Kornimate/medical-research-clean huggingface dataset:
study of efficacy and tolerability of systane complete in patients with dry eye disease

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate the clinical effectiveness and tolerability of systane® complete in adult patients with dry eye disease. fluorescein-stained tear film break-up time (tfbut) will be evaluated as the primary objective.

patients will attend 4 scheduled visits: screening visit (day -7 to day 0), visit 1/baseline visit (day 1), visit 2 (day 14) and visit 3 (day 28).

Eligibility criteria:
inclusion criteria: * must have tfbut of ≤ 5 seconds in at least one eye at screening visit. * must have best corrected visual acuity (bcva) of ≥ 20/80 (or ≥ 55 letters score or ≥ 0.6 early treatment diabetic retinopathy study (etdrs) log of the minimum angle of resolution (logmar) value) in both eyes at the screening visit. * must be willing to discontinue use of all artificial tear supplements and use only the study product as directed for the entire study duration. exclusion criteria: * history of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes. * use of any topical ocular medication preserved with benzalkonium chloride or other products known to be toxic to the tear film lipid layer within 1 month prior to the screening visit. other protocol-specified inclusion and exclusion criteria may apply.

Keywords: mixed dry eye aqueous-deficient dry eye lipid-deficient dry eye evaporative dry eye tear film eye drops artificial tears lipid layer eye symptoms meibomian gland dysfunction mgd systane systane complete nanoemulsion
specific enteral nutrition in malnourished, dialysis patients with chronic kidney disease. efficacy, safety, quality of life

Conditions: Chronic Kidney Disease; Renal Failure Chronic Requiring Hemodialysis; Severe Malnutrition; Tolerance; Quality of Life; Activity; Appetite and General Nutritional Disorders

Summary: the objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (sen) realdiet®renal pockets, as well as the impact on the patients' quality of life.


Eligibility criteria:
inclusion criteria: * chronic kidney disease patient on hemodialysis for at least 3 months, with a minimum of three hemodialysis sessions of 4 hours per week * patients aged 18 years * written, free and informed consent given by the patient * patient insured under the social security system or equivalent * patients who did not receive enteral nutrition during the 3 months preceding inclusion ; taking an oral nutritional supplement, or per-dialytic parenteral nutrition or total parenteral nutrition is not a criterion of non-inclusion * patient in a state of malnutrition * defined by the presence of at least 3 out of 5 of the following criteria : * weight loss greater than 10% observed in the last six months * serum albumin \<35 g / l * serum prealbumin \<300 mg / l * bmi \<20 * npna \<1 g / kg / day for 2 consecutive months and * presenting * food intake \<20 kcal / kg / day or * failure of other nutritional care methods, namely, oral nutritional supplements and / or peridialytic parenteral nutrition, or total parenteral nutrition * lack of compliance after one month, to the nutritional care methods mentioned above. • patients for whom the decision to prescribe enteral feeding was previously taken exclusion criteria: * patients with a history of intolerance to enteral feeding * index kt/veq (balanced) \< or = 1.2 or index kt/vsp (single pool) \< or = 1.4 according to the method used * patients with a disease compromising the short-term (4-6 months) prognosis (cancer or other disease in the terminal phase) * pregnant patient * patient with a known allergy to at least one of the following : milk protein, soy, fish * patient whose digestive tract is not functional or patient in shock * patient protected under guardianship * patient in exclusion period after participation in another clinical trial.

Keywords: chronic kidney disease hemodialysis severe malnutrition enteral nutrition
nkg2d-car-nk92 cells immunotherapy for solid tumors

Conditions: Relapsed/Refractory Solid Tumors

Summary: the purpose of this clinical investigation is to evaluate the safety and effects of nkg2d-car-nk92 infusions in the treatment of relapsed/refractory solid tumors.


Eligibility criteria:
inclusion criteria: 1. age: ≥ 18 years old and ≤ 75 years old, male or female. 2. histopathology confirmed the diagnosis of malignant tumors (including breast cancer, lung cancer, gastric cancer, ovarian cancer, cervical cancer, renal carcinoma, malignant melanoma, osteosarcoma and lymphoma). 3. expected survival time ≥3 months. 4. disease must be measurable according to the corresponding guidelines. 5. fail or unwilling to receive third-line treatment. 6. ecog: 0-2. 7. the last cytotoxic drug, radiotherapy or surgery≧4 weeks. 8. hb≧90g/l, anc≧1.5×10\^9/l, plt≧80×10\^9/l, tbil≦1.5×upper limit of normal, alt/ast≦2.5×upper limit of normal, alt/ast≦5×upper limit of normal if have liver metastasis, cr≦1.5×upper limit of normal or ccr≧60ml/min. 9. women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test; 10. written informed consent form must be signed before enrollment. 11. patient with mica/b+ cell tumors confirmed by pathology and histology. exclusion criteria: 1. the patient has other malignancies or has been diagnosed with other malignancies within the last 5 years (except clinically cured carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, and thyroid papillary carcinoma). 2. patients with brain metastases with symptoms or with symptom control for less than 3 months. 3. active autoimmune disease. 4. severe autoimmune diseases or congenital immunodeficiency. 5. concomitant serious infection or other serious underlying medical condition. 6. active hepatitis patients (including hepatitis b and c). 7. history of severe immediate hypersensitivity to any of the biological products including penicillin. 8. drug abuse, medical, psychological or social conditions that may interfere with a subject's participation in the study or evaluation of the results of the study. 9. simultaneous participation in another clinical trial within 4 weeks. 10. cell therapy or gene therapy in the previous 1 month. 11. a history of immunodeficiency, including hiv positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation. 12. investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study.
study to compare bictegravir/lenacapavir versus current therapy in people with hiv-1 who are successfully treated with a complicated regimen

Conditions: HIV-1-infection

Summary: the goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (bic) plus lenacapavir (len), versus current therapy (phase 2) and bic/len fixed-dose combination (fdc) versus current therapy (phase 3) in people living with hiv (pwh).


Eligibility criteria:
key inclusion criteria: * if plasma hiv-1 rna measurements in the 6 months prior to screening are available, all levels must be \< 50 copies/ml. * at least one documented plasma hiv-1 rna level measured between 6 and 12 months (± 2 months) prior to screening. this and any other hiv-1 rna measurements documented in this period must be \< 50 copies/ml * plasma hiv-1 rna levels \< 50 copies/ml at screening. * currently receiving a complex antiretroviral (arv) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (str), and on this regimen for at least 6 months prior to the screening visit. the criteria to define a complex regimen in this study are as follows: * a regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (nrti) plus at least 1 other third agent (ie, an agent from a class other than nrtis) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; biktarvy®)(bvy) + darunavir/cobicistat, bvy + etravirine), or * a regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or * a regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents. * no documented or suspected resistance to bictegravir (bic). * estimated glomerular filtration rate ≥ 15 ml/min according to the cockcroft-gault formula for creatinine clearance (clcr) who are not on renal replacement therapy. key exclusion criteria: * prior use of, or exposure to, lenacapavir (len) * active tuberculosis infection * chronic hepatitis b virus (hbv) infection note: other protocol defined inclusion/exclusion criteria may apply.
an extension study of telbivudine, lamivudine or telbivudine plus lamivudine in patients with chronic hepatitis b

Conditions: Hepatitis B

Summary: this is an extension study for patients who have previously completed idenix study nv-02b-003. this study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis b.


Eligibility criteria:
inclusion criteria: * patient has completed protocol nv-02b-003 without a serious adverse event attributed to study drug * patient remains seropositive for hepatitis b surface antigen (hbsag) other protocol-defined inclusion criteria may apply. exclusion criteria: * patient is pregnant or breast-feeding * patient has signs of decompensated chronic hepatitis b other protocol-defined exclusion criteria may apply.
evaluation of association between obstructive sleep apnea and the severity of coronary artery disease

Conditions: Coronary Artery Disease

Summary: it is widely accepted that coronary artery disease (cad) is related to a high mortality. it is predicted that an increase of approximately 21.3 million cardiovascular events and 7.7 million cardiovascular deaths over 2010 to 2030 in china.1 male sex, diabetes mellitus, hypertension, hypercholesterolemia, obesity and smoking are all traditionally considered as risk factors for cad. in recent decades, tremendous progress toward the prevention and treatment of traditional cardiovascular risk factors have helped decrease the morbidity and mortality from cad, but the condition remains a major public health challenge worldwide. looking into the other potential risk factors (osa) for cad, it may help to develop additional preventative strategies and further reduce the incidence and mortality of cad.

before initiating the study, all potential subjects were invited to attend an educational program that explained the purpose and methodology of this study. after getting informed consent from patients, demographic data including age, sex, medical history (including comorbidities and risk factors), current medicine, lifestyle habits, height (cm), and weight (kg) were recorded, and body mass index (bmi) was calculated as weight divided by height squared (kilograms per square meter, kg/m2). the included subjects need to perform transthoracic echocardiography or provide an echocardiographic examination within one month. cad diagnosis was determined based on the results of the coronary angiography, using stenosis 50% cutoffs considered have coronary diseases or not. consecutive patients of both sexes with coronary angiography from outpatient or inpatient departments of fuwai hospital were recruited into the study. the inclusion criteria were chinese, aged 35 to 75 years with cad verified by coronary angiography, and able to give informed written consent. the subjects were excluded if they had new york heart association class iii-iv degree with ejection fraction \< 45%, severe pulmonary disease, significant psychiatric disease, or history of pharyngeal surgery for osa or current use of cpap treatment for osa. they were also excluded if they declined to participate or were unable to provide informed consent.

Eligibility criteria:
inclusion criteria: * aged 35 to 75 years with cad * cad was verified by coronary angiography exclusion criteria: * patients had new york heart association class iii-iv degree with ejection fraction \< 45% * severe pulmonary disease * significant psychiatric disease * history of pharyngeal surgery for osa or current use of cpap treatment for osa * subjects declined to participate or were unable to provide informed consent.
mobile health technology for palliative care patients

Conditions: Metastatic Cancer; Mobile Health; Chronic Disease

Summary: to test the potential and acceptance of wireless activity tracking in palliative care patients leaving hospital care. explorative study, collaboration project of the clinic of radiation-oncology, university hospital zurich and the wearable computing laboratory, swiss federal institut of technology. patients receive a tracking bracelet and a smart phone in order to gather objective physical activity parameters as step count, sleep duration, heart rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and distress. quality of life (qol) will be captured by paper questionnaire. correlations between patients' physical activity patterns and the pain and distress level assessed from electronic scales as well as qol-questionnaire will be performed. acceptance will be evaluated by quantitative questionnaires and interviews. the proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on fostering early interventions for symptom relief and support of qol.


Eligibility criteria:
inclusion criteria: * established diagnosis of metastatic cancer or other severe illness with limited life-expectancy (physicians guess \ 8 weeks) * karnofsky index ≥50% * ecog≤ 2 * aged \> 18 years * passed a short handling test with devices (tracking bracelet, smart phone) exclusion criteria: * relevant cognitive impairment * insufficient knowledge of german language.
the effect of central sensitization on assessment capacity of patients

Conditions: Symptomatic Irreversible Pulpitis; Acute Apical Periodontitis of Pulpal Origin

Summary: the aim of this study is to evaluate the effect of dental hyperalgesia and mechanical allodynia on the assessment capacity of individuals in a local turkish population. the hypothesis of this study is that excessive amounts of pain and a major functional shift in the somatosensory system due to central sensitization might cause unwitting intent.

it included patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. all enrolled subjects volunteered and signed a written informed consent. patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study. a total of 30 patients were included in the study. a data sheet including patients' demographic data, diagnostic data, and data of explicit declaration of intent was completed. all pain scores were recorded according to the visual analog scale (vas). after the demographic data, diagnostic data. patients were explicitly informed that the answers they were going to provide to the questions related to their explicit declaration of intent would not affect their diagnosis or the treatment they would undergo.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. all enrolled subjects volunteered and signed a written informed consent exclusion criteria: * patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study.

Keywords: capacity clinical ethics autonomy competence
evaluation of single-dose pharmacokinetics of intravenous daptomycin in patients with thermal injury

Conditions: Burn Injury

Summary: the purpose of this study is to determine single dose pharmacokinetics of daptomycin consecutively in 10 patients on three different time points after severe burn injury.


Eligibility criteria:
inclusion criteria: * male or female of 18 years or older * second and/or third degree thermal injury * total body surface area burned ≥ 15% * hospitalisation in the icu for burn injured patients of the university hospital zürich * probability of icu stay of \>14 days * written informed consent by the patient or in patients unable to be informed or to sign according to section 4.4 of the study protocol exclusion criteria: * evidence of renal failure (creatinine clearance \<30ml/min) or continuous renal replacement therapy such as continuous hemofiltration * history of muscle disease or skeletal muscle disorder * creatine-phosphokinase (cpk) ≥ 5 times the upper limit of normal (uln) * history of hypersensitivity to the drug * pregnancy * severe coagulation disorder
il-26 and systemic lupus erythematosus

Conditions: Diagnosis of Lupus According to ACR criteriaAgreement for the Blood Sampling

Summary: treatment of multisystemic forms of lupus displays severe side effects and limited efficacy, underscoring the need to better dissection of the pathogenic mechanisms. concordant with preliminary data, il26 signaling could be impaired in systemic lupus. moreover, il 26 could be a marker of the disease activity and then a potential therapeutic target. in the present study, serum il 26 level in lupus patients and control will be measured.


Eligibility criteria:
inclusion criteria: * diagnostic of lupus according to acr criteria ( four criteria are necessary) * age \> 18 years old exclusion criteria: * treatment by cyclophosphamide, rituximab, belimumab in the year before inclusion study
continuous glucose monitoring and insulin pump therapy in diabetic gastroparesis

Conditions: Diabetic Gastroparesis

Summary: a pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of continuous glucose monitoring (cgms) in conjunction with an insulin pump to improve glycemic control for treatment of type 1 and type 2 diabetic patients with gastroparesis

this multicenter, uncontrolled, open label treatment study is to assess the safety of cgms in guiding insulin pump therapy for 24 weeks by measuring mild, moderate, and severe hypoglycemic episodes in patients with type 1 and type 2 diabetes and gastroparesis.

Eligibility criteria:
inclusion criteria: * age 18 - 70 years old at registration * type 1 or type 2 diabetes mellitus for at least 2 years * symptoms of gastroparesis (nausea, vomiting, early satiety, bloating, fullness, discomfort) for at least 1 year prior to registration * gastroparesis cardinal symptom index (gcsi) score of 18 * delayed gastric emptying on gastric scintigraphy within 1 year of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours * hemoglobin a1c of at least 8.0% at registration regardless of current therapy. individuals already receiving diabetes therapy via an insulin pump will be eligible for study participation if, in the opinion of the investigators, he/she may acquire additional benefit from continuous glucose monitoring that might improve glycemic control * normal upper endoscopy within 1 year of registration * no clinical or imaging evidence of obstruction * successful mastering of use of cgms during the run-in period exclusion criteria: * prior gastric surgery including fundoplication * other systemic disease potentially causative of gastrointestinal symptoms * acute or chronic renal insufficiency with creatinine \>1.5 mg/dl * psychiatric disease or eating disorder * pregnancy * any other condition which, in the opinion of the investigators, would impede compliance or hinder completion of the study

Keywords: diabetes gastroparesis
advancing dignity, health, and optimism in connection with long acting injectables

Conditions: HIV

Summary: adhoc-la is an observational study of people living with hiv who either are taking, or have taken, a long-acting injectable therapy to manage their hiv. data from this study will be used to research the ways in which hiv impacts the lives of these patients.

adhoc-la is an observational study that uses an online questionnaire to collect data on adults living with hiv who are currently taking, or have previously taken, long-acting injectable therapy to manage their hiv. the questionnaire includes information on sociodemographic factors, activities and interests, hiv diagnosis and status, health care use and satisfaction, antiretroviral therapy, comorbid medical conditions, health and well-being, substance use, and sexual practices.

Eligibility criteria:
eligibility criteria: 1. have an hiv-1 infection 2. a) currently take a long-acting injectable therapy for hiv supplied by viiv as part of a viiv-sponsored, long-acting injectables therapy trial (latte-2, atlas-2m, customize, polar, flair, or solar), or b) currently take a long-acting injectable therapy for hiv prescribed by their provider, not in conjunction with a viiv-sponsored clinical trial, or c) no longer taking long-acting injectable therapy for hiv, but previously received three or more injections of long-acting injectable therapy, either: * supplied by viiv as part of a viiv-sponsored, long-acting injectables therapy trial (latte-2, atlas-2m, customize, polar, flair, or solar), or * prescribed by their provider, unrelated to a viiv-sponsored clinical trial. 3. age 18 or above 4. have no known acute medical problem requiring immediate inpatient treatment 5. able to read and write in english 6. able and willing to provide online informed consent and to complete the online profile 7. not currently enrolled in another clinical trial in which the participant is receiving a long-acting injectable therapy for hiv. participants who meet the eligibility criteria but are still receiving viiv-supplied drug may enroll in the registry, but will not begin the online questionnaire until they are rolled off of viiv-supplied long-acting injectable therapy.

Keywords: hiv plwh long acting injectable