Kornimate/medical-research-clean huggingface dataset:
a multi-centre, randomised, controlled, masked phase 2 study of the safety and efficacy of kio-101 ophthalmic solution, versus vehicle control in the treatment of dry eye disease in patients with autoimmune disease

Conditions: Dry Eye Disease

Summary: a multi-centre, randomised, controlled, masked phase 2 study of the safety and efficacy of kio-101 ophthalmic solution, versus vehicle control in the treatment of dry eye disease in patients with autoimmune disease


Eligibility criteria:
inclusion criteria: * have a diagnosis of autoimmune disease (psoriatic arthritis, systemic lupus erythematosus (sle), or fibromyalgia) ≤ 10 years * have an ocular discomfort score (ods) score of ≥3 at screening * have an average vas score ≥ 50 at screening; and ≥ 40 at baseline, visit 2/day 1 * schirmer's 1 test \>1 but \< 10 mm at screening. * national eye institute (nei) corneal fluorescein staining score of ≥ 4 at screening (day 14) provided that the total nei score did not change \> ± 2 grades from screening (day -14) to baseline (day 1) visits, as confirmed by the investigator * have a best spectacle corrected visual accuity (bscva) score of 20/200 (+1.0 logmar) or better in both eyes at both the screening and baseline visits * have a conjunctival hyperaemia score of grade 2 or more on the efron scale in both eyes exclusion criteria: * have a history or presence of any ocular disorder or condition (other than dry eye disease (ded)) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety * have an autoimmune based vasculitis * have a history of ra \> 10 years. * have a schirmer's 1 test score of 0 to 1mm at screening * have had a corneal transplant in either or both eyes * have had puncta or intracanalicular plug present in either eyelid within 1 year prior to the screening visit or anticipated plug insertion or occlusion at any time during the study
brain effects of sacral neuromodulation

Conditions: Urinary Tract Disease

Summary: sacral neuromodulation (snm) has become an accepted treatment for patients with refractory lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence, non-obstructive chronic urinary retention and chronic pelvic pain syndrome. modulation of central afferent activity is considered critical to this therapeutic effect but the neural mechanisms are poorly understood. we hypothesize that snm has a significant effect on brain activity detectable by positron emission tomography (pet).


Eligibility criteria:
inclusion criteria: * patients with refractory lower urinary tract dysfunction scheduled for sacral neuromodulation exclusion criteria: * pregnancy * age \<18 years * claustrophobia

Keywords: refractory lower urinary tract dysfunction sacral neuromodulation brain effects neuroimaging neuromodulation
intense therapeutic ultrasound (itu) to treat plantar fasciitis

Conditions: Plantar Fasciitis; Plantar Fasciitis, Chronic; Ultrasound Therapy

Summary: it was previously hypothesized that patients receiving intense therapeutic ultrasound (itu) in addition to the standard of care would have a more rapid resolution of pain, faster return to activities, and a decrease in intra- and perifascial lesions.

intense therapeutic ultrasound (itu) is an established ultrasound-based therapy in which sound waves are concentrated and focused into a well-defined specific area of musculoskeletal tissue. previous researches hipothesize that the application of itu improve and accelerate healing in patients with chronic plantar fasciitis.

Eligibility criteria:
inclusion criteria: * both sex patients. * plantar fasciitis diagnosis: pain during walking during the first steps in the morning; pain due to palpation of plantar fasciia insertion. * chronic pain of at least 6 month. * longitudinal thickness of the plantar fasciia more than 4 millimeters. * no previous surgery in the plantar fasciia. * no previous application of alternative treatments such us shock waves or injections (last ninety days) exclusion criteria: * platelet count disorder or anticoagulation therapy. * anti-inflammatories usual treatment for the treatment of plantar fasciitis. * diabetic foot syndrome. * presence of metabolic disease such us: hypertension, hiper or hipothyroidism. * pregnancy or breastfeeding. * previous treatment with fluoroquinolones antibiotic. * bilateral plantar fasciitis. * diagnosed autoimmune disesase. * morphofunctional disorders in the foot and ankle. * diagnosed fibromyalgia. * heel disestesy.
the role of kl-6 in the clinical diagnosis of ild

Conditions: Interstitial Lung Disease

Summary: the purpose of the study is to evaluate the significance of kl-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ild) by detecting serum kl-6 levels among patients with ild, and comparing them to the clinical diagnostic criteria and other respiratory diseases. in addition, the study discusses the value of kl-6 levels in terms of ild treatment effect evaluation through the detection of serum kl-6 levels before treatment and after treatment.

as a multi-center, double-blind clinical study, the trial is divided into two parts. part 1: the purpose of this part is to evaluate the role of kl-6 as a biomarker in the clinical diagnosis of interstitial lung disease (ild) by detecting serum kl-6 levels among patients with ild, and comparing them to the clinical diagnostic criteria and other respiratory diseases, including pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and healthy control group. part 2: the purpose of this part is to study the value of kl-6 levels in terms of ild treatment effect evaluation through the detection of serum kl-6 levels before treatment and 30-90 days after treatment. treatment includes anti fibrosis, anti-inflammatory and other conventional therapies.

Eligibility criteria:
inclusion criteria: * serums from patients with ild, pulmonary tuberculosis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease and health * serums from patients with ild: before treatment and 30-90 days after treatment exclusion criteria: * serums from patients with cancer * serums with visible precipitate * serums with floc

Keywords: interstitial lung disease diagnosis krebs von den lungen-6
comparison of beck depression score in multipar and nulliparous women who have gone under dilatation and curettage

Conditions: Depression; Anxiety Depression; Pregnancy Early

Summary: it is aimed to compare the beck depression and anxiety values of the nulliparous and multipar pregnant women who undergo optional abortion below 12 weeks and to evaluate the effect of the parity on depression and anxiety.

the beck depression and anxiety scale consists of questionnaire questions asked to the patient, and the value on 17 indicates advanced depression. the bdi inventory has maximum of 63 and minimum of 0 scores: (0-10): are considered normal ups and downs (11-16): mild mood disturbance (17-20): borderline clinical depression (21-30): moderate depression, (31-40): severe depression, over 40: extreme depression. a persistent score of !17, requires psychiatric treatment

Eligibility criteria:
inclusion criteria: * healthy * women with a pregnancy less than 12 weeks * no psychiatric disease or drug use exclusion criteria: * those who have had a psychiatric diagnosis before, * women under the age of 18, * psychiatric drug users, * those who have experienced a major trauma or disease * during the 3-month follow-up period, who developed complications during the procedure pregnant again * women with a pregnancy greater than 12 weeks

Keywords: beck depression beck anxiety parite curettage
effects of pn2034 in insulin-dependent patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this study is designed to evaluate the safety and efficacy of pn2034 in insulin-dependent type 2 diabetics as measured by the change in average daily insulin dose from baseline to week 12. the effects of pn2034 on hba1c, fasting plasma glucose (fpg), and lipid levels will also be measured.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus * 21 to 65 years of age * on stable doses of insulin (\>/= 40 units/day) alone or with metformin for at least 3 months * hba1c level of \>/=7.5% but \</=10.0% * fasting blood sugar level \>/= 125 mg/dl but \</= 279 mg/dl * bmi 26-43 kg/m2 * direct bilirubin \< 1.5x the upper limit of normal (uln) * serum creatinine \< 1.5 mg/dl (males) or \< 1.4 mg/dl (females) * blood urea nitrogen (bun)\</=40 mg/dl * all other clinical laboratory parameters (hematology, serum chemistry, and urinalysis) within normal limits or not clinically significant * ecg normal, or abnormalities not clinically significant * surgically sterile,postmenopausal,or using adequate contraception and have a negative pregnancy test at screening * able to perform daily self-monitoring of blood glucose (smbg) tests * willing and able to sign an informed consent form exclusion criteria: * diagnosed with type 1 diabetes mellitus or has a history of ketoacidosis * treatment with tzds or any other oral antidiabetic (excluding metformin) within 3 months prior to screening or during study treatment * change in lipid-lowering medication within 2 months of screening * taken systemic corticosteroids within 1 month prior to screening or during study treatment * history of or current/active cardiovascular disease * significant current pulmonary conditions * significant thyroid disease * cpk value \> 3x uln * a female who is pregnant or lactating * systolic bp \> 160 mm hg or a diastolic bp \> 90 mm hg at screening * previous or current history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission within 5 years prior to randomization * liver function tests (alt, ast, alp) \> 2 times uln, or active liver disease at screening * history of positive hiv * positive hepatitis b test at screening * weight loss or gain \>/= 15 lbs within 3 months of screening * history of substance abuse (including alcohol abuse) within 2 years prior to screening * donated and/or received any blood or blood products within 3 months prior to randomization * taken an investigational study medication within 30 days prior to screening or during the study

Keywords: diabetes, type 2
colorectal cancer legal and administrative burden support: a pilot clinical trial

Conditions: Colorectal Cancer

Summary: this is a single center single-arm, pilot study of proactive and early connection with free legal care services for persons with advanced colorectal cancer to assess the feasibility, acceptability, and preliminary efficacy of this intervention in improving financial and psychosocial outcomes. participants will receive free, personalized legal care services from cancer legal care (clc), a nonprofit organization located in the twin cities of minnesota. the duration of study participation is 6 months, however, participants may continue to access free personalized legal care services beyond this period. all participants continue to receive standard of care as prescribed by their treating physician.


Eligibility criteria:
inclusion criteria: * diagnosis of advanced stage colorectal cancer. * estimated life expectancy of over 6 months in the opinion of the treating oncologist. * 18 years of age or older at the time of consent. * able to understand, speak, read, and write in english. * able to provide voluntary written consent prior to the performance of any research related activity. exclusion criteria: * lacks capacity to consent/has diminished capacity to consent.
disitamab vedotin combined therapy for locally advanced or metastatic nsclc patients with her2 alterations

Conditions: Non Small Cell Lung Cancer; ERBB2 Mutation-Related Tumors; RC48; Disitamab Vedotin

Summary: disitamab vedotin combined therapy locally advanced or metastatic nsclc patients with her2 alterations.

this study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with her2 mutation, amplification, or her2 mutation (mutation, amplification, protein over-expression) using disitamab vedotin（rc48） combined with tislelizumab or third-generation egfr-tki furmonertinib, in the aim of providing new treatment strategies for lung cancer patients with her2 pathway activation.

Eligibility criteria:
inclusion criteria: 1. age: 18 (inclusive) or above, regardless of gender. 2. histologically or cytologically confirmed locally advanced or metastatic nsclc, not suitable for radical surgery or radiotherapy (tnm 8th edition).". 3. biomarker: * arm 1: her2 alterations, no other driver gene mutations； * arm 2: egfr mutations accompanied by her2 alterations; * arm 3: her2 gene mutations, no other driver gene alterations; 4. number of treatment lines: * arm 1-2: patients who have not previously received systemic treatment for advanced diseases; * arm3:failed with at least one line of standard treatment or intolerance; 5. patients who have previously undergone neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy, or radiochemotherapy for the purpose of curing non metastatic diseases must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the randomization date. 6. there is at least one measurable lesion that meets the definition of the recist 1.1 standard at baseline. 7. ecog fitness status score: 0 or 1 point. 8. estimated survival time ≥ 3 months. exclusion criteria: 1. central nervous system metastasis or meningeal metastasis with clinical symptoms. 2. have a history of autoimmune diseases, immunodeficiency, including hiv positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 3. active hepatitis b (hepatitis b virus titer\>1000 copies/ml or 200 iu/ml); hepatitis c virus and syphilis infection. 4. have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug. 5. known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
dairy proteins and postprandial appetite regulation and energy expenditure

Conditions: Obesity

Summary: the aim of this study is to examine the effect of dairy proteins (whey and casein) on postprandial appetite regulation and energy expenditure.

several studies have shown that a high protein intake is associated with a increased loss of body weight and body fat as compared to a diet with a normal or low protein content. the effect seems to be due to a higher diet induced thermogenesis and increase satiety. milk has a high content of proteins. it contains two very different types of protein: whey and casein. whey is a soluble protein whereas casein clots into the stomach, which delays its gastric emptying and thus probably results in a slower release of amino acids. it is therefore very likely that the two types of protein affect the thermogenesis and appetite regulation differently. the aim of the present study is to examine the effect of dairy proteins (whey and casein) on postprandial energy expenditure, substrate oxidation and appetite regulation. the study will have a cross-over design including four meals each including a test drink (milk, casein drink, whey drink or water).

Eligibility criteria:
inclusion criteria: * healthy males * body mass index (bmi) 25-30 kg/m2 * 18-50 years * weight stable exclusion criteria: * smoker * regular use of medicine * elitist athletes * participation in other intervention studies

Keywords: dairy proteins appetite regulation energy expenditure
comparison of the efficacy of intraocular lens optic capture and in-the-bag implantation over 1 year in children with congenital cataract

Conditions: Congenital Cataract; Intraocular Lens Implantation; Optic Capture

Summary: approximately 30 eyes with congenital cataract who underwent primary or secondary intraocular lens implantation surgery at zhejiang eye hospital from march 2018 to december 2020 were enrolled. according to the implantation method of iol, patients were devided into the optic capture group and the endocapsular group. and through the clinical parameters of postoperative best corrected visual acuity (bcva), intraocular pressure (iop), iol position and whether appear visual axis opacity to compare the outcome of the 2 iol implantation methods.


Eligibility criteria:
inclusion criteria: * children aged 1 to 10 years diagnosed with congenital cataract * underwent i / ii iol implantation in our hospital * corneal diameter more than 9mm * good compliance exclusion criteria: * patients with other ocular or systemic diseases * patients whose iol cannot be implanted in or after the capsule due to ocular conditions * children with a history of other ocular surgery * low compliance
evaluation of an online intervention to help lgbtq youth cope with bullying

Conditions: Bullying of Child

Summary: the purpose of this research study is to conduct a pilot randomized controlled trial of a game-based intervention is able to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and gender minority (sgm) youth. the goals of the proposed study are to: (1) test the feasibility and acceptability of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors among sgm youth; and (2) using a randomized controlled trial, test the efficacy of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among sgm youth.

the purpose of this research study is to conduct a pilot randomized controlled trial of a game-based intervention is able to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and gender minority (sgm) youth. the goals of the proposed study are to: (1) test the feasibility and acceptability of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors among sgm youth; and (2) using a randomized controlled trial, test the efficacy of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among sgm youth.

Eligibility criteria:
inclusion criteria: * must identify as lesbian, gay, bisexual, queer, transgender or another sexual or gender minority * must have bullying experience * must have access to a computer and email exclusion criteria: * residence outside of united states * not within the age range
oxygenation of the cerebrum and cooling during transcatheter aortic valve implantation (tavi) procedures - part ii

Conditions: Aortic Valve Stenosis; Stroke

Summary: the aim of this study is to assess the possible neuroprotective effects of cooling (targeted cooling of the brain to 33°c) during transcatheter aortic valve implantation (tavi) procedures. from start of anesthesia, until final valve implantation, local cooling (by the rhinochill device) will be applied to the brain. effect of cooling on cerebral oxygenation, by cerebral oxygen saturation monitoring (nirs foresight technology) during the tavi procedure will be continuously assessed during native valve manipulation and during final valve deployment (=primary endpoint of he study). as secondary endpoints, neuropsychological testing performed before and after tavi procedure will assess the effects of the use of cooling during the tavi procedure. neuron-specific enolase (nse) and s100-beta will be analyzed during and up to 72hrs after tavi to compare the cerebral ischemic damage between cooled and non-cooled patients. and finally, diffusion-weighted mri of the brain will be performed 5 days before and 5-7 days after tavi to compare the number and total amount of cerebral ischemic insults between cooled and non-cooled patients. the hypothesis behind this study is that by local cooling of the brain during manipulation of the calcified aorta and aortic valve, the brain might be protected from cerebral ischemic insults.


Eligibility criteria:
inclusion criteria: * pts scheduled for transcatheter aortic valve implantation exclusion criteria: * pts with pacemaker already implanted * pts with recent stroke or transient ischemic attacks (tia) (6months) * pts with extreme claustrophobia for mri brain examination
survival rate of all ceramic restorations treated with air-water-blasting protocol

Conditions: Survival, Prosthesis

Summary: this study evaluates retrospectively the survival rate of all-ceramic restorations, cemented using awb technique (test) compared to those cemented with conventional technique (control)

a retrospective study on ceramic restorations, placed in the period 2003-2014, will be performed to assess the survival rate of all-ceramic restorations cemented adhesively. the effectiveness of cementation largely depend on the method used. the air-water-blasting performed prior to conventional acid-etch of dental tissues offers an increase in bond strength compared to the conventional etching technique.

Eligibility criteria:
inclusion criteria: * patients who received at least one ceramic restoration exclusion criteria: * patients who received feldspathic ceramic restorations
metal ion concentration between coated and uncoated tka

Conditions: Knee Osteoarthritis

Summary: metal ion release from metal implants may have side effects. it can be reduced by coating of the implant. this study compares coated and uncoated tka.

patients are randomized to receive a coated or uncoated tka. patients are assessed before surgery, after 3 month, 1 year and 5 years. blood samples are collected in 7.5 ml s-monovette® tubes (for trace metal analysis, sarstedt ag, germany) using a specific steel needle for trace metal analysis (sarstedt ag, germany). within one hour, plasma was separated by centrifugation at 2500g for ten minutes. samples were stored at -20°c before being analysed for chromium, cobalt, molybdenum and nickel content using a graphite furnace atomic absorption spectrometer z-8270 with polarisation-zeeman-absorption (hitachi ltd., japan). the accuracy and precision of the method is validated to \< 10% using the control materials seronormtm trace elements serum (sero as, norway). the detection limit of the method is estimated at 0.5µg/l for chromium, cobalt and molybdenum, 1.0µg/l for nickel (mean + 3 standard deviations from buffer). all probes having ion levels below the detection limit were adjusted to 0.25µg/l for chromium, cobalt and molybdenum and 0.5µg/l for nickel. clinical outcome is measured with the knee society score, oxford knee score, short-form 36 and university of los angeles activity score.

Eligibility criteria:
inclusion criteria: * indication to tka * no other metal implant exclusion criteria: * no informed consent * not able to understand study and/or questionnaires * need of a higher constrained implant

Keywords: total knee arthroplasty total knee replacement outcome metal ion concentration results