Kornimate/medical-research-clean huggingface dataset:
nimotuzumab combined with icis for the treatment of advanced liver cancer after first line treatment failure

Conditions: HCC

Summary: this is a phase ii, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy

this study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protopd-1 (or pd-l1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, d1, qw in combination with pd-1 (or pd-l1) inhibitor in the later line of treatment until disease progression and intolerable toxicity

Eligibility criteria:
inclusion criteria: * subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (hcc), or the clinical diagnosis meets the american association of liver diseases (aasld) diagnostic criteria for hepatocellular carcinoma； * prior experience of targeted, immune, progression after conventional therapy, or intolerance (including tkis,icis, chemotherapy, vegf monoclonal antibody, or icis in combination with tkis/vegfs monoclonal antibody/chemotherapy)； * child-pugh liver function rating within 7 days prior to the first dose of study drug: grade a or better grade b (≤ 7 points) ; * phase b or c as assessed by bclc; or phase iii as assessed by cnlc; * within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mrecist v1.1； * egfr postive and ras wildtype； exclusion criteria: * dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma； * history of hepatic encephalopathy within 6 months prior to the first dose of this study； * portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose； * symptomatic brain or meningeal metastases (unless patient is treated\> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable)
performance of microtextured dental implants

Conditions: Partially Edentulous Jaw

Summary: the study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar. the investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.

zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.

Eligibility criteria:
inclusion criteria: 1. be a current registered university of alabama at birmingham (uab)dental school patient 2. existence of one or more missing teeth scheduled to be replaced with dental implants 3. healthy enough to undergo proposed therapy without compromising existing health 4. able to consent for their own inclusion 5. able to read and understand the informed consent form 6. demonstrated willingness to comply with protocol requirements and timeline exclusion criteria: 1. any health condition that in the opinion of the investigators may adversely affect bone healing 2. any medication that in the opinion of the investigators may adversely affect bone healing 3. any indication of an inability to make autonomous decisions 4. reported pregnancy at the time of enrollment -

Keywords: dental implants screw-vent dental implants
connecting seniors to care

Conditions: Dementia

Summary: the purpose of this study is to assess the feasibility of implementing the virtual assistant devices into the daily routine of participants and their caregivers,to measure social determinants of health,depression,cognitive impairment,nutritional and functional status in the cognitively impaired participants


Eligibility criteria:
inclusion criteria: * cognitive impairment as reported in the mental health screening/assessment section on the interfaith ministries of greater houston's meals on wheels program (imgh mow) intake form * are on the imgh mow waiting list * medically stable exclusion criteria: * do not have cognitive impairment * have a pre-diagnosed terminal illness * unable to ambulate, and/or are unable to use their upper extremities.

Keywords: nutrition virtual assistant device frailty social determinants of health
cell-free circulating dna in primary cutaneous lymphomas

Conditions: Mycosis Fungoides; Lymphoma, Large B-cell, Diffuse

Summary: to evaluate the possibility of detecting cell-free circulating tumoral dna in potentially aggressive primary cutaneous lymphomas, the investigator opted to search a representative tumor sample mutation in the blood of these patients, by digital pcr. patients with mycosis fungoides, primary cutaneous t-cell lymphoma helper follicular phenotype and primary cutaneous diffuse large b-cell lymphoma, leg-type will be included and 4 blood samples will be collected during 12 months.

primary cutaneous lymphomas represent the second extra nodal localization of lymphomas, and are constituted by t-cell and b-cell phenotype lymphomas. mycosis fungoides, a t-cell epidermotropic lymphoma, is the most frequent. its clinical behavior is usually indolent but some patients have an aggressive evolution. among b-cell cutaneous lymphomas, primary cutaneous diffuse large b-cell lymphoma, leg type (pcdlbcl-lt) is the most aggressive. cytogenetic and molecular studies on these tumours led to a genetic characterization of these entities. therefore, there is not any biologic marker that can help monitoring these lymphomas. in solid tumors, mutations exhibited by the tumour tissue has been detected in plasma of patients, assessing the possibility to detect cell-free circulating tumoral dna in a blood sample, with correlations with clinical characteristics and metastatic outcome. the concept of liquid biopsies, allowing the detection of tumour mutation in plasma has been validated in nodal diffuse large b-cell lymphoma. that's why the purpose is to evaluate the possibility to detect cell-free circulating tumoral dna in primary cutaneous lymphomas, using a highly sensitive method (digital pcr), combined with a next generation sequencing panel of the tumour sample.

Eligibility criteria:
inclusion criteria: * age \> 18 years; * french social security system affiliation or equivalent; * patient with an aggressive cutaneous lymphoma (pcdlbcl-lt, mycosis fungoides, t helper follicular cutaneous lymphoma) diagnosed and monitored at the university hospital of bordeaux; * written and informed consent obtained for genetic blood test; * biopsy sample available for molecular analysis. exclusion criteria: * another cancer (except "in situ" and surgery treated cutaneous carcinomas) in the precedent 5 years.

Keywords: cell-free circulating dna; digital pcr liquid biopsy
measurement of serum microrna in acne vulgaris patient

Conditions: Acne Vulgaris

Summary: the aim of the study is to: 1. evaluation of serum microrna in acne vulgaris and compare to control group 2. evaluate correlation with acne vulgaris severity

acne vulgaris is a common chronic skin disease involving blockage and inflammation of pilosebaceous units. acne vulgaris is characterized by non-inflammatory, open or closed comedones and by inflammatory lesions include papules, pustules and nodules. affecting mostly the face but also the back and chest. acne vulgaris may have a psychological impact on any patient, regardless of the severity or the grade of the disease. prevalence of self-reported acne was 34.7%. females significantly reported acne more frequently than males (39.1% vs. 30.3%) prevalence of clinically confirmed acne was 24.4%, with higher rates among females (28.6%) than males (20.2%).(4) the pathogenesis result from increased sebum production (due to increased activity of androgens and (igf-1), excessive deposition of keratin in pilosebaceous follicles leading to comedo formation, colonization of the follicle by propionibacterium acnes bacteria, and the local release of pro-inflammatory chemicals in the skin through certain inflammatory mechanisms. recently, inflammation is a key feature in the pathogenesis of acne vulgaris , with various chemokines and cytokines that contribute to fuel a vicious cycle. in addition, genetics is also a key factor in the pathophysiology of acne. micrornas(mirnas) are a class of endogenous, short (19-23 nucleotides in length), which regulate the expression of genes via translational repression or degradation of target messenger rnas.recently, the role of mirnas has also been reviewed for the pathogenesis of various inflammatory skin conditions such as psoriasis, eczema, atopic dermatitis and toxic epidermal necrolysis. mirnas are present not only in the intracellular space, but also in extracellular spaces such as serum, urine, and saliva. this study is the first to evaluate microrna in serum of acne vulgaris patients.

Eligibility criteria:
inclusion criteria: * 1. healthy persons of both sexes with mild, moderate and severe acne vulgaris. * 2. patients with acne vulgaris not receiving any topical or systemic treatments for acne at least 6 months exclusion criteria: * 1. pregnant and lactating women * 2. patients with history of cardiovascular disorder, renal disease, malignancy, chronic liver disease * 3. patients with history of depression or mental illness * 4. diabetes type 2 * 5. obesity * 6. patient with history of melasma, psoriasis, eczema, atopic dermatitis and toxic epidermal necrolysis.
the possible influence of different follow-up modalities on overall survival in ovarian cancer

Conditions: Patient Reported Outcome Measures; Ovarian Neoplasms

Summary: the study is designed as an observational cohort study, aiming to evaluate, whether a structured recording of symptoms by a mobile app contributes insight in the follow-up modalities of ovarian cancer patients.

the observational study will examine different follow-up modalities for ovarian cancer patients with the ultimate goal of improving follow-up strategies for an improved well-being and better clinical outcomes. the primary objective is to quantify the effects of conservative clinical diagnostics by collecting symptoms via epro in addition to intensive diagnostics (ca-125 testing, imaging diagnostics) during follow-up, on survival, time to clinical recurrence and well-being.

Eligibility criteria:
inclusion criteria: * women aged ≥ 18 years * between diagnosis and the first follow-up visit after the end of their antineoplastic treatment (systemic therapy or surgical treatment) for ovarian cancer. * german, english, french, or italian speaking * personal smartphone (ios or android system); one of the latest three main versions exclusion criteria: • patients whose compliance must be questioned, e.g. due to a psychiatric disorder, private life situation or insufficient knowledge on smartphone use and do not have a suitable caregiver to assist them with symptom reporting.

Keywords: epro pro electronic patient reported outcome ovarian cancer
does a safety difference exist between iv push and iv piggyback antibiotics?

Conditions: Infection

Summary: this study compares whether or not a safety difference exists between delivering antibiotics via iv push or iv piggyback method.

this study compares whether or not a safety difference exists between delivering antibiotics via the iv push or iv piggyback method. it will be a single center, prospective, double-blinded, double-dummy, randomized controlled trial on a convenience sample of patients presenting to the ed receiving select beta-lactam antibiotics. patients will be randomized to iv push antibiotic plus iv piggyback placebo or iv push placebo plus iv piggyback antibiotic. patients will only be enrolled when a pharmacist who is familiar with the study is available to prepare medications. treatment group assignment will be predetermined using an excel random number generator. an investigator will conduct an informed consent with the patient. only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. if the patient consents to the study, a pharmacist involved in the study will prepare the iv push syringe and iv piggyback. the iv push syringe and iv piggyback will be prepared in a manner that makes the contents blinded. preparation of the iv push syringe and iv piggyback are standardized. the syringe and piggyback will be handed to the nurse for administration. the iv push antibiotic will be administered over 2-3 minutes and the iv piggyback antibiotic will be administered over 30 minutes. the iv push and iv piggyback will be administered at the same time. a research assistant will conduct surveys with the patient at the start of administration and every 15 minutes for a total of 90 minutes to observe for any adverse drug reactions. during the 90-minute observation period, other medications will be allowed to be administered to the patient. all medications received during this time period will be documented in the patient data sheet. if an adverse drug reaction occurs, the attending physician or medical resident caring for the patient will be notified to come evaluate the patient. adverse drug reaction severity will be determined by the attending physician or medical resident based on a predetermined scale. adverse drug reaction information will be collected to determine correlation of adverse drug reaction to drug administration. adverse drug reactions deemed as serious will be reported to the institutional review board (irb) within 5 days of the event.

Eligibility criteria:
inclusion criteria: * age 18 or older * patients who present to the adult ed in whom iv aztreonam, cefazolin, cefoxitin, ceftriaxone, cefepime, ertapenem, or meropenem is ordered by the treating physician exclusion criteria: * pregnant or breastfeeding * non-english speaking patient * attending provider excludes patient * unable to consent * prisoner * allergy to any beta-lactam antibiotic

Keywords: iv intravenous iv push piggyback antibiotics beta lactam infection
occlusal adjustment as treatment for chronic orofacial pain

Conditions: Temporomandibular Joint Disorders; Orofacial Pain

Summary: the purpose of this study is to determine whether occlusal adjustment by selective grinding and/or occlusal addition is an effective treatment of chronic temporomandibular joint disorders.

temporomandibular disorders (tmd) are very common disorders in daily dentistry and oral and maxillofacial practice. the key symptoms are jaw joint pain and limited mouth opening. other than trauma, the causes remain unknown; consequently, there are no treatments based on specific etiologies. in our experience, patients can usually receive beneficial occlusal adjustments if these are carefully planned and performed in two steps: (1) elimination of premature contacts, which reduces loads in the temporomandibular joints, and (2) individualized remodeling of lateral anterior guidance to facilitate unilateral alternate chewing. the study will use stratified blocking randomization to blindly assign patients to the real or placebo treatment groups in order to evaluate the null hypothesis (h0) that "occlusal adjustment of sufficient quality has no effect on chronic pain and/or limited mouth opening in tmd patients."

Eligibility criteria:
inclusion criteria: * people suitable for inclusion in the study are full dentate patients * aged between 18 and 65 years * patients with chronic tmd pain (and usually with associated limited mouth opening) for whom occlusal adjustment could achieve normal occlusion, both static and functionally equilibrated exclusion criteria: * pregnancy * trauma * previous tmj surgery * patient refusal to consent to participate in the study or significant concerns about the study * limited collaboration * concurrent active treatment with orthodontics, and active periodontal disease

Keywords: temporomandibular joint disorders (tmd) orofacial pain limited mouth opening craniomandibular dysfunction syndrome axiography gnatography preferred chewing side occlusal adjustment selective grinding handedness bruxism tmd costen's syndrome myofascial pain tmd treatment pain
assessing the value of a dosage of anti-cetuximab in the therapeutic management of patients with colon cancer or upper aero-digestive tract and candidates for treatment with cetuximab

Conditions: Colon Cancer; Head and Neck Cancer; Allergic Reaction

Summary: the main objective of this study is to validate the utility of ige anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of nci) and thus reduce the incidence of severe reactions.


Eligibility criteria:
inclusion criteria: * patient informed consent, * patient aged over 18 years * patients with a who performance status ≤ 2, * colon cancer or upper aero-digestive tract cytologically or histologically proven * patients with an indication to the theoretical use of cetuximab for colon neoplasia or upper aero-digestive tract, * haematological and biochemical compatible with combination therapy with cetuximab. exclusion criteria: * patients previously treated with cetuximab, * a person deprived of liberty or under supervision.

Keywords: cancer colon head and neck cetuximab anti-cetuximab dosage
endogenous pain facilitation and inhibition in postpartum women

Conditions: Pain Inhibition and Facilitation in Post Partum Women

Summary: this study seeks to further understand these three observations - (1) that the time period surrounding childbirth accelerates recovery from pain after injury (2) that this likely reflects dampened facilitating mechanisms and exaggerated inhibitory mechanisms, and (3) that stress may interfere with this protection. in this study the investigators will compare women within 2 weeks of delivery to age matched controls and anticipate that pain inhibition is increased after delivery, pain facilitation is decreased, and that there is a relationship between these pain responses and the degree of pre-existing stress.

nearly half of the world's population experiences labor and delivery processes which are associated with microscopic or gross tissue injury to the mother. since this experience is widespread and occurs relatively early in life, the psychosocial, medical, and financial consequences of chronic pain following childbirth could be enormous. surprisingly, previous studies with long term follow up of new mothers have included pain as a secondary measure and / or have focused on prevalence of pain without determining whether pain predated delivery or even pregnancy itself. the investigators recently performed a long term follow up study of over 1,200 women, and noted that pain which began during the childbirth itself was surprisingly rare in comparison to other physical injuries. additionally, two central factors hypothesized to confer risk of chronic pain after other injuries including surgery, pre-dating chronic pain and degree of tissue and nerve injury, contributed minimally to the acute and sub-acute pain after childbirth. these two observations, low incidence of chronic pain and minimal effect of degree of tissue injury and history of chronic pain on sub-acute pain, point towards a potential protective effect of pregnancy or delivery on the response to physical injury.

Eligibility criteria:
inclusion criteria: * female * 10-14 days postpartum, term vaginal delivery * breastfeeding (postpartum women) * health non-pregnant female (nulliparous or at least 1 year beyond delivery) exclusion criteria: * allergy to chili peppers * pregnant * pain medication (narcotic or non-narcotic) within 4 hours of study visit average pain in the 24 hours preceding the study visit \>3. postpartum women that score \>13 on the edinburgh postnatal depression scale

Keywords: pain facilitation inhibition oxytocin postpartum
intermittent negative pressure to improve blood flow in patients with peripheral artery disease: optimal pulse pressure regime

Conditions: Peripheral Artery Disease; Intermittent Claudication; Lower Extremity Claudication

Summary: recent studies have shown that applying intermittent negative pressure (inp) with short negative pressure (-40 mmhg) pulses to the lower extremities increase arterial blood flow velocity and skin blood flow. however, the optimal magnitude of negative pressure to improve blood flow is not known, and needs further investigation. peripheral arterial blood flow velocity, skin blood flow and skin temperature in the foot will be recorded at different levels of oscillating negative pressure to identify a pressure range which is practically, while at the same time induce clinically relevant changes in blood flow parameters. heart rate and blood pressure will be recorded to monitor the effects on the central circulation.

cross sectional study design. the equipment for physiological measurements will be attached to the patient, and the foot will then be placed in the pressure chamber. the device induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure. pressure levels of 0 mmhg, -10mmhg, -20 mmhg, -40 mmhg and -60 mmhg will be tested. patients will be recruited from the out-patient clinic at department of vascular surgery, oslo university hospital, aker. inclusion criteria: diagnosed peripheral artery disease (pad), ankle-brachial index \<0.9 outcome measures: arterial blood flow: ultrasound doppler from peripheral arteries in the foot. skin blood flow: laser doppler to measure acral skin blood perfusion. skin temperature systemic blood pressure: finger arterial pressure will continuously be acquired by a photoplethysmographic pressure recording device (finometer). ankle brachial index pressure recordings inside the pressure chamber: continuously monitoring of pressure within the pressure chamber using a digital differential manometer.

Eligibility criteria:
inclusion criteria: * diagnosed peripheral artery disease * ankle-brachial index \<0.9 exclusion criteria: * incapable to make an informed consent * diagnosis of severe psychiatric disease * severe heart disease such as unstable angina pectoris, severe heart failure (nyha iv), severe valve failure * systemic infection * use of vasoactive substances
food-effect, drug-drug interaction (ddi), and formulation bridging study

Conditions: Inflammatory Bowel Disease

Summary: this is a phase 1, open-label, 2-cohort, food-effect, ddi, and formulation bridging study.


Eligibility criteria:
inclusion criteria: * male or female between 18 to 55 years old * male subjects must abstain from sexual intercourse or use a highly effective method of birth control * women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control * body mass index (bmi) 18 to 32 kg/m2 * willing and able to give informed consent * additional inclusion criteria apply exclusion criteria: * planning to conceive a child during the study or within 2 months after the last dose of study drug * is positive for hepatitis a, b or c, and/or hiv * has clinically significant abnormalities in baseline laboratory evaluations * subject has a clinically significant abnormal electrocardiogram (ecg) * participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device) * additional exclusion criteria apply

Keywords: healthy volunteers drug-drug interaction itraconazole cyp3a p-gp inflammatory bowel disease ibd irritable bowel syndrome ibs