desire'\* in the second week of the observation period (1 week before the start of the treatment period) \*"loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "4. almost never" or "5. never". exclusion criteria: at the time of temporary registration exclude patients with any of the following conditions * patients with organ-related constipation or suspected of having organ-related constipation * patients with or suspected of having functional ileus * patients with or suspected of having inguinal hernia * patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection) * patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy * patients with complications of malignancy however, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered. * pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study * patients with serious renal, hepatic, or cardiac disease * patients with drug allergy to the study drug * patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent however, observational studies are excluded. * other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study. at the time of registration、dosing start criteria * patients who increased the dose of concomitantly restricted drugs during the observation period * patients who used concomitantly prohibited drugs during the observation period
comprehensive therapy to relieving the risk of recurrence and metastasis for colorectal cancer

Conditions: Colorectal Cancer

Summary: comprehensive therapy of traditional chinese medicine (cttcm) could relieve risk of recurrence and metastasis for stage ii \& iii colorectal cancer, the investigators take this clinical trial with retrospective-prospective cohort study based on previous studies by international multi-center way. if the study shows a positive result, a pragmatic randomized controlled study with prospective, multi-centre and large-sample design will be given continuously. the aim is to establish recommended programs suggested by cttcm strategies under conventional western medicine therapy (cwmt) for stage ii \& iii colorectal cancer.

cttcm: taking tcm decoction based on syndrome differentiation daily and each dosage is decocted two times for intervention one year with a chinese patent medicine at least. cwmt: with or without chemotherapy/or radiotherapy after the radical operation (r0) (according to the latest nccn clinical guideline).

Eligibility criteria:
inclusion criteria: * patient who is diagnosed colorectal cancer by patho\& cytologic diagnosis since accepting radical operation within half a year. * stage ii or iii colorectal cancer. * 18-75 yr. * being able to participate and sign the informed consent. exclusion criteria: * pregnant woman, psychotic. * patient who put together with other cancer. * existed serious complaint and functional disturbance (impairment) with non-tumorous in arch-organ. * reactiveness cerebrovascular disease (cvd) . * uncontrolled infection and metabolic disease. * one item of tumor marks is progressed, and it still is progressed when patient recheck. * tumor that it is neo-occurred in each organ or pelvic cavity or abdominal cavity without definite patho-quality.

Keywords: cohort study colorectal cancer traditional chinese medicine risk of recurrence and metastasis
[68ga]ga-nota-sna002 (pd-l1 pet tracer) for pet/ct in patients with solid tumors

Conditions: Solid Tumor; Positron-Emission Tomography(PET)

Summary: the purpose of this study is to evaluate the safety of \[68ga\]ga-nota-sna002 and investigate the uptake of \[68ga\]ga-nota-sna002 in patients with solid tumors.

after being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. patients will receive an injection of \[68ga\]ga-nota-sna002 (1.0-5.0mci) in day1 and will undergo pet/ct scanning to determine uptake of \[68ga\]ga-nota-sna002 in tumor lesions and reference tissues.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years (including boundary values); 2. have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (icf); 3. performance status (ecog) score 0-2 points (see appendix 1 for details); 4. basal heart rate 60-100 beats/min (including boundary values); 5. blood pressure measurement \< hypertension grade 1 level (including a history of hypertension, systolic blood pressure \< 140 and diastolic blood pressure \< 90 mmhg by exercise or drug treatment); 6. patients with confirmed solid tumors; 7. patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (recistv1.1); 8. imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced ct, enhanced mri or 18f-flurodeoxyglucose(fdg) pet/ct results are acceptable); 9. patients obtained with immunohistochemical pd-l1 expression results within the previous month. exclusion criteria: 1. those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment; 2. those who have extremely poor nutritional status and cannot tolerate the trial; 3. known or suspected evidence of active autoimmune disease; 4. patients taking high doses of hormones, such as more than 20mg of hydrocortisone or 5mg of prednisone in the morning and more than 10mg of hydrocortisone or 2.5mg of prednisone at night； 5. those with known severe allergy to sna002, similar drugs or excipients； 6. patients with brain metastases； 7. serum virology tests: positive results for any of hepatitis b virus surface antigen, hepatitis c virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies； 8. women who are pregnant or breastfeeding. 9. those who, in the opinion of the investigator, are not suitable to participate in this clinical study.
performance of novel bed side scores as predictors of hospital outcome in acute exacerbation of chronic obstructive pulmonary disease among women; cohort study

Conditions: COPD Exacerbation

Summary: * assess predictors of mortality in copd exacerbation between men and women. * evaluate the clinical outcomes in acute exacerbation of copd in women. * evaluate the validity of new scoring systems ( nivo, decaf, hacor ) as a predictor for hospital outcome in acute exacerbation of copd. * compare these new scoring system with the most widely used apache iv. * assessment of serum level of granulocyte colony stimulating factor ( gm-csf) in detecting the severity of copd exacerbation.


Eligibility criteria:
inclusion criteria: * patients with aecopd leading to hypoxemia, hypercapnia and respiratory acidosis with ph \ 45 mm of hg will be admitted to the respiratory intensive care unit (icu) for niv or the ward will be eligible for inclusion and not in need for mechanical ventilation exclusion criteria: * requirement for emergency intubation. * other contraindications to nippv including cardiac or respiratory arrest; nonrespiratory organ failure (eg, severe encephalopathy, severe gastrointestinal bleeding, hemodynamic instability with or without unstable cardiac angina); facial surgery or trauma; upper-airway obstruction; inability to protect the airway and/or high risk of aspiration; and inability to clear secretions.(6) * age \< 35 years.

Keywords: nivo, decaf, hacor
serum protein patterns in participants with mycosis fungoides/cutaneous t-cell lymphoma, psoriasis, or normal skin

Conditions: Lymphoma

Summary: rationale: the presence of specific serum proteins may allow a doctor to determine if a patient has mycosis fungoides/cutaneous t-cell lymphoma. purpose: this clinical trial is studying how well blood protein analysis detects mycosis fungoides/cutaneous t-cell lymphoma.

objectives: * determine whether computer-assisted, higher-order analysis of participant low molecular weight serum proteins can detect distinctive proteomic patterns in participants with normal skin vs mycosis fungoides/cutaneous t-cell lymphoma vs psoriasis. * determine whether these proteomic patterns can distinguish between various stages of cutaneous t-cell lymphoma. outline: this is a pilot study. participants complete a general and skin health questionnaire and undergo a whole-body skin examination. blood samples are taken and analyzed for low molecular weight serum proteins by mass spectroscopy. projected accrual: a total of 141-423 participants (47-94 each of healthy volunteers, psoriasis patients, and t3 cutaneous t-cell lymphoma patients and 141 t1, t2, and t4 mycosis fungoides patients) will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * meets criteria for 1 of the following categories: * healthy skin volunteer * no significant inflammatory or neoplastic disease of the skin or internal organs * diagnosis of 1 of the following skin diseases\*: * psoriasis * plaque-type disease * psoriasis area and severity index score at least 12 * mycosis fungoides/cutaneous t-cell lymphoma * clinical diagnosis of t1-t4 skin disease with a compatible pathologic diagnosis note: \*stable or worsening disease on no therapy or topical therapy only within the past 2 weeks patient characteristics: age * 18 to 85 performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * not pregnant * no known hiv-1-related diseases * no known htlv-1-related diseases * willing to undergo brief skin examination and fill out a questionnaire regarding skin and general health prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * more than 2 weeks since prior systemic therapy for skin disease

Keywords: recurrent cutaneous t-cell non-hodgkin lymphoma stage i cutaneous t-cell non-hodgkin lymphoma stage ii cutaneous t-cell non-hodgkin lymphoma stage iii cutaneous t-cell non-hodgkin lymphoma stage iv cutaneous t-cell non-hodgkin lymphoma recurrent mycosis fungoides/sezary syndrome stage i mycosis fungoides/sezary syndrome stage ii mycosis fungoides/sezary syndrome stage iii mycosis fungoides/sezary syndrome stage iv mycosis fungoides/sezary syndrome
evaluation of the performance of monthly replacement sphere lens designs in habitual soft contact lens wearers

Conditions: Myopia; Hyperopia

Summary: the objective of the study is to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (frp) lenses when worn for one month.

this study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different frp lens types. each lens type will be worn for approximately one month.

Eligibility criteria:
inclusion criteria: * is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer; * has read and signed an information consent letter; * is willing and able to follow instructions and maintain the appointment schedule; * self-reports having a full eye examination in the previous two years; * self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone; * has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator; * anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; * habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (note: the habitual contact lens brand is restricted such that no more than one third are to be the biofinity brand (or their equivalent private label brand name) and no more than one third are to be an alcon brand; * has refractive astigmatism no higher than -0.75dc in each eye; * can be fit and achieve binocular distance vision of at least 20/30 snellen (available lens parameters are sphere +6.00 to -6.00d, 0.25d steps). exclusion criteria: * is participating in any concurrent clinical or research study; * has any known active ocular disease and/or infection that contraindicates contact lens wear; * has a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable; * is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; * has known sensitivity to the diagnostic sodium fluorescein used in the study; * self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; * has undergone refractive error surgery or intraocular surgery.
treatment of androgenetic alopecia in females, 12 beam

Conditions: Androgenetic Alopecia; Hair Loss; Female Pattern Baldness

Summary: the purpose of this study is to evaluate the efficacy of the hairmax lasercomb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.

this is a randomized double-blind, sham controlled clinical study, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). the trial with 63 female subjects, who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have fitzpatrick skin types i-iv, with classifications of ludwig i-4, ii-1, ii-2, or frontal, have active hair loss within the last 12 months. subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration. initial efficacy endpoint for each subject will be assessed at visit 4 (week 16). safety analysis will be assessed based on the reports of adverse events during study.

Eligibility criteria:
inclusion criteria: * diagnosis of androgenetic alopecia * fitzpatrick skin types i-iv * ludwig i-4, ii-1, ii-2, or frontal * active hair loss within last 12 months exclusion criteria: * photosensitivity to laser light * malignancy in the target area * pregnancy * lactating females

Keywords: androgenetic alopecia hair loss female pattern baldness
work-to-rest ratios

Conditions: Hyperthermia

Summary: the purpose of the study is to compare physiological responses to two hours of work adhering to two variations of a work-to-rest ratio in a hot environment.


Eligibility criteria:
inclusion criteria: * healthy 18-39 year old individuals * physically active exclusion criteria: * history of cardiovascular, metabolic, respiratory, neural, or renal disease * hypertensive or tachycardic during the screening visit (systolic blood pressure ≥ 140 mmhg, diastolic blood pressure ≥ 90 mmhg, resting heart rate ≥ 100 bpm) * taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., acetaminophen, beta blockers, statins, aspirin) * any form of tobacco or nicotine use in the past six months * current musculoskeletal injury impacting physical activity * a positive pregnancy test at any point in the study * study physician discretion based on any other medical condition or medication
aesthetic restorations in deciduous anterior teeth

Conditions: Dental Caries in Children

Summary: this study proposes to conduct a randomized clinical trial (rct), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified icdas c+ score, with involvement of more than two surfaces. this sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins; and another group with monochromatic resin with chameleon effect and polyvinyl crowns.


Eligibility criteria:
inclusion criteria: * children ranging in age from 12 to 60 months with at least one active cavitated caries lesion involving more than 2 surfaces (c+ score) in deciduous upper incisors will be included. exclusion criteria: * patients with special needs, with general health conditions that may affect the oral cavity, whose guardians do not sign the inform consent form will be excluded. in addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula near the tooth and teeth with previous restorations; less than 2/3 of root (radiographically assessed), teeth without an antagonist, teeth with previous restorations and children with bruxism and/or deep bite.
development of an insomnia treatment for depressed adolescents

Conditions: Insomnia; Depression

Summary: major depressive disorder (mdd) occurs at least 11% of adolescents and approximately 53-90% of those adolescents have insomnia. if left untreated, insomnia increases the risk of relapse and recurrence of depressive episodes, unintentional injuries, poor school performance, substance use, obesity, and the risk for suicide. this project seeks to develop a nonpharmacological treatment for insomnia in adolescents with depression that is feasible and effective. the specific methodologies that will help accomplish these results are: 1) use of focus groups of adolescents with depression and insomnia to determine how the current standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for insomnia; cbti) among adults can be modified for use by adolescents with depression and 2) determine the preliminary effectiveness, feasibility, and tolerability of group cbti in adolescents with depression (cbti-ad) developed using feedback from the focus groups. this project will help to improve the quality and scope of delivery of mental health services in michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate depression in adolescents and b) to provide mental health professionals with a nonpharmacological treatment option for insomnia in adolescents with depression.


Eligibility criteria:
inclusion criteria: * between 13-19 years of age * are depressed * have insomnia exclusion criteria: * are not depressed * do not have insomnia * currently using a sleep aid * have bipolar depression * have psychotic disorder * have a sleep disorder other than insomnia

Keywords: adolescent depression insomnia