Kornimate/medical-research-clean huggingface dataset:
comparison of outcomes of multiple platforms for assisted robotic - prostate

Conditions: Prostate Cancer

Summary: the object of this exploratory clinical trial is to evaluate post-operative complications in a population that underwent robotic assisted radical prostatectomy (rarp) made with multiple platforms: * davinci; * hugo; * versius. the questions it aims to answer are: * does the estimation of the post-operative complications suggest something? * are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable? participants will be invited to fill out questionnaires and join one of these three groups: 1. surgery with the davinci platform; 2. surgery with the hugo platform; 3. surgery with the versius platform.


Eligibility criteria:
inclusion criteria: * age \> 18 and \< 90 years; * organ-localized prostate cancer with a surgical indication of radical prostatectomy; * informed consent provided. exclusion criteria: * age \ 90 years; * contraindication to radical prostatectomy procedure; * non-organ confined prostate cancer; * refusal to participate.

Keywords: robotic-assisted surgery prostatectomy multiple surgical platforms postoperative complications operative outcomes
a study to evaluate the effectiveness of voriconazole + micafungin versus voriconazole alone for invasive aspergillosis

Conditions: Aspergillosis/Blood; Aspergillosis/Invasive

Summary: to evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.


Eligibility criteria:
inclusion criteria: * proven, probable or possible invasive aspergillosis * patient is 2 years of age or older exclusion criteria: * the patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin b, or lipid formulation of amphotericin b) for \>7 days immediately prior to randomization for treatment of the possible, probable, or proven invasive aspergillosis for which the patient is being enrolled. * the patient has been treated with voriconazole for \> 7 days immediately prior to randomization

Keywords: aspergillosis/blood micafungin voriconazole aspergillus
implementation of cbt-i in cancer clinics

Conditions: Insomnia

Summary: insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. when untreated, which is the rule rather than the exception, insomnia often becomes chronic. chronic insomnia is associated with numerous negative consequences (e.g., increased risk for psychological disorders, health care costs). a large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (cbt-i) in cancer patients, but cbt-i is still not offered routinely in cancer clinics. self-administered cbt-i (e.g., video-based intervention) has been developed to increase patients' access to this treatment. however, results of clinical trials have suggested that these minimal treatments would be better used as a first step of a stepped care model. in stepped care, patients receive only the level of intervention they need. generally, the entry level is a minimal, less costly, intervention (e.g., self-help intervention) followed by a more intensive form of treatment if needed (if the patient is still symptomatic). the investigators have recently assessed the efficacy of a stepped care model to administer cbt-i in cancer patients, which includes a web-based cbt-i (called insomnet) followed by up to 3 sessions with a psychotherapist if the patient is still symptomatic. results of this study suggest that this model of care is non-inferior to a standard face-to-face treatment (savard, ivers, et al., in revision), while being more cost-effective. a stepped care cbt-i could therefore be offered in routine cancer care clinics. this project will assess the feasibility and effectiveness of implementing a stepped care cbt-i in real-world cancer clinics, using a non-randomized stepped wedge design to compare the effects of our program (active phase) with a passive phase. the program is called insomnia in patients with cancer - personalized treatment (impact). the stepped care cbt-i (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.


Eligibility criteria:
inclusion criteria: * have received a diagnosis of non-metastatic cancer (any type) * to be aged 18 years and older * to be readily able to read and understand french or english * having the minimum cognitive abilities to read, understand and memorize information * having access to internet exclusion criteria: * having a psychological comorbidity needing clinical attention (e.g., major depressive disorder) * having severe cognitive impairments (e.g., diagnosis of parkinson's disease, dementia) * having insomnia due to a temporary condition (e.g., acute pain, short-term medication side effects, environmental factors)

Keywords: insomnia cancer cognitive-behavioral therapy stepped care model self-administered treatment web-based intervention implementation cost-effectiveness
pharmacokinetics, efficacy, safety, and immunogenicity of sb5 versus humira in subjects with moderate to severe chronic plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this is a phase iv, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of sb5 versus humira in subjects with moderate to severe chronic plaque psoriasis.

the primary objective of this study is to assess the pharmacokinetic similarity in subjects with moderate to severe plaque psoriasis who switch between humira and sb5 to those receiving humira continuously. all entered subjects will be treated with humira during a lead-in period of 13 weeks. at week 13, subjects who achieved at least a 50% reduction in psoriasis area and severity index (pasi50) response will be randomized in a 1:1 ratio to either be switched between humira and sb5 or continue on humira.

Eligibility criteria:
inclusion criteria: * have no history of adalimumab and cell-depleting biologics * have no history of any other biologics use within 6 months prior to week 0 * have plaque psoriasis diagnosed at least 6 months, with or without psoriatic arthritis * have plaque psoriasis with the involvement and severity of total affected bsa ≥ 10%, pasi score of ≥ 12 and pga score of ≥ 3 (moderate) * considered to be a candidate for phototherapy or systemic therapy for psoriasis * adequate hematological, renal, and hepatic function by central lab * non-childbearing potential female, or childbearing potential female subjects or male subjects with their partners who agree to use at least two forms of appropriate contraception method from screening until 5 months after the last dose of ip exclusion criteria: * have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced psoriasis * have other skin disease than psoriasis that requires topical, phototherapy or systemic therapy * known allergic reactions or hypersensitivity to adalimumab or to any ingredients of sb5 or humira * have received phototherapy or conventional systemic therapy within 4 weeks prior to week 0 * have received topical therapy for psoriasis within 2 weeks prior to week 0, however class 6/7 corticosteroids are allowed on face and groin * women who are pregnant or nursing at screening, or men and women planning pregnancy during the study period and until 5 months after the last dose of ip * have received a live or live attenuated viral vaccine or a live bacterial vaccine within 8 weeks prior to week 0. non-live covid-19 vaccines are allowed * have active or latent tuberculosis * history of ongoing infection or a positive test of hbv, hcv, or hiv infection * history of sepsis, chronic or recurrent infection * history of lymphoproliferative disease or leukaemia * history of malignancy within the last 5 years

Keywords: psoriasis adalimumab
fluoroscopy versus ultrasound guidance for sacral lateral branch radiofrequency ablation

Conditions: Sacroiliac Joint Arthritis; Back Pain

Summary: sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly s1-3, with variable contributions from l5 dorsal ramus and s4 lateral branch). sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. with the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. to our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. this study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.


Eligibility criteria:
inclusion criteria: * low back pain due to sacroiliac joint dysfunction \>6 months with a score ≥ 4 on a numeric rating scale. * 50% pain relief after prognostic sacral lateral branch block * at least 3 positive physical examination maneuvers \[ faber ( flexioni abduction and external rotation), posh (posteripr shear), reab ( resisted abduction), gaenslen's test, distraction test\] * refractory to conservative therapy exclusion criteria: the exclusion criteria were; * uncontrolled psychiatric or neurological illness * sacroiliac joint pain due to other disorders, * lumbar radiculopathy * rheumatological diseases * systemic active infections * malignancies, previous surgery on the affected sacroiliac joint, * history of traumatic hip injury, * history of bleeding disorders, * platelet values \< 150.000 / µl, * sacroiliac joint injection within the preceding 3 months, * allergy to local anesthetics and steroids, * pregnancy, inability to concent, implanted pacemaker or defibrilator.
safety of acupuncture and intracutaneous needles in pediatric cancer patients: a retrospective study (acusafe2021)

Conditions: Cancer Pediatric; Neutropenia; Thrombocytopenia; Bacteremia; Infection;Skin;Localised; Safety Issues

Summary: this study aims to demonstrate the safety of intracutaneous needles in pediatric cancer patients. for this, a two-year retrospective study will be carried out to determine the incidence of adverse effects related to acupuncture and the use of intracutaneous needles in the patient in active treatment and survivor.

retrospective study of review of medical records. it is a single-center, descriptive, observational study. there are no comparison or control groups. no type of patient selection (randomization or blinding) will be performed. the medical records of patients treated at the integrative pediatric oncology unit from september 2019 to september 2021 who have received acupuncture treatment (disposable intracutaneous needles) will be reviewed. the number of treatments applied, the localization of the treatment, the average number of sessions per patient, and the total number of intracutaneous needles and punctured needles from september 2019 to september 2021. likewise, the blood cultures and other adverse effects will be reviewed up to 72 hours after the removal of the needles and the intracutaneous needles (seirin new pyonex press tack®).

Eligibility criteria:
inclusion criteria: * pediatric oncology patients from september 2019 to september 2021 who have received treatment with acupuncture. * pediatric oncology patients from september 2019 to september 2021 who have received treatment with intracutaneous needles (pyonex). exclusion criteria: * pediatric oncology patients who have not received treatment with acupuncture or intracutaneous needles.

Keywords: acupuncture intracutaneous needle cancer children neutropenia thrombocytopenia infection safety bacteremia
metabolic effects of a diet replaced with essential amino acids

Conditions: Obesity Morbid; Weight Loss

Summary: the effectiveness of low-protein diets supplemented with essential aminoacid (eaa) formulas in genetic disorders of amino acid (aa) catabolism, such as maple syrup urine disease (msud), is widely recognized (blackburn pr et al. 2017). the main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - eaa-ac). for this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in piancavallo. the enrolled patients divided, randomly, into two groups will be given: eaa-ac group a low-calorie and low-protein diet integrated with 4 sachets of eaa-ac supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. the parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (hand grip, 6mwt or tug) but also through the analysis of mitochondrial function in pbmc and circulating levels of mtdna; the improvement of the glucose picture and the lipid profile. 1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing.


Eligibility criteria:
inclusion criteria: - obesity (bmi \>35kg/m2) exclusion criteria: * type 2 diabetes mellitus * renal failure * heart failure (new york heart association nyha, class iv) * liver cirrhosis * neoplasms * muscular or non-autonomic pathologies * neurological-neurodegenerative pathologies * cognitive decline * non-menopausal women. * patients who have undergone bariatric surgery in the previous 12 months * patients on pharmacological treatment for weight loss in the last three weeks * patients using vitamin and amino acid supplements in the last three weeks * patients on hormone therapy (e.g. l-thyroxine, testosterone).

Keywords: muscle mass during weight loss
zanubrutinib and lenalidomide as maintenance therapy in dlbcl

Conditions: Diffuse Large B-cell Lymphoma

Summary: the goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with dlbcl.

the investigators will evaluate safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with diffuse large b-cell lymphoma post complete remission and have completed planed courses of chemotherapy . event-free survival (efs), progression-free survival (pfs), overall survival (os), adverse events (aes) will be assessed.

Eligibility criteria:
inclusion criteria: * pathologically confirmed diffuse large b cell lymphoma according world health organization (who) classification; * patient is ≥ 18 years of age at the time of signing the informed consent form (icf). * patient must understand and voluntarily sign an icf prior to any study-specific assessments/procedures being conducted; * patient is willing and able to adhere to the study visit schedule and other protocol requirements; * patient has recieved complete remission and has completed planed courses of chemotherapy * meet the following lab criteria: absolute neutrophil count (anc) ≥ 1,5 x 10\^9/l (≥ 1 x 10\^9/l if bone marrow (bm) involvement by lymphoma)；platelet ≥ 75 x 10\^9/l (≥ 50 x 10\^9/l if bm involvement by lymphoma)； hemoglobin ≥ 8 g/dl. anticipated life expectancy at least 3 months exclusion criteria: * active or uncontrolled infections requiring systemic treatment within 14 days before enrollment; * any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy; * pregnant or lactating women
study to evaluate the efficacy and safety of oral difelikefalin for moderate to severe pruritus in subjects with notalgia paresthetica

Conditions: Pruritus; Notalgia Paresthetica

Summary: this is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (bid) oral difelikefalin for moderate-to-severe pruritus in adult subjects with np.

part a of this study will evaluate the benefit-risk of 3 doses of difelikefalin compared to placebo. the dose with the best benefit-risk profile will be further evaluated in part b. part a of this study comprises a 28-day screening period, a 7-day run-in period, an 8-week double-blind treatment period, a 2-week treatment discontinuation period, and a safety follow-up visit (14 days after the last dose of study treatment). part b of this study will evaluate the efficacy, safety, and tolerability of oral difelikefalin. the dose of oral difelikefalin to be assessed in part b will depend on the results of part a. part b of this study comprises a 28-day screening period, a 7-day run-in period, an 8-week double-blind treatment period, up to a 52-week ole period, and a safety follow-up visit. subjects who participated in part a of the study may not participate in part b. all subjects will sign an informed consent form (icf) and undergo screening for study eligibility.

Eligibility criteria:
key inclusion criteria: to be eligible for inclusion into the study, a patient must meet the following criteria: * subject has clinically confirmed diagnosis of active notalgia paresthetica; * subject has a history of chronic pruritus due to notalgia paresthetica; * subject has moderate to severe pruritus; * female subject is not pregnant or nursing during any period of the study. key exclusion criteria: a patient will be excluded from the study if any of the following criteria are met: * subject has pruritus attributed to a cause other than notalgia paresthetica; * subject has any clinically significant medical condition or physical/laboratory/ecg/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.

Keywords: notalgia paresthetica pruritus cr845 chronic itch difelikefalin itch itching generalized pruritus np neuropathic itch
endothelial cell loss after penetrating keratoplasty

Conditions: Keratoconus

Summary: this work aimed at the assessment of corneal endothelial cell loss after toric icl implantation for correction of myopia and astigmatism after penetrating keratoplasty.

penetrating keratoplasty (pkp) is considered a safe and effective procedure.this work aimed at the assessment of corneal endothelial cell loss after toric icl implantation for correction of myopia and astigmatism after penetrating keratoplasty.

Eligibility criteria:
inclusion criteria: * pkp for keratoconus, and then toric icl was implanted after minimum of one year with stable refraction exclusion criteria: * less than 18 and unable to give informed consent
a study of hgs1036 in combination with chemotherapy in subjects with advanced solid malignancies

Conditions: Cancer

Summary: the primary purpose of this study is to determine the maximally tolerated dose (mtd) of hgs1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, or docetaxel.

this study will consist of 3 regimens each containing 2 dose levels of hgs1036 and full dose chemotherapy. patients will be treated in sequence with hgs1036 at planned dose levels of 10 mg/kg and 20 mg/kg. patients who demonstrate stable disease or better may continue to receive hgs1036 until progressive disease, unacceptable toxicity, patient requests discontinuation of study treatment, or the investigator feels further treatment is not in the patient's best interest. after discontinuation of hgs1036, subjects will be followed for 30 days after the last dose of hgs1036 for safety. the end of study will be defined as 1 year after the last subject begins treatment of hgs1036. any subject still receiving hgs1036 at this pre-defined end of study, may continue to receive hgs1036, but the only study assessments required will be for safety.

Eligibility criteria:
inclusion criteria: * have a histological or cytological diagnosis of malignant solid neoplasm requiring systemic chemotherapy. * age ≥18 years. * ecog performance status 0-1. * adequate organ function. * adequate hematological function. * have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures. * consent to collection of previously obtained, archival biopsy or surgical specimens of the currently treated malignancy when available. exclusion criteria: * significant cardiac disease. * eye trauma or disease. * ocular surgery or blunt force trauma to the eye requiring treatment within 3 months prior to first dose of hgs1036. * presence or history of ≥ grade 2 hemoptysis within 2 weeks of the first dose of hgs1036. * major surgery within 4 weeks of the first dose of hgs1036. * prior organ or allogeneic stem cell transplant. * non-healing or chronic wounds. * receipt of any anti-cancer therapy within 4 weeks prior to first dose of hgs1036. * receipt of any biological therapy (such as monoclonal antibodies) within 6 weeks of the first dose of hgs1036. * active cns involvement by primary or metastatic tumor. * documented active infection requiring the use of systemic antibiotics. * pregnancy or lactation. * known hiv-positive serology, aids, or an aids-related illness. * conditions likely to increase the potential for abdominal perforation or fistula formation.

Keywords: solid tumors cancer lung cancer prostate cancer mesothelioma small cell lung cancer
benefits of the hiresolutiontm bionic ear system in adults with low-frequency hearing

Conditions: Severe-to-profound Hearing Loss

Summary: the goal of this investigation is to generate the needed pmcf data for the hifocus mid-scala electrode. as a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing implanted with the hifocus mid-scala electrode. the hifocus mid-scala electrode array is designed to allow surgeons the flexibility to use a variety of contemporary surgical techniques that have been shown to enable easy insertion and to minimize cochlear trauma (see, e.g., adunka and buchman, 2007; friedland and runge-samuelson, 2009; roland et al., 2007). temporal bone experiments have shown the hifocus mid-scala electrode array to be straightforward to insert while causing minimal trauma to cochlear structures during and after surgery (lenarz et al., 2010). in addition , the hifocus mid-scala has already shown to be a safe electrode and promising post op clinical results in the premarketing study that is now in the final stage.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * definite postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education. * local language proficiency * bilateral, sensorineural hearing loss exclusion criteria: * previous inner ear surgery or active middle ear pathology. * cochlear malformation or obstruction * presence of additional disabilities that would prevent or interfere with participation in the required study procedures * medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures * evidence of central auditory lesion or compromised auditory nerve * concurrent participation in other study