Kornimate/medical-research-clean huggingface dataset:
comparative study of 0.5% carboxymethylcellulose with 0.005% stabilized oxychlorocomplex (purite™) versus 0.5% carboxymethylcellulose in the treatment of dry eye

Conditions: Dry Eye Syndromes

Summary: to compare if 0.5% carboxymethylcellulose with 0.005% soc (stabilized oxychloro complex) have the same effectiveness and safety as 0.5% carboxymethylcellulose on dry eye patients.

dry eye is the very common disorder of tear film. there are millions of people who have dry eye around the world. dry eye patients may suffer from redness, sandy sensation, itching, excessive watering, burning sensation, excessive mucous discharge, blurred vision, contact lens intolerance, and increased risk of ocular surface damage and ocular infection. currently, there is no curative treatment for dry eye. the mainstay of treatment is still artificial tear supplement or punctual occlusion. in moderate to severe dry eye patients, the standard replacement is using non-preservative artificial tear more than 4 times a day. however, non-preservative artificial tear has some limitation such as inconvenience to carry, expensive, ocular surface trauma due to sharp plastic tip. recently, there is improvement in using new disappearing preservatives in artificial tears. one of the new preservative is stabilized oxychlorocomplex (soc, purite™) which can dissipate into water and sodium chloride, components of natural tears when exposed to light. it also has bactericidal and viricidal activities. scanning electron microscopy also reveals that, carboxymethylcellulose (cmc) with soc has a very low toxicity to corneal epithelium than other preservative. the past study had documented that 0.5% cmc preserved with soc was safe, comfortable and well tolerated for mild to moderate dry eye patients when applying 4-8 times daily. the objective of this study was comparing efficacy, tolerability, and safety of 0.5% carboxymethylcellulose(cmc) with stabilized oxychlorocomplex(soc) and 0.5% carboxymethylcellulose alone in patients with moderate to severe dry eye symptoms and/or signs.

Eligibility criteria:
inclusion criteria: * out patients of ophthalmology department, king chulalongkorn memorial hospital, who have symptoms and/or signs of dry eye * bilateral dry eye symptoms and/or signs with equal severity between both eyes * age \> 18 years, capable of following the study protocol, and considered be able to return for all scheduled visit exclusion criteria: * different severity of dryness between both eyes * current or recent use of topical ophthalmic medications that could affect dry eye condition * history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of study result * recent contact lens wear (within one month) * known hypersensitivity to 0.005% soc or carboxymethylcellulose * pregnancy or planned pregnancy * having received permanent punctal occlusion

Keywords: dry eye syndromes therapy
structuring of a lung cancer screening program including clinical, radiological and biological phenotyping useful for the development of individualized risk prediction tools: prevalung etoile

Conditions: Smoking-related Pathology; Atheroma; Chronic Bronchitis; Non-progressive Cancer > 5 Years; Lung Cancer

Summary: patients treated at the hôpital nord de marseille for at least one smoking-related pathology (atheroma, chronic bronchitis, non-progressive cancer \> 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the nlst or nelson studies or american recommendations) interventional study with minimal risks and constraints, with evaluation of lung cancer prevalence; immunological, blood inflammatory and microbiota profile determine the maximum clinical, radiological, and biological phenotyping completeness rate following the implementation of a new lung cancer screening care pathway with multidimensional clinical, radiological, and biological phenotyping capabilities


Eligibility criteria:
inclusion criteria: age 45- 75 years and * medical follow-up for a smoking-related pathology : * atheroma * chronic obstructive pulmonary disease / emphysema * history of non evolving cancer \> 5 years among: ent, lung, breast, cervical, excreto-urinary cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia chronic myeloid leukemia, * daily smoking for at least 10 years prior to the disease or nlst inclusion criteria: * age 55 - 74 years * cumulative smoking ≥ 30 pack-years * active or quit for less than 15 years or inclusion criterion in nelson: * age 50-75 years * smoking: * \> 15 cigarettes/d for more than 25 years or * \> 10 cigarettes /d for more than 30 years * active smoking or cessation \< 10 years or new american recommendations : * age 50 - 80 years * smoking ≥20 pa * active or weaned \<15 years exclusion criteria: history of cancer \< 5 years (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma basal cell carcinoma of the skin and prostate cancer with undetectable psa) * symptoms of lung cancer (unintentional weight loss \> 7 kg in 1 year, hemoptysis) * known history of pulmonary nodule with specialized follow-up * history of pulmonary fibrosis or pulmonary hypertension * patient under guardianship or curatorship * active pulmonary parenchymal infection * severe cardiac or respiratory insufficiency (rest dyspnea) * patient not affiliated to the social security system (beneficiary or beneficiary's right) * patient deprived of liberty * performance status (who) 2, 3 or 4 * pregnant or breastfeeding women
enteral nutrition in cancer patients

Conditions: Malnutrition; Cancer

Summary: context and objective: tumor and its therapy have adverse effects on the nutritional status of cancer patients, leading to nutritional support. the aim was to study enteral nutrition indications, as well as its compliance and the impact on nutritional status. design and setting: clinical trial, iop, unifesp-epm. methods: patients older than 1 year followed during anticancer therapy were included from january 2002 to january 2004. they received industrialized oral supplementation - nutren 1.0 or jr (ios) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was observed, tube feeding with the same supplement (tfr) was indicated.


Eligibility criteria:
inclusion criteria: * were on chemotherapy; * age above one year; * malnutrition; * a z-score of weight for height (zw/h) \< -1.0 to -2.0 in children and ≥ 5th to \< 15th of body mass index (bmi) in adolescents were considered as mild malnutrition; * a zw/h \< -2.0 in children and \< 5th of bmi in adolescents as severe, respectively; * in adults, the world health organization (who) cut-off values were applied: \< 18.5 mild and \< 17 severe malnutrition. exclusion criteria: * were on corticosteroid or hormonal therapy; * had swallowing abnormalities; * had parenteral or tube feeding therapy; * had palliative care; * presence of non cancer-related diseases.

Keywords: nutritional support cancer malnutrition child adolescent pediatric
muscle stimulation during dise

Conditions: Obstructive Sleep Apnea

Summary: drug-induced sleep endoscopy (dise) is a widely used tool for assessing collapse patterns of the upper airway anatomy during sleep. hypoglossal nerve stimulation therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. we propose a study examining the physiologic effect of palatoglossus and genioglossus muscle stimulation during dise.

this is a single-arm study involving the use of a diagnostic device (muscle stimulator) that is not currently utilized in any clinical decision-making processes for osa patients. all patients scheduled for dise as part of their regular clinical care will be screened for enrollment via the previously described inclusion and exclusion criteria. the study is not blinded. no diagnostic information collected from muscle stimulation will be used in clinical decision-making processes.

Eligibility criteria:
inclusion criteria: 1. adult patient (≥18 years old) 2. a diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr. 3. intolerant of cpap therapy due to physical or psychosocial limitations as determined by clinical history 4. scheduled to undergo dise as part of routine clinical assessment for further evaluation of pharyngeal anatomy exclusion criteria: 1. unable to consent for research due to a pre-existing neurologic condition as determined by pi 2. unable to consent for research due to language barriers 3. a history of egg allergy as determined by history or self-reports 4. currently pregnant as determined by patient report or pre-operative anesthesia evaluation 5. cardiopulmonary or other medical conditions precluding safe propofol sedation as determined by pre-operative anesthesia evaluation 6. history of palatal or pharyngeal airway surgery including tonsillectomy as determined by clinical history and exam 7. history of radiation treatment to the head or neck as determined by history and/or physical exam
study to assess the safety of treatment of articular cartilage lesions with cartilife®

Conditions: Articular Cartilage Lesion of Knee

Summary: the purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocytes (cartilife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. the patients will be assessed clinically using clinical, biochemical and ikdc (international knee documentation committee) outcomes preoperatively as well as 4, 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.


Eligibility criteria:
inclusion criteria: * patients at least 19 years old * defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume) * defect: isolated icrs (international cartilage repair society) grade iii or iv single defect chondral lesion on articular cartilage * the joint space is maintained over 50% relative to baseline * patients that are able to walk without aid * patients that agree to abide by strict rehabilitation protocols and follow-up programs * patients who provide written consent to the participation of the clinical trial exclusion criteria: * patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis * patients with arthritis associated with autoimmune disease * patients hypersensitive to bovine protein * patients with haemophilia or markedly reduced immune function * patients hypersensitive to antibiotics such as gentamicin * patients with arterial bleeding and severe venous bleeding * patients with other diseases including tumors except for cartilaginous defects of joints * patients with a history of radiation treatment and chemotherapy within the past two years * patients who are pregnant, nursing a baby or likely to get pregnant * patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration * other cases where the investigator deems the patient ineligible for participation

Keywords: arthritis articular cartilage autologous chondrocyte implantation degenerative arthritis cartilage lesion cartilage defect
combined spinal-epidural versus traditional labor epidural

Conditions: Labour Pain

Summary: the purpose of this study to compare the use of spinal-epidural versus traditional labor epidural on maternal and fetal effects. the hope is to determine the safest and most effective epidural method of relieving pain during labor.

combined spinal-epidural anesthesia (cse) was developed to allow excellent pain control for the pregnant woman who arrives in advanced labor and does not have much time for the anesthetic to have its effect. this has been extended recently to women in all stages of labor because of its rapid and excellent control of pain. recent case series comparing cse with traditional epidural have shown a slight difference in the rate of hypotension and fetal bradycardia, with the cse technique having a higher rate of both of these side effects. this study will compare the two techniques in a prospective, randomized method. the aim is to compare the maternal and fetal effects of two neuraxial block techniques for pain control during labor, to document blood pressure changes in upper and lower extremities pre- and post- block placement, and to document side effects (e.g. pruritus) and patient satisfaction with both techniques.

Eligibility criteria:
inclusion criteria: * patient is able to read, understand and voluntarily sign the approved informed consent form (icf) prior to any study- specific procedure; * must be between 18 to 50 years of age. * must be carrying a singleton fetus at term. * must have less than a body mass index of 40. * must be in labor, or is having a medical induction of labor. exclusion criteria: * patient who has chronic renal disease, pre-existing hypertension, or pre-eclampsia. * patient who is undergoing an elective cesarean delivery * patient who has a presence of non-reassuring fetal status * patient who has an abnormal or non-reassuring fetal heart rate (fhr) pattern

Keywords: epidural labour pain pregnant women epidural anesthesia labour, obstetric labor pain labor, obstetric labor analgesia
viola post market surveillance clinical protocol

Conditions: Coronary Artery Disease

Summary: the goal of this post marketing surveillance clinical trial is to learn about viola as a proximal seal device in patients undergoing coronary artery grafting (cabg) surgery. the main objective is to evaluate the clinical safety and performance of the viola. participants will be treated with routine cabg with use of viola for maintaining hemostasis when suturing the proximal anastomosis. patients will be followed for any clinical events at 6 weeks and 9 months post surgery.

the goal of this post marketing surveillance clinical trial is to collect post market data on the safety and performance of viola as a proximal seal device in patients undergoing coronary artery grafting (cabg) surgery. the main objective is to evaluate the clinical safety and performance of the viola. participants will be treated with routine cabg with use of viola for maintaining hemostasis when suturing the proximal anastomosis. data will be collected intraoperatively, at discharge, at 6 weeks, and at 9 months post cabg.

Eligibility criteria:
inclusion criteria: 1. patient scheduled for isolated cabg on clinical grounds 2. one or more bypass grafts originating from the aorta 3. ability to give their informed written consent 4. ability and willingness to comply with study follow up requirements 5. patient is ≥ 18 years of age exclusion criteria: 1. emergency cabg surgery (cardiogenic shock, inotropic pressure support, iabp) 2. prior clinical stroke less than one year before surgery 3. pre-operative neurological deficits 4. chronic atrial fibrillation 5. aortic external diameter less than 25 mm measured intraoperatively 6. no proximal aortic anastomosis eligible for viola use, assessed intraoperatively according to surgeon's discretion (e.g inadequate punch size, thin-walled aorta). 7. symptomatic carotid disease 8. acute mi within 24 hours of planned surgery 9. euroscore ii ≥ 4 10. known allergy to nickel 11. women of child bearing age 12. participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Keywords: cabg coronary artery bypass grafting
et 140202 -t cell combined with tae or sorafenib in the treatment of liver cancer

Conditions: Hepatocellular Carcinoma; Liver Cancer; Liver Neoplasms; Metastatic Liver Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of et 140202 -t cell combined with tae or sorafenib in the treatment of liver cancer

the molecular target for et140202-t cells is hla-a02 complexed with a hla-a02-restricted peptide of alpha fetoprotein (afp), which is expressed on 60-80 percent of hepatocellular carcinoma (hcc). this clinical study evaluates the safety and pharmacokinetics of et140202-t cells with tae or sorafenib in patients with hcc who have no available curative therapeutic options and a poor overall prognosis.

Eligibility criteria:
inclusion criteria: * afp-expressing hcc and serum afp \>10 x uln * abandon or failure in first or second line treatment * molecular hla class i typing confirms participant carries at least one hla-a02 allele * child-pugh score of a or b, ecog 0-2, life expectancy \> 6 months * measurable disease as defined by: at least 1 liver lesion that can be accurately and serially measured. * negative serum pregnancy test for women with childbearing potential * adequate organ function as defined below: 1. a pretreatment measured creatinine clearance (absolute value) of ≥50 ml/minute. 2. patients must have a serum direct bilirubin ≤3 x uln, alt and ast ≤5 x uln. 3. ejection fraction measured by echocardiogram or muga \>50% (evaluation done within 6 weeks of screening does not need to be repeated) 4. dlco or fev1 \>45% predicted 5. absolute neutrophil count (anc) ≥ 1500/mm3 (10\^9/l), platelet count ≥ 50,000/mm3 (10\^9/l) 6. inr ≤1.5 x uln 7. informed consent/assent: all subjects must have the ability to understand and the willingness to sign a written informed consent. exclusion criteria: * patients with decompensated cirrhosis: child-pugh score c * patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver. * patients with an organ transplantation history * patients with dependence on corticosteroids * patients with active autoimmune diseases requiring systemic immunosuppressive therapy * patients who are currently receiving or received within past 30 days anti-cancer therapy, local treatments for liver tumors (radiotherapy, embolism, ablation) or liver surgery * patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy) * participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within two years. patients with a history of successfully-treated tumors with no sign of recurrence in the last two years may be enrolled. * patients with other uncontrolled diseases, such as active infections acute or chronic active hepatitis b or hepatitis c. * women who are pregnant or breast-feed * hiv-infection
patient insights following use of leo 90100 aerosol foam and daivobet® gel in subjects with psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: to gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

an international, multi-centre, prospective, open-label, randomised, 2-arm, cross-over study with 14-days once daily treatment in subjects with psoriasis vulgaris. to gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

Eligibility criteria:
inclusion: 1. at day 1 (visit 1), a clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs amenable to treatment with a maximum of 60 g of study medication per week 2. psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the body surface area (bsa) at day 1 (visit 1) 3. a physician's global assessment of disease severity (pga) of at least mild on trunk and/or limbs at day 1 (visit 1) 4. a modified pasi (m-pasi) score of at least 2 on the trunk and/or limbs at day 1 (visit 1) exclusion: 1. topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to randomisation. 2. any previous topical treatment with calcipotriol plus betamethasone gel (daivobet® gel or xamiol® gel). 3. psoralen combined with ultraviolet a (puva) therapy within 4 weeks prior to randomisation. 4. ultraviolet b (uvb) therapy within 2 weeks prior to randomisation. 5. planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps etc.) during the trial. 6. subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation. 7. previously randomised into a clinical trial involving leo 90100. 8. current participation in any other interventional clinical trial. 9. previously randomised into this trial. 10. current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. 11. subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ulcers and wounds. 12. other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis. 13. known or suspected disorders of calcium metabolism associated with hypercalcaemia. 14. known or suspected severe renal insufficiency or severe hepatic disorders.
trial of pindolol augmentation in venlafaxine treated patients with major depression

Conditions: Major Depression

Summary: this study investigates the hypothesis that pindolol can accelerate the response to antidepressants in patients with major depression treated with venlafaxine.

antidepressant therapy has a delayed onset of action of 4-6 weeks. pindolol has in some studies shown an accelerating effect. in this study we investigate the effect of 20 mg of pindolol retarded formulation in combination with venlafaxine compared to placebo pindolol and venlafaxine for a duration of 19 days. effect is measured by the hamilton depression rating scale and the preskorn scale (self-rating).

Eligibility criteria:
inclusion criteria: * major depression exclusion criteria: * allergy towards pindolol, venlafaxine or other tablet constituents * liver or kidney impairment * diabetics * age below 18 years * severe cardiac disease * asthma.

Keywords: major depression pindolol venlafaxine augmentation major depression (dsm-ivr)
acute stroke advancing program using telemedicine

Conditions: Stroke

Summary: the purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on iv thrombolysis.

the rate of intravenous thrombolysis with tissue-type plasminogen activator or urokinase for stroke patients was extremely low in china. it has been demonstrated that telestroke may help to increase the rate of intravenous thrombolysis and improve the stroke care quality in the local hospitals. the aim of this study is to evaluate the effectiveness and safety of decision making of intravenous thrombolysis via telemedicine consultation system for acute ischemic stroke patients in china this trial network consists of one hub hospital (xijing hospital) and 14 spoke hospitals in the remote area of shanxi province. the telemedicine consultation system is an interactive, 2-way, wireless, audiovisual system based on portable hardwares--tablet computer or smartphone. before this study, we have been investigating the usual stroke care quality in the spoke hospitals without the guidance from the hub hospital, which will be used as the historical control of this study. after that, the teleconsultation system will be introduced.

Eligibility criteria:
inclusion criteria: * patients older than 18 years and less than 80 years * acute ischemic stroke * presenting to emergency department of spoke hospitals within 4.5 hours of stroke symptom onset * national institutes of health stroke scale (nihss) between 4 and 25 * signed consent form by the patient or his relatives exclusion criteria: * time of symptom onset unclear * unlikely to complete study through 3-month follow-up

Keywords: stroke thrombolysis tissue plasminogen activator urokinase telemedicine