Kornimate/medical-research-clean huggingface dataset:
preoperative silicone ointment and wound healing

Conditions: Wound Heal; Scar; Scar, Hypertrophic; Keloid; Keloid Scar Following Surgery; Surgical Incision

Summary: optimal scar healing is of great importance to patients, especially following surgery of the head and neck. this study evaluates the effectiveness of preoperative silicone ointment in wound healing in head and neck surgeries.

following surgical procedures, the formation of hypertrophic scars and keloids affects patients' well-being, including quality of life and mental/psychological health. scars in certain areas, including the face, neck, ears, and upper chest and back, are especially likely to develop abnormally. due to these adverse outcomes, patients often request products and procedures that will improve the appearance of scars. few studies have addressed preoperative measures that can improve scar healing. surgeons often recommend that patients apply moisturizing ointments to the area of the incision prior to surgery; however, this is based on clinical consensus and is not evidence-based. silicone products are understood to promote hydration of the skin and are considered first-line prophylactic and treatment therapy for abnormal scars (hypertrophic scars and keloids) when used after a surgery or injury. this study seeks to evaluate preoperative application of silicone ointment and its effect on surgical scar healing. the success of surgical scar healing will be determined by researcher and participant ratings on validated scar assessment scales. the secondary objective of this study is to evaluate the effect of preoperative application of silicone ointment on postoperative wound complications.

Eligibility criteria:
inclusion criteria: * scheduled to undergo non-emergent surgery of the head and/or neck for a benign (non-cancerous) condition * able to comply with all study procedures for the duration of the study * provision of signed and dated informed consent form exclusion criteria: * current use of products intended to improve scar healing (silicone or otherwise); skincare products not specifically marketed for scar healing are acceptable * known allergic reactions to components of the silicone ointment * dermatologic conditions that disrupt the integrity of the skin, e.g. severe acne, psoriasis * need for tracheostomy postoperatively * have any form of active malignancy at the time of surgery * have a history of radiation involving the surgical site * prior surgery involving all or part of the planned surgical incision * current use of chronic steroids or other immunosuppressive medications * lack of decision-making capacity * not fluent in english

Keywords: wound healing surgical incision scar hypertrophic scar keloid silicone ointment
clinical assessment of a hydraglyde® regimen

Conditions: Refractive Errors; Myopia; Hypermetropia

Summary: the purpose of this study is to evaluate worn air optix® plus hydraglyde® (aohg) lenses cleaned and disinfected with hydraglyde® containing lens solutions compared to each of the control habitual silicone hydrogel (sihy) lenses cleaned and disinfected with habitual multi-purpose solution (mps) for cholesterol uptake.


Eligibility criteria:
inclusion criteria: * must sign informed consent document; * vision correctable to 0.1 (logmar) or better in each eye at distance with habitual lenses; * manifest cylinder (at screening) less than or equal to 0.75 diopter (d) in each eye and spectacle add \<+0.50 d in each eye; * current full-time wearer of spherical samfilcon a, comfilcon a, senofilcon c monthly or senofilcon a 2-week replacement lens within the power range of lens powers available; * current user of an mps (excluding ofpm) to care for lenses; * willing to answer text messages on a daily basis during the study; * willing to discontinue artificial tears during the study and rewetting drops on the days of study visits; * use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study; * other protocol specific inclusion criteria may apply. exclusion criteria: * habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week); * any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear; * history of herpetic keratitis, corneal surgery or irregular cornea; * prior refractive surgery; * any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; * currently using or have not discontinued restasis®, xiidra™ and/or topical steroids within the past 7 days; * use of mechanical eyelid therapy or eyelid scrubs within 14 days before visit 1 and not willing to discontinue during the study; * monocular (only 1 eye with functional vision) or fit with only 1 lens; * known pregnancy or lactating; * other protocol specific exclusion criteria may apply.
evaluation of isostretching effects in patients with mechanical and postural chronic low back pain

Conditions: Chronic Low Back Pain

Summary: isostretching is effective in treating chronic back pain to improve pain, quality of life and functional capacity.

objective: this study investigated the influence of isostretching on patients with chronic low back pain. methods: it was a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blind assessment. fifty-four patients with chronic low back pain were randomized to an experimental group and a control group. the experimental group performed isostretching twice a week for 45 days, while the control group remained on the waiting list for physical therapy. patients were submitted to evaluations at baseline, after 20 and 45 days of treatment with regard to pain, quality of life, functional capacity, and satisfaction. results: the experimental group exhibited statistically significant improvements in comparison to the control group with regard to pain (p = .003), functional capacity (p = .026), patient satisfaction (p \< .001), and quality of life as determined by the functional capacity (p = .012), physical aspects (p = .011) and pain (p = .006) subscales of the sf-36. the experimental group used a significantly lesser amount of pain medication than the control group (p = .03). conclusion: isostretching was effective in reducing pain and in improving function, patient satisfaction and some aspects of quality of life in patients with chronic low back pain.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with chronic low back pain with pain located between the last rib and the gluteal fold over 12 weeks; * mechanical back pain that worsens with exertion and relieved by rest; * pain between 3 and 8 cm measured by analog pain scale. exclusion criteria: * subjects who presented pain root * fibromyalgia * severe scoliosis with abnormal alignment of the spine (cobb angle\> 40); tumors in the column; infiltration in the lumbar spine in the last three months; previous surgery of the spine (patients return to work or process expulsion) * have changed or initiated physical activity in the last three months * body mass index greater than 30 kg/m2

Keywords: low back pain pain incapacity life quality rehabilitation
brown seaweed as a breast cancer preventive

Conditions: Breast Cancer

Summary: japanese postmenopausal women in japan have about one ninth the rate of american postmenopausal women. rates of breast cancer double even after just ten years among japanese women who migrate to the us. diet is thought to be an important factor, and the investigators were interested in whether dietary seaweed, with and without soy supplements, could influence known biomarkers of breast cancer risk in american women.

33 healthy postmenopausal women were randomized to 6 wk seaweed then 1 wk seaweed plus soy or 6 wk placebo then 1 wk placebo plus soy. blood and urine samples were collected at the end of each treatment period and analyzed for estrogen, homocysteine, antioxidants, insulin-like growth factors and thyroid hormones. urine was analyzed for phytoestrogens and iodine.

Eligibility criteria:
inclusion criteria: * postmenopausal (self-reported cessation of menstruation 1 y prior to enrollment) * if breast cancer survivor, all therapy completed at least 6 months prior to enrollment * agreed to eat their normal diet, avoiding seaweeds and phytoestrogen-rich foods, * restricting alcoholic intake to #2 drinks (24 g alcohol)/wk -continuing habitual intake of vitamins, supplements, and medications during the study. - exclusion criteria: * no allergies to seaweed, soy, shellfish, or iodine * no current use of tobacco; * no thyroid dysfunction or treatment within the previous 5 y; * negative thyroid peroxidase antibodies as determined by screening; * no hormone replacement therapy or for breast cancer survivors, no chemotherapy or radiation treatments within the preceding 6 mo * no history of cancer (other than breast cancer) * no current gastrointestinal disorders or diabetes; omnivorous eating habits, including meat and dairy products at least twice/wk * no oral antibiotics, iodine containing medications, or corticosteroids treatment within the previous 3 mo.

Keywords: homocysteine insulin-like growth factor insulin-like growth factor binding protein serum estrogen urinary phytoestrogens thyroid hormones
sertraline combined with fluvoxamine in the treatment of refractory obsessive-compulsive disorder

Conditions: OCD

Summary: to verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole

to verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole, and to observe the indicators of improving patients' cognitive function and adverse drug reactions, so as to provide evidence-based evidence for supplementing the treatment guidelines for obsessive-compulsive disorder

Eligibility criteria:
inclusion criteria: * the diagnostic criteria of ocd in the diagnostic and statistical manual of mental disorders 5th edition (dsm-v), as well as the definition of refractory ocd, are as follows: failure to respond to oral treatment with at least two effective doses of antidepressants, including: fluoxetine (≥20mg/ d), fluvoxamine (≥200mg/d), sertraline (≥150mg/d), and paroxetine (≥ 40mg/d) were all treated for at least 12 weeks. the yale-brown compulsive scale (y-bocs) score decreased by \< 35%. * the total score of yale- brown compulsion scale (y-bocs) ≥16 points. (3)age 12 \~ 45 years. exclusion criteria: * exclusion of severe organic brain disease; * severe physical illness; * other mental disorders such as tics, disruptive disorders, eating disorders and autism spectrum disorders; * pediatric streptococcal infection causedby autoimmune neuropsychiatric disease (pandas); * alcohol and drug dependence; angle-closure glaucoma; * suicidal tendencies; * previous history of drug allergies related to research; * pregnant and lactating women.

Keywords: sertraline ocd fluvoxamine
video balance-based exercise in persons with stroke

Conditions: Stroke

Summary: this study is to compare the effects of interactive video balance-based exercise (ivbe) intervention and conventional rehabilitation on the balance and functional performance in stroke survivors. fifteen participants will receive interactive video balance-based exercise, while the other half will receive conventional rehabilitation.

thirty individuals with stroke are recruited and allocated to 2 groups in this study. fifteen participants in group a will undergo 30 minutes a day and 3 days a week interactive video balance-based exercise intervention for four weeks. another 15 participants allocated to the group b will receive 30 minutes a day and 3 days a week conventional rehabilitation for four weeks. time up go test (tug), berg balance scale (bbs), modified falls efficacy scale (mfes), motricity index (mi), functional ambulation category (fac) were assessed before and after intervention in both groups

Eligibility criteria:
inclusion criteria: 1. patients present with unilateral hemiplegia caused by a first-ever stroke 2. cognitive ability is sufficient to understand the nature of study (mini-mental state examination score\>=23) 3. medical and psychological condition stable exclusion criteria: 1. patients having severe spasticity (modified ashworth scale \> 3) 2. severe hearing or eye problem 3. intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation

Keywords: interactive video balance-based exercise conventional physiotherapy
hepatosplenic candidiasis : petscan and immune response analysis

Conditions: Invasive Fungal Disease; Chronic Disseminated Candidiasis; Hematological Malignancies; Hematopoietic Stem Cell Transplantation; Neutropenia

Summary: the purpose of this study is to determine whether f18 fluorodeoxyglucose (18f-fdg) positron-emission tomography scan (pet scan) is useful for the therapy strategy of hepatosplenic candidiasis.

chronic disseminated candidiasis, often referred to as hepatosplenic candidiasis (hsc), is an infection due to candida spp. that mainly involves the liver and spleen. hsc occurs mostly in patients with profound and prolonged neutropenia, which is more often seen in patients with hematologic malignancies. despite an appropriate antifungal prophylaxis, the incidence of hsc in france might be closed to 5% in patients suffering from acute leukemia. early and adequate diagnosis and treatment of hsc are crucial, as treatment delays can negatively affect the prognosis of the underlying condition. current guidelines recommend a 6-month duration treatment. prolonged treatments up to 6 months are frequent, leading to antifungal toxicity and cost increase. preliminary study by our team has already assessed f18 fluorodeoxyglucose (18f-fdg) positron-emission tomography scan (pet scan) as a diagnostic tool for hsc. 18f-fdg pet scan could be helpful in the diagnosis, follow-up and therapy strategy of hsc, helping to stop antifungal treatment. other molecular, immunological and serological tools have to be developed in order to avoid hepatic biopsies. actually, mycological evidence of infection is found in only 20% of the cases. the pathogenesis of hsc is also not well understood, but it is believed that it may be due to an unbalanced adaptive immune response that leads to an exacerbated inflammatory reaction, resulting in an immune reconstitution inflammatory syndrome (iris). in that context, a better understanding of the disease pathophysiology and of the potential genetic susceptibility could have an impact on therapy strategy. for example, new approaches such as the use of adjuvant high-dose corticosteroids have been shown beneficial. this study is the first step to improve hsc diagnosis and therapy strategy.

Eligibility criteria:
patients' inclusion criteria: * adults aged ≥18 years-old * hospitalized for hematological malignancy or hematopoietic stem cell transplantation * recent (\>2months), prolonged (\>10 days), profound (\>100 pmn/mm3), feverish neutropenia * suspected hepatosplenic candidiasis (typical small nodular lesions on abdominal rmi or ct) patients' exclusion criteria: - hepatosplenic lesions of other proven origin patients' non-inclusion criteria: * life expectancy \>3 months * pregnancy * hiv infection * hepatic biopsy within 3 weeks before 18f-fdg pet scan

Keywords: positron-emission tomography scan fluorodeoxyglucose f18 magnetic resonance imaging enzyme-linked immunospot assay immune reconstitution inflammatory syndrome real-time polymerase chain reaction beta-1,3-d-glucan candida spp. genetic susceptibility genotype
pharmacokinetics, safety and tolerability of the combination of bi 207127 and faldaprevir in renal impaired patients

Conditions: Renal Insufficiency

Summary: the objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of bi 207127 and faldaprevir after 3 days of dosing (bi 207127 bid, faldaprevir qd) and a single dose of bi 207127 and faldaprevir on day 4.


Eligibility criteria:
inclusion criteria: * healthy volunteers (males and females) or patients with impaired renal function (estimated glomerular filtration rate (egfr) between 89 and 15) in relatively good health as determined by past medical history, physical examination, vital signs, ecg and laboratory assessments (aside from abnormalities specific for renal impairment) * age from 18 to 79 years * subjects must be able to understand and comply with study requirements exclusion criteria: * any relevant deviation from healthy conditions for healthy volunteers * subjects with significant diseases other than renal impairment will be excluded. a significant disease is defined as a disease which in the opinion of the investigator: * put the patient at risk because of participation in the study * may influence the results of the study * may influence the patients ability to participate in the study * is not in a stable condition * diabetic or hypertensive patients can be entered in this trial if the disease is not significant according to these criteria
pharmaco kinetic variability of infliximab in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: infliximab is a chimeric monoclonal antibody directed towards tumor necrosis factor -alpha that is largely used in inflammatory diseases such as rheumatoid arthritis (ra). a relationship between dose and clinical outcomes was shown in populations of ra patients but there is an interindividual variability of this relationship. at an individual level, this dose-effet relationship can be separated into the dose-concentration (pharmacokinetic or pk) and the concentration-effet (pharmacokinetic-pharmacodynamic or pk-pd) relationships. serum trough concentrations of infliximab have been shown to be variable between patients receiving the same treatment regimen. this pk variability may be explained by several factors (e.g. genetic and immunological factors). the concentration-effect relationship may also be variable and the sources of this variability need to be studied as well. to date no detailed infliximab pk analysis has been published. the sources of variability of the dose-effect relationship need to be characterized to optimize infliximab dosing regimen in patients. the fakir study is a multicenter prospective observational study that will focus on patients treated with infliximab. its aims are: 1. to characterize the pk and pk-pd variability of infliximab in ra, using clinical criteria and biomarkers, assessed over time ; 2. to study the influence of the polymorphism of fcgrt (the gene encoding fcrn) on the pk variability of infliximab; to study the influence of the polymorphism of fcgr3a (the gene encoding fc gamma riiia) on the pk-pd variability of infliximab; and to study the influence of antibodies toward infliximab on the pk and pk-pd variabilities of infliximab.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis according to acr criteria * patient already receiving infliximab for more than 14 weeks * no modification of the dose regimen of infliximab since the last infusion * no modification of disease modifying anti rheumatic drugs since the last 4 weeks exclusion criteria: * surgery scheduled during the duration of the study * pregnancy * infection, malignancy, immune reaction to infliximab or demyelinating diseases
evaluation of fkb238 and avastin in patients with advanced/recurrent non-squamous non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this research study is to compare the effectiveness and safety of fkb238 against avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * newly diagnosed advanced (stage iv) /recurrent non-squamous nsclc for which they had not received any systemic anti-cancer therapy for metastatic disease * histologically or cytologically confirmed diagnosis of predominantly non-squamous nsclc * existence of at least 1 measurable lesion by recist v1.1 * adequate hematological, renal and liver function * eastern collaborative oncology group performance status (ecog ps) 0 or 1 * life expectancy longer than 6 months exclusion criteria: * small cell lung cancer (sclc) or combination sclc and nsclc. squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature * any unresolved toxicities from prior systemic therapy * known sensitizing epidermal growth factor receptor (egfr) mutations or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (eml4-alk) translocation positive mutations * previous dosing with vascular endothelial growth factor (vegf) inhibitor * known hypersensitivity to any excipients of the investigational products (ips) and combination chemotherapy * use of prohibited concomitant medication * known hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) infection * fertile men or women of childbearing potential not using adequate contraception. other inclusion/exclusion criteria may apply.

Keywords: cancer bevacizumab carboplatin paclitaxel
innovative drug delivery nanophotonic platform for implementation of sarcoma therapy

Conditions: Bone and Soft Tissue Tumors

Summary: deeply aims to improve sarcoma therapy by the development of an innovative nanophotonic delivery approach to be applied in the future as an integrated local therapy for patients with inoperable tumors or with oligometastases. the major aim of the project is the development of innovative nanocarriers loaded with chemotherapeutic agents, whose delivery will be improved by the use of an optic fiber (optoporation). after the synthesis, and characterization of nps, a prototype will be produced and preclinically validated on patient-derived biological material. this wide comprehensive methodological approach will ensure the obtainment of robust data to be faster exploited toward clinical applications.


Eligibility criteria:
inclusion criteria: * patients eligible for the study will be male or female, with an age ranging from 0- to 85 years, undergoing surgery or biopsy for stss or bss including osteosarcomas. * included patients may have undergone or may be still in treatment with chemotherapy (also neo-adjuvant settings), targeted therapy, radiotherapy, or combination therapy. * irst will enroll only adult patients (age \&gt; 18 years). * signed informed consent from all subjects enrolled in the study. ior patients will have to sign both the specific project informed consent and the ior biobank informed consent. exclusion criteria: * patients not affected by stss or bss will be excluded from the study, as well as patients with multiple primary tumors.

Keywords: sarcomas nanocarriers therapy nanophotonic